TITLE 21—FOOD AND DRUGS

        

CHAPTER 1—ADULTERATED OR MISBRANDED FOODS OR DRUGS

SUBCHAPTER I—FEDERAL FOOD AND DRUGS ACT OF 1906

        

SUBCHAPTER II—MISCELLANEOUS PROVISIONS

        

SUBCHAPTER I—FEDERAL FOOD AND DRUGS ACT OF 1906

§§1 to 5. Repealed. June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784

Section 1, act June 30, 1906, ch. 3915, §1, 34 Stat. 768, made it unlawful to manufacture adulterated or misbranded foods or drugs in Territories or District of Columbia and provided penalty for violations. See sections 331 and 333 of this title.

Section 2, act June 30, 1906, ch. 3915, §2, 34 Stat. 768, prohibited introduction, shipment, delivery or sale of adulterated or misbranded foods or drugs in interstate or foreign commerce, provided penalty for violations and exempted exports conforming to specifications of foreign purchaser and not in conflict with laws of foreign country importing the same. See sections 331, 333 and 381 of this title.

Section 3, acts June 30, 1906, ch. 3915, §3, 34 Stat. 768; Mar. 4, 1913, ch. 141, §1, 37 Stat. 736, authorized Secretaries of the Treasury, Agriculture, and Commerce to make uniform rules and regulations for enforcement of food and drug laws, including collection and examination of specimens. See section 371 of this title.

Section 4, act June 30, 1906, ch. 3915, §12, 34 Stat. 772, provided that act or omission of officer, agent, and so forth, of corporation, shall be deemed act or omission of corporation.

Section 5, act June 30, 1906, ch. 3915, §12, 34 Stat. 772, defined "territory" and "person". See section 321 of this title and section 1 of Title 1, General Provisions.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, which repealed sections 1 to 5, 7 to 14, and 15 of this title, provided that the repeal of those sections should take effect upon the effective date of act June 25, 1938, which was to take effect twelve months after the date of its enactment. Act June 23, 1939, ch. 242, §2(b), 53 Stat. 854, provided that: "The provisions of such act of June 30, 1906, as amended, to the extent that they impose, or authorize the imposition of, any requirement imposed by section 403(k) of the Federal Food, Drug, and Cosmetic Act [section 343(k) of this title], shall remain in force until January 1, 1940."

§6. Transferred

Editorial Notes

Codification

Section, act Mar. 4, 1923, ch. 268, 42 Stat. 1500, was transferred to section 321a of this title.

§§7 to 14. Repealed. June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784

Section 7, act June 30, 1906, ch. 3915, §6, 34 Stat. 769, defined "drug" and "food". See section 321 of this title.

Section 8, act June 30, 1906, ch. 3915, §7, 34 Stat. 769, deemed drugs to be adulterated when sold having a difference from recognized standards, except where there is an explanatory statement on or in container, and when sold below professed standard; confectioneries, when containing mineral substances, poisonous color or flavors, other deleterious ingredients, liquors or narcotics; food, when concerned with injurious mixtures, use of substitutes, abstraction of valuable constituents, concealment of damage or inferiority, deleterious ingredients, preservatives in shipment conditionally excepted, animal or vegetable substances unfit for food and products of animals diseased or having died otherwise than by slaughter. See sections 342 and 351 of this title.

Section 9, act June 30, 1906, ch. 3915, §8, 34 Stat. 771, defined "misbranded" and provided for its application to drugs and food. See sections 343 and 352 of this title.

Section 10, acts June 30, 1906, ch. 3915, §8, 34 Stat. 771; Aug. 23, 1912, ch. 352, 37 Stat. 416; Mar. 3, 1913, ch. 117, 37 Stat. 732; July 24, 1919, ch. 26, 41 Stat. 271; July 8, 1930, ch. 874, 46 Stat. 1019, deemed drugs to be misbranded when there is an imitation or use of name of other article, when there is removal and substitution of contents of package or failure to state on label quantity or proportion of narcotics therein, and when there is a false statement of curative or therapeutic effect; and food, when there is an imitation or use of name of other article, when there is a false label or brand removal and substitution of contents of package, or failure to state or label quantity or proportion of narcotics therein, when the packages are not marked with weight, with certain variations and exemptions permitted, when there are false or misleading statements on package or label as to ingredients or substances; and food, when mixtures or compounds under distinctive names, the articles are labeled, branded as compounds, imitations, or blends; construed the term "blend" and related to disclosure of trade formulas of proprietary foods, and canned food. See sections 321b, 341, 343 and 352 of this title.

Section 11, acts June 30, 1906, ch. 3915, §4, 34 Stat. 769; Jan. 18, 1927, ch. 39, 44 Stat. 1003, provided for examination of specimens, notice of adulteration or misbranding, hearing, certification of violations to United States district attorney and notice of judgment.

Section 12, act June 30, 1906, ch. 3915, §5, 34 Stat. 769, provided for prosecution by district attorneys for enforcement of penalties.

Section 13, act June 30, 1906, ch. 3915, §9, 34 Stat. 771, provided for a seller's guaranty as protection to dealer. See section 333 of this title.

Section 14, act June 30, 1906, ch. 3915, §10, 34 Stat. 771, provided for seizure of articles by libel for condemnation, at suit of and in name of United States, in United States district court where found, conforming to proceedings in admiralty, with right to trial by jury, destruction or sale of adulterated or misbranded articles, bond and payment of proceeds into Treasury of United States. See sections 332, 334 and 337 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

For effective date of repeal, see section 1002(a) of act June 25, 1938, set out as a note under sections 1 to 5 of this title.

§14a. Transferred

Editorial Notes

Codification

Section, act June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712, 48 Stat. 1204, and amended, which related to examination of sea food on request of packer, marking of food with results, fees, and penalties, was successively renumbered section 702A and then 706 of the Federal Food, Drug, and Cosmetic Act by act July 12, 1943, ch. 221, title II, §201, 57 Stat. 500, and by Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498, and was successively classified to section 372a and then 376 of this title.

§15. Repealed. June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784

Section, act June 30, 1906, ch. 3915, §11, 34 Stat. 772, provided for examination of samples of imports, refusal of admission and delivery to consignee, delivery to consignee pending examination and decision on bond and charges for storage and lien therefor. See section 381 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

For effective date of repeal, see section 1002(a) of act June 25, 1938, set out as a note under sections 1 to 5 of this title.

SUBCHAPTER II—MISCELLANEOUS PROVISIONS

§16. Introduction into, or sale in, State or Territory or District of Columbia of dairy or food products falsely labeled or branded

No person or persons, company or corporation, shall introduce into any State or Territory of the United States or the District of Columbia from any other State or Territory of the United States or the District of Columbia, or sell in the District of Columbia or in any Territory any dairy or food products which shall be falsely labeled or branded as to the State or Territory in which they are made, produced, or grown, or cause or procure the same to be done by others.

(July 1, 1902, ch. 1357, §1, 32 Stat. 632.)

§17. Penalty for sale or introduction of falsely labeled dairy or food products; venue

If any person or persons violate the provisions of section 16 of this title, either in person or through another, he shall be guilty of a misdemeanor and shall be punished by a fine of not less than $500 nor more than $2,000. The jurisdiction for the prosecution of said misdemeanor shall be within the district of the United States court in which it is committed.

(July 1, 1902, ch. 1357, §2, 32 Stat. 632.)

§18. Suspension of importation of adulterated articles

Whenever the President is satisfied that there is good reason to believe that any importation is being made, or is about to be made, into the United States, from any foreign country, of any article used for human food or drink that is adulterated to an extent dangerous to the health or welfare of the people of the United States, or any of them, he may issue his proclamation suspending the importation of such articles from such country for such period of time as he may think necessary to prevent such importation; and during such period it shall be unlawful to import into the United States from the countries designated in the proclamation of the President any of the articles the importation of which is so suspended.

(Aug. 30, 1890, ch. 839, §4, 26 Stat. 415.)

§19. Repealed. May 29, 1928, ch. 901, §1(100), 45 Stat. 993

Section, act May 23, 1908, ch. 192, 35 Stat. 261, related to report to Congress of expenditures in enforcing food and drug laws.

§20. Apples in interstate commerce; standard grades

The standard grades for apples when packed in barrels which shall be shipped or delivered for shipment in interstate or foreign commerce, or which shall be sold or offered for sale within the District of Columbia or the Territories of the United States shall be as follows: Apples of one variety, which are well-grown specimens, hand picked, of good color for the variety, normal shape, practically free from insect and fungous injury, bruises, and other defects, except such as are necessarily caused in the operation of packing, or apples of one variety which are not more than 10 per centum below the foregoing specifications shall be "Standard grade minimum size two and one-half inches", if the minimum size of the apples is two and one-half inches in transverse diameter; "Standard grade minimum size two and one-fourth inches", if the minimum size of the apples is two and one-fourth inches in transverse diameter; or "Standard grade minimum size two inches", if the minimum size of the apples is two inches in transverse diameter.

(Aug. 3, 1912, ch. 273, §2, 37 Stat. 250.)

§21. Branding grades on barrels of apples

The barrels in which apples are packed in accordance with the provisions of sections 20 to 23 of this title may be branded in accordance with the provisions of section 20 of this title.

(Aug. 3, 1912, ch. 273, §3, 37 Stat. 251.)

§22. Barrels misbranded

Barrels packed with apples shall be deemed to be misbranded within the meaning of sections 20 to 23 of this title—

First. If the barrel bears any statement, design, or device indicating that the apples contained therein are "Standard" grade and the apples when packed do not conform to the requirements prescribed by section 20 of this title.

Second. If the barrel bears any statement, design, or device indicating that the apples contained therein are "Standard" grade and the barrel fails to bear also a statement of the name of the variety, the name of the locality where grown, and the name of the packer or the person by whose authority the apples were packed and the barrel marked.

(Aug. 3, 1912, ch. 273, §5, 37 Stat. 251.)

§23. Penalties

Any person, firm or corporation, or association who shall knowingly pack or cause to be packed apples in barrels or who shall knowingly sell or offer for sale such barrels in violation of the provisions of sections 20 to 23 of this title shall be liable to a penalty of $1 and costs for each such barrel so sold or offered for sale, to be recovered at the suit of the United States in any court of the United States having jurisdiction.

(Aug. 3, 1912, ch. 273, §6, 37 Stat. 251.)

Editorial Notes

Codification

Section is also set out as section 233 of Title 15, Commerce and Trade.

§24. Omitted

Editorial Notes

Codification

Section, act Mar. 4, 1915, ch. 144, 38 Stat. 1102, related to payment of the cost of inspection under a provision authorizing the investigation of the character of chemical and physical tests applied to American food products in foreign countries and the inspection of such products before shipment to such countries at the request of the shippers or owners. That provision was repeated in subsequent appropriation acts but was omitted from the appropriation act of July 12, 1943, ch. 221, 57 Stat. 494, and from all subsequent appropriation acts.

§25. Oleomargarine, butterine, or imitation butter or cheese transported into a State subject to its police powers

All articles known as oleomargarine, butterine, imitation, process, renovated, or adulterated butter, or imitation cheese, or any substance in the semblance of butter or cheese not the usual product of the dairy and not made exclusively of pure and unadulterated milk or cream, transported into any State or Territory or the District of Columbia, and remaining therein for use, consumption, sale, or storage therein, shall, upon the arrival within the limits of such State or Territory or the District of Columbia, be subject to the operation and effect of the laws of such State or Territory or the District of Columbia, enacted in the exercise of its police powers to the same extent and in the same manner as though such articles or substances had been produced in such State or Territory or the District of Columbia, and shall not be exempt therefrom by reason of being introduced therein in original packages or otherwise.

(May 9, 1902, ch. 784, §1, 32 Stat. 193.)

§26. Omitted

Editorial Notes

Codification

Section, which was from the appropriation acts of Jan. 18, 1927, ch. 39, 44 Stat. 984; May 16, 1928, ch. 572, 45 Stat. 548; Feb. 16, 1929, ch. 227, 45 Stat. 1198; May 27, 1930, ch. 341, 46 Stat. 424, and subsequent Department of Agriculture Appropriation Acts to and including act June 28, 1944, ch. 296, §4, 58 Stat. 461, and related to inspection of food and other products, is covered by section 2256 of Title 7, Agriculture.

CHAPTER 2—TEAS

§§41 to 50. Repealed. Pub. L. 104–128, §2, Apr. 9, 1996, 110 Stat. 1198

Section 41, acts Mar. 2, 1897, ch. 358, §1, 29 Stat. 604; May 16, 1908, ch. 170, 35 Stat. 163; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; May 24, 1962, Pub. L. 87–456, title III, §303(a), 76 Stat. 77; Aug. 23, 1988, Pub. L. 100–418, title I, §1214(l), 102 Stat. 1158, prohibited unlawful importation of substandard tea.

Section 42, acts Mar. 2, 1897, ch. 358, §2, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, related to establishment and composition of board of experts in teas.

Section 43, acts Mar. 2, 1897, ch. 358, §3, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, authorized establishment of purity standards.

Section 44, acts Mar. 2, 1897, ch. 358, §4, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, related to bonds of importers, examination of imported teas, and importation at ports without examiners.

Section 45, act Mar. 2, 1897, ch. 358, §5, 29 Stat. 605, related to delivery permits and reexamination and retention of substandard teas.

Section 46, acts Mar. 2, 1897, ch. 358, §7, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, 713, related to examiners and examination according to usages of trade.

Section 46a, acts Mar. 2, 1897, ch. 358, §13, formerly act July 1, 1941, ch. 269, title II, 55 Stat. 478; renumbered §13 of act Mar. 2, 1897, and amended Aug. 10, 1993, Pub. L. 103–66, title IV, §4401, 107 Stat. 378, related to deposit of fee prior to examination.

Section 47, acts Mar. 2, 1897, ch. 358, §6, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, 713; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, required referral of disputes to United States Board of Tea Appeals and authorized board to permit delivery or order destruction or exportation of substandard teas.

Section 48, acts Mar. 2, 1897, ch. 358, §8, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, related to reexaminations, including findings by examiner and assistance of experts.

Section 49, acts Mar. 2, 1897, ch. 358, §9, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, related to reimporting rejected teas and forfeitures for violation of provisions.

Section 50, acts Mar. 2, 1897, ch. 358, §10, 29 Stat. 607; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, authorized issuance of regulations.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Pub. L. 104–128, §3, Apr. 9, 1996, 110 Stat. 1198, provided that: "This Act [repealing this chapter] shall take effect on the date of enactment of this Act [Apr. 9, 1996]."

Short Title of Repeal

Pub. L. 104–128, §1, Apr. 9, 1996, 110 Stat. 1198, provided that: "This Act [repealing this chapter] may be cited as the 'Federal Tea Tasters Repeal Act of 1996'."

Short Title

Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in part that act Mar. 2, 1897, which was classified generally to this chapter, could be cited as the Tea Importation Act.

CHAPTER 3—FILLED MILK

        

Statutory Notes and Related Subsidiaries

Federal Food, Drug, and Cosmetic Act

Nothing contained in chapter 9 (§301 et seq.) of this title shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of sections 61 to 64 of this title, see section 392(b) of this title.

Bureau of Dairy Industry

General provisions, see sections 401 to 404 of Title 7, Agriculture.

§61. Definitions

Whenever used in this chapter—

(a) The term "person" includes an individual, partnership, corporation, or association;

(b) The term "interstate or foreign commerce" means commerce (1) between any State, Territory, or possession, or the District of Columbia, and any place outside thereof; (2) between points within the same State, Territory, or possession, or within the District of Columbia, but through any place outside thereof; or (3) within any Territory or possession, or within the District of Columbia; and

(c) The term "filled milk" means any milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated, to which has been added, or which has been blended or compounded with, any fat or oil other than milk fat, so that the resulting product is in imitation or semblance of milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated. This definition shall not include any distinctive proprietary food compound not readily mistaken in taste for milk or cream or for evaporated, condensed, or powdered milk, or cream where such compound (1) is prepared and designed for feeding infants and young children and customarily used on the order of a physician; (2) is packed in individual cans containing not more than sixteen and one-half ounces and bearing a label in bold type that the content is to be used only for said purpose; (3) is shipped in interstate or foreign commerce exclusively to physicians, wholesale and retail druggists, orphan asylums, child-welfare associations, hospitals, and similar institutions and generally disposed of by them.

(Mar. 4, 1923, ch. 262, §1, 42 Stat. 1486.)

Statutory Notes and Related Subsidiaries

Short Title

Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in part that act Mar. 4, 1923, which enacted this chapter, may be cited as the "Filled Milk Act".

§62. Manufacture, shipment, or delivery for shipment in interstate or foreign commerce prohibited

It is declared that filled milk, as defined in section 61 of this title, is an adulterated article of food, injurious to the public health, and its sale constitutes a fraud upon the public. It shall be unlawful for any person to manufacture within any Territory or possession, or within the District of Columbia, or to ship or deliver for shipment in interstate or foreign commerce, any filled milk.

(Mar. 4, 1923, ch. 262, §2, 42 Stat. 1487.)

§63. Penalties; acts of agents deemed acts of principals

Any person violating any provision of this chapter shall upon conviction thereof be subject to a fine of not more than $1,000 or imprisonment of not more than one year, or both. When construing and enforcing the provisions of this chapter, the act, omission, or failure of any person acting for or employed by any individual, partnership, corporation, or association, within the scope of his employment or office, shall in every case be deemed the act, omission, or failure, of such individual, partnership, corporation, or association, as well as of such person.

(Mar. 4, 1923, ch. 262, §3, 42 Stat. 1487.)

Editorial Notes

Codification

The original text of this section contained a further provision that no penalty should be enforced for any violation occurring within 30 days after act Mar. 4, 1923 became law and was omitted as temporary and obsolete.

§64. Regulations for enforcement

The Secretary of Health and Human Services is authorized and directed to make and enforce such regulations as may in his judgment be necessary to carry out the purposes of this chapter.

(Mar. 4, 1923, ch. 262, §4, as added Aug. 27, 1935, ch. 743, 49 Stat. 885; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.

CHAPTER 4—ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS

SUBCHAPTER I—EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS

        

SUBCHAPTER II—IMPORTATION OF CATTLE AND QUARANTINE

        

SUBCHAPTER III—PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

        

SUBCHAPTER IV—IMPORTATION OF MILK AND CREAM

        

SUBCHAPTER I—EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS

§§71 to 92. Transferred

Editorial Notes

Codification

Section 71, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which related to inspection of meat and meat food products, examination of cattle before slaughtering, separate slaughtering of diseased animals and examination of carcasses, was transferred to section 603 of this title.

Section 72, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which related to post mortem examination of carcasses, marking and labeling, destruction of condemned carcasses, and reinspection, was transferred to section 604 of this title.

Section 73, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which related to examination of carcasses brought into slaughtering or packing establishments and of meat food products issued from and returned thereto, was transferred to section 605 of this title.

Section 74, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which related to examination and inspection of meat food products, marks of inspection, destruction of condemned products, and products for export, was transferred to section 606 of this title and was subsequently repealed by Pub. L. 110–234, title XI, §11016(b)(1)(B), May 22, 2008, 122 Stat. 1369, and Pub. L. 110–246, §4(a), title XI, §11016(b)(1)(B), June 18, 2008, 122 Stat. 1664, 2131.

Section 75, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which related to labeling of receptacles and coverings of meat and meat food products inspected and passed, supervision by inspectors, prohibition of sales under false names, was transferred to section 607 of this title.

Section 76, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which related to sanitary inspection and regulation of slaughtering and packing establishments, and rejection of meat or meat food products unfit for food, was transferred to section 608 of this title.

Section 77, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which related to examination of cattle and food products thereof slaughtered and prepared during night time, was transferred to section 609 of this title.

Section 78, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which related to prohibition of transportation of carcasses, meat, or meat food products not properly inspected and marked, was transferred to section 610 of this title.

Section 79, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to forgery, alteration, and unauthorized use of marks, labels, and certificates, was transferred to section 611 of this title.

Section 80, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to inspection of animals for export, was transferred to section 612 of this title and was subsequently repealed by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508.

Section 81, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to certificates of condition of animals for export, was transferred to section 613 of this title and was subsequently repealed by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508.

Section 82, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to clearance to vessels carrying cattle for export with proper certificate of inspection, was transferred to section 614 of this title and was subsequently repealed by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508.

Section 83, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to inspection of carcasses, the meat of which is intended for export, was transferred to section 615 of this title.

Section 84, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to certificates of condition of carcasses, the meat of which is intended for export, was transferred to section 616 of this title.

Section 85, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to clearance to vessels carrying meat for export with proper certificate of inspection, was transferred to section 617 of this title.

Section 86, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to official certificates of inspection and delivery of copies thereof to different parties, was transferred to section 618 of this title.

Section 87, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which related to prohibition of transportation or sale of meat or meat food products without complying with provisions of inspection law, was transferred to section 619 of this title.

Section 88, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which related to offenses and penalties, was transferred to section 620 of this title.

Section 89, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which related to appointment of inspectors, their duties, and rule making authority of the Secretary of Agriculture, was transferred to section 621 of this title.

Section 90, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which related to penalties for bribery, was transferred to section 622 of this title.

Section 91, acts Mar. 4, 1907, ch. 2907, 34 Stat. 1265; June 29, 1938, ch. 810, 52 Stat. 1235, which related to definitions, exceptions to inspection requirements in case of farmers and retailers, and penalties for sale of meat and meat food products unfit for food, was transferred to section 623 of this title.

Section 92, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, which was a proviso following the first sentence of section 91 of this title, was restored to that section and has been transferred to section 623 of this title.

§93. Repealed. May 29, 1928, ch. 901, §1(92), 45 Stat. 993

Section, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, related to statement in annual estimates as to persons employed, their compensation and expenses.

§§94 to 95. Transferred

Editorial Notes

Codification

Section 94, act June 30, 1914, ch. 131, 38 Stat. 420, which related to inspection of reindeer, was transferred to section 692 of this title.

Section 94a, act May 23, 1908, ch. 192, 35 Stat. 254, which related to inspection of dairy products for export, was transferred to section 693 of this title.

Section 95, acts June 30, 1906, ch. 3913, 34 Stat. 679; June 26, 1934, ch. 756, §2, 48 Stat. 1225, which related to authorization of appropriations for expenses of inspection, was transferred to section 694 of this title.

§96. Repealed. Pub. L. 90–201, §18, Dec. 15, 1967, 81 Stat. 600

Section, act July 24, 1919, ch. 26, 41 Stat. 241, provided for marking horse meat transported in interstate commerce. See section 619 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§§97 to 97d. Omitted

Editorial Notes

Codification

Sections 97 to 97d, act July 30, 1947, ch. 356, title I, §1, 61 Stat. 531, 532, set up a meat inspection fund and provided for payment for meat inspection service by the persons or organizations who were furnished such inspection on and after July 1, 1947. These provisions ceased to be effective on July 1, 1948, under section 98 of this title which requires the cost of such inspection to be borne by the United States. The unobligated balance in the meat inspection fund was carried to the general fund of the Treasury by act June 19, 1948, ch. 543, §1, 62 Stat. 515.

§98. Transferred

Editorial Notes

Codification

Section, act June 5, 1948, ch. 423, 62 Stat. 344, which related to payment of cost of meat inspection, was transferred to section 695 of this title.

§99. Repealed. July 28, 1953, ch. 251, title I, §101, 67 Stat. 208

Section, act Aug. 31, 1951, ch. 374, title I, §101, 65 Stat. 229, related to reimbursement for excess expenses of meat inspection.

SUBCHAPTER II—IMPORTATION OF CATTLE AND QUARANTINE

§101. Suspension of importation of all animals

Whenever, in the opinion of the President, it shall be necessary for the protection of animals in the United States against infectious or contagious diseases, he may, by proclamation, suspend the importation of all or any class of animals for a limited time, and may change, modify, revoke, or renew such proclamation, as the public good may require; and during the time of such suspension the importation of any such animals shall be unlawful.

(Aug. 30, 1890, ch. 839, §9, 26 Stat. 416.)

§§102 to 105. Repealed. Pub. L. 107–171, title X, §10418(a)(6), May 13, 2002, 116 Stat. 507

Section 102, act Aug. 30, 1890, ch. 839, §7, 26 Stat. 416, related to quarantine of imported animals.

Section 103, act Aug. 30, 1890, ch. 839, §8, 26 Stat. 416, related to prohibition of importation of animals except at quarantine ports, slaughter of infected animals, appraisal, and payment.

Section 104, act Aug. 30, 1890, ch. 839, §6, 26 Stat. 416; June 28, 1926, ch. 700, §2, 44 Stat. 775; Feb. 28, 1931, ch. 348, 46 Stat. 1460; July 22, 1954, ch. 558, §32, 68 Stat. 510; Jan. 28, 1956, ch. 12, §1, 70 Stat. 5; Pub. L. 97–461, §4, Jan. 12, 1983, 96 Stat. 2524; Pub. L. 103–182, title III, §361(b), Dec. 8, 1993, 107 Stat. 2122; Pub. L. 103–465, title IV, §431(h), Dec. 8, 1994, 108 Stat. 4969, related to importation of animals.

Section 105, act Aug. 30, 1890, ch. 839, §10, 26 Stat. 417; Pub. L. 103–182, title III, §361(c), Dec. 8, 1993, 107 Stat. 2122; Pub. L. 103–465, title IV, §431(i), Dec. 8, 1994, 108 Stat. 4969, related to inspection of animals.

§§106, 107. Omitted

Editorial Notes

Codification

Sections, acts Aug. 10, 1917, ch. 52, §9, 40 Stat. 275; Nov. 21, 1918, ch. 212, §3, 40 Stat. 1048, related to slaughter of tick-infested cattle. Section 12 of act Aug. 10, 1917, provided that the act should cease to be in effect when the national emergency resulting from World War I had passed.

SUBCHAPTER III—PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

§§111, 112. Repealed. Pub. L. 107–171, title X, §10418(a)(7), (8), May 13, 2002, 116 Stat. 507, 508

Section 111, act Feb. 2, 1903, ch. 349, §2, 32 Stat. 792; July 22, 1954, ch. 558, §33, 68 Stat. 510; Jan. 28, 1956, ch. 12, §2, 70 Stat. 5, related to regulations to prevent contagious diseases.

Section 112, act May 29, 1884, ch. 60, §4, 23 Stat. 32; Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to investigations as to pleuropneumonia and other diseases and regulations.

Statutory Notes and Related Subsidiaries

Short Title

Act Feb. 2, 1903, ch. 349, 32 Stat. 791, classified to former sections 112 and 120 to 122 of this title, is popularly known as the Cattle Contagious Diseases Act of 1903.

Act May 29, 1884, ch. 60, 23 Stat. 31, classified to former sections 112, 113 to 114a–1, 115, 116, 117 to 120, and 130 of this title and section 391 of Title 7, Agriculture, is popularly known as the Animal Industry Act.

§112a. Omitted

Editorial Notes

Codification

Section, act Feb. 7, 1928, ch. 30, 45 Stat. 59, amended acts May 29, 1884, ch. 60, 23 Stat. 31; Feb. 2, 1903, ch. 349, 32 Stat. 791; and Mar. 3, 1905, ch. 1496, 33 Stat. 1264, to include live poultry in their provisions, added "and/or live poultry" following "live stock" wherever the term "live stock" appeared, and extended the penalties, terms, and provisions of said acts to live poultry. For complete classification of such acts to the Code, see Short Title note set out under section 112 of this title and Tables.

§113. Repealed. Pub. L. 107–171, title X, §10418(a)(7), (8), May 13, 2002, 116 Stat. 507, 508

Section, act May 29, 1884, ch. 60, §5, 23 Stat. 32; Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to measures to prevent exportation of diseased livestock and live poultry.

§113a. Establishment of research laboratories for foot-and-mouth disease and other animal diseases; research contracts; employment of technicians and scientists; appropriations

The Secretary of Agriculture is authorized to establish research laboratories, including the acquisition of necessary land, buildings, or facilities, and also the making of research contracts under the authority contained in section 3105(a) of title 7, for research and study, in the United States or elsewhere, of foot-and-mouth disease and other animal diseases which in the opinion of the Secretary constitute a threat to the livestock industry of the United States: Provided, That no live virus of foot-and-mouth disease may be introduced for any purpose into any part of the mainland of the United States (except coastal islands separated therefrom by water navigable for deep-water navigation and which shall not be connected with the mainland by any tunnel) unless the Secretary determines that it is necessary and in the public interest for the conduct of research and study in the United States (except at Brookhaven National Laboratory in Upton, New York) and issues a permit under such rules as the Secretary shall promulgate to protect animal health, except that the Secretary of Agriculture may transport said virus in the original package across the mainland under adequate safeguards, and except further, that in the event of outbreak of foot-and-mouth disease in this country, the Secretary of Agriculture may, at his discretion, permit said virus to be brought into the United States under adequate safeguards. To carry out the provisions of this section, the Secretary is authorized to employ technical experts or scientists: Provided, That the number so employed shall not exceed five and that the maximum compensation for each shall not exceed the highest rate of grade 18 of the General Schedule. There is authorized to be appropriated such sums as Congress may deem necessary; in addition, the Secretary is authorized to utilize in carrying out this section, funds otherwise available for the control or eradication of such diseases.

(May 29, 1884, ch. 60, §12, as added Apr. 24, 1948, ch. 229, 62 Stat. 198; amended July 31, 1956, ch. 804, title I, §119, 70 Stat. 742; Pub. L. 85–573, July 31, 1958, 72 Stat. 454; Pub. L. 87–793, §1001(e), Oct. 11, 1962, 76 Stat. 864; Pub. L. 88–426, title III, §305(1), Aug. 14, 1964, 78 Stat. 422; Pub. L. 101–624, title XVI, §1618(b), Nov. 28, 1990, 104 Stat. 3733.)

Editorial Notes

Codification

Provisions that authorized the Secretary to employ technical experts and scientists "without regard to the Classification Act", meaning the Classification Act of 1923, were omitted as obsolete. Sections 1202 and 1204 of the Classification Act of 1949, 63 Stat. 972, 973, repealed the 1923 Act and all laws or parts of laws inconsistent with the 1949 Act. While section 1106(a) of the 1949 Act provided that references in other laws to the 1923 Act should be held and considered to mean the 1949 Act, it did not have the effect of continuing the exception contained in this section because of section 1106(b) which provided that the application of the 1949 Act to any position, officer, or employee shall not be affected by section 1106(a). The Classification Act of 1949 was repealed by Pub. L. 89–554, Sept. 6, 1966, §8(a), 80 Stat. 632 (the first section of which revised and enacted Title 5, Government Organization and Employees, into law). Section 5102 of Title 5 contains the applicability provisions of the 1949 Act, and section 5103 of Title 5 authorizes the Office of Personnel Management to determine the applicability to specific positions and employees.

Amendments

1990—Pub. L. 101–624 substituted "United States (except" for "United States except" and "tunnel) unless the Secretary determines that it is necessary and in the public interest for the conduct of research and study in the United States (except at Brookhaven National Laboratory in Upton, New York) and issues a permit under such rules as the Secretary shall promulgate to protect animal health," for "tunnel, and".

1962—Pub. L. 87–793 substituted "shall not exceed the highest rate of grade 18 of the General Schedule" for "shall not exceed $19,000 per annum".

1958—Pub. L. 85–573 inserted in proviso clause of first sentence the exception clause respecting transportation of virus in original package across mainland under adequate safeguards.

Statutory Notes and Related Subsidiaries

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–793 effective on first day of first pay period which begins on or after Oct. 11, 1962.

Repeals

Act July 31, 1956, ch. 804, title I, §119, 70 Stat. 742, which increased the maximum compensation of technical experts or scientists, was repealed by Pub. L. 88–426, title III, §305(1), Aug. 14, 1964, 78 Stat. 422.

Live Virus Foot and Mouth Disease Research

Pub. L. 110–234, title VII, §7524, May 22, 2008, 122 Stat. 1273, and Pub. L. 110–246, §4(a), title VII, §7524, June 18, 2008, 122 Stat. 1664, 2034, provided that:

"(a) In General.—The Secretary [of Agriculture] shall issue a permit required under section 12 of the Act of May 29, 1884 (21 U.S.C. 113a) to the Secretary of Homeland Security for work on the live virus of foot and mouth disease at any facility that is a successor to the Plum Island Animal Disease Center and charged with researching high-consequence biological threats involving zoonotic and foreign animal diseases (referred to in this section as the 'successor facility').

"(b) Limitation to Single Facility.—Not more than 1 facility shall be issued a permit under subsection (a).

"(c) Limitation on Validity.—The permit issued under this section shall be valid unless the Secretary determines that the study of live foot and mouth disease virus at the successor facility is not being carried out in accordance with the regulations promulgated by the Secretary pursuant to the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401 et seq.).

"(d) Authority.—The suspension, revocation, or other impairment of the permit issued under this section—

"(1) shall be made by the Secretary; and

"(2) is a nondelegable function."

[Pub. L. 110–234 and Pub. L. 110–246 enacted identical provisions. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.]

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

§§114 to 114d–1. Repealed. Pub. L. 107–171, title X, §10418(a)(8), (9), May 13, 2002, 116 Stat. 508

Section 114, act May 29, 1884, ch. 60, §3, 23 Stat. 32, related to regulations for suppression of diseases and cooperation of States and Territories.

Section 114a, act May 29, 1884, ch. 60, §11, as added Sept. 21, 1944, ch. 412, title I, §101(a), 58 Stat. 734; amended Oct. 30, 1951, ch. 637, §1, 65 Stat. 693; Aug. 8, 1953, ch. 381, 67 Stat. 493; Aug. 3, 1956, ch. 950, §2, 70 Stat. 1032; Pub. L. 87–518, §7, July 2, 1962, 76 Stat. 131; Pub. L. 101–624, title XXV, §2509(c)(2), Nov. 28, 1990, 104 Stat. 4071, related to control and eradication of diseases, cooperation of States and farmers' associations, purchase and destruction of diseased animals, and defined "State" for statutory purposes.

A prior section 11 of act May 29, 1884, required annual reports to Congress concerning the suppression of contagious diseases among domestic animals, and was classified to section 560 of former Title 5, prior to repeal by act May 29, 1928, ch. 901, §1, 45 Stat. 993.

Section 114a–1, act May 29, 1884, ch. 60, §13, as added Oct. 30, 1951, ch. 637, §2, 65 Stat. 693, related to interstate movement of domestic animals reacting to tests for brucellosis, immediate slaughter, and rules and regulations.

Section 114b, act Feb. 28, 1947, ch. 8, §1, 61 Stat. 7; Pub. L. 89–521, §1, July 27, 1966, 80 Stat. 330; Pub. L. 92–152, §1, Nov. 5, 1971, 85 Stat. 418; Pub. L. 94–231, §3, Mar. 15, 1976, 90 Stat. 216; Pub. L. 101–255, §1(1), Mar. 15, 1990, 104 Stat. 114; Pub. L. 101–624, title XXV, §2505, Nov. 28, 1990, 104 Stat. 4068, related to cooperation in animal disease control.

Section 114c, act Feb. 28, 1947, ch. 8, §2, 61 Stat. 7; Aug. 3, 1956, ch. 950, §3, 70 Stat. 1033; Pub. L. 92–152, §2, Nov. 5, 1971, 85 Stat. 419; Pub. L. 101–255, §1(2), Mar. 15, 1990, 104 Stat. 114, related to use of funds.

Section 114d, act Feb. 28, 1947, ch. 8, §3, as added Pub. L. 101–255, §1(3), Mar. 15, 1990, 104 Stat. 114, related to sale of sterile screwworms.

A prior section 114d, act Feb. 28, 1947, ch. 8, §3, 61 Stat. 8, related to reports by Secretary of Agriculture to Congress with respect to activities carried on under sections 114b and 114c of this title, prior to repeal by Pub. L. 86–533, §1(20), June 29, 1960, 74 Stat. 249.

Section 114d–1, act Feb. 28, 1947, ch. 8, §5, as added Pub. L. 89–521, §2, July 27, 1966, 80 Stat. 330; amended Pub. L. 101–255, §1(5), Mar. 15, 1990, 104 Stat. 114, related to cooperation with public and private entities.

Statutory Notes and Related Subsidiaries

Short Title

Section 6 of act Feb. 28, 1947, ch. 8, as added by Pub. L. 101–255, §1(6), Mar. 15, 1990, 104 Stat. 114, provided that the act Feb. 28, 1947, ch. 8, which enacted sections 114b to 114d–1 of this title and provisions set out as a note under former section 114b of this title, could be referred to as the "Animal Disease Control Cooperation Act of 1947".

§§114d–2 to 114d–6. Repealed. Pub. L. 92–152, §3, Nov. 5, 1971, 85 Stat. 419

Section 114d–2, Pub. L. 90–388, §1, July 6, 1968, 82 Stat. 294, provided for cooperation with Central America in control and eradication of foot-and-mouth disease or rinderpest.

Section 114d–3, Pub. L. 90–388, §2, July 6, 1968, 82 Stat. 294, provided for uses of funds.

Section 114d–4, Pub. L. 90–388, §3, July 6, 1968, 82 Stat. 294, defined governments of Central America.

Section 114d–5, Pub. L. 90–388, §4, July 6, 1968, 82 Stat. 294, provided for cooperation with public and private organizations and individuals.

Section 114d–6, Pub. L. 90–388, §5, July 6, 1968, 82 Stat. 294, provided for authorization of appropriations.

§§114e to 114h. Repealed. Pub. L. 107–171, title X, §10418(a)(10), (11), May 13, 2002, 116 Stat. 508

Section 114e, act June 16, 1948, ch. 477, §1, 62 Stat. 458, related to research and investigations into the control and eradication of cattle grubs.

Section 114f, act June 16, 1948, ch. 477, §2, 62 Stat. 458, defined the term "State" and authorized appropriations.

Section 114g, Pub. L. 87–209, §1, Sept. 6, 1961, 75 Stat. 481, related to hog cholera eradication program.

Section 114h, Pub. L. 87–209, §2, Sept. 6, 1961, 75 Stat. 481, related to advisory committee.

§114i. Pseudorabies eradication

(a) Findings

Congress finds that efforts to eradicate pseudorabies in United States swine populations by the Department of Agriculture in cooperation with State agencies and the pork industry have a high priority and should be continued until pseudorabies is completely eradicated in the United States.

(b) Establishment of program

The Secretary of Agriculture shall establish and carry out a program for the eradication of pseudorabies in United States swine populations.

(c) Use of funds for testing and control of pseudorabies

The Secretary shall ensure that not less than 65 percent of the funds appropriated for the program established under subsection (b) shall be used for testing and screening of animals and for other purposes directly related to the eradication or control of pseudorabies. This requirement on the use of appropriated funds for this program shall not be implemented in a manner that would adversely affect any other animal or plant disease or pest eradication or control program.

(d) Authorization of appropriations

There are authorized to be appropriated for each of the fiscal years 1991 through 2007 such sums as may be necessary for the purpose of carrying out the program established under subsection (b).

(Pub. L. 101–624, title XXV, §2506, Nov. 28, 1990, 104 Stat. 4068; Pub. L. 104–127, title IX, §916, Apr. 4, 1996, 110 Stat. 1187; Pub. L. 107–171, title X, §10505, May 13, 2002, 116 Stat. 511.)

Editorial Notes

Amendments

2002—Subsec. (d). Pub. L. 107–171 substituted "2007" for "2002".

1996—Subsec. (d). Pub. L. 104–127 substituted "2002" for "1995".

§§115 to 128. Repealed. Pub. L. 107–171, title X, §10418(a)(7), (8), (12)–(14), May 13, 2002, 116 Stat. 507, 508

Section 115, act May 29, 1884, ch. 60, §6, 23 Stat. 32; June 28, 1926, ch. 700, §1, 44 Stat. 774; Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87–763, Oct. 9, 1962, 76 Stat. 762, prohibited transportation of diseased livestock and live poultry.

Section 116, act May 29, 1884, ch. 60, 23 Stat. 31; May 31, 1920, ch. 217, 41 Stat. 699, related to excepted shipment of certain cattle.

Section 117, act May 29, 1884, ch. 60, §7, 23 Stat. 32; Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 95–439, §1, Oct. 10, 1978, 92 Stat. 1061; Pub. L. 97–461, §5, Jan. 12, 1983, 96 Stat. 2524, related to penalties for transportation of diseased livestock or live poultry.

Section 118, act May 29, 1884, ch. 60, §9, 23 Stat. 33; June 25, 1948, ch. 646, §1, 62 Stat. 909, related to duty of United States attorneys.

Section 119, act May 29, 1884, ch. 60, §2, 23 Stat. 31; Feb. 9, 1889, ch. 122, §1, 25 Stat. 659; July 14, 1890, ch. 707, 26 Stat. 288; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to appointment of agents to examine and report on methods of treatment of animals, and means for suppression of diseases.

Section 120, act May 29, 1884, ch. 60, §§4, 5, 23 Stat. 32; Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to regulation of exportation and transportation of infected livestock and live poultry.

Section 121, act Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to shipments from areas suspected to be infected and to control of animals and live poultry.

Section 122, act Feb. 2, 1903, ch. 349, §3, 32 Stat. 792; Pub. L. 97–461, §6, Jan. 12, 1983, 96 Stat. 2525, related to offenses and penalties.

Section 123, act Mar. 3, 1905, ch. 1496, §1, 33 Stat. 1264; Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87–518, §8(a), July 2, 1962, 76 Stat. 131; Pub. L. 95–439, §2, Oct. 10, 1978, 92 Stat. 1061, related to quarantine.

Section 124, act Mar. 3, 1905, ch. 1496, §2, 33 Stat. 1264; Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87–518, §8(b), July 2, 1962, 76 Stat. 131, prohibited transportation or delivery therefor from quarantined State or Territory or portion thereof, of quarantined animals and live poultry.

Section 125, act Mar. 3, 1905, ch. 1496, §3, 33 Stat. 1265; Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87–518, §8(b), July 2, 1962, 76 Stat. 131; Pub. L. 95–439, §3, Oct. 10, 1978, 92 Stat. 1061, related to regulations for inspection, disinfection, and certification, and delivery and shipment of quarantined animals and live poultry from State or Territory.

Section 126, act Mar. 3, 1905, ch. 1496, §4, 33 Stat. 1265; Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87–518, §8(b), July 2, 1962, 76 Stat. 131, related to moving quarantined animals and live poultry from State or Territory, under regulations.

Section 127, act Mar. 3, 1905, ch. 1496, §6, 33 Stat. 1265; Pub. L. 97–461, §7, Jan. 12, 1983, 96 Stat. 2525, related to penalties for transportation from quarantined State, Territory, etc.

Section 128, act June 30, 1914, ch. 131, 38 Stat. 419; Pub. L. 87–518, §9, July 2, 1962, 76 Stat. 131, related to extension of quarantine law to carriers in interstate commerce.

Statutory Notes and Related Subsidiaries

Short Title

Act Mar. 3, 1905, ch. 1496, 33 Stat. 1264, which enacted sections 123 to 127 of this title, was popularly known as the "Cattle Contagious Diseases Act of 1905".

§129. Omitted

Editorial Notes

Codification

Section, Pub. L. 107–76, title I, Nov. 28, 2001, 115 Stat. 712, related to transfer of funds for emergency arrest of animal, poultry, or plant diseases or pests, and was from the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2002. Similar provisions which are permanent are classified to sections 7772 and 8316 of Title 7, Agriculture.

Prior Provisions

Provisions similar to those in this section were contained in the following prior appropriation acts:

Pub. L. 106–387, §1(a) [title I], Oct. 28, 2000, 114 Stat. 1549, 1549A-9, repealed by Pub. L. 107–171, title X, §10418(a)(15), May 13, 2002, 116 Stat. 508.

Pub. L. 106–78, title I, Oct. 22, 1999, 113 Stat. 1143.

Pub. L. 105–277, div. A, §101(a) [title I], Oct. 21, 1998, 112 Stat. 2681, 2681-8.

Pub. L. 105–86, title I, Nov. 18, 1997, 111 Stat. 2086.

Pub. L. 104–180, title I, Aug. 6, 1996, 110 Stat. 1576.

Pub. L. 104–37, title I, Oct. 21, 1995, 109 Stat. 307.

Pub. L. 103–330, title I, Sept. 30, 1994, 108 Stat. 2443.

Pub. L. 103–111, title I, Oct. 21, 1993, 107 Stat. 1054.

Pub. L. 102–341, title I, Aug. 14, 1992, 106 Stat. 882.

Pub. L. 102–142, title I, Oct. 28, 1991, 105 Stat. 886.

Pub. L. 101–506, title I, Nov. 5, 1990, 104 Stat. 1323.

Pub. L. 101–161, title I, Nov. 21, 1989, 103 Stat. 959.

Pub. L. 100–460, title I, Oct. 1, 1988, 102 Stat. 2237.

Pub. L. 100–202, §101(k) [title I], Dec. 22, 1987, 101 Stat. 1329–322, 1329-331.

Pub. L. 99–500, §101(a) [title I], Oct. 18, 1986, 100 Stat. 1783, 1783-8, and Pub. L. 99–591, §101(a) [title I], Oct. 30, 1986, 100 Stat. 3341, 3341-8.

Pub. L. 99–190, §101(a) [H.R. 3037, title I], Dec. 19, 1985, 99 Stat. 1185; Pub. L. 100–202, §106, Dec. 22, 1987, 101 Stat. 1329–433.

Pub. L. 97–370, title I, Dec. 18, 1982, 96 Stat. 1792.

Pub. L. 97–103, title I, Dec. 23, 1981, 95 Stat. 1472.

Pub. L. 96–528, title I, Dec. 15, 1980, 94 Stat. 3099.

Pub. L. 96–108, title I, Nov. 9, 1979, 93 Stat. 826.

Pub. L. 95–448, title I, Oct. 11, 1978, 92 Stat. 1076.

Pub. L. 95–97, title I, Aug. 12, 1977, 91 Stat. 813.

Pub. L. 94–351, title I, July 12, 1976, 90 Stat. 854.

Pub. L. 94–122, title I, Oct. 21, 1975, 89 Stat. 645.

Pub. L. 93–563, title I, Dec. 31, 1974, 88 Stat. 1824.

Pub. L. 93–135, title I, Oct. 24, 1973, 87 Stat. 472.

Pub. L. 92–399, title I, Aug. 22, 1972, 86 Stat. 594.

Pub. L. 92–73, title I, Aug. 10, 1971, 85 Stat. 185.

Pub. L. 91–566, title I, Dec. 22, 1970, 84 Stat. 1482.

Pub. L. 91–127, title I, Nov. 26, 1969, 83 Stat. 246.

Pub. L. 90–463, title I, Aug. 8, 1968, 82 Stat. 640.

Pub. L. 90–113, title I, Oct. 24, 1967, 81 Stat. 321.

Pub. L. 89–556, title I, Sept. 7, 1966, 80 Stat. 690.

Pub. L. 89–316, title I, Nov. 2, 1965, 79 Stat. 1166.

Pub. L. 88–573, title I, Sept. 2, 1964, 78 Stat. 863.

Pub. L. 88–250, title I, Dec. 30, 1963, 77 Stat. 821.

Pub. L. 87–879, title I, Oct. 24, 1962, 76 Stat. 1204.

Pub. L. 87–112, title I, July 26, 1961, 75 Stat. 228.

Pub. L. 86–532, title I, June 29, 1960, 74 Stat. 233.

Pub. L. 86–80, title I, July 8, 1959, 73 Stat. 168.

Pub. L. 85–459, title I, June 13, 1958, 72 Stat. 189.

Pub. L. 85–118, title I, Aug. 2, 1957, 71 Stat. 330.

June 4, 1956, ch. 355, title I, 70 Stat. 230.

May 23, 1955, ch. 43, title I, 69 Stat. 52.

June 29, 1954, ch. 409, title I, 68 Stat. 305.

July 28, 1953, ch. 251, title III, 67 Stat. 223.

July 5, 1952, ch. 574, title III, 66 Stat. 354.

Aug. 31, 1951, ch. 374, title II, 65 Stat. 243.

Sept. 6, 1950, ch. 896, Ch. VI, title I, 64 Stat. 661.

June 29, 1949, ch. 280, title I, 63 Stat. 332.

June 19, 1948, ch. 543, 62 Stat. 515.

July 30, 1947, ch. 356, title I, 61 Stat. 532.

June 22, 1946, ch. 445, 60 Stat. 278.

May 5, 1945, ch. 109, 59 Stat. 144.

June 28, 1944, ch. 296, 58 Stat. 434.

July 12, 1943, ch. 215, 57 Stat. 403.

July 22, 1942, ch. 516, 56 Stat. 676.

July 1, 1941, ch. 267, 55 Stat. 418.

June 25, 1940, ch. 421, 54 Stat. 542.

June 30, 1939, ch. 253, title I, 53 Stat. 951.

June 16, 1938, ch. 464, title I, 52 Stat. 722.

June 29, 1937, ch. 404, 50 Stat. 406.

June 4, 1936, ch. 489, 49 Stat. 1432.

May 17, 1935, ch. 131, title I, 49 Stat. 257.

Mar. 26, 1934, ch. 89, 48 Stat. 477.

Mar. 3, 1933, ch. 203, 47 Stat. 1442.

July 7, 1932, ch. 443, 47 Stat. 620.

Feb. 23, 1931, ch. 278, 46 Stat. 1252.

May 27, 1930, ch. 341, 46 Stat. 403.

Feb. 16, 1929, ch. 227, 45 Stat. 1198.

May 16, 1928, ch. 572, 45 Stat. 548.

Jan. 18, 1927, ch. 39, 44 Stat. 1005.

May 11, 1926, ch. 286, 44 Stat. 529.

Feb. 10, 1925, ch. 200, 43 Stat. 851.

Dec. 5, 1924, ch. 4, 43 Stat. 683.

June 5, 1924, ch. 266, 43 Stat. 458.

Apr. 2, 1924, ch. 81, 43 Stat. 40.

Feb. 26, 1923, ch. 119, 42 Stat. 1318.

May 11, 1922, ch. 185, 42 Stat. 536.

Mar. 4, 1917, ch. 179, 39 Stat. 1167.

§§129a to 131. Repealed. Pub. L. 107–171, title X, §10418(a)(1), (8), (16), May 13, 2002, 116 Stat. 507, 508

Section 129a, Pub. L. 97–46, §1, Sept. 25, 1981, 95 Stat. 953; Pub. L. 106–224, title IV, §438(b), June 20, 2000, 114 Stat. 454, related to transfer of funds for emergency arrest of animal or poultry diseases. Section was formerly classified to section 147b of Title 7, Agriculture.

Section 130, act May 29, 1884, ch. 60, §8, 23 Stat. 33; 1967 Reorg. Plan No. 3, §402(430), eff. Aug. 11, 1967, 32 F.R. 11669, 81 Stat. 948; Pub. L. 93–198, title IV, §401, Dec. 24, 1973, 87 Stat. 793, related to pleuropneumonia in District of Columbia and duties of Council of the District of Columbia.

Section 131, act May 26, 1910, ch. 256, 36 Stat. 440, related to fences along international boundary lines to keep out diseased animals.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 97–46, §2, Sept. 25, 1981, 95 Stat. 953, provided that section 129a of this title was to become effective Sept. 25, 1981, prior to repeal by Pub. L. 107–171, title X, §10418(a)(1), May 13, 2002, 116 Stat. 507.

§132. Transferred

Editorial Notes

Codification

Section, act May 23, 1908, ch. 192, 35 Stat. 254, which related to inspection of dairy products for export, was transferred to section 693 of this title.

§133. Repealed. July 13, 1949, ch. 307, 63 Stat. 410

Section, act July 24, 1946, ch. 592, 60 Stat. 633, related to establishment of a quarantine station on Swan Island.

§§134 to 135b. Repealed. Pub. L. 107–171, title X, §10418(a)(17), (18), May 13, 2002, 116 Stat. 508

Section 134, Pub. L. 87–518, §1, July 2, 1962, 76 Stat. 129, related to definitions for Pub. L. 87–518.

Section 134a, Pub. L. 87–518, §2, July 2, 1962, 76 Stat. 129, related to seizure, quarantine, and disposal of livestock or poultry to guard against introduction or dissemination of communicable disease.

Section 134b, Pub. L. 87–518, §3, July 2, 1962, 76 Stat. 130, related to regulations for clean and sanitary movement of animals.

Section 134c, Pub. L. 87–518, §4, July 2, 1962, 76 Stat. 130, related to regulations for movement of animals affected or exposed to communicable disease.

Section 134d, Pub. L. 87–518, §5, July 2, 1962, 76 Stat. 130, related to inspections, seizures, and issuance of warrants.

Section 134e, Pub. L. 87–518, §6, July 2, 1962, 76 Stat. 131; Pub. L. 97–461, §8, Jan. 12, 1983, 96 Stat. 2525, related to enforcement provisions.

Section 134f, Pub. L. 87–518, §11, July 2, 1962, 76 Stat. 132, related to promulgation of regulations.

Section 134g, Pub. L. 87–518, §12, July 2, 1962, 76 Stat. 132, related to authority in addition to other laws and repeal of inconsistent provisions.

Section 134h, Pub. L. 87–518, §13, July 2, 1962, 76 Stat. 132, related to separability.

Section 135, Pub. L. 91–239, §1, May 6, 1970, 84 Stat. 202; Pub. L. 103–465, title IV, §431(j), Dec. 8, 1994, 108 Stat. 4969, related to the establishment of international animal quarantine station, acceptance of gifts, cooperation with breeders' organizations, and collection of fees.

Section 135a, Pub. L. 91–239, §2, May 6, 1970, 84 Stat. 202; Pub. L. 97–461, §9, Jan. 12, 1983, 96 Stat. 2525, related to smuggling penalties.

Section 135b, Pub. L. 91–239, §3, May 6, 1970, 84 Stat. 202, related to authorization of appropriations.

§136. Additional inspection services

The Secretary of Agriculture, in carrying out regulations prohibiting or restricting the entry of materials that may harbor pests, or diseases, is authorized to enter into agreements with operators or owners of vessels or aircraft for the purpose of providing inspection services at points of entry in the United States in addition to the regular or on-call basis currently available in connection with such vessels or aircraft. Any such agreement shall provide for the payment by the operator or owner of an amount determined by the Secretary to be necessary to defray the costs of providing additional service pursuant to such agreement.

(Pub. L. 101–624, title XXV, §2508, Nov. 28, 1990, 104 Stat. 4069.)

§136a. Collection of fees for inspection services

(a) Quarantine and inspection fees

(1) Fees authorized

The Secretary of Agriculture may prescribe and collect fees sufficient—

(A) to cover the cost of providing agricultural quarantine and inspection services in connection with the arrival at a port in the customs territory of the United States, or the preclearance or preinspection at a site outside the customs territory of the United States, of an international passenger, commercial vessel, commercial aircraft, commercial truck, or railroad car;

(B) to cover the cost of administering this subsection; and

(C) through fiscal year 2002, to maintain a reasonable balance in the Agricultural Quarantine Inspection User Fee Account established under paragraph (5).

(2) Limitation

In setting the fees under paragraph (1), the Secretary shall ensure that the amount of the fees is commensurate with the costs of agricultural quarantine and inspection services with respect to the class of persons or entities paying the fees. The costs of the services with respect to passengers as a class includes the costs of related inspections of the aircraft or other vehicle.

(3) Status of fees

Fees collected under this subsection by any person on behalf of the Secretary are held in trust for the United States and shall be remitted to the Secretary in such manner and at such times as the Secretary may prescribe.

(4) Late payment penalties

If a person subject to a fee under this subsection fails to pay the fee when due, the Secretary shall assess a late payment penalty, and the overdue fees shall accrue interest, as required by section 3717 of title 31.

(5) Agricultural Quarantine Inspection User Fee Account

(A) Establishment

There is established in the Treasury of the United States a fund, to be known as the "Agricultural Quarantine Inspection User Fee Account", which shall contain all of the fees collected under this subsection and late payment penalties and interest charges collected under paragraph (4) through fiscal year 2002.

(B) Use of account

For each of fiscal years 1996 through 2002, funds in the Agricultural Quarantine Inspection User Fee Account shall be available, in such amounts as are provided in advance in appropriations Acts, to cover the costs associated with the provision of agricultural quarantine and inspection services and the administration of this subsection. Amounts made available under this subparagraph shall be available until expended.

(C) Excess fees

Fees and other amounts collected under this subsection in any of fiscal years 1996 through 2002 in excess of $100,000,000 shall be available for the purposes specified in subparagraph (B) until expended, without further appropriation.

(6) Use of amounts collected after fiscal year 2002

After September 30, 2002, the unobligated balance in the Agricultural Quarantine Inspection User Fee Account and fees and other amounts collected under this subsection shall be credited to the Department of Agriculture accounts that incur the costs associated with the provision of agricultural quarantine and inspection services and the administration of this subsection. The fees and other amounts shall remain available to the Secretary until expended without fiscal year limitation.

(7) Staff years

The number of full-time equivalent positions in the Department of Agriculture attributable to the provision of agricultural quarantine and inspection services and the administration of this subsection shall not be counted toward the limitation on the total number of full-time equivalent positions in all agencies specified in section 5(b) of the Federal Workforce Restructuring Act of 1994 (Public Law 103–226; 5 U.S.C. 3101 note) or other limitation on the total number of full-time equivalent positions.

(b) Omitted

(c) Animal inspection and veterinary diagnostics

(1) Animal inspection

The Secretary may prescribe and collect fees to reimburse the Secretary for the cost of carrying out the provisions of the Federal Animal Quarantine Laws that relate to the importation, entry, and exportation of animals, articles, or means of conveyance.

(2) Veterinary diagnostics

The Secretary may prescribe and collect fees to recover the costs of carrying out the provisions of the Animal Health Protection Act [7 U.S.C. 8301 et seq.] that relate to veterinary diagnostics.

(3) Fees

All fees collected pursuant to this subsection and any late payment penalties or accrued interest collected pursuant to this subsection shall be credited to the accounts that incur the cost and shall remain available until expended without fiscal year limitation.

(4) Liability

Any person for whom an activity related to the importation, entry, or exportation of an animal, article, or means of conveyance or relating to veterinary diagnostics, is performed pursuant to the section, shall be liable for payment of fees assessed. Upon failure to pay such fees when due, the Secretary shall assess a late payment penalty, and such overdue fees shall accrue interest, as required by section 3717 of title 31. All fees, late payment penalties, and accrued interest collected shall be credited to such accounts that incur the costs and shall remain available until expended without fiscal year limitation.

(5) Leins ¹

(A) In general

The Secretary shall have a lien against the animal, article, means of conveyance, or facility for which services have been provided under this section for the fees, any late payment penalty, and any accrued interest assessed under this subsection.

(B) Other animals, etc.

In the case of any person who fails to make payment when due under this subsection, the Secretary shall have a lien against any animal, article, or means of conveyance thereafter imported, moved in interstate commerce, or attempted to be exported by the person after the date of such failure until the date on which such owner or operator make ² full payment to the Secretary under this subsection.

(C) Sales of animals, etc.

(i) Authority

The Secretary may, if a person does not pay fees, late payment penalties, or accrued interest on such, after providing reasonable notice of default to such person, sell at public sale after reasonable public notice, or otherwise dispose of, any such animal, article, means of conveyance or facility on which the Secretary has a lien under this paragraph.

(ii) Excess proceeds

If the sale proceeds under clause (i) exceed the fees due, any late payment penalty assessed, any accrued interest on such, and the expenses associated with the sale, such excess shall be paid to the owner of the animal, article, means of conveyance, or facility if such owner submits an application for such excess together with proof of ownership not later than 6 months after the date of such sale. If no such application is made, such excess shall be credited to accounts that incur the costs associated with the fees collected and shall remain available until expended, without fiscal year limitation. The Secretary shall suspend performance of services to persons who have failed to pay fees, late payment penalty, or accrued interest under this section.

(d) Regulations

The Secretary may prescribe such regulations as the Secretary determines necessary to carry out the provisions of this section.

(e) Recovery of amounts owed

An action may be brought for the recovery of fees, late payment penalties, and accrued interest which have not been paid in accordance with this section against any person obligated for payment of such assessments under this section in any United States district court or other United States court for any territory or possession in any jurisdiction in which such person is found or resides or transacts business, and such court shall have jurisdiction to hear and decide such action.

(f) Definitions

(1) Animal quarantine laws

For purposes of this section, the term "animal quarantine laws" means—

(A) section 306 of the Tariff Act of 1930 ³ (19 U.S.C. 1306);

(B) section 9 of the Act of August 30, 1890 (21 U.S.C. 101);

(C) the Animal Health Protection Act [7 U.S.C. 8301 et seq.]; or

(D) any other Act administered by the Secretary relating to plant or animal diseases or pests.

(2) Customs territory

For the purposes of subsection (a), the term "customs territory of the United States" means the 50 States, the District of Columbia, and Puerto Rico.

(3) Person

For the purposes of this section, the term "person" means an individual, corporation, partnership, trust, association, or any other public or private entity, or any officer, employee, or agent thereof.

(4) United States

For the purposes of subsection (b), the term "United States" means the several States of the United States, the District of Columbia, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

(5) Vessel

For the purposes of subsection (a), the term "vessel" does not include any ferry.

(Pub. L. 101–624, title XXV, §2509, Nov. 28, 1990, 104 Stat. 4069; Pub. L. 101–508, title I, §1203, Nov. 5, 1990, 104 Stat. 1388–11; Pub. L. 102–237, title X, §1015, Dec. 13, 1991, 105 Stat. 1902; Pub. L. 104–127, title IX, §917, Apr. 4, 1996, 110 Stat. 1187; Pub. L. 107–171, title X, §10418(b)(5), May 13, 2002, 116 Stat. 509.)

Editorial Notes

References in Text

The Animal Health Protection Act, referred to in subsecs. (c)(2), (f)(1)(C), is subtitle E (§§10401–10418) of title X of Pub. L. 107–171, May 13, 2002, 116 Stat. 494, which is classified principally to chapter 109 (§8301 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 8301 of Title 7 and Tables.

Section 306 of the Tariff Act of 1930 (19 U.S.C. 1306), referred to in subsec. (f)(1)(A), was repealed by Pub. L. 107–171, title X, §10418(a)(5), May 13, 2002, 116 Stat. 507.

Codification

Section is comprised of section 2509 of Pub. L. 101–624. Subsec. (b) and another subsec. (c)(2) of section 2509 of Pub. L. 101–624 amended section 7759(f) of Title 7, Agriculture, and section 114a of this title, respectively.

Amendments

2002—Subsec. (c)(2). Pub. L. 107–171, §10418(b)(5)(A), added par. (2) relating to veterinary diagnostics.

Subsec. (f)(1)(B) to (O). Pub. L. 107–171, §10418(b)(5)(B), added subpars. (B) to (D) and struck out former subpars. (B) to (O), which read as follows:

"(B) sections 6 through 10 of the Act of August 30, 1890 (26 Stat. 416, chapter 839; 21 U.S.C. 101–105);

"(C) section 2 of the Act of February 2, 1903 (32 Stat. 792, chapter 349; 21 U.S.C. 111);

"(D) the Act of May 29, 1884 (23 Stat. 32, chapter 60; 21 U.S.C. 112 to 114a–1, 115, 117–119, and 130) (commonly known as the 'Animal Industry Act');

"(E) the Act of February 28, 1947 (61 Stat. 7, chapter 8; 21 U.S.C. 114b, 114c, and 114d–1);

"(F) the Act of June 16, 1948 (62 Stat. 458, chapter 477; 21 U.S.C. 114e and 114f);

"(G) Public Law 87–209 (21 U.S.C. 114g and 114h);

"(H) the Act of May 31, 1920 (41 Stat. 699, chapter 217; 21 U.S.C. 116);

"(I) the Act of February 2, 1903 (32 Stat. 791, chapter 349; 21 U.S.C. 112 and 120–122) (commonly known as the 'Cattle Contagious Diseases Act of 1903');

"(J) the Act of March 3, 1905 (33 Stat. 1264, chapter 1496; 21 U.S.C. 123–127) (commonly known as the 'Cattle Contagious Diseases Act of 1905');

"(K) the matter under the heading 'Bureau of Animal Industry' of the Act of June 30, 1914 (38 Stat. 419, chapter 131; 21 U.S.C. 128);

"(L) section 101 of Public Law 92–73 (21 U.S.C. 129);

"(M) the matter under the heading 'Miscellaneous' of the Act of May 26, 1910 (36 Stat. 440, chapter 256; 21 U.S.C. 131);

"(N) sections 1 through 6 and 11 through 13 of Public Law 87–518 (21 U.S.C. 134–134h); or

"(O) any other Act administered by the Secretary relating to plant or animal diseases or pests, other than the first section of Public Law 91–239 (21 U.S.C. 135)."

1996—Subsec. (a). Pub. L. 104–127 added subsec. (a) and struck out heading and text of former subsec. (a) which consisted of pars. (1) to (4) relating to quarantine, inspection, and transportation fees.

1991—Subsec. (a)(1). Pub. L. 102–237, §1015(1), designated existing provisions as subpar. (A), realigned margin, added heading, and added subpars. (B) to (D).

Subsec. (a)(3)(B)(ii). Pub. L. 102–237, §1015(2), added cl. (ii) and struck out former cl. (ii) which read as follows: "The Secretary of Treasury shall use the Account to provide reimbursements to any appropriations accounts that incur the costs associated with the services authorized in paragraph (1). Any such reimbursement shall be subject to appropriations under clause (v)."

Subsec. (a)(4). Pub. L. 102–237, §1015(3), substituted "Subject to the limits set forth in paragraph (1), the" for "The".

1990—Subsec. (a)(1). Pub. L. 101–508, §1203(1), substituted "an international passenger, commercial vessel, commercial aircraft, commercial truck, or railroad car." for "a commercial vessel, commercial aircraft, commercial truck, or railroad car,".

Subsec. (a)(3)(B)(ii). Pub. L. 101–508, §1203(2)(A), inserted at end "Any such reimbursement shall be subject to appropriations under clause (v)."

Subsec. (a)(3)(B)(v). Pub. L. 101–508, §1203(2)(B), added cl. (v).

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

Amendment by Pub. L. 101–508 effective Nov. 29, 1990, see section 1301 of Pub. L. 101–508, set out as an Effective Date note under section 1994 of Title 7, Agriculture.

Report on Agricultural Quarantine Inspection Fund

Pub. L. 104–66, title I, §1012(c), Dec. 21, 1995, 109 Stat. 712, provided that: "The Secretary of Agriculture shall not be required to submit a report to the appropriate committees of Congress on the status of the Agricultural Quarantine Inspection fund more frequently than annually."

¹ So in original. Probably should be "Liens".

² So in original. Probably should be "makes".

³ See References in Text note below.

SUBCHAPTER IV—IMPORTATION OF MILK AND CREAM

Statutory Notes and Related Subsidiaries

Federal Food, Drug, and Cosmetic Act

Nothing contained in chapter 9 (§301 et seq.) of this title shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of this subchapter, see section 392(b) of this title.

§141. Prohibition of importation without permit

On and after May 16, 1927, the importation into the United States of milk and cream is prohibited unless the person by whom such milk or cream is shipped or transported into the United States holds a valid permit from the Secretary of Health and Human Services.

(Feb. 15, 1927, ch. 155, §1, 44 Stat. 1101; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Short Title

Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in part that act Feb. 15, 1927, which is classified to this subchapter, may be cited as "Import Milk Act".

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.

§142. Milk or cream when unfit for importation

Milk or cream shall be considered unfit for importation (1) when all cows producing such milk or cream are not healthy and a physical examination of all such cows has not been made within one year previous to such milk being offered for importation; (2) when such milk or cream, if raw, is not produced from cows which have passed a tuberculin test applied by a duly authorized official veterinarian of the United States, or of the country in which such milk or cream is produced, within one year previous to the time of the importation, showing that such cows are free from tuberculosis; (3) when the sanitary conditions of the dairy farm or plant in which such milk or cream is produced or handled do not score at least fifty points out of one hundred points according to the methods for scoring as provided by the score cards used by the Bureau of Dairy Industry of the United States Department of Agriculture at the time such dairy farms or plants are scored; (4) in the case of raw milk if the number of bacteria per cubic centimeter exceeds three hundred thousand and in the case of raw cream seven hundred and fifty thousand, in the case of pasteurized milk if the number of bacteria per cubic centimeter exceeds one hundred thousand, and in the case of pasteurized cream five hundred thousand; (5) when the temperature of milk or cream at the time of importation exceeds fifty degrees Fahrenheit.

(Feb. 15, 1927, ch. 155, §2, 44 Stat. 1101.)

Statutory Notes and Related Subsidiaries

Transfer of Functions

Agricultural Research Service became the successor to functions of Bureau of Dairy Industry under Secretary of Agriculture's Memorandum 1320, Supplement 4, Nov. 2, 1953.

§143. Inspection; certified statement in lieu thereof; waiver of requirements of section 142; regulations; suspension and revocation of permits

The Secretary of Health and Human Services shall cause such inspections to be made as are necessary to insure that milk and cream are so produced and handled as to comply with the provisions of section 142 of this title, and in all cases when he finds that such milk and/or cream is produced and handled so as not to be unfit for importation under clauses 1, 2, and 3 of section 142 of this title, he shall issue to persons making application therefor permits to ship milk and/or cream into the United States: Provided, That in lieu of the inspections to be made by or under the direction of the Secretary he may, in his discretion, accept a duly certified statement signed by a duly accredited official of an authorized department of any foreign government and/or of any State of the United States or any municipality thereof that the provisions in clauses 1, 2, and 3 of section 142 of this title have been complied with. Such certificate of the accredited official of an authorized department of any foreign government shall be in the form prescribed by the Secretary, who is authorized and directed to prescribe such form as well as rules and regulations regulating the issuance of permits to import milk or cream into the United States.

The Secretary is authorized, in his discretion, to waive the requirement of clause 4 of section 142 of this title when issuing permits to operators of condenseries in which milk and/or cream is used when sterilization of the milk and/or cream is a necessary process: Provided, however, That no milk and/or cream shall be imported whose bacterial count per cubic centimeter in any event exceeds one million two hundred thousand: Provided, further, That such requirements shall not be waived unless the farm producing such milk to be imported is within a radius of fifteen miles of the condensery in which it is to be processed: Provided further, That if milk and/or cream imported when the requirements of clause 4 of section 142 of this title, have been so waived, is sold, used, or disposed of in its raw state or otherwise than as condensed milk by any person, the permit shall be revoked and the importer shall be subject to fine, imprisonment, or other penalty prescribed by this subchapter.

The Secretary is directed to waive the requirements of clauses 2 and 5 of section 142 of this title insofar as the same relate to milk when issuing permits to operators of, or to producers for delivery to, creameries and condensing plants in the United States within twenty miles of the point of production of the milk, and who import no raw milk except for pasteurization or condensing: Provided, That if milk imported when the requirements of clauses 2 and 5 of section 142 of this title have been so waived is sold, used, or disposed of in its raw state, or otherwise than as pasteurized, condensed, or evaporated milk by any person, the permit shall be revoked and the importer shall be subjected to fine, imprisonment, or other penalty prescribed by this subchapter.

The Secretary is authorized and directed to make and enforce such regulations as may in his judgment be necessary to carry out the purpose of this subchapter for the handling of milk and cream, for the inspection of milk, cream, cows, barns, and other facilities used in the production and handling of milk and/or cream and the handling, keeping, transporting, and importing of milk and/or cream: Provided, however, That unless and until the Secretary shall provide for inspections to ascertain that clauses 1, 2, and 3 of section 142 of this title have been complied with, the Secretary shall issue temporary permits to any applicants therefor to ship or transport milk and/or cream into the United States.

The Secretary is authorized to suspend or revoke any permit for the shipment of milk or cream into the United States when he shall find that the holder thereof has failed to comply with the provisions of or has violated this subchapter or any of the regulations made hereunder, or that the milk and/or cream brought or shipped by the holder of such permit into the United States is not produced and handled in conformity with, or that the quality thereof does not conform to, all of the provisions of section 142 of this title.

(Feb. 15, 1927, ch. 155, §3, 44 Stat. 1102; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.

§144. Unlawful receiving of imported milk or cream

It shall be unlawful for any person in the United States to receive milk or cream imported into the United States unless the importation is in accordance with the provisions of this subchapter.

(Feb. 15, 1927, ch. 155, §4, 44 Stat. 1103.)

§145. Penalties

Any person who knowingly violates any provision of this subchapter shall, in addition to all other penalties prescribed by law, be punished by a fine of not less than $50 nor more than $2,000, or by imprisonment for not more than one year, or by both such fine and imprisonment.

(Feb. 15, 1927, ch. 155, §5, 44 Stat. 1103.)

§146. Authorization of appropriations

There is authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, the sum of $50,000 per annum, to enable the Secretary of Health and Human Services to carry out the provisions of this subchapter.

(Feb. 15, 1927, ch. 155, §6, 44 Stat. 1103; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see Transfer of Functions notes set out under section 321 of this title.

§147. Repeal of inconsistent laws

Any laws or parts of laws inconsistent with this subchapter are repealed.

(Feb. 15, 1927, ch. 155, §7, 44 Stat. 1103.)

§148. Powers of State with respect to milk or cream lawfully imported

Nothing in this subchapter is intended nor shall be construed to affect the powers of any State, or any political subdivision thereof, to regulate the shipment of milk or cream into, or the handling, sale, or other disposition of milk or cream in, such State or political subdivision after the milk and/or cream shall have been lawfully imported under the provisions of this subchapter.

(Feb. 15, 1927, ch. 155, §8, 44 Stat. 1103.)

§149. Definitions

When used in this subchapter—

(a) The term "person" means an individual, partnership, association, or corporation.

(b) The term "United States" means the fifty States and the District of Columbia.

(Feb. 15, 1927, ch. 155, §9, 44 Stat. 1103; Pub. L. 86–70, §19, June 25, 1959, 73 Stat. 145; Pub. L. 86–624, §15, July 12, 1960, 74 Stat. 415.)

Editorial Notes

Amendments

1960—Subsec. (b). Pub. L. 86–624 substituted "means the fifty States and the District of Columbia" for "means continental United States, including Alaska".

1959—Subsec. (b). Pub. L. 86–70 inserted ", including Alaska" after "continental United States".

CHAPTER 5—VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS

        

Statutory Notes and Related Subsidiaries

Federal Food, Drug, and Cosmetic Act

Nothing contained in chapter 9 (§301 et seq.) of this title shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of this chapter, see section 392(b) of this title.

§151. Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments

It shall be unlawful for any person, firm, or corporation to prepare, sell, barter, or exchange in the District of Columbia, or in the Territories, or in any place under the jurisdiction of the United States, or to ship or deliver for shipment in or from the United States, the District of Columbia, any territory of the United States, or any place under the jurisdiction of the United States, any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals, and no person, firm, or corporation shall prepare, sell, barter, exchange, or ship as aforesaid any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals, unless and until the said virus, serum, toxin, or analogous product shall have been prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding an unsuspended and unrevoked license issued by the Secretary of Agriculture as hereinafter authorized.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 832; Pub. L. 99–198, title XVII, §1768(a), Dec. 23, 1985, 99 Stat. 1654.)

Editorial Notes

Codification

The sections of this chapter are comprised of the sentences of the eighth paragraph under the heading "Bureau of Animal Industry," in the Department of Agriculture Appropriation Act, 1914, as amended.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Amendments

1985—Pub. L. 99–198 substituted "in or from the United States, the District of Columbia, any territory of the United States, or any place under the jurisdiction of the United States" for "from one State or Territory or the District of Columbia to any other State or Territory or the District of Columbia".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Pub. L. 99–198, title XVII, §1768(f), Dec. 23, 1985, 99 Stat. 1655, provided that:

"(1) Except as provided in paragraph (2), the amendments made by this section [enacting sections 154a and 159 of this title and amending this section and sections 154 and 157 of this title] shall become effective on the date of enactment of this Act [Dec. 23, 1985].

"(2)(A) Subject to subparagraphs (B) through (D), in the case of a person, firm, or corporation preparing, selling, bartering, exchanging, or shipping a virus, serum, toxin, or analogous product during the 12-month period ending on the date of enactment of this Act [Dec. 23, 1985] solely for intrastate commerce or for exportation, such product shall not after such date of enactment, as a result of its not having been licensed or produced in a licensed establishment, be considered in violation of the eighth paragraph of the matter under the heading 'BUREAU OF ANIMAL INDUSTRY' of the Act entitled 'An Act making appropriations for the Department of Agriculture for the fiscal year ending June thirtieth, nineteen hundred and fourteen', approved March 14, 1913 (as amended by this section) [this chapter], until the first day of the 49th month following the date of enactment of this Act.

"(B) The exemption granted by subparagraph (A) may be extended by the Secretary of Agriculture for a period up to 12 months in an individual case on a showing by a person, firm, or corporation of good cause and a good faith effort to comply with such eighth paragraph with due diligence.

"(C) The exemption granted by subparagraph (A) must be claimed by the person, firm, or corporation preparing such product by the first day of the 13th month following the date of enactment of this Act [Dec. 23, 1985], in the form and manner prescribed by the Secretary, unless the Secretary grants an extension of the time to claim such exemption in an individual case for good cause shown.

"(D) On the issuance by the Secretary of a license to such person, firm, or corporation for such product prior to the first day of the 49th month following the date of enactment of this Act [Dec. 23, 1985], or the end of an extension of the exemption granted by the Secretary, the exemption granted by subparagraph (A) shall terminate with respect to such product."

Short Title

Act Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 832, which is classified to this chapter, is popularly known as the "Virus-Serum-Toxin Act".

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

Appropriations

An appropriation of $25,000 was made by act Mar. 4, 1913, for the purpose of carrying into effect these provisions. The appropriation for the fiscal year 1926 was by act Feb. 10, 1925, ch. 200, 43 Stat. 827.

§152. Importation regulated and prohibited

The importation into the United States of any virus, serum, toxin, or analogous product for use in the treatment of domestic animals, and the importation of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, is prohibited without (1) a permit from the Secretary of Agriculture, or (2) in the case of an article originating in Canada, such permit or, in lieu of such permit, such certification by Canada as may be prescribed by the Secretary of Agriculture.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 832; Pub. L. 100–449, title III, §301(d), Sept. 28, 1988, 102 Stat. 1868.)

Amendment of Section

For termination of amendment by section 501(c) of Pub. L. 100–449, see Effective and Termination Dates of 1988 Amendment note below.

Editorial Notes

Codification

See note set out under section 151 of this title.

Amendments

1988—Pub. L. 100–449 temporarily amended section generally. Prior to amendment, section read as follows: "The importation into the United States, without a permit from the Secretary of Agriculture, of any virus, serum, toxin, or analogous product for use in the treatment of domestic animals, and the importation of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, are prohibited." See Effective and Termination Dates of 1988 Amendment note below.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1988 Amendment

Amendment by Pub. L. 100–449 effective on the date the United States-Canada Free-Trade Agreement enters into force (Jan. 1, 1989), and to cease to have effect on the date the Agreement ceases to be in force, see section 501(a), (c) of Pub. L. 100–449, set out in a note under section 2112 of Title 19, Customs Duties.

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

§153. Inspection of imports; denial of entry and destruction

The Secretary of Agriculture is authorized to cause the Bureau of Animal Industry to examine and inspect all viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals, which are being imported or offered for importation into the United States, to determine whether such viruses, serums, toxins, and analogous products are worthless, contaminated, dangerous, or harmful, and if it shall appear that any such virus, serum, toxin, or analogous product, for use in the treatment of domestic animals, is worthless, contaminated, dangerous, or harmful, the same shall be denied entry and shall be destroyed or returned at the expense of the owner or importer.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 832.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Statutory Notes and Related Subsidiaries

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

§154. Regulations for preparation and sale; licenses

The Secretary of Agriculture is authorized to make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange, or shipment as aforesaid of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, or otherwise to carry out this chapter, and to issue, suspend, and revoke licenses for the maintenance of establishments for the preparation of viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals, intended for sale, barter, exchange, or shipment as aforesaid.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 832; Pub. L. 99–198, title XVII, §1768(b), Dec. 23, 1985, 99 Stat. 1654.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Amendments

1985—Pub. L. 99–198 inserted "or otherwise to carry out this chapter," after "domestic animals,".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–198 effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99–198, set out as a note under section 151 of this title.

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

§154a. Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria

In order to meet an emergency condition, limited market or local situation, or other special circumstance (including production solely for intrastate use under a State-operated program), the Secretary may issue a special license under an expedited procedure on such conditions as are necessary to assure purity, safety, and a reasonable expectation of efficacy. The Secretary shall exempt by regulation from the requirement of preparation pursuant to an unsuspended and unrevoked license any virus, serum, toxin, or analogous product prepared by any person, firm, or corporation—

(1) solely for administration to animals of such person, firm, or corporation;

(2) solely for administration to animals under a veterinarian-client-patient relationship in the course of the State licensed professional practice of veterinary medicine by such person, firm, or corporation; or

(3) solely for distribution within the State of production pursuant to a license granted by such State under a program determined by the Secretary to meet criteria under which the State—

(A) may license virus, serum, toxin, and analogous products and establishments that produce such products;

(B) may review the purity, safety, potency, and efficacy of such products prior to licensure;

(C) may review product test results to assure compliance with applicable standards for purity, safety, and potency, prior to release to the market;

(D) may deal effectively with violations of State law regulating virus, serum, toxin, and analogous products; and

(E) exercises the authority referred to in subclauses (A) through (D) consistent with the intent of this chapter of prohibiting the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous products.

(Mar. 4, 1913, ch. 145, §1 [part], as added Pub. L. 99–198, title XVII, §1768(c), Dec. 23, 1985, 99 Stat. 1654.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99–198, set out as an Effective Date of 1985 Amendment note under section 151 of this title.

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

§155. Permits for importation

The Secretary of Agriculture is authorized to issue permits for the importation into the United States of viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals, which are not worthless, contaminated, dangerous, or harmful.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Statutory Notes and Related Subsidiaries

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

§156. Licenses conditioned on permitting inspection; suspension of licenses

All licenses issued under authority of this chapter to establishments where such viruses, serums, toxins, or analogous products are prepared for sale, barter, exchange, or shipment as aforesaid, shall be issued on condition that the licensee shall permit the inspection of such establishments and of such products and their preparation; and the Secretary of Agriculture may suspend or revoke any permit or license issued under authority of said chapter, after opportunity for hearing has been granted the licensee or importer, when the Secretary of Agriculture is satisfied that such license or permit is being used to facilitate or effect the preparation, sale, barter, exchange, or shipment as aforesaid, or the importation into the United States of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning act Mar. 4, 1913, ch. 145, 37 Stat. 828, which enacted this chapter, sections 155 and 393 of Title 7, Agriculture, section 316 of Title 15, Commerce and Trade, sections 501, 502, 512, 558, and 560 of Title 16, Conservation, and section 630 of former Title 31, Money and Finance, and amended section 83 of former Title 5, Executive Departments and Government Officers and Employees, and sections 518 and 673 of Title 16.

Section 316 of Title 15 was omitted from the Code as superseded by section 5701 et seq. of Title 5, Government Organization and Employees. Section 630 of former Title 31 was repealed by act Sept. 12, 1950, ch. 946, title III, §301(64), 64 Stat. 842. Section 83 of former Title 5 was repealed and reenacted as section 5946 of Title 5 by Pub. L. 89–554, Sept. 6, 1966, 80 Stat. 514. For complete classification of act Mar. 4, 1913, to the Code, see Tables.

Codification

See note set out under section 151 of this title.

Statutory Notes and Related Subsidiaries

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

§157. Inspection

Any officer, agent, or employee of the Department of Agriculture duly authorized by the Secretary of Agriculture for the purpose may, at any hour during the daytime or nighttime, enter and inspect any establishment where any virus, serum, toxin, or analogous product for use in the treatment of domestic animals is prepared for sale, barter, exchange, or shipment as aforesaid.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833; Pub. L. 99–198, title XVII, §1768(d), Dec. 23, 1985, 99 Stat. 1655.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Amendments

1985—Pub. L. 99–198 struck out "licensed under this chapter" after "enter and inspect any establishment".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–198 effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99–198, set out as a note under section 151 of this title.

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

§158. Offenses; punishment

Any person, firm, or corporation who shall violate any of the provisions of this chapter shall be deemed guilty of a misdemeanor, and shall, upon conviction, be punished by a fine of not exceeding $1,000 or by imprisonment not exceeding one year, or by both such fine and imprisonment, in the discretion of the court.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833.)

Editorial Notes

References in Text

For explanation of "this chapter", referred to in text, see References in Text note set out under section 156 of this title.

Codification

See note set out under section 151 of this title.

§159. Enforcement; penalties applicable; Congressional findings

The procedures of sections 672, 673, and 674 of this title (relating to detentions, seizures and condemnations, and injunctions, respectively) shall apply to the enforcement of this chapter with respect to any product prepared, sold, bartered, exchanged, or shipped in violation of this chapter or a regulation promulgated under this chapter. The provisions (including penalties) of section 675 of this title shall apply to the performance of official duties under this chapter. Congress finds that (i) the products and activities that are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce or the free flow thereof, and (ii) regulation of the products and activities as provided in this chapter is necessary to prevent and eliminate burdens on such commerce and to effectively regulate such commerce.

(Mar. 4, 1913, ch. 145, §1 (part), as added Pub. L. 99–198, title XVII, §1768(e), Dec. 23, 1985, 99 Stat. 1655.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99–198, set out as an Effective Date of 1985 Amendment note under section 151 of this title.

CHAPTER 5A—BUREAU OF NARCOTICS

§§161 to 165. Omitted

Editorial Notes

Codification

Section 161, acts June 14, 1930, ch. 488, §1, 46 Stat. 585; Oct. 15, 1949, ch. 695, §6(a), 63 Stat. 881, established a Bureau of Narcotics in the Department of the Treasury and provided for appointment of a Commissioner of Narcotics for the Bureau with duty of making an annual report to Congress.

Section 162, acts June 14, 1930, ch. 488, §2, 46 Stat. 585; June 26, 1930, ch. 623, §1, 46 Stat. 819; Oct. 27, 1970, Pub. L. 91–513, title III, §1101(a)(4), 84 Stat. 1291, provided for appointment and compensation of a deputy commissioner and other personnel for the Bureau of Narcotics, required the deputy to be an acting Commissioner during absence or disability of the Commissioner or a vacancy in the office, and authorized designation of a member of the Treasury Department as an acting Commissioner in event there is no Commissioner or deputy commissioner.

Section 163, act Mar. 3, 1927, ch. 348, §4(a), 44 Stat. 1382, provided for transfer of control of narcotic drugs to the Secretary of the Treasury from the Commissioner of Internal Revenue and his assistants, agents, and inspectors.

Section 164, acts June 14, 1930, ch. 488, §3, 46 Stat. 586; June 26, 1930, ch. 623, §2, 46 Stat. 819; Ex. Ord. No. 6639, Mar. 10, 1934, abolished the Federal Narcotics Control Board and transferred powers of such Board to the Commissioner of Narcotics, authorized the Secretary of the Treasury to confer or impose his duties under section 163 of this title upon the Commissioner or other personnel of the Bureau of Narcotics, continued in effect orders, rules, and regulations in existence on July 1, 1930, until modified, superseded, or repealed by the Commissioner, with approval of the Secretary of the Treasury, and provided for determination before such Bureau of Narcotics of proceedings, investigations, and other matters pending on July 1, 1930 before Bureau of Prohibition or Federal Narcotics Control Board respecting narcotic drug law administration or enforcement. Bureau of Prohibition personnel, records, property, and unexpended balances of appropriations were previously transferred to Bureau of Narcotics as were powers of the Attorney General respecting the Bureau of Prohibition to the Commissioner of Internal Revenue.

Section 165, act June 14, 1930, ch. 488, §5, 46 Stat. 587, provided for review of decisions of Commissioner of Narcotics by the Secretary of the Treasury.

Executive Documents

Transfer of Functions

Functions of the Secretary of the Treasury administered through or respecting the Bureau of Narcotics and all functions of the Bureau, the Commissioner of Narcotics, and the officers, employees and agencies of the Bureau were transferred to the Attorney General and the Bureau and the office of Commissioner of Narcotics were abolished by Reorg. Plan No. 1 of 1968, eff. Apr. 8, 1968, 33 F.R. 5611, 82 Stat. 1367, set out in the Appendix to Title 5, Government Organization and Employees. All positions, personnel, property, records, and unexpended balances of appropriations, allocations, and other funds of the Bureau and the Treasury Department, in connection with functions transferred under this reorganization plan, were transferred to the Justice Department.

The Bureau of Narcotics and Dangerous Drugs, including the office of Director thereof, in the Department of Justice was abolished by Reorg. Plan No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, set out in the Appendix to Title 5, Government Organization and Employees. Reorg. Plan No. 2 of 1973 also created in the Department of Justice a single, comprehensive agency for the enforcement of drug laws to be known as the Drug Enforcement Administration, empowered the Attorney General to authorize the performance by officers, employees, and agencies of the Department of functions transferred to him, and directed the Attorney General to coordinate all drug law enforcement functions to assure maximum cooperation between the Drug Enforcement Administration, the Federal Bureau of Investigation, and the other units of the Department of Justice involved in drug law enforcement.

CHAPTER 6—NARCOTIC DRUGS

Executive Documents

Executive Order No. 10302

Ex. Ord. No. 10302, Nov. 5, 1951, 16 F.R. 11257, formerly set out as a note preceding section 171, which established the Interdepartmental Committee on Narcotics, was revoked by Ex. Ord. No. 11529, Apr. 24, 1970, 35 F.R. 6697.

IMPORTATION OR EXPORTATION

§§171 to 174. Repealed. Pub. L. 91–513, title III, §1101(a)(2), (4), Oct. 27, 1970, 84 Stat. 1291

Section 171, acts Feb. 9, 1909, ch. 100, §1, 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 14, 1930, ch. 488, §3, 46 Stat. 586; July 1, 1944, ch. 377, §8, 58 Stat. 721; Mar. 8, 1946, ch. 81, §7, 60 Stat. 39; Aug. 8, 1953, ch. 394, §8, 67 Stat. 506, defined "narcotic drug", "United States", and "person". See section 801 et seq. of this title.

Section 172, acts Feb. 9, 1909, ch. 100, §2(a), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; June 7, 1924, ch. 352, 43 Stat. 657, established a Federal Narcotics Control Board. Act May 26, 1922, ch. 202, §1, 42 Stat. 596, also classified to this section, was repealed by Pub. L. 89–554, §8(a), Sept. 6, 1966, 80 Stat. 645.

Section 173, acts Feb. 9, 1909, ch. 100, §2(b), (d), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; June 14, 1930, ch. 488, §3, 46 Stat. 586, prohibited importation of narcotic drugs. See section 801 et seq. of this title.

Section 173a, act June 14, 1930, ch. 488, §6, 46 Stat. 587, provided for importation of additional amounts of coca leaves.

Section 174, acts Feb. 9, 1909, ch. 100, §2(c), (f), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; Nov. 2, 1951, ch. 666, §§1, 5(1), 65 Stat. 767; July 18, 1956, ch. 629, title I, §105, 70 Stat. 570, set penalties for bringing narcotic drugs into the United States contrary to law. See chapter 13 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective on first day of seventh calendar month that begins after Oct. 27, 1970, see section 1105(a) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Pub. L. 91–513, title III, §1103, Oct. 27, 1970, 84 Stat. 1294, provided that:

"(a) Prosecutions for any violation of law occurring prior to the effective date of section 1101 [the first day of the seventh calendar month that begins after Oct. 26, 1970] shall not be affected by the repeals or amendments made by such section or section 1102 [repealing sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199, 501 to 517 of this title, sections 1401 to 1407, and 3616 of Title 18, Crimes and Criminal Procedure, sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to 4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237, 7238, and 7491 of Title 26, Internal Revenue Code, sections 529a and 529g of former Title 31, Money and Finance, and section 1421m of Title 48, Territories and Insular Possessions, and amending sections 162 and 967 of this title, section 4251 of Title 18, section 1584 of Title 19, Customs Duties, sections 4901, 4905, 6808, 7012, 7103, 7236, 7607, 7609, 7641, 7651, and 7655 of Title 26, section 2901 of Title 28, Judiciary and Judicial Procedure, sections 529d, 529e, and 529f of former Title 31, section 304m of former Title 40, Public Buildings, Property, and Works, section 3411 of Title 42, The Public Health and Welfare, section 239a of Title 46, Shipping, and section 787 of former Title 49, Transportation], or abated by reason thereof.

"(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of section 1101 [the first day of the seventh calendar month that begins after Oct. 26, 1970] shall not be affected by the repeals or amendments made by such section or section 1102, or abated by reason thereof."

§175. Repealed. June 27, 1952, ch. 477, title IV, §403(a)(10), 66 Stat. 279

Section, acts Feb. 9, 1909, ch. 100, §2(e), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, related to deportation of convicted aliens. See section 1251 et seq. of Title 8, Aliens and Nationality.

§§176 to 185. Repealed. Pub. L. 91–513, title III, §1101(a)(2), (9), Oct. 27, 1970, 84 Stat. 1291, 1292

Section 176, acts Feb. 9, 1909, ch. 100, §2(g), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202 §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, covered liability of masters of vessels and persons in charge of railroad cars and other vehicles used to carry narcotic drugs.

Section 176a, act Feb. 9, 1909, ch. 100, §2(h), as added July 18, 1956, ch. 629, title I, §106, 70 Stat. 570, covered illegal importation of marihuana and set penalties for such illegal importation. See section 801 et seq. of this title.

Section 176b, act Feb. 9, 1909, ch. 100, §2(i), as added July 18, 1956, ch. 629, title I, §107, 70 Stat. 571, prohibited sale of heroin to juveniles and set penalties for such illegal sale. See section 801 et seq. of this title.

Section 177, acts Feb. 9, 1909, ch. 100, §2(a), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, vested administration of Narcotic Drugs Import and Export Act in Department of the Treasury.

Section 178, act Feb. 9, 1909, ch. 100, §4, as added Jan. 17, 1914, ch. 9, 38 Stat. 275, prohibited possession of smoking opium. See section 801 et seq. of this title.

Section 179, act Feb. 9, 1909, ch. 100, §4, as added Jan. 17, 1914, ch. 9, 38 Stat. 275, covered liability of masters of vessels and persons in charge of railroad cars or other vehicles for possession of smoking heroin. See section 801 et seq. of this title.

Section 180, act Feb. 9, 1909, ch. 100, §5, as added Jan. 17, 1914, ch. 9, 38 Stat. 275; amended May 26, 1922, ch. 202, §2, 42 Stat. 597; June 14, 1930, ch. 488, §3, 46 Stat. 586, prohibited admission of smoking opium even for transportation to another country or for transferal from one vessel to another.

Section 181, act Feb. 9, 1909, ch. 100, §3, as added Jan. 17, 1914, ch. 9, 38 Stat. 275, created a presumption of illegal importation based upon presence of smoking opium in United States.

Section 182, act Feb. 9, 1909, ch. 100, §6, as added Jan. 17, 1914, ch. 9, 348 Stat. 275; amended May 26, 1922, ch. 202, §2, 42 Stat. 597; June 14, 1930, ch. 488, §3, 46 Stat. 586; Apr. 22, 1960, Pub. L. 86–429, §15, 74 Stat. 66, forbade exportation of narcotic drugs. See section 801 et seq. of this title.

Section 183, act Feb. 9, 1909, ch. 100, §7, as added Jan. 17, 1914, ch. 9, 38 Stat. 277, set out penalties for illegal exportation of narcotic drugs.

Section 184, act Feb. 9, 1909, ch. 100, §8, as added Jan. 17, 1914, ch. 9, 38 Stat. 277; amended May 26, 1922, ch. 202, §3, 42 Stat. 598, provided for seizure and forfeiture of narcotic drugs found on vessels and not shown on manifest or landed from vessels without a permit.

Section 184a, acts July 11, 1941, ch. 289, §1, 55 Stat. 584; July 18, 1956, ch. 629, title I, §108, 70 Stat. 571, made illegal bringing on board a vessel of United States any narcotic drugs not constituting a part of the cargo.

Section 185, act Feb. 9, 1909, ch. 100, §9, as added May 26, 1922, ch. 202, §4, 42 Stat. 598, authorized the citation of act Feb. 9, 1909, ch. 100, as the "Narcotic Drugs Import and Export Act".

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title.

MARIHUANA AND HEALTH REPORTING

§§186, 187. Transferred

Editorial Notes

Codification

Section 186, Pub. L. 91–296, title V, §501, June 30, 1970, 84 Stat. 352, which related to congressional findings as to marihuana use, the need for a better understanding of the health consequences, and the lack of information thereto, was transferred and set out as a note under section 242 of Title 42, The Public Health and Welfare.

Section 187, Pub. L. 91–296, title V, §502, June 30, 1970, 84 Stat. 352, which directed the Secretary of Health, Education and Welfare to report to Congress on the current information on the health consequence of marihuana use, with recommendations for legislative and administrative action and to submit a preliminary report no later than 90 days after June 30, 1970, was transferred and set out as a note under section 242 of Title 42.

DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM POPPY

§§188 to 188n. Repealed. Pub. L. 91–513, title III, §1101(a)(7), Oct. 27, 1970, 84 Stat. 1292

Sections, acts Dec. 11, 1942, ch. 720, 56 Stat. 1045; June 25, 1959, Pub. L. 86–70, §20, 73 Stat. 145; July 12, 1960, Pub. L. 86–624, §16, 74 Stat. 415, known as the "Opium Poppy Control Act of 1942", provided for the domestic control of production and distribution of the opium poppy. Sections 1 to 17 of said Act of Dec. 11, 1942, were classified, respectively, to sections 188, 188 notes, and 188a to 188n of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under section 171 of this title.

IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY UNITED STATES CITIZENS

§§191 to 193. Repealed. Pub. L. 91–513, title III, §1101(a)(1), Oct. 27, 1970, 84 Stat. 1291

Sections, acts Feb. 23, 1887, ch. 210, 24 Stat. 409; June 25, 1948, ch. 646, §§5, 39, 62 Stat. 986, 992, prohibited importation of opium by Chinese subjects and the trafficking in, in China, of opium by United States citizens. Sections 1 to 3 of said Act of Feb. 23, 1887, were classified to sections 191 to 193, respectively, of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a Savings Provision note under section 171 of this title.

MISCELLANEOUS

§196. Repealed. July 1, 1944, ch. 373, title XIII, §1313, 58 Stat. 714

Section, act June 14, 1930, ch. 488, §4(b), (c), 46 Stat. 587; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, related to studies and investigations by Surgeon General of the Public Health Service. See section 242 of Title 42, The Public Health and Welfare.

Editorial Notes

Renumbering of Repealing Act

Title XIII, §1313, formerly title VI, §611, of act July 1, 1944, which repealed these sections, was renumbered title VII, §711, by act Aug. 13, 1946, ch. 958, §5, 60 Stat. 1049; §713, by act Feb. 28, 1948, ch. 83, §9(b), 62 Stat. 47; title VIII, §813, by act July 30, 1956, ch. 779, §3(b), 70 Stat. 721; title IX, §913, by Pub. L. 88–581, §4(b), Sept. 4, 1964, 78 Stat. 919; title X, §1013, by Pub. L. 89–239, §3(b), Oct. 6, 1965, 79 Stat. 931; title XI, §1113, by Pub. L. 91–572, §6(b), Dec. 24, 1970, 84 Stat. 1506; title XII, §1213, by Pub. L. 92–294, §3(b), May 16, 1972, 86 Stat. 137; title XIII, §1313, by Pub. L. 93–154, §2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was repealed by Pub. L. 93–222, §7(b), Dec. 29, 1973, 87 Stat. 936.

§§197, 198. Repealed. Pub. L. 91–513, title III, §1101(a)(4), Oct. 27, 1970, 84 Stat. 1291

Section 197, act June 14, 1930, ch. 488, §7, 46 Stat. 587, directed Secretary of the Treasury to cooperate with Secretary of State in discharge of international obligations of United States concerning traffic in narcotic drugs.

Section 198, acts June 14, 1930, ch. 488, §8, 46 Stat. 587; July 18, 1956, ch. 629, title III, §302, 70 Stat. 575, directed Secretary of the Treasury to cooperate with the several States in suppression of abuse of narcotic drugs in their respective jurisdictions.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title.

§§198a to 198c. Transferred

Editorial Notes

Codification

Section 198a, act Aug. 11, 1955, ch. 800, §1, 69 Stat. 684, as amended, which related to the authority of Secretary of the Treasury to issue subpenas, administer oaths and compel attendance of witnesses for purpose of any investigation, was transferred to section 967 of this title.

Section 198b, act Aug. 11, 1955, ch. 800, §2, 69 Stat. 685, which related to service of subpenas and proof of service, was transferred to section 968 of this title.

Section 198c, act Aug. 11, 1955, ch. 800, §3, 69 Stat. 685, which related to contempt proceedings, was transferred to section 969 of this title.

§199. Repealed. Pub. L. 91–513, title III, §1101(a)(5), Oct. 27, 1970, 84 Stat. 1292

Section, act July 3, 1930, ch. 829, 46 Stat. 850, authorized payment to persons giving information concerning violations of narcotics laws. See section 886(a) of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of this section by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under section 171 of this title.

§§200 to 200b. Repealed. Nov. 2, 1951, ch. 666, §5(2), 65 Stat. 769

Sections, acts Aug. 12, 1937, ch. 598, §§1–3, 50 Stat. 627; July 1, 1944, ch. 377, §9, 58 Stat. 721; Mar. 8, 1946, ch. 81, §8, 60 Stat. 39, related to punishment for offenses after first offense. See section 801 et seq. of this title.

Statutory Notes and Related Subsidiaries

Savings Provision

Act Nov. 2, 1951, ch. 666, §6, 65 Stat. 769, provided that any rights or liabilities now existing under former sections 200 to 200b of this title should not be affected by their repeal.

CHAPTER 7—PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA

        

§201. Doing business without a license unlawful; employment of Chinese subjects

It shall be unlawful in the consular districts of the United States in China for any person whose permanent allegiance is due to the United States not licensed as a pharmacist within the meaning of this chapter to conduct or manage any pharmacy, drug or chemical store, apothecary shop, or other place of business for the retailing, compounding, or dispensing of any drugs, chemicals, or poisons, or for the compounding of physicians' prescriptions, or to keep exposed for sale at retail, any drugs, chemicals, or poisons, except as hereinafter provided, or, except as hereinafter provided, for any person whose permanent allegiance is due to the United States not licensed as a pharmacist within the meaning of this chapter to compound, dispense, or sell, at retail, any drug, chemical, poison, or pharmaceutical preparation upon the prescription of a physician, or otherwise, or to compound physicians' prescriptions, except as an aid to and under the proper supervision of a pharmacist licensed under this chapter. And it shall be unlawful for any person, firm, or corporation owing permanent allegiance to the United States owning partly or wholly or managing a pharmacy, drug store, or other place of business to cause or permit any person other than a licensed pharmacist to compound, dispense, or sell at retail any drug, medicine, or poison, except as an aid to and under the proper supervision of a licensed pharmacist. Where it is necessary for a person, firm, or corporation whose permanent allegiance is due to the United States and owning partly or wholly or managing a pharmacy, drug store, or other place of business to employ Chinese subjects to compound, dispense, or sell at retail any drug, medicine, or poison, such person, firm, or corporation, owner, part owner, or manager of a pharmacy, drug store, or other place of business may employ such Chinese subjects when their character, ability, and age of twenty-one years or over have been certified to by at least two recognized and reputable practitioners of medicine, or two pharmacists licensed under this chapter whose permanent allegiance is due to the United States.

(Mar. 3, 1915, ch. 74, §1, 38 Stat. 817.)

Editorial Notes

Codification

Section is comprised of part of section 1 of act Mar. 3, 1915. Remainder of such section 1 is classified to section 202 of this title.

§202. Certain classes of persons and corporations excepted; insecticides

Nothing in section 201 of this title shall be construed to interfere with any recognized and reputable practitioner of medicine, dentistry, or veterinary surgery in the compounding of his own prescriptions, or to prevent him from supplying to his patients such medicines as he may deem proper, except as hereinafter provided; nor with the exclusively wholesale business of any person, firm, or corporation whose permanent allegiance is due to the United States dealing and licensed as pharmacists, or having in their employ at least one person who is so licensed, except as hereinafter provided; nor with the sale by persons, firms, or corporations whose permanent allegiance is due to the United States other than pharmacists of poisonous substances sold exclusively for use in the arts, or as insecticides, when such substances are sold in unbroken packages bearing labels having plainly printed upon them the name of the contents, the word "Poison", when practicable the name of at least one suitable antidote, and the name and address of the vender.

(Mar. 3, 1915, ch. 74, §1, 38 Stat. 818.)

Editorial Notes

Codification

Section is comprised of part of section 1 of act Mar. 3, 1915. Remainder of such section 1 is classified to section 201 of this title.

§203. Application for license; requirements; qualifications for license

Every person whose permanent allegiance is due to the United States desiring to practice as a pharmacist in the consular districts in China shall file with the consul an application, duly verified under oath, setting forth the name and age of the applicant, the place or places at which he pursued and the time spent in the study of pharmacy, the experience which the applicant has had in compounding physicians' prescriptions under the direction of a licensed pharmacist, and the name and location of the school or college of pharmacy, if any, of which he is a graduate, and shall submit evidence sufficient to show to the satisfaction of said consul that he is of good moral character and not addicted to the use of alcoholic liquors or narcotic drugs so as to render him unfit to practice pharmacy. Applicants shall be not less than twenty-one years of age and shall have had at least four years' experience in the practice of pharmacy or shall have served three years under the instruction of a regularly licensed pharmacist, and any applicant who has been graduated from a school or college of pharmacy recognized by the proper board of his State, Territory, District of Columbia, or other possession of the United States as in good standing shall be entitled to practice upon presentation of his diploma.

(Mar. 3, 1915, ch. 74, §2, 38 Stat. 818.)

Editorial Notes

Codification

The words "now practicing as a pharmacist or," which preceded "desiring to practice" in the original text of this section, were omitted as obsolete.

§204. Issuance of license

If the applicant for license as a pharmacist has complied with the requirements of section 203 of this title, the consul shall issue to him a license which shall entitle him to practice pharmacy in the consular districts of the United States in China, subject to the provisions of this chapter.

(Mar. 3, 1915, ch. 74, §3, 38 Stat. 819.)

§205. Display of license in pharmacy

Every license to practice pharmacy shall be conspicuously displayed by the person to whom the same has been issued in the pharmacy, drug store, or place of business, if any, of which the said person is the owner or part owner or manager.

(Mar. 3, 1915, ch. 74, §5, 38 Stat. 819.)

§206. Revocation of license

The license of any person whose permanent allegiance is due to the United States to practice pharmacy in the consular districts of the United States in China may be revoked by the consul if such person be found to have obtained such license by fraud, or be addicted to the use of any narcotic or stimulant, or to be suffering from physical or mental disease, in such manner and to such extent as to render it expedient that in the interests of the public his license be canceled; or to be of an immoral character; or if such person be convicted in any court of competent jurisdiction of any offense involving moral turpitude. It shall be the duty of the consul to investigate any case in which it is discovered by him or made to appear to his satisfaction that any license issued under the provisions of this chapter is revocable and shall, after full hearing, if in his judgment the facts warrant it, revoke such license.

(Mar. 3, 1915, ch. 74, §4, 38 Stat. 819.)

§207. Restrictions on sales; written orders or prescriptions

It shall be unlawful for any person, firm, or corporation whose permanent allegiance is due to the United States, either personally or by servant or agent or as the servant or agent of any other person or of any firm or corporation, to sell, furnish, or give away any cocaine, salts of cocaine, or preparation containing cocaine or salts of cocaine, or morphine or preparation containing morphine or salts of morphine, or any opium or preparation containing opium, or any chloral hydrate or preparation containing chloral hydrate, except upon the original written order or prescription of a recognized and reputable practitioner of medicine, dentistry, or veterinary medicine, which order or prescription shall be dated and shall contain the name of the person for whom prescribed, or, if ordered by a practitioner of veterinary medicine, shall state the kind of animal for which ordered and shall be signed by the person giving the order or prescription. Such order or prescription shall be, for a period of three years, retained on file by the person, firm, or corporation who compounds or dispenses the article ordered or prescribed, and it shall not be compounded or dispensed after the first time except upon the written order of the original prescriber.

(Mar. 3, 1915, ch. 74, §6, 38 Stat. 819.)

Editorial Notes

Codification

Section is comprised of part of section 6 of act Mar. 3, 1915. Remainder of such section 6 is classified to section 208 of this title.

§208. Certain preparations and sales excepted

The provisions of section 207 of this title shall not apply to preparations containing not more than two grains of opium or not more than one-quarter grain of morphine, or not more than one-quarter grain of cocaine, or not more than two grains of chloral hydrate in the fluid ounce, or, of a solid preparation, in one avoirdupois ounce, nor shall they apply to preparations sold in good faith for diarrhea and cholera, each bottle or package of which is accompanied by specific directions for use and caution against habitual use, nor to liniments or ointments sold in good faith as such when plainly labeled "for external use only", nor to powder of ipecac and opium, commonly known as Dover's powder, when sold in quantities not exceeding twenty grains. The provisions of this section or section 207 of this title shall not be construed to permit the selling, furnishing, giving away, or prescribing for the use of any habitual users of the same any cocaine, salts of cocaine, or preparation containing cocaine or salts of cocaine, or morphine or salts of morphine, or preparations containing morphine or salts of morphine, or any opium or preparation containing opium, or any chloral hydrate or preparation containing chloral hydrate. But the preceding sentence shall not be construed to prevent any recognized or reputable practitioner of medicine whose permanent allegiance is due to the United States from furnishing in good faith for the use of any habitual user of narcotic drugs who is under his professional care such substances as he may deem necessary for their treatment, when such prescriptions are not given or substances furnished for the purpose of evading the provisions of this section. But the provisions of this section or section 207 of this title shall not apply to sales at wholesale between jobbers, manufacturers, and retail druggists, hospitals, and scientific or public institutions.

(Mar. 3, 1915, ch. 74, §6, 38 Stat. 819.)

Editorial Notes

Codification

Section is comprised of section 6 of act Mar. 3, 1915. Remainder of such section 6 is classified to section 207 of this title.

§209. Poisons; book entry of sale; labels

It shall be unlawful for any person, firm, or corporation whose permanent allegiance is due to the United States to sell or deliver to any other person any of the following-described substances, or any poisonous compound, combination, or preparation thereof, to wit: The compounds of and salts of antimony, arsenic, barium, chromium, copper, gold, lead, mercury, silver, and zinc, the caustic hydrates of sodium and potassium, solution or water of ammonia, methyl alcohol, paregoric, the concentrated mineral acids, oxalic and hydrocyanic acids and their salts, yellow phosphorus, Paris green, carbolic acid, the essential oils of almonds, pennyroyal, tansy, rue, and savin; croton oil, creosote, chloroform, cantharides, or aconite, belladonna, bitter almonds, colchicum, cotton root, cocculus indicus, conium, cannabis indica, digitalis, ergot, hyoscyamus, ignatia, lobelia, nux vomica, physostigma, phytolacca, strophanthus, stramonium, veratrum viride, or any of the poisonous alkaloids or alkaloidal salts derived from the foregoing, or any other poisonous alkaloids or their salts, or any other virulent poison, except in the manner following, and, moreover, if the applicant be less than eighteen years of age, except upon the written order of a person known or believed to be an adult.

It shall first be learned, by due inquiry, that the person to whom delivery is about to be made is aware of the poisonous character of the substance and that it is desired for a lawful purpose, and the box, bottle, or other package shall be plainly labeled with the name of the substance, the word "Poison", the name of at least one suitable antidote, when practicable, and the name and address of the person, firm, or corporation dispensing the substance. And before delivery be made of any of the foregoing substances, excepting solution or water of ammonia and sulphate of copper, there shall be recorded in a book kept for that purpose the name of the article, the quantity delivered, the purpose for which it is to be used, the date of delivery, the name and address of the person for whom it is procured, and the name of the individual personally dispensing the same; and said book shall be preserved by the owner thereof for at least three years after the date of the last entry therein. The foregoing provisions shall not apply to articles dispensed upon the order of persons believed by the dispenser to be recognized and reputable practitioners of medicine, dentistry, or veterinary surgery. When a physician writes upon his prescription a request that it be marked or labeled "Poison" the pharmacist shall, in the case of liquids, place the same in a colored glass, roughened bottle, of the kind commonly known in trade as a "poison bottle", and, in the case of dry substances, he shall place a poison label upon the container. The record of sale and delivery above mentioned shall not be required of manufacturers and wholesalers who shall sell any of the foregoing substances at wholesale to licensed pharmacists, but the box, bottle, or other package containing such substance, when sold at wholesale, shall be properly labeled with the name of the substance, the word "Poison," and the name and address of the manufacturer or wholesaler. It shall not be necessary, in sales either at wholesale or at retail, to place a poison label upon, nor to record the delivery of, the sulphide of antimony, or the oxide or carbonate of zinc, or of colors ground in oil and intended for use as paints, or calomel; nor in the case of preparations containing any of the substances named in this section, when a single box, bottle, or other package, or when the bulk of one-half fluid ounce or the weight of one-half avoirdupois ounce does not contain more than an adult medicinal dose of such substance; nor in the case of liniments or ointments sold in good faith as such, when plainly labeled "For external use only"; nor, in the case of preparations put up and sold in the form of pills, tablets, or lozenges, containing any of the substances enumerated in this section and intended for internal use, when the dose recommended does not contain more than one-fourth of an adult medicinal dose of such substance.

For the purpose of this and of every other section of this chapter no box, bottle, or other package shall be regarded as having been labeled "Poison" unless the word "Poison" appears conspicuously thereon, printed in plain, uncondensed gothic letters in red ink.

(Mar. 3, 1915, ch. 74, §7, 38 Stat. 820.)

§210. Pharmacist; unauthorized use of title

It shall be unlawful for any person whose permanent allegiance is due to the United States, not legally licensed as a pharmacist, to take, use, or exhibit the title of pharmacist, or licensed or registered pharmacist, or the title of druggist or apothecary, or any other title or description of like import.

(Mar. 3, 1915, ch. 74, §10, 38 Stat. 821.)

§211. Preservation of originals of prescriptions compounded and copies thereof; inspection of prescriptions by consular officers; marking containers of drugs

Every person, firm, or corporation whose permanent allegiance is due to the United States owning, partly owning, or managing a drug store or pharmacy shall keep in his place of business a suitable book or file, in which shall be preserved for a period of not less than three years the original of every prescription compounded or dispensed at such store or pharmacy, or a copy of such prescription, except when the preservation of the original is required by section 207 or 208 of this title. Upon request the owner, part owner, or manager of such store shall furnish to the prescribing physician, or to the person for whom such prescription was compounded or dispensed, a true and correct copy thereof. Any prescription required by section 207 or 208 of this title, and any prescription for, or register of sales of, substances mentioned in such sections shall at all times be open to inspection by duly authorized consular officers in the consular districts of the United States in China. No person, firm, or corporation whose permanent allegiance is due to the United States shall, in a consular district, compound or dispense any drug or drugs or deliver the same to any other person without marking on the container thereof the name of the drug or drugs contained therein and directions for using the same.

(Mar. 3, 1915, ch. 74, §9, 38 Stat. 821.)

§212. Offenses; punishment; duty to enforce provisions

Any person, firm, or corporation, whose permanent allegiance is due to the United States, violating any of the provisions of this chapter shall be deemed guilty of a misdemeanor and, upon conviction thereof, shall be punished by a fine of not less than $50 and not more than $100 or by imprisonment for not less than one month and not more than sixty days, or by both such fine and imprisonment, in the discretion of the court, and if the offense be continuing in its character, each week or part of a week during which it continues shall constitute a separate and distinct offense. And it shall be the duty of the consular and judicial officers of the United States in China to enforce the provisions of this chapter.

(Mar. 3, 1915, ch. 74, §11, 38 Stat. 821.)

§213. Fraudulent representations to evade or defeat restrictions

No person, firm, or corporation whose permanent allegiance is due to the United States seeking to procure in the consular districts of the United States in China any substance the sale of which is regulated by the provisions of this chapter shall make any fraudulent representations so as to evade or defeat the restrictions herein imposed.

(Mar. 3, 1915, ch. 74, §8, 38 Stat. 821.)

§214. Previous laws unaffected

Nothing in this chapter shall be construed as modifying or revoking any of the provisions of sections 191 to 193 ¹ of this title.

(Mar. 3, 1915, ch. 74, §13, 38 Stat. 822.)

Editorial Notes

References in Text

Sections 191 to 193 of this title, referred to in text, were repealed by Pub. L. 91–513, title III, §1101(a)(1), Oct. 27, 1970, 84 Stat. 1291. See section 801 et seq. of this title.

¹ See References in Text note below.

§215. "Consul" defined

The word "consul" as used in this chapter shall mean the consular officer in charge of the district concerned.

(Mar. 3, 1915, ch. 74, §12, 38 Stat. 822.)

CHAPTER 8—NARCOTIC FARMS

§§221 to 237. Repealed. July 1, 1944, ch. 373, title XIII, §1313, 58 Stat. 714

Section 221, act Jan. 19, 1929, ch. 82, §1, 45 Stat. 1085, defined "habit-forming narcotic drug", "narcotic", and "addict". See section 201 of Title 42, The Public Health and Welfare.

Section 222, act Jan. 19, 1929, ch. 82, §2, 45 Stat. 1085, provided for narcotic farms.

Section 222a, act June 23, 1935, ch. 725, §1, 49 Stat. 1840, provided name for narcotic farm at Lexington, Ky.

Section 222b, act Mar. 28, 1938, ch. 55, §1, 52 Stat. 134, provided name for narcotic farm at Fort Worth, Texas.

Section 223, act Jan. 19, 1929, ch. 82, §3, 45 Stat. 1085; 1939 Reorg. Plan No. I, §205(b), eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1425, provided for an annual estimate of expenses of maintenance of narcotic farms.

Section 224, act Jan. 19, 1929, ch. 82, §4, 45 Stat. 1086, provided for construction of buildings for two of the narcotic farms.

Section 225, acts Jan. 19, 1929, ch. 82, §5, 45 Stat. 1086; June 14, 1930, ch. 488, §4(a), 46 Stat. 586; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, provided for control and management of narcotic farms.

Section 226, act Jan. 19, 1929, ch. 82, §6, 45 Stat. 1086; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for care and treatment of addicts.

Section 227, act Jan. 19, 1929, ch. 82, §7, 45 Stat. 1086, provided for transfer to and from farms of addicts who are prisoners.

Section 228, act Jan. 19, 1929, ch. 82, §8, 45 Stat. 1087, provided that it was the duty of prosecuting officers to report convicted persons believed to be addicts.

Section 229, act Jan. 19, 1929, ch. 82, §9, 45 Stat. 1087; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for employment of addicts.

Section 230, act Jan. 19, 1929, ch. 82, §10, 45 Stat. 1087, provided for parole of inmates.

Section 231, act Jan. 19, 1929, ch. 82, §11, 45 Stat. 1087; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for discharge of addicts.

Section 232, act Jan. 19, 1929, ch. 82, §12, 45 Stat. 1088; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for admission of voluntary patients.

Section 233, act Jan. 19, 1929, ch. 82, §13, 45 Stat. 1088; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for furnishing of gratuities and transportation to discharged convicts.

Section 234, act. Jan. 19, 1929, ch. 82, §14, 45 Stat. 1089; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided penalties for introduction of narcotic drugs into a narcotic farm.

Section 235, act Jan. 19, 1929, ch. 82, §15, 45 Stat. 1089, provided penalties for escape of inmates.

Section 236, act Jan. 19, 1929, ch. 82, §16, 45 Stat. 1089, provided penalties for procuring of escape by inmates.

Section 237, act Jan. 19, 1929, ch. 82, §17, 45 Stat. 1089, provided for deportation of alien inmates who are entitled to a discharge from narcotic farms.

Editorial Notes

Renumbering of Repealing Act

Title XIII, §1313, formerly title VI, §611, of act July 1, 1944, which repealed these sections, was renumbered title VII, §711, by act Aug. 13, 1946, ch. 958, §5, 60 Stat. 1049; §713, by act Feb. 28, 1948, ch. 83, §9(b), 62 Stat. 47; title VIII, §813, by act July 30, 1956, ch. 779, §3(b), 70 Stat. 721; title IX, §913, by Pub. L. 88–581, §4(b), Sept. 4, 1964, 78 Stat. 919; title X, §1013, by Pub. L. 89–239, §3(b), Oct. 6, 1965, 79 Stat. 931; title XI, §1113, by Pub. L. 91–572, §6(b), Dec. 24, 1970, 84 Stat. 1506; title XII, §1213, by Pub. L. 92–294, §3(b), May 16, 1972, 86 Stat. 137; title XIII, §1313, by Pub. L. 93–154, §2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was repealed by Pub. L. 93–222, §7(b), Dec. 29, 1973, 87 Stat. 936.

 

CHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER I—SHORT TITLE

        

SUBCHAPTER II—DEFINITIONS

        

SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES

        

SUBCHAPTER IV—FOOD

        

SUBCHAPTER V—DRUGS AND DEVICES

Part A—Drugs and Devices

        

Part B—Drugs for Rare Diseases or Conditions

        

Part C—Electronic Product Radiation Control

        

Part D—Dissemination of Treatment Information

        

Part E—General Provisions Relating to Drugs and Devices

        

Part F—New Animal Drugs for Minor Use and Minor Species

        

Part G—Medical Gases

        

Part H—Pharmaceutical Distribution Supply Chain

        

Part I—Nonprescription Sunscreen and Other Active Ingredients

        

SUBCHAPTER VI—COSMETICS

        

SUBCHAPTER VII—GENERAL AUTHORITY

Part A—General Administrative Provisions

        

Part B—Colors

        

Part C—Fees

subpart 1—freedom of information fees

        

subpart 2—fees relating to drugs

        

subpart 3—fees relating to devices

        

subpart 4—fees relating to animal drugs

        

subpart 5—fees relating to generic new animal drugs

        

subpart 6—fees related to food

        

subpart 7—fees relating to generic drugs

        

subpart 8—fees relating to biosimilar biological products

        

subpart 9—fees relating to outsourcing facilities

        

subpart 10—fees relating to over-the-counter drugs

        

Part D—Information and Education

        

Part E—Environmental Impact Review

        

Part F—National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics

        

Part G—Safety Reports

        

Part H—Serious Adverse Event Reports

        

Part I—Reagan-Udall Foundation for the Food and Drug Administration

        

SUBCHAPTER VIII—IMPORTS AND EXPORTS

        

SUBCHAPTER IX—TOBACCO PRODUCTS

        

SUBCHAPTER X—MISCELLANEOUS

        

SUBCHAPTER I—SHORT TITLE

§301. Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

(June 25, 1938, ch. 675, §1, 52 Stat. 1040.)

Statutory Notes and Related Subsidiaries

Effective Date; Postponement in Certain Cases

Act June 23, 1939, ch. 242, §§1, 2, 53 Stat. 853, 854, provided that:

"[Sec. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this title].

"(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940[,] the effective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; and 602(b) [362(b) of this title] of such Act with respect to lithographed labeling which was manufactured prior to February 1, 1939, and to containers bearing labeling which, prior to February 1, 1939, was lithographed, etched, stamped, pressed, printed, fused or blown on or in such containers, where compliance with such provisions would be unduly burdensome by reason of causing the loss of valuable stocks of such labeling or containers, and where such postponement would not prevent the public interest being adequately served: Provided, That in no case shall such regulations apply to labeling which would not have complied with the requirements of the Food and Drugs Act of June 30, 1906, as amended.

"Sec. 2. (a) The provisions of section 8 [section 10 of this title], paragraph fifth, under the heading 'In the case of food:', of the Food and Drugs Act of June 30, 1906, as amended, and regulations promulgated thereunder, and all other provisions of such Act to the extent that they may relate to the enforcement of such section 8 [section 10 of this title] and of such regulations, shall remain in force until January 1, 1940.

"(b) The provisions of such Act of June 30, 1906, as amended, [sections 1 to 5, 7 to 15, and 372a of this title] to the extent that they impose, or authorize the imposition of, any requirement imposed by section 403(k) of the Federal Food, Drug, and Cosmetic Act [section 343(k) of this title], shall remain in force until January 1, 1940.

"(c) Notwithstanding the provisions of section 1 of this Act, such section shall not apply—

"(1) to the provisions of section 502(d) and (e) of the Federal Food, Drug, and Cosmetic Act [352(d), (e) of this title], insofar as such provisions relate to any substance named in section 8 [section 10 of this title], paragraph second, under the heading 'In the case of drugs:', of the Food and Drugs Act of June 30, 1906, as amended, or a derivative of any such substance; or

"(2) to the provisions of section 502(b), (d), (e), (f), (g), and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d) to (h) of this title], insofar as such provisions relate to drugs to which section 505 [355 of this title] of such Act applies."

Effective Date

Act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, provided that: "This Act [enacting this chapter and repealing sections 1 to 5 and 7 to 15 of this title], shall take effect twelve months after the date of its enactment [June 25, 1938]. The Federal Food and Drugs Act of June 30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1–15), shall remain in force until such effective date, and, except as otherwise provided in this subsection, is hereby repealed effective upon such date: Provided, That the provisions of section 701 [section 371 of this title] shall become effective on the enactment of this Act, and thereafter the Secretary is authorized hereby to (1) conduct hearings and to promulgate regulations which shall become effective on or after the effective date of this Act as the Secretary shall direct, and (2) designate prior to the effective date of this Act food having common or usual names and exempt such food from the requirements of clause (2) of section 403(i) [section 343(i) of this title] for a reasonable time to permit the formulation, promulgation, and effective application of definitions and standards of identity therefor as provided by section 401 [section 341 of this title]: Provided further, That sections 502(j), 505, and 601(a) [sections 352(j), 355, 361(a), respectively of this title], and all other provisions of this Act to the extent that they may relate to the enforcement of such sections, shall take effect on the date of the enactment of this Act, except that in the case of a cosmetic to which the proviso of section 601(a) [section 361(a) of this title], relates, such cosmetic shall not, prior to the ninetieth day after such date of enactment, be deemed adulterated by reason of the failure of its label to bear the legend prescribed in such proviso: Provided further, That the Act of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 [section 321a of this title]; 42 Stat. 1500, ch. 268), defining butter and providing a standard therefor; the Act of July 24, 1919 (U.S.C., 1934 ed., title 21, sec. 10 [section 321b of this title]; 41 Stat. 271, ch. 26], defining wrapped meats as in package form; and the amendment to the Food and Drugs Act, section 10A, approved August 27, 1935 (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a [section 372a of this title]) shall remain in force and effect and be applicable to the provisions of this Act."

Short Title of 2023 Amendment

Pub. L. 118–15, div. B, title III, §2301(a), Sept. 30, 2023, 137 Stat. 86, provided that: "This chapter [chapter 1 (§§2301–2307) of subtitle A of title III of div. B of Pub. L. 118–15, amending sections 379j–11 to 379j–13 of this title, enacting provisions set out as notes under sections 379j–11 to 379j–13 of this title, and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title] may be cited as the 'Animal Drug User Fee Amendments of 2023'."

Pub. L. 118–15, div. B, title III, §2311(a), Sept. 30, 2023, 137 Stat. 90, provided that: "This chapter [chapter 2 (§§2311–2316) of subtitle A of title III of div. B of Pub. L. 118–15, amending sections 379j–21 and 379j–22 of this title, enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–21 and 379j–22 of this title] may be cited as the 'Animal Generic Drug User Fee Amendments of 2023'."

Short Title of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3001, Dec. 29, 2022, 136 Stat. 5807, provided that: "This title [see Tables for classification] may be cited as the 'Food and Drug Omnibus Reform Act of 2022'."

Pub. L. 117–328, div. FF, title III, §3501, Dec. 29, 2022, 136 Stat. 5847, provided that: "This subtitle [subtitle E (§§3501–3508), enacting sections 364 to 364j of this title, amending sections 331, 361, 362, 374, and 381 of this title, and enacting provisions set out as notes under sections 331, 364, 364d, and 364e of this title] may be cited as the 'Modernization of Cosmetics Regulation Act of 2022'."

Pub. L. 117–180, div. F, §1, Sept. 30, 2022, 136 Stat. 2139, provided that: "This division [see Tables for classification] may be cited as the 'FDA User Fee Reauthorization Act of 2022'."

Pub. L. 117–180, div. F, title I, §1001(a), Sept. 30, 2022, 136 Stat. 2140, provided that: "This title [amending sections 379g, 379h, and 379h–2 of this title, enacting notes set out under sections 379g and 379h–2 of this title, and repealing notes set out under sections 379g and 379h–2 of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2022'."

Pub. L. 117–180, div. F, title II, §2001(a), Sept. 30, 2022, 136 Stat. 2147, provided that: "This title [amending sections 360d, 360m, and 379i to 379j–1 of this title, enacting notes set out under sections 360d, 379i, and 379j–1 of this title, and repealing provisions set out as notes under sections 379i and 379j–1 of this title] may be cited as the 'Medical Device User Fee Amendments of 2022'."

Pub. L. 117–180, div. F, title III, §3001(a), Sept. 30, 2022, 136 Stat. 2155, provided that: "This title [amending sections 379j–42 and 379j–43 of this title, enacting provisions set out as notes under sections 379j–41 and 379j–43 of this title, and repealing provisions set out as notes under sections 379j–41 and 379j–43 of this title] may be cited as the 'Generic Drug User Fee Amendments of 2022'."

Pub. L. 117–180, div. F, title IV, §4001(a), Sept. 30, 2022, 136 Stat. 2160, provided that: "This title [amending sections 379j–51 to 379j–53 of this title, enacting provisions set out as notes under sections 379j–51 and 379j–53 of this title, and repealing provisions set out as notes under sections 379j–51 and 379j–53 of this title] may be cited as the 'Biosimilar User Fee Amendments of 2022'."

Pub. L. 117–101, §1, Mar. 15, 2022, 136 Stat. 47, provided that: "This Act [amending section 379dd of this title and section 290b of Title 42, The Public Health and Welfare] may be cited as the 'Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act'."

Short Title of 2021 Amendment

Pub. L. 117–79, §1, Dec. 23, 2021, 135 Stat. 1533, provided that: "This Act [enacting section 360ee–1 of this title, section 280g–7b of Title 42, The Public Health and Welfare, and provisions set out as notes under sections 360aa and 360ee of this title] may be cited as the 'Accelerating Access to Critical Therapies for ALS Act'."

Pub. L. 117–11, §1, Apr. 23, 2021, 135 Stat. 262, provided that: "This Act [amending section 321 of this title and enacting provisions set out as a note under section 321 of this title] may be cited as the 'Food Allergy Safety, Treatment, Education, and Research Act of 2021' or the 'FASTER Act of 2021'."

Pub. L. 116–304, §1, Jan. 5, 2021, 134 Stat. 4915, provided that: "This Act [amending sections 321 and 381 of this title] may be cited as the 'Safeguarding Therapeutics Act'."

Pub. L. 116–290, §1, Jan. 5, 2021, 134 Stat. 4889, provided that: "This Act [amending section 355 of this title and enacting provisions set out as a note under section 355 of this title] may be cited as the 'Orange Book Transparency Act of 2020'."

Short Title of 2018 Amendment

Pub. L. 115–271, §1(a), Oct. 24, 2018, 132 Stat. 3894, provided that: "This Act [see Tables for classification] may be cited as the 'Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act' or the 'SUPPORT for Patients and Communities Act'."

Pub. L. 115–271, title III, §3011, Oct. 24, 2018, 132 Stat. 3935, provided that: "This chapter [chapter 2 (§§3011–3014) of subtitle A of title III of Pub. L. 115–271, enacting sections 360bbb–8d and 384f of this title, amending sections 331 and 381 of this title, and enacting provisions set out as a note under section 331 of this title] may be cited as the 'Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act' or the 'SCREEN Act'."

Pub. L. 115–271, title III, §3021, Oct. 24, 2018, 132 Stat. 3938, provided that: "This chapter [chapter 3 (§§3021, 3022) of subtitle A of title III of Pub. L. 115–271, enacting section 384g of this title and amending sections 331, 335a, and 381 of this title] may be cited as the 'Stop Illicit Drug Importation Act of 2018'."

Pub. L. 115–271, title III, §3031, Oct. 24, 2018, 132 Stat. 3940, provided that: "This chapter [chapter 4 (§§3031, 3032) of subtitle A of title III of Pub. L. 115–271, amending section 355–1 of this title] may be cited as the 'Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018' or the 'SOUND Disposal and Packaging Act'."

Pub. L. 115–234, §1, Aug. 14, 2018, 132 Stat. 2427, provided that: "This Act [amending sections 348, 352, 360b, 360ccc, 360ccc–1, 379j–11 to 379j–13, 379–21, 379j–22, and 2102 of this title, enacting provisions set out as notes under this section and sections 348, 352, 360b, 360ccc–1, 379j–11 to 379j–13, 379j–21, and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–12, 379j–13, 379j–21, and 379j–22 of this title] may be cited as the 'Animal Drug and Animal Generic Drug User Fee Amendments of 2018'."

Pub. L. 115–234, title I, §101(a), Aug. 14, 2018, 132 Stat. 2428, provided that: "This title [amending sections 379j–11 to 379j–13 of this title, enacting provisions set out as notes under sections 379j–11 to 379j–13 of this title, and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title] may be cited as the 'Animal Drug User Fee Amendments of 2018'."

Pub. L. 115–234, title II, §201(a), Aug. 14, 2018, 132 Stat. 2432, provided that: "This title [amending sections 379j–21 and 379j–22 of this title, enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–21 and 379j–22 of this title] may be cited as the 'Animal Generic Drug User Fee Amendments of 2018'."

Pub. L. 115–176, §1, May 30, 2018, 132 Stat. 1372, provided that: "This Act [enacting section 360bbb–0a of this title and provisions set out as a note under section 360bbb–0a of this title] may be cited as the 'Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017'."

Short Title of 2017 Amendment

Pub. L. 115–52, §1, Aug. 18, 2017, 131 Stat. 1005, provided that: "This Act [see Tables for classification] may be cited as the 'FDA Reauthorization Act of 2017'."

Pub. L. 115–52, title I, §101(a), Aug. 18, 2017, 131 Stat. 1006, provided that: "This title [amending sections 379h, 379h–2, and 379j–12 of this title, enacting provisions set out as notes under sections 379g and 379h–2 of this title, and repealing provisions set out as notes under sections 379g and 379h–2 of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2017'."

Pub. L. 115–52, title II, §201(a), Aug. 18, 2017, 131 Stat. 1013, provided that: "This title [amending sections 360d, 360e, 360m, 379d–3, 379i, 379j, 379j–1, and 379k–1 of this title, enacting provisions set out as notes under sections 379i and 379j–1 of this title, and repealing provisions set out as a note under section 379i of this title] may be cited as the 'Medical Device User Fee Amendments of 2017'."

Pub. L. 115–52, title III, §301(a), Aug. 18, 2017, 131 Stat. 1020, provided that: "This title [amending sections 379j–41 to 379j–43 of this title, enacting provisions set out as notes under sections 379j–41 and 379j–43 of this title, and repealing provisions set out as notes under sections 379j–41 and 379j–43 of this title] may be cited as the 'Generic Drug User Fee Amendments of 2017'."

Pub. L. 115–52, title IV, §401(a), Aug. 18, 2017, 131 Stat. 1028, provided that: "This title [amending sections 379j–51 to 379j–53 of this title, enacting provisions set out as notes under sections 379j–51 and 379j–53 of this title, and repealing provisions set out as notes under sections 379j–51 and 379j–53 of this title] may be cited as the 'Biosimilar User Fee Amendments of 2017'."

Short Title of 2016 Amendment

Pub. L. 114–229, §1, Sept. 30, 2016, 130 Stat. 943, provided that: "This Act [amending section 360ff of this title and enacting provisions set out as a note under section 360ff of this title] may be cited as the 'Advancing Hope Act of 2016'."

Pub. L. 114–146, §1, Apr. 19, 2016, 130 Stat. 357, provided that: "This Act [amending section 360n of this title] may be cited as the 'Adding Zika Virus to the FDA Priority Review Voucher Program Act'."

Short Title of 2015 Amendment

Pub. L. 114–114, §1, Dec. 28, 2015, 129 Stat. 3129, provided that: "This Act [amending section 331 of this title and enacting provisions set out as notes under section 331 of this title] may be cited as the 'Microbead-Free Waters Act of 2015'."

Pub. L. 114–89, §1, Nov. 25, 2015, 129 Stat. 698, provided that: "This Act [amending sections 355, 360b, 360ccc to 360ccc–2, 811, 823, and 953 of this title, section 156 of Title 35, Patents, and section 262 of Title 42, The Public Health and Welfare] may be cited as the 'Improving Regulatory Transparency for New Medical Therapies Act'."

Short Title of 2014 Amendment

Pub. L. 113–233, §1, Dec. 16, 2014, 128 Stat. 2127, provided that: "This Act [amending section 360n of this title] may be cited as the 'Adding Ebola to the FDA Priority Review Voucher Program Act'."

Pub. L. 113–195, §1, Nov. 26, 2014, 128 Stat. 2035, provided that: "This Act [enacting part I of subchapter V of this chapter and provisions set out as a note under section 360fff of this title] may be cited as the 'Sunscreen Innovation Act'."

Short Title of 2013 Amendment

Pub. L. 113–54, §1, Nov. 27, 2013, 127 Stat. 587, provided that: "This Act [enacting part H of subchapter V and subpart 9 of part C of subchapter VII of this chapter and sections 353a–1 and 353b of this title, amending sections 331, 333, 352 to 353a, 353b, 353c, and 360eee–1 of this title, and enacting provisions set out as notes under this section and sections 331, 333, and 353 of this title] may be cited as the 'Drug Quality and Security Act'."

Pub. L. 113–54, title I, §101, Nov. 27, 2013, 127 Stat. 587, provided that: "This Act [probably means "This title", enacting subpart 9 of part C of subchapter VII of this chapter and sections 353a–1 and 353b of this title, amending sections 331, 352, 353a, 353b, and 353c of this title, and enacting provisions set out as notes under this section and section 331 of this title] may be cited as the 'Compounding Quality Act'."

Pub. L. 113–54, title II, §201, Nov. 27, 2013, 127 Stat. 599, provided that: "This title [enacting part H of subchapter V of this chapter, amending sections 331, 333, 352, 353, and 360eee–1 of this title, and enacting provisions set out as notes under sections 331, 333, and 353 of this title] may be cited as the 'Drug Supply Chain Security Act'."

Pub. L. 113–14, §1, June 13, 2013, 127 Stat. 451, provided that: "This Act [amending sections 379j–11 to 379j–13, 379j–21, and 379j–22 of this title, enacting provisions set out as notes under this section and sections 379j–11 to 379j–13, 379j–21, and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–11, 379j–21, and 379j–22 of this title] may be cited as the 'Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013'."

Pub. L. 113–14, title I, §101(a), June 13, 2013, 127 Stat. 451, provided that: "This title [amending sections 379j–11 to 379j–13 of this title, enacting provisions set out as notes under sections 379j–11 to 379j–13 of this title, and repealing provisions set out as notes under section 379j–11 of this title] may be cited as the 'Animal Drug User Fee Amendments of 2013'."

Pub. L. 113–14, title II, §201(a), June 13, 2013, 127 Stat. 464, provided that: "This title [amending sections 379j–21 and 379j–22 of this title, enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–21 and 379j–22 of this title] may be cited as the 'Animal Generic Drug User Fee Amendments of 2013'."

Short Title of 2012 Amendment

Pub. L. 112–193, §1, Oct. 5, 2012, 126 Stat. 1443, provided that: "This Act [amending sections 352, 379j, and 379j–42 of this title and enacting provisions set out as a note under section 379j–42 of this title] may be cited as the 'FDA User Fee Corrections Act of 2012'."

Pub. L. 112–144, §1, July 9, 2012, 126 Stat. 993, provided that: "This Act [see Tables for classification] may be cited as the 'Food and Drug Administration Safety and Innovation Act'."

Pub. L. 112–144, title I, §101(a), July 9, 2012, 126 Stat. 996, provided that: "This title [amending sections 379g, 379h, and 379h–2 of this title, enacting provisions set out as notes under sections 379g and 379h–2 of this title, and repealing provisions set out as notes under sections 379g and 379h–2 of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2012'."

Pub. L. 112–144, title II, §201(a), July 9, 2012, 126 Stat. 1002, provided that: "This title [enacting section 379d–3 of this title, amending sections 360e, 379i, 379j, and 379j–1 of this title, enacting provisions set out as notes under section 379i of this title, and repealing provisions set out as notes under section 379i of this title] may be cited as the 'Medical Device User Fee Amendments of 2012'."

Pub. L. 112–144, title III, §301(a), July 9, 2012, 126 Stat. 1008, provided that: "This title [enacting sections 379d–4 and 379j–41 to 379j–43 of this title, amending sections 352 and 379d–3 of this title, and enacting provisions set out as notes under sections 379j–41 and 379j–43 of this title] may be cited as the 'Generic Drug User Fee Amendments of 2012'."

Pub. L. 112–144, title IV, §401(a), July 9, 2012, 126 Stat. 1026, provided that: "This title [enacting sections 379j–51 to 379j–53 of this title, amending sections 379d–4 and 379g of this title, and enacting provisions set out as notes under sections 379g, 379j–51, and 379j–53 of this title] may be cited as the 'Biosimilar User Fee Act of 2012'."

Short Title of 2009 Amendment

Pub. L. 111–31, div. A, §1(a), June 22, 2009, 123 Stat. 1776, provided that: "This division [enacting subchapter IX of this chapter, amending sections 321, 331, 333, 334, 355, 360m, 372 to 374, 375, 379a, 381, 391 to 393, 394 to 399a, and 679 of this title and sections 1333, 1334, 4402, 4406, and 4408 of Title 15, Commerce and Trade, enacting provisions set out as notes under sections 331, 333, 387, and 387c of this title and sections 1333 and 4402 of Title 15, and amending provisions set out as notes under this section and section 392 of this title] may be cited as the 'Family Smoking Prevention and Tobacco Control Act'."

Short Title of 2008 Amendment

Pub. L. 110–316, title I, §101(a), Aug. 14, 2008, 122 Stat. 3509, provided that: "This title [enacting section 379j–13 of this title, amending sections 360b, 379j–11, and 379j–12 of this title, and enacting provisions set out as notes under sections 360b and 379j–11 of this title] may be cited as the 'Animal Drug User Fee Amendments of 2008'."

Pub. L. 110–316, title II, §201(a), Aug. 14, 2008, 122 Stat. 3515, provided that: "This title [enacting sections 379j–21 and 379j–22 of this title, amending sections 379k, 379l, and 379o of this title, and enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title] may be cited as the 'Animal Generic Drug User Fee Act of 2008'."

Short Title of 2007 Amendment

Pub. L. 110–85, §1, Sept. 27, 2007, 121 Stat. 823, provided that: "This Act [enacting part I of subchapter VII of this chapter, chapter 26 of this title, sections 350f, 353b, 355–1, 355d, 355e, 360a, 360e–1, 360n, 360bbb–5, 360bbb–6, 379d–1, 379d–2, 379h–1, 379h–2, 379j–1, and 399a of this title, and section 247d–5a of Title 42, The Public Health and Welfare, amending sections 321, 331, 333, 334, 352, 355, 355a, 355c, 360, 360e, 360i, 360j, 360l, 360m, 360ee, 374, 379g, 379h, 379i, 379j, 379j–11, 379l, 381, and 393a of this title and sections 247d–3b, 262, 282, 283, 283a–2, 283a–3, 284m, 285g–10, 288–6, and 290b of Title 42, enacting provisions set out as notes under this section and sections 331, 350f, 352, 355, 355a, 355c, 360j, 379g, 379h, 379h–2, 379i, and 2110 of this title and section 282 of Title 42, and amending provisions set out as notes under section 284m of Title 42] may be cited as the 'Food and Drug Administration Amendments Act of 2007'."

Pub. L. 110–85, title I, §101(a), Sept. 27, 2007, 121 Stat. 825, provided that: "This title [enacting sections 379h–1 and 379h–2 of this title, amending sections 379g, 379h, and 379j–11 of this title, and enacting provisions set out as notes under sections 379g, 379h, and 379h–2 of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2007'."

Pub. L. 110–85, title II, §201(a), Sept. 27, 2007, 121 Stat. 842, provided that: "This title [enacting section 379j–1 of this title, amending sections 333, 360, 360i, 360m, 374, 379i, and 379j of this title, and enacting provisions set out as notes under section 379i of this title] may be cited as the 'Medical Device User Fee Amendments of 2007'."

Pub. L. 110–85, title III, §301, Sept. 27, 2007, 121 Stat. 859, provided that: "This title [enacting section 360e–1 of this title, amending sections 360j, 360l, and 393a of this title and section 282 of Title 42, The Public Health and Welfare, enacting provisions set out as notes under section 360j of this title and section 282 of Title 42, and amending provisions set out as a note under section 284m of Title 42] may be cited as the 'Pediatric Medical Device Safety and Improvement Act of 2007'."

Pub. L. 110–85, title IV, §401, Sept. 27, 2007, 121 Stat. 866, provided that: "This title [enacting section 355d of this title, amending section 355c of this title, and enacting provisions set out as a note under section 355c of this title] may be cited as the 'Pediatric Research Equity Act of 2007'."

Pub. L. 110–85, title V, §501, Sept. 27, 2007, 121 Stat. 876, provided that: "This title [amending section 355a of this title and sections 284m, 285g–10, 288–6, and 290b of Title 42, The Public Health and Welfare, enacting provisions set out as a note under section 355a of this title, and amending provisions set out as a note under section 284m of Title 42] may be cited as the 'Best Pharmaceuticals for Children Act of 2007'."

Short Title of 2006 Amendment

Pub. L. 109–462, §1, Dec. 22, 2006, 120 Stat. 3469, provided that: "This Act [enacting sections 379aa and 379aa–1 of this title, amending sections 331, 343, 352, and 381 of this title, and enacting provisions set out as notes under sections 331, 343, 352, 379aa, and 381 of this title] may be cited as the 'Dietary Supplement and Nonprescription Drug Consumer Protection Act'."

Short Title of 2005 Amendments

Pub. L. 109–59, title VII, §7201, Aug. 10, 2005, 119 Stat. 1911, provided that: "This subtitle [subtitle B (§§7201–7204) of title VII of Pub. L. 109–59, enacting section 350e of this title, amending sections 331, 342, and 373 of this title and section 5701 of Title 49, Transportation, omitting sections 5702 to 5714 of Title 49, and enacting provisions set out as a note under section 331 of this title] may be cited as the 'Sanitary Food Transportation Act of 2005'."

Pub. L. 109–43, §1, Aug. 1, 2005, 119 Stat. 439, provided that: "This Act [amending sections 352 and 379j of this title, enacting provisions set out as a note under section 352 of this title, and amending provisions set out as notes under sections 352 and 379i of this title] may be cited as the 'Medical Device User Fee Stabilization Act of 2005'."

Short Title of 2004 Amendments

Pub. L. 108–282, title I, §101, Aug. 2, 2004, 118 Stat. 891, provided that: "This title [enacting sections 360ccc to 360ccc–2 of this title, amending sections 321, 331, 352, 353, 354, and 360b of this title, enacting provisions set out as notes under sections 360ccc and 393 of this title, and amending provisions set out as a note under section 360b of this title] may be cited as the 'Minor Use and Minor Species Animal Health Act of 2004'."

Pub. L. 108–282, title II, §201, Aug. 2, 2004, 118 Stat. 905, provided that: "This title [enacting section 374a of this title and section 242r of Title 42, The Public Health and Welfare, amending sections 321, 343, and 343–1 of this title, and enacting provisions set out as notes under sections 321 and 343 of this title and sections 243 and 300d–2 of Title 42] may be cited as the 'Food Allergen Labeling and Consumer Protection Act of 2004'."

Pub. L. 108–214, §1, Apr. 1, 2004, 118 Stat. 572, provided that: "This Act [amending sections 331, 352, 360, 360e, 374, 379i, and 379j of this title and provisions set out as notes under sections 352, 360l, and 379j of this title] may be cited as the 'Medical Devices Technical Corrections Act'."

Short Title of 2003 Amendments

Pub. L. 108–155, §1, Dec. 3, 2003, 117 Stat. 1936, provided that: "This Act [enacting section 355c of this title, amending sections 355, 355a, and 355b of this title and sections 262 and 284m of Title 42, The Public Health and Welfare, enacting provisions set out as a note under section 355c of this title, and amending provisions set out as notes under section 355a of this title and section 284m of Title 42] may be cited as the 'Pediatric Research Equity Act of 2003'."

Pub. L. 108–130, §1, Nov. 18, 2003, 117 Stat. 1361, provided that: "This Act [enacting sections 379j–11 and 379j–12 of this title and provisions set out as notes under section 379j–11 of this title] may be cited as the 'Animal Drug User Fee Act of 2003'."

Short Title of 2002 Amendments

Pub. L. 107–281, §1, Nov. 6, 2002, 116 Stat. 1992, provided that: "This Act [amending sections 360cc and 360ee of this title and enacting provisions set out as a note under section 360ee of this title] may be cited as the 'Rare Diseases Orphan Product Development Act of 2002'."

Pub. L. 107–250, §1(a), Oct. 26, 2002, 116 Stat. 1588, provided that: "This Act [enacting sections 379i and 379j of this title and section 289g–3 of Title 42, The Public Health and Welfare, amending sections 321, 331, 333, 335a, 352, 353, 360, 360c, 360e, 360m, and 374 of this title, and enacting provisions set out as notes under sections 352, 360e, 360j, 360l, 379i, and 379j of this title and section 289g–3 of Title 42] may be cited as the 'Medical Device User Fee and Modernization Act of 2002'."

Pub. L. 107–188, title V, §501, June 12, 2002, 116 Stat. 687, provided that: "This subtitle [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending sections 356b, 379g, and 379h of this title and enacting provisions set out as notes under sections 356b and 379g of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2002'."

Pub. L. 107–109, §1, Jan. 4, 2002, 115 Stat. 1408, provided that: "This Act [enacting sections 355b and 393a of this title and section 284m of Title 42, The Public Health and Welfare, amending sections 321, 355, 355a, and 379h of this title and sections 282, 284k, 284l, 285a–2, and 290b of Title 42, and enacting provisions set out as notes under sections 355 and 355a of this title and sections 284m and 289 of Title 42] may be cited as the 'Best Pharmaceuticals for Children Act'."

Short Title of 2000 Amendment

Pub. L. 106–387, §1(a) [title VII, §745(a)], Oct. 28, 2000, 114 Stat. 1549, 1549A-35, provided that: "This section [enacting section 384 of this title, amending sections 331, 333, and 381 of this title, and enacting provisions set out as a note under section 384 of this title] may be cited as the 'Medicine Equity and Drug Safety Act of 2000'."

Pub. L. 106–387, §1(a) [title VII, §746(a)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40, provided that: "This section [amending section 381 of this title and enacting provisions set out as a note under section 381 of this title] may be cited as the 'Prescription Drug Import Fairness Act of 2000'."

Short Title of 1998 Amendment

Pub. L. 105–324, §1, Oct. 30, 1998, 112 Stat. 3035, provided that: "This Act [amending sections 321 and 346a of this title] may be cited as the 'Antimicrobial Regulation Technical Corrections Act of 1998'."

Short Title of 1997 Amendment

Pub. L. 105–115, §1(a), Nov. 21, 1997, 111 Stat. 2296, provided that: "This Act [enacting sections 343–3, 353a, 355a, 356 to 356c, 360m, 360aaa to 360aaa–6, 360bbb to 360bbb–2, 379k, 379l, 379o, 379r, 379s, 379v, 396, and 397 of this title and sections 247b–8 and 299a–3 of Title 42, The Public Health and Welfare, amending sections 321, 331, 334, 335a, 343, 348, 351 to 353, 355, 360, 360b to 360e, 360g, 360i, 360j, 360l, 360aa to 360cc, 360ee, 371, 374, 379a, 379g, 379h, 381 to 383, 393, and 802 of this title, section 45C of Title 26, Internal Revenue Code, section 156 of Title 35, Patents, section 8126 of Title 38, Veterans' Benefits, and sections 262, 263a, and 282 of Title 42, repealing sections 356 and 357 of this title, and enacting provisions set out as notes under sections 321, 348, 351, 352, 353a, 355 to 356b, 360i, 360l, 360m, 360aaa, 371, 379g, 379h, 379k, and 393 of this title and sections 247b–8 and 282 of Title 42] may be cited as the 'Food and Drug Administration Modernization Act of 1997'."

Short Title of 1996 Amendments

Pub. L. 104–250, §1(a), Oct. 9, 1996, 110 Stat. 3151, provided that: "This Act [enacting section 354 of this title, amending sections 331, 353, and 360b of this title, and enacting provisions set out as notes under section 360b of this title] may be cited as the 'Animal Drug Availability Act of 1996'."

Pub. L. 104–170, title IV, §401(a), Aug. 3, 1996, 110 Stat. 1513, provided that: "This title [amending sections 321, 331, 333, 342, and 346a of this title] may be cited as the 'Food Quality Protection Act of 1996'."

[Another "Food Quality Protection Act of 1996", was enacted by Pub. L. 104–170, §1, 110 Stat. 1489, which is set out as a note under section 136 of Title 7, Agriculture.]

Pub. L. 104–134, title II, §2101(a), Apr. 26, 1996, 110 Stat. 1321–313, provided that: "This chapter [chapter 1A (§§2101–2105) of title II of Pub. L. 104–134, enacting section 382 of this title and amending sections 331 and 381 of this title and section 262 of Title 42, The Public Health and Welfare] may be cited as the 'FDA Export Reform and Enhancement Act of 1996'."

Short Title of 1994 Amendments

Pub. L. 103–417, §1(a), Oct. 25, 1994, 108 Stat. 4325, provided that: "This Act [enacting sections 343–2 and 350b of this title and section 287c–11 of Title 42, The Public Health and Welfare, amending sections 321, 331, 342, 343, and 350 of this title and section 281 of Title 42, and enacting provisions set out as notes under sections 321 and 343 of this title] may be cited as the 'Dietary Supplement Health and Education Act of 1994'."

Pub. L. 103–396, §1, Oct. 22, 1994, 108 Stat. 4153, provided that: "This Act [amending sections 331, 343–1, 360b, and 371 of this title and enacting provisions set out as notes under section 360b of this title] may be cited as the 'Animal Medicinal Drug Use Clarification Act of 1994'."

Short Title of 1993 Amendment

Pub. L. 103–80, §1, Aug. 13, 1993, 107 Stat. 773, provided that: "This Act [amending sections 321, 331 to 333, 334, 335b, 341 to 343, 346a, 350a, 352, 355 to 358, 360b to 360e, 360i, 360cc, 360hh to 360ss, 361, 371, 372, 373, 374, 376, 379e, and 381 of this title and section 263b of Title 42, The Public Health and Welfare, and enacting provisions set out as a note under section 343 of this title] may be cited as the 'Nutrition Labeling and Education Act Amendments of 1993'."

Short Title of 1992 Amendments

Pub. L. 102–571, title I, §101(a), Oct. 29, 1992, 106 Stat. 4491, provided that: "This title [enacting sections 379g and 379h of this title, transferring sections 372a, 376, and 379c of this title to sections 376, 379e and 379f, respectively, of this title, amending sections 321, 331, 342, 343, 346a, 351, 352, 360j, 361, 362, 453, 601, and 1033 of this title, enacting provisions set out as notes under section 379g of this title, and amending provisions set out as notes under sections 343 and 343–1 of this title] may be cited as the 'Prescription Drug User Fee Act of 1992'."

Pub. L. 102–571, title II, §201, Oct. 29, 1992, 106 Stat. 4500, provided that: "This title [enacting provisions set out as notes under sections 343 and 393 of this title and amending provisions set out as notes under sections 343 and 343–1 of this title] may be cited as the 'Dietary Supplement Act of 1992'."

Pub. L. 102–353, §1(a), Aug. 26, 1992, 106 Stat. 941, provided that: "This Act [amending sections 333, 353, and 381 of this title and enacting provisions set out as a note under section 353 of this title] may be cited as the 'Prescription Drug Amendments of 1992'."

Pub. L. 102–300, §1(a), June 16, 1992, 106 Stat. 238, provided that: "This Act [amending sections 321, 331, 334, 346a, 352, 353, 356, 357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to 372a, 376, and 381 of this title and section 262 of Title 42, The Public Health and Welfare and enacting and amending provisions set out as notes under section 360i of this title] may be cited as the 'Medical Device Amendments of 1992'."

Pub. L. 102–282, §1(a), May 13, 1992, 106 Stat. 149, provided that: "This Act [enacting sections 335a to 335c of this title, amending sections 321, 336, 337, and 355 of this title, and enacting provisions set out as notes under section 335a of this title] may be cited as the 'Generic Drug Enforcement Act of 1992'."

Short Title of 1990 Amendments

Pub. L. 101–635, §1(a), Nov. 28, 1990, 104 Stat. 4583, provided that: "This Act [enacting sections 379b to 379d and 394 of this title] may be cited as the 'Food and Drug Administration Revitalization Act'."

Pub. L. 101–629, §1(a), Nov. 28, 1990, 104 Stat. 4511, provided that: "This Act [enacting sections 360l and 383 of this title, amending sections 321, 333, 351, 353, and 360c to 360j of this title and sections 263b to 263n of Title 42, The Public Health and Welfare, redesignating sections 263b to 263n of Title 42 as sections 360gg to 360ss of this title, repealing section 263b of Title 42, and enacting provisions set out as notes under sections 333, 360c, 360i, 360j, 360hh and 383 of this title] may be cited as the 'Safe Medical Devices Act of 1990'."

Pub. L. 101–535, §1(a), Nov. 8, 1990, 104 Stat. 2353, provided that: "This Act [enacting section 343–1 of this title, amending sections 321, 337, 343, 345, and 371 of this title, and enacting provisions set out as notes under sections 343 and 343–1 of this title] may be cited as the 'Nutrition Labeling and Education Act of 1990'."

Short Title of 1988 Amendments

Pub. L. 100–670, §1(a), Nov. 16, 1988, 102 Stat. 3971, provided that: "This Act [amending sections 321, 353, and 360b of this title, section 2201 of Title 28, Judiciary and Judicial Procedure, and sections 156 and 271 of Title 35, Patents, and enacting provisions set out as notes under section 360b of this title] may be cited as the 'Generic Animal Drug and Patent Term Restoration Act'."

Pub. L. 100–607, title V, §501, Nov. 4, 1988, 102 Stat. 3120, provided that: "This title [enacting section 393 of this title, amending sections 5315 and 5316 of Title 5, Government Organization and Employees, and enacting provisions set out as notes under section 393 of this title] may be cited as the 'Food and Drug Administration Act of 1988'."

Pub. L. 100–293, §1(a), Apr. 22, 1988, 102 Stat. 95, provided that: "This Act [amending sections 331, 333, 353, and 381 of this title and enacting provisions set out as notes under section 353 of this title] may be cited as the 'Prescription Drug Marketing Act of 1987'."

Pub. L. 100–290, §1, Apr. 18, 1988, 102 Stat. 90, provided that: "This Act [amending sections 360bb and 360ee of this title, enacting provisions set out as a note under section 360aa of this title, and amending provisions set out as a note under section 236 of Title 42, The Public Health and Welfare] may be cited as the 'Orphan Drug Amendments of 1988'."

Short Title of 1986 Amendment

Pub. L. 99–660, title I, §101(a), Nov. 14, 1986, 100 Stat. 3743, provided that: "This title [enacting section 382 of this title, amending sections 241 and 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under section 333 of this title and section 262 of Title 42] may be cited as the 'Drug Export Amendments Act of 1986'."

Short Title of 1985 Amendment

Pub. L. 99–91, §1, Aug. 15, 1985, 99 Stat. 387, provided that: "This Act [amending sections 360aa to 360cc, and 360ee of this title, and sections 295g–1 and 6022 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under section 360aa of this title and section 236 of Title 42] may be cited as the 'Orphan Drug Amendments of 1985'."

Short Title of 1984 Amendment

Pub. L. 98–417, §1, Sept. 24, 1984, 98 Stat. 1585, provided: "That this Act [enacting section 156 of Title 35, Patents, amending sections 355 and 360cc of this title, sections 68b, 68c, and 70b of Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary and Judicial Procedure, and sections 271 and 282 of Title 35, and enacting provisions set out as notes under section 355 of this title and section 68b of Title 15] may be cited as the 'Drug Price Competition and Patent Term Restoration Act of 1984'."

Short Title of 1983 Amendments

Pub. L. 98–22, §1, Apr. 22, 1983, 97 Stat. 173, provided: "That this Act [amending provisions set out as a note under section 348 of this title] may be cited as the 'Saccharin Study and Labeling Act Amendment of 1983'."

Pub. L. 97–414, §1(a), Jan. 4, 1983, 96 Stat. 2049, provided that: "This Act [enacting part B of subchapter V of chapter 9 of this title, section 44H of Title 26, Internal Revenue Code, section 155 of Title 35, Patents, and sections 236, 255, and 298b–4 of Title 42, The Public Health and Welfare, amending sections 1274, 1472, 2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and Trade, section 904 of this title, sections 280C and 6096 of Title 26, and sections 209, 231, 242k, 242m, 243, 254c, 254j, 254m, 254o, 254p, 256, 294j, 295g–1, 295g–4, 295h, 295h–1a, 297–1, 300, 300a–1, 300a–3, 300b, 300e–1, 300m, 300n–5, 300q–2, 300u–5, 300w–3, 300x–1, 300x–4, 300y–11, 4577, and 4588 of Title 42, enacting provisions set out as notes under section 360aa of this title, section 44H of Title 26, and sections 241, 255, 287i, and 300x–1 of Title 42, and repealing provisions set out as a note under section 300t–11 of Title 42] may be cited as the 'Orphan Drug Act'."

Short Title of 1981 Amendment

Pub. L. 97–42, §1, Aug. 14, 1981, 95 Stat. 946, provided: "That this Act [amending provisions set out as a note under section 348 of this title] may be cited as the 'Saccharin Study and Labeling Act Amendment of 1981'."

Short Title of 1980 Amendment

Pub. L. 96–359, §1, Sept. 26, 1980, 94 Stat. 1190, provided: "That this Act [enacting section 350a of this title, amending sections 321, 331, 374, 830, 841 to 843, and 873 of this title, and enacting a provision set out as a note under section 350a of this title] may be cited as the 'Infant Formula Act of 1980'."

Short Title of 1977 Amendment

Pub. L. 95–203, §1, Nov. 23, 1977, 91 Stat. 1451, provided that: "This Act [enacting section 343a of this title, amending sections 321 and 343 of this title, enacting provisions set out as notes under sections 343 and 348 of this title, and amending provisions set out as notes under sections 218 and 289l–1 of Title 42, The Public Health and Welfare] may be cited as the 'Saccharin Study and Labeling Act'."

Short Title of 1976 Amendment

Pub. L. 94–295, §1(a), May 28, 1976, 90 Stat. 539, provided that: "This Act [enacting sections 360c to 360k, 379, and 379a of this title and section 3512 of Title 42, The Public Health and Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360, 374, 379e, and 381 of this title and section 55 of Title 15, Commerce and Trade] may be cited as the 'Medical Device Amendments of 1976'."

Short Title of 1972 Amendment

Pub. L. 92–387, §1, Aug. 16, 1972, 86 Stat. 559, provided that: "This Act [amending sections 331, 335, and 360 of this title and enacting provisions set out as notes under section 360 of this title] may be cited as the 'Drug Listing Act of 1972'."

Short Title of 1968 Amendments

Pub. L. 90–602, §1, Oct. 18, 1968, 82 Stat. 1173, provided that: "This Act [enacting provisions now comprising part C (§§360hh–360ss) of subchapter III of this chapter and provisions set out as notes under section 360hh of this title] may be cited as the 'Radiation Control for Health and Safety Act of 1968'."

Pub. L. 90–399, §1, July 13, 1968, 82 Stat. 342, provided: "That this Act [enacting section 360b of this title, amending sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title, and enacting provisions set out as a note under section 360b of this title] may be cited as the 'Animal Drug Amendments of 1968'."

Short Title of 1965 Amendment

Pub. L. 89–74, §1, July 15, 1965, 79 Stat. 226, provided: "That this Act [amending sections 321, 331, 333, 334, 360, and 372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure, and enacting provisions set out as notes under sections 321 and 352 of this title] may be cited as the 'Drug Abuse Control Amendments of 1965'."

Short Title of 1962 Amendment

Pub. L. 87–781, §1, Oct. 10, 1962, 76 Stat. 780, provided in part that such Act [enacting sections 358 to 360 of this title, amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e, and 381 of this title, and enacting provisions set out as notes under sections 321, 331, 332, 352, 355, 358, 360, and 374 of this title] may be cited as the 'Drug Amendments of 1962'."

Short Title of 1960 Amendment

Pub. L. 86–618, §1, July 12, 1960, 74 Stat. 397, provided: "That this Act [amending sections 321, 331, 333, 342, 346, 351, 352, 361, 362, 371, and 379e of this title, repealing sections 354 and 364 of this title, and enacting notes set out under this section] may be cited as the 'Color Additive Amendments of 1960'."

Short Title of 1958 Amendment

Pub. L. 85–929, §1, Sept. 6, 1958, 72 Stat. 1784, provided: "That this Act [amending sections 321, 331, 342, 346, 348 of this title and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321, 342, and 451 of this title] may be cited as the 'Food Additives Amendment of 1958'."

Severability

Pub. L. 113–54, title I, §106(b), Nov. 27, 2013, 127 Stat. 598, provided that: "If any provision of this Act [see Short Title of 2013 Amendment note above] (including the amendments made by this Act) is declared unconstitutional, or the applicability of this Act (including the amendments made by this Act) to any person or circumstance is held invalid, the constitutionality of the remainder of this Act (including the amendments made by this Act) and the applicability thereof to other persons and circumstances shall not be affected."

Pub. L. 110–85, title XI, §1105, Sept. 27, 2007, 121 Stat. 975, provided that: "If any provision of this Act [see Short Title of 2007 Amendment note above], an amendment made [by] this Act, or the application of such provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or circumstances shall not be affected thereby."

Hazardous Substances

Federal Hazardous Substances Act as not modifying this chapter, see Pub. L. 86–613, §18, July 12, 1960, 74 Stat. 380, set out as an Effect Upon Federal and State Laws note under section 1261 of Title 15, Commerce and Trade.

SUBCHAPTER II—DEFINITIONS

§321. Definitions; generally

For the purposes of this chapter—

(a)(1) The term "State", except as used in the last sentence of section 372(a) of this title, means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.

(2) The term "Territory" means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.

(b) The term "interstate commerce" means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.

(c) The term "Department" means Department of Health and Human Services.

(d) The term "Secretary" means the Secretary of Health and Human Services.

(e) The term "person" includes individual, partnership, corporation, and association.

(f) The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia,¹ official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

(2) The term "counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.

(h)(1) The term "device" (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 360j(o) of this title.

(2) The term "counterfeit device" means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.

(i) The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

(j) The term "official compendium" means the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.

(k) The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

(l) The term "immediate container" does not include package liners.

(m) The term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.

(o) The representation of a drug, in its labeling, as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.

(p) The term "new drug" means—

(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or

(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

(q)(1)(A) Except as provided in clause (B), the term "pesticide chemical" means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.], including all active and inert ingredients of such pesticide. Notwithstanding any other provision of law, the term "pesticide" within such meaning includes ethylene oxide and propylene oxide when such substances are applied on food.

(B) In the case of the use, with respect to food, of a substance described in clause (A) to prevent, destroy, repel, or mitigate microorganisms (including bacteria, viruses, fungi, protozoa, algae, and slime), the following applies for purposes of clause (A):

(i) The definition in such clause for the term "pesticide chemical" does not include the substance if the substance is applied for such use on food, or the substance is included for such use in water that comes into contact with the food, in the preparing, packing, or holding of the food for commercial purposes. The substance is not excluded under this subclause from such definition if the substance is ethylene oxide or propylene oxide, and is applied for such use on food. The substance is not so excluded if the substance is applied for such use on a raw agricultural commodity, or the substance is included for such use in water that comes into contact with the commodity, as follows:

(I) The substance is applied in the field.

(II) The substance is applied at a treatment facility where raw agricultural commodities are the only food treated, and the treatment is in a manner that does not change the status of the food as a raw agricultural commodity (including treatment through washing, waxing, fumigating, and packing such commodities in such manner).

(III) The substance is applied during the transportation of such commodity between the field and such a treatment facility.

(ii) The definition in such clause for the term "pesticide chemical" does not include the substance if the substance is a food contact substance as defined in section 348(h)(6) of this title, and any of the following circumstances exist: The substance is included for such use in an object that has a food contact surface but is not intended to have an ongoing effect on any portion of the object; the substance is included for such use in an object that has a food contact surface and is intended to have an ongoing effect on a portion of the object but not on the food contact surface; or the substance is included for such use in or is applied for such use on food packaging (without regard to whether the substance is intended to have an ongoing effect on any portion of the packaging). The food contact substance is not excluded under this subclause from such definition if any of the following circumstances exist: The substance is applied for such use on a semipermanent or permanent food contact surface (other than being applied on food packaging); or the substance is included for such use in an object that has a semipermanent or permanent food contact surface (other than being included in food packaging) and the substance is intended to have an ongoing effect on the food contact surface.

With respect to the definition of the term "pesticide" that is applicable to the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.], this clause does not exclude any substance from such definition.

(2) The term "pesticide chemical residue" means a residue in or on raw agricultural commodity or processed food of—

(A) a pesticide chemical; or

(B) any other added substance that is present on or in the commodity or food primarily as a result of the metabolism or other degradation of a pesticide chemical.

(3) Notwithstanding subparagraphs (1) and (2), the Administrator may by regulation except a substance from the definition of "pesticide chemical" or "pesticide chemical residue" if—

(A) its occurrence as a residue on or in a raw agricultural commodity or processed food is attributable primarily to natural causes or to human activities not involving the use of any substances for a pesticidal purpose in the production, storage, processing, or transportation of any raw agricultural commodity or processed food; and

(B) the Administrator, after consultation with the Secretary, determines that the substance more appropriately should be regulated under one or more provisions of this chapter other than sections 342(a)(2)(B) and 346a of this title.

(r) The term "raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

(s) The term "food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—

(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or

(2) a pesticide chemical; or

(3) a color additive; or

(4) any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [21 U.S.C. 601 et seq.];

(5) a new animal drug; or

(6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.

(t)(1) The term "color additive" means a material which—

(A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and

(B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto;

except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.

(2) The term "color" includes black, white, and intermediate grays.

(3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest.

(u) The term "safe" as used in paragraph (s) of this section and in sections 348, 360b, 360ccc, and 379e of this title, has reference to the health of man or animal.

(v) The term "new animal drug" means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed,—

(1) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a "new animal drug" if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or

(2) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

Provided that any drug intended for minor use or use in a minor species that is not the subject of a final regulation published by the Secretary through notice and comment rulemaking finding that the criteria of paragraphs (1) and (2) have not been met (or that the exception to the criterion in paragraph (1) has been met) is a new animal drug.

(w) The term "animal feed", as used in paragraph (w) ² of this section, in section 360b of this title, and in provisions of this chapter referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal.

(x) The term "informal hearing" means a hearing which is not subject to section 554, 556, or 557 of title 5 and which provides for the following:

(1) The presiding officer in the hearing shall be designated by the Secretary from officers and employees of the Department who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action.

(2) Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney.

(3) Before the hearing, each party to the hearing shall be given reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the action taken or proposed by the Secretary which is the subject of the hearing and a general summary of the information which will be presented by the Secretary at the hearing in support of such action.

(4) At the hearing the parties to the hearing shall have the right to hear a full and complete statement of the action of the Secretary which is the subject of the hearing together with the information and reasons supporting such action, to conduct reasonable questioning, and to present any oral or written information relevant to such action.

(5) The presiding officer in such hearing shall prepare a written report of the hearing to which shall be attached all written material presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the presiding officer's report of the hearing.

(6) The Secretary may require the hearing to be transcribed. A party to the hearing shall have the right to have the hearing transcribed at his expense. Any transcription of a hearing shall be included in the presiding officer's report of the hearing.

(y) The term "saccharin" includes calcium saccharin, sodium saccharin, and ammonium saccharin.

(z) The term "infant formula" means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.

(aa) The term "abbreviated drug application" means an application submitted under section 355(j) of this title for the approval of a drug that relies on the approved application of another drug with the same active ingredient to establish safety and efficacy, and—

(1) in the case of section 335a of this title, includes a supplement to such an application for a different or additional use of the drug but does not include a supplement to such an application for other than a different or additional use of the drug, and

(2) in the case of sections 335b and 335c of this title, includes any supplement to such an application.

(bb) The term "knowingly" or "knew" means that a person, with respect to information—

(1) has actual knowledge of the information, or

(2) acts in deliberate ignorance or reckless disregard of the truth or falsity of the information.

(cc) For purposes of section 335a of this title, the term "high managerial agent"—

(1) means—

(A) an officer or director of a corporation or an association,

(B) a partner of a partnership, or

(C) any employee or other agent of a corporation, association, or partnership,

having duties such that the conduct of such officer, director, partner, employee, or agent may fairly be assumed to represent the policy of the corporation, association, or partnership, and

(2) includes persons having management responsibility for—

(A) submissions to the Food and Drug Administration regarding the development or approval of any drug product,

(B) production, quality assurance, or quality control of any drug product, or

(C) research and development of any drug product.

(dd) For purposes of sections 335a and 335b of this title, the term "drug product" means a drug subject to regulation under section 355, 360b, or 382 of this title or under section 262 of title 42.

(ee) The term "Commissioner" means the Commissioner of Food and Drugs.

(ff) The term "dietary supplement"—

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

(2) means a product that—

(A)(i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this title; or

(ii) complies with section 350(c)(1)(B)(ii) of this title;

(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and

(C) is labeled as a dietary supplement; and

(3) does—

(A) include an article that is approved as a new drug under section 355 of this title or licensed as a biologic under section 262 of title 42 and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 342(f) of this title; and

(B) not include—

(i) an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or

(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,

which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.³

Except for purposes of paragraph (g) and section 350f of this title, a dietary supplement shall be deemed to be a food within the meaning of this chapter.

(gg) The term "processed food" means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.

(hh) The term "Administrator" means the Administrator of the United States Environmental Protection Agency.

(ii) The term "compounded positron emission tomography drug"—

(1) means a drug that—

(A) exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is used for the purpose of providing dual photon positron emission tomographic diagnostic images; and

(B) has been compounded by or on the order of a practitioner who is licensed by a State to compound or order compounding for a drug described in subparagraph (A), and is compounded in accordance with that State's law, for a patient or for research, teaching, or quality control; and

(2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic synthesizer, or other apparatus or computer program to be used in the preparation of such a drug.

(jj) The term "antibiotic drug" means any drug (except drugs for use in animals other than humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative thereof.

(kk) Priority supplement.—The term "priority supplement" means a drug application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997 (111 Stat. 2298).

(ll)(1) The term "single-use device" means a device that is intended for one use, or on a single patient during a single procedure.

(2)(A) The term "reprocessed", with respect to a single-use device, means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.

(B) A single-use device that meets the definition under clause (A) shall be considered a reprocessed device without regard to any description of the device used by the manufacturer of the device or other persons, including a description that uses the term "recycled" rather than the term "reprocessed".

(3) The term "original device" means a new, unused single-use device.

(mm)(1) The term "critical reprocessed single-use device" means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use.

(2) The term "semi-critical reprocessed single-use device" means a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.

(nn) The term "major species" means cattle, horses, swine, chickens, turkeys, dogs, and cats, except that the Secretary may add species to this definition by regulation.

(oo) The term "minor species" means animals other than humans that are not major species.

(pp) The term "minor use" means the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually.

(qq) The term "major food allergen" means any of the following:

(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame.

(2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following:

(A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil.

(B) A food ingredient that is exempt under paragraph (6) or (7) of section 343(w) of this title.

(rr)(1) The term "tobacco product" means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

(2) The term "tobacco product" does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 353(g) of this title.

(3) The products described in paragraph (2) shall be subject to subchapter V of this chapter.

(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this chapter (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).

(5) The term "tobacco product" does not mean an article that is a food under paragraph (f), if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine.

(ss) The term "critical food" means a food that is—

(1) an infant formula; or

(2) a medical food, as defined in section 360ee(b)(3) of this title.

(June 25, 1938, ch. 675, §201, 52 Stat. 1040; July 22, 1954, ch. 559, §1, 68 Stat. 511; Pub. L. 85–929, §2, Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86–618, title I, §101, July 12, 1960, 74 Stat. 397; Pub. L. 87–781, title I, §102(a), title III, §307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89–74, §§3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90–399, §102, July 13, 1968, 82 Stat. 351; Pub. L. 90–639, §§1, 4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91–513, title II, §701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92–516, §3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94–278, title V, §502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94–295, §3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95–203, §4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96–359, §3, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100–670, title I, §107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101–535, §5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101–629, §16(b), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102–282, §6, May 13, 1992, 106 Stat. 161; Pub. L. 102–300, §6(a), (b), June 16, 1992, 106 Stat. 240; Pub. L. 102–571, title I, §107(1), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §§3(b), (dd)(1), 4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103–417, §§3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104–170, title IV, §402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105–115, title I, §§121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111 Stat. 2320, 2325, 2327; Pub. L. 105–324, §2(a), (c), Oct. 30, 1998, 112 Stat. 3035, 3037; Pub. L. 107–109, §5(b)(1), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107–250, title III, §302(d), Oct. 26, 2002, 116 Stat. 1619; Pub. L. 108–282, title I, §102(b)(1), (5)(A), (B), title II, §203(c)(1), Aug. 2, 2004, 118 Stat. 891, 902, 908; Pub. L. 110–85, title X, §1005(c), Sept. 27, 2007, 121 Stat. 968; Pub. L. 111–31, div. A, title I, §101(a), June 22, 2009, 123 Stat. 1783; Pub. L. 114–255, div. A, title III, §3060(d), Dec. 13, 2016, 130 Stat. 1133; Pub. L. 116–304, §2(b), Jan. 5, 2021, 134 Stat. 4916; Pub. L. 117–11, §2(a), Apr. 23, 2021, 135 Stat. 262; Pub. L. 117–103, div. P, title I, §111(a), Mar. 15, 2022, 136 Stat. 789; Pub. L. 117–328, div. FF, title III, §3401(a)(2), Dec. 29, 2022, 136 Stat. 5838.)

Editorial Notes

References in Text

The Food and Drugs Act of June 30, 1906, as amended, referred to in par. (p)(1), and the Food and Drug Act of June 30, 1906, as amended, referred to in par. (v)(1), is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (q)(1), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.

The Poultry Products Inspection Act, referred to in par. (s)(4), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.

The Meat Inspection Act of March 4, 1907, as amended and extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90–201, 81 Stat. 584, which are classified generally to subchapters I to IV (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L. 105–115, which is set out as a note under section 379g of this title.

Amendments

2022—Par. (rr)(1). Pub. L. 117–103, §111(a)(1), inserted ", or containing nicotine from any source," after "from tobacco".

Par. (rr)(5). Pub. L. 117–103, §111(a)(2), added subpar. (5).

Par. (ss). Pub. L. 117–328 added par. (ss).

2021—Par. (h). Pub. L. 116–304 redesignated introductory provisions as subpar. (1) and former subpars. (1) to (3) as cls. (A) to (C), respectively, of subpar. (1) and added subpar. (2).

Par. (qq)(1). Pub. L. 117–11 substituted "soybeans, and sesame" for "and soybeans".

2016—Par. (h). Pub. L. 114–255 inserted at end of concluding provisions "The term 'device' does not include software functions excluded pursuant to section 360j(o) of this title."

2009—Par. (rr). Pub. L. 111–31 added par. (rr).

2007—Par. (ff). Pub. L. 110–85 substituted "paragraph (g) and section 350f of this title" for "paragraph (g)" in concluding provisions.

2004–Par. (u). Pub. L. 108–282, §102(b)(5)(A), substituted "360b, 360ccc" for "360b".

Par. (v). Pub. L. 108–282, §102(b)(5)(B), inserted concluding provisions.

Pars. (nn) to (pp). Pub. L. 108–282, §102(b)(1), added pars. (nn) to (pp).

Par. (qq). Pub. L. 108–282, §203(c)(1), added par. (qq).

2002—Par. (kk). Pub. L. 107–109 added par. (kk).

Pars. (ll), (mm). Pub. L. 107–250 added pars. (ll) and (mm).

1998—Par. (q)(1). Pub. L. 105–324, §2(a), added subpar. (1) and struck out former subpar. (1) which read as follows: "The term 'pesticide chemical' means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide."

Par. (q)(3). Pub. L. 105–324, §2(c), substituted "subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in introductory provisions.

1997—Par. (aa). Pub. L. 105–115, §125(b)(2)(A), struck out "or 357" after "section 355(j)".

Par. (dd). Pub. L. 105–115, §125(b)(2)(A), struck out "357," after "section 355,".

Par. (ff)(3)(A). Pub. L. 105–115, §125(b)(2)(A), struck out ", certified as an antibiotic under section 357 of this title," before "or licensed as a biologic".

Par. (ii). Pub. L. 105–115, §121(a), added par. (ii).

Par. (jj). Pub. L. 105–115, §125(e), added par. (jj).

1996—Par. (q). Pub. L. 104–170, §402(a), amended par. (q) generally. Prior to amendment, par. (q) read as follows: "The term 'pesticide chemical' means any substance which, alone, in chemical combination or in formulation with one or more other substances, is 'a pesticide' within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities."

Par. (s)(1), (2). Pub. L. 104–170, §402(b), amended subpars. (1) and (2) generally. Prior to amendment, subpars. (1) and (2) read as follows:

"(1) a pesticide chemical in or on a raw agricultural commodity; or

"(2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or".

Pars. (gg), (hh). Pub. L. 104–170, §402(c), added pars. (gg) and (hh).

1994—Par. (g)(1). Pub. L. 103–417, §10(a), amended last sentence generally. Prior to amendment, last sentence read as follows: "A food for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug under clause (B) solely because the label or labeling contains such a claim."

Par. (s)(6). Pub. L. 103–417, §3(b), added subpar. (6).

Par. (ff). Pub. L. 103–417, §3(a), added par. (ff).

1993—Pars. (c), (d). Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture".

Par. (h). Pub. L. 103–80, §4(b), amended directory language of Pub. L. 102–300, §6(a)(1). See 1992 amendment note below.

Pars. (v) to (ff). Pub. L. 103–80, §3(b), redesignated pars. (w) to (ff) as (v) to (ee), respectively.

1992—Pars. (c), (d). Pub. L. 102–300, §6(b)(1), which directed the substitution of "Health and Human Services" for "Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions notes below.

Par. (h). Pub. L. 102–300, §6(a)(1), as amended by Pub. L. 103–80, §4(b), substituted "its primary" for "any of its principal" in two places in concluding provisions.

Par. (u). Pub. L. 102–571 substituted "379e" for "376".

Par. (y)(1). Pub. L. 102–300, §6(b)(2), struck out "of Health, Education, and Welfare" after "employees of the Department".

Pars. (bb) to (ee). Pub. L. 102–282 added pars. (bb) to (ee).

Par. (ff). Pub. L. 102–300, §6(a)(2), added par. (ff).

1990—Par. (g)(1). Pub. L. 101–629, §16(b)(1), struck out "; but does not include devices or their components, parts, or accessories" after "clause (A), (B), or (C)".

Pub. L. 101–535 inserted at end "A food for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug under clause (B) solely because the label or labeling contains such a claim."

Par. (h)(3). Pub. L. 101–629, §16(b)(2), which directed the amendment of subpar. (3) by substituting "its primary" for "any of its principal", could not be executed because "any of its principal" did not appear in subpar. (3).

1988—Par. (w)(3). Pub. L. 100–670 struck out subpar. (3) which read as follows: "which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof, except when there is in effect a published order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A) the requirement of certification of batches of such drug, as provided for in section 360b(n) of this title, is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and (B) that neither subparagraph (1) nor (2) of this paragraph (w) applies to such drug."

1980—Par. (aa). Pub. L. 96–359 added par. (aa).

1977—Par. (z). Pub. L. 95–203 added par. (z).

1976—Par. (h). Pub. L. 94–295, §3(a)(1)(A), expanded definition of "device" to include implements, machines, implants, in vitro reagents, and other similar or related articles, added recognition in the National Formulary or the United States Pharmacopeia, or any supplement to the Formulary or Pharmacopeia, to the enumeration of conditions under which a device may qualify for inclusion under this chapter, and inserted requirements that a device be one which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

Par. (n). Pub. L. 94–278 inserted "or advertising" after "labeling" wherever appearing.

Par. (y). Pub. L. 94–295, §3(a)(2), added par. (y).

1972—Par. (q). Pub. L. 92–516 substituted reference to pesticide for reference to economic poison.

1970—Par. (a)(2). Pub. L. 91–513, §701(g), struck out reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334, 337, 360, 360a, 372, 373, 374, and 375 of this title as they apply to depressant or stimulant drugs.

Par. (v). Pub. L. 91–513, §701(a), struck out par. (v) which defined "depressant or stimulant drug".

1968—Par. (a)(2). Pub. L. 90–639, §4(a), extended provisions to cover depressant and stimulant drugs, the containers thereof, and equipment used in manufacturing, compounding, or processing such drugs, to the Canal Zone.

Par. (p). Pub. L. 90–399, §102(a), (b), inserted "(except a new animal drug or an animal feed bearing or containing a new animal drug)" after "Any drug" in subpars. (1) and (2), respectively.

Par. (s)(5). Pub. L. 90–399, §102(c), added subpar. (5).

Par. (u). Pub. L. 90–399, §102(d), inserted reference to section 360b of this title.

Par. (v)(3). Pub. L. 90–639, §1, inserted reference to lysergic acid diethylamide.

Pars. (w), (x). Pub. L. 90–399, §102(e), added pars. (w) and (x).

1965—Par. (g). Pub. L. 89–74, §9(b), designated existing provisions as subpar. (1), redesignated cls. (1) to (4) thereof as (A) to (D), substituted "(A), (B), or (C)" for "(1), (2), or (3)" and added subpar. (2).

Par. (v). Pub. L. 89–74, §3(a), added par. (v).

1962—Par. (a). Pub. L. 87–781, §307(a), designated existing provisions as subpar. (2), inserted "Commonwealth of Puerto Rico and the", and added subpar. (1).

Par. (p)(1). Pub. L. 87–781, §102(a)(1), inserted "and effectiveness" after "to evaluate the safety", and "and effective" after "as safe".

Par. (p)(2). Pub. L. 87–781, §102(a)(2), inserted "and effectiveness" after "safety".

1960—Par. (s). Pub. L. 86–618, §101(a), excluded color additives from definition of "food additive".

Par. (t). Pub. L. 86–618, §101(c), added par. (t). Former par. (t) redesignated (u).

Par. (u). Pub. L. 86–618, §101(b), redesignated par. (t) as (u) and inserted reference to section 376 of this title.

1958—Pars. (s), (t). Pub. L. 85–929 added pars. (s) and (t).

1954—Pars. (q), (r). Act July 22, 1954, added pars. (q) and (r).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–103, div. P, title I, §111(c), Mar. 15, 2022, 136 Stat. 789, provided that: "The amendments made by subsections (a) and (b) [amending this section and section 387a of this title] shall take effect 30 days after the date of enactment of this Act [Mar. 15, 2022]."

Effective Date of 2021 Amendment

Pub. L. 117–11, §2(b), Apr. 23, 2021, 135 Stat. 262, provided that: "The amendment made by subsection (a) [amending this section] shall apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023."

Effective Date of 2004 Amendment

Pub. L. 108–282, title II, §203(d), Aug. 2, 2004, 118 Stat. 908, provided that: "The amendments made by this section [amending this section and sections 343 and 343–1 of this title] shall apply to any food that is labeled on or after January 1, 2006."

Effective Date of 1997 Amendment

Pub. L. 105–115, title V, §501, Nov. 21, 1997, 111 Stat. 2380, provided that: "Except as otherwise provided in this Act [see Short Title of 1997 Amendment note set out under section 301 of this title], this Act and the amendments made by this Act, other than the provisions of and the amendments made by sections 111, 121, 125, and 307 [enacting section 355a of this title, amending this section and sections 331, 335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381, and 382 of this title, section 45C of Title 26, Internal Revenue Code, section 156 of Title 35, Patents, and section 8126 of Title 38, Veterans' Benefits, repealing sections 356 and 357 of this title, and enacting provisions set out as notes under sections 351 and 355 of this title], shall take effect 90 days after the date of enactment of this Act [Nov. 21, 1997]."

Effective Date of 1990 Amendment

Amendment by Pub. L. 101–535 effective six months after the date of the promulgation of final regulations to implement section 343(r) of this title, or if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations (Nov. 8, 1992), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101–535, set out as a note under section 343 of this title.

Effective Date of 1976 Amendment

Amendment by Pub. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of Pub. L. 94–278, set out as a note under section 334 of this title.

Effective Date of 1972 Amendment

Amendment by Pub. L. 92–516 effective at the close of Oct. 21, 1972, except if regulations are necessary for the implementation of any provision that becomes effective on Oct. 21, 1972, and continuation in effect of subchapter I of chapter 6 of Title 7, and regulations thereunder, relating to the control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92–516, and regulations thereunder, see section 4 of Pub. L. 92–516, set out as an Effective Date note under section 136 of Title 7, Agriculture.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1968 Amendments; Transitional Provisions

Pub. L. 90–639, §6, Oct. 24, 1968, 82 Stat. 1362, provided that: "The amendments made by this Act [amending this section, sections 331, 333, 334, and 360a of this title, and provisions set out as a note under section 289a of Title 42, The Public Health and Welfare] shall apply only with respect to violations of the Federal Food, Drug, and Cosmetic Act [this chapter] committed after the date of the enactment of this Act [Oct. 24, 1968]."

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, except that in the case of a drug (other than one subject to section 360b(n) of this title) intended for use in animals other than man which, on Oct. 9, 1962, was commercially used or sold in the United States, was not a new drug as defined in par. (p) of this section then in force, and was not covered by an effective application under section 355 of this title, the words "effectiveness" and "effective" contained in par. (v) of this section not applicable to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day, see section 108(a), (b)(3) of Pub. L. 90–399, as amended, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Effective Date of 1965 Amendment

Pub. L. 89–74, §11, July 15, 1965, 79 Stat. 235, provided that: "The foregoing provisions of this Act [see Short Title of 1965 Amendment note set out under section 301 of this title] shall take effect on the first day of the seventh calendar month [Feb. 1, 1966] following the month in which this Act is enacted [July 15, 1965]; except that (1) the Secretary shall permit persons, owning or operating any establishment engaged in manufacturing, preparing, propagating, compounding, processing, wholesaling, jobbing, or distributing any depressant or stimulant drug, as referred to in the amendments made by section 4 of this Act to section 510 of the Federal Food, Drug, and Cosmetic Act [section 360 of this title], to register their name, places of business, and establishments, and other information prescribed by such amendments, with the Secretary prior to such effective date, and (2) sections 201(v) and 511(g) of the Federal Food, Drug, and Cosmetic Act, as added by this act [par. (v) of this section and par. (g) of section 360a of this title], and the provisions of sections 8 [amending section 372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure] and 10 [set out as a note under this section] shall take effect upon the date of enactment of this Act [July 15, 1965]."

Effective Date of 1962 Amendment

Pub. L. 87–781, title I, §107, Oct. 10, 1962, 76 Stat. 788, provided that:

"(a) Except as otherwise provided in this section, the amendments made by the foregoing sections of this part A [amending this section and sections 331, 332, 348, 351 to 353, 355, 357, 379e of this title, and enacting provisions set out as a note under section 355 of this title] shall take effect on the date of enactment of this Act [Oct. 10, 1962].

"(b) The amendments made by sections 101, 103, 105, and 106 of this part A [amending sections 331, 332, 351, 352, 355, and 357 of this title] shall, with respect to any drug, take effect on the first day of the seventh calendar month following the month in which this Act is enacted [Oct. 1962].

"(c)(1) As used in this subsection, the term 'enactment date' means the date of enactment of this Act; and the term 'basic Act' means the Federal Food, Drug, and Cosmetic Act [this chapter].

"(2) An application filed pursuant to section 505(b) of the basic Act [section 355(b) of this title] which was 'effective' within the meaning of that Act on the day immediately preceding the enactment date shall be deemed as of the enactment date, to be an application 'approved' by the Secretary within the meaning of the basic Act as amended by this Act.

"(3) In the case of any drug with respect to which an application filed under section 505(b) of the basic Act is deemed to be an approved application on the enactment date by virtue of paragraph (2) of this subsection—

"(A) the amendments made by this Act to section 201(p), and to subsections (b) and (d) of section 505, of the basic Act [par. (p) of this section, and subsecs. (b) and (d) of section 355 of this title], insofar as such amendments relate to the effectiveness of drugs, shall not, so long as approval of such application is not withdrawn or suspended pursuant to section 505(e) of that Act [section 355(e) of this title], apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling covered by such approved application, but shall apply to any changed use, or conditions of use, prescribed, recommended, or suggested in its labeling, including such conditions of use as are the subject of an amendment or supplement to such application pending on, or filed after, the enactment date; and

"(B) clause (3) of the first sentence of section 505(e) of the basic Act, as amended by this Act [section 355(e) of this title], shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling covered by such approved application (except with respect to such use, or conditions of use, as are the subject of an amendment or supplement to such approved application, which amendment or supplement has been approved after the enactment date under section 505 of the basic Act as amended by this Act [section 355 of this title]) until whichever of the following first occurs: (i) the expiration of the two-year period beginning with the enactment date; (ii) the effective date of an order under section 505(e) of the basic Act [section 355(e) of this title], other than clause (3) of the first sentence of such section 505(e) [section 355(e) of this title], withdrawing or suspending the approval of such application.

"(4) In the case of any drug which, on the day immediately preceding the enactment date, (A) was commercially used or sold in the United States, (B) was not a new drug as defined by section 201(p) of the basic Act as then in force [par. (p) of this section], and (C) was not covered by an effective application under section 505 of that Act [section 355 of this title], the amendments to section 201(p) [par. (p) of this section] made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day."

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date of 1958 Amendment

Amendment by Pub. L. 85–929 effective Sept. 6, 1958, see section 6(a) of Pub. L. 85–929, set out as a note under section 342 of this title.

Effective Date of 1954 Amendment

For effective date of amendment by act July 22, 1954, see section 5 of that act, set out as a note under section 342 of this title.

Construction of Amendments by Pub. L. 102–282

Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.

Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.

Savings Provision

Pub. L. 91–513, title II, §702, Oct. 27, 1970, 84 Stat. 1283, as amended by Pub. L. 93–481, §2, Oct. 26, 1974, 88 Stat. 1455, provided that:

"(a) Prosecutions for any violation of law occurring prior to the effective date [see Effective Date of 1970 Amendment note above] of section 701 [repealing section 360a of this title, and amending sections 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure, and section 242 of Title 42, The Public Health and Welfare] shall not be affected by the repeals or amendments made by such section, or abated by reason thereof.

"(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of section 701 shall not be affected by the repeals or amendments made by such section, or abated by reason thereof.

"(c) All administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on the date of enactment of this Act [Oct. 27, 1970] shall be continued and brought to final determination in accord with laws and regulations in effect prior to such date of enactment. Where a drug is finally determined under such proceedings to be a depressant or stimulant drug, as defined in section 201(v) of the Federal Food, Drug, and Cosmetic Act [par. (v) of this section], such drug shall automatically be controlled under this title [subchapter I of chapter 13 of this title] by the Attorney General without further proceedings and listed in the appropriate schedule after he has obtained the recommendation of the Secretary. Any drug with respect to which such a final determination has been made prior to the date of enactment of this Act which is not listed in section 202 [section 812 of this title] within schedules I through V shall automatically be controlled under this title [subchapter I of chapter 13 of this title] by the Attorney General without further proceedings, and be listed in the appropriate schedule, after he has obtained the recommendations of the Secretary.

"(d) Notwithstanding subsection (a) of this section or section 1103 [of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title], section 4202 of title 18, United States Code, shall apply to any individual convicted under any of the laws repealed by this title or title III [subchapter I or subchapter II of chapter 13 of this title] without regard to the terms of any sentence imposed on such individual under such law."

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Federal Food, Drug, and Cosmetic Act, to the extent such functions related to administration and enforcement of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), transferred to Consumer Product Safety Commission by section 2079 of Title 15, Commerce and Trade.

Regulation of Tobacco

Pub. L. 117–103, div. P, title I, §111(e), Mar. 15, 2022, 136 Stat. 790, provided that: "Effective 30 days after the date of enactment of this Act [Mar. 15, 2022], with respect to any regulation promulgated or related guidance issued, in whole or part, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) before the date that is 30 days after such date of enactment, the term 'tobacco product' shall have the meaning of, and shall be deemed amended to reflect the meaning of, such term as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)), as amended by subsection (a). Products that are tobacco products under such section 201(rr), as so amended, shall be subject to all requirements of regulations for tobacco products. The Secretary of Health and Human Services shall publish a notice in the Federal Register to update the Code of Federal Regulations to reflect such deemed amendment to existing regulations and guidance."

Pub. L. 105–115, title IV, §422, Nov. 21, 1997, 111 Stat. 2380, provided that: "Nothing in this Act [see Short Title of 1997 Amendment note set out under section 301 of this title] or the amendments made by this Act shall be construed to affect the question of whether the Secretary of Health and Human Services has any authority to regulate any tobacco product, tobacco ingredient, or tobacco additive. Such authority, if any, shall be exercised under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] as in effect on the day before the date of the enactment of this Act [Nov. 21, 1997]."

Congressional Findings Relating to Pub. L. 103–417

Pub. L. 103–417, §2, Oct. 25, 1994, 108 Stat. 4325, provided that: "Congress finds that—

"(1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;

"(2) the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;

"(3)(A) there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and

"(B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;

"(4) healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty;

"(5) preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures;

"(6)(A) promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures; and

"(B) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country;

"(7) there is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;

"(8) consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;

"(9) national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition;

"(10) studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs;

"(11) the United States will spend over $1,000,000,000,000 on health care in 1994, which is about 12 percent of the Gross National Product of the United States, and this amount and percentage will continue to increase unless significant efforts are undertaken to reverse the increase;

"(12)(A) the nutritional supplement industry is an integral part of the economy of the United States;

"(B) the industry consistently projects a positive trade balance; and

"(C) the estimated 600 dietary supplement manufacturers in the United States produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000;

"(13) although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;

"(14) dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and

"(15)(A) legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness; and

"(B) a rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements."

Dissemination of Information Regarding the Dangers of Drug Abuse

Pub. L. 90–639, §5, Oct. 24, 1968, 82 Stat. 1362, provided that: "It is the sense of the Congress that, because of the inadequate knowledge on the part of the people of the United States of the substantial adverse effects of misuse of depressant and stimulant drugs, and of other drugs liable to abuse, on the individual, his family, and the community, the highest priority should be given to Federal programs to disseminate information which may be used to educate the public, particularly young persons, regarding the dangers of drug abuse."

Congressional Findings and Declaration of Policy

Pub. L. 89–74, §2, July 15, 1965, 79 Stat. 226, provided that: "The Congress hereby finds and declares that there is a widespread illicit traffic in depressant and stimulant drugs moving in or otherwise affecting interstate commerce; that the use of such drugs, when not under the supervision of a licensed practitioner, often endangers safety on the highways (without distinction of interstate and intrastate traffic thereon) and otherwise has become a threat to the public health and safety, making additional regulation of such drugs necessary regardless of the intrastate or interstate origin of such drugs; that in order to make regulation and protection of interstate commerce in such drugs effective, regulation of intrastate commerce is also necessary because, among other things, such drugs, when held for illicit sale, often do not bear labeling showing their place of origin and because in the form in which they are so held or in which they are consumed a determination of their place of origin is often extremely difficult or impossible; and that regulation of interstate commerce without the regulation of intrastate commerce in such drugs, as provided in this Act [see Short Title of 1965 Amendment note set out under section 301 of this title], would discriminate against and adversely affect interstate commerce in such drugs."

Effect of Drug Abuse Control Amendments of 1965 on State Laws

Pub. L. 89–74, §10, July 15, 1965, 79 Stat. 235, provided that:

"(a) Nothing in this Act [enacting section 360a of this title, amending sections 321, 331, 333, 334, 360, and 372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure, and enacting provisions set out as notes under sections 321, 352, and 360a of this title] shall be construed as authorizing the manufacture, compounding, processing, possession, sale, delivery, or other disposal of any drug in any State in contravention of the laws of such State.

"(b) No provision of this Act nor any amendment made by it shall be construed as indicating an intent on the part of the Congress to occupy the field in which such provision or amendment operates to the exclusion of any State law on the same subject matter, unless there is a direct and positive conflict between such provision or amendment and such State law so that the two cannot be reconciled or consistently stand together.

"(c) No amendment made by this Act shall be construed to prevent the enforcement in the courts of any State of any statute of such State prescribing any criminal penalty for any act made criminal by any such amendment."

Effect of Drug Amendments of 1962 on State Laws

Pub. L. 87–781, title II, §202, Oct. 10, 1962, 76 Stat. 793, provided that: "Nothing in the amendments made by this Act [enacting sections 358 to 360, amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e, and 381 of this title, and enacting provisions set out as notes under sections 321, 331, 332, 352, 355, 360, and 374 of this title] to the Federal Food, Drug, and Cosmetic Act [this chapter] shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law."

Definitions

Pub. L. 105–115, §2, Nov. 21, 1997, 111 Stat. 2297, provided that: "In this Act [see Short Title of 1997 Amendment note set out under section 301 of this title], the terms 'drug', 'device', 'food', and 'dietary supplement' have the meaning given such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)."

Executive Documents

Transfer of Functions

Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Drug Abuse Control Amendments of 1965 [see Short Title of 1965 Amendment note set out under section 301 of this title] transferred to Attorney General except function of regulating counterfeiting of those drugs which are not "depressant or stimulant" drugs, see section 2 of Reorg. Plan No. 1 of 1968, set out in the Appendix to Title 5, Government Organization and Employees.

Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out in the Appendix to Title 5, Government Organization and Employees. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953.

Food and Drug Administration in Department of Agriculture and its functions, except those functions relating to administration of Insecticide Act of 1910 and Naval Stores Act, transferred to Federal Security Agency, to be administered under direction and supervision of Federal Security Administrator, by Reorg. Plan No. IV of 1940, set out in the Appendix to Title 5.

¹ So in original. Probably should be "Pharmacopeia,".

² So in original. Probably should be paragraph "(v)".

³ So in original. Provision probably should be set flush with subpar. (B).

§321a. "Butter" defined

For the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at Large, page 768) "butter" shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for.

(Mar. 4, 1923, ch. 268, 42 Stat. 1500.)

Editorial Notes

References in Text

The Food and Drug Act of June 30, 1906, referred to in text, is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter.

Codification

Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, was formerly classified to section 6 of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that this section should remain in force and effect and be applicable to the provisions of this chapter.

§321b. "Package" defined

The word "package" where it occurs the second and last time in the act entitled "An act to amend section 8 of an act entitled, 'An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes,' " approved March 3, 1913, shall include and shall be construed to include wrapped meats inclosed in papers or other materials as prepared by the manufacturers thereof for sale.

(July 24, 1919, ch. 26, 41 Stat. 271.)

Editorial Notes

References in Text

An act approved March 3, 1913, referred to in text, is act Mar. 3, 1913, ch. 117, 37 Stat. 732, which amended section 10 of this title. For complete classification of this Act to the Code, see Tables.

"An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes", referred to in text, is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter.

Codification

Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, was formerly classified to the last sentence of paragraph third of section 10 of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that this section should remain in force and effect and be applicable to the provisions of this chapter.

§321c. Nonfat dry milk; "milk" defined

For the purposes of the Federal Food, Drug, and Cosmetic Act of June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) [21 U.S.C. 301 et seq.] nonfat dry milk is the product resulting from the removal of fat and water from milk, and contains the lactose, milk proteins, and milk minerals in the same relative proportions as in the fresh milk from which made. It contains not over 5 per centum by weight of moisture. The fat content is not over 1½ per centum by weight unless otherwise indicated.

The term "milk", when used herein, means sweet milk of cows.

(Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70 Stat. 486.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch. 675, sec. 1, 52 Stat. 1040), referred to in text, probably means act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter (§301 et seq.). For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section was not enacted as a part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, but was made applicable thereto.

Amendments

1956—Act July 2, 1956, substituted "nonfat dry milk" for "nonfat dry milk solids or defatted milk solids".

§321d. Market names for catfish and ginseng

(a) Catfish labeling

(1) In general

Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)—

(A) the term "catfish" may only be considered to be a common or usual name (or part thereof) for fish classified within the family Ictaluridae; and

(B) only labeling or advertising for fish classified within that family may include the term "catfish".

(2) Omitted

(b) Ginseng labeling

(1) In general

Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)—

(A) the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax; and

(B) only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term "ginseng".

(2) Omitted

(Pub. L. 107–171, title X, §10806, May 13, 2002, 116 Stat. 526.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(1), (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section is comprised of section 10806 of Pub. L. 107–171. Subsecs. (a)(2) and (b)(2) of section 10806 of Pub. L. 107–171 amended section 343 of this title.

Section was enacted as part of the Farm Security and Rural Investment Act of 2002, and not as part of Federal Food, Drug, and Cosmetic Act which comprises this chapter.

SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES

§331. Prohibited acts

The following acts and the causing thereof are prohibited:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.

(c) The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,¹ 360bbb–3, or 364c of this title.

(e) The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 ² of this title (except when such violation is committed by a farm).

(f) The refusal to permit entry or inspection as authorized by section 374 of this title.

(g) The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.

(h) The giving of a guaranty or undertaking referred to in section 333(c)(2) of this title, which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, tobacco product, or cosmetic; or the giving of a guaranty or undertaking referred to in section 333(c)(3) of this title, which guaranty or undertaking is false.

(i)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of section 344 or 379e of this title.

(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug.

(3) The doing of any act which causes a drug to be a counterfeit drug, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit drug.

(j) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this chapter, any information acquired under authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc–1, 360ccc–2, 374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of this title concerning any method or process which as a trade secret is entitled to protection; or the violating of section 346a(i)(2) of this title or any regulation issued under that section..¹This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee.

(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.

(l) Repealed. Pub. L. 105–115, title IV, §421, Nov. 21, 1997, 111 Stat. 2380.

(m) The sale or offering for sale of colored oleomargarine or colored margarine, or the possession or serving of colored oleomargarine or colored margarine in violation of subsections (b) or (c) of section 347 of this title.

(n) The using, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with section 374 of this title.

(o) In the case of a prescription drug distributed or offered for sale in interstate commerce, the failure of the manufacturer, packer, or distributor thereof to maintain for transmittal, or to transmit, to any practitioner licensed by applicable State law to administer such drug who makes written request for information as to such drug, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved by the Secretary. Nothing in this paragraph shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this chapter.

(p) The failure to register in accordance with section 360 or 387e of this title, the failure to provide any information required by section 360(j), 360(k), 387e(i), or 387e(j) of this title, or the failure to provide a notice required by section 360(j)(2) or 387e(i)(3) of this title.

(q)(1) The failure or refusal—

(A) to comply with any requirement prescribed under section 360h, 360j(g), 387c(b), 387g, 387h, or 387o of this title;

(B) to furnish any notification or other material or information required by or under section 360i, 360j(g), 387d, 387i, or 387t of this title; or

(C) to comply with a requirement under section 360l or 387m of this title.

(2) With respect to any device or tobacco product, the submission of any report that is required by or under this chapter that is false or misleading in any material respect.

(3) The failure to comply with any requirement under section 360n–2(b)(2) of this title (relating to ensuring device cybersecurity).

(r) The movement of a device, drug, or tobacco product in violation of an order under section 334(g) of this title or the removal or alteration of any mark or label required by the order to identify the device, drug, or tobacco product as detained.

(s) The failure to provide the notice required by section 350a(c) or 350a(e) of this title, the failure to make the reports required by section 350a(f)(1)(B) of this title, the failure to retain the records required by section 350a(b)(4) of this title, or the failure to meet the requirements prescribed under section 350a(f)(3) of this title.

(t) The importation of a drug in violation of section 381(d)(1) of this title, the sale, purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of section 353(c) of this title, the sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the counterfeiting of such a coupon in violation of section 353(c)(2) of this title, the distribution of a drug sample in violation of section 353(d) of this title or the failure to otherwise comply with the requirements of section 353(d) of this title, the distribution of drugs in violation of section 353(e) of this title, failure to comply with the requirements under section 360eee–1 of this title, the failure to comply with the requirements under section 360eee–3 of this title, as applicable, or the failure to otherwise comply with the requirements of section 353(e) of this title.

(u) The failure to comply with any requirements of the provisions of, or any regulations or orders of the Secretary, under section 360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.

(v) The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 350b of this title.

(w) The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 381(d)(3) of this title; the failure to submit a certificate of analysis as required under such section; the failure to maintain records or to submit records or reports as required by such section; the release into interstate commerce of any article or portion thereof imported into the United States under such section or any finished product made from such article or portion, except for export in accordance with section 381(e) or 382 of this title, or with section 262(h) of title 42; or the failure to so export or to destroy such an article or portions thereof, or such a finished product.

(x) The falsification of a declaration of conformity submitted under section 360d(c) of this title or the failure or refusal to provide data or information requested by the Secretary under paragraph (3) of such section.

(y) In the case of a drug, device, or food—

(1) the submission of a report or recommendation by a person accredited under section 360m of this title that is false or misleading in any material respect;

(2) the disclosure by a person accredited under section 360m of this title of confidential commercial information or any trade secret without the express written consent of the person who submitted such information or secret to such person; or

(3) the receipt by a person accredited under section 360m of this title of a bribe in any form or the doing of any corrupt act by such person associated with a responsibility delegated to such person under this chapter.

(z) Omitted.

(aa) The importation of a prescription drug in violation of section 384 of this title, the falsification of any record required to be maintained or provided to the Secretary under such section, or any other violation of regulations under such section.

(bb) The transfer of an article of food in violation of an order under section 334(h) of this title, or the removal or alteration of any mark or label required by the order to identify the article as detained.

(cc) The importing or offering for import into the United States of an article of food or a drug by, with the assistance of, or at the direction of, a person debarred from such activity under section 335a(b)(3) of this title.

(dd) The failure to register in accordance with section 350d of this title.

(ee) The importing or offering for import into the United States of an article of food in violation of the requirements under section 381(m) of this title.

(ff) The importing or offering for import into the United States of a drug or device with respect to which there is a failure to comply with a request of the Secretary to submit to the Secretary a statement under section 381(o) of this title.

(gg) The knowing failure to comply with paragraph (7)(E) of section 374(g) of this title; the knowing inclusion by a person accredited under paragraph (2) of such section of false information in an inspection report under paragraph (7)(A) of such section; or the knowing failure of such a person to include material facts in such a report.

(hh) The failure by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food to comply with the sanitary transportation practices prescribed by the Secretary under section 350e of this title.

(ii) The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 364, 379aa, or 379aa–1 of this title) or the falsification of a serious adverse event report (as defined under section 379aa or 379aa–1 of this title or required under section 364a(a) of this title) submitted to the Secretary.

(jj)(1) The failure to submit the certification required by section 282(j)(5)(B) of title 42, or knowingly submitting a false certification under such section.

(2) The failure to submit clinical trial information required under subsection (j) of section 282 of title 42.

(3) The submission of clinical trial information under subsection (j) of section 282 of title 42 that is false or misleading in any particular under paragraph (5)(D) of such subsection (j).

(kk) The dissemination of a television advertisement without complying with section 353c ² of this title.

(ll) The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 355 of this title, a biological product licensed under section 262 of title 42, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless—

(1) such drug or such biological product was marketed in food before any approval of the drug under section 355 of this title, before licensure of the biological product under such section 262 of title 42, and before any substantial clinical investigations involving the drug or the biological product have been instituted;

(2) the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, approving the use of such drug or such biological product in the food;

(3) the use of the drug or the biological product in the food is to enhance the safety of the food to which the drug or the biological product is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with—

(A) a regulation issued under section 348 of this title prescribing conditions of safe use in food;

(B) a regulation listing or affirming conditions under which the use of the drug or the biological product in food is generally recognized as safe;

(C) the conditions of use identified in a notification to the Secretary of a claim of exemption from the premarket approval requirements for food additives based on the notifier's determination that the use of the drug or the biological product in food is generally recognized as safe, provided that the Secretary has not questioned the general recognition of safety determination in a letter to the notifier;

(D) a food contact substance notification that is effective under section 348(h) of this title; or

(E) such drug or biological product had been marketed for smoking cessation prior to September 27, 2007; or

(4) the drug is a new animal drug whose use is not unsafe under section 360b of this title.

(mm) The failure to submit a report or provide a notification required under section 350f(d) of this title.

(nn) The falsification of a report or notification required under section 350f(d) of this title.

(oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 333(f) of this title.

(pp) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 387k of this title.

(qq)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.

(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.

(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product.

(rr) The charitable distribution of tobacco products.

(ss) The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade.

(tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that—

(1) the product is approved by the Food and Drug Administration;

(2) the Food and Drug Administration deems the product to be safe for use by consumers;

(3) the product is endorsed by the Food and Drug Administration for use by consumers; or

(4) the product is safe or less harmful by virtue of—

(A) its regulation or inspection by the Food and Drug Administration; or

(B) its compliance with regulatory requirements set by the Food and Drug Administration;

including any such statement or representation rendering the product misbranded under section 387c of this title.

(uu) The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 350g of this title.

(vv) The failure to comply with the requirements under section 350h of this title.

(ww) The failure to comply with section 350i of this title.

(xx) The refusal or failure to follow an order under section 350l of this title.

(yy) The knowing and willful failure to comply with the notification requirement under section 350f(h) of this title.

(zz) The importation or offering for importation of a food if the importer (as defined in section 384a of this title) does not have in place a foreign supplier verification program in compliance with such section 384a of this title.

(aaa) The failure to register in accordance with section 381(s) of this title.

(bbb) The failure to notify the Secretary in violation of section 360bbb–7 of this title.

(ccc)(1) The resale of a compounded drug that is labeled "not for resale" in accordance with section 353b of this title.

(2) With respect to a drug to be compounded pursuant to section 353a or 353b of this title, the intentional falsification of a prescription, as applicable.

(3) The failure to report drugs or adverse events by an entity that is registered in accordance with subsection (b) of section 353b of this title.

(ddd)(1) The manufacture or the introduction or delivery for introduction into interstate commerce of a rinse-off cosmetic that contains intentionally-added plastic microbeads.

(2) In this paragraph—

(A) the term "plastic microbead" means any solid plastic particle that is less than five millimeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof; and

(B) the term "rinse-off cosmetic" includes toothpaste.

(eee) The failure to comply with any order issued under section 360bbb–8d of this title.

(fff)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device.

(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark or imprint of another or any likeness of any of the foregoing upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device.

(3) The doing of any act which causes a device to be a counterfeit device, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit device.

(ggg) The failure of a sponsor of a product approved under accelerated approval pursuant to section 356(c) of this title—

(1) to conduct with due diligence any postapproval study required under section 356(c) of this title with respect to such product; or

(2) to submit timely reports with respect to such product in accordance with section 356b(a)(2) of this title.

(hhh) The failure to register or submit listing information in accordance with section 364c of this title.

(iii) The refusal or failure to follow an order under section 364g of this title.

(June 25, 1938, ch. 675, §301, 52 Stat. 1042; Dec. 22, 1941, ch. 613, §1, 55 Stat. 851; July 6, 1945, ch. 281, §1, 59 Stat. 463; Mar. 10, 1947, ch. 16, §1, 61 Stat. 11; June 24, 1948, ch. 613, §1, 62 Stat. 582; Mar. 16, 1950, ch. 61, §3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, §2, 67 Stat. 477; Pub. L. 85–929, §5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86–618, title I, §§104, 105(a), July 12, 1960, 74 Stat. 403; Pub. L. 87–781, title I, §§103(c), 104(e)(1), 106(c), 114(a), title III, §304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795; Pub. L. 89–74, §§5, 9(c), July 15, 1965, 79 Stat. 232, 235; Pub. L. 90–399, §103, July 13, 1968, 82 Stat. 352; Pub. L. 90–639, §2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91–513, title II, §701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 92–387, §4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94–295, §§3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582; Pub. L. 96–359, §5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 99–570, title IV, §4014(b)(2), Oct. 27, 1986, 100 Stat. 3207–120; Pub. L. 100–293, §7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101–502, §5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101–508, title IV, §4755(c)(2), Nov. 5, 1990, 104 Stat. 1388–210; Pub. L. 102–300, §3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102–571, title I, §107(2), (3), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L. 103–396, §2(b)(1), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103–417, §10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L. 104–134, title II, §2103, Apr. 26, 1996, 110 Stat. 1321–319; Pub. L. 104–170, title IV, §403, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 104–250, §5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L. 105–115, title I, §125(a)(2)(A), (C), (b)(2)(B), title II, §§204(b), 210(c), title IV, §§401(b), 421, Nov. 21, 1997, 111 Stat. 2325, 2336, 2345, 2364, 2380; Pub. L. 106–387, §1(a) [title VII, §745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 1549A-39; Pub. L. 107–188, title III, §§303(b), 304(d), 305(b), 306(c), 307(b), 321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 668, 670, 672, 676, 677; Pub. L. 107–250, title II, §201(d), Oct. 26, 2002, 116 Stat. 1609; Pub. L. 108–136, div. A, title XVI, §1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108–173, title XI, §1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108–214, §2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108–282, title I, §102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109–59, title VII, §7202(d), (e), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 109–462, §§2(c), 3(b), 4(a), Dec. 22, 2006, 120 Stat. 3472, 3475; Pub. L. 110–85, title VIII, §801(b)(1), title IX, §§901(d)(1), 912(a), title X, §1005(d), Sept. 27, 2007, 121 Stat. 920, 939, 951, 968; Pub. L. 111–31, div. A, title I, §103(b), June 22, 2009, 123 Stat. 1833; Pub. L. 111–353, title I, §§102(d)(1), 103(e), 105(c), 106(d), title II, §§204(j)(1), 206(d), 211(b), (c), title III, §301(b), Jan. 4, 2011, 124 Stat. 3889, 3898, 3904, 3906, 3937, 3943, 3953, 3954; Pub. L. 112–144, title VII, §§714(a), 715(a), July 9, 2012, 126 Stat. 1073, 1075; Pub. L. 113–54, title I, §103(a), title II, §206(a), Nov. 27, 2013, 127 Stat. 597, 639; Pub. L. 114–114, §2(a), Dec. 28, 2015, 129 Stat. 3129; Pub. L. 114–255, div. A, title III, §3101(a)(2)(A), Dec. 13, 2016, 130 Stat. 1152; Pub. L. 115–271, title III, §§3012(a), 3022(b)(1), Oct. 24, 2018, 132 Stat. 3935, 3938; Pub. L. 117–328, div. FF, title II, §2513(a), title III, §§3210(c), 3305(b), 3503(a)(1), (4)(A), (B), Dec. 29, 2022, 136 Stat. 5805, 5824, 5833, 5858.)

Editorial Notes

References in Text

Section 2223 of this title, referred to in par. (e), was in the original "section 204 of the FDA Food Safety Modernization Act", meaning section 204 of Pub. L. 111–353, which enacted section 2223 of this title and amended this section and section 381 of this title.

Section 353c of this title, referred to in par. (kk), was in the original a reference to section 503B of act June 25, 1938, and was translated as if it referred to section 503C of that Act, to reflect the probable intent of Congress and the renumbering of section 503B as 503C by Pub. L. 113–54, title I, §102(a)(1), Nov. 27, 2013, 127 Stat. 587, and its transfer to section 353c of this title. A new section 503B, which was enacted by section 102(a)(2) of Pub. L. 113–54, is classified to section 353b of this title and does not relate to television advertisements.

Amendments

2022—Subsec. (d). Pub. L. 117–328, §3503(a)(1)(B), which directed the substitution of ", 360bbb–3, or 364c" for "or 360bbb–3" in par. (d), was executed by making the substitution in subsec. (d) to reflect the probable intent of Congress.

Subsec. (e). Pub. L. 117–328, §3503(a)(4)(A), substituted "360bbb–3, 364a, 373" for "360bbb–3, 373" and "360bbb–3, 364a, 364g, 379aa" for "360bbb–3, 379aa".

Subsec. (q)(3). Pub. L. 117–328, §3305(b), added par. (3).

Subsec. (ii). Pub. L. 117–328, §3503(a)(4)(B)(ii), inserted "or required under section 364a(a) of this title" after "report (as defined under section 379aa or 379aa–1 of this title.

Pub. L. 117–328, §3503(a)(4)(B)(i), substituted "364, 379aa, or 379aa–1 of this title) or" for "379aa or 379aa–1 of this title) or".

Subsec. (fff). Pub. L. 117–328, §2513(a), added subsec. (fff).

Subsec. (ggg). Pub. L. 117–328, §3210(c), added subsec. (ggg).

Subsecs. (hhh), (iii). Pub. L. 117–328, §3503(a)(1)(A), added subsecs. (hhh) and (iii).

2018—Par. (cc). Pub. L. 115–271, §3022(b)(1), inserted "or a drug" after "food" and "from such activity" after "person debarred".

Par. (eee). Pub. L. 115–271, §3012(a), added par. (eee).

2016—Subsec. (r). Pub. L. 114–255 inserted ", drug," after "device" in two places.

2015—Par. (ddd). Pub. L. 114–114 added par. (ddd).

2013—Par. (t). Pub. L. 113–54, §206(a), struck out "or" after "the requirements of section 353(d) of this title," and inserted ", failure to comply with the requirements under section 360eee–1 of this title, the failure to comply with the requirements under section 360eee–3 of this title, as applicable," after "in violation of section 353(e) of this title".

Par. (ccc). Pub. L. 113–54, §103(a), added par. (ccc).

2012—Par. (aaa). Pub. L. 112–144, §714(a), added par. (aaa).

Par. (bbb). Pub. L. 112–144, §715(a), added par. (bbb).

2011—Par. (d). Pub. L. 111–353, §102(d)(1), inserted "350d," after "344,".

Par. (e). Pub. L. 111–353, §§204(j)(1), 211(c), substituted "350f(j)" for "350f(g)" and inserted before period at end "; or the violation of any recordkeeping requirement under section 2223 of this title (except when such violation is committed by a farm)".

Par. (uu). Pub. L. 111–353, §103(e), added par. (uu).

Par. (vv). Pub. L. 111–353, §105(c), added par. (vv).

Par. (ww). Pub. L. 111–353, §106(d), added par. (ww).

Par. (xx). Pub. L. 111–353, §206(d), added par. (xx).

Par. (yy). Pub. L. 111–353, §211(b), added par. (yy).

Par. (zz). Pub. L. 111–353, §301(b), added par. (zz).

2009—Pars. (a) to (c). Pub. L. 111–31, §103(b)(1)–(3), inserted "tobacco product," after "device,".

Par. (e). Pub. L. 111–31, §103(b)(4)(B), which directed substitution of "379aa–1, 387i, or 387t of this title or the refusal to permit access to" for "or 379aa–1 of this title or the refusal to permit access to", was executed by making the substitution for "or 379aa–1 of this title, or the refusal to permit access to", to reflect the probable intent of Congress.

Pub. L. 111–31, §103(b)(4)(A), struck out period after "360ccc–1(i)".

Pars. (g), (h). Pub. L. 111–31, §103(b)(5), (6), inserted "tobacco product," after "device,".

Par. (j). Pub. L. 111–31, §103(b)(7), struck out period after "360ccc–2" and substituted "379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b)" for "379, or 379e".

Par. (k). Pub. L. 111–31, §103(b)(8), inserted "tobacco product," after "device,".

Par. (p). Pub. L. 111–31, §103(b)(9), added par. (p) and struck out former par. (p) which read as follows: "The failure to register in accordance with section 360 of this title, the failure to provide any information required by section 360(j) or 360(k) of this title, or the failure to provide a notice required by section 360(j)(2) of this title."

Par. (q)(1). Pub. L. 111–31, §103(b)(10), added subpar. (1) and struck out former subpar. (1) which read as follows: "The failure or refusal to (A) comply with any requirement prescribed under section 360h or 360j(g) of this title, (B) furnish any notification or other material or information required by or under section 360i or 360j(g) of this title, or (C) comply with a requirement under section 360l of this title."

Par. (q)(2). Pub. L. 111–31, §103(b)(11), substituted "device or tobacco product," for "device,".

Par. (r). Pub. L. 111–31, §103(b)(12), inserted "or tobacco product" after "device" in two places.

Pars. (oo) to (tt). Pub. L. 111–31, §103(b)(13), added pars. (oo) to (tt).

2007—Par. (e). Pub. L. 110–85, §1005(d)(1), substituted "350c, 350f(g)," for "350c," and "350c(b), 350f" for "350c(b)".

Par. (jj). Pub. L. 110–85, §801(b)(1), added par. (jj).

Par. (kk). Pub. L. 110–85, §901(d)(1), added par. (kk).

Par. (ll). Pub. L. 110–85, §912(a), added par. (ll).

Pars. (mm), (nn). Pub. L. 110–85, §1005(d)(2), added pars. (mm) and (nn).

2006—Par. (e). Pub. L. 109–462, §3(b), substituted "374(a), 379aa, or 379aa–1" for "374(a), or 379aa" and "360bbb–3, 379aa, or 379aa–1" for "360bbb–3, or 379aa".

Pub. L. 109–462, §2(c), substituted ", 374(a), or 379aa" for ", or 374(a)" and ", 360bbb–3, or 379aa" for ", or 360bbb–3".

Par. (ii). Pub. L. 109–462, §4(a), added par. (ii).

2005—Par. (e). Pub. L. 109–59, §7202(d), inserted "350e," before "354," in two places.

Par. (hh). Pub. L. 109–59, §7202(e), added par. (hh).

2004—Par. (e). Pub. L. 108–282, §102(b)(5)(C), which directed the substitution of "360b(a)(4)(C), 360b (j), (l) or (m), 360ccc–1(i)." for "360b(a)(4)(C), 360b(j), (l) or (m)" was executed by making the substitution for "360b(a)(4)(C), 360b(j), (l), or (m)", to reflect the probable intent of Congress.

Par. (j). Pub. L. 108–282, §102(b)(5)(D), substituted "360j, 360ccc, 360ccc–1, 360ccc–2." for "360j".

Par. (gg). Pub. L. 108–214 amended par. (gg) generally. Prior to amendment, text read as follows: "The knowing failure of a person accredited under paragraph (2) of section 374(g) of this title to comply with paragraph (7)(E) of such section; the knowing inclusion by such a person of false information in an inspection report under paragraph (7)(A) of such section; or the knowing failure of such a person to include material facts in such a report."

2003—Par. (d). Pub. L. 108–136 substituted "section 344, 355, or 360bbb–3" for "section 344 or 355".

Par. (e). Pub. L. 108–136 inserted "360bbb–3," after "350c, 354," and substituted "360i, or 360bbb–3" for "or 360i".

Par. (aa). Pub. L. 108–173 substituted "prescription drug in violation of section 384" for "covered product in violation of section 384".

2002—Par. (e). Pub. L. 107–188, §306(c)(1), substituted "by section 350a, 350c, 354, 373, or 374(a) of this title" for "by section 350a, 354, or 373 of this title" and "under section 350a, 350c(b)" for "under section 350a".

Par. (j). Pub. L. 107–188, §306(c)(2), inserted "350c," after "350a,".

Par. (w). Pub. L. 107–188, §322(b), amended par. (w) generally. Prior to amendment, par. (w) read as follows: "The making of a knowingly false statement in any record or report required or requested under subparagraph (A) or (B) of section 381(d)(3) of this title, the failure to submit or maintain records as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this title, the release into interstate commerce of any article imported into the United States under section 381(d)(3) of this title or any finished product made from such article (except for export in accordance with section 381(e) or 382 of this title or section 262(h) of title 42), or the failure to export or destroy any component, part or accessory not incorporated into a drug, biological product or device that will be exported in accordance with section 381(e) or 382 of this title or section 262(h) of title 42."

Par. (bb). Pub. L. 107–188, §303(b), added par. (bb).

Par. (cc). Pub. L. 107–188, §304(d), added par. (cc).

Par. (dd). Pub. L. 107–188, §305(b), added par. (dd).

Par. (ee). Pub. L. 107–188, §307(b), added par. (ee).

Par. (ff). Pub. L. 107–188, §321(b)(2), added par. (ff).

Par. (gg). Pub. L. 107–250 added par. (gg).

2000—Par. (aa). Pub. L. 106–387 added par. (aa).

1997—Par. (e). Pub. L. 105–115, §125(b)(2)(B), struck out "357(d) or (g)," after "355(i) or (k),".

Par. (i)(1). Pub. L. 105–115, §125(a)(2)(C), struck out ", 356, 357," before "or 379e of this title".

Par. (j). Pub. L. 105–115, §125(a)(2)(A), struck out "356, 357," before "360,".

Par. (l). Pub. L. 105–115, §421, struck out par. (l) which read as follows: "The using, on the labeling of any drug or device or in any advertising relating to such drug or device, of any representation or suggestion that approval of an application with respect to such drug or device is in effect under section 355, 360e, or 360j(g) of this title, as the case may be, or that such drug or device complies with the provisions of such section."

Par. (x). Pub. L. 105–115, §204(b), added par. (x).

Par. (y). Pub. L. 105–115, §210(c), added par. (y).

Par. (z). Pub. L. 105–115, §401(b), temporarily added par. (z) which related to dissemination of information in violation of section 360aaa of this title. See Effective and Termination Dates of 1997 Amendment note below.

1996—Par. (e). Pub. L. 104–250 inserted ", 354," before "or 373 of this title" and "354," before "355(i) or (k)".

Par. (j). Pub. L. 104–170 inserted before period at end of first sentence "; or the violating of section 346a(i)(2) of this title or any regulation issued under that section."

Pars. (u) to (w). Pub. L. 104–134 redesignated par. (u) relating to introduction into interstate commerce of unsafe dietary supplement as (v) and added par. (w).

1994—Par. (e). Pub. L. 103–396, §2(b)(1)(A), substituted "357(d) or (g), 360b(a)(4)(C)," for "357(d) or (g),".

Par. (u). Pub. L. 103–417 added par. (u) relating to introduction into interstate commerce of unsafe dietary supplement.

Pub. L. 103–396, §2(b)(1)(B), added par. (u) relating to failure to comply with regulations or orders of Secretary.

1993—Par. (j). Pub. L. 103–80, §3(c)(1), substituted "379, or 379e" for "379e, or 379".

Par. (s). Pub. L. 103–80, §3(c)(2), substituted "350a(e)" for "350a(d)".

1992—Pars. (i)(1), (j). Pub. L. 102–571 substituted "379e" for "376".

Par. (q)(1)(C). Pub. L. 102–300 added cl. (C).

1990—Par. (e). Pub. L. 101–502 substituted "or (k)" for "or (j)".

Par. (j). Pub. L. 101–508 inserted at end "This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee."

1988—Par. (t). Pub. L. 100–293 added par. (t).

1986—Par. (s). Pub. L. 99–570 amended par. (s) generally. Prior to amendment, par. (s) read as follows: "The failure to provide the notice required by section 350a(b) or 350a(c), the failure to make the reports required by section 350a(d)(1)(B), or the failure to meet the requirements prescribed under section 350a(d)(2)."

1980—Par. (e). Pub. L. 96–359, §5(b), inserted reference to section 350a of this title in two places.

Par. (j). Pub. L. 96–359, §5(c), inserted reference to section 350a of this title.

Par. (s). Pub. L. 96–359, §5(a), added par. (s).

1976—Par. (e). Pub. L. 94–295, §3(b)(2), inserted references to sections 360e(f) and 360i of this title.

Par. (j). Pub. L. 94–295, §3(b)(3), inserted references to sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of this title.

Par. (l). Pub. L. 94–295, §3(b)(4), substituted "drug or device" for "drug" wherever appearing, and inserted references to sections 360e and 360j(g) of this title.

Par. (p). Pub. L. 94–295, §4(b)(1), substituted "section 360(j) or 360(k) of this title," for "section 360(j) of this title,".

Par. (q). Pub. L. 94–295, §3(b)(1), added par. (q).

Par. (r). Pub. L. 94–295, §7(b), added par. (r).

1972—Par. (p). Pub. L. 92–387 added failure to provide information required by section 360(j) of this title, and failure to provide notice required by section 360(j)(2) of this title as prohibited acts.

1970—Par. (q). Pub. L. 91–513 struck out par. (q) which set out penalties for illegal manufacture, sale, disposition, possession and other traffic in stimulant and depressant drugs. See section 801 et seq. of this title.

1968—Par. (e). Pub. L. 90–399, §103(1), struck out "or" before "357(d) or (g)" and inserted ", or 360b(j), (l), or (m)" after "357(d) or (g)". Amendment striking out "or" was executed as described, notwithstanding directory language that "or" before "357," be stricken out, to reflect the probable intent of Congress.

Par. (j). Pub. L. 90–399, §103(2), inserted reference to section 360b of this title.

Par. (q). Pub. L. 90–639 divided cl. (3), which referred simply to possession in violation of section 360a(c) of this title, into subcls. (A) and (B) which refer, respectively, to possession in violation of section 360a(c)(1) of this title and possession in violation of section 360a(c)(2) of this title.

1965—Par. (i). Pub. L. 89–74, §9(c), designated existing provisions as subpar. (1) and added subpars. (2) and (3).

Par. (q). Pub. L. 89–74, §5, added par. (q).

1962—Par. (e). Pub. L. 87–781, §§103(c), 106(c), prohibited the failure to establish or maintain any record, or make any report, required under sections 355(i) or (j) and 507(d) or (g) of this title, or the refusal to permit access to, or verification or copying of, any such required record.

Par. (l). Pub. L. 87–781, §104(e)(1), inserted "approval of" before "an application", and substituted "in effect" for "effective".

Par. (o). Pub. L. 87–781, §114(a), added par. (o).

Par. (p). Pub. L. 87–781, §304, added par. (p).

1960—Par. (i). Pub. L. 86–618, §105(a), struck out references to sections 346(b), 354, and 364 of this title and inserted reference to section 376 of this title.

Par. (j). Pub. L. 86–618, §104, inserted reference to section 376 of this title.

1958—Par. (j). Pub. L. 85–929, inserted reference to section 348 of this title.

1953—Par. (n). Act Aug. 7, 1953, added par. (n).

1950—Par. (m). Act Mar. 16, 1950, added par. (m).

1948—Par. (k). Act June 24, 1948, inserted "(whether or not the first sale)" so as to make it clear that this subsection is not limited to the case where the act occurs while the article is held for the first sale after interstate shipment, and extended coverage of subsection to acts which result in adulteration.

1947—Par. (j). Act Mar. 10, 1947, inserted reference to sections 356 and 357 of this title.

1945—Par. (i). Act July 6, 1945, inserted reference to section 357 of this title.

1941—Par. (i). Act Dec. 22, 1941, inserted reference to section 356 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3305(d), Dec. 29, 2022, 136 Stat. 5833, provided that: "The amendments made by subsections (a) and (b) [enacting section 360n–2 of this title and amending this section] shall take effect 90 days after the date of enactment of this Act [Dec. 29, 2022]. An application or submission submitted before such effective date shall not be subject to the requirements under subsection (a) or (b) of section 524B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360n–2(a), (b)], as added by this section."

Pub. L. 117–328, div. FF, title III, §3503(b)(1), Dec. 29, 2022, 136 Stat. 5859, provided that: "The amendments made by subsection (a) [amending this section and sections 361, 362, and 381 of this title] shall take effect on the date that is 1 year after the date of enactment of this Act [Dec. 29, 2022]."

Effective Date of 2018 Amendment

Pub. L. 115–271, title III, §3012(d), Oct. 24, 2018, 132 Stat. 3936, provided that: "Sections 301(eee) [21 U.S.C. 331(eee)] and 569D [21 U.S.C. 360bbb–8d] of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall be effective beginning on the date of enactment of this Act [Oct. 24, 2018]."

Effective Date of 2015 Amendment

Pub. L. 114–114, §2(b), Dec. 28, 2015, 129 Stat. 3129, provided that:

"(1) In general.—The amendment made by subsection (a) [amending this section] applies—

"(A) with respect to manufacturing, beginning on July 1, 2017, and with respect to introduction or delivery for introduction into interstate commerce, beginning on July 1, 2018; and

"(B) notwithstanding subparagraph (A), in the case of a rinse-off cosmetic that is a nonprescription drug, with respect to manufacturing, beginning on July 1, 2018, and with respect to the introduction or delivery for introduction into interstate commerce, beginning on July 1, 2019.

"(2) Nonprescription drug.—For purposes of this subsection, the term 'nonprescription drug' means a drug not subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1))."

Effective Date of 2011 Amendment

Amendment by section 103(e) of Pub. L. 111–353 effective 18 months after Jan. 4, 2011, and applicable to a small business (as defined in the regulations promulgated under section 350g(n) of this title) beginning on the date that is 6 months after the effective date of such regulations and to a very small business (as defined in such regulations) beginning on the date that is 18 months after the effective date of such regulations, see section 103(i) of Pub. L. 111–353, set out as an Effective Date note under section 350g of this title.

Pub. L. 111–353, title III, §301(d), Jan. 4, 2011, 124 Stat. 3955, provided that: "The amendments made by this section [enacting section 384a of this title and amending this section and section 381 of this title] shall take effect 2 years after the date of enactment of this Act [Jan. 4, 2011]."

Effective Date of 2007 Amendment

Pub. L. 110–85, title IX, §909, Sept. 27, 2007, 121 Stat. 950, provided that:

"(a) Effective Date.—This subtitle [subtitle A (§§901–909) of title IX of Pub. L. 110–85, enacting sections 353b and 355–1 of this title, amending this section, sections 333, 352, and 355 of this title, and section 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 352, 355, and 355a of this title] takes effect 180 days after the date of the enactment of this Act [Sept. 27, 2007].

"(b) Drugs Deemed to Have Risk Evaluation and Mitigation Strategies.—

"(1) In general.—A drug that was approved before the effective date of this Act [probably means "this subtitle", see above] is, in accordance with paragraph (2), deemed to have in effect an approved risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355–1] (as added by section 901) (referred to in this section as the 'Act') if there are in effect on the effective date of this Act elements to assure safe use—

"(A) required under section 314.520 or section 601.42 of title 21, Code of Federal Regulations; or

"(B) otherwise agreed to by the applicant and the Secretary for such drug.

"(2) Elements of strategy; enforcement.—The approved risk evaluation and mitigation strategy in effect for a drug under paragraph (1)—

"(A) is deemed to consist of the timetable required under section 505–1(d) and any additional elements under subsections (e) and (f) of such section in effect for such drug on the effective date of this Act; and

"(B) is subject to enforcement by the Secretary to the same extent as any other risk evaluation and mitigation strategy under section 505–1 of the Act, except that sections 303(f)(4) and 502(y) and (z) of the Act [21 U.S.C. 333(f)(4), 352(y), (z)] (as added by section 902) shall not apply to such strategy before the Secretary has completed review of, and acted on, the first assessment of such strategy under such section 505–1.

"(3) Submission.—Not later than 180 days after the effective date of this Act, the holder of an approved application for which a risk evaluation and mitigation strategy is deemed to be in effect under paragraph (1) shall submit to the Secretary a proposed risk evaluation and mitigation strategy. Such proposed strategy is subject to section 505–1 of the Act as if included in such application at the time of submission of the application to the Secretary."

Effective Date of 2006 Amendment

Amendment by section 2(c) of Pub. L. 109–462 effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109–462, set out as a note under section 352 of this title.

Amendment by section 3(b) of Pub. L. 109–462 effective 1 year after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109–462, set out as a note under section 343 of this title.

Pub. L. 109–462, §4(b), Dec. 22, 2006, 120 Stat. 3475, provided that: "The amendment made by this section [amending this section] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006]."

Effective Date of 2005 Amendment

Pub. L. 109–59, title VII, §7204, Aug. 10, 2005, 119 Stat. 1914, provided that: "This subtitle [subtitle B (§§7201–7204) of title VII of Pub. L. 109–59, enacting section 350e of this title, amending this section, sections 342 and 373 of this title, and section 5701 of Title 49, Transportation, omitting sections 5702 to 5714 of Title 49, and enacting provisions set out as a note under section 301 of this title] takes effect on October 1, 2005."

Effective Date of 2002 Amendment

Pub. L. 107–188, title III, §321(c), June 12, 2002, 116 Stat. 676, provided that: "The amendments made by this section [amending this section and sections 360 and 381 of this title] take effect upon the expiration of the 180-day period beginning on the date of the enactment of this Act [June 12, 2002]."

Pub. L. 107–188, title III, §322(c), June 12, 2002, 116 Stat. 678, provided that: "The amendments made by this section [amending this section and section 381 of this title] take effect upon the expiration of the 90-day period beginning on the date of the enactment of this Act [June 12, 2002]."

Effective and Termination Dates of 1997 Amendment

Amendment by sections 204, 210, and 421 of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Amendment by section 401(b) of Pub. L. 105–115 effective 1 year after Nov. 21, 1997, or upon Secretary's issuance of final regulations pursuant to section 401(c) of Pub. L. 105–115, whichever is sooner, and ceases to be effective Sept. 30, 2006, see section 401(d), (e) of Pub. L. 105–115, set out as an Effective and Termination Dates note under former section 360aaa of this title.

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–396 effective upon adoption of final regulations under section 2(c) of Pub. L. 103–396, set out as a Regulations note under section 360b of this title, see section 2(d) of Pub. L. 103–396, set out as a note under section 360b of this title.

Effective Date of 1990 Amendment

Pub. L. 101–508, title IV, §4755(c)(2), Nov. 5, 1990, 104 Stat. 1388–210, provided that the amendment made by section 4755(c)(2) is effective as if included in subtitle D of title VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L. 101–239, title VI, §§6601, 6602, Dec. 19, 1989, 103 Stat. 2285, see 42 U.S.C. 300aa–1 note, 300aa–10 note.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–293 effective upon expiration of 90 days after Apr. 22, 1988, see section 8(a) of Pub. L. 100–293, set out as a note under section 353 of this title.

Effective Date of 1972 Amendment

Amendment by Pub. L. 92–387 effective on first day of sixth month beginning after Aug. 16, 1972, see section 5 of Pub. L. 92–387, set out as a note under section 360 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1968 Amendments

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Amendment by Pub. L. 90–639 applicable only with respect to violations of this chapter committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Effective Date of 1968 Amendments; Transitional Provisions note under section 321 of this title.

Effective Date of 1965 Amendment

Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

Effective Date of 1962 Amendment

Amendment by sections 103(c) and 106(c) of Pub. L. 87–781 effective on first day of seventh calendar month following Oct. 1962, and amendment by section 104(e)(1) of Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Pub. L. 87–781, title I, §114(b), Oct. 10, 1962, 76 Stat. 791, provided that: "This section [amending this section] shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted [October 1962]."

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date of 1958 Amendment

Amendment by Pub. L. 85–929 effective Sept. 6, 1958, see section 6(a) of Pub. L. 85–929, set out as a note under section 342 of this title.

Effective Date of 1950 Amendment

Amendment by act Mar. 16, 1950, effective July 1, 1950, see section 7 of that act, set out as an Effective Date note under section 347 of this title.

Regulations

Pub. L. 113–54, title I, §104, Nov. 27, 2013, 127 Stat. 597, provided that: "In promulgating any regulations to implement this title [enacting subpart 9 of part C of subchapter VII of this chapter and sections 353a–1 and 353b of this title, amending this section and sections 352, 353a, 352b, and 353c of this title, and enacting provisions set out as notes under section 301 of this title] (and the amendments made by this title), the Secretary of Health and Human Services shall—

"(1) issue a notice of proposed rulemaking that includes the proposed regulation;

"(2) provide a period of not less than 60 calendar days for comments on the proposed regulation; and

"(3) publish the final regulation not more than 18 months following publication of the proposed rule and not less than 30 calendar days before the effective date of such final regulation."

Secretary of Health and Human Services to promulgate regulations to implement amendments made by section 401 of Pub. L. 105–115 not later than 1 year after Nov. 21, 1997, see section 401(c) of Pub. L. 105–115, set out as a note under section 360aaa of this title.

Savings Provisions

Pub. L. 113–54, title II, §208, Nov. 27, 2013, 127 Stat. 640, provided that: "Except as provided in the amendments made by paragraphs (1), (2), and (3) of section 204(a) [amending section 353 of this title] and by section 206(a) [amending this section], nothing in this title [enacting part H of subchapter V of this chapter, amending this section and sections 333, 352, 353, and 360eee–1 of this title, and enacting provisions set out as notes under sections 301, 333, and 353 of this title] (including the amendments made by this title) shall be construed as altering any authority of the Secretary of Health and Human Services with respect to a drug subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)) under any other provision of such Act [21 U.S.C. 301 et seq.] or the Public Health Service Act (42 U.S.C. 201 et seq.)."

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Construction of 2022 Amendment

Nothing in amendment made by section 3210(c) of Pub. L. 117–328 to be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 356(c) of this title for which a notice of proposed withdrawal has been published in the Federal Register prior to Dec. 29, 2022, see section 3210(f) of Pub. L. 117–328, set out as a note under section 356 of this title.

Pub. L. 117–328, div. FF, title III, §3305(c), Dec. 29, 2022, 136 Stat. 5833, provided that: "Nothing in this section [enacting section 360n–2 of this title, amending this section, and enacting provisions set out as notes under this section and section 360n–2 of this title], including the amendments made by this section, shall be construed to affect the Secretary's [of Health and Human Services] authority related to ensuring that there is a reasonable assurance of the safety and effectiveness of devices, which may include ensuring that there is a reasonable assurance of the cybersecurity of certain cyber devices, including for devices approved or cleared prior to the date of enactment of this Act [Dec. 29, 2022]."

[For definition of "device" as used in section 3305(c) of Pub. L. 117–328, set out above, see section 321(h) of this title, as made applicable by section 3305(h) of Pub. L. 117–328, which is set out as a note under section 360n–2 of this title.]

Nothing in amendment made by section 3503(a)(1), (4)(A), (B) of Pub. L. 117–328, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a Construction; Confidentiality note under section 364 of this title.

Construction of 2015 Amendment

Pub. L. 114–114, §2(d), Dec. 28, 2015, 129 Stat. 3130, provided that: "Nothing in this Act [amending this section and enacting provisions set out as notes under this section and section 301 of this title] (or the amendments made by this Act) shall be construed to apply with respect to drugs that are not also cosmetics (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321))."

Construction of 2011 Amendment

Nothing in amendments by sections 103(e), 105(c), 106(d), 204(j)(1), 211(b), (c), and 301(b) of Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, see section 2206 of this title.

Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

Construction of 2009 Amendments

Pub. L. 111–31, div. A, title I, §103(p), June 22, 2009, 123 Stat. 1838, provided that: "Nothing in this section [amending this section and sections 333, 334, 355, 360m, 372 to 374, 375, 379a, 381, 393, 399, and 679 of this title and enacting provisions set out as notes under sections 333 and 387c of this title] is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands."

Construction of 2002 Amendments

Pub. L. 107–188, title III, §315, June 12, 2002, 116 Stat. 675, provided that: "Nothing in this title [enacting sections 350c, 350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319, and 8320 of Title 7, Agriculture, and section 247b–20 of Title 42, The Public Health and Welfare, amending this section, sections 334, 335a, 342, 343, 360, 372, 374, and 381 of this title, and section 43 of Title 18, Crimes and Criminal Procedure, and enacting provisions set out as notes under this section and sections 341, 350c, 350d, and 381 of this title], or an amendment made by this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations."

Preemption of State Laws

Pub. L. 114–114, §2(c), Dec. 28, 2015, 129 Stat. 3129, provided that: "No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect restrictions with respect to the manufacture or introduction or delivery for introduction into interstate commerce of rinse-off cosmetics containing plastic microbeads (as defined in section 301(ddd) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)) that are not identical to the restrictions under such section 301(ddd) that have begun to apply under subsection (b) [set out as a note above]."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original.

² See References in Text note below.

§332. Injunction proceedings

(a) Jurisdiction of courts

The district courts of the United States and the United States courts of the Territories shall have jurisdiction, for cause shown ¹ to restrain violations of section 331 of this title, except paragraphs (h), (i), and (j).

(b) Violation of injunction

In case of violation of an injunction or restraining order issued under this section, which also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the accused, by a jury.

(June 25, 1938, ch. 675, §302, 52 Stat. 1043; Pub. L. 87–781, title I, §103(d), title II, §201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, §3(d), Aug. 13, 1993, 107 Stat. 775.)

Editorial Notes

Amendments

1993—Subsec. (a). Pub. L. 103–80, §3(d)(1), struck out ", and subject to the provisions of section 17 (relating to notice to opposite party) of the Act entitled 'An Act to supplement existing laws against unlawful restraints and monopolies, and for other purposes', approved October 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 381)," after "for cause shown".

Subsec. (b). Pub. L. 103–80, §3(d)(2), struck out at end "Such trial shall be conducted in accordance with the practice and procedure applicable in the case of proceedings subject to the provisions of section 22 of such Act of October 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 387)."

1962—Subsec. (a). Pub. L. 87–781, §103(d), struck out "(e)," after "paragraphs".

Pub. L. 87–781, §201(c), struck out "(f)," after "paragraphs".

Statutory Notes and Related Subsidiaries

Effective Date of 1962 Amendment

Amendment by section 103(c) of Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Pub. L. 87–781, title II, §203, Oct. 10, 1962, 76 Stat. 793, provided that: "The amendments made by this title [amending this section and section 374 of this title and enacting provisions set out as notes under sections 321 and 374 of this title] shall take effect on the date of enactment of this Act [Oct. 10, 1962]."

¹ So in original. Probably should be followed by a comma.

§333. Penalties

(a) Violation of section 331 of this title; second violation; intent to defraud or mislead

(1) Any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both.

(2) Notwithstanding the provisions of paragraph (1) of this section,¹ if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.

(b) Prescription drug marketing violations

(1) Notwithstanding subsection (a), any person who violates section 331(t) of this title by—

(A) knowingly importing a drug in violation of section 381(d)(1) of this title,

(B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell, purchase, or trade a drug or drug sample, in violation of section 353(c)(1) of this title,

(C) knowingly selling, purchasing, or trading a coupon, knowingly offering to sell, purchase, or trade such a coupon, or knowingly counterfeiting such a coupon, in violation of section 353(c)(2) of this title, or

(D) knowingly distributing drugs in violation of section 353(e)(1) of this title,

shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.

(2) Any manufacturer or distributor who distributes drug samples by means other than the mail or common carrier whose representative, during the course of the representative's employment or association with that manufacturer or distributor, violated section 331(t) of this title because of a violation of section 353(c)(1) of this title or violated any State law prohibiting the sale, purchase, or trade of a drug sample subject to section 353(b) of this title or the offer to sell, purchase, or trade such a drug sample shall, upon conviction of the representative for such violation, be subject to the following civil penalties:

(A) A civil penalty of not more than $50,000 for each of the first two such violations resulting in a conviction of any representative of the manufacturer or distributor in any 10-year period.

(B) A civil penalty of not more than $1,000,000 for each violation resulting in a conviction of any representative after the second conviction in any 10-year period.

For the purposes of this paragraph, multiple convictions of one or more persons arising out of the same event or transaction, or a related series of events or transactions, shall be considered as one violation.

(3) Any manufacturer or distributor who violates section 331(t) of this title because of a failure to make a report required by section 353(d)(3)(E) of this title shall be subject to a civil penalty of not more than $100,000.

(4)(A) If a manufacturer or distributor or any representative of such manufacturer or distributor provides information leading to the institution of a criminal proceeding against, and conviction of, any representative of that manufacturer or distributor for a violation of section 331(t) of this title because of a sale, purchase, or trade or offer to purchase, sell, or trade a drug sample in violation of section 353(c)(1) of this title or for a violation of State law prohibiting the sale, purchase, or trade or offer to sell, purchase, or trade a drug sample, the conviction of such representative shall not be considered as a violation for purposes of paragraph (2).

(B) If, in an action brought under paragraph (2) against a manufacturer or distributor relating to the conviction of a representative of such manufacturer or distributor for the sale, purchase, or trade of a drug or the offer to sell, purchase, or trade a drug, it is shown, by clear and convincing evidence—

(i) that the manufacturer or distributor conducted, before the institution of a criminal proceeding against such representative for the violation which resulted in such conviction, an investigation of events or transactions which would have led to the reporting of information leading to the institution of a criminal proceeding against, and conviction of, such representative for such purchase, sale, or trade or offer to purchase, sell, or trade, or

(ii) that, except in the case of the conviction of a representative employed in a supervisory function, despite diligent implementation by the manufacturer or distributor of an independent audit and security system designed to detect such a violation, the manufacturer or distributor could not reasonably have been expected to have detected such violation,

the conviction of such representative shall not be considered as a conviction for purposes of paragraph (2).

(5) If a person provides information leading to the institution of a criminal proceeding against, and conviction of, a person for a violation of section 331(t) of this title because of the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample in violation of section 353(c)(1) of this title, such person shall be entitled to one-half of the criminal fine imposed and collected for such violation but not more than $125,000.

(6) Notwithstanding subsection (a), any person who is a manufacturer or importer of a prescription drug under section 384(b) of this title and knowingly fails to comply with a requirement of section 384(e) of this title that is applicable to such manufacturer or importer, respectively, shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.

(7) Notwithstanding subsection (a)(2), any person that knowingly and intentionally adulterates a drug such that the drug is adulterated under subsection (a)(1), (b), (c), or (d) of section 351 of this title and has a reasonable probability of causing serious adverse health consequences or death to humans or animals shall be imprisoned for not more than 20 years or fined not more than $1,000,000, or both.

(8) Notwithstanding subsection (a), any person who violates section 331(i)(3) of this title by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit drug, or who violates section 331(fff)(3) of this title by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit device, shall be imprisoned for not more than 10 years or fined in accordance with title 18, or both.

(c) Exceptions in certain cases of good faith, etc.

No person shall be subject to the penalties of subsection (a)(1) of this section, (1) for having received in interstate commerce any article and delivered it or proffered delivery of it, if such delivery or proffer was made in good faith, unless he refuses to furnish on request of an officer or employee duly designated by the Secretary the name and address of the person from whom he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; or (2) for having violated section 331(a) or (d) of this title, if he establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the article, to the effect, in case of an alleged violation of section 331(a) of this title, that such article is not adulterated or misbranded, within the meaning of this chapter designating this chapter or to the effect, in case of an alleged violation of section 331(d) of this title, that such article is not an article which may not, under the provisions of section 344 or 355 of this title, be introduced into interstate commerce; or (3) for having violated section 331(a) of this title, where the violation exists because the article is adulterated by reason of containing a color additive not from a batch certified in accordance with regulations promulgated by the Secretary under this chapter, if such person establishes a guaranty or undertaking signed by, and containing the name and address of, the manufacturer of the color additive, to the effect that such color additive was from a batch certified in accordance with the applicable regulations promulgated by the Secretary under this chapter; or (4) for having violated section 331(b), (c) or (k) of this title by failure to comply with section 352(f) of this title in respect to an article received in interstate commerce to which neither section 353(a) nor 353(b)(1) of this title is applicable, if the delivery or proffered delivery was made in good faith and the labeling at the time thereof contained the same directions for use and warning statements as were contained in the labeling at the time of such receipt of such article; or (5) for having violated section 331(i)(2) of this title if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in a drug being a counterfeit drug, or for having violated section 331(i)(3) of this title if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the drug was a counterfeit drug; or (6) for having violated section 331(fff)(2) of this title if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in a device being a counterfeit device, or for having violated section 331(fff)(3) of this title if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the device was a counterfeit device.

(d) Exceptions involving misbranded food

No person shall be subject to the penalties of subsection (a)(1) of this section for a violation of section 331 of this title involving misbranded food if the violation exists solely because the food is misbranded under section 343(a)(2) of this title because of its advertising.

(e) Prohibited distribution of human growth hormone

(1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 355 of this title and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both.

(2) Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.

(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].

(4) As used in this subsection the term "human growth hormone" means somatrem, somatropin, or an analogue of either of them.

(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.

(f) Violations related to devices

(1)(A) Except as provided in subparagraph (B), any person who violates a requirement of this chapter which relates to devices shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. For purposes of the preceding sentence, a person accredited under paragraph (2) of section 374(g) of this title who is substantially not in compliance with the standards of accreditation under such section, or who poses a threat to public health or fails to act in a manner that is consistent with the purposes of such section, shall be considered to have violated a requirement of this chapter that relates to devices.

(B) Subparagraph (A) shall not apply—

(i) to any person who violates the requirements of section 360i(a) or 360j(f) of this title unless such violation constitutes (I) a significant or knowing departure from such requirements, or (II) a risk to public health,

(ii) to any person who commits minor violations of section 360i(e) or 360i(g) of this title (only with respect to correction reports) if such person demonstrates substantial compliance with such section, or

(iii) to violations of section 351(a)(2)(A) of this title which involve one or more devices which are not defective.

(2)(A) Any person who introduces into interstate commerce or delivers for introduction into interstate commerce an article of food that is adulterated within the meaning of section 342(a)(2)(B) of this title or any person who does not comply with a recall order under section 350l of this title shall be subject to a civil money penalty of not more than $50,000 in the case of an individual and $250,000 in the case of any other person for such introduction or delivery, not to exceed $500,000 for all such violations adjudicated in a single proceeding.

(B) This paragraph shall not apply to any person who grew the article of food that is adulterated. If the Secretary assesses a civil penalty against any person under this paragraph, the Secretary may not use the criminal authorities under this section to sanction such person for the introduction or delivery for introduction into interstate commerce of the article of food that is adulterated. If the Secretary assesses a civil penalty against any person under this paragraph, the Secretary may not use the seizure authorities of section 334 of this title or the injunction authorities of section 332 of this title with respect to the article of food that is adulterated.

(C) In a hearing to assess a civil penalty under this paragraph, the presiding officer shall have the same authority with regard to compelling testimony or production of documents as a presiding officer has under section 346a(g)(2)(B) of this title. The third sentence of paragraph (5)(A) shall not apply to any investigation under this paragraph.

(3)(A) Any person who violates section 331(jj) of this title shall be subject to a civil monetary penalty of not more than $10,000 for all violations adjudicated in a single proceeding.

(B) If a violation of section 331(jj) of this title is not corrected within the 30-day period following notification under section 282(j)(5)(C)(ii) ² of title 42, the person shall, in addition to any penalty under subparagraph (A), be subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period until the violation is corrected.

(4)(A) Any responsible person (as such term is used in section 355–1 of this title) that violates a requirement of section 355(o), 355(p), or 355–1 of this title shall be subject to a civil monetary penalty of—

(i) not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or

(ii) in the case of a violation that continues after the Secretary provides written notice to the responsible person, the responsible person shall be subject to a civil monetary penalty of $250,000 for the first 30-day period (or any portion thereof) that the responsible person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding.

(B) In determining the amount of a civil penalty under subparagraph (A)(ii), the Secretary shall take into consideration whether the responsible person is making efforts toward correcting the violation of the requirement of section 355(o), 355(p), or 355–1 of this title for which the responsible person is subject to such civil penalty.

(5)(A) A civil penalty under paragraph (1), (2), (3), (4), or (9) shall be assessed, or a no-tobacco-sale order may be imposed, by the Secretary by an order made on the record after opportunity for a hearing provided in accordance with this subparagraph and section 554 of title 5. Before issuing such an order, the Secretary shall give written notice to the person to be assessed a civil penalty, or upon whom a no-tobacco-sale order is to be imposed, under such order of the Secretary's proposal to issue such order and provide such person an opportunity for a hearing on the order. In the course of any investigation, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation.

(B) In determining the amount of a civil penalty, or the period to be covered by a no-tobacco-sale order, the Secretary shall take into account the nature, circumstances, extent, and gravity of the violation or violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require. A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.

(C) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed under paragraph (1), (2), (3), (4), or (9). The amount of such penalty, when finally determined, or the amount agreed upon in compromise, may be deducted from any sums owing by the United States to the person charged.

(D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.

(6) Any person who requested, in accordance with paragraph (5)(A), a hearing respecting the assessment of a civil penalty or the imposition of a no-tobacco-sale order and who is aggrieved by an order assessing a civil penalty or the imposition of a no-tobacco-sale order may file a petition for judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such person resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessment was issued, or on which the no-tobacco-sale order was imposed, as the case may be.

(7) If any person fails to pay an assessment of a civil penalty—

(A) after the order making the assessment becomes final, and if such person does not file a petition for judicial review of the order in accordance with paragraph (6), or

(B) after a court in an action brought under paragraph (6) has entered a final judgment in favor of the Secretary,

the Attorney General shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.

(8) If the Secretary finds that a person has committed repeated violations of section 387f(d)(5) of this title or of restrictions promulgated under section 387f(d) of this title at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer's request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available.

(9) Civil Monetary Penalties for Violation of Tobacco Product Requirements.—

(A) In general.—Subject to subparagraph (B), any person who violates a requirement of this chapter which relates to tobacco products shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding.

(B) Enhanced penalties.—

(i) Any person who intentionally violates a requirement of section 387b(5), 387b(6), 387d, 387h(c), or 387k(a) of this title, shall be subject to a civil monetary penalty of—

(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or

(II) in the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding.

(ii) Any person who violates a requirement of section 387k(g)(2)(C)(ii) or 387k(i)(1) of this title, shall be subject to a civil monetary penalty of—

(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or

(II) in the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding.

(iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the Secretary shall take into consideration whether the person is making efforts toward correcting the violation of the requirements of the section for which such person is subject to such civil penalty.

(g) Violations regarding direct-to-consumer advertising

(1) With respect to a person who is a holder of an approved application under section 355 of this title for a drug subject to section 353(b) of this title or under section 262 of title 42, any such person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No other civil monetary penalties in this chapter (including the civil penalty in subsection (f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of such a notice, all violations under this paragraph occurring in a single day shall be considered one violation. With respect to advertisements that appear in magazines or other publications that are published less frequently than daily, each issue date (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations under this paragraph.

(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after providing written notice to the person to be assessed a civil penalty and an opportunity for a hearing in accordance with this paragraph and section 554 of title 5. If upon receipt of the written notice, the person to be assessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, including information pertaining to the factors described in paragraph (3).

(3) The Secretary, in determining the amount of the civil penalty under paragraph (1), shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors:

(A) Whether the person submitted the advertisement or a similar advertisement for review under section 379h–1 of this title.

(B) Whether the person submitted the advertisement for review if required under section 353c ² of this title.

(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the person disseminated or caused another party to disseminate the advertisement before the end of the 45-day comment period.

(D) Whether the person incorporated any comments made by the Secretary with regard to the advertisement into the advertisement prior to its dissemination.

(E) Whether the person ceased distribution of the advertisement upon receipt of the written notice referred to in paragraph (2) for such advertisement.

(F) Whether the person had the advertisement reviewed by qualified medical, regulatory, and legal reviewers prior to its dissemination.

(G) Whether the violations were material.

(H) Whether the person who created the advertisement or caused the advertisement to be created acted in good faith.

(I) Whether the person who created the advertisement or caused the advertisement to be created has been assessed a civil penalty under this provision within the previous 1-year period.

(J) The scope and extent of any voluntary, subsequent remedial action by the person.

(K) Such other matters, as justice may require.

(4)(A) Subject to subparagraph (B), no person shall be required to pay a civil penalty under paragraph (1) if the person submitted the advertisement to the Secretary and disseminated or caused another party to disseminate such advertisement after incorporating each comment received from the Secretary.

(B) The Secretary may retract or modify any prior comments the Secretary has provided to an advertisement submitted to the Secretary based on new information or changed circumstances, so long as the Secretary provides written notice to the person of the new views of the Secretary on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under paragraph (1).

(5) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed under paragraph (1). The amount of such penalty, when finally determined, or the amount charged upon in compromise, may be deducted from any sums owed by the United States to the person charged.

(6) Any person who requested, in accordance with paragraph (2), a hearing with respect to the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty, may file a petition for de novo judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such person resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessments was issued.

(7) If any person fails to pay an assessment of a civil penalty under paragraph (1)—

(A) after the order making the assessment becomes final, and if such person does not file a petition for judicial review of the order in accordance with paragraph (6), or

(B) after a court in an action brought under paragraph (6) has entered a final judgment in favor of the Secretary,

the Attorney General of the United States shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.

(June 25, 1938, ch. 675, §303, 52 Stat. 1043; Oct. 26, 1951, ch. 578, §2, 65 Stat. 649; Pub. L. 86–618, title I, §105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89–74, §§7, 9(d), July 15, 1965, 79 Stat. 233, 235; Pub. L. 90–639, §3, Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91–513, title II, §701(b), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 94–278, title V, §502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100–293, §7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100–690, title II, §2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101–629, §17(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101–647, title XIX, §1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102–353, §3, Aug. 26, 1992, 106 Stat. 941; Pub. L. 103–80, §3(e), Aug. 13, 1993, 107 Stat. 775; Pub. L. 103–322, title XXXIII, §330015, Sept. 13, 1994, 108 Stat. 2146; Pub. L. 104–170, title IV, §407, Aug. 3, 1996, 110 Stat. 1535; Pub. L. 106–387, §1(a) [title VII, §745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40; Pub. L. 107–250, title II, §201(c), Oct. 26, 2002, 116 Stat. 1609; Pub. L. 108–173, title XI, §1121(b)(2), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 110–85, title II, §226(b), title VIII, §801(b)(2), title IX, §§901(d)(4), 902(b), Sept. 27, 2007, 121 Stat. 854, 920, 940, 943; Pub. L. 111–31, div. A, title I, §103(c), June 22, 2009, 123 Stat. 1835; Pub. L. 111–353, title II, §206(c), Jan. 4, 2011, 124 Stat. 3943; Pub. L. 112–144, title VII, §716, July 9, 2012, 126 Stat. 1075; Pub. L. 113–54, title II, §207(a), Nov. 27, 2013, 127 Stat. 640; Pub. L. 115–52, title VI, §604(b), Aug. 18, 2017, 131 Stat. 1048; Pub. L. 116–94, div. N, title I, §603(d)(2), Dec. 20, 2019, 133 Stat. 3124; Pub. L. 117–328, div. FF, title II, §2513(b), Dec. 29, 2022, 136 Stat. 5805.)

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (e)(3), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Section 282(j)(5)(C)(ii) of title 42, referred to in subsec. (f)(3)(B), was in the original "section 402(j)(5)(C)(ii)", and was translated as meaning section 402(j)(5)(C)(ii) of the Public Health Service Act to reflect the probable intent of Congress because there is no subsec. (j) of section 402 of the Federal Food, Drug, and Cosmetic Act and section 402(j)(5)(C)(ii) of the Public Health Service Act relates to notification of noncompliance with clinical trial information requirements.

Section 353c of this title, referred to in subsec. (g)(3)(B), was in the original a reference to section 503B of act June 25, 1938, and was translated as if it referred to section 503C of that Act, to reflect the probable intent of Congress and the renumbering of section 503B as 503C by Pub. L. 113–54, title I, §102(a)(1), Nov. 27, 2013, 127 Stat. 587, and its transfer to section 353c of this title. A new section 503B, which was enacted by section 102(a)(2) of Pub. L. 113–54, is classified to section 353b of this title and does not relate to television advertisements.

Amendments

2022—Subsec. (b)(8). Pub. L. 117–328, §2513(b)(1), inserted ", or who violates section 331(fff)(3) of this title by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit device," after "a counterfeit drug".

Subsec. (c)(6). Pub. L. 117–328, §2513(b)(2), added cl. (6).

2019—Subsec. (f)(8). Pub. L. 116–94 inserted "section 387f(d)(5) of this title or of" after "repeated violations of".

2017—Subsec. (b)(8). Pub. L. 115–52 added par. (8).

2013—Subsec. (b)(1)(D). Pub. L. 113–54 substituted "353(e)(1)" for "353(e)(2)(A)".

2012—Subsec. (b)(7). Pub. L. 112–144 added par. (7).

2011—Subsec. (f)(2)(A). Pub. L. 111–353 inserted "or any person who does not comply with a recall order under section 350l of this title" after "section 342(a)(2)(B) of this title".

2009—Subsec. (f)(5)(A). Pub. L. 111–31, §103(c)(1)(A), (B), substituted "paragraph (1), (2), (3), (4), or (9)" for "paragraph (1), (2), (3), or (4)", "shall be assessed, or a no-tobacco-sale order may be imposed," for "shall be assessed", and "assessed a civil penalty, or upon whom a no-tobacco-sale order is to be imposed," for "assessed a civil penalty".

Subsec. (f)(5)(B). Pub. L. 111–31, §103(c)(1)(C), inserted "or the period to be covered by a no-tobacco-sale order," after "penalty," and inserted at end "A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order."

Subsec. (f)(5)(C). Pub. L. 111–31, §103(c)(1)(A), substituted "paragraph (1), (2), (3), (4), or (9)" for "paragraph (1), (2), (3), or (4)".

Subsec. (f)(5)(D). Pub. L. 111–31, §103(c)(1)(D), added subpar. (D).

Subsec. (f)(6). Pub. L. 111–31, §103(c)(2), inserted "or the imposition of a no-tobacco-sale order" after "penalty" in two places and substituted "issued, or on which the no-tobacco-sale order was imposed, as the case may be." for "issued."

Subsec. (f)(8), (9). Pub. L. 111–31, §103(c)(3), added pars. (8) and (9).

2007—Subsec. (f). Pub. L. 110–85, §226(b)(1), redesignated subsec. (g) as (f).

Subsec. (f)(1)(B)(ii). Pub. L. 110–85, §226(b)(2), substituted "360i(g)" for "360i(f)".

Subsec. (f)(2)(C). Pub. L. 110–85, §801(b)(2)(C), substituted "paragraph (5)(A)" for "paragraph (3)(A)".

Subsec. (f)(3). Pub. L. 110–85, §801(b)(2)(B), added par. (3). Former par. (3) redesignated (5).

Subsec. (f)(4). Pub. L. 110–85, §902(b)(1), added par. (4).

Pub. L. 110–85, §801(b)(2)(A), redesignated par. (4) as (6).

Subsec. (f)(5). Pub. L. 110–85, §801(b)(2)(A), redesignated par. (3) as (5). Former par. (5) redesignated (7).

Subsec. (f)(5)(A), (C). Pub. L. 110–85, §902(b)(2), substituted "paragraph (1), (2), (3), or (4)" for "paragraph (1), (2), or (3)".

Pub. L. 110–85, §801(b)(2)(D), substituted "paragraph (1), (2), or (3)" for "paragraph (1) or (2)".

Subsec. (f)(6). Pub. L. 110–85, §801(b)(2)(A), (E), redesignated par. (4) as (6) and substituted "paragraph (5)(A)" for "paragraph (3)(A)".

Subsec. (f)(7). Pub. L. 110–85, §801(b)(2)(A), (F), redesignated par. (5) as (7) and substituted "paragraph (6)" for "paragraph (4)" wherever appearing.

Subsec. (g). Pub. L. 110–85, §901(d)(4), added subsec. (g).

Pub. L. 110–85, §226(b)(1), redesignated subsec. (g) as (f).

2003—Subsec. (b)(6). Pub. L. 108–173, which directed amendment of subsec. (a)(6) by substituting "prescription drug under section 384(b)" for "covered product pursuant to section 384(a)", was executed by making the substitution in subsec. (b)(6), to reflect the probable intent of Congress.

2002—Subsec. (g)(1)(A). Pub. L. 107–250 inserted at end "For purposes of the preceding sentence, a person accredited under paragraph (2) of section 374(g) of this title who is substantially not in compliance with the standards of accreditation under such section, or who poses a threat to public health or fails to act in a manner that is consistent with the purposes of such section, shall be considered to have violated a requirement of this chapter that relates to devices."

2000—Subsec. (b)(6). Pub. L. 106–387 added par. (6).

1996—Subsec. (g)(2). Pub. L. 104–170, §407(1), (2), added par. (2). Former par. (2) redesignated (3).

Subsec. (g)(3). Pub. L. 104–170, §407(1), (3), redesignated par. (2) as (3) and substituted "paragraph (1) or (2)" for "paragraph (1)" in subpars. (A) and (C). Former par. (3) redesignated (4).

Subsec. (g)(4). Pub. L. 104–170, §407(1), (4), redesignated par. (3) as (4) and substituted "paragraph (3)(A)" for "paragraph (2)(A)". Former par. (4) redesignated (5).

Subsec. (g)(5). Pub. L. 104–170, §407(1), (5), redesignated par. (4) as (5) and substituted "paragraph (4)" for "paragraph (3)" wherever appearing.

1994—Subsec. (e). Pub. L. 103–322 amended directory language of Pub. L. 101–647. See 1990 Amendment note below.

1993—Subsecs. (e) to (g). Pub. L. 103–80, which directed the amendment of this section by redesignating the second subsec. (e) and subsec. (f) as subsecs. (f) and (g), respectively, could only be executed by designating subsec. (f) as (g) because this section did not contain a second subsec. (e) subsequent to amendment of Pub. L. 101–647 by Pub. L. 103–322. See 1990 and 1994 amendment notes for subsec. (e) under this section.

1992—Subsec. (b)(1). Pub. L. 102–353, §3(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Notwithstanding subsection (a) of this section, any person who violates section 331(t) of this title because of an importation of a drug in violation of section 381(d)(1) of this title, because of a sale, purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of section 353(c) of this title, because of the sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the counterfeiting of such a coupon in violation of section 353(c)(2) of this title, or the distribution of drugs in violation of section 353(e)(2)(A) of this title shall be imprisoned for not more than 10 years or fined not more than $250,000, or both."

Subsec. (b)(4)(A). Pub. L. 102–353, §3(b)(1), substituted "the institution of a criminal proceeding against, and conviction of," for "the arrest and conviction of".

Subsec. (b)(4)(B)(i). Pub. L. 102–353, §3(b)(1), (2), substituted "before the institution of a criminal proceeding against" for "before the arrest of" and "the institution of a criminal proceeding against, and conviction of," for "the arrest and conviction of".

Subsec. (b)(5). Pub. L. 102–353, §3(b)(3), substituted "the institution of a criminal proceeding against, and conviction of," for "the arrest and conviction of".

Subsec. (c). Pub. L. 102–353, §3(b)(4), substituted "subsection (a)(1) of this section" for "subsection (a) of this section".

Subsec. (d). Pub. L. 102–353, §3(b)(4), (5), substituted "subsection (a)(1) of this section" for "subsection (a) of this section" and struck out ", and no person shall be subject to the penalties of subsection (b) of this section for such a violation unless the violation is committed with the intent to defraud or mislead" after "advertising".

1990—Subsec. (e). Pub. L. 101–647, as amended by Pub. L. 103–322, amended subsec. (e) generally. Prior to amendment, subsec. (e) read as follows:

"(e)(1) Except as provided in paragraph (2), any person who distributes or possesses with the intent to distribute any anabolic steroid for any use in humans other than the treatment of disease pursuant to the order of a physician shall be imprisoned for not more than three years or fined under title 18, or both.

"(2) Any person who distributes or possesses with the intent to distribute to an individual under 18 years of age, any anabolic steroid for any use in humans other than the treatment of disease pursuant to the order of a physician shall be imprisoned for not more than six years or fined under title 18, or both."

Subsec. (f). Pub. L. 101–629 added subsec. (f).

1988—Subsecs. (a), (b). Pub. L. 100–293 designated existing subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a), substituted "paragraph (1)" for "subsection (a)" in par. (2), and added subsec. (b).

Subsec. (e). Pub. L. 100–690 added subsec. (e).

1976—Subsec. (d). Pub. L. 94–278 added subsec. (d).

1970—Subsec. (a). Pub. L. 91–513 struck out reference to subsec. (b) and transferred to subsec. (b) provisions covering second offenses and offenses committed with intent to defraud or mislead.

Subsec. (b). Pub. L. 91–513 inserted provisions covering second offenses and offenses committed with intent to defraud or mislead formerly set out in subsec. (a) and struck out provisions covering violations involving depressant and stimulant drugs. See section 801 et seq. of this title.

1968—Subsecs. (a), (b). Pub. L. 90–639 made a general revision in the penalties prescribed for offenses involving depressant or stimulant drugs, set a fine of not to exceed $10,000 or imprisonment of not more than 5 years for offenses involving the unlawful manufacturing of, sale, or disposal of, or possession with intent to sell, a depressant or stimulant drug or involving counterfeit depressant or stimulant drugs, stiffened the penalties for unlawful sales or other disposals by persons over 18 to persons under 21, and set new penalties for possession of a depressant or stimulant drug for purposes other than sale or other disposal.

1965—Subsec. (a). Pub. L. 89–74, §7(a), inserted proviso limiting the penalties for depressant or stimulant drug violations to two years imprisonment or $5,000 fine or both for first offense and to two years imprisonment or $15,000 fine or both for subsequent offenses.

Subsec. (b). Pub. L. 89–74, §7(b), inserted parenthetical exception provision.

Subsec. (c)(5). Pub. L. 89–74, §9(d), added cl. (5).

1960—Subsec. (c)(3). Pub. L. 86–618 substituted "a color additive" for "a coal-tar color", "the color additive" for "the coal-tar color" and "such color additive was" for "such color was".

1951—Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).

Statutory Notes and Related Subsidiaries

Effective Date of 2013 Amendment

Pub. L. 113–54, title II, §207(b), Nov. 27, 2013, 127 Stat. 640, provided that: "The amendment made by subsection (a) [amending this section] shall take effect on January 1, 2015."

Effective Date of 2009 Amendment

Pub. L. 111–31, div. A, title I, §103(q)(3), (4), June 22, 2009, 123 Stat. 1840, provided that:

"(3) General effective date.—The amendments made by paragraphs (2) [amending this section], (3) [amending this section], and (4) [no par. (4) has been enacted] of subsection (c) shall take effect upon the issuance of guidance described in paragraph (1) of this subsection [set out as a Guidance note below].

"(4) Special effective date.—The amendment made by subsection (c)(1) [amending this section] shall take effect on the date of enactment of this Act [June 22, 2009]."

Effective Date of 2007 Amendment

Amendment by sections 901(d)(4) and 902(b) of Pub. L. 110–85 effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as a note under section 331 of this title.

Effective Date of 1994 Amendment

Pub. L. 103–322, title XXXIII, §330015, Sept. 13, 1994, 108 Stat. 2146, provided that the amendment made by that section is effective as of the date on which section 1904 of Pub. L. 101–647, which amended this section, took effect.

Effective Date of 1990 Amendment

Pub. L. 101–629, §17(b), Nov. 28, 1990, 104 Stat. 4528, provided that:

"(b) Effective Date of Application to Device User Facilities.—

"(1) The Secretary of Health and Human Services shall conduct a study to determine whether there has been substantial compliance with the requirements of section 519(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user facilities (as defined in section 519(b)(5)(A) of such Act). The Secretary shall report the results of the study to the Congress after the expiration of 45 months after the date of the enactment of this Act [Nov. 28, 1990].

"(2)(A) If upon the expiration of 48 months after the date of the enactment of this Act [Nov. 28, 1990] the Secretary has not made the report required by paragraph (1), section 303(f) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added by the amendment made by subsection (a), shall take effect with respect to device user facilities (as defined in section 519(b)(5)(A) of such Act). [Secretary of Health and Human Services had not made the report required by par. (1) on the expiration of 48 months after Nov. 28, 1990.]

"(B) If in the report under paragraph (1) the Secretary reports that there has been substantial compliance with the requirements of such section 519(b) by a type of device user facility and if the Secretary does not make a determination under subparagraph (C) with respect to such type of facility, such section 303(f) shall not take effect with respect to such type of facility.

"(C) If the Secretary determines in the report under paragraph (1) that there is not substantial compliance with the requirements of such section 519(b) by a type of device user facility or if the Secretary makes such a determination after making the report under paragraph (1), such section 303(f) shall take effect with respect to such type of facility upon the effective date of the report."

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–293 effective upon expiration of 90 days after Apr. 22, 1988, see section 8(a) of Pub. L. 100–293, set out as a note under section 353 of this title.

Effective Date of 1976 Amendment

Amendment by Pub. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of Pub. L. 94–278, set out as a note under section 334 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–639 applicable only with respect to violations of this chapter committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Effective Date of 1968 Amendments; Transitional Provisions note under section 321 of this title.

Effective Date of 1965 Amendment

Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date of 1951 Amendment

Act Oct. 26, 1951, ch. 578, §3, 65 Stat. 649, provided that: "The provisions of this Act [amending this section and section 353 of this title] shall take effect six months after the date of its enactment [Oct. 26, 1951]."

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Guidance

Pub. L. 111–31, div. A, title I, §103(q)(1), (2), June 22, 2009, 123 Stat. 1838, 1839, as amended by Pub. L. 116–94, div. N, title I, §603(d)(1), Dec. 20, 2019, 133 Stat. 3124, provided that:

"(1) In general.—The Secretary of Health and Human Services shall issue guidance [see 76 F.R. 22905, effective Apr. 15, 2011]—

"(A) defining the term 'repeated violation', as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil penalties in accordance with paragraph (2);

"(B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer's registration or to the retailer's registered agent if the retailer has provider [sic] such agent information to the Food and Drug Administration prior to the violation;

"(C) providing for a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer's request a hearing by telephone or at the nearest regional or field office of the Food and Drug Administration, and providing for an expedited procedure for the administrative appeal of an alleged violation;

"(D) providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet;

"(E) establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph (2) within the time periods provided for in such paragraph;

"(F) providing that good faith reliance on the presentation of a false government-issued photographic identification that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including—

"(i) adopting and enforcing a written policy against sales to minors;

"(ii) informing its employees of all applicable laws;

"(iii) establishing disciplinary sanctions for employee noncompliance; and

"(iv) requiring its employees to verify age by way of photographic identification or electronic scanning device; and

"(G) providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in determining whether to compromise, modify, or terminate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F).

"(2) Penalties for violations.—

"(A) In general.—The amount of the civil penalty to be applied for violations of section 906(d)(5) [probably means section 906(d)(5) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 387f(d)(5)] or of restrictions promulgated under section 906(d) [21 U.S.C. 387f(d)], as described in paragraph (1), shall be as follows:

"(i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed—

"(I) in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer;

"(II) in the case of a second violation within a 12-month period, $250;

"(III) in the case of a third violation within a 24-month period, $500;

"(IV) in the case of a fourth violation within a 24-month period, $2,000;

"(V) in the case of a fifth violation within a 36-month period, $5,000; and

"(VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis.

"(ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed—

"(I) in the case of the first violation, $250;

"(II) in the case of a second violation within a 12-month period, $500;

"(III) in the case of a third violation within a 24-month period, $1,000;

"(IV) in the case of a fourth violation within a 24-month period, $2,000;

"(V) in the case of a fifth violation within a 36-month period, $5,000; and

"(VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis.

"(B) Training program.—For purposes of subparagraph (A), the term 'approved training program' means a training program that complies with standards developed by the Food and Drug Administration for such programs.

"(C) Consideration of state penalties.—The Secretary shall coordinate with the States in enforcing the provisions of this Act [probably means div. A of Pub. L. 111–31, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables for classifications] and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer of section 906(d)(5) [21 U.S.C. 387f(d)(5)] or of any restriction promulgated under section 906(d) [21 U.S.C. 387f(d)], shall consider the amount of any penalties paid by the retailer to a State for the same violation."

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

Enforcement

Pub. L. 99–660, title I, §103, Nov. 14, 1986, 100 Stat. 3751, provided that: "For the fines authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333], see section 3623 of title 18, United States Code, for the period ending October 31, 1986 [probably should be October 31, 1987], and sections 3559 and 3571 of such title for the period beginning November 1, 1986 [probably should be November 1, 1987]."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original. Words "of this section" probably should not appear.

² See References in Text note below.

§333a. Repealed. Pub. L. 101–647, title XIX, §1905, Nov. 29, 1990, 104 Stat. 4853

Section, Pub. L. 100–690, title II, §2401, Nov. 18, 1988, 102 Stat. 4230, related to forfeiture and illegal trafficking in steroids or human growth hormones.

§334. Seizure

(a) Grounds and jurisdiction

(1) Any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce, or which may not, under the provisions of section 331(ll), 344, or 355 of this title, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States or United States court of a Territory within the jurisdiction of which the article is found. No libel for condemnation shall be instituted under this chapter, for any alleged misbranding if there is pending in any court a libel for condemnation proceeding under this chapter based upon the same alleged misbranding, and not more than one such proceeding shall be instituted if no such proceeding is so pending, except that such limitations shall not apply (A) when such misbranding has been the basis of a prior judgment in favor of the United States, in a criminal, injunction, or libel for condemnation proceeding under this chapter, or (B) when the Secretary has probable cause to believe from facts found, without hearing, by him or any officer or employee of the Department that the misbranded article is dangerous to health, or that the labeling of the misbranded article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer. In any case where the number of libel for condemnation proceedings is limited as above provided the proceeding pending or instituted shall, on application of the claimant, seasonably made, be removed for trial to any district agreed upon by stipulation between the parties, or, in case of failure to so stipulate within a reasonable time, the claimant may apply to the court of the district in which the seizure has been made, and such court (after giving the United States attorney for such district reasonable notice and opportunity to be heard) shall by order, unless good cause to the contrary is shown, specify a district of reasonable proximity to the claimant's principal place of business, to which the case shall be removed for trial.

(2) The following shall be liable to be proceeded against at any time on libel of information and condemned in any district court of the United States or United States court of a Territory within the jurisdiction of which they are found: (A) Any drug that is a counterfeit drug, (B) Any container of a counterfeit drug, (C) Any punch, die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit drug or drugs, (D) Any adulterated or misbranded device, (E) Any adulterated or misbranded tobacco product, (F) Any device that is a counterfeit device, (G) Any container, packaging, or labeling of a counterfeit device, and (H) Any punch, die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit device or devices.

(3)(A) Except as provided in subparagraph (B), no libel for condemnation may be instituted under paragraph (1) or (2) against any food which—

(i) is misbranded under section 343(a)(2) of this title because of its advertising, and

(ii) is being held for sale to the ultimate consumer in an establishment other than an establishment owned or operated by a manufacturer, packer, or distributor of the food.

(B) A libel for condemnation may be instituted under paragraph (1) or (2) against a food described in subparagraph (A) if—

(i)(I) the food's advertising which resulted in the food being misbranded under section 343(a)(2) of this title was disseminated in the establishment in which the food is being held for sale to the ultimate consumer,

(II) such advertising was disseminated by, or under the direction of, the owner or operator of such establishment, or

(III) all or part of the cost of such advertising was paid by such owner or operator; and

(ii) the owner or operator of such establishment used such advertising in the establishment to promote the sale of the food.

(b) Procedure; multiplicity of pending proceedings

The article, equipment, or other thing proceeded against shall be liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty; except that on demand of either party any issue of fact joined in any such case shall be tried by jury. When libel for condemnation proceedings under this section, involving the same claimant and the same issues of adulteration or misbranding, are pending in two or more jurisdictions, such pending proceedings, upon application of the claimant seasonably made to the court of one such jurisdiction, shall be consolidated for trial by order of such court, and tried in (1) any district selected by the claimant where one of such proceedings is pending; or (2) a district agreed upon by stipulation between the parties. If no order for consolidation is so made within a reasonable time, the claimant may apply to the court of one such jurisdiction and such court (after giving the United States attorney for such district reasonable notice and opportunity to be heard) shall by order, unless good cause to the contrary is shown, specify a district of reasonable proximity to the claimant's principal place of business, in which all such pending proceedings shall be consolidated for trial and tried. Such order of consolidation shall not apply so as to require the removal of any case the date for trial of which has been fixed. The court granting such order shall give prompt notification thereof to the other courts having jurisdiction of the cases covered thereby.

(c) Availability of samples of seized goods prior to trial

The court at any time after seizure up to a reasonable time before trial shall by order allow any party to a condemnation proceeding, his attorney or agent, to obtain a representative sample of the article seized and a true copy of the analysis, if any, on which the proceeding is based and the identifying marks or numbers, if any, of the packages from which the samples analyzed were obtained.

(d) Disposition of goods after decree of condemnation; claims for remission or mitigation of forfeitures

(1) Any food, drug, device, tobacco product, or cosmetic condemned under this section shall, after entry of the decree, be disposed of by destruction or sale as the court may, in accordance with the provisions of this section, direct and the proceeds thereof, if sold, less the legal costs and charges, shall be paid into the Treasury of the United States; but such article shall not be sold under such decree contrary to the provisions of this chapter or the laws of the jurisdiction in which sold. After entry of the decree and upon the payment of the costs of such proceedings and the execution of a good and sufficient bond conditioned that such article shall not be sold or disposed of contrary to the provisions of this chapter or the laws of any State or Territory in which sold, the court may by order direct that such article be delivered to the owner thereof to be destroyed or brought into compliance with the provisions of this chapter, under the supervision of an officer or employee duly designated by the Secretary, and the expenses of such supervision shall be paid by the person obtaining release of the article under bond. If the article was imported into the United States and the person seeking its release establishes (A) that the adulteration, misbranding, or violation did not occur after the article was imported, and (B) that he had no cause for believing that it was adulterated, misbranded, or in violation before it was released from customs custody, the court may permit the article to be delivered to the owner for exportation in lieu of destruction upon a showing by the owner that all of the conditions of section 381(e) of this title can and will be met. The provisions of this sentence shall not apply where condemnation is based upon violation of section 342(a)(1), (2), or (6), section 351(a)(3), section 352(j), or section 361(a) or (d) of this title. Where such exportation is made to the original foreign supplier, then subparagraphs (A) and (B) of section 381(e)(1) of this title and the preceding sentence shall not be applicable; and in all cases of exportation the bond shall be conditioned that the article shall not be sold or disposed of until the applicable conditions of section 381(e) of this title have been met. Any person seeking to export an imported article pursuant to any of the provisions of this subsection shall establish that the article was intended for export at the time the article entered commerce. Any article condemned by reason of its being an article which may not, under section 344 or 355 of this title, be introduced into interstate commerce, shall be disposed of by destruction.

(2) The provisions of paragraph (1) of this subsection shall, to the extent deemed appropriate by the court, apply to any equipment or other thing which is not otherwise within the scope of such paragraph and which is referred to in paragraph (2) of subsection (a).

(3) Whenever in any proceeding under this section, involving paragraph (2) of subsection (a), the condemnation of any equipment or thing (other than a drug) is decreed, the court shall allow the claim of any claimant, to the extent of such claimant's interest, for remission or mitigation of such forfeiture if such claimant proves to the satisfaction of the court (i) that he has not committed or caused to be committed any prohibited act referred to in such paragraph (2) and has no interest in any drug referred to therein, (ii) that he has an interest in such equipment or other thing as owner or lienor or otherwise, acquired by him in good faith, and (iii) that he at no time had any knowledge or reason to believe that such equipment or other thing was being or would be used in, or to facilitate, the violation of laws of the United States relating to counterfeit drugs.

(e) Costs

When a decree of condemnation is entered against the article, court costs and fees, and storage and other proper expenses, shall be awarded against the person, if any, intervening as claimant of the article.

(f) Removal of case for trial

In the case of removal for trial of any case as provided by subsection (a) or (b)—

(1) The clerk of the court from which removal is made shall promptly transmit to the court in which the case is to be tried all records in the case necessary in order that such court may exercise jurisdiction.

(2) The court to which such case was removed shall have the powers and be subject to the duties, for purposes of such case, which the court from which removal was made would have had, or to which such court would have been subject, if such case had not been removed.

(g) Administrative restraint; detention orders

(1) If during an inspection conducted under section 374 of this title of a facility or a vehicle, a device, drug, or tobacco product which the officer or employee making the inspection has reason to believe is adulterated or misbranded is found in such facility or vehicle, such officer or employee may order the device, drug, or tobacco product detained (in accordance with regulations prescribed by the Secretary) for a reasonable period which may not exceed twenty days unless the Secretary determines that a period of detention greater than twenty days is required to institute an action under subsection (a) or section 332 of this title, in which case he may authorize a detention period of not to exceed thirty days. Regulations of the Secretary prescribed under this paragraph shall require that before a device, drug, or tobacco product may be ordered detained under this paragraph the Secretary or an officer or employee designated by the Secretary approve such order. A detention order under this paragraph may require the labeling or marking of a device, drug, or tobacco product during the period of its detention for the purpose of identifying the device, drug, or tobacco product as detained. Any person who would be entitled to claim a device, drug, or tobacco product if it were seized under subsection (a) may appeal to the Secretary a detention of such device, drug, or tobacco product under this paragraph. Within five days of the date an appeal of a detention is filed with the Secretary, the Secretary shall after affording opportunity for an informal hearing by order confirm the detention or revoke it.

(2)(A) Except as authorized by subparagraph (B), a device, drug, or tobacco product subject to a detention order issued under paragraph (1) shall not be moved by any person from the place at which it is ordered detained until—

(i) released by the Secretary, or

(ii) the expiration of the detention period applicable to such order,

whichever occurs first.

(B) A device or drug subject to a detention order under paragraph (1) may be moved—

(i) in accordance with regulations prescribed by the Secretary, and

(ii) if not in final form for shipment, at the discretion of the manufacturer of the device or drug for the purpose of completing the work required to put it in such form.

(h) Administrative detention of foods

(1) Detention authority

(A) In general

An officer or qualified employee of the Food and Drug Administration may order the detention, in accordance with this subsection, of any article of food that is found during an inspection, examination, or investigation under this chapter conducted by such officer or qualified employee, if the officer or qualified employee has reason to believe that such article is adulterated or misbranded.

(B) Secretary's approval

An article of food may be ordered detained under subparagraph (A) only if the Secretary or an official designated by the Secretary approves the order. An official may not be so designated unless the official is the director of the district under this chapter in which the article involved is located, or is an official senior to such director.

(2) Period of detention

An article of food may be detained under paragraph (1) for a reasonable period, not to exceed 20 days, unless a greater period, not to exceed 30 days, is necessary, to enable the Secretary to institute an action under subsection (a) or section 332 of this title. The Secretary shall by regulation provide for procedures for instituting such action on an expedited basis with respect to perishable foods.

(3) Security of detained article

An order under paragraph (1) with respect to an article of food may require that such article be labeled or marked as detained, and shall require that the article be removed to a secure facility, as appropriate. An article subject to such an order shall not be transferred by any person from the place at which the article is ordered detained, or from the place to which the article is so removed, as the case may be, until released by the Secretary or until the expiration of the detention period applicable under such order, whichever occurs first. This subsection may not be construed as authorizing the delivery of the article pursuant to the execution of a bond while the article is subject to the order, and section 381(b) of this title does not authorize the delivery of the article pursuant to the execution of a bond while the article is subject to the order.

(4) Appeal of detention order

(A) In general

With respect to an article of food ordered detained under paragraph (1), any person who would be entitled to be a claimant for such article if the article were seized under subsection (a) may appeal the order to the Secretary. Within five days after such an appeal is filed, the Secretary, after providing opportunity for an informal hearing, shall confirm or terminate the order involved, and such confirmation by the Secretary shall be considered a final agency action for purposes of section 702 of title 5. If during such five-day period the Secretary fails to provide such an opportunity, or to confirm or terminate such order, the order is deemed to be terminated.

(B) Effect of instituting court action

The process under subparagraph (A) for the appeal of an order under paragraph (1) terminates if the Secretary institutes an action under subsection (a) or section 332 of this title regarding the article of food involved.

(i) Procedures for promulgating regulations

(1) In general

In promulgating a regulation implementing this section, the Secretary shall—

(A) issue a notice of proposed rulemaking that includes the proposed regulation;

(B) provide a period of not less than 60 days for comments on the proposed regulation; and

(C) publish the final regulation not less than 30 days before the regulation's effective date.

(2) Restrictions

Notwithstanding any other provision of Federal law, in implementing this section, the Secretary shall only promulgate regulations as described in paragraph (1).

(June 25, 1938, ch. 675, §304, 52 Stat. 1044; June 24, 1948, ch. 613, §2, 62 Stat. 582; Aug. 7, 1953, ch. 350, §3, 67 Stat. 477; Pub. L. 85–250, Aug. 31, 1957, 71 Stat. 567; Pub. L. 89–74, §6, July 15, 1965, 79 Stat. 232; Pub. L. 90–639, §4(b), Oct. 24, 1968, 82 Stat. 1362; Pub. L. 91–513, title II, §701(c), (d), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 94–278, title V, §502(a)(2)(C), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94–295, §§3(c), 7(a), May 28, 1976, 90 Stat. 576, 582; Pub. L. 102–300, §6(c), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(f), Aug. 13, 1993, 107 Stat. 775; Pub. L. 105–115, title IV, §418, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 107–188, title III, §303(a), June 12, 2002, 116 Stat. 663; Pub. L. 110–85, title IX, §912(b)(1), Sept. 27, 2007, 121 Stat. 952; Pub. L. 111–31, div. A, title I, §103(d), June 22, 2009, 123 Stat. 1836; Pub. L. 111–353, title II, §207(a), Jan. 4, 2011, 124 Stat. 3944; Pub. L. 112–144, title VII, §709(a), (b)(2), July 9, 2012, 126 Stat. 1069; Pub. L. 117–328, div. FF, title II, §2513(c), Dec. 29, 2022, 136 Stat. 5805.)

Editorial Notes

Amendments

2022—Subsec. (a)(2)(F) to (H). Pub. L. 117–328 added cls. (F) to (H).

2012—Subsec. (g)(1). Pub. L. 112–144, §709(a)(1), inserted ", drug," after "device" wherever appearing.

Subsec. (g)(2)(A). Pub. L. 112–144, §709(a)(2), inserted ", drug," after "(B), a device".

Subsec. (g)(2)(B). Pub. L. 112–144, §709(a)(3), inserted "or drug" after "device" in introductory provisions and in cl. (ii).

Subsec. (i). Pub. L. 112–144, §709(b)(2), added subsec. (i).

2011—Subsec. (h)(1)(A). Pub. L. 111–353 substituted "reason to believe" for "credible evidence or information indicating" and "is adulterated or misbranded" for "presents a threat of serious adverse health consequences or death to humans or animals".

2009—Subsec. (a)(2)(E). Pub. L. 111–31, §103(d)(1), added cl. (E).

Subsec. (d)(1). Pub. L. 111–31, §103(d)(2), inserted "tobacco product," after "device," in first sentence.

Subsec. (g)(1). Pub. L. 111–31, §103(d)(3), inserted "or tobacco product" after "device" wherever appearing.

Subsec. (g)(2)(A). Pub. L. 111–31, §103(d)(4), inserted "or tobacco product" after "device" in introductory provisions.

2007—Subsec. (a)(1). Pub. L. 110–85 substituted "section 331(ll), 344, or 355" for "section 344 or 355".

2002—Subsec. (h). Pub. L. 107–188 added subsec. (h).

1997—Subsec. (d)(1). Pub. L. 105–115 substituted "subparagraphs (A) and (B) of section 381(e)(1) of this title" for "paragraphs (1) and (2) of section 381(e) of this title" and inserted "Any person seeking to export an imported article pursuant to any of the provisions of this subsection shall establish that the article was intended for export at the time the article entered commerce." before "Any article condemned by reason".

1993—Subsec. (a)(1). Pub. L. 103–80, §3(f)(1), substituted "found. No libel" for "found: Provided, however, That no libel".

Subsec. (d)(1). Pub. L. 103–80, §3(f)(2), substituted "sold. After entry" for "sold: Provided, That after entry", "met. The provisions of this sentence" for "met: Provided, however, That the provisions of this sentence", "title. Where such exportation" for "title: And provided further, That where such exportation", and "the preceding sentence shall not be applicable" for "the foregoing proviso shall not be applicable".

1992—Subsec. (d)(1). Pub. L. 102–300 substituted "381(e)" for "381(d)" in three places and "paragraphs" for "clauses" before "(1) and (2) of section 381(e)".

1976—Subsec. (a)(1). Pub. L. 94–295, §3(c)(1), struck out "device," after "Any article of food, drug,".

Subsec. (a)(2). Pub. L. 94–295, §3(c)(2), (3), added cl. (D) covering adulterated or misbranded devices.

Subsec. (a)(3). Pub. L. 94–278 added par. (3).

Subsec. (g). Pub. L. 94–295, §7(a), added subsec. (g).

1970—Subsec. (a)(2). Pub. L. 91–513, §701(c), struck out cls. (A) and (D) which dealt with depressant or stimulant drugs, struck out reference to depressant or stimulant drugs in cl. (C), and redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C), respectively.

Subsec. (d)(3)(iii). Pub. L. 91–513, §701(d), struck out reference to depressant or stimulant drugs.

1968—Subsec. (a). Pub. L. 90–639 inserted references to the United States courts of Territories.

1965—Subsec. (a). Pub. L. 89–74, §6(a), designated existing provisions as par. (1), redesignated cls. (1) and (2) of proviso as (A) and (B), and added par. (2).

Subsec. (b). Pub. L. 89–74, §6(b)(1), inserted "equipment, or other thing proceeded against" after "article" in first sentence.

Subsec. (d). Pub. L. 89–74, §6(b)(2), designated existing provisions as par. (1), redesignated cls. (1) and (2) of the second sentence thereof as (A) and (B), and added pars. (2) and (3).

1957—Subsec. (d). Pub. L. 85–250 permitted, under certain circumstances, reexportation of articles condemned at places other than original port of entry.

1953—Subsec. (c). Act Aug. 7, 1953, provided that a true copy of the analysis in any case shall be furnished the owner.

1948—Subsec. (a). Act June 24, 1948, inserted "or while held for sale (whether or not the first sale) after shipment in interstate commerce" to make this subsection coextensive with section 331(k) of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Pub. L. 112–144, title VII, §709(c), July 9, 2012, 126 Stat. 1070, provided that: "The amendments made by subsection (a) [amending this section] shall not take effect until the Secretary has issued a final regulation under subsection (b) [amending this section and enacting provisions set out as a note under this section]."

[Final regulation issued May 29, 2014, effective June 30, 2014. See 79 F.R. 30716.]

Effective Date of 2011 Amendment

Pub. L. 111–353, title II, §207(c), Jan. 4, 2011, 124 Stat. 3944, provided that: "The amendment made by this section [amending this section] shall take effect 180 days after the date of enactment of this Act [Jan. 4, 2011]."

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1976 Amendment

Pub. L. 94–278, title V, §502(c), Apr. 22, 1976, 90 Stat. 413, provided that: "The amendments made by subsection (a) [amending this section and sections 321, 333, and 343 of this title] shall take effect 180 days after the date of the enactment of this Act [Apr. 22, 1976]."

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–639 applicable only with respect to violations of this chapter committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Effective Date of 1968 Amendments; Transitional Provisions note under section 321 of this title.

Effective Date of 1965 Amendment

Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

Regulations

Pub. L. 112–144, title VII, §709(b)(1), July 9, 2012, 126 Stat. 1069, provided that: "Not later than 2 years after the date of the enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall promulgate regulations in accordance with section 304(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 334(i)], as added by paragraph (2) of this subsection, to implement administrative detention authority with respect to drugs, as authorized by the amendments made by subsection (a) [amending this section]. Before promulgating such regulations, the Secretary shall consult with stakeholders, including manufacturers of drugs."

Pub. L. 111–353, title II, §207(b), Jan. 4, 2011, 124 Stat. 3944, provided that: "Not later than 120 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall issue an interim final rule amending subpart K of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section [amending this section]."

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§335. Hearing before report of criminal violation

Before any violation of this chapter is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding.

(June 25, 1938, ch. 675, §305, 52 Stat. 1045.)

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§335a. Debarment, temporary denial of approval, and suspension

(a) Mandatory debarment; certain drug applications

(1) Corporations, partnerships, and associations

If the Secretary finds that a person other than an individual has been convicted, after May 13, 1992, of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any abbreviated drug application, the Secretary shall debar such person from submitting, or assisting in the submission of, any such application.

(2) Individuals

If the Secretary finds that an individual has been convicted of a felony under Federal law for conduct—

(A) relating to the development or approval, including the process for development or approval, of any drug product, or

(B) otherwise relating to the regulation of any drug product under this chapter,

the Secretary shall debar such individual from providing services in any capacity to a person that has an approved or pending drug product application.

(b) Permissive debarment; certain drug applications; food imports

(1) In general

The Secretary, on the Secretary's own initiative or in response to a petition, may, in accordance with paragraph (2) or (3), debar—

(A) a person other than an individual from submitting or assisting in the submission of any abbreviated drug application;

(B) an individual from providing services in any capacity to a person that has an approved or pending drug product application;

(C) a person from importing an article of food or offering such an article for import into the United States; or

(D) a person from importing or offering for import into the United States a drug.

(2) Persons subject to permissive debarment; certain drug applications

The following persons are subject to debarment under subparagraph (A) or (B) of paragraph (1):

(A) Corporations, partnerships, and associations

Any person other than an individual that the Secretary finds has been convicted—

(i) for conduct that—

(I) relates to the development or approval, including the process for the development or approval, of any abbreviated drug application; and

(II) is a felony under Federal law (if the person was convicted before May 13, 1992), a misdemeanor under Federal law, or a felony under State law, or

(ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in clause (i) or a felony described in subsection (a)(1),

if the Secretary finds that the type of conduct which served as the basis for such conviction undermines the process for the regulation of drugs.

(B) Individuals

(i) Any individual whom the Secretary finds has been convicted of—

(I) a misdemeanor under Federal law or a felony under State law for conduct relating to the development or approval, including the process for development or approval, of any drug product or otherwise relating to the regulation of drug products under this chapter, or

(II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony described in subsection (a)(2),

if the Secretary finds that the type of conduct which served as the basis for such conviction undermines the process for the regulation of drugs.

(ii) Any individual whom the Secretary finds has been convicted of—

(I) a felony which is not described in subsection (a)(2) or clause (i) of this subparagraph and which involves bribery, payment of illegal gratuities, fraud, perjury, false statement, racketeering, blackmail, extortion, falsification or destruction of records, or interference with, obstruction of an investigation into, or prosecution of, any criminal offense, or

(II) a conspiracy to commit, or aiding or abetting, such felony,

if the Secretary finds, on the basis of the conviction of such individual and other information, that such individual has demonstrated a pattern of conduct sufficient to find that there is reason to believe that such individual may violate requirements under this chapter relating to drug products.

(iii) Any individual whom the Secretary finds materially participated in acts that were the basis for a conviction for an offense described in subsection (a) or in clause (i) or (ii) for which a conviction was obtained, if the Secretary finds, on the basis of such participation and other information, that such individual has demonstrated a pattern of conduct sufficient to find that there is reason to believe that such individual may violate requirements under this chapter relating to drug products.

(iv) Any high managerial agent whom the Secretary finds—

(I) worked for, or worked as a consultant for, the same person as another individual during the period in which such other individual took actions for which a felony conviction was obtained and which resulted in the debarment under subsection (a)(2), or clause (i), of such other individual,

(II) had actual knowledge of the actions described in subclause (I) of such other individual, or took action to avoid such actual knowledge, or failed to take action for the purpose of avoiding such actual knowledge,

(III) knew that the actions described in subclause (I) were violative of law, and

(IV) did not report such actions, or did not cause such actions to be reported, to an officer, employee, or agent of the Department or to an appropriate law enforcement officer, or failed to take other appropriate action that would have ensured that the process for the regulation of drugs was not undermined, within a reasonable time after such agent first knew of such actions,

if the Secretary finds that the type of conduct which served as the basis for such other individual's conviction undermines the process for the regulation of drugs.

(3) Persons subject to permissive debarment; food or drug importation

A person is subject to debarment under paragraph (1)(C) if—

(A) the person has been convicted of a felony for conduct relating to the importation into the United States of any food;

(B) the person has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals;

(C) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 802 of this title);

(D) the person has engaged in a pattern of importing or offering for import—

(i) controlled substances that are prohibited from importation under section 1401(m) of title 19; or

(ii) adulterated or misbranded drugs that are—

(I) not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or

(II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary.

(4) Stay of certain orders

An order of the Secretary under clause (iii) or (iv) of paragraph (2)(B) shall not take effect until 30 days after the order has been issued.

(5) Definition

For purposes of paragraph (3)(D), the term "pattern of importing or offering for import" means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.

(c) Debarment period and considerations

(1) Effect of debarment

The Secretary—

(A) shall not accept or review (other than in connection with an audit under this section) any abbreviated drug application submitted by or with the assistance of a person debarred under subsection (a)(1) or (b)(2)(A) during the period such person is debarred,

(B) shall, during the period of a debarment under subsection (a)(2) or (b)(2)(B), debar an individual from providing services in any capacity to a person that has an approved or pending drug product application and shall not accept or review (other than in connection with an audit under this section) an abbreviated drug application from such individual, and

(C) shall, if the Secretary makes the finding described in paragraph (6) or (7) of section 335b(a) of this title, assess a civil penalty in accordance with section 335b of this title.

(2) Debarment periods

(A) In general

The Secretary shall debar a person under subsection (a) or (b) for the following periods:

(i) The period of debarment of a person (other than an individual) under subsection (a)(1) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under subsection (a) occurs within 10 years after such person has been debarred under subsection (a)(1), the period of debarment shall be permanent.

(ii) The debarment of an individual under subsection (a)(2) shall be permanent.

(iii) The period of debarment of any person under paragraph (2) or (3) of subsection (b) shall not be more than 5 years.

The Secretary may determine whether debarment periods shall run concurrently or consecutively in the case of a person debarred for multiple offenses.

(B) Notification

Upon a conviction for an offense described in subsection (a) or (b) or upon execution of an agreement with the United States to plead guilty to such an offense, the person involved may notify the Secretary that the person acquiesces to debarment and such person's debarment shall commence upon such notification.

(3) Considerations

In determining the appropriateness and the period of a debarment of a person under subsection (b) and any period of debarment beyond the minimum specified in subparagraph (A)(i) of paragraph (2), the Secretary shall consider where applicable—

(A) the nature and seriousness of any offense involved,

(B) the nature and extent of management participation in any offense involved, whether corporate policies and practices encouraged the offense, including whether inadequate institutional controls contributed to the offense,

(C) the nature and extent of voluntary steps to mitigate the impact on the public of any offense involved, including the recall or the discontinuation of the distribution of suspect drugs, full cooperation with any investigations (including the extent of disclosure to appropriate authorities of all wrongdoing), the relinquishing of profits on drug approvals fraudulently obtained, and any other actions taken to substantially limit potential or actual adverse effects on the public health,

(D) whether the extent to which changes in ownership, management, or operations have corrected the causes of any offense involved and provide reasonable assurances that the offense will not occur in the future,

(E) whether the person to be debarred is able to present adequate evidence that current production of drugs subject to abbreviated drug applications and all pending abbreviated drug applications are free of fraud or material false statements, and

(F) prior convictions under this chapter or under other Acts involving matters within the jurisdiction of the Food and Drug Administration.

(d) Termination of debarment

(1) Application

Any person that is debarred under subsection (a) (other than a person permanently debarred) or any person that is debarred under subsection (b) may apply to the Secretary for termination of the debarment under this subsection. Any information submitted to the Secretary under this paragraph does not constitute an amendment or supplement to pending or approved abbreviated drug applications.

(2) Deadline

The Secretary shall grant or deny any application respecting a debarment which is submitted under paragraph (1) within 180 days of the date the application is submitted.

(3) Action by the Secretary

(A) Corporations

(i) Conviction reversal

If the conviction which served as the basis for the debarment of a person under subsection (a)(1) or paragraph (2)(A) or (3) of subsection (b) is reversed, the Secretary shall withdraw the order of debarment.

(ii) Application

Upon application submitted under paragraph (1), the Secretary shall terminate the debarment of a person if the Secretary finds that—

(I) changes in ownership, management, or operations have fully corrected the causes of the offense involved and provide reasonable assurances that the offense will not occur in the future, and

(II) in applicable cases, sufficient audits, conducted by the Food and Drug Administration or by independent experts acceptable to the Food and Drug Administration, demonstrate that pending applications and the development of drugs being tested before the submission of an application are free of fraud or material false statements.

 In the case of persons debarred under subsection (a)(1), such termination shall take effect no earlier than the expiration of one year from the date of the debarment.

(B) Individuals

(i) Conviction reversal

If the conviction which served as the basis for the debarment of an individual under subsection (a)(2) or clause (i), (ii), (iii), or (iv) of subsection (b)(2)(B) or subsection (b)(3) is reversed, the Secretary shall withdraw the order of debarment.

(ii) Application

Upon application submitted under paragraph (1), the Secretary shall terminate the debarment of an individual who has been debarred under subsection (b)(2)(B) or subsection (b)(3) if such termination serves the interests of justice and adequately protects the integrity of the drug approval process or the food importation process, as the case may be.

(4) Special termination

(A) Application

Any person that is debarred under subsection (a)(1) (other than a person permanently debarred under subsection (c)(2)(A)(i)) or any individual who is debarred under subsection (a)(2) may apply to the Secretary for special termination of debarment under this subsection. Any information submitted to the Secretary under this subparagraph does not constitute an amendment or supplement to pending or approved abbreviated drug applications.

(B) Corporations

Upon an application submitted under subparagraph (A), the Secretary may take the action described in subparagraph (D) if the Secretary, after an informal hearing, finds that—

(i) the person making the application under subparagraph (A) has demonstrated that the felony conviction which was the basis for such person's debarment involved the commission of an offense which was not authorized, requested, commanded, performed, or recklessly tolerated by the board of directors or by a high managerial agent acting on behalf of the person within the scope of the board's or agent's office or employment,

(ii) all individuals who were involved in the commission of the offense or who knew or should have known of the offense have been removed from employment involving the development or approval of any drug subject to sections ¹ 355 of this title,

(iii) the person fully cooperated with all investigations and promptly disclosed all wrongdoing to the appropriate authorities, and

(iv) the person acted to mitigate any impact on the public of any offense involved, including the recall, or the discontinuation of the distribution, of any drug with respect to which the Secretary requested a recall or discontinuation of distribution due to concerns about the safety or efficacy of the drug.

(C) Individuals

Upon an application submitted under subparagraph (A), the Secretary may take the action described in subparagraph (D) if the Secretary, after an informal hearing, finds that such individual has provided substantial assistance in the investigations or prosecutions of offenses which are described in subsection (a) or (b) or which relate to any matter under the jurisdiction of the Food and Drug Administration.

(D) Secretarial action

The action referred to in subparagraphs (B) and (C) is—

(i) in the case of a person other than an individual—

(I) terminating the debarment immediately, or

(II) limiting the period of debarment to less than one year, and

(ii) in the case of an individual, limiting the period of debarment to less than permanent but to no less than 1 year,

whichever best serves the interest of justice and protects the integrity of the drug approval process.

(e) Publication and list of debarred persons

The Secretary shall publish in the Federal Register the name of any person debarred under subsection (a) or (b), the effective date of the debarment, and the period of the debarment. The Secretary shall also maintain and make available to the public a list, updated no less often than quarterly, of such persons, of the effective dates and minimum periods of such debarments, and of the termination of debarments.

(f) Temporary denial of approval

(1) In general

The Secretary, on the Secretary's own initiative or in response to a petition, may, in accordance with paragraph (3), refuse by order, for the period prescribed by paragraph (2), to approve any abbreviated drug application submitted by any person—

(A) if such person is under an active Federal criminal investigation in connection with an action described in subparagraph (B),

(B) if the Secretary finds that such person—

(i) has bribed or attempted to bribe, has paid or attempted to pay an illegal gratuity, or has induced or attempted to induce another person to bribe or pay an illegal gratuity to any officer, employee, or agent of the Department of Health and Human Services or to any other Federal, State, or local official in connection with any abbreviated drug application, or has conspired to commit, or aided or abetted, such actions, or

(ii) has knowingly made or caused to be made a pattern or practice of false statements or misrepresentations with respect to material facts relating to any abbreviated drug application, or the production of any drug subject to an abbreviated drug application, to any officer, employee, or agent of the Department of Health and Human Services, or has conspired to commit, or aided or abetted, such actions, and

(C) if a significant question has been raised regarding—

(i) the integrity of the approval process with respect to such abbreviated drug application, or

(ii) the reliability of data in or concerning such person's abbreviated drug application.

Such an order may be modified or terminated at any time.

(2) Applicable period

(A) In general

Except as provided in subparagraph (B), a denial of approval of an application of a person under paragraph (1) shall be in effect for a period determined by the Secretary but not to exceed 18 months beginning on the date the Secretary finds that the conditions described in subparagraphs (A), (B), and (C) of paragraph (1) exist. The Secretary shall terminate such denial—

(i) if the investigation with respect to which the finding was made does not result in a criminal charge against such person, if criminal charges have been brought and the charges have been dismissed, or if a judgment of acquittal has been entered, or

(ii) if the Secretary determines that such finding was in error.

(B) Extension

If, at the end of the period described in subparagraph (A), the Secretary determines that a person has been criminally charged for an action described in subparagraph (B) of paragraph (1), the Secretary may extend the period of denial of approval of an application for a period not to exceed 18 months. The Secretary shall terminate such extension if the charges have been dismissed, if a judgment of acquittal has been entered, or if the Secretary determines that the finding described in subparagraph (A) was in error.

(3) Informal hearing

Within 10 days of the date an order is issued under paragraph (1), the Secretary shall provide such person with an opportunity for an informal hearing, to be held within such 10 days, on the decision of the Secretary to refuse approval of an abbreviated drug application. Within 60 days of the date on which such hearing is held, the Secretary shall notify the person given such hearing whether the Secretary's refusal of approval will be continued, terminated, or otherwise modified. Such notification shall be final agency action.

(g) Suspension authority

(1) In general

If—

(A) the Secretary finds—

(i) that a person has engaged in conduct described in subparagraph (B) of subsection (f)(1) in connection with 2 or more drugs under abbreviated drug applications, or

(ii) that a person has engaged in flagrant and repeated, material violations of good manufacturing practice or good laboratory practice in connection with the development, manufacturing, or distribution of one or more drugs approved under an abbreviated drug application during a 2-year period, and—

(I) such violations may undermine the safety and efficacy of such drugs, and

(II) the causes of such violations have not been corrected within a reasonable period of time following notice of such violations by the Secretary, and

(B) such person is under an active investigation by a Federal authority in connection with a civil or criminal action involving conduct described in subparagraph (A),

the Secretary shall issue an order suspending the distribution of all drugs the development or approval of which was related to such conduct described in subparagraph (A) or suspending the distribution of all drugs approved under abbreviated drug applications of such person if the Secretary finds that such conduct may have affected the development or approval of a significant number of drugs which the Secretary is unable to identify. The Secretary shall exclude a drug from such order if the Secretary determines that such conduct was not likely to have influenced the safety or efficacy of such drug.

(2) Public health waiver

The Secretary shall, on the Secretary's own initiative or in response to a petition, waive the suspension under paragraph (1) (involving an action described in paragraph (1)(A)(i)) with respect to any drug if the Secretary finds that such waiver is necessary to protect the public health because sufficient quantities of the drug would not otherwise be available. The Secretary shall act on any petition seeking action under this paragraph within 180 days of the date the petition is submitted to the Secretary.

(h) Termination of suspension

The Secretary shall withdraw an order of suspension of the distribution of a drug under subsection (g) if the person with respect to whom the order was issued demonstrates in a petition to the Secretary—

(1)(A) on the basis of an audit by the Food and Drug Administration or by experts acceptable to the Food and Drug Administration, or on the basis of other information, that the development, approval, manufacturing, and distribution of such drug is in substantial compliance with the applicable requirements of this chapter, and

(B) changes in ownership, management, or operations—

(i) fully remedy the patterns or practices with respect to which the order was issued, and

(ii) provide reasonable assurances that such actions will not occur in the future, or

(2) the initial determination was in error.

The Secretary shall act on a submission of a petition under this subsection within 180 days of the date of its submission and the Secretary may consider the petition concurrently with the suspension proceeding. Any information submitted to the Secretary under this subsection does not constitute an amendment or supplement to a pending or approved abbreviated drug application.

(i) Procedure

The Secretary may not take any action under subsection (a), (b), (c), (d)(3), (g), or (h) with respect to any person unless the Secretary has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this subsection, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation.

(j) Judicial review

(1) In general

Except as provided in paragraph (2), any person that is the subject of an adverse decision under subsection (a), (b), (c), (d), (f), (g), or (h) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary's decision) a petition requesting that the decision be modified or set aside.

(2) Exception

Any person that is the subject of an adverse decision under clause (iii) or (iv) of subsection (b)(2)(B) may obtain a review of such decision by the United States District Court for the District of Columbia or a district court of the United States for the district in which the person resides, by filing in such court (within 30 days following the date the person is notified of the Secretary's decision) a complaint requesting that the decision be modified or set aside. In such an action, the court shall determine the matter de novo.

(k) Certification

Any application for approval of a drug product shall include—

(1) a certification that the applicant did not and will not use in any capacity the services of any person debarred under subsection (a) or (b), in connection with such application, and

(2) if such application is an abbreviated drug application, a list of all convictions, described in subsections (a) and (b) which occurred within the previous 5 years, of the applicant and affiliated persons responsible for the development or submission of such application.

(l) Applicability

(1) Conviction

For purposes of this section, a person is considered to have been convicted of a criminal offense—

(A) when a judgment of conviction has been entered against the person by a Federal or State court, regardless of whether there is an appeal pending,

(B) when a plea of guilty or nolo contendere by the person has been accepted by a Federal or State court, or

(C) when the person has entered into participation in a first offender, deferred adjudication, or other similar arrangement or program where judgment of conviction has been withheld.

(2) Effective dates

Subsection (a), subparagraph (A) of subsection (b)(2), clauses (i) and (ii) of subsection (b)(2)(B), and subsection (b)(3)(A) shall not apply to a conviction which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection (a) or (b). Clauses (iii) and (iv) of subsection (b)(2)(B), subsection (b)(3)(B), and subsections (f) and (g) shall not apply to an act or action which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection (b), (f), or (g). Clause (iv) of subsection (b)(2)(B) shall not apply to an action which occurred before June 1, 1992. Subsection (k) shall not apply to applications submitted to the Secretary before June 1, 1992.

(m) Devices; mandatory debarment regarding third-party inspections and reviews

(1) In general

If the Secretary finds that a person has been convicted of a felony under section 331(gg) of this title, the Secretary shall debar such person from being accredited under section 360m(b) or 374(g)(2) of this title and from carrying out activities under an agreement described in section 383(b) of this title.

(2) Debarment period

The Secretary shall debar a person under paragraph (1) for the following periods:

(A) The period of debarment of a person (other than an individual) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under such paragraph occurs within 10 years after such person has been debarred under such paragraph, the period of debarment shall be permanent.

(B) The debarment of an individual shall be permanent.

(3) Termination of debarment; judicial review; other matters

Subsections (c)(3), (d), (e), (i), (j), and (l)(1) apply with respect to a person (other than an individual) or an individual who is debarred under paragraph (1) to the same extent and in the same manner as such subsections apply with respect to a person who is debarred under subsection (a)(1), or an individual who is debarred under subsection (a)(2), respectively.

(June 25, 1938, ch. 675, §306, as added Pub. L. 102–282, §2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105–115, title I, §125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107–188, title III, §304(a)–(c), June 12, 2002, 116 Stat. 665, 666; Pub. L. 107–250, title II, §203, Oct. 26, 2002, 116 Stat. 1610; Pub. L. 115–271, title III, §3022(b)(2), Oct. 24, 2018, 132 Stat. 3938.)

Editorial Notes

Prior Provisions

A prior section 306 of act June 25, 1938, was renumbered section 309 and is classified to section 336 of this title.

Amendments

2018—Subsec. (b)(1). Pub. L. 115–271, §3022(b)(2)(A)(i), inserted "or (3)" after "paragraph (2)" in introductory provisions.

Subsec. (b)(1)(D). Pub. L. 115–271, §3022(b)(2)(A)(ii)–(v), added subpar. (D).

Subsec. (b)(3). Pub. L. 115–271, §3022(b)(2)(B)(i), inserted "or drug" after "food" in heading.

Subsec. (b)(3)(C), (D). Pub. L. 115–271, §3022(b)(2)(B)(ii)–(iv), added subpars. (C) and (D).

Subsec. (b)(5). Pub. L. 115–271, §3022(b)(2)(C), added par. (5).

2002—Subsec. (a). Pub. L. 107–188, §304(b)(1), substituted "Mandatory debarment; certain drug applications" for "Mandatory debarment" in heading.

Subsec. (b). Pub. L. 107–188, §304(b)(2)(A), substituted "Permissive debarment; certain drug applications; food imports" for "Permissive debarment" in heading.

Subsec. (b)(1)(C). Pub. L. 107–188, §304(a)(1), added subpar. (C).

Subsec. (b)(2). Pub. L. 107–188, §304(b)(2)(B), substituted "permissive debarment; certain drug applications" for "permissive debarment" in heading.

Pub. L. 107–188, §304(a)(2)(A), inserted "subparagraph (A) or (B) of" before "paragraph (1)" in introductory provisions.

Subsec. (b)(3), (4). Pub. L. 107–188, §304(a)(2)(B), (C), added par. (3) and redesignated former par. (3) as (4).

Subsec. (c)(2)(A)(iii). Pub. L. 107–188, §304(b)(3), substituted "paragraph (2) or (3) of subsection (b)" for "subsection (b)(2)".

Subsec. (d)(3)(A)(i). Pub. L. 107–188, §304(b)(4)(A), substituted "subsection (a)(1) or paragraph (2)(A) or (3) of subsection (b)" for "subsection (a)(1) or (b)(2)(A)".

Subsec. (d)(3)(A)(ii)(II). Pub. L. 107–188, §304(b)(4)(B), inserted "in applicable cases," before "sufficient audits".

Subsec. (d)(3)(B)(i). Pub. L. 107–188, §304(b)(4)(C), inserted "or subsection (b)(3)" after "subsection (b)(2)(B)".

Subsec. (d)(3)(B)(ii). Pub. L. 107–188, §304(b)(4)(C), (D), inserted "or subsection (b)(3)" after "subsection (b)(2)(B)" and "or the food importation process, as the case may be" before period.

Subsec. (l)(2). Pub. L. 107–188, §304(c), in first sentence struck out "and" after "subsection (b)(2)," and inserted ", and subsection (b)(3)(A)" after "subsection (b)(2)(B)" and in second sentence inserted ", subsection (b)(3)(B)," after "subsection (b)(2)(B)".

Subsec. (m). Pub. L. 107–250 added subsec. (m).

1997—Subsec. (d)(4)(B)(ii). Pub. L. 105–115 struck out "or 357" after "355".

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 102–282, §7, May 13, 1992, 106 Stat. 162, provided that: "No amendment made by this Act [enacting this section and sections 335b and 335c of this title and amending sections 321, 336, 337, and 355 of this title] shall preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by this Act."

Congressional Findings

Pub. L. 102–282, §1(c), May 13, 1992, 106 Stat. 149, provided that: "The Congress finds that—

"(1) there is substantial evidence that significant corruption occurred in the Food and Drug Administration's process of approving drugs under abbreviated drug applications,

"(2) there is a need to establish procedures designed to restore and to ensure the integrity of the abbreviated drug application approval process and to protect the public health, and

"(3) there is a need to establish procedures to bar individuals who have been convicted of crimes pertaining to the regulation of drug products from working for companies that manufacture or distribute such products."

¹ So in original. Probably should be "section".

§335b. Civil penalties

(a) In general

Any person that the Secretary finds—

(1) knowingly made or caused to be made, to any officer, employee, or agent of the Department of Health and Human Services, a false statement or misrepresentation of a material fact in connection with an abbreviated drug application,

(2) bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any officer, employee, or agent of the Department of Health and Human Services in connection with an abbreviated drug application,

(3) destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document or other material evidence which was the property of or in the possession of the Department of Health and Human Services for the purpose of interfering with that Department's discharge of its responsibilities in connection with an abbreviated drug application,

(4) knowingly failed to disclose, to an officer or employee of the Department of Health and Human Services, a material fact which such person had an obligation to disclose relating to any drug subject to an abbreviated drug application,

(5) knowingly obstructed an investigation of the Department of Health and Human Services into any drug subject to an abbreviated drug application,

(6) is a person that has an approved or pending drug product application and has knowingly—

(A) employed or retained as a consultant or contractor, or

(B) otherwise used in any capacity the services of,

a person who was debarred under section 335a of this title, or

(7) is an individual debarred under section 335a of this title and, during the period of debarment, provided services in any capacity to a person that had an approved or pending drug product application,

shall be liable to the United States for a civil penalty for each such violation in an amount not to exceed $250,000 in the case of an individual and $1,000,000 in the case of any other person.

(b) Procedure

(1) In general

(A) Action by the Secretary

A civil penalty under subsection (a) shall be assessed by the Secretary on a person by an order made on the record after an opportunity for an agency hearing on disputed issues of material fact and the amount of the penalty. In the course of any investigation or hearing under this subparagraph, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation.

(B) Action by the Attorney General

In lieu of a proceeding under subparagraph (A), the Attorney General may, upon request of the Secretary, institute a civil action to recover a civil money penalty in the amount and for any of the acts set forth in subsection (a). Such an action may be instituted separately from or in connection with any other claim, civil or criminal, initiated by the Attorney General under this chapter.

(2) Amount

In determining the amount of a civil penalty under paragraph (1), the Secretary or the court shall take into account the nature, circumstances, extent, and gravity of the act subject to penalty, the person's ability to pay, the effect on the person's ability to continue to do business, any history of prior, similar acts, and such other matters as justice may require.

(3) Limitation on actions

No action may be initiated under this section—

(A) with respect to any act described in subsection (a) that occurred before May 13, 1992, or

(B) more than 6 years after the date when facts material to the act are known or reasonably should have been known by the Secretary but in no event more than 10 years after the date the act took place.

(c) Judicial review

Any person that is the subject of an adverse decision under subsection (b)(1)(A) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary's decision) a petition requesting that the decision be modified or set aside.

(d) Recovery of penalties

The Attorney General may recover any civil penalty (plus interest at the currently prevailing rates from the date the penalty became final) assessed under subsection (b)(1)(A) in an action brought in the name of the United States. The amount of such penalty may be deducted, when the penalty has become final, from any sums then or later owing by the United States to the person against whom the penalty has been assessed. In an action brought under this subsection, the validity, amount, and appropriateness of the penalty shall not be subject to judicial review.

(e) Informants

The Secretary may award to any individual (other than an officer or employee of the Federal Government or a person who materially participated in any conduct described in subsection (a)) who provides information leading to the imposition of a civil penalty under this section an amount not to exceed—

(1) $250,000, or

(2) one-half of the penalty so imposed and collected,

whichever is less. The decision of the Secretary on such award shall not be reviewable.

(June 25, 1938, ch. 675, §307, as added Pub. L. 102–282, §3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103–80, §3(g), Aug. 13, 1993, 107 Stat. 776.)

Editorial Notes

Prior Provisions

A prior section 307 of act June 25, 1938, was renumbered section 310 and is classified to section 337 of this title.

Amendments

1993—Subsec. (b)(3)(A). Pub. L. 103–80 made technical amendment to reference to May 13, 1992, to reflect correction of corresponding provision of original act.

Statutory Notes and Related Subsidiaries

Construction

This section not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.

§335c. Authority to withdraw approval of abbreviated drug applications

(a) In general

The Secretary—

(1) shall withdraw approval of an abbreviated drug application if the Secretary finds that the approval was obtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statement, and

(2) may withdraw approval of an abbreviated drug application if the Secretary finds that the applicant has repeatedly demonstrated a lack of ability to produce the drug for which the application was submitted in accordance with the formulations or manufacturing practice set forth in the abbreviated drug application and has introduced, or attempted to introduce, such adulterated or misbranded drug into commerce.

(b) Procedure

The Secretary may not take any action under subsection (a) with respect to any person unless the Secretary has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this subsection, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation.

(c) Applicability

Subsection (a) shall apply with respect to offenses or acts regardless of when such offenses or acts occurred.

(d) Judicial review

Any person that is the subject of an adverse decision under subsection (a) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary's decision) a petition requesting that the decision be modified or set aside.

(June 25, 1938, ch. 675, §308, as added Pub. L. 102–282, §4, May 13, 1992, 106 Stat. 160.)

Statutory Notes and Related Subsidiaries

Construction

This section not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.

§336. Report of minor violations

Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning.

(June 25, 1938, ch. 675, §309, formerly §306, 52 Stat. 1045; renumbered §309, Pub. L. 102–282, §2, May 13, 1992, 106 Stat. 150.)

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§337. Proceedings in name of United States; provision as to subpoenas

(a) Except as provided in subsection (b), all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States. Subpoenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any proceeding under this section.

(b)(1) A State may bring in its own name and within its jurisdiction proceedings for the civil enforcement, or to restrain violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if the food that is the subject of the proceedings is located in the State.

(2) No proceeding may be commenced by a State under paragraph (1)—

(A) before 30 days after the State has given notice to the Secretary that the State intends to bring such proceeding,

(B) before 90 days after the State has given notice to the Secretary of such intent if the Secretary has, within such 30 days, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding, or

(C) if the Secretary is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action pertaining to such food.

In any court proceeding described in subparagraph (C), a State may intervene as a matter of right.

(June 25, 1938, ch. 675, §310, formerly §307, 52 Stat. 1046; Sept. 3, 1954, ch. 1263, §37, 68 Stat. 1239; Pub. L. 101–535, §4, Nov. 8, 1990, 104 Stat. 2362; renumbered §310, Pub. L. 102–282, §2, May 13, 1992, 106 Stat. 150.)

Editorial Notes

Amendments

1990—Pub. L. 101–535 substituted "(a) Except as provided in subsection (b), all" for "All" and "any proceeding under this section" for "any such proceeding" and added subsec. (b).

1954—Act Sept. 3, 1954, struck out reference to section 654 of title 28.

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

Amendment by Pub. L. 101–535 effective 24 months after Nov. 8, 1990, except that such amendment effective Dec. 31, 1993, with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances, see section 10(a)(1)(C) of Pub. L. 101–535, set out as a note under section 343 of this title.

Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.

§337a. Extraterritorial jurisdiction

There is extraterritorial jurisdiction over any violation of this chapter relating to any article regulated under this chapter if such article was intended for import into the United States or if any act in furtherance of the violation was committed in the United States.

(June 25, 1938, ch. 675, §311, as added Pub. L. 112–144, title VII, §718, July 9, 2012, 126 Stat. 1077.)

SUBCHAPTER IV—FOOD

§341. Definitions and standards for food

Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container. No definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables, or butter, except that definitions and standards of identity may be established for avocadoes, cantaloupes, citrus fruits, and melons. In prescribing any standard of fill of container, the Secretary shall give due consideration to the natural shrinkage in storage and in transit of fresh natural food and to need for the necessary packing and protective material. In the prescribing of any standard of quality for any canned fruit or canned vegetable, consideration shall be given and due allowance made for the differing characteristics of the several varieties of such fruit or vegetable. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Secretary shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. Any definition and standard of identity prescribed by the Secretary for avocadoes, cantaloupes, citrus fruits, or melons shall relate only to maturity and to the effects of freezing.

(June 25, 1938, ch. 675, §401, 52 Stat. 1046; Apr. 15, 1954, ch. 143, §1, 68 Stat. 54; Aug. 1, 1956, ch. 861, §1, 70 Stat. 919; Pub. L. 103–80, §3(h), Aug. 13, 1993, 107 Stat. 776.)

Editorial Notes

Amendments

1993—Pub. L. 103–80 substituted "or reasonable standards of fill of container. No definition" for "and/or reasonable standards of fill of container: Provided, That no definition".

1956—Act Aug. 1, 1956, designated provisions constituting subsec. (a) as entire section and repealed subsec. (b) which provided the procedure for establishment of regulations and is covered by section 371(e) of this title.

1954—Act Apr. 15, 1954, designated existing provisions as subsec. (a) and added subsec. (b).

Statutory Notes and Related Subsidiaries

Savings Provision

Act Aug. 1, 1956, ch. 861, §3, 70 Stat. 919, provided that: "In any case in which, prior to the enactment of this Act [Aug. 1, 1956], a public hearing has been begun in accordance with section 401 of the Federal Food, Drug, and Cosmetic Act [341 of this title] upon a proposal to issue, amend, or repeal any regulation contemplated by such section, or has been begun in accordance with section 701(e) of such Act [section 371(e) of this title] upon a proposal to issue, amend, or repeal any regulation contemplated by section 403(j), 404(a), 406(a) or (b), 501(b), 502(d), 502(h), 504 or 604 of such Act [section 343(j), 344(a), 346(a) or (b), 351(b), 352(d), 352(h), 354, or 364 of this title], the provisions of such section 401 or 701(e), as the case may be, as in force immediately prior to the date of the enactment of this Act [Aug. 1, 1956], shall be applicable as though this Act [amending this section and section 371(e) of this title] had not been enacted."

Food Safety and Security Strategy

Pub. L. 107–188, title III, §301, June 12, 2002, 116 Stat. 662, provided that:

"(a) In General.—The President's Council on Food Safety (as established by Executive Order No. 13100 [set out below]) shall, in consultation with the Secretary of Transportation, the Secretary of the Treasury, other relevant Federal agencies, the food industry, consumer and producer groups, scientific organizations, and the States, develop a crisis communications and education strategy with respect to bioterrorist threats to the food supply. Such strategy shall address threat assessments; technologies and procedures for securing food processing and manufacturing facilities and modes of transportation; response and notification procedures; and risk communications to the public.

"(b) Authorization of Appropriations.—For the purpose of implementing the strategy developed under subsection (a), there are authorized to be appropriated $750,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year."

Food Safety Commission

Pub. L. 107–171, title X, §10807, May 13, 2002, 116 Stat. 527, provided that:

"(a) Establishment.—

"(1) In general.—There is established a commission to be known as the 'Food Safety Commission' (referred to in this section as the 'Commission').

"(2) Membership.—

"(A) Composition.—The Commission shall be composed of 15 members (including a Chairperson, appointed by the President[)].

"(B) Eligibility.—

"(i) In general.—Members of the Commission—

     "(I) shall have specialized training or significant experience in matters under the jurisdiction of the Commission; and

     "(II) shall represent, at a minimum—

"(aa) consumers;

"(bb) food scientists;

"(cc) the food industry; and

"(dd) health professionals.

"(ii) Federal employees.—Not more than 3 members of the Commission may be Federal employees.

"(C) Date of appointments.—The appointment of the members of the Commission shall be made as soon as practicable after the date on which funds authorized to be appropriated under subsection (e)(1) are made available.

"(D) Vacancies.—A vacancy on the Commission—

"(i) shall not affect the powers of the Commission; and

"(ii) shall be filled—

     "(I) not later than 60 days after the date on which the vacancy occurs; and

     "(II) in the same manner as the original appointment was made.

"(3) Meetings.—

"(A) Initial meeting.—The initial meeting of the Commission shall be conducted not later than 30 days after the date of appointment of the final member of the Commission.

"(B) Other meetings.—The Commission shall meet at the call of the Chairperson.

"(4) Quorum; standing rules.—

"(A) Quorum.—A majority of the members of the Commission shall constitute a quorum to conduct business.

"(B) Standing rules.—At the first meeting of the Commission, the Commission shall adopt standing rules of the Commission to guide the conduct of business and decisionmaking of the Commission.

"(b) Duties.—

"(1) Recommendations.—The Commission shall make specific recommendations to enhance the food safety system of the United States, including a description of how each recommendation would improve food safety.

"(2) Components.—Recommendations made by the Commission under paragraph (1) shall address all food available commercially in the United States.

"(3) Report.—Not later than 1 year after the date on which the Commission first meets, the Commission shall submit to the President and Congress—

"(A) the findings, conclusions, and recommendations of the Commission, including a description of how each recommendation would improve food safety;

"(B) a summary of any other material used by the Commission in the preparation of the report under this paragraph; and

"(C) if requested by 1 or more members of the Commission, a statement of the minority views of the Commission.

"(c) Powers of the Commission.—

"(1) Hearings.—The Commission may, for the purpose of carrying out this section, hold such hearings, meet and act at such times and places, take such testimony, and receive such evidence as the Commission considers advisable.

"(2) Information from federal agencies.—

"(A) In general.—The Commission may secure directly, from any Federal agency, such information as the Commission considers necessary to carry out this section.

"(B) Provision of information.—

"(i) In general.—Subject to subparagraph (C), on the request of the Commission, the head of a Federal agency described in subparagraph (A) may furnish information requested by the Commission to the Commission.

"(ii) Administration.—The furnishing of information by a Federal agency to the Commission shall not be considered a waiver of any exemption available to the agency under section 552 of title 5, United States Code.

"(C) Information to be kept confidential.—

"(i) In general.—For purposes of section 1905 of title 18, United States Code—

     "(I) the Commission shall be considered an agency of the Federal Government; and

     "(II) any individual employed by an individual, entity, or organization that is a party to a contract with the Commission under this section shall be considered an employee of the Commission.

"(ii) Prohibition on disclosure.—Information obtained by the Commission, other than information that is available to the public, shall not be disclosed to any person in any manner except to an employee of the Commission as described in clause (i), for the purpose of receiving, reviewing, or processing the information.

"(d) Commission Personnel Matters.—

"(1) Members.—

"(A) Compensation.—A member of the Commission shall serve without compensation for the services of the member on the Commission.

"(B) Travel expenses.—A member of the Commission shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for an employee of an agency under subchapter I of chapter 57 of title 5, United States Code, while away from the home or regular place of business of the member in the performance of the duties of the Commission.

"(2) Staff.—

"(A) In general.—The Chairperson of the Commission may, without regard to the civil service laws (including regulations), appoint and terminate the appointment of an executive director and such other additional personnel as are necessary to enable the Commission to perform the duties of the Commission.

"(B) Confirmation of executive director.—The employment of an executive director shall be subject to confirmation by the Commission.

"(C) Compensation.—

"(i) In general.—Except as provided in clause (ii), the Chairperson of the Commission may fix the compensation of the executive director and other personnel without regard to the provisions of chapter 51 and subchapter III of chapter 53 of title 5, United States Code, relating to classification of positions and General Schedule pay rates.

"(ii) Maximum rate of pay.—The rate of pay for the executive director and other personnel shall not exceed the rate payable for level II of the Executive Schedule under section 5316 of title 5, United States Code.

"(3) Detail of federal government employees.—

"(A) In general.—An employee of the Federal Government may be detailed to the Commission, without reimbursement, for such period of time as is permitted by law.

"(B) Civil service status.—The detail of the employee shall be without interruption or loss of civil service status or privilege.

"(4) Procurement of temporary and intermittent services.—The Chairperson of the Commission may procure temporary and intermittent services in accordance with section 3109(b) of title 5, United States Code, at rates for individuals that do not exceed the daily equivalent of the annual rate of basic pay prescribed for level II of the Executive Schedule under section 5316 of that title.

"(e) Authorization of Appropriations.—

"(1) In general.—There is authorized to be appropriated such sums as are necessary to carry out this section.

"(2) Limitation.—No payment may be made under subsection (d) except to the extent provided for in advance in an appropriations Act.

"(f) Termination.—The Commission shall terminate on the date that is 60 days after the date on which the Commission submits the recommendations and report under subsection (b)(3)."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

Ex. Ord. No. 13100. President's Council on Food Safety

Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as amended by Ex. Ord. No. 13286, §16, Feb. 28, 2003, 68 F.R. 10623, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, and in order to improve the safety of the food supply through science-based regulation and well-coordinated inspection, enforcement, research, and education programs, it is hereby ordered as follows:

Section 1. Establishment of President's Council on Food Safety. (a) There is established the President's Council on Food Safety ("Council"). The Council shall comprise the Secretaries of Agriculture, Commerce, Health and Human Services, and Homeland Security, the Director of the Office of Management and Budget (OMB), the Administrator of the Environmental Protection Agency, the Assistant to the President for Science and Technology/Director of the Office of Science and Technology Policy, the Assistant to the President for Domestic Policy, and the Director of the National Partnership for Reinventing Government. The Council shall consult with other Federal agencies and State, local, and tribal government agencies, and consumer, producer, scientific, and industry groups, as appropriate.

(b) The Secretaries of Agriculture and of Health and Human Services and the Assistant to the President for Science and Technology/Director of the Office of Science and Technology Policy shall serve as Joint Chairs of the Council.

Sec. 2. Purpose. The purpose of the Council shall be to develop a comprehensive strategic plan for Federal food safety activities, taking into consideration the findings and recommendations of the National Academy of Sciences report "Ensuring Safe Food from Production to Consumption" and other input from the public on how to improve the effectiveness of the current food safety system. The Council shall make recommendations to the President on how to advance Federal efforts to implement a comprehensive science-based strategy to improve the safety of the food supply and to enhance coordination among Federal agencies, State, local, and tribal governments, and the private sector. The Council shall advise Federal agencies in setting priority areas for investment in food safety.

Sec. 3. Specific Activities and Functions. (a) The Council shall develop a comprehensive strategic Federal food safety plan that contains specific recommendations on needed changes, including measurable outcome goals. The principal goal of the plan should be the establishment of a seamless, science-based food safety system. The plan should address the steps necessary to achieve this goal, including the key public health, resource, and management issues regarding food safety. The planning process should consider both short-term and long-term issues including new and emerging threats and the special needs of vulnerable populations such as children and the elderly. In developing this plan, the Council shall consult with all interested parties, including State and local agencies, tribes, consumers, producers, industry, and academia.

(b) Consistent with the comprehensive strategic Federal food safety plan described in section 3(a) of this order, the Council shall advise agencies of priority areas for investment in food safety and ensure that Federal agencies annually develop coordinated food safety budgets for submission to the OMB that sustain and strengthen existing capacities, eliminate duplication, and ensure the most effective use of resources for improving food safety. The Council shall also ensure that Federal agencies annually develop a unified budget for submission to the OMB for the President's Food Safety Initiative and such other food safety issues as the Council determines appropriate.

(c) The Council shall ensure that the Joint Institute for Food Safety Research (JIFSR), in consultation with the National Science and Technology Council, establishes mechanisms to guide Federal research efforts toward the highest priority food safety needs. The JIFSR shall report to the Council on a regular basis on its efforts: (i) to develop a strategic plan for conducting food safety research activities consistent with the President's Food Safety Initiative and such other food safety activities as the JIFSR determines appropriate; and (ii) to coordinate efficiently, within the executive branch and with the private sector and academia, all Federal food safety research.

Sec. 4. Cooperation. All actions taken by the Council shall, as appropriate, promote partnerships and cooperation with States, tribes, and other public and private sector efforts wherever possible to improve the safety of the food supply.

Sec. 5. General Provisions. This order is intended only to improve the internal management of the executive branch and is not intended to, nor does it, create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, its officers or any person. Nothing in this order shall affect or alter the statutory responsibilities of any Federal agency charged with food safety responsibilities.

§342. Adulterated food

A food shall be deemed to be adulterated—

(a) Poisonous, insanitary, etc., ingredients

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.¹ (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.

(b) Absence, substitution, or addition of constituents

(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

(c) Color additives

If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.

(d) Confectionery containing alcohol or nonnutritive substance

If it is confectionery, and—

(1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health;

(2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the State in which such confectionery is intended to be offered for sale; or

(3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph, issue regulations allowing or prohibiting the use of particular nonnutritive substances.

(e) Oleomargarine containing filthy, putrid, etc., matter

If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for food.

(f) Dietary supplement or ingredient: safety

(1) If it is a dietary supplement or contains a dietary ingredient that—

(A) presents a significant or unreasonable risk of illness or injury under—

(i) conditions of use recommended or suggested in labeling, or

(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;

(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;

(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5 to affirm or withdraw the declaration; or

(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.

In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.

(2) Before the Secretary may report to a United States attorney a violation of paragraph ² (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.

(g) Dietary supplement: manufacturing practices

(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2).

(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5.

(h) Reoffer of food previously denied admission

If it is an article of food imported or offered for import into the United States and the article of food has previously been refused admission under section 381(a) of this title, unless the person reoffering the article affirmatively establishes, at the expense of the owner or consignee of the article, that the article complies with the applicable requirements of this chapter, as determined by the Secretary.

(i) Noncompliance with sanitary transportation practices

If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 350e of this title.

(June 25, 1938, ch. 675, §402, 52 Stat. 1046; Mar. 16, 1950, ch. 61, §3(d), 64 Stat. 21; July 22, 1954, ch. 559, §2, 68 Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85–929, §3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86–2, Mar. 17, 1959, 73 Stat. 3; Pub. L. 86–618, title I, §§102(a)(1), (2), 105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89–477, June 29, 1966, 80 Stat. 231; Pub. L. 90–399, §104, July 13, 1968, 82 Stat. 352; Pub. L. 99–252, §10, Feb. 27, 1986, 100 Stat. 35; Pub. L. 102–571, title I, §107(4), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §3(i), Aug. 13, 1993, 107 Stat. 776; Pub. L. 103–417, §§4, 9, Oct. 25, 1994, 108 Stat. 4328, 4332; Pub. L. 104–170, title IV, §404, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 107–188, title III, §309, June 12, 2002, 116 Stat. 673; Pub. L. 109–59, title VII, §7202(a), Aug. 10, 2005, 119 Stat. 1911.)

Editorial Notes

Amendments

2005—Par. (i). Pub. L. 109–59 added par. (i).

2002—Par. (h). Pub. L. 107–188 added par. (h).

1996—Par. (a). Pub. L. 104–170 added subpar. (2) and struck out former subpar. (2) which read as follows: "(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; (iii) a color additive; or (iv) a new animal drug) which is unsafe within the meaning of section 346 of this title, or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 346a(a) of this title, or (C) if it is, or if it bears or contains, any food additive which is unsafe within the meaning of section 348 of this title: Provided, That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 346a of this title and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of sections 346 and 348 of this title, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity, or (D) if it is, or it bears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of section 360b of this title;". That part of Pub. L. 104–170 which directed the substitution of "or (3) if it consists" for "(3) if it consists" was executed by making the substitution for "(3) If it consists" to reflect the probable intent of Congress.

1994—Par. (f). Pub. L. 103–417, §4, added par. (f).

Par. (g). Pub. L. 103–417, §9, added par. (g).

1993—Par. (a). Pub. L. 103–80, §3(i)(1), substituted a period for "; or" at end of subpar. (1) and "If it" for "if it" at beginning of par. (3). That part of Pub. L. 103–80, §3(i)(1), which directed the substitution of a period for "; or" at end of subpar. (2) could not be executed because "; or" did not appear.

Par. (d)(1). Pub. L. 103–80, §3(i)(2), substituted ", except that this subparagraph" for ": Provided, That this clause".

Par. (d)(3). Pub. L. 103–80, §3(i)(3), substituted ", except that this subparagraph shall not apply" for ": Provided, That this clause shall not apply" and ", except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph" for ": And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause".

1992—Par. (c). Pub. L. 102–571 substituted "379e(a)" for "376(a)".

1986—Par. (d)(2). Pub. L. 99–252 inserted provision that this clause not apply to confectionery introduced or delivered for introduction into or received or held for sale in, interstate commerce if the sale is permitted under the laws of the State in which the confectionery is intended to be offered for sale.

1968—Par. (a)(2). Pub. L. 90–399 added cls. (A)(iv) and (D).

1966—Par. (d). Pub. L. 89–477 permitted the imbedding of nonnutritive objects in confectionery foods if in the judgment of the Secretary of Health, Education, and Welfare, as provided by regulation, the imbedding of the object is of practical functional value to the confectionery product and would not render it injurious or hazardous to health, raised to one-half of 1 per centum by volume the upper limit for the allowable use of alcohol derived solely from the use of flavoring extracts, allowed the use of safe nonnutritive substances in and on confectionery foods by reason of their use for some practical and functional purpose in the manufacture, packaging, or storage of the confectionery foods if the use of the substances does not promote deception of the consumer or otherwise result in adulteration or misbranding, authorized the Secretary to issue regulations on the use of particular nonnutritive substances, and removed reference to nonnutritive masticatory substances added to chewing gum and harmless flavoring, harmless resinous glaze not in excess of four-tenths of 1 per centum, natural gum, authorized coloring, and pectin.

1960—Par. (a). Pub. L. 86–618, §102(a)(1), substituted "other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive" for "(except a pesticide chemical in or on a raw agricultural commodity and except a food additive)" in cl. (2)(A).

Par. (c). Pub. L. 86–618, §102(a)(2), amended par. (c) generally, substituting provisions deeming a food adulterated if it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376 of this title for provisions which related to food that bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 346 of this title, and struck out provisos which related to the use of color on oranges.

Par. (d). Pub. L. 86–618, §105(c), substituted "authorized coloring" for "harmless coloring".

1959—Par. (c). Pub. L. 86–2 extended from Mar. 1, 1959, to May 1, 1959, the period during which par. is inapplicable to oranges which have been colored with F.D. & C. Red 32, and inserted proviso requiring Secretary to establish regulations prescribing the conditions under which Citrus Red No. 2 may be safely used in coloring certain mature oranges, and providing for separately listing and for certification of batches of such color.

1958—Par. (a). Pub. L. 85–929, among other changes, inserted cl. (2)(C) relating to food additive unsafe within the meaning of section 348 of this title, and to pesticide chemical, and added cl. (7) relating to radiated food.

1956—Par. (c). Act July 9, 1956, inserted second proviso relating to coloring of oranges.

1954—Par. (a)(2). Act July 22, 1954, provided in the case of any raw agricultural commodity bearing or containing a pesticide chemical, that such commodity shall be deemed to be adulterated if such pesticide chemical is unsafe within the meaning of section 346a of this title.

1950—Par. (e). Act Mar. 16, 1950, added par. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–59 effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as a note under section 331 of this title.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date of Nematocide, Plant Regulator, Defoliant, and Desiccant Amendment of 1959

Effective date of par. (a)(2) as in force prior to July 22, 1954, with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on a raw agricultural commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86–139, Aug. 7, 1959, 73 Stat. 288.

Effective Date of 1958 Amendment

Pub. L. 85–929, §6, Sept. 6, 1958, 72 Stat. 1788, as amended by Pub. L. 87–19, §2, Apr. 7, 1961, 75 Stat. 42; Pub. L. 88–625, §2, Oct. 3, 1964, 78 Stat. 1002, provided that:

"(a) Except as provided in subsections (b) and (c) of this section, this Act [amending this section, sections 321, 331, 346, and 348 of this title, and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321 and 451 of this title] shall take effect on the date of its enactment [Sept. 6, 1958].

"(b) Except as provided in subsection (c) of this section, section 3 of this Act [amending this section and section 346 of this title] shall take effect on the one hundred and eightieth day after the date of enactment of this Act [Sept. 6, 1958].

"(c) With respect to any particular commercial use of a food additive, if such use was made of such additive before January 1, 1958, section 3 of this Act [amending this section and section 346 of this title] shall take effect—

"(1) Either (A) one year after the effective date established in subsection (b) of this section, or (B) at the end of such additional period (but not later than two years from such effective date established in subsection (b)) as the Secretary of Health, Education, and Welfare [now Health and Human Services] may prescribe on the basis of a finding that such extension involves no undue risk to the public health and that conditions exist which necessitate the prescribing of such an additional period, or

"(2) on the date on which an order with respect to such use under section 409 of the Federal Food, Drug, and Cosmetic Act [section 348 of this title] becomes effective,

whichever date first occurs. Whenever the Secretary has, pursuant to clause (1)(B) of this subsection, extended the effective date of section 3 of this Act [amending this section] to March 5, 1961, or has on that date a request for such extension pending before him, with respect to any such particular use of a food additive, he may, notwithstanding the parenthetical time limitation in that clause, further extend such effective date, not beyond June 30, 1964, under the authority of that clause (but subject to clause (2)) with respect to such use of the additive (or a more limited specified use or uses thereof) if, in addition to making the findings required by clause (1)(B), he finds (i) that bona fide action to determine the applicability of such section 409 [section 348 of this title] to such use or uses, or to develop the scientific data necessary for action under such section, was commenced by an interested person before March 6, 1960, and was thereafter pursued with reasonable diligence, and (ii) that in the Secretary's judgment such extension is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary as a basis for action under such section 409 [section 348 of this title]: Provided, That if the Secretary has, pursuant to this sentence, granted an extension to June 30, 1964, he may, upon making the findings required by clause (1)(B) of this subsection and clauses (i) and (ii) of this sentence, further extend such effective date, but not beyond December 31, 1965. The Secretary may at any time terminate an extension so granted if he finds that it should not have been granted, or that by reason of a change in circumstances the basis for such extension no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such extension."

Effective Date of 1954 Amendment

Act July 22, 1954, ch. 559, §5, 68 Stat. 517, provided that: "This Act [amending this section and section 321 of this title and enacting sections 346a and 346b of this title] shall take effect upon the date of its enactment [July 22, 1954], except that with respect to pesticide chemicals for which tolerances or exemptions have not been established under section 408 of the Federal Food, Drug, and Cosmetic Act [section 346a of this title], the amendment to section 402(a) of such Act [par. (a) of this section] made by section 2 of this Act shall not be effective—

"(1) for the period of one year following the date of the enactment of this Act [July 22, 1954]; or

"(2) for such additional period following such period of one year, but not extending beyond two years after the date of the enactment of this Act [July 22, 1954] as the Secretary of Health, Education, and Welfare [now Health and Human Services] may prescribe on the basis of a finding that conditions exist which necessitate the prescribing of such additional period."

Effective Date of 1950 Amendment

Amendment by act Mar. 16, 1950, effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as an Effective Date note under section 347 of this title.

Effective Date; Postponement

Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Short Title

Pub. L. 88–625, §1, Oct. 3, 1964, 78 Stat. 1002, provided: "That this Act [amending provisions set out as a note under this section and section 135 of Title 7, Agriculture] may be cited as the 'Food Additives Transitional Provisions Amendment of 1964'."

Updating Guidance Relating to Fish and Fisheries Products Hazards and Controls

Pub. L. 111–353, title I, §103(h), Jan. 4, 2011, 124 Stat. 3898, provided that: "The Secretary shall, not later than 180 days after the date of enactment of this Act [Jan. 4, 2011], update the Fish and Fisheries Products Hazards and Control Guidance to take into account advances in technology that have occurred since the previous publication of such Guidance by the Secretary."

Guidance Relating to Post Harvest Processing of Raw Oysters

Pub. L. 111–353, title I, §114, Jan. 4, 2011, 124 Stat. 3921, provided that:

"(a) In General.—Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Program's Model Ordinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal Regulations (or any successor regulations)[)], where such guidance, regulation or suggested amendment relates to post harvest processing for raw oysters, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report which shall include—

"(1) an assessment of how post harvest processing or other equivalent controls feasibly may be implemented in the fastest, safest, and most economical manner;

"(2) the projected public health benefits of any proposed post harvest processing;

"(3) the projected costs of compliance with such post harvest processing measures;

"(4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters;

"(5) criteria for ensuring post harvest processing standards will be applied equally to shellfish imported from all nations of origin;

"(6) an evaluation of alternative measures to prevent, eliminate, or reduce to an acceptable level the occurrence of foodborne illness; and

"(7) the extent to which the Food and Drug Administration has consulted with the States and other regulatory agencies, as appropriate, with regard to post harvest processing measures.

"(b) Limitation.—Subsection (a) shall not apply to the guidance described in section 103(h) [section 103(h) of Pub. L. 111–353, set out as a note above].

"(c) Review and Evaluation.—Not later than 30 days after the Secretary issues a proposed regulation or guidance described in subsection (a), the Comptroller General of the United States shall—

"(1) review and evaluate the report described in (a) and report to Congress on the findings of the estimates and analysis in the report;

"(2) compare such proposed regulation or guidance to similar regulations or guidance with respect to other regulated foods, including a comparison of risks the Secretary may find associated with seafood and the instances of those risks in such other regulated foods; and

"(3) evaluate the impact of post harvest processing on the competitiveness of the domestic oyster industry in the United States and in international markets.

"(d) Waiver.—The requirement of preparing a report under subsection (a) shall be waived if the Secretary issues a guidance that is adopted as a consensus agreement between Federal and State regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference.

"(e) Public Access.—Any report prepared under this section shall be made available to the public."

Domestic Fish or Fish Product Compliance With Food Safety Standards or Procedures Deemed To Have Met Requirements for Federal Commodity Purchase Programs

Pub. L. 104–180, title VII, §733, Aug. 6, 1996, 110 Stat. 1601, provided that: "Hereafter, notwithstanding any other provision of law, any domestic fish or fish product produced in compliance with food safety standards or procedures accepted by the Food and Drug Administration as satisfying the requirements of the 'Procedures for the Safe and Sanitary Processing and Importing of Fish and Fish Products' (published by the Food and Drug Administration as a final regulation in the Federal Register of December 18, 1995), shall be deemed to have met any inspection requirements of the Department of Agriculture or other Federal agency for any Federal commodity purchase program, including the program authorized under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c) except that the Department of Agriculture or other Federal agency may utilize lot inspection to establish a reasonable degree of certainty that fish or fish products purchased under a Federal commodity purchase program, including the program authorized under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c), meet Federal product specifications."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original. The period probably should be "; or".

² So in original. Probably should be "subparagraph".

§343. Misbranded food

A food shall be deemed to be misbranded—

(a) False or misleading label

If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to which section 350 of this title applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 350(b)(2) of this title.

(b) Offer for sale under another name

If it is offered for sale under the name of another food.

(c) Imitation of another food

If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated.

(d) Misleading container

If its container is so made, formed, or filled as to be misleading.

(e) Package form

If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, except that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

(f) Prominence of information on label

If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(g) Representation as to definition and standard of identity

If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 341 of this title, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.

(h) Representation as to standards of quality and fill of container

If it purports to be or is represented as—

(1) a food for which a standard of quality has been prescribed by regulations as provided by section 341 of this title, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 341 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

(3) a food that is pasteurized unless—

(A) such food has been subjected to a safe process or treatment that is prescribed as pasteurization for such food in a regulation promulgated under this chapter; or

(B)(i) such food has been subjected to a safe process or treatment that—

(I) is reasonably certain to achieve destruction or elimination in the food of the most resistant microorganisms of public health significance that are likely to occur in the food;

(II) is at least as protective of the public health as a process or treatment described in subparagraph (A);

(III) is effective for a period that is at least as long as the shelf life of the food when stored under normal and moderate abuse conditions; and

(IV) is the subject of a notification to the Secretary, including effectiveness data regarding the process or treatment; and

(ii) at least 120 days have passed after the date of receipt of such notification by the Secretary without the Secretary making a determination that the process or treatment involved has not been shown to meet the requirements of subclauses (I) through (III) of clause (i).

For purposes of paragraph (3), a determination by the Secretary that a process or treatment has not been shown to meet the requirements of subclauses (I) through (III) of subparagraph (B)(i) shall constitute final agency action under such subclauses.

(i) Label where no representation as to definition and standard of identity

Unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient and if the food purports to be a beverage containing vegetable or fruit juice, a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food; except that spices, flavorings, and colors not required to be certified under section 379e(c) of this title ¹ unless sold as spices, flavorings, or such colors, may be designated as spices, flavorings, and colorings without naming each. To the extent that compliance with the requirements of clause (2) of this paragraph is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.

(j) Representation for special dietary use

If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses.

(k) Artificial flavoring, artificial coloring, or chemical preservatives

If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact, except that to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. The provisions of this paragraph and paragraphs (g) and (i) with respect to artificial coloring shall not apply in the case of butter, cheese, or ice cream. The provisions of this paragraph with respect to chemical preservatives shall not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil.

(l) Pesticide chemicals on raw agricultural commodities

If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the common or usual name and the function of such chemical, except that no such declaration shall be required while such commodity, having been removed from the shipping container, is being held or displayed for sale at retail out of such container in accordance with the custom of the trade.

(m) Color additives

If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 379e of this title.

(n) Packaging or labeling of drugs in violation of regulations

If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15.

(o) Repealed. Pub. L. 106–554, §1(a)(1) [title V, §517], Dec. 21, 2000, 114 Stat. 2763, 2763A-73

(p) Repealed. Pub. L. 104–124, §1, Apr. 1, 1996, 110 Stat. 882

(q) Nutrition information

(1) Except as provided in subparagraphs (3), (4), and (5), if it is a food intended for human consumption and is offered for sale, unless its label or labeling bears nutrition information that provides—

(A)(i) the serving size which is an amount customarily consumed and which is expressed in a common household measure that is appropriate to the food, or

(ii) if the use of the food is not typically expressed in a serving size, the common household unit of measure that expresses the serving size of the food,

(B) the number of servings or other units of measure per container,

(C) the total number of calories—

(i) derived from any source, and

(ii) derived from the total fat,

in each serving size or other unit of measure of the food,

(D) the amount of the following nutrients: Total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in each serving size or other unit of measure,

(E) any vitamin, mineral, or other nutrient required to be placed on the label and labeling of food under this chapter before October 1, 1990, if the Secretary determines that such information will assist consumers in maintaining healthy dietary practices.

The Secretary may by regulation require any information required to be placed on the label or labeling by this subparagraph or subparagraph (2)(A) to be highlighted on the label or labeling by larger type, bold type, or contrasting color if the Secretary determines that such highlighting will assist consumers in maintaining healthy dietary practices.

(2)(A) If the Secretary determines that a nutrient other than a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should be included in the label or labeling of food subject to subparagraph (1) for purposes of providing information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices, the Secretary may by regulation require that information relating to such additional nutrient be included in the label or labeling of such food.

(B) If the Secretary determines that the information relating to a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or clause (A) of this subparagraph to be included in the label or labeling of food is not necessary to assist consumers in maintaining healthy dietary practices, the Secretary may by regulation remove information relating to such nutrient from such requirement.

(3) For food that is received in bulk containers at a retail establishment, the Secretary may, by regulation, provide that the nutrition information required by subparagraphs (1) and (2) be displayed at the location in the retail establishment at which the food is offered for sale.

(4)(A) The Secretary shall provide for furnishing the nutrition information required by subparagraphs (1) and (2) with respect to raw agricultural commodities and raw fish by issuing voluntary nutrition guidelines, as provided by clause (B) or by issuing regulations that are mandatory as provided by clause (D).

(B)(i) Upon the expiration of 12 months after November 8, 1990, the Secretary, after providing an opportunity for comment, shall issue guidelines for food retailers offering raw agricultural commodities or raw fish to provide nutrition information specified in subparagraphs (1) and (2). Such guidelines shall take into account the actions taken by food retailers during such 12-month period to provide to consumers nutrition information on raw agricultural commodities and raw fish. Such guidelines shall only apply—

(I) in the case of raw agricultural commodities, to the 20 varieties of vegetables most frequently consumed during a year and the 20 varieties of fruit most frequently consumed during a year, and

(II) to the 20 varieties of raw fish most frequently consumed during a year.

The vegetables, fruits, and raw fish to which such guidelines apply shall be determined by the Secretary by regulation and the Secretary may apply such guidelines regionally.

(ii) Upon the expiration of 12 months after November 8, 1990, the Secretary shall issue a final regulation defining the circumstances that constitute substantial compliance by food retailers with the guidelines issued under subclause (i). The regulation shall provide that there is not substantial compliance if a significant number of retailers have failed to comply with the guidelines. The size of the retailers and the portion of the market served by retailers in compliance with the guidelines shall be considered in determining whether the substantial-compliance standard has been met.

(C)(i) Upon the expiration of 30 months after November 8, 1990, the Secretary shall issue a report on actions taken by food retailers to provide consumers with nutrition information for raw agricultural commodities and raw fish under the guidelines issued under clause (A). Such report shall include a determination of whether there is substantial compliance with the guidelines.

(ii) If the Secretary finds that there is substantial compliance with the guidelines, the Secretary shall issue a report and make a determination of the type required in subclause (i) every two years.

(D)(i) If the Secretary determines that there is not substantial compliance with the guidelines issued under clause (A), the Secretary shall at the time such determination is made issue proposed regulations requiring that any person who offers raw agricultural commodities or raw fish to consumers provide, in a manner prescribed by regulations, the nutrition information required by subparagraphs (1) and (2). The Secretary shall issue final regulations imposing such requirements 6 months after issuing the proposed regulations. The final regulations shall become effective 6 months after the date of their promulgation.

(ii) Regulations issued under subclause (i) may require that the nutrition information required by subparagraphs (1) and (2) be provided for more than 20 varieties of vegetables, 20 varieties of fruit, and 20 varieties of fish most frequently consumed during a year if the Secretary finds that a larger number of such products are frequently consumed. Such regulations shall permit such information to be provided in a single location in each area in which raw agricultural commodities and raw fish are offered for sale. Such regulations may provide that information shall be expressed as an average or range per serving of the same type of raw agricultural commodity or raw fish. The Secretary shall develop and make available to the persons who offer such food to consumers the information required by subparagraphs (1) and (2).

(iii) Regulations issued under subclause (i) shall permit the required information to be provided in each area of an establishment in which raw agricultural commodities and raw fish are offered for sale. The regulations shall permit food retailers to display the required information by supplying copies of the information provided by the Secretary, by making the information available in brochure, notebook or leaflet form, or by posting a sign disclosing the information. Such regulations shall also permit presentation of the required information to be supplemented by a video, live demonstration, or other media which the Secretary approves.

(E) For purposes of this subparagraph, the term "fish" includes freshwater or marine fin fish, crustaceans, and mollusks, including shellfish, amphibians, and other forms of aquatic animal life.

(F) No person who offers raw agricultural commodities or raw fish to consumers may be prosecuted for minor violations of this subparagraph if there has been substantial compliance with the requirements of this paragraph.

(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to food—

(i) except as provided in clause (H)(ii)(III), which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments,

(ii) except as provided in clause (H)(ii)(III), which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is of the type described in subclause (i), and which is offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment,

(iii) which is an infant formula subject to section 350a of this title,

(iv) which is a medical food as defined in section 360ee(b) of this title, or

(v) which is described in section 345(2) of this title.

(B) Subparagraphs (1) and (2) shall not apply to the label of a food if the Secretary determines by regulations that compliance with such subparagraphs is impracticable because the package of such food is too small to comply with the requirements of such subparagraphs and if the label of such food does not contain any nutrition information.

(C) If a food contains insignificant amounts, as determined by the Secretary, of all the nutrients required by subparagraphs (1) and (2) to be listed in the label or labeling of food, the requirements of such subparagraphs shall not apply to such food if the label, labeling, or advertising of such food does not make any claim with respect to the nutritional value of such food. If a food contains insignificant amounts, as determined by the Secretary, of more than one-half the nutrients required by subparagraphs (1) and (2) to be in the label or labeling of the food, the Secretary shall require the amounts of such nutrients to be stated in a simplified form prescribed by the Secretary.

(D) If a person offers food for sale and has annual gross sales made or business done in sales to consumers which is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers which is not more than $50,000, the requirements of subparagraphs (1), (2), (3), and (4) shall not apply with respect to food sold by such person to consumers unless the label or labeling of food offered by such person provides nutrition information or makes a nutrition claim.

(E)(i) During the 12-month period for which an exemption from subparagraphs (1) and (2) is claimed pursuant to this subclause, the requirements of such subparagraphs shall not apply to any food product if—

(I) the labeling for such product does not provide nutrition information or make a claim subject to paragraph (r),

(II) the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 100 full-time equivalent employees,

(III) such person provided the notice described in subclause (iii), and

(IV) in the case of a food product which was sold in the 12-month period preceding the period for which an exemption was claimed, fewer than 100,000 units of such product were sold in the United States during such preceding period, or in the case of a food product which was not sold in the 12-month period preceding the period for which such exemption is claimed, fewer than 100,000 units of such product are reasonably anticipated to be sold in the United States during the period for which such exemption is claimed.

(ii) During the 12-month period after the applicable date referred to in this sentence, the requirements of subparagraphs (1) and (2) shall not apply to any food product which was first introduced into interstate commerce before May 8, 1994, if the labeling for such product does not provide nutrition information or make a claim subject to paragraph (r), if such person provided the notice described in subclause (iii), and if—

(I) during the 12-month period preceding May 8, 1994, the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 300 full-time equivalent employees and fewer than 600,000 units of such product were sold in the United States,

(II) during the 12-month period preceding May 8, 1995, the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 300 full-time equivalent employees and fewer than 400,000 units of such product were sold in the United States, or

(III) during the 12-month period preceding May 8, 1996, the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 200 full-time equivalent employees and fewer than 200,000 units of such product were sold in the United States.

(iii) The notice referred to in subclauses (i) and (ii) shall be given to the Secretary prior to the beginning of the period during which the exemption under subclause (i) or (ii) is to be in effect, shall state that the person claiming such exemption for a food product has complied with the applicable requirements of subclause (i) or (ii), and shall—

(I) state the average number of full-time equivalent employees such person employed during the 12 months preceding the date such person claims such exemption,

(II) state the approximate number of units the person claiming the exemption sold in the United States,

(III) if the exemption is claimed for a food product which was sold in the 12-month period preceding the period for which the exemption was claimed, state the approximate number of units of such product which were sold in the United States during such preceding period, and, if the exemption is claimed for a food product which was not sold in such preceding period, state the number of units of such product which such person reasonably anticipates will be sold in the United States during the period for which the exemption was claimed, and

(IV) contain such information as the Secretary may require to verify the information required by the preceding provisions of this subclause if the Secretary has questioned the validity of such information.

If a person is not an importer, has fewer than 10 full-time equivalent employees, and sells fewer than 10,000 units of any food product in any year, such person is not required to file a notice for such product under this subclause for such year.

(iv) In the case of a person who claimed an exemption under subclause (i) or (ii), if, during the period of such exemption, the number of full-time equivalent employees of such person exceeds the number in such subclause or if the number of food products sold in the United States exceeds the number in such subclause, such exemption shall extend to the expiration of 18 months after the date the number of full-time equivalent employees or food products sold exceeded the applicable number.

(v) For any food product first introduced into interstate commerce after May 8, 2002, the Secretary may by regulation lower the employee or units of food products requirement of subclause (i) if the Secretary determines that the cost of compliance with such lower requirement will not place an undue burden on persons subject to such lower requirement.

(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)—

(I) the term "unit" means the packaging or, if there is no packaging, the form in which a food product is offered for sale to consumers,

(II) the term "food product" means food in any sized package which is manufactured by a single manufacturer or which bears the same brand name, which bears the same statement of identity, and which has similar preparation methods, and

(III) the term "person" in the case of a corporation includes all domestic and foreign affiliates of the corporation.

(F) A dietary supplement product (including a food to which section 350 of this title applies) shall comply with the requirements of subparagraphs (1) and (2) in a manner which is appropriate for the product and which is specified in regulations of the Secretary which shall provide that—

(i) nutrition information shall first list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consumption has been established by the Secretary, except that a dietary ingredient shall not be required to be listed if it is not present in a significant amount, and shall list any other dietary ingredient present and identified as having no such recommendation;

(ii) the listing of dietary ingredients shall include the quantity of each such ingredient (or of a proprietary blend of such ingredients) per serving;

(iii) the listing of dietary ingredients may include the source of a dietary ingredient; and

(iv) the nutrition information shall immediately precede the ingredient information required under subclause (i), except that no ingredient identified pursuant to subclause (i) shall be required to be identified a second time.

(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food which is sold by a food distributor if the food distributor principally sells food to restaurants or other establishments in which food is served for immediate human consumption and does not manufacture, process, or repackage the food it sells.

(H) Restaurants, Retail Food Establishments, and Vending Machines.—

(i) General requirements for restaurants and similar retail food establishments.—Except for food described in subclause (vii), in the case of food that is a standard menu item that is offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establishment shall disclose the information described in subclauses (ii) and (iii).

(ii) Information required to be disclosed by restaurants and retail food establishments.—Except as provided in subclause (vii), the restaurant or similar retail food establishment shall disclose in a clear and conspicuous manner—

(I)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu listing the item for sale, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and

(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu and designed to enable the public to understand, in the context of a total daily diet, the significance of the caloric information that is provided on the menu;

(II)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu board, including a drive-through menu board, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and

(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu board, designed to enable the public to understand, in the context of a total daily diet, the significance of the nutrition information that is provided on the menu board;

(III) in a written form, available on the premises of the restaurant or similar retail establishment and to the consumer upon request, the nutrition information required under clauses (C) and (D) of subparagraph (1); and

(IV) on the menu or menu board, a prominent, clear, and conspicuous statement regarding the availability of the information described in item (III).

(iii) Self-service food and food on display.—Except as provided in subclause (vii), in the case of food sold at a salad bar, buffet line, cafeteria line, or similar self-service facility, and for self-service beverages or food that is on display and that is visible to customers, a restaurant or similar retail food establishment shall place adjacent to each food offered a sign that lists calories per displayed food item or per serving.

(iv) Reasonable basis.—For the purposes of this clause, a restaurant or similar retail food establishment shall have a reasonable basis for its nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means, as described in section 101.10 of title 21, Code of Federal Regulations (or any successor regulation) or in a related guidance of the Food and Drug Administration.

(v) Menu variability and combination meals.—The Secretary shall establish by regulation standards for determining and disclosing the nutrient content for standard menu items that come in different flavors, varieties, or combinations, but which are listed as a single menu item, such as soft drinks, ice cream, pizza, doughnuts, or children's combination meals, through means determined by the Secretary, including ranges, averages, or other methods.

(vi) Additional information.—If the Secretary determines that a nutrient, other than a nutrient required under subclause (ii)(III), should be disclosed for the purpose of providing information to assist consumers in maintaining healthy dietary practices, the Secretary may require, by regulation, disclosure of such nutrient in the written form required under subclause (ii)(III).

(vii) Nonapplicability to certain food.—

(I) In general.—Subclauses (i) through (vi) do not apply to—

(aa) items that are not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use);

(bb) daily specials, temporary menu items appearing on the menu for less than 60 days per calendar year, or custom orders; or

(cc) such other food that is part of a customary market test appearing on the menu for less than 90 days, under terms and conditions established by the Secretary.

(II) Written forms.—Subparagraph (5)(C) shall apply to any regulations promulgated under subclauses (ii)(III) and (vi).

(viii) Vending machines.—

(I) In general.—In the case of an article of food sold from a vending machine that—

(aa) does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article or does not otherwise provide visible nutrition information at the point of purchase; and

(bb) is operated by a person who is engaged in the business of owning or operating 20 or more vending machines,

the vending machine operator shall provide a sign in close proximity to each article of food or the selection button that includes a clear and conspicuous statement disclosing the number of calories contained in the article.

(ix) Voluntary provision of nutrition information.—

(I) In general.—An authorized official of any restaurant or similar retail food establishment or vending machine operator not subject to the requirements of this clause may elect to be subject to the requirements of such clause, by registering biannually the name and address of such restaurant or similar retail food establishment or vending machine operator with the Secretary, as specified by the Secretary by regulation.

(II) Registration.—Within 120 days of March 23, 2010, the Secretary shall publish a notice in the Federal Register specifying the terms and conditions for implementation of item (I), pending promulgation of regulations.

(III) Rule of construction.—Nothing in this subclause shall be construed to authorize the Secretary to require an application, review, or licensing process for any entity to register with the Secretary, as described in such item.

(x) Regulations.—

(I) Proposed regulation.—Not later than 1 year after March 23, 2010, the Secretary shall promulgate proposed regulations to carry out this clause.

(II) Contents.—In promulgating regulations, the Secretary shall—

(aa) consider standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of food service workers, variations in ingredients, and other factors, as the Secretary determines; and

(bb) specify the format and manner of the nutrient content disclosure requirements under this subclause.

(III) Reporting.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a quarterly report that describes the Secretary's progress toward promulgating final regulations under this subparagraph.

(xi) Definition.—In this clause, the term "menu" or "menu board" means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.

(r) Nutrition levels and health-related claims

(1) Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended for human consumption which is offered for sale and for which a claim is made in the label or labeling of the food which expressly or by implication—

(A) characterizes the level of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food unless the claim is made in accordance with subparagraph (2), or

(B) characterizes the relationship of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food to a disease or a health-related condition unless the claim is made in accordance with subparagraph (3) or (5)(D).

A statement of the type required by paragraph (q) that appears as part of the nutrition information required or permitted by such paragraph is not a claim which is subject to this paragraph and a claim subject to clause (A) is not subject to clause (B).

(2)(A) Except as provided in subparagraphs (4)(A)(ii) and (4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a claim described in subparagraph (1)(A)—

(i) may be made only if the characterization of the level made in the claim uses terms which are defined in regulations of the Secretary,

(ii) may not state the absence of a nutrient unless—

(I) the nutrient is usually present in the food or in a food which substitutes for the food as defined by the Secretary by regulation, or

(II) the Secretary by regulation permits such a statement on the basis of a finding that such a statement would assist consumers in maintaining healthy dietary practices and the statement discloses that the nutrient is not usually present in the food,

(iii) may not be made with respect to the level of cholesterol in the food if the food contains, as determined by the Secretary by regulation, fat or saturated fat in an amount which increases to persons in the general population the risk of disease or a health related condition which is diet related unless—

(I) the Secretary finds by regulation that the level of cholesterol is substantially less than the level usually present in the food or in a food which substitutes for the food and which has a significant market share, or the Secretary by regulation permits a statement regarding the absence of cholesterol on the basis of a finding that cholesterol is not usually present in the food and that such a statement would assist consumers in maintaining healthy dietary practices and the regulation requires that the statement disclose that cholesterol is not usually present in the food, and

(II) the label or labeling of the food discloses the level of such fat or saturated fat in immediate proximity to such claim and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of cholesterol,

(iv) may not be made with respect to the level of saturated fat in the food if the food contains cholesterol unless the label or labeling of the food discloses the level of cholesterol in the food in immediate proximity to such claim and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of saturated fat,

(v) may not state that a food is high in dietary fiber unless the food is low in total fat as defined by the Secretary or the label or labeling discloses the level of total fat in the food in immediate proximity to such statement and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of dietary fiber, and

(vi) may not be made if the Secretary by regulation prohibits the claim because the claim is misleading in light of the level of another nutrient in the food.

(B) If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food and the Secretary makes a determination that the food contains a nutrient at a level that increases to persons in the general population the risk of a disease or health-related condition that is diet related, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim, the following statement: "See nutrition information for ______ content." The blank shall identify the nutrient associated with the increased disease or health-related condition risk. In making the determination described in this clause, the Secretary shall take into account the significance of the food in the total daily diet.

(C) Subparagraph (2)(A) does not apply to a claim described in subparagraph (1)(A) and contained in the label or labeling of a food if such claim is contained in the brand name of such food and such brand name was in use on such food before October 25, 1989, unless the brand name contains a term defined by the Secretary under subparagraph (2)(A)(i). Such a claim is subject to paragraph (a).

(D) Subparagraph (2) does not apply to a claim described in subparagraph (1)(A) which uses the term "diet" and is contained in the label or labeling of a soft drink if (i) such claim is contained in the brand name of such soft drink, (ii) such brand name was in use on such soft drink before October 25, 1989, and (iii) the use of the term "diet" was in conformity with section 105.66 of title 21 of the Code of Federal Regulations. Such a claim is subject to paragraph (a).

(E) Subclauses (i) through (v) of subparagraph (2)(A) do not apply to a statement in the label or labeling of food which describes the percentage of vitamins and minerals in the food in relation to the amount of such vitamins and minerals recommended for daily consumption by the Secretary.

(F) Subclause (i) clause (A) does not apply to a statement in the labeling of a dietary supplement that characterizes the percentage level of a dietary ingredient for which the Secretary has not established a reference daily intake, daily recommended value, or other recommendation for daily consumption.

(G) A claim of the type described in subparagraph (1)(A) for a nutrient, for which the Secretary has not promulgated a regulation under clause (A)(i), shall be authorized and may be made with respect to a food if—

(i) a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its subdivisions has published an authoritative statement, which is currently in effect, which identifies the nutrient level to which the claim refers;

(ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may notify any person who is making a claim as authorized by clause (C) that such person has not submitted all the information required by such clause) before the first introduction into interstate commerce of the food with a label containing the claim, (I) a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such person relied for determining that the requirements of subclause (i) have been satisfied, (II) a copy of the statement referred to in subclause (i) upon which such person relied in making the claim, and (III) a balanced representation of the scientific literature relating to the nutrient level to which the claim refers;

(iii) the claim and the food for which the claim is made are in compliance with clauses (A) and (B), and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and

(iv) the claim is stated in a manner so that the claim is an accurate representation of the authoritative statement referred to in subclause (i) and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet.

For purposes of this clause, a statement shall be regarded as an authoritative statement of a scientific body described in subclause (i) only if the statement is published by the scientific body and shall not include a statement of an employee of the scientific body made in the individual capacity of the employee.

(H) A claim submitted under the requirements of clause (G) may be made until—

(i) such time as the Secretary issues a regulation—

(I) prohibiting or modifying the claim and the regulation has become effective, or

(II) finding that the requirements of clause (G) have not been met, including finding that the petitioner had not submitted all the information required by such clause; or

(ii) a district court of the United States in an enforcement proceeding under subchapter III has determined that the requirements of clause (G) have not been met.

(3)(A) Except as provided in subparagraph (5), a claim described in subparagraph (1)(B) may only be made—

(i) if the claim meets the requirements of the regulations of the Secretary promulgated under clause (B), and

(ii) if the food for which the claim is made does not contain, as determined by the Secretary by regulation, any nutrient in an amount which increases to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of the food in the total daily diet, except that the Secretary may by regulation permit such a claim based on a finding that such a claim would assist consumers in maintaining healthy dietary practices and based on a requirement that the label contain a disclosure of the type required by subparagraph (2)(B).

(B)(i) The Secretary shall promulgate regulations authorizing claims of the type described in subparagraph (1)(B) only if the Secretary determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.

(ii) A regulation described in subclause (i) shall describe—

(I) the relationship between a nutrient of the type required in the label or labeling of food by paragraph (q)(1) or (q)(2) and a disease or health-related condition, and

(II) the significance of each such nutrient in affecting such disease or health-related condition.

(iii) A regulation described in subclause (i) shall require such claim to be stated in a manner so that the claim is an accurate representation of the matters set out in subclause (ii) and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet.

(C) Notwithstanding the provisions of clauses (A)(i) and (B), a claim of the type described in subparagraph (1)(B) which is not authorized by the Secretary in a regulation promulgated in accordance with clause (B) shall be authorized and may be made with respect to a food if—

(i) a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its subdivisions has published an authoritative statement, which is currently in effect, about the relationship between a nutrient and a disease or health-related condition to which the claim refers;

(ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may notify any person who is making a claim as authorized by clause (C) that such person has not submitted all the information required by such clause) before the first introduction into interstate commerce of the food with a label containing the claim, (I) a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such person relied for determining that the requirements of subclause (i) have been satisfied, (II) a copy of the statement referred to in subclause (i) upon which such person relied in making the claim, and (III) a balanced representation of the scientific literature relating to the relationship between a nutrient and a disease or health-related condition to which the claim refers;

(iii) the claim and the food for which the claim is made are in compliance with clause (A)(ii) and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and

(iv) the claim is stated in a manner so that the claim is an accurate representation of the authoritative statement referred to in subclause (i) and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet.

For purposes of this clause, a statement shall be regarded as an authoritative statement of a scientific body described in subclause (i) only if the statement is published by the scientific body and shall not include a statement of an employee of the scientific body made in the individual capacity of the employee.

(D) A claim submitted under the requirements of clause (C) may be made until—

(i) such time as the Secretary issues a regulation under the standard in clause (B)(i)—

(I) prohibiting or modifying the claim and the regulation has become effective, or

(II) finding that the requirements of clause (C) have not been met, including finding that the petitioner has not submitted all the information required by such clause; or

(ii) a district court of the United States in an enforcement proceeding under subchapter III has determined that the requirements of clause (C) have not been met.

(4)(A)(i) Any person may petition the Secretary to issue a regulation under subparagraph (2)(A)(i) or (3)(B) relating to a claim described in subparagraph (1)(A) or (1)(B). Not later than 100 days after the petition is received by the Secretary, the Secretary shall issue a final decision denying the petition or file the petition for further action by the Secretary. If the Secretary does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary denies the petition or the petition is deemed to be denied, the petition shall not be made available to the public. If the Secretary files the petition, the Secretary shall deny the petition or issue a proposed regulation to take the action requested in the petition not later than 90 days after the date of such decision. If the Secretary does not act within such 90 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary issues a proposed regulation, the rulemaking shall be completed within 540 days of the date the petition is received by the Secretary. If the Secretary does not issue a regulation within such 540 days, the Secretary shall provide the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate the reasons action on the regulation did not occur within such 540 days.

(ii) Any person may petition the Secretary for permission to use in a claim described in subparagraph (1)(A) terms that are consistent with the terms defined by the Secretary under subparagraph (2)(A)(i). Within 90 days of the submission of such a petition, the Secretary shall issue a final decision denying the petition or granting such permission.

(iii) Any person may petition the Secretary for permission to use an implied claim described in subparagraph (1)(A) in a brand name. After publishing notice of an opportunity to comment on the petition in the Federal Register and making the petition available to the public, the Secretary shall grant the petition if the Secretary finds that such claim is not misleading and is consistent with terms defined by the Secretary under subparagraph (2)(A)(i). The Secretary shall grant or deny the petition within 100 days of the date it is submitted to the Secretary and the petition shall be considered granted if the Secretary does not act on it within such 100 days.

(B) A petition under clause (A)(i) respecting a claim described in subparagraph (1)(A) or (1)(B) shall include an explanation of the reasons why the claim meets the requirements of this paragraph and a summary of the scientific data which supports such reasons.

(C) If a petition for a regulation under subparagraph (3)(B) relies on a report from an authoritative scientific body of the United States, the Secretary shall consider such report and shall justify any decision rejecting the conclusions of such report.

(5)(A) This paragraph does not apply to infant formulas subject to section 350a(h) of this title and medical foods as defined in section 360ee(b) of this title.

(B) Subclauses (iii) through (v) of subparagraph (2)(A) and subparagraph (2)(B) do not apply to food which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments.

(C) A subparagraph (1)(A) claim made with respect to a food which claim is required by a standard of identity issued under section 341 of this title shall not be subject to subparagraph (2)(A)(i) or (2)(B).

(D) A subparagraph (1)(B) claim made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances shall not be subject to subparagraph (3) but shall be subject to a procedure and standard, respecting the validity of such claim, established by regulation of the Secretary.

(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if—

(A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,

(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and

(C) the statement contains, prominently displayed and in boldface type, the following: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.".

A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.

(7) The Secretary may make proposed regulations issued under this paragraph effective upon publication pending consideration of public comment and publication of a final regulation if the Secretary determines that such action is necessary—

(A) to enable the Secretary to review and act promptly on petitions the Secretary determines provide for information necessary to—

(i) enable consumers to develop and maintain healthy dietary practices;

(ii) enable consumers to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food; or

(iii) ensure that scientifically sound nutritional and health information is provided to consumers as soon as possible; or

(B) to enable the Secretary to act promptly to ban or modify a claim under this paragraph.

Such proposed regulations shall be deemed final agency action for purposes of judicial review.

(s) Dietary supplements

If—

(1) it is a dietary supplement; and

(2)(A) the label or labeling of the supplement fails to list—

(i) the name of each ingredient of the supplement that is described in section 321(ff) of this title; and

(ii)(I) the quantity of each such ingredient; or

(II) with respect to a proprietary blend of such ingredients, the total quantity of all ingredients in the blend;

(B) the label or labeling of the dietary supplement fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient;

(C) the supplement contains an ingredient described in section 321(ff)(1)(C) of this title, and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived;

(D) the supplement—

(i) is covered by the specifications of an official compendium;

(ii) is represented as conforming to the specifications of an official compendium; and

(iii) fails to so conform; or

(E) the supplement—

(i) is not covered by the specifications of an official compendium; and

(ii)(I) fails to have the identity and strength that the supplement is represented to have; or

(II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional specifications, based on validated assay or other appropriate methods, that the supplement is represented to meet.

A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.

(t) Catfish

If it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae.

(u) Ginseng

If it purports to be or is represented as ginseng, unless it is an herb or herbal ingredient derived from a plant classified within the genus Panax.

(v) Failure to label; health threat

If—

(1) it fails to bear a label required by the Secretary under section 381(n)(1) of this title (relating to food refused admission into the United States);

(2) the Secretary finds that the food presents a threat of serious adverse health consequences or death to humans or animals; and

(3) upon or after notifying the owner or consignee involved that the label is required under section 381 of this title, the Secretary informs the owner or consignee that the food presents such a threat.

(w) Major food allergen labeling requirements

(1) If it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either—

(A) the word "Contains", followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i); or

(B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when—

(i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived; or

(ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 321(qq)(2)(A) or (B) of this title.

(2) As used in this subsection, the term "name of the food source from which the major food allergen is derived" means the name described in section 321(qq)(1) of this title; provided that in the case of a tree nut, fish, or Crustacean shellfish, the term "name of the food source from which the major food allergen is derived" means the name of the specific type of nut or species of fish or Crustacean shellfish.

(3) The information required under this subsection may appear in labeling in lieu of appearing on the label only if the Secretary finds that such other labeling is sufficient to protect the public health. A finding by the Secretary under this paragraph (including any change in an earlier finding under this paragraph) is effective upon publication in the Federal Register as a notice.

(4) Notwithstanding subsection (g), (i), or (k), or any other law, a flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen shall be subject to the labeling requirements of this subsection.

(5) The Secretary may by regulation modify the requirements of subparagraph (A) or (B) of paragraph (1), or eliminate either the requirement of subparagraph (A) or the requirements of subparagraph (B) of paragraph (1), if the Secretary determines that the modification or elimination of the requirement of subparagraph (A) or the requirements of subparagraph (B) is necessary to protect the public health.

(6)(A) Any person may petition the Secretary to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection.

(B) The Secretary shall approve or deny such petition within 180 days of receipt of the petition or the petition shall be deemed denied, unless an extension of time is mutually agreed upon by the Secretary and the petitioner.

(C) The burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.

(D) A determination regarding a petition under this paragraph shall constitute final agency action.

(E) The Secretary shall promptly post to a public site all petitions received under this paragraph within 14 days of receipt and the Secretary shall promptly post the Secretary's response to each.

(7)(A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing—

(i) scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein; or

(ii) a determination by the Secretary that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 348 of this title.

(B) The food ingredient may be introduced or delivered for introduction into interstate commerce as a food ingredient that is not a major food allergen 90 days after the date of receipt of the notification by the Secretary, unless the Secretary determines within the 90-day period that the notification does not meet the requirements of this paragraph, or there is insufficient scientific evidence to determine that the food ingredient does not contain allergenic protein or does not cause an allergenic response that poses a risk to human health.

(C) The Secretary shall promptly post to a public site all notifications received under this subparagraph within 14 days of receipt and promptly post any objections thereto by the Secretary.

(x) Nonmajor food allergen labeling requirements

Notwithstanding subsection (g), (i), or (k), or any other law, a spice, flavoring, coloring, or incidental additive that is, or that bears or contains, a food allergen (other than a major food allergen), as determined by the Secretary by regulation, shall be disclosed in a manner specified by the Secretary by regulation.

(y) Dietary supplements

If it is a dietary supplement that is marketed in the United States, unless the label of such dietary supplement includes a domestic address or domestic phone number through which the responsible person (as described in section 379aa–1 of this title) may receive a report of a serious adverse event with such dietary supplement.

(June 25, 1938, ch. 675, §403, 52 Stat. 1047; Pub. L. 86–537, §1, June 29, 1960, 74 Stat. 251; Pub. L. 86–618, title I, §102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91–601, §6(c), formerly §7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, §1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 94–278, title V, §502(a)(1), Apr. 22, 1976, 90 Stat. 411; Pub. L. 95–203, §4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat. 1452, 1453; Pub. L. 101–535, §§2(a), 3(a), 7, Nov. 8, 1990, 104 Stat. 2353, 2357, 2364; Pub. L. 102–108, §2(a), (c), Aug. 17, 1991, 105 Stat. 549; Pub. L. 102–571, title I, §107(5), (6), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §§2(b), 3(j), Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103–417, §§6, 7(a)–(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104–124, §1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105–115, title III, §§301–305, Nov. 21, 1997, 111 Stat. 2350–2353; Pub. L. 106–554, §1(a)(1) [title V, §517], Dec. 21, 2000, 114 Stat. 2763, 2763A-73; Pub. L. 107–171, title X, §§10806(a)(2), (b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L. 107–188, title III, §308(b), June 12, 2002, 116 Stat. 672; Pub. L. 108–282, title II, §203(a), Aug. 2, 2004, 118 Stat. 906; Pub. L. 109–462, §3(c), Dec. 22, 2006, 120 Stat. 3475; Pub. L. 111–148, title IV, §4205(a), (b), Mar. 23, 2010, 124 Stat. 573.)

Editorial Notes

Amendments

2010—Par. (q)(5)(A)(i). Pub. L. 111–148, §4205(a)(1), inserted "except as provided in clause (H)(ii)(III)," before "which is served".

Par. (q)(5)(A)(ii). Pub. L. 111–148, §4205(a)(2), inserted "except as provided in clause (H)(ii)(III)," before "which is processed".

Par. (q)(5)(H). Pub. L. 111–148, §4205(b), added cl. (H).

2006—Par. (y). Pub. L. 109–462 added par. (y).

2004—Pars. (w), (x). Pub. L. 108–282 added pars. (w) and (x).

2002—Par. (h). Pub. L. 107–171, §10808(b), added subpar. (3) and concluding provisions.

Par. (t). Pub. L. 107–171, §10806(a)(2), added par. (t).

Par. (u). Pub. L. 107–171, §10806(b)(2), added par. (u).

Par. (v). Pub. L. 107–188 added par. (v).

2000—Par. (o). Pub. L. 106–554, which directed repeal of section 403(o) of the Food, Drug, and Cosmetic Act, was executed by repealing par. (o) of this section, which is section 403 of the Federal Food, Drug, and Cosmetic Act, to reflect the probable intent of Congress. Prior to repeal, par. (o) provided that a food containing saccharin was to be deemed misbranded unless a specified warning statement was placed in a conspicuous place on its label.

1997—Par. (r)(2)(B). Pub. L. 105–115, §305, amended cl. (B) generally. Prior to amendment, cl. (B) read as follows: "If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim, the following statement: 'See __________ for nutrition information.'. In the statement—

"(i) the blank shall identify the panel on which the information described in the statement may be found, and

"(ii) if the Secretary determines that the food contains a nutrient at a level which increases to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of the food in the total daily diet, the statement shall also identify such nutrient."

Par. (r)(2)(G), (H). Pub. L. 105–115, §304, added cls. (G) and (H).

Par. (r)(3)(C), (D). Pub. L. 105–115, §303, added cls. (C) and (D).

Par. (r)(4)(A)(i). Pub. L. 105–115, §302, inserted after second sentence "If the Secretary does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner.", inserted "or the petition is deemed to be denied" after "If the Secretary denies the petition", and inserted at end "If the Secretary does not act within such 90 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary issues a proposed regulation, the rulemaking shall be completed within 540 days of the date the petition is received by the Secretary. If the Secretary does not issue a regulation within such 540 days, the Secretary shall provide the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate the reasons action on the regulation did not occur within such 540 days."

Par. (r)(7). Pub. L. 105–115, §301, added subpar. (7).

1996—Par. (p). Pub. L. 104–124 struck out par. (p), which deemed products containing saccharin and offered for sale, but not for immediate consumption, by retail establishment, to be misbranded, unless notice of information required by subsec. (o) was provided by manufacturer and prominently displayed near product.

1994—Par. (q)(5)(F). Pub. L. 103–417, §7(b), amended cl. (F) generally. Prior to amendment, cl. (F) read as follows: "If a food to which section 350 of this title applies (as defined in section 350(c) of this title) contains one or more of the nutrients required by subparagraph (1) or (2) to be in the label or labeling of the food, the label or labeling of such food shall comply with the requirements of subparagraphs (1) and (2) in a manner which is appropriate for such food and which is specified in regulations of the Secretary."

Par. (r)(2)(F). Pub. L. 103–417, §7(c), added cl. (F).

Par. (r)(6). Pub. L. 103–417, §6, added subpar. (6).

Par. (s). Pub. L. 103–417, §10(c), inserted at end: "A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings."

Pub. L. 103–417, §7(a), added par. (s).

1993—Par. (e). Pub. L. 103–80, §3(j)(1), substituted "count, except that" for "count: Provided, That".

Par. (i). Pub. L. 103–80, §3(j)(2), substituted "unless sold as spices, flavorings, or such colors" for ", other than those sold as such" and "naming each. To the extent" for "naming each: Provided, That, to the extent".

Par. (k). Pub. L. 103–80, §3(j)(3), substituted ", except that" for ": Provided, That".

Par. (l). Pub. L. 103–80, §3(j)(4), substituted "chemical, except that" for "chemical: Provided, however, That".

Par. (q)(5)(E) to (G). Pub. L. 103–80, §2(b), added cl. (E) and redesignated former cls. (E) and (F) as (F) and (G), respectively.

Par. (r)(1)(B). Pub. L. 103–80, §3(j)(5), substituted "(5)(D)" for "5(D)".

Par. (r)(4)(B). Pub. L. 103–80, §3(j)(6), substituted "paragraph" for "subsection".

1992—Par. (i). Pub. L. 102–571, §107(5), substituted "379e(c)" for "376(c)".

Par. (m). Pub. L. 102–571, §107(6), substituted "379e" for "376".

1991—Par. (i). Pub. L. 102–108, §2(c), amended directory language of Pub. L. 101–535, §7(1), (3). See 1990 Amendment note below.

Par. (q)(4)(A). Pub. L. 102–108, §2(a), substituted "(D)" for "(C)".

1990—Par. (i). Pub. L. 101–535, §7, as amended by Pub. L. 102–108, §2(c), substituted "Unless" for "If it is not subject to the provisions of paragraph (g) unless", inserted "and if the food purports to be a beverage containing vegetable or fruit juice, a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food", and substituted "colors not required to be certified under section 376(c) of this title" for "colorings" the first time appearing.

Par. (q). Pub. L. 101–535, §2(a), added par. (q).

Par. (r). Pub. L. 101–535, §3(a), added par. (r).

1977—Par. (o). Pub. L. 95–203, §4(a)(1), added par. (o).

Par. (p). Pub. L. 95–203, §4(b)(1), added par. (p).

1976—Par. (a). Pub. L. 94–278 inserted "(1)" after "If" and inserted ", or (2) in the case of a food to which section 350 of this title applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 350(b)(2) of this title" after "any particular".

1970—Par. (n). Pub. L. 91–601 added par. (n).

1960—Par. (k). Pub. L. 86–537, §1(1), exempted pesticide chemicals when used in or on a raw agricultural commodity which is the produce of the soil.

Par. (l). Pub. L. 86–537, §1(2), added par. (l).

Par. (m). Pub. L. 86–618 added par. (m).

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Effective Date of 2006 Amendment

Pub. L. 109–462, §3(d)(1), (2), Dec. 22, 2006, 120 Stat. 3475, provided that:

"(1) In general.—Except as provided in paragraph (2), the amendments made by this section [enacting section 379aa–1 of this title and amending this section and section 331 of this title] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006].

"(2) Misbranding.—Section 403(y) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(y)] (as added by this section) shall apply to any dietary supplement labeled on or after the date that is 1 year after the date of enactment of this Act [Dec. 22, 2006]."

Effective Date of 2004 Amendment

Amendment by Pub. L. 108–282 applicable to any food that is labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108–282, set out as a note under section 321 of this title.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1994 Amendment

Pub. L. 103–417, §7(e), Oct. 25, 1994, 108 Stat. 4331, provided that: "Dietary supplements—

"(1) may be labeled after the date of the enactment of this Act [Oct. 25, 1994] in accordance with the amendments made by this section [amending this section and section 350 of this title], and

"(2) shall be labeled after December 31, 1996, in accordance with such amendments."

Effective Date of 1990 Amendment

Pub. L. 101–535, §10(a), Nov. 8, 1990, 104 Stat. 2365, as amended by Pub. L. 102–571, title II, §202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided that:

"(1) Except as provided in paragraph (2)—

"(A) the amendments made by section 2 [amending this section] shall take effect 6 months after—

"(i) the date of the promulgation of all final regulations required to implement section 403(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)], or

"(ii) if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations [Nov. 8, 1992, see 57 F.R. 56347],

except that section 403(q)(4) of such Act shall take effect as prescribed by such section,

"(B) the amendments made by section 3 [amending this section] shall take effect 6 months after—

"(i) the date of the promulgation of final regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act, or

"(ii) if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations [Nov. 8, 1992, see 57 F.R. 56347], except that any person marketing a food the brand name of which contains a term defined by the Secretary under section 403(r)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act shall be given an additional 6 months to comply with section 3,

"(C) the amendments made by section 4 [amending section 337 of this title] shall take effect 24 months after the date of the enactment of this Act [Nov. 8, 1990], except that such amendments shall take effect with respect to such dietary supplements [probably means dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances, see section 202(a)(1) of Pub. L. 102–571, set out below] on December 31, 1993, and

"(D) the amendments made by section 5 [amending sections 321 and 345 of this title] shall take effect on the date the amendments made by section 3 take effect.

"(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act (as added by section 2) shall not apply with respect to food which was labeled before the effective date of the amendments made by section 2 and section 403(r) of the Federal Food, Drug, and Cosmetic Act (as added by section 3) shall not apply with respect to food which was labeled before the effective date of the amendments made by section 3.

"(3)(A) If the Secretary finds that a person who is subject to section 403(q)(4) of such Act is unable to comply with the requirements of such section upon the effective date of final regulations to implement section 403(q) of such Act or of proposed regulations to be considered as such final regulations because the Secretary has not made available to such person the information required by such section, the Secretary shall delay the application of such section to such person for such time as the Secretary may require to provide such information.

"(B) If the Secretary finds that compliance with section 403(q) or 403(r)(2) of such Act would cause an undue economic hardship, the Secretary may delay the application of such sections for no more than one year."

Pub. L. 101–535, §10(c), Nov. 8, 1990, 104 Stat. 2367, as amended by Pub. L. 102–108, §1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102–571, title I, §107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:

"(1) Except as provided in paragraphs (2) and (3), the amendments made by section 7 [amending this section] shall take effect one year after the date of the enactment of this Act [Nov. 8, 1990].

"(2)(A) If a food subject to section 403(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or more colors required to be certified under section 721(c) [of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a label which was printed before July 1, 1991, and which is attached to the food before May 8, 1993, such food shall not be subject to the amendments made by section 7(1) and section 7(3) [amending this section].

"(B) If a food described in subparagraph (A)—

"(i) bears a label which was printed after July 1, 1991, but before the date the proposed regulation described in clause (ii) takes effect as a final regulation and which was attached to the food before May 8, 1993, and

"(ii) meets the requirements of the proposed regulation of the Secretary of Health and Human Services published in 56 Fed. Reg. 28592–28636 (June 21, 1991) as it pertains to the amendments made by this Act [see Short Title of 1990 Amendment note set out under section 301 of this title],

such food shall not be subject to the amendments made by section 7(1) and section 7(3) [amending this section].

"(3) A food purported to be a beverage containing a vegetable or fruit juice which bears a label attached to the food before May 8, 1993, shall not be subject to the amendments made by section 7(2) [amending this section]."

Effective Date of 1977 Amendment

Pub. L. 95–203, §4(a)(2), Nov. 23, 1977, 91 Stat. 1453, provided that: "The amendment made by paragraph (1) [amending this section] shall apply only with respect to food introduced or delivered for introduction in interstate commerce on and after the 90th day after the date of the enactment of this Act [Nov. 23, 1977]."

Pub. L. 95–203, §4(b)(2), Nov. 23, 1977, 91 Stat. 1453, provided that: "The amendment made by paragraph (1) [amending this section] shall apply with respect to food which is sold in retail establishments on or after the 90th day after the effective date of the regulations of the Secretary of Health, Education, and Welfare [now Secretary of Health and Human Services] under paragraph (p)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(p)(4)]."

Effective Date of 1976 Amendment

Amendment by Pub. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of Pub. L. 94–278, set out as a note under section 334 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date; Postponement

Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such subsections effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers bearing certain labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Construction of Amendment by Pub. L. 111–148

Pub. L. 111–148, title IV, §4205(d), Mar. 23, 2010, 124 Stat. 576, provided that: "Nothing in the amendments made by this section [amending this section and section 343–1 of this title] shall be construed—

"(1) to preempt any provision of State or local law, unless such provision establishes or continues into effect nutrient content disclosures of the type required under section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)] (as added by subsection (b)) and is expressly preempted under subsection (a)(4) of such section;

"(2) to apply to any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food; or

"(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)(ix)] (as added by subsection (b)), to apply to any restaurant or similar retail food establishment other than a restaurant or similar retail food establishment described in section 403(q)(5)(H)(i) of such Act [21 U.S.C. 343(q)(5)(H)(i)]."

Construction of Amendment by Pub. L. 108–282

Pub. L. 108–282, title II, §203(b), Aug. 2, 2004, 118 Stat. 908, provided that: "The amendments made by this section [amending this section and sections 321 and 343–1 of this title] that require a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or labeling for other food allergens."

Construction of Amendment by Pub. L. 107–188

Nothing in amendment by Pub. L. 107–188 to be construed to limit authority of Secretary of Health and Human Services or Secretary of the Treasury to require marking of articles of food imported or offered for import into the United States which are refused admission, see section 308(c) of Pub. L. 107–188, set out as a note under section 381 of this title.

Construction of Amendments by Pub. L. 101–535

Pub. L. 101–535, §9, Nov. 8, 1990, 104 Stat. 2365, provided that: "The amendments made by this Act [enacting section 343–1 of this title and amending this section and sections 321, 337, 345, and 371 of this title] shall not be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the Federal Meat Inspection Act [21 U.S.C. 601 et seq.], the Poultry Products Inspection Act [21 U.S.C. 451 et seq.], and the Egg Products Inspection Act [21 U.S.C. 1031 et seq.]."

Regulations

Pub. L. 101–535, §2(b), Nov. 8, 1990, 104 Stat. 2356, as amended by Pub. L. 102–571, title II, §202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500, 4501, provided that:

"(1) The Secretary of Health and Human Services shall issue proposed regulations to implement section 403(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)] within 12 months after the date of the enactment of this Act [Nov. 8, 1990], except that the Secretary shall issue, not later than June 15, 1993, proposed regulations that are applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances to implement such section. Not later than 24 months after the date of the enactment of this Act, the Secretary shall issue final regulations to implement the requirements of such section, except that the Secretary shall issue, not later than December 31, 1993, such a final regulation applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances..[sic] Such regulations shall—

"(A) require the required information to be conveyed to the public in a manner which enables the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet,

"(B) include regulations which establish standards, in accordance with paragraph (1)(A), to define serving size or other unit of measure for food,

"(C) permit the label or labeling of food to include nutrition information which is in addition to the information required by such section 403(q) and which is of the type described in subparagraph (1) or (2) of such section, and

"(D) permit the nutrition information on the label or labeling of a food to remain the same or permit the information to be stated as a range even though (i) there are minor variations in the nutritional value of the food which occur in the normal course of the production or processing of the food, or (ii) the food is comprised of an assortment of similar foods which have variations in nutritional value.

"(2) If the Secretary of Health and Human Services does not promulgate final regulations under paragraph (1) upon the expiration of 24 months after the date of the enactment of this Act, the proposed regulations issued in accordance with paragraph (1) shall be considered as the final regulations upon the expiration of such 24 months, except that the proposed regulations applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances shall not be considered to be final regulations until December 31, 1993. There shall be promptly published in the Federal Register notice of new status of the proposed regulations [see 57 F.R. 56347].

"(3) If the Secretary of Health and Human Services does not promulgate final regulations under section 403(q)(4) of the Federal Food, Drug, and Cosmetic Act upon the expiration of 6 months after the date on which the Secretary makes a finding that there has been no substantial compliance with section 403(q)(4)(C) of such Act, the proposed regulations issued in accordance with such section shall be considered as the final regulations upon the expiration of such 6 months. There shall be promptly published in the Federal Register notice of new status of the proposed regulations."

[Pub. L. 102–571, title II, §202(a)(2)(C), Oct. 29, 1992, 106 Stat. 4501, provided that: "The amendments made by subparagraph (B) [amending sections 2(b) and 3(b) of Pub. L. 101–535, set out above and below] shall not be construed to modify the effective date of final regulations under sections 2(b) and 3(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535] (21 U.S.C. 343 note) with respect to foods that are not such dietary supplements."]

Pub. L. 101–535, §3(b), Nov. 8, 1990, 104 Stat. 2360, as amended by Pub. L. 102–571, title II, §202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500, 4501, provided that:

"(1)(A) Within 12 months of the date of the enactment of this Act [Nov. 8, 1990], the Secretary of Health and Human Services shall issue proposed regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(r)], except that the Secretary shall issue, not later than June 15, 1993, proposed regulations that are applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances to implement such section. Such regulations—

"(i) shall identify claims described in section 403(r)(1)(A) of such Act which comply with section 403(r)(2) of such Act,

"(ii) shall identify claims described in section 403(r)(1)(B) of such Act which comply with section 403(r)(3) of such Act,

"(iii) shall, in defining terms used to characterize the level of any nutrient in food under section 403(r)(2)(A)(i) of such Act, define—

"(I) free,

"(II) low,

"(III) light or lite,

"(IV) reduced,

"(V) less, and

"(VI) high,

unless the Secretary finds that the use of any such term would be misleading,

"(iv) shall permit statements describing the amount and percentage of nutrients in food which are not misleading and are consistent with the terms defined in section 403(r)(2)(A)(i) of such Act,

"(v) shall provide that if multiple claims subject to section 403(r)(1)(A) of such Act are made on a single panel of the food label or page of a labeling brochure, a single statement may be made to satisfy section 403(r)(2)(B) of such Act,

"(vi) shall determine whether claims respecting the following nutrients and diseases meet the requirements of section 403(r)(3) of such Act: Calcium and osteoporosis, dietary fiber and cancer, lipids and cardiovascular disease, lipids and cancer, sodium and hypertension, and dietary fiber and cardiovascular disease,

"(vii) shall not require a person who proposes to make a claim described in section 403(r)(1)(B) of such Act which is in compliance with such regulations to secure the approval of the Secretary before making such claim,

"(viii) may permit a claim described in section 403(r)(1)(A) of such Act to be made for butter,

"(ix) may, in defining terms under section 403(r)(2)(A)(i), include similar terms which are commonly understood to have the same meaning, and

"(x) shall establish, as required by section 403(r)(5)(D), the procedure and standard respecting the validity of claims made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances and shall determine whether claims respecting the following nutrients and diseases meet the requirements of section 403(r)(5)(D) of such Act: folic acid and neural tube defects, antioxident [sic] vitamins and cancer, zinc and immune function in the elderly, and omega-3 fatty acids and heart disease.

"(B) Not later than 24 months after the date of the enactment of this Act, the Secretary shall issue final regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act, except that the Secretary shall issue, not later than December 31, 1993, such a final regulation applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances..[sic]

"(2) If the Secretary does not promulgate final regulations under paragraph (1)(B) upon the expiration of 24 months after the date of the enactment of this Act, the proposed regulations issued in accordance with paragraph (1)(A) shall be considered as the final regulations upon the expiration of such 24 months, except that the proposed regulations applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances shall not be considered to be final regulations until December 31, 1993. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations [see 57 F.R. 56347]."

[For construction of amendment made by section 202(a)(2)(B) of Pub. L. 102–571 to section 3(b) of Pub. L. 101–535 set out above, see section 202(a)(2)(C) of Pub. L. 102–571 set out above following section 2(b) of Pub. L. 101–535.]

Labeling Exemption for Single Ingredient Foods and Products

Pub. L. 115–334, title XII, §12516, Dec. 20, 2018, 132 Stat. 5000, provided that: "The food labeling requirements under section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar, honey, agave, or syrup, including maple syrup, that is packaged and offered for sale as a single-ingredient food bear the declaration 'Includes X g Added Sugars.'."

Findings

Pub. L. 108–282, title II, §202, Aug. 2, 2004, 118 Stat. 905, provided that: "Congress finds that—

"(1) it is estimated that—

"(A) approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies; and

"(B) each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food;

"(2)(A) eight major foods or food groups—milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans—account for 90 percent of food allergies;

"(B) at present, there is no cure for food allergies; and

"(C) a food allergic consumer must avoid the food to which the consumer is allergic;

"(3)(A) in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in 1999, the Food and Drug Administration found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels; and

"(B) nationally, the number of recalls because of unlabeled allergens rose to 121 in 2000 from about 35 a decade earlier;

"(4) a recent study shows that many parents of children with a food allergy were unable to correctly identify in each of several food labels the ingredients derived from major food allergens;

"(5)(A) ingredients in foods must be listed by their 'common or usual name';

"(B) in some cases, the common or usual name of an ingredient may be unfamiliar to consumers, and many consumers may not realize the ingredient is derived from, or contains, a major food allergen; and

"(C) in other cases, the ingredients may be declared as a class, including spices, flavorings, and certain colorings, or are exempt from the ingredient labeling requirements, such as incidental additives; and

"(6)(A) celiac disease is an immune-mediated disease that causes damage to the gastrointestinal tract, central nervous system, and other organs;

"(B) the current recommended treatment is avoidance of glutens in foods that are associated with celiac disease; and

"(C) a multicenter, multiyear study estimated that the prevalence of celiac disease in the United States is 0.5 to 1 percent of the general population."

Rulemakings on Labeling

Pub. L. 118–42, div. B, title VII, §745, Mar. 9, 2024, 138 Stat. 112, provided that:

"(a) After the effective date of any final rule the Food and Drug Administration (FDA) publishes in connection with its proposed rule to update these requirements (87 Federal Register 59168, issued on September 29, 2022), manufacturers may also continue to comply with the previous requirements promulgated by the FDA for the implied nutrient content claim 'healthy' through the 'compliance date' FDA provides in the final rule.

"(b) Any food product manufactured and labeled as 'healthy' during the compliance period FDA provides in that final rule shall not be directly or indirectly subject to any state-law requirements that are not identical to either (i) the Federal requirements for the implied nutrition content claim 'healthy' that were in effect as of the date FDA issues the final rule, or (ii) the updated Federal requirements that FDA promulgates in the final rule, assuming the updated requirements go into effect during the regulatory compliance period."

Pub. L. 108–282, title II, §206, Aug. 2, 2004, 118 Stat. 910, provided that: "Not later than 2 years after the date of enactment of this Act [Aug. 2, 2004], the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term 'gluten-free' on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term 'gluten-free' on the labeling of foods."

Pub. L. 107–171, title X, §10809, May 13, 2002, 116 Stat. 531, provided that: "The Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall publish a proposed rule and, with due consideration to public comment, a final rule to revise, as appropriate, the current regulation governing the labeling of foods that have been treated to reduce pest infestation or pathogens by treatment by irradiation using radioactive isotope, electronic beam, or x-ray. Pending promulgation of the final rule required by this subsection [probably should be "this section"], any person may petition the Secretary for approval of labeling, which is not false or misleading in any material respect, of a food which has been treated by irradiation using radioactive isotope, electronic beam, or x-ray. The Secretary shall approve or deny such a petition within 180 days of receipt of the petition, or the petition shall be deemed denied, except to the extent additional agency review is mutually agreed upon by the Secretary and the petitioner. Any denial of a petition under this subsection shall constitute final agency action subject to judicial review by the United States Court of Appeals for the District of Columbia Circuit. Any labeling approved through the foregoing petition process shall be subject to the provisions of the final rule referred to in the first sentence of the subparagraph on the effective date of such final rule."

Commission on Dietary Supplement Labels

Pub. L. 103–417, §12, Oct. 25, 1994, 108 Stat. 4332, provided that:

"(a) Establishment.—There shall be established as an independent agency within the executive branch a commission to be known as the Commission on Dietary Supplement Labels (hereafter in this section referred to as the 'Commission').

"(b) Membership.—

"(1) Composition.—The Commission shall be composed of 7 members who shall be appointed by the President.

"(2) Expertise requirement.—The members of the Commission shall consist of individuals with expertise and experience in dietary supplements and in the manufacture, regulation, distribution, and use of such supplements. At least three of the members of the Commission shall be qualified by scientific training and experience to evaluate the benefits to health of the use of dietary supplements and one of such three members shall have experience in pharmacognosy, medical botany, traditional herbal medicine, or other related sciences. Members and staff of the Commission shall be without bias on the issue of dietary supplements.

"(c) Functions of the Commission.—The Commission shall conduct a study on, and provide recommendations for, the regulation of label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims. In making such recommendations, the Commission shall evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families.

"(d) Administrative Powers of the Commission.—

"(1) Hearings.—The Commission may hold hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Commission considers advisable to carry out the purposes of this section.

"(2) Information from federal agencies.—The Commission may secure directly from any Federal department or agency such information as the Commission considers necessary to carry out the provisions of this section.

"(3) Authorization of appropriations.—There are authorized to be appropriated such sums as may be necessary to carry out this section.

"(e) Reports and Recommendations.—

"(1) Final report required.—Not later than 24 months after the date of enactment of this Act [Oct. 25, 1994], the Commission shall prepare and submit to the President and to the Congress a final report on the study required by this section.

"(2) Recommendations.—The report described in paragraph (1) shall contain such recommendations, including recommendations for legislation, as the Commission deems appropriate.

"(3) Action on recommendations.—Within 90 days of the issuance of the report under paragraph (1), the Secretary of Health and Human Services shall publish in the Federal Register a notice of any recommendation of Commission for changes in regulations of the Secretary for the regulation of dietary supplements and shall include in such notice a notice of proposed rulemaking on such changes together with an opportunity to present views on such changes. Such rulemaking shall be completed not later than 2 years after the date of the issuance of such report. If such rulemaking is not completed on or before the expiration of such 2 years, regulations of the Secretary published in 59 FR 395–426 on January 4, 1994, shall not be in effect."

Extension of Compliance Deadline for Certain Food Products Packaged Prior to August 8, 1994

Pub. L. 103–261, May 26, 1994, 108 Stat. 705, provided: "That before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the provision of section 403(i) of such Act added by section 7(2) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535], shall not apply with respect to a food product which is contained in a package for which the label was printed before May 8, 1994 (or before August 8, 1994, in the case of a juice or milk food product if the person responsible for the labeling of such food product exercised due diligence in obtaining before such date labels which are in compliance with such sections 403(q) and 403(r)(2) and such provision of section 403(i)), if, before June 15, 1994, the person who introduces or delivers for introduction such food product into interstate commerce submits to the Secretary of Health and Human Services a certification that such person will comply with this section and will comply with such sections 403(q) and 403(r)(2) and such provision of section 403(i) after August 8, 1994."

Limitations on Application of Small Business Exemption

Pub. L. 103–80, §2(a), Aug. 13, 1993, 107 Stat. 773, provided that:

"(1) Before may 8, 1995.—Before May 8, 1995, the exemption provided by section 403(q)(5)(D) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(D)] shall be available in accordance with the regulations of the Secretary of Health and Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993).

"(2) After may 8, 1995.—After May 8, 1995, the exemption provided by section 403(q)(5)(D) of the Federal Food, Drug, and Cosmetic Act shall only be available with respect to food when it is sold to consumers."

Prohibition on Implementation of Pub. L. 101–535 With Respect to Dietary Supplements

Pub. L. 102–571, title II, §202(a)(1), Oct. 29, 1992, 106 Stat. 4500, provided that: "Notwithstanding any other provision of law and except as provided in subsection (b) [set out as a note below] and in the amendment made by paragraph (2)(A) [amending provisions set out as notes above], the Secretary of Health and Human Services may not implement the Nutrition Labeling and Education Act of 1990 (Public Law 101–535; 104 Stat. 2353) [see Short Title of 1990 Amendments note set out under section 301 of this title], or any amendment made by such Act, earlier than December 15, 1993, with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances."

Health Claims Made With Respect to Dietary Supplements

Pub. L. 102–571, title II, §202(b), Oct. 29, 1992, 106 Stat. 4501, provided that: "Notwithstanding section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions set out as notes above and amending provisions set out as notes above and under section 343–1 of this title], the Secretary of Health and Human Services may, earlier than December 15, 1993, approve claims made with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances that are claims described in clauses (vi) and (x) of section 3(b)(1)(A) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535] (21 U.S.C. 343 note)."

United States Recommended Daily Allowances of Vitamins or Minerals

Pub. L. 102–571, title II, §203, Oct. 29, 1992, 106 Stat. 4502, provided that: "Notwithstanding any other provision of Federal law, no regulations that require the use of, or are based upon, recommended daily allowances of vitamins or minerals may be promulgated before November 8, 1993 (other than regulations establishing the United States recommended daily allowances specified at section 101.9(c)(7)(iv) of title 21, Code of Federal Regulations, as in effect on October 6, 1992, or regulations under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such recommended daily allowances)."

Consumer Education

Pub. L. 101–535, §2(c), Nov. 8, 1990, 104 Stat. 2357, provided that: "The Secretary of Health and Human Services shall carry out activities which educate consumers about—

"(1) the availability of nutrition information in the label or labeling of food, and

"(2) the importance of that information in maintaining healthy dietary practices."

Studies Concerning Carcinogenic and Other Toxic Substances in Food and Impurities in and Toxicity of Saccharin

Pub. L. 95–203, §2, Nov. 23, 1977, 91 Stat. 1451, directed Secretary of Health, Education, and Welfare to conduct a study concerning carcinogenic and other toxic substances in food and impurities in and toxicity of saccharin and make a report respecting the carcinogenic and other substances to Committee on Human Resources of the Senate within 12 months of Nov. 23, 1977, and a report respecting saccharin to such committee within 15 months of Nov. 23, 1977.

Report to Congressional Committees Respecting Action Taken Pursuant to Former Par. (o)(2)

Pub. L. 95–203, §4(a)(3), Nov. 23, 1977, 91 Stat. 1453, provided that the Secretary was to report to specified congressional committees any action taken under former par. (o)(2) of this section.

State or Territorial Requirements

Pub. L. 86–537, §2, June 29, 1960, 74 Stat. 251, provided that: "Nothing in the amendments made by the first section of this Act [amending this section] shall affect any requirement of the laws of any State or Territory."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original. Probably should be followed by a comma.

§343–1. National uniform nutrition labeling

(a) Except as provided in subsection (b), no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—

(1) any requirement for a food which is the subject of a standard of identity established under section 341 of this title that is not identical to such standard of identity or that is not identical to the requirement of section 343(g) of this title, except that this paragraph does not apply to a standard of identity of a State or political subdivision of a State for maple syrup that is of the type required by sections 341 and 343(g) of this title,

(2) any requirement for the labeling of food of the type required by section 343(c), 343(e), 343(i)(2), 343(w), or 343(x) of this title that is not identical to the requirement of such section, except that this paragraph does not apply to a requirement of a State or political subdivision of a State that is of the type required by section 343(c) of this title and that is applicable to maple syrup,

(3) any requirement for the labeling of food of the type required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or 343(k) of this title that is not identical to the requirement of such section, except that this paragraph does not apply to a requirement of a State or political subdivision of a State that is of the type required by section 343(h)(1) of this title and that is applicable to maple syrup,

(4) any requirement for nutrition labeling of food that is not identical to the requirement of section 343(q) of this title, except that this paragraph does not apply to food that is offered for sale in a restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items unless such restaurant or similar retail food establishment complies with the voluntary provision of nutrition information requirements under section 343(q)(5)(H)(ix) of this title, or

(5) any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title, except a requirement respecting a claim made in the label or labeling of food which is exempt under section 343(r)(5)(B) of this title.

Paragraph (3) shall take effect in accordance with section 6(b) of the Nutrition Labeling and Education Act of 1990.

(b) Upon petition of a State or a political subdivision of a State, the Secretary may exempt from subsection (a), under such conditions as may be prescribed by regulation, any State or local requirement that—

(1) would not cause any food to be in violation of any applicable requirement under Federal law,

(2) would not unduly burden interstate commerce, and

(3) is designed to address a particular need for information which need is not met by the requirements of the sections referred to in subsection (a).

(June 25, 1938, ch. 675, §403A, as added Pub. L. 101–535, §6(a), Nov. 8, 1990, 104 Stat. 2362; amended Pub. L. 102–108, §2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103–396, §3(a), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 108–282, title II, §203(c)(2), Aug. 2, 2004, 118 Stat. 908; Pub. L. 111–148, title IV, §4205(c), Mar. 23, 2010, 124 Stat. 576.)

Editorial Notes

References in Text

Section 6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535], referred to in subsec. (a), is set out below.

Amendments

2010—Subsec. (a)(4). Pub. L. 111–148 substituted "except that this paragraph does not apply to food that is offered for sale in a restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items unless such restaurant or similar retail food establishment complies with the voluntary provision of nutrition information requirements under section 343(q)(5)(H)(ix) of this title" for "except a requirement for nutrition labeling of food which is exempt under subclause (i) or (ii) of section 343(q)(5)(A) of this title".

2004—Subsec. (a)(2). Pub. L. 108–282 substituted "343(i)(2), 343(w), or 343(x)" for "or 343(i)(2)".

1994—Subsec. (a)(1). Pub. L. 103–396, §3(a)(1), inserted at end "except that this paragraph does not apply to a standard of identity of a State or political subdivision of a State for maple syrup that is of the type required by sections 341 and 343(g) of this title,".

Subsec. (a)(2). Pub. L. 103–396, §3(a)(2), inserted at end "except that this paragraph does not apply to a requirement of a State or political subdivision of a State that is of the type required by section 343(c) of this title and that is applicable to maple syrup,".

Subsec. (a)(3). Pub. L. 103–396, §3(a)(3), inserted at end "except that this paragraph does not apply to a requirement of a State or political subdivision of a State that is of the type required by section 343(h)(1) of this title and that is applicable to maple syrup,".

1991—Subsec. (a)(5). Pub. L. 102–108 substituted "section 343(r)(5)(B) of this title" for "clause (B) of such section".

Statutory Notes and Related Subsidiaries

Effective Date of 2004 Amendment

Amendment by Pub. L. 108–282 applicable to any food that is labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108–282, set out as a note under section 321 of this title.

Effective Date

Pub. L. 101–535, §10(b), Nov. 8, 1990, 104 Stat. 2366, as amended by Pub. L. 102–571, title I, §107(16), title II, §202(a)(4), Oct. 29, 1992, 106 Stat. 4499, 4501, provided that:

"(1) In general.—Except as provided in paragraph (2), the amendments made by section 6 [enacting this section] shall take effect—

"(A) with respect to a requirement of a State or political subdivision described in paragraph (1) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act [subsec. (a)(1) of this section], on the date of the enactment of this Act [Nov. 8, 1990],

"(B) with respect to a requirement of a State or political subdivision described in paragraph (2) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, one year after the date of the enactment of this Act,

"(C) with respect to a requirement of a State or political subdivision described in paragraph (3) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, as prescribed by section 6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535, set out below],

"(D) with respect to a requirement of a State or political subdivision described in paragraph (4) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, on the date regulations to implement section 403(q) of such Act [21 U.S.C. 343(q)] take effect, and

"(E) with respect to a requirement of a State or political subdivision described in paragraph (5) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, on the date regulations to implement section 403(r) of such Act take effect.

"(2) Exception.—If a State or political subdivision submits a petition under section 403A(b) of the Federal Food, Drug, and Cosmetic Act for a requirement described in section 403A(a) of such Act within 18 months of the date of the enactment of this Act, paragraphs (3) through (5) of such section 403A(a) shall not apply with respect to such State or political subdivision requirement until—

"(A) 24 months after the date of the enactment of this Act, or

"(B) action on the petition,

whichever occurs later.

"(3) Requirements pertaining to certain claims.—Notwithstanding subparagraphs (D) and (E) of paragraph (1) and except with respect to claims approved in accordance with section 202(b) of the Dietary Supplement Act of 1992 [Pub. L. 102–571, set out as a note under section 343 of this title], the requirements described in paragraphs (4) and (5) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(4) and (5)) that pertain to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances shall not take effect until the date final regulations take effect to implement subsection (q) or (r), as appropriate, of section 403 of such Act with respect to such dietary supplements."

Pub. L. 101–535, §6(b), Nov. 8, 1990, 104 Stat. 2363, provided that:

"(1) For the purpose of implementing section 403A(a)(3) [21 U.S.C. 343–1(a)(3)], the Secretary of Health and Human Services shall enter into a contract with a public or nonprofit private entity to conduct a study of—

"(A) State and local laws which require the labeling of food that is of the type required by sections 403(b), 403(d), 403(f), 403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(b), (d), (f), (h), (i)(1), (k)], and

"(B) the sections of the Federal Food, Drug, and Cosmetic Act referred to in subparagraph (A) and the regulations issued by the Secretary to enforce such sections to determine whether such sections and regulations adequately implement the purposes of such sections.

"(2) The contract under paragraph (1) shall provide that the study required by such paragraph shall be completed within 6 months of the date of the enactment of this Act [Nov. 8, 1990].

"(3)(A) Within 9 months of the date of the enactment of this Act, the Secretary shall publish a proposed list of sections which are adequately being implemented by regulations as determined under paragraph (1)(B) and sections which are not adequately being implemented by regulations as so determined. After publication of the lists, the Secretary shall provide 60 days for comments on such lists.

"(B) Within 24 months of the date of the enactment of this Act, the Secretary shall publish a final list of sections which are adequately being implemented by regulations and a list of sections which are not adequately being implemented by regulations. With respect to a section which is found by the Secretary to be adequately implemented, no State or political subdivision of a State may establish or continue in effect as to any food in interstate commerce any requirement which is not identical to the requirement of such section.

"(C) Within 24 months of the date of the enactment of this Act, the Secretary shall publish proposed revisions to the regulations found to be inadequate under subparagraph (B) and within 30 months of such date shall issue final revisions. Upon the effective date of such final revisions, no State or political subdivision may establish or continue in effect any requirement which is not identical to the requirement of the section which had its regulations revised in accordance with this subparagraph.

"(D)(i) If the Secretary does not issue a final list in accordance with subparagraph (B), the proposed list issued under subparagraph (A) shall be considered the final list and States and political subdivisions shall be preempted with respect to sections found to be adequate in such proposed list in accordance with subparagraph (B).

"(ii) If the Secretary does not issue final revisions of regulations in accordance with subparagraph (C), the proposed revisions issued under such subparagraph shall be considered the final revisions and States and political subdivisions shall be preempted with respect to sections the regulations of which are revised by the proposed revisions.

"(E) Subsection (b) of section 403A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the prohibition prescribed by subparagraphs (B) and (C)."

Construction of Pub. L. 101–535

Pub. L. 101–535, §6(c), Nov. 8, 1990, 104 Stat. 2364, provided that:

"(1) The Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535, see Short Title of 1990 Amendment note set out under section 301 of this title] shall not be construed to preempt any provision of State law, unless such provision is expressly preempted under section 403A of the Federal Food, Drug, and Cosmetic Act [this section].

"(2) The amendment made by subsection (a) [enacting this section] and the provisions of subsection (b) [set out as a note above] shall not be construed to apply to any requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food.

"(3) The amendment made by subsection (a), the provisions of subsection (b) and paragraphs (1) and (2) of this subsection shall not be construed to affect preemption, express or implied, of any such requirement of a State or political subdivision, which may arise under the Constitution, any provision of the Federal Food, Drug, and Cosmetic Act [this chapter] not amended by subsection (a), any other Federal law, or any Federal regulation, order, or other final agency action reviewable under chapter 7 of title 5, United States Code."

Amendments by Pub. L. 101–535 not to be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.

Delayed Applicability of Certain Provisions

Pub. L. 102–408, title III, §310, Oct. 13, 1992, 106 Stat. 2090, provided that: "Notwithstanding any other provision of law, section 403A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(1)) shall not apply with respect to any requirement of any State or political subdivision regarding maple syrup until September 1, 1994."

§343–2. Dietary supplement labeling exemptions

(a) In general

A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it—

(1) is not false or misleading;

(2) does not promote a particular manufacturer or brand of a dietary supplement;

(3) is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement;

(4) if displayed in an establishment, is physically separate from the dietary supplements; and

(5) does not have appended to it any information by sticker or any other method.

(b) Application

Subsection (a) shall not apply to or restrict a retailer or wholesaler of dietary supplements in any way whatsoever in the sale of books or other publications as a part of the business of such retailer or wholesaler.

(c) Burden of proof

In any proceeding brought under subsection (a), the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading.

(June 25, 1938, ch. 675, §403B, as added Pub. L. 103–417, §5, Oct. 25, 1994, 108 Stat. 4328.)

§343–3. Disclosure

(a) No provision of section 321(n), 343(a), or 348 of this title shall be construed to require on the label or labeling of a food a separate radiation disclosure statement that is more prominent than the declaration of ingredients required by section 343(i)(2) of this title.

(b) In this section, the term "radiation disclosure statement" means a written statement that discloses that a food has been intentionally subject to radiation.

(June 25, 1938, ch. 675, §403C, as added Pub. L. 105–115, title III, §306, Nov. 21, 1997, 111 Stat. 2353.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§343a. Repealed. Pub. L. 106–554, §1(a)(1) [title V, §517], Dec. 21, 2000, 114 Stat. 2763, 2763A-73

Section, Pub. L. 95–203, §4(c), (d), Nov. 23, 1977, 91 Stat. 1453, 1454, related to distribution of information on health risks of saccharin.

§344. Emergency permit control

(a) Conditions on manufacturing, processing, etc., as health measure

Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he then, and in such case only, shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such temporary period, no person shall introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor, or packer holds a permit issued by the Secretary as provided by such regulations.

(b) Violation of permit; suspension and reinstatement

The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the Secretary shall, immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued or as amended.

(c) Inspection of permit-holding establishments

Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.

(June 25, 1938, ch. 675, §404, 52 Stat. 1048.)

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§345. Regulations making exemptions

The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.

(June 25, 1938, ch. 675, §405, 52 Stat. 1049; Pub. L. 101–535, §5(a), Nov. 8, 1990, 104 Stat. 2362.)

Editorial Notes

Amendments

1990—Pub. L. 101–535 inserted at end "This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title."

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

Amendment by Pub. L. 101–535 effective six months after the date of the promulgation of final regulations to implement section 343(r) of this title, or if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations (Nov. 8, 1992), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101–535, set out as a note under section 343 of this title.

Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§346. Tolerances for poisonous or deleterious substances in food; regulations

Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title; but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of section 342(a) of this title. In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

(June 25, 1938, ch. 675, §406, 52 Stat. 1049; Pub. L. 85–929, §3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86–618, title I, §103(a)(1), July 12, 1960, 74 Stat. 398.)

Editorial Notes

Amendments

1960—Pub. L. 86–618 repealed subsec. (b) which required Secretary to promulgate regulations for listing of coal-tar colors.

1958—Subsec. (a). Pub. L. 85–929 substituted "clause (2)(A)" for "clause (2)" in first sentence.

Statutory Notes and Related Subsidiaries

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date of Nematocide, Plant Regulator, Defoliant, and Desiccant Amendment of 1959

Effective date of subsec. (a) as in force prior to July 22, 1954, with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on a raw agricultural commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86–139, Aug. 7, 1959, 73 Stat. 288.

Effective Date of 1958 Amendment

For effective date of amendment by Pub. L. 85–929, see section 6(b), (c) of Pub. L. 85–929, set out as a note under section 342 of this title.

Executive Documents

Transfer of Functions

Functions vested in Secretary of Health, Education, and Welfare [now Health and Human Services] in establishing tolerances for pesticide chemicals under this section together with authority to monitor compliance with tolerances and effectiveness of surveillance and enforcement and to provide technical assistance to States and conduct research under this chapter and section 201 et seq. of Title 42, The Public Health and Welfare, transferred to Administrator of Environmental Protection Agency by Reorg. Plan No. 3 of 1970, §2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086, set out in the Appendix to Title 5, Government Organization and Employees.

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.

§346a. Tolerances and exemptions for pesticide chemical residues

(a) Requirement for tolerance or exemption

(1) General rule

Except as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed unsafe for the purpose of section 342(a)(2)(B) of this title unless—

(A) a tolerance for such pesticide chemical residue in or on such food is in effect under this section and the quantity of the residue is within the limits of the tolerance; or

(B) an exemption from the requirement of a tolerance is in effect under this section for the pesticide chemical residue.

For the purposes of this section, the term "food", when used as a noun without modification, shall mean a raw agricultural commodity or processed food.

(2) Processed food

Notwithstanding paragraph (1)—

(A) if a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a pesticide chemical residue that is present in or on a processed food because the food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title despite the lack of a tolerance for the pesticide chemical residue in or on the processed food if the pesticide chemical has been used in or on the raw agricultural commodity in conformity with a tolerance under this section, such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concentration of the pesticide chemical residue in the processed food is not greater than the tolerance prescribed for the pesticide chemical residue in the raw agricultural commodity; or

(B) if an exemption for the requirement for a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a pesticide chemical residue that is present in or on a processed food because the food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title.

(3) Residues of degradation products

If a pesticide chemical residue is present in or on a food because it is a metabolite or other degradation product of a precursor substance that itself is a pesticide chemical or pesticide chemical residue, such a residue shall not be considered to be unsafe within the meaning of section 342(a)(2)(B) of this title despite the lack of a tolerance or exemption from the need for a tolerance for such residue in or on such food if—

(A) the Administrator has not determined that the degradation product is likely to pose any potential health risk from dietary exposure that is of a different type than, or of a greater significance than, any risk posed by dietary exposure to the precursor substance;

(B) either—

(i) a tolerance is in effect under this section for residues of the precursor substance in or on the food, and the combined level of residues of the degradation product and the precursor substance in or on the food is at or below the stoichiometrically equivalent level that would be permitted by the tolerance if the residue consisted only of the precursor substance rather than the degradation product; or

(ii) an exemption from the need for a tolerance is in effect under this section for residues of the precursor substance in or on the food; and

(C) the tolerance or exemption for residues of the precursor substance does not state that it applies only to particular named substances and does not state that it does not apply to residues of the degradation product.

(4) Effect of tolerance or exemption

While a tolerance or exemption from the requirement for a tolerance is in effect under this section for a pesticide chemical residue with respect to any food, the food shall not by reason of bearing or containing any amount of such a residue be considered to be adulterated within the meaning of section 342(a)(1) of this title.

(b) Authority and standard for tolerance

(1) Authority

The Administrator may issue regulations establishing, modifying, or revoking a tolerance for a pesticide chemical residue in or on a food—

(A) in response to a petition filed under subsection (d); or

(B) on the Administrator's own initiative under subsection (e).

As used in this section, the term "modify" shall not mean expanding the tolerance to cover additional foods.

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or leave in effect a tolerance for a pesticide chemical residue in or on a food only if the Administrator determines that the tolerance is safe. The Administrator shall modify or revoke a tolerance if the Administrator determines it is not safe.

(ii) Determination of safety

As used in this section, the term "safe", with respect to a tolerance for a pesticide chemical residue, means that the Administrator has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.

(iii) Rule of construction

With respect to a tolerance, a pesticide chemical residue meeting the standard under clause (i) is not an eligible pesticide chemical residue for purposes of subparagraph (B).

(B) Tolerances for eligible pesticide chemical residues

(i) Definition

As used in this subparagraph, the term "eligible pesticide chemical residue" means a pesticide chemical residue as to which—

(I) the Administrator is not able to identify a level of exposure to the residue at which the residue will not cause or contribute to a known or anticipated harm to human health (referred to in this section as a "nonthreshold effect");

(II) the lifetime risk of experiencing the nonthreshold effect is appropriately assessed by quantitative risk assessment; and

(III) with regard to any known or anticipated harm to human health for which the Administrator is able to identify a level at which the residue will not cause such harm (referred to in this section as a "threshold effect"), the Administrator determines that the level of aggregate exposure is safe.

(ii) Determination of tolerance

Notwithstanding subparagraph (A)(i), a tolerance for an eligible pesticide chemical residue may be left in effect or modified under this subparagraph if—

(I) at least one of the conditions described in clause (iii) is met; and

(II) both of the conditions described in clause (iv) are met.

(iii) Conditions regarding use

For purposes of clause (ii), the conditions described in this clause with respect to a tolerance for an eligible pesticide chemical residue are the following:

(I) Use of the pesticide chemical that produces the residue protects consumers from adverse effects on health that would pose a greater risk than the dietary risk from the residue.

(II) Use of the pesticide chemical that produces the residue is necessary to avoid a significant disruption in domestic production of an adequate, wholesome, and economical food supply.

(iv) Conditions regarding risk

For purposes of clause (ii), the conditions described in this clause with respect to a tolerance for an eligible pesticide chemical residue are the following:

(I) The yearly risk associated with the nonthreshold effect from aggregate exposure to the residue does not exceed 10 times the yearly risk that would be allowed under subparagraph (A) for such effect.

(II) The tolerance is limited so as to ensure that the risk over a lifetime associated with the nonthreshold effect from aggregate exposure to the residue is not greater than twice the lifetime risk that would be allowed under subparagraph (A) for such effect.

(v) Review

Five years after the date on which the Administrator makes a determination to leave in effect or modify a tolerance under this subparagraph, and thereafter as the Administrator deems appropriate, the Administrator shall determine, after notice and opportunity for comment, whether it has been demonstrated to the Administrator that a condition described in clause (iii)(I) or clause (iii)(II) continues to exist with respect to the tolerance and that the yearly and lifetime risks from aggregate exposure to such residue continue to comply with the limits specified in clause (iv). If the Administrator determines by such date that such demonstration has not been made, the Administrator shall, not later than 180 days after the date of such determination, issue a regulation under subsection (e)(1) to modify or revoke the tolerance.

(vi) Infants and children

Any tolerance under this subparagraph shall meet the requirements of subparagraph (C).

(C) Exposure of infants and children

In establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, the Administrator—

(i) shall assess the risk of the pesticide chemical residue based on—

(I) available information about consumption patterns among infants and children that are likely to result in disproportionately high consumption of foods containing or bearing such residue among infants and children in comparison to the general population;

(II) available information concerning the special susceptibility of infants and children to the pesticide chemical residues, including neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals; and

(III) available information concerning the cumulative effects on infants and children of such residues and other substances that have a common mechanism of toxicity; and

(ii) shall—

(I) ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue; and

(II) publish a specific determination regarding the safety of the pesticide chemical residue for infants and children.

The Secretary of Health and Human Services and the Secretary of Agriculture, in consultation with the Administrator, shall conduct surveys to document dietary exposure to pesticides among infants and children. In the case of threshold effects, for purposes of clause (ii)(I) an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children. Notwithstanding such requirement for an additional margin of safety, the Administrator may use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.

(D) Factors

In establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, the Administrator shall consider, among other relevant factors—

(i) the validity, completeness, and reliability of the available data from studies of the pesticide chemical and pesticide chemical residue;

(ii) the nature of any toxic effect shown to be caused by the pesticide chemical or pesticide chemical residue in such studies;

(iii) available information concerning the relationship of the results of such studies to human risk;

(iv) available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups of consumers);

(v) available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity;

(vi) available information concerning the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances, including dietary exposure under the tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupational sources;

(vii) available information concerning the variability of the sensitivities of major identifiable subgroups of consumers;

(viii) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects; and

(ix) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.

(E) Data and information regarding anticipated and actual residue levels

(i) Authority

In establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide chemical residue, the Administrator may consider available data and information on the anticipated residue levels of the pesticide chemical in or on food and the actual residue levels of the pesticide chemical that have been measured in food, including residue data collected by the Food and Drug Administration.

(ii) Requirement

If the Administrator relies on anticipated or actual residue levels in establishing, modifying, or leaving in effect a tolerance, the Administrator shall pursuant to subsection (f)(1) require that data be provided five years after the date on which the tolerance is established, modified, or left in effect, and thereafter as the Administrator deems appropriate, demonstrating that such residue levels are not above the levels so relied on. If such data are not so provided, or if the data do not demonstrate that the residue levels are not above the levels so relied on, the Administrator shall, not later than 180 days after the date on which the data were required to be provided, issue a regulation under subsection (e)(1), or an order under subsection (f)(2), as appropriate, to modify or revoke the tolerance.

(F) Percent of food actually treated

In establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide chemical residue, the Administrator may, when assessing chronic dietary risk, consider available data and information on the percent of food actually treated with the pesticide chemical (including aggregate pesticide use data collected by the Department of Agriculture) only if the Administrator—

(i) finds that the data are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide chemical residue;

(ii) finds that the exposure estimate does not understate exposure for any significant subpopulation group;

(iii) finds that, if data are available on pesticide use and consumption of food in a particular area, the population in such area is not dietarily exposed to residues above those estimated by the Administrator; and

(iv) provides for the periodic reevaluation of the estimate of anticipated dietary exposure.

(3) Detection methods

(A) General rule

A tolerance for a pesticide chemical residue in or on a food shall not be established or modified by the Administrator unless the Administrator determines, after consultation with the Secretary, that there is a practical method for detecting and measuring the levels of the pesticide chemical residue in or on the food.

(B) Detection limit

A tolerance for a pesticide chemical residue in or on a food shall not be established at or modified to a level lower than the limit of detection of the method for detecting and measuring the pesticide chemical residue specified by the Administrator under subparagraph (A).

(4) International standards

In establishing a tolerance for a pesticide chemical residue in or on a food, the Administrator shall determine whether a maximum residue level for the pesticide chemical has been established by the Codex Alimentarius Commission. If a Codex maximum residue level has been established for the pesticide chemical and the Administrator does not propose to adopt the Codex level, the Administrator shall publish for public comment a notice explaining the reasons for departing from the Codex level.

(c) Authority and standard for exemptions

(1) Authority

The Administrator may issue a regulation establishing, modifying, or revoking an exemption from the requirement for a tolerance for a pesticide chemical residue in or on food—

(A) in response to a petition filed under subsection (d); or

(B) on the Administrator's initiative under subsection (e).

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or leave in effect an exemption from the requirement for a tolerance for a pesticide chemical residue in or on food only if the Administrator determines that the exemption is safe. The Administrator shall modify or revoke an exemption if the Administrator determines it is not safe.

(ii) Determination of safety

The term "safe", with respect to an exemption for a pesticide chemical residue, means that the Administrator has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.

(B) Factors

In making a determination under this paragraph, the Administrator shall take into account, among other relevant considerations, the considerations set forth in subparagraphs (C) and (D) of subsection (b)(2).

(3) Limitation

An exemption from the requirement for a tolerance for a pesticide chemical residue in or on food shall not be established or modified by the Administrator unless the Administrator determines, after consultation with the Secretary—

(A) that there is a practical method for detecting and measuring the levels of such pesticide chemical residue in or on food; or

(B) that there is no need for such a method, and states the reasons for such determination in issuing the regulation establishing or modifying the exemption.

(d) Petition for tolerance or exemption

(1) Petitions and petitioners

Any person may file with the Administrator a petition proposing the issuance of a regulation—

(A) establishing, modifying, or revoking a tolerance for a pesticide chemical residue in or on a food; or

(B) establishing, modifying, or revoking an exemption from the requirement of a tolerance for such a residue.

(2) Petition contents

(A) Establishment

A petition under paragraph (1) to establish a tolerance or exemption for a pesticide chemical residue shall be supported by such data and information as are specified in regulations issued by the Administrator, including—

(i)(I) an informative summary of the petition and of the data, information, and arguments submitted or cited in support of the petition; and

(II) a statement that the petitioner agrees that such summary or any information it contains may be published as a part of the notice of filing of the petition to be published under this subsection and as part of a proposed or final regulation issued under this section;

(ii) the name, chemical identity, and composition of the pesticide chemical residue and of the pesticide chemical that produces the residue;

(iii) data showing the recommended amount, frequency, method, and time of application of that pesticide chemical;

(iv) full reports of tests and investigations made with respect to the safety of the pesticide chemical, including full information as to the methods and controls used in conducting those tests and investigations;

(v) full reports of tests and investigations made with respect to the nature and amount of the pesticide chemical residue that is likely to remain in or on the food, including a description of the analytical methods used;

(vi) a practical method for detecting and measuring the levels of the pesticide chemical residue in or on the food, or for exemptions, a statement why such a method is not needed;

(vii) a proposed tolerance for the pesticide chemical residue, if a tolerance is proposed;

(viii) if the petition relates to a tolerance for a processed food, reports of investigations conducted using the processing method(s) used to produce that food;

(ix) such information as the Administrator may require to make the determination under subsection (b)(2)(C);

(x) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects;

(xi) information regarding exposure to the pesticide chemical residue due to any tolerance or exemption already granted for such residue;

(xii) practical methods for removing any amount of the residue that would exceed any proposed tolerance; and

(xiii) such other data and information as the Administrator requires by regulation to support the petition.

If information or data required by this subparagraph is available to the Administrator, the person submitting the petition may cite the availability of the information or data in lieu of submitting it. The Administrator may require a petition to be accompanied by samples of the pesticide chemical with respect to which the petition is filed.

(B) Modification or revocation

The Administrator may by regulation establish the requirements for information and data to support a petition to modify or revoke a tolerance or to modify or revoke an exemption from the requirement for a tolerance.

(3) Notice

A notice of the filing of a petition that the Administrator determines has met the requirements of paragraph (2) shall be published by the Administrator within 30 days after such determination. The notice shall announce the availability of a description of the analytical methods available to the Administrator for the detection and measurement of the pesticide chemical residue with respect to which the petition is filed or shall set forth the petitioner's statement of why such a method is not needed. The notice shall include the summary required by paragraph (2)(A)(i)(I).

(4) Actions by the Administrator

(A) In general

The Administrator shall, after giving due consideration to a petition filed under paragraph (1) and any other information available to the Administrator—

(i) issue a final regulation (which may vary from that sought by the petition) establishing, modifying, or revoking a tolerance for the pesticide chemical residue or an exemption of the pesticide chemical residue from the requirement of a tolerance (which final regulation shall be issued without further notice and without further period for public comment);

(ii) issue a proposed regulation under subsection (e), and thereafter issue a final regulation under such subsection; or

(iii) issue an order denying the petition.

(B) Priorities

The Administrator shall give priority to petitions for the establishment or modification of a tolerance or exemption for a pesticide chemical residue that appears to pose a significantly lower risk to human health from dietary exposure than pesticide chemical residues that have tolerances in effect for the same or similar uses.

(C) Expedited review of certain petitions

(i) Date certain for review

If a person files a complete petition with the Administrator proposing the issuance of a regulation establishing a tolerance or exemption for a pesticide chemical residue that presents a lower risk to human health than a pesticide chemical residue for which a tolerance has been left in effect or modified under subsection (b)(2)(B), the Administrator shall complete action on such petition under this paragraph within 1 year.

(ii) Required determinations

If the Administrator issues a final regulation establishing a tolerance or exemption for a safer pesticide chemical residue under clause (i), the Administrator shall, not later than 180 days after the date on which the regulation is issued, determine whether a condition described in subclause (I) or (II) of subsection (b)(2)(B)(iii) continues to exist with respect to a tolerance that has been left in effect or modified under subsection (b)(2)(B). If such condition does not continue to exist, the Administrator shall, not later than 180 days after the date on which the determination under the preceding sentence is made, issue a regulation under subsection (e)(1) to modify or revoke the tolerance.

(e) Action on Administrator's own initiative

(1) General rule

The Administrator may issue a regulation—

(A) establishing, modifying, suspending under subsection (l)(3), or revoking a tolerance for a pesticide chemical or a pesticide chemical residue;

(B) establishing, modifying, suspending under subsection (l)(3), or revoking an exemption of a pesticide chemical residue from the requirement of a tolerance; or

(C) establishing general procedures and requirements to implement this section.

(2) Notice

Before issuing a final regulation under paragraph (1), the Administrator shall issue a notice of proposed rulemaking and provide a period of not less than 60 days for public comment on the proposed regulation, except that a shorter period for comment may be provided if the Administrator for good cause finds that it would be in the public interest to do so and states the reasons for the finding in the notice of proposed rulemaking.

(f) Special data requirements

(1) Requiring submission of additional data

If the Administrator determines that additional data or information are reasonably required to support the continuation of a tolerance or exemption that is in effect under this section for a pesticide chemical residue on a food, the Administrator shall—

(A) issue a notice requiring the person holding the pesticide registrations associated with such tolerance or exemption to submit the data or information under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(2)(B)];

(B) issue a rule requiring that testing be conducted on a substance or mixture under section 4 of the Toxic Substances Control Act [15 U.S.C. 2603]; or

(C) publish in the Federal Register, after first providing notice and an opportunity for comment of not less than 60 days' duration, an order—

(i) requiring the submission to the Administrator by one or more interested persons of a notice identifying the person or persons who will submit the required data and information;

(ii) describing the type of data and information required to be submitted to the Administrator and stating why the data and information could not be obtained under the authority of section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or section 4 of the Toxic Substances Control Act [15 U.S.C. 2603];

(iii) describing the reports of the Administrator required to be prepared during and after the collection of the data and information;

(iv) requiring the submission to the Administrator of the data, information, and reports referred to in clauses (ii) and (iii); and

(v) establishing dates by which the submissions described in clauses (i) and (iv) must be made.

The Administrator may under subparagraph (C) revise any such order to correct an error. The Administrator may under this paragraph require data or information pertaining to whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.

(2) Noncompliance

If a submission required by a notice issued in accordance with paragraph (1)(A), a rule issued under paragraph (1)(B), or an order issued under paragraph (1)(C) is not made by the time specified in such notice, rule, or order, the Administrator may by order published in the Federal Register modify or revoke the tolerance or exemption in question. In any review of such an order under subsection (g)(2), the only material issue shall be whether a submission required under paragraph (1) was not made by the time specified.

(g) Effective date, objections, hearings, and administrative review

(1) Effective date

A regulation or order issued under subsection (d)(4), (e)(1), or (f)(2) shall take effect upon publication unless the regulation or order specifies otherwise. The Administrator may stay the effectiveness of the regulation or order if, after issuance of such regulation or order, objections are filed with respect to such regulation or order pursuant to paragraph (2).

(2) Further proceedings

(A) Objections

Within 60 days after a regulation or order is issued under subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C), any person may file objections thereto with the Administrator, specifying with particularity the provisions of the regulation or order deemed objectionable and stating reasonable grounds therefor. If the regulation or order was issued in response to a petition under subsection (d)(1), a copy of each objection filed by a person other than the petitioner shall be served by the Administrator on the petitioner.

(B) Hearing

An objection may include a request for a public evidentiary hearing upon the objection. The Administrator shall, upon the initiative of the Administrator or upon the request of an interested person and after due notice, hold a public evidentiary hearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections. The presiding officer in such a hearing may authorize a party to obtain discovery from other persons and may upon a showing of good cause made by a party issue a subpoena to compel testimony or production of documents from any person. The presiding officer shall be governed by the Federal Rules of Civil Procedure in making any order for the protection of the witness or the content of documents produced and shall order the payment of reasonable fees and expenses as a condition to requiring testimony of the witness. On contest, such a subpoena may be enforced by a Federal district court.

(C) Final decision

As soon as practicable after receiving the arguments of the parties, the Administrator shall issue an order stating the action taken upon each such objection and setting forth any revision to the regulation or prior order that the Administrator has found to be warranted. If a hearing was held under subparagraph (B), such order and any revision to the regulation or prior order shall, with respect to questions of fact at issue in the hearing, be based only on substantial evidence of record at such hearing, and shall set forth in detail the findings of facts and the conclusions of law or policy upon which the order or regulation is based.

(h) Judicial review

(1) Petition

In a case of actual controversy as to the validity of any regulation issued under subsection (e)(1)(C), or any order issued under subsection (f)(1)(C) or (g)(2)(C), or any regulation that is the subject of such an order, any person who will be adversely affected by such order or regulation may obtain judicial review by filing in the United States Court of Appeals for the circuit wherein that person resides or has its principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within 60 days after publication of such order or regulation, a petition praying that the order or regulation be set aside in whole or in part.

(2) Record and jurisdiction

A copy of the petition under paragraph (1) shall be forthwith transmitted by the clerk of the court to the Administrator, or any officer designated by the Administrator for that purpose, and thereupon the Administrator shall file in the court the record of the proceedings on which the Administrator based the order or regulation, as provided in section 2112 of title 28. Upon the filing of such a petition, the court shall have exclusive jurisdiction to affirm or set aside the order or regulation complained of in whole or in part. As to orders issued following a public evidentiary hearing, the findings of the Administrator with respect to questions of fact shall be sustained only if supported by substantial evidence when considered on the record as a whole.

(3) Additional evidence

If a party applies to the court for leave to adduce additional evidence and shows to the satisfaction of the court that the additional evidence is material and that there were reasonable grounds for the failure to adduce the evidence in the proceeding before the Administrator, the court may order that the additional evidence (and evidence in rebuttal thereof) shall be taken before the Administrator in the manner and upon the terms and conditions the court deems proper. The Administrator may modify prior findings as to the facts by reason of the additional evidence so taken and may modify the order or regulation accordingly. The Administrator shall file with the court any such modified finding, order, or regulation.

(4) Final judgment; Supreme Court review

The judgment of the court affirming or setting aside, in whole or in part, any regulation or any order and any regulation which is the subject of such an order shall be final, subject to review by the Supreme Court of the United States as provided in section 1254 of title 28. The commencement of proceedings under this subsection shall not, unless specifically ordered by the court to the contrary, operate as a stay of a regulation or order.

(5) Application

Any issue as to which review is or was obtainable under this subsection shall not be the subject of judicial review under any other provision of law.

(i) Confidentiality and use of data

(1) General rule

Data and information that are or have been submitted to the Administrator under this section or section 348 of this title in support of a tolerance or an exemption from a tolerance shall be entitled to confidential treatment for reasons of business confidentiality and to exclusive use and data compensation to the same extent provided by sections 3 and 10 of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a, 136h].

(2) Exceptions

(A) In general

Data and information that are entitled to confidential treatment under paragraph (1) may be disclosed, under such security requirements as the Administrator may provide by regulation, to—

(i) employees of the United States authorized by the Administrator to examine such data and information in the carrying out of their official duties under this chapter or other Federal statutes intended to protect the public health; or

(ii) contractors with the United States authorized by the Administrator to examine such data and information in the carrying out of contracts under this chapter or such statutes.

(B) Congress

This subsection does not authorize the withholding of data or information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee.

(3) Summaries

Notwithstanding any provision of this subsection or other law, the Administrator may publish the informative summary required by subsection (d)(2)(A)(i) and may, in issuing a proposed or final regulation or order under this section, publish an informative summary of the data relating to the regulation or order.

(j) Status of previously issued regulations

(1) Regulations under section 346

Regulations affecting pesticide chemical residues in or on raw agricultural commodities promulgated, in accordance with section 371(e) of this title, under the authority of section 346(a) ¹ of this title upon the basis of public hearings instituted before January 1, 1953, shall be deemed to be regulations issued under this section and shall be subject to modification or revocation under subsections (d) and (e), and shall be subject to review under subsection (q).

(2) Regulations under section 348

Regulations that established tolerances for substances that are pesticide chemical residues in or on processed food, or that otherwise stated the conditions under which such pesticide chemicals could be safely used, and that were issued under section 348 of this title on or before August 3, 1996, shall be deemed to be regulations issued under this section and shall be subject to modification or revocation under subsection (d) or (e), and shall be subject to review under subsection (q).

(3) Regulations under section 346a

Regulations that established tolerances or exemptions under this section that were issued on or before August 3, 1996, shall remain in effect unless modified or revoked under subsection (d) or (e), and shall be subject to review under subsection (q).

(4) Certain substances

With respect to a substance that is not included in the definition of the term "pesticide chemical" under section 321(q)(1) of this title but was so included on the day before October 30, 1998, the following applies as of October 30, 1998:

(A) Notwithstanding paragraph (2), any regulation applying to the use of the substance that was in effect on the day before October 30, 1998, and was on such day deemed in such paragraph to have been issued under this section, shall be considered to have been issued under section 348 of this title.

(B) Notwithstanding paragraph (3), any regulation applying to the use of the substance that was in effect on such day and was issued under this section (including any such regulation issued before August 3, 1996) is deemed to have been issued under section 348 of this title.

(k) Transitional provision

If, on the day before August 3, 1996, a substance that is a pesticide chemical was, with respect to a particular pesticidal use of the substance and any resulting pesticide chemical residue in or on a particular food—

(1) regarded by the Administrator or the Secretary as generally recognized as safe for use within the meaning of the provisions of subsection (a) or section 321(s) of this title as then in effect; or

(2) regarded by the Secretary as a substance described by section 321(s)(4) of this title;

such a pesticide chemical residue shall be regarded as exempt from the requirement for a tolerance, as of August 3, 1996. The Administrator shall by regulation indicate which substances are described by this subsection. Any exemption under this subsection may be modified or revoked as if it had been issued under subsection (c).

(l) Harmonization with action under other laws

(1) Coordination with FIFRA

To the extent practicable and consistent with the review deadlines in subsection (q), in issuing a final rule under this subsection that suspends or revokes a tolerance or exemption for a pesticide chemical residue in or on food, the Administrator shall coordinate such action with any related necessary action under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.].

(2) Revocation of tolerance or exemption following cancellation of associated registrations

If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide Act, cancels the registration of each pesticide that contains a particular pesticide chemical and that is labeled for use on a particular food, or requires that the registration of each such pesticide be modified to prohibit its use in connection with the production, storage, or transportation of such food, due in whole or in part to dietary risks to humans posed by residues of that pesticide chemical on that food, the Administrator shall revoke any tolerance or exemption that allows the presence of the pesticide chemical, or any pesticide chemical residue that results from its use, in or on that food. Subsection (e) shall apply to actions taken under this paragraph. A revocation under this paragraph shall become effective not later than 180 days after—

(A) the date by which each such cancellation of a registration has become effective; or

(B) the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever is later.

(3) Suspension of tolerance or exemption following suspension of associated registrations

(A) Suspension

If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide Act, suspends the use of each registered pesticide that contains a particular pesticide chemical and that is labeled for use on a particular food, due in whole or in part to dietary risks to humans posed by residues of that pesticide chemical on that food, the Administrator shall suspend any tolerance or exemption that allows the presence of the pesticide chemical, or any pesticide chemical residue that results from its use, in or on that food. Subsection (e) shall apply to actions taken under this paragraph. A suspension under this paragraph shall become effective not later than 60 days after the date by which each such suspension of use has become effective.

(B) Effect of suspension

The suspension of a tolerance or exemption under subparagraph (A) shall be effective as long as the use of each associated registration of a pesticide is suspended under the Federal Insecticide, Fungicide, and Rodenticide Act. While a suspension of a tolerance or exemption is effective the tolerance or exemption shall not be considered to be in effect. If the suspension of use of the pesticide under that Act is terminated, leaving the registration of the pesticide for such use in effect under that Act, the Administrator shall rescind any associated suspension of tolerance or exemption.

(4) Tolerances for unavoidable residues

In connection with action taken under paragraph (2) or (3), or with respect to pesticides whose registrations were suspended or canceled prior to August 3, 1996, under the Federal Insecticide, Fungicide, and Rodenticide Act, if the Administrator determines that a residue of the canceled or suspended pesticide chemical will unavoidably persist in the environment and thereby be present in or on a food, the Administrator may establish a tolerance for the pesticide chemical residue. In establishing such a tolerance, the Administrator shall take into account both the factors set forth in subsection (b)(2) and the unavoidability of the residue. Subsection (e) shall apply to the establishment of such tolerance. The Administrator shall review any such tolerance periodically and modify it as necessary so that it allows no greater level of the pesticide chemical residue than is unavoidable.

(5) Pesticide residues resulting from lawful application of pesticide

Notwithstanding any other provision of this chapter, if a tolerance or exemption for a pesticide chemical residue in or on a food has been revoked, suspended, or modified under this section, an article of that food shall not be deemed unsafe solely because of the presence of such pesticide chemical residue in or on such food if it is shown to the satisfaction of the Secretary that—

(A) the residue is present as the result of an application or use of a pesticide at a time and in a manner that was lawful under the Federal Insecticide, Fungicide, and Rodenticide Act; and

(B) the residue does not exceed a level that was authorized at the time of that application or use to be present on the food under a tolerance, exemption, food additive regulation, or other sanction then in effect under this chapter;

unless, in the case of any tolerance or exemption revoked, suspended, or modified under this subsection or subsection (d) or (e), the Administrator has issued a determination that consumption of the legally treated food during the period of its likely availability in commerce will pose an unreasonable dietary risk.

(6) Tolerance for use of pesticides under an emergency exemption

If the Administrator grants an exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136p) for a pesticide chemical, the Administrator shall establish a tolerance or exemption from the requirement for a tolerance for the pesticide chemical residue. Such a tolerance or exemption from a tolerance shall have an expiration date. The Administrator may establish such a tolerance or exemption without providing notice or a period for comment on the tolerance or exemption. The Administrator shall promulgate regulations within 365 days after August 3, 1996, governing the establishment of tolerances and exemptions under this paragraph. Such regulations shall be consistent with the safety standard under subsections (b)(2) and (c)(2) and with section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act.

(m) Fees

(1) Amount

The Administrator shall by regulation require the payment of such fees as will in the aggregate, in the judgment of the Administrator, be sufficient over a reasonable term to provide, equip, and maintain an adequate service for the performance of the Administrator's functions under this section. Under the regulations, the performance of the Administrator's services or other functions under this section, including—

(A) the acceptance for filing of a petition submitted under subsection (d);

(B) establishing, modifying, leaving in effect, or revoking a tolerance or establishing, modifying, leaving in effect, or revoking an exemption from the requirement for a tolerance under this section;

(C) the acceptance for filing of objections under subsection (g); or

(D) the certification and filing in court of a transcript of the proceedings and the record under subsection (h);

may be conditioned upon the payment of such fees. The regulations may further provide for waiver or refund of fees in whole or in part when in the judgment of the Administrator such a waiver or refund is equitable and not contrary to the purposes of this subsection.

(2) Deposit

All fees collected under paragraph (1) shall be deposited in the Reregistration and Expedited Processing Fund created by section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a–1(k)]. Such fees shall be available to the Administrator, without fiscal year limitation, for the performance of the Administrator's services or functions as specified in paragraph (1).

(3) Prohibition

During the period beginning on December 29, 2022, and ending on September 30, 2027, the Administrator shall not collect any tolerance fees under paragraph (1).

(n) National uniformity of tolerances

(1) "Qualifying pesticide chemical residue" defined

For purposes of this subsection, the term "qualifying pesticide chemical residue" means a pesticide chemical residue resulting from the use, in production, processing, or storage of a food, of a pesticide chemical that is an active ingredient and that—

(A) was first approved for such use in a registration of a pesticide issued under section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(5)] on or after April 25, 1985, on the basis of data determined by the Administrator to meet all applicable requirements for data prescribed by regulations in effect under that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or

(B) was approved for such use in a reregistration eligibility determination issued under section 4(g) of that Act [7 U.S.C. 136a–1(g)] on or after August 3, 1996.

(2) "Qualifying Federal determination" defined

For purposes of this subsection, the term "qualifying Federal determination" means a tolerance or exemption from the requirement for a tolerance for a qualifying pesticide chemical residue that—

(A) is issued under this section after August 3, 1996, and determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an exemption); or

(B)(i) pursuant to subsection (j) is remaining in effect or is deemed to have been issued under this section, or is regarded under subsection (k) as exempt from the requirement for a tolerance; and

(ii) is determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an exemption).

(3) Limitation

The Administrator may make the determination described in paragraph (2)(B)(ii) only by issuing a rule in accordance with the procedure set forth in subsection (d) or (e) and only if the Administrator issues a proposed rule and allows a period of not less than 30 days for comment on the proposed rule. Any such rule shall be reviewable in accordance with subsections (g) and (h).

(4) State authority

Except as provided in paragraphs (5), (6), and (8) no State or political subdivision may establish or enforce any regulatory limit on a qualifying pesticide chemical residue in or on any food if a qualifying Federal determination applies to the presence of such pesticide chemical residue in or on such food, unless such State regulatory limit is identical to such qualifying Federal determination. A State or political subdivision shall be deemed to establish or enforce a regulatory limit on a pesticide chemical residue in or on a food if it purports to prohibit or penalize the production, processing, shipping, or other handling of a food because it contains a pesticide residue (in excess of a prescribed limit).

(5) Petition procedure

(A) In general

Any State may petition the Administrator for authorization to establish in such State a regulatory limit on a qualifying pesticide chemical residue in or on any food that is not identical to the qualifying Federal determination applicable to such qualifying pesticide chemical residue.

(B) Petition requirements

Any petition under subparagraph (A) shall—

(i) satisfy any requirements prescribed, by rule, by the Administrator; and

(ii) be supported by scientific data about the pesticide chemical residue that is the subject of the petition or about chemically related pesticide chemical residues, data on the consumption within such State of food bearing the pesticide chemical residue, and data on exposure of humans within such State to the pesticide chemical residue.

(C) Authorization

The Administrator may, by order, grant the authorization described in subparagraph (A) if the Administrator determines that the proposed State regulatory limit—

(i) is justified by compelling local conditions; and

(ii) would not cause any food to be a violation of Federal law.

(D) Treatment

In lieu of any action authorized under subparagraph (C), the Administrator may treat a petition under this paragraph as a petition under subsection (d) to modify or revoke a tolerance or an exemption. If the Administrator determines to treat a petition under this paragraph as a petition under subsection (d), the Administrator shall thereafter act on the petition pursuant to subsection (d).

(E) Review

Any order of the Administrator granting or denying the authorization described in subparagraph (A) shall be subject to review in the manner described in subsections (g) and (h).

(6) Urgent petition procedure

Any State petition to the Administrator pursuant to paragraph (5) that demonstrates that consumption of a food containing such pesticide residue level during the period of the food's likely availability in the State will pose a significant public health threat from acute exposure shall be considered an urgent petition. If an order by the Administrator to grant or deny the requested authorization in an urgent petition is not made within 30 days of receipt of the petition, the petitioning State may establish and enforce a temporary regulatory limit on a qualifying pesticide chemical residue in or on the food. The temporary regulatory limit shall be validated or terminated by the Administrator's final order on the petition.

(7) Residues from lawful application

No State or political subdivision may enforce any regulatory limit on the level of a pesticide chemical residue that may appear in or on any food if, at the time of the application of the pesticide that resulted in such residue, the sale of such food with such residue level was lawful under this section and under the law of such State, unless the State demonstrates that consumption of the food containing such pesticide residue level during the period of the food's likely availability in the State will pose an unreasonable dietary risk to the health of persons within such State.

(8) Savings

Nothing in this chapter preempts the authority of any State or political subdivision to require that a food containing a pesticide chemical residue bear or be the subject of a warning or other statement relating to the presence of the pesticide chemical residue in or on such food.

(o) Consumer right to know

Not later than 2 years after August 3, 1996, and annually thereafter, the Administrator shall, in consultation with the Secretary of Agriculture and the Secretary of Health and Human Services, publish in a format understandable to a lay person, and distribute to large retail grocers for public display (in a manner determined by the grocer), the following information, at a minimum:

(1) A discussion of the risks and benefits of pesticide chemical residues in or on food purchased by consumers.

(2) A listing of actions taken under subparagraph (B) of subsection (b)(2) that may result in pesticide chemical residues in or on food that present a yearly or lifetime risk above the risk allowed under subparagraph (A) of such subsection, and the food on which the pesticide chemicals producing the residues are used.

(3) Recommendations to consumers for reducing dietary exposure to pesticide chemical residues in a manner consistent with maintaining a healthy diet, including a list of food that may reasonably substitute for food listed under paragraph (2).

Nothing in this subsection shall prevent retail grocers from providing additional information.

(p) Estrogenic substances screening program

(1) Development

Not later than 2 years after August 3, 1996, the Administrator shall in consultation with the Secretary of Health and Human Services develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.

(2) Implementation

Not later than 3 years after August 3, 1996, after obtaining public comment and review of the screening program described in paragraph (1) by the scientific advisory panel established under section 25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136w(d)] or the science advisory board established by section 4365 ¹ of title 42, the Administrator shall implement the program.

(3) Substances

In carrying out the screening program described in paragraph (1), the Administrator—

(A) shall provide for the testing of all pesticide chemicals; and

(B) may provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such substance.

(4) Exemption

Notwithstanding paragraph (3), the Administrator may, by order, exempt from the requirements of this section a biologic substance or other substance if the Administrator determines that the substance is anticipated not to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.

(5) Collection of information

(A) In general

The Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing in accordance with the screening program described in paragraph (1), and submit information obtained from the testing to the Administrator, within a reasonable time period that the Administrator determines is sufficient for the generation of the information.

(B) Procedures

To the extent practicable the Administrator shall minimize duplicative testing of the same substance for the same endocrine effect, develop, as appropriate, procedures for fair and equitable sharing of test costs, and develop, as necessary, procedures for handling of confidential business information.

(C) Failure of registrants to submit information

(i) Suspension

If a registrant of a substance referred to in paragraph (3)(A) fails to comply with an order under subparagraph (A) of this paragraph, the Administrator shall issue a notice of intent to suspend the sale or distribution of the substance by the registrant. Any suspension proposed under this paragraph shall become final at the end of the 30-day period beginning on the date that the registrant receives the notice of intent to suspend, unless during that period a person adversely affected by the notice requests a hearing or the Administrator determines that the registrant has complied fully with this paragraph.

(ii) Hearing

If a person requests a hearing under clause (i), the hearing shall be conducted in accordance with section 554 of title 5. The only matter for resolution at the hearing shall be whether the registrant has failed to comply with an order under subparagraph (A) of this paragraph. A decision by the Administrator after completion of a hearing shall be considered to be a final agency action.

(iii) Termination of suspensions

The Administrator shall terminate a suspension under this subparagraph issued with respect to a registrant if the Administrator determines that the registrant has complied fully with this paragraph.

(D) Noncompliance by other persons

Any person (other than a registrant) who fails to comply with an order under subparagraph (A) shall be liable for the same penalties and sanctions as are provided under section 16 of the Toxic Substances Control Act [15 U.S.C. 2615] in the case of a violation referred to in that section. Such penalties and sanctions shall be assessed and imposed in the same manner as provided in such section 16.

(6) Agency action

In the case of any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on humans, the Administrator shall, as appropriate, take action under such statutory authority as is available to the Administrator, including consideration under other sections of this chapter, as is necessary to ensure the protection of public health.

(7) Report to Congress

Not later than 4 years after August 3, 1996, the Administrator shall prepare and submit to Congress a report containing—

(A) the findings of the Administrator resulting from the screening program described in paragraph (1);

(B) recommendations for further testing needed to evaluate the impact on human health of the substances tested under the screening program; and

(C) recommendations for any further actions (including any action described in paragraph (6)) that the Administrator determines are appropriate based on the findings.

(q) Schedule for review

(1) In general

The Administrator shall review tolerances and exemptions for pesticide chemical residues in effect on the day before August 3, 1996, as expeditiously as practicable, assuring that—

(A) 33 percent of such tolerances and exemptions are reviewed within 3 years of August 3, 1996;

(B) 66 percent of such tolerances and exemptions are reviewed within 6 years of August 3, 1996; and

(C) 100 percent of such tolerances and exemptions are reviewed within 10 years of August 3, 1996.

In conducting a review of a tolerance or exemption, the Administrator shall determine whether the tolerance or exemption meets the requirements of subsections ² (b)(2) or (c)(2) and shall, by the deadline for the review of the tolerance or exemption, issue a regulation under subsection (d)(4) or (e)(1) to modify or revoke the tolerance or exemption if the tolerance or exemption does not meet such requirements.

(2) Priorities

In determining priorities for reviewing tolerances and exemptions under paragraph (1), the Administrator shall give priority to the review of the tolerances or exemptions that appear to pose the greatest risk to public health.

(3) Publication of schedule

Not later than 12 months after August 3, 1996, the Administrator shall publish a schedule for review of tolerances and exemptions established prior to August 3, 1996. The determination of priorities for the review of tolerances and exemptions pursuant to this subsection is not a rulemaking and shall not be subject to judicial review, except that failure to take final action pursuant to the schedule established by this paragraph shall be subject to judicial review.

(r) Temporary tolerance or exemption

The Administrator may, upon the request of any person who has obtained an experimental permit for a pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] or upon the Administrator's own initiative, establish a temporary tolerance or exemption for the pesticide chemical residue for the uses covered by the permit. Subsections (b)(2), (c)(2), (d), and (e) shall apply to actions taken under this subsection.

(s) Savings clause

Nothing in this section shall be construed to amend or modify the provisions of the Toxic Substances Control Act [15 U.S.C. 2601 et seq.] or the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.].

(June 25, 1938, ch. 675, §408, as added July 22, 1954, ch. 559, §3, 68 Stat. 511; amended Pub. L. 85–791, §20, Aug. 28, 1958, 72 Stat. 947; Pub. L. 91–515, title VI, §601(d)(1), Oct. 30, 1970, 84 Stat. 1311; Pub. L. 92–157, title III, §303(a), Nov. 18, 1971, 85 Stat. 464; Pub. L. 92–516, §3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 98–620, title IV, §402(25)(A), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102–571, title I, §107(7), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §3(k), Aug. 13, 1993, 107 Stat. 776; Pub. L. 104–170, title IV, §405, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 105–324, §2(b), Oct. 30, 1998, 112 Stat. 3036; Pub. L. 110–94, §4(d)(2), Oct. 9, 2007, 121 Stat. 1002; Pub. L. 112–177, §2(a)(3), Sept. 28, 2012, 126 Stat. 1329; Pub. L. 116–8, §2(c), Mar. 8, 2019, 133 Stat. 485; Pub. L. 117–328, div. HH, title VI, §703(b), Dec. 29, 2022, 136 Stat. 6002.)

Editorial Notes

References in Text

The Federal Rules of Civil Procedure, referred to in subsec. (g)(2)(B), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

Section 346 of this title, referred to in subsec. (j)(1), originally consisted of subsecs. (a) and (b). Subsec. (a) was redesignated as the entire section 346 and subsec. (b) was repealed by Pub. L. 86–618, title I, §103(a)(1), 74 Stat. 398.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.

Section 4365 of title 42, referred to in subsec. (p)(2), was in the original "section 8 of the Environmental Research, Development, and Demonstration Act of 1978", and was translated as meaning section 8 of the Environmental Research, Development, and Demonstration Authorization Act of 1978, to reflect the probable intent of Congress.

The Toxic Substances Control Act, referred to in subsec. (s), is Pub. L. 94–469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is classified generally to chapter 53 (§2601 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 2601 of Title 15 and Tables.

Codification

August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A), and (p)(1), (2), (7), was in the original references to the date of enactment of this subsection and the date of enactment of this section, which was translated as meaning the date of enactment of Pub. L. 104–170, which amended this section generally, to reflect the probable intent of Congress.

Amendments

2022—Subsec. (m)(3). Pub. L. 117–328 substituted "December 29, 2022, and ending on September 30, 2027" for "October 1, 2007, and ending on September 30, 2023".

2019—Subsec. (m)(3). Pub. L. 116–8 substituted "2023" for "2017".

2012—Subsec. (m)(3). Pub. L. 112–177 substituted "September 30, 2017" for "September 30, 2012".

2007—Subsec. (m)(3). Pub. L. 110–94 added par. (3).

1998—Subsec. (j)(4). Pub. L. 105–324 added par. (4).

1996—Pub. L. 104–170 amended section generally, substituting, in subsec. (a), provisions relating to requirement for tolerance or exemption for provisions relating to conditions for safety; in subsec. (b), provisions relating to authority and standard for tolerance for provisions relating to establishment of tolerances; in subsec. (c), provisions relating to authority and standard for exemptions for provisions relating to exemptions; in subsec. (d), provisions relating to petition for tolerance or exemption for provisions relating to regulations pursuant to petition, publication of notice, time for issuance, referral to advisory committees, effective date, and hearings; in subsec. (e), provisions relating to action on Administrator's own initiative for provisions relating to regulations pursuant to Administrator's proposals; in subsec. (f), provisions relating to special data requirements for provisions relating to data submitted as confidential; in subsec. (g), provisions relating to effective date, objections, hearings, and administrative review for provisions relating to advisory committees and their appointment, composition, compensation, and clerical assistance; in subsec. (h), provisions relating to judicial review for provisions relating to right of consultation; in subsec. (i), provisions relating to confidentiality and use of data for provisions relating to judicial review; in subsec. (j), provisions relating to status of previously issued regulations for provisions relating to temporary tolerances; in subsec. (k), provisions relating to transitions for provisions relating to regulations based on public hearings before January 1, 1953; in subsec. (l), provisions relating to harmonization with action under other laws for provisions relating to pesticides under Federal Insecticide, Fungicide, and Rodenticide Act, functions of Administrator of Environmental Protection Agency, certifications, hearings, time limitations, opinions, and regulations; in subsec. (m), provisions relating to fees for provisions relating to amendment of regulations; in subsec. (n), provisions relating to national uniformity of tolerances for provisions relating to guaranties; in subsec. (o), provisions relating to consumer right to know for provisions relating to payment of fees, services or functions conditioned on payment, and waiver or refund of fees; and adding subsecs. (p) to (s).

1993—Pub. L. 103–80, §3(k)(6), substituted "Administrator" for "Secretary" wherever appearing except when followed by "of Agriculture".

Subsec. (a)(1). Pub. L. 103–80, §3(k)(1), substituted "Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the 'Administrator')" for "Secretary of Health and Human Services".

Subsec. (d)(5). Pub. L. 103–80, §3(k)(2), substituted "section 556(c) of title 5" for "section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))".

Subsec. (l). Pub. L. 103–80, §3(k)(3), substituted "In the event" for "It the event" before "a hearing is requested".

Subsec. (n). Pub. L. 103–80, §3(k)(4), made technical amendment to reference to section 333(c) of this title to reflect amendment of corresponding provision of original act.

Subsec. (o). Pub. L. 103–80, §3(k)(5), which directed the substitution of "Administrator" for "Secretary of Health and Human Services" wherever appearing in the original text, was executed by making the substitution in the first sentence before "shall by regulation require", the only place "Secretary of Health and Human Services" appeared in the original text.

1992—Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102–300 substituted "Health and Human Services" for "Health, Education, and Welfare" wherever appearing in the original statutory text.

Subsec. (g). Pub. L. 102–571 substituted "379e" for "376".

1984—Subsec. (i)(5). Pub. L. 98–620 struck out provision that required the court to advance on the docket and expedite the disposition of all causes filed therein pursuant to this section.

1972—Subsecs. (d)(1), (e), (l). Pub. L. 92–516 substituted references to pesticide for references to economic poison wherever appearing therein.

1971—Subsec. (g). Pub. L. 92–157 struck out ", which the Secretary shall by rules and regulations prescribe," after "as compensation for their services a reasonable per diem" prior to amendment in 1970, by Pub. L. 91–515, which overlooked such language when amending subsec. (g) as provided in 1970 Amendment note.

1970—Subsec. (g). Pub. L. 91–515 substituted provisions authorizing members of an advisory committee to receive compensation and travel expenses in accordance with section 376(b)(5)(D) of this title, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent on committee work, and necessary traveling and subsistence expenses while serving away from their places of residence.

1958—Subsec. (i)(2). Pub. L. 85–791, §20(a), in first sentence, substituted "transmitted by the clerk of the court to the Secretary, or" for "served upon the Secretary, or upon", substituted "file in the court the record of the proceedings" for "certify and file in the court a transcript of the proceedings and the record", and inserted "as provided in section 2112 of title 28", and which, in second sentence, substituted "the filing of such petition" for "such filing".

Subsec. (i)(3). Pub. L. 85–791, §20(b), in first sentence, substituted "transmitted by the clerk of the court to the Secretary of Agriculture, or" for "served upon the Secretary of Agriculture, or upon", substituted "file in the court the record of the proceedings" for "certify and file in the court a transcript of the proceedings and the record", and inserted "as provided in section 2112 of title 28", and, in second sentence, substituted "the filing of such petition" for "such filing".

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–177 effective Oct. 1, 2012, see section 2(c) of Pub. L. 112–177, set out as a note under section 136a–1 of Title 7, Agriculture.

Effective Date of 2007 Amendment

Amendment by Pub. L. 110–94 effective Oct. 1, 2007, see section 6 of Pub. L. 110–94, set out as a note under section 136a of Title 7, Agriculture.

Effective Date of 1984 Amendment

Amendment by Pub. L. 98–620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Pub. L. 98–620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure.

Effective Date of 1972 Amendment

Amendment by Pub. L. 92–516 effective at close of Oct. 21, 1972, except if regulations are necessary for implementation of any provision that becomes effective on Oct. 21, 1972, and continuation in effect of subchapter I of chapter 6 of Title 7, Agriculture, and regulations thereunder, relating to control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92–516 and regulations thereunder, see section 4 of Pub. L. 92–516, set out as an Effective Date note under section 136 of Title 7.

Extension of Prohibition of Tolerance Fees

Pub. L. 115–141, div. M, title IV, §401(c), Mar. 23, 2018, 132 Stat. 1050, provided that: "Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) shall be applied by substituting 'September 30, 2018' for 'September 30, 2017'."

Regulation of Sulfuryl Fluoride

Pub. L. 113–79, title X, §10015, Feb. 7, 2014, 128 Stat. 952, provided that: "Notwithstanding any other provision of law, the Administrator of the Environmental Protection Agency shall exclude nonpesticideal sources of fluoride from any aggregate exposure assessment required under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) when assessing tolerances associated with residues from the pesticide."

Tolerance Fees

Pub. L. 108–199, div. G, title V, §501(d)(2), Jan. 23, 2004, 118 Stat. 422, provided that: "Notwithstanding section 408(m)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)), during the period beginning on October 1, 2003, and ending on September 30, 2008, the Administrator of the Environmental Protection Agency shall not collect any tolerance fees under that section."

Data Collection Activities To Assure Health of Infants and Children

Pub. L. 104–170, title III, §301, Aug. 3, 1996, 110 Stat. 1511, provided that:

"(a) In General.—The Secretary of Agriculture, in consultation with the Administrator of the Environmental Protection Agency and the Secretary of Health and Human Services, shall coordinate the development and implementation of survey procedures to ensure that adequate data on food consumption patterns of infants and children are collected.

"(b) Procedures.—To the extent practicable, the procedures referred to in subsection (a) shall include the collection of data on food consumption patterns of a statistically valid sample of infants and children.

"(c) Residue Data Collection.—The Secretary of Agriculture shall ensure that the residue data collection activities conducted by the Department of Agriculture in cooperation with the Environmental Protection Agency and the Department of Health and Human Services, provide for the improved data collection of pesticide residues, including guidelines for the use of comparable analytical and standardized reporting methods, and the increased sampling of foods most likely consumed by infants and children."

¹ See References in Text note below.

² So in original. Probably should be "subsection".

§346b. Authorization of appropriations

There are authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of sections 321(q), (r), 342(a)(2), and 346a of this title.

(July 22, 1954, ch. 559, §4, 68 Stat. 517.)

Editorial Notes

Codification

Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§347. Intrastate sales of colored oleomargarine

(a) Law governing

Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the same manner and to the same extent to the provisions of this chapter as if it had been introduced in interstate commerce.

(b) Labeling and packaging requirements

No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless—

(1) such oleomargarine or margarine is packaged,

(2) the net weight of the contents of any package sold in a retail establishment is one pound or less,

(3) there appears on the label of the package (A) the word "oleomargarine" or "margarine" in type or lettering at least as large as any other type or lettering on such label, and (B) a full and accurate statement of all the ingredients contained in such oleomargarine or margarine, and

(4) each part of the contents of the package is contained in a wrapper which bears the word "oleomargarine" or "margarine" in type or lettering not smaller than 20-point type.

The requirements of this subsection shall be in addition to and not in lieu of any of the other requirements of this chapter.

(c) Sales in public eating places

No person shall possess in a form ready for serving colored oleomargarine or colored margarine at a public eating place unless a notice that oleomargarine or margarine is served is displayed prominently and conspicuously in such place and in such manner as to render it likely to be read and understood by the ordinary individual being served in such eating place or is printed or is otherwise set forth on the menu in type or lettering not smaller than that normally used to designate the serving of other food items. No person shall serve colored oleomargarine or colored margarine at a public eating place, whether or not any charge is made therefor, unless (1) each separate serving bears or is accompanied by labeling identifying it as oleomargarine or margarine, or (2) each separate serving thereof is triangular in shape.

(d) Exemption from labeling requirements

Colored oleomargarine or colored margarine when served with meals at a public eating place shall at the time of such service be exempt from the labeling requirements of section 343 of this title (except paragraphs (a) and (f)) if it complies with the requirements of subsection (b) of this section.

(e) Color content of oleomargarine

For the purpose of this section colored oleomargarine or colored margarine is oleomargarine or margarine having a tint or shade containing more than one and six-tenths degrees of yellow, or of yellow and red collectively, but with an excess of yellow over red, measured in terms of Lovibond tintometer scale or its equivalent.

(June 25, 1938, ch. 675, §407, as added Mar. 16, 1950, ch. 61, §3(c), 64 Stat. 20.)

Statutory Notes and Related Subsidiaries

Effective Date

Act Mar. 16, 1950, ch. 61, §7, 64 Stat. 22, provided that: "This Act [enacting this section and sections 347a and 347b of this title and amending sections 331 and 342 of this title and sections 45 and 55 of Title 15, Commerce and Trade] shall become effective on July 1, 1950."

Transfer of Appropriations

Act Mar. 16, 1950, ch. 61, §5, 64 Stat. 22, provided that: "So much of the unexpended balances of appropriations, allocations, or other funds (including funds available for the fiscal year ending June 30, 1950) for the use of the Bureau of Internal Revenue of the Treasury Department in the exercise of functions under the Oleomargarine Tax Act (26 U.S.C., §2300, subchapter A) [now section 4591 et seq. of Title 26, Internal Revenue Code], as the Director of the Bureau of the Budget [now Director of the Office of Management and Budget] may determine, shall be transferred to the Federal Security Agency (Food and Drug Administration) [now the Department of Health and Human Services] for use in the enforcement of this Act [see Effective Date note above]."

§347a. Congressional declaration of policy regarding oleomargarine sales

The Congress hereby finds and declares that the sale, or the serving in public eating places, of colored oleomargarine or colored margarine without clear identification as such or which is otherwise adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] depresses the market in interstate commerce for butter and for oleomargarine or margarine clearly identified and neither adulterated nor misbranded, and constitutes a burden on interstate commerce in such articles. Such burden exists, irrespective of whether such oleomargarine or margarine originates from an interstate source or from the State in which it is sold.

(Mar. 16, 1950, ch. 61, §3(a), 64 Stat. 20.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as a note under section 347 of this title.

§347b. Contravention of State laws

Nothing in this Act shall be construed as authorizing the possession, sale, or serving of colored oleomargarine or colored margarine in any State or Territory in contravention of the laws of such State or Territory.

(Mar. 16, 1950, ch. 61, §6, 64 Stat. 22.)

Editorial Notes

References in Text

This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64 Stat. 20, which is classified to sections 331, 342, 347 to 347b of this title, and sections 45 and 55 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Tables.

Codification

Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as a note under section 347 of this title.

§348. Food additives

(a) Unsafe food additives; exception for conformity with exemption or regulation

A food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of section 342(a) of this title, unless—

(1) it and its use or intended use conform to the terms of an exemption which is in effect pursuant to subsection (j) of this section;

(2) there is in effect, and it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or

(3) in the case of a food additive as defined in this chapter that is a food contact substance, there is—

(A) in effect, and such substance and the use of such substance are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or

(B) a notification submitted under subsection (h) that is effective.

While such a regulation relating to a food additive, or such a notification under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under section 342(a)(1) of this title.

(b) Petition for regulation prescribing conditions of safe use; contents; description of production methods and controls; samples; notice of regulation

(1) Any person may, with respect to any intended use of a food additive, file with the Secretary a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used.

(2) Such petition shall, in addition to any explanatory or supporting data, contain—

(A) the name and all pertinent information concerning such food additive, including, where available, its chemical identity and composition;

(B) a statement of the conditions of the proposed use of such additive, including all directions, recommendations, and suggestions proposed for the use of such additive, and including specimens of its proposed labeling;

(C) all relevant data bearing on the physical or other technical effect such additive is intended to produce, and the quantity of such additive required to produce such effect;

(D) a description of practicable methods for determining the quantity of such additive in or on food, and any substance formed in or on food, because of its use; and

(E) full reports of investigations made with respect to the safety for use of such additive, including full information as to the methods and controls used in conducting such investigations.

(3) Upon request of the Secretary, the petitioner shall furnish (or, if the petitioner is not the manufacturer of such additive, the petitioner shall have the manufacturer of such additive furnish, without disclosure to the petitioner) a full description of the methods used in, and the facilities and controls used for, the production of such additive.

(4) Upon request of the Secretary, the petitioner shall furnish samples of the food additive involved, or articles used as components thereof, and of the food in or on which the additive is proposed to be used.

(5) Notice of the regulation proposed by the petitioner shall be published in general terms by the Secretary within thirty days after filing.

(c) Approval or denial of petition; time for issuance of order; evaluation of data; factors

(1) The Secretary shall—

(A) by order establish a regulation (whether or not in accord with that proposed by the petitioner) prescribing, with respect to one or more proposed uses of the food additive involved, the conditions under which such additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or in which such additive may be used, the maximum quantity which may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and shall notify the petitioner of such order and the reasons for such action; or

(B) by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.

(2) The order required by paragraph (1)(A) or (B) of this subsection shall be issued within ninety days after the date of filing of the petition, except that the Secretary may (prior to such ninetieth day), by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition.

(3) No such regulation shall issue if a fair evaluation of the data before the Secretary—

(A) fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe: Provided, That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal, except that this proviso shall not apply with respect to the use of a substance as an ingredient of feed for animals which are raised for food production, if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii) that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (f) and (g)) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal; or

(B) shows that the proposed use of the additive would promote deception of the consumer in violation of this chapter or would otherwise result in adulteration or in misbranding of food within the meaning of this chapter.

(4) If, in the judgment of the Secretary, based upon a fair evaluation of the data before him, a tolerance limitation is required in order to assure that the proposed use of an additive will be safe, the Secretary—

(A) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the physical or other technical effect for which such additive is intended; and

(B) shall not establish a regulation for such proposed use if he finds upon a fair evaluation of the data before him that such data do not establish that such use would accomplish the intended physical or other technical effect.

(5) In determining, for the purposes of this section, whether a proposed use of a food additive is safe, the Secretary shall consider among other relevant factors—

(A) the probable consumption of the additive and of any substance formed in or on food because of the use of the additive;

(B) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet; and

(C) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.

(d) Regulation issued on Secretary's initiative

The Secretary may at any time, upon his own initiative, propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such additive may be safely used, and the reasons therefor. After the thirtieth day following publication of such a proposal, the Secretary may by order establish a regulation based upon the proposal.

(e) Publication and effective date of orders

Any order, including any regulation established by such order, issued under subsection (c) or (d) of this section, shall be published and shall be effective upon publication, but the Secretary may stay such effectiveness if, after issuance of such order, a hearing is sought with respect to such order pursuant to subsection (f).

(f) Objections and public hearing; basis and contents of order; statement

(1) Within thirty days after publication of an order made pursuant to subsection (c) or (d) of this section, any person adversely affected by such an order may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections. The Secretary shall, after due notice, as promptly as possible hold such public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public.

(2) Such order shall be based upon a fair evaluation of the entire record at such hearing, and shall include a statement setting forth in detail the findings and conclusions upon which the order is based.

(3) The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication, unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions.

(g) Judicial review

(1) In a case of actual controversy as to the validity of any order issued under subsection (f), including any order thereunder with respect to amendment or repeal of a regulation issued under this section, any person who will be adversely affected by such order may obtain judicial review by filing in the United States Court of Appeals for the circuit wherein such person resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within sixty days after the entry of such order, a petition praying that the order be set aside in whole or in part.

(2) A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28. Upon the filing of such petition the court shall have jurisdiction, which upon the filing of the record with it shall be exclusive, to affirm or set aside the order complained of in whole or in part. Until the filing of the record the Secretary may modify or set aside his order. The findings of the Secretary with respect to questions of fact shall be sustained if based upon a fair evaluation of the entire record at such hearing.

(3) The court, on such judicial review, shall not sustain the order of the Secretary if he failed to comply with any requirement imposed on him by subsection (f)(2) of this section.

(4) If application is made to the court for leave to adduce additional evidence, the court may order such additional evidence to be taken before the Secretary and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may seem proper, if such evidence is material and there were reasonable grounds for failure to adduce such evidence in the proceedings below. The Secretary may modify his findings as to the facts and order by reason of the additional evidence so taken, and shall file with the court such modified findings and order.

(5) The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28. The commencement of proceedings under this section shall not, unless specifically ordered by the court to the contrary, operate as a stay of an order.

(h) Notification relating to food contact substance

(1) Subject to such regulations as may be promulgated under paragraph (3), a manufacturer or supplier of a food contact substance may, at least 120 days prior to the introduction or delivery for introduction into interstate commerce of the food contact substance, notify the Secretary of the identity and intended use of the food contact substance, and of the determination of the manufacturer or supplier that the intended use of such food contact substance is safe under the standard described in subsection (c)(3)(A). The notification shall contain the information that forms the basis of the determination and all information required to be submitted by regulations promulgated by the Secretary.

(2)(A) A notification submitted under paragraph (1) shall become effective 120 days after the date of receipt by the Secretary and the food contact substance may be introduced or delivered for introduction into interstate commerce, unless the Secretary makes a determination within the 120-day period that, based on the data and information before the Secretary, such use of the food contact substance has not been shown to be safe under the standard described in subsection (c)(3)(A), and informs the manufacturer or supplier of such determination.

(B) A decision by the Secretary to object to a notification shall constitute final agency action subject to judicial review.

(C) In this paragraph, the term "food contact substance" means the substance that is the subject of a notification submitted under paragraph (1), and does not include a similar or identical substance manufactured or prepared by a person other than the manufacturer identified in the notification.

(3)(A) The process in this subsection shall be utilized for authorizing the marketing of a food contact substance except where the Secretary determines that submission and review of a petition under subsection (b) is necessary to provide adequate assurance of safety, or where the Secretary and any manufacturer or supplier agree that such manufacturer or supplier may submit a petition under subsection (b).

(B) The Secretary is authorized to promulgate regulations to identify the circumstances in which a petition shall be filed under subsection (b), and shall consider criteria such as the probable consumption of such food contact substance and potential toxicity of the food contact substance in determining the circumstances in which a petition shall be filed under subsection (b).

(4) The Secretary shall keep confidential any information provided in a notification under paragraph (1) for 120 days after receipt by the Secretary of the notification. After the expiration of such 120 days, the information shall be available to any interested party except for any matter in the notification that is a trade secret or confidential commercial information.

(5)(A)(i) Except as provided in clause (ii), the notification program established under this subsection shall not operate in any fiscal year unless—

(I) an appropriation equal to or exceeding the applicable amount under clause (iv) is made for such fiscal year for carrying out such program in such fiscal year; and

(II) the Secretary certifies that the amount appropriated for such fiscal year for the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in subclause (I)) equals or exceeds the amount appropriated for the Center for fiscal year 1997, excluding any amount appropriated for new programs.

(ii) The Secretary shall, not later than April 1, 1999, begin accepting and reviewing notifications submitted under the notification program established under this subsection if—

(I) an appropriation equal to or exceeding the applicable amount under clause (iii) is made for the last six months of fiscal year 1999 for carrying out such program during such period; and

(II) the Secretary certifies that the amount appropriated for such period for the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in subclause (I)) equals or exceeds an amount equivalent to one-half the amount appropriated for the Center for fiscal year 1997, excluding any amount appropriated for new programs.

(iii) For the last six months of fiscal year 1999, the applicable amount under this clause is $1,500,000, or the amount specified in the budget request of the President for the six-month period involved for carrying out the notification program in fiscal year 1999, whichever is less.

(iv) For fiscal year 2000 and subsequent fiscal years, the applicable amount under this clause is $3,000,000, or the amount specified in the budget request of the President for the fiscal year involved for carrying out the notification program under this subsection, whichever is less.

(B) For purposes of carrying out the notification program under this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1999 through fiscal year 2003, except that such authorization of appropriations is not effective for a fiscal year for any amount that is less than the applicable amount under clause (iii) or (iv) of subparagraph (A), whichever is applicable.

(C) Not later than April 1 of fiscal year 1998 and February 1 of each subsequent fiscal year, the Secretary shall submit a report to the Committees on Appropriations of the House of Representatives and the Senate, the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate that provides an estimate of the Secretary of the costs of carrying out the notification program established under this subsection for the next fiscal year.

(6) In this section, the term "food contact substance" means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.

(i) Amendment or repeal of regulations

The Secretary shall by regulation prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of such regulations. The Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under subsection (h) to no longer be effective.

(j) Exemptions for investigational use

Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

(k) Food additives intended for use in animal food

(1) In taking action on a petition under subsection (c) for, or for recognition of, a food additive intended for use in animal food, the Secretary shall review reports of investigations conducted in foreign countries, provided by the petitioner.

(2) Not later than 12 months after August 14, 2018, the Secretary shall post on the internet website of the Food and Drug Administration—

(A) the number of petitions for food additives intended for use in animal food filed under subsection (b) that are pending;

(B) how long each such petition submitted under subsection (b) has been pending, including such petitions the Secretary has extended under subsection (c)(2); and

(C) the number of study protocols that have been pending review for over 50 days, and the number that have received an extension.

(3) In the case of a food additive petition intended for use in animal food, the Secretary shall provide information to the petitioner on the required contents of such petition. If the Secretary requires additional studies beyond what the petitioner proposed, the Secretary shall provide the scientific rationale for such requirement.

(June 25, 1938, ch. 675, §409, as added Pub. L. 85–929, §4, Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86–546, §2, June 29, 1960, 74 Stat. 255; Pub. L. 87–781, title I, §104(f)(1), Oct. 10, 1962, 76 Stat. 785; Pub. L. 98–620, title IV, §402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105–115, title III, §309, Nov. 21, 1997, 111 Stat. 2354; Pub. L. 115–234, title III, §306(a), Aug. 14, 2018, 132 Stat. 2440.)

Editorial Notes

Amendments

2018—Subsec. (k). Pub. L. 115–234 added subsec. (k).

1997—Subsec. (a). Pub. L. 105–115, §309(a)(4), in closing provisions, substituted "While such a regulation relating to a food additive, or such a notification under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under section 342(a)(1) of this title." for "While such a regulation relating to a food additive is in effect, a food shall not, by reason of bearing or containing such an additive in accordance with the regulation, be considered adulterated within the meaning of clause (1) of section 342(a) of this title."

Subsec. (a)(1). Pub. L. 105–115, §309(a)(1), substituted "subsection (j)" for "subsection (i)".

Subsec. (a)(3). Pub. L. 105–115, §309(a)(1)(B), (2), (3), added par. (3).

Subsec. (h). Pub. L. 105–115, §309(b)(2), added subsec. (h). Former subsec. (h) redesignated (i).

Subsec. (i). Pub. L. 105–115, §309(b)(1), (3), redesignated subsec. (h) as (i) and inserted at end "The Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under subsection (h) to no longer be effective."

Subsec. (j). Pub. L. 105–115, §309(b)(1), (4), redesignated subsec. (i) as (j) and substituted "subsections (b) to (i)" for "subsections (b) to (h)".

1984—Subsec. (g)(2). Pub. L. 98–620 struck out provision that required the court to advance on the docket and expedite the disposition of all causes filed therein pursuant to this section.

1962—Subsec. (c)(3)(A). Pub. L. 87–781 excepted proviso from applying to use of a substance as an ingredient of feed for animals raised for food production, if under conditions of use specified in proposed labeling, and which conditions are reasonably certain to be followed in practice, such additive will not adversely affect the animals and no residue will be found in any edible portion of such animal after slaughter, or in any food from the living animal.

1960—Subsec. (g)(2). Pub. L. 86–546 substituted "forthwith transmitted by the clerk of the court to the Secretary, or any officer" for "served upon the Secretary, or upon any officer", "shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28" for "shall certify and file in the court a transcript of the proceedings and the record on which he based his order", and "Upon the filing of such petition the court shall have jurisdiction, which upon the filing of the record with it shall be exclusive," for "Upon such filing, the court shall have exclusive jurisdiction", and inserted sentence authorizing the Secretary to modify or set aside his order until the filing of the record.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1984 Amendment

Amendment by Pub. L. 98–620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Pub. L. 98–620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure.

Effective Date of 1962 Amendment; Exceptions

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as an Effective Date of 1962 Amendment note under section 321 of this title.

Effective Date

Section effective Sept. 6, 1958, see section 6(a) of Pub. L. 85–929, set out as an Effective Date of 1958 Amendment note under section 342 of this title.

Guidance on Pre-Petition Consultation Process for Animal Food Additives

Pub. L. 115–234, title III, §306(c), Aug. 14, 2018, 132 Stat. 2441, provided that:

"(1) In general.—Not later than 18 months after the date of enactment of this Act [Aug. 14, 2018], the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall publish draft guidance relating to the voluntary pre-petition consultation process for food additives intended for use in animal food.

"(2) Contents.—The guidance under paragraph (1) shall include—

"(A) the recommended format to submit to the Food and Drug Administration existing data, including any applicable foreign data, for assessment prior to submission of a food additive petition for animal food under section 409(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 348(b)];

"(B) the manner and the number of days by which the Food and Drug Administration intends to review and respond to such existing data, including with respect to providing a scientific rationale for any additional data request;

"(C) circumstances under which the submission of study protocols is recommended prior to submission of a food additive petition under such section 409(b);

"(D) the manner in which the Secretary intends to inform the person submitting a study protocol for a food additive if the review of such study protocol will take longer than 50 days; and

"(E) best practices for communication between the Food and Drug Administration and industry on the development of pre-petition submissions of study protocols and existing data for food additives.

"(3) Final guidance.—The guidance under paragraph (1) shall be finalized, withdrawn, or reissued not later than 1 year after the close of the comment period on the draft guidance."

Glass and Ceramic Ware

Pub. L. 105–115, title III, §308, Nov. 21, 1997, 111 Stat. 2353, provided that:

"(a) In General.—The Secretary may not implement any requirement which would ban, as an unapproved food additive, lead and cadmium based enamel in the lip and rim area of glass and ceramic ware before the expiration of one year after the date such requirement is published.

"(b) Lead and Cadmium Based Enamel.—Unless the Secretary determines, based on available data, that lead and cadmium based enamel on glass and ceramic ware—

"(1) which has less than 60 millimeters of decorating area below the external rim, and

"(2) which is not, by design, representation, or custom of usage intended for use by children,

is unsafe, the Secretary shall not take any action before January 1, 2003, to ban lead and cadmium based enamel on such glass and ceramic ware. Any action taken after January 1, 2003, to ban such enamel on such glass and ceramic ware as an unapproved food additive shall be taken by regulation and such regulation shall provide that such products shall not be removed from the market before 1 year after publication of the final regulation."

Moratorium on Authority of Secretary With Respect to Saccharin

Pub. L. 95–203, §3, Nov. 23, 1977, 91 Stat. 1452, as amended by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96–273, June 17, 1980, 94 Stat. 536; Pub. L. 97–42, §2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98–22, §2, Apr. 22, 1983, 97 Stat. 173; Pub. L. 99–46, May 24, 1985, 99 Stat. 81; Pub. L. 100–71, title I, §101, July 11, 1987, 101 Stat. 431; Pub. L. 102–142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L. 104–180, title VI, §602, Aug. 6, 1996, 110 Stat. 1594, provided that: "During the period ending May 1, 2002, the Secretary—

"(1) may not amend or revoke the interim food additive regulation of the Food and Drug Administration of the Department of Health and Human Services applicable to saccharin and published on March 15, 1977 (section 180.37 of part 180, subchapter B, chapter 1, title 21, Code of Federal Regulations (42 Fed. Reg. 14638)), or

"(2) may, except as provided in section 4 [enacting section 343a of this title, amending sections 321 and 343 of this title, and enacting provisions set out as notes under section 343 of this title] and the amendments made by such section, not take any other action under the Federal Food, Drug, and Cosmetic Act [this chapter] to prohibit or restrict the sale or distribution of saccharin, any food permitted by such interim food additive regulation to contain saccharin, or any drug or cosmetic containing saccharin,

solely on the basis of the carcinogenic or other toxic effect of saccharin as determined by any study made available to the Secretary before the date of the enactment of this Act [Nov. 23, 1977] which involved human studies or animal testing, or both."

[Definition of "saccharin" as used in section 3 of Pub. L. 95–203, set out above, to include calcium saccharin, sodium saccharin, and ammonium saccharin, see Pub. L. 95–203, §2(d), Nov. 23, 1997, 91 Stat. 1452.]

§349. Bottled drinking water standards; publication in Federal Register

(a) Except as provided in subsection (b), whenever the Administrator of the Environmental Protection Agency prescribes interim or revised national primary drinking water regulations under section 1412 of the Public Health Service Act [42 U.S.C. 300g–1], the Secretary shall consult with the Administrator and within 180 days after the promulgation of such drinking water regulations either promulgate amendments to regulations under this chapter applicable to bottled drinking water or publish in the Federal Register his reasons for not making such amendments.

(b)(1) Not later than 180 days before the effective date of a national primary drinking water regulation promulgated by the Administrator of the Environmental Protection Agency for a contaminant under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the Secretary shall promulgate a standard of quality regulation under this subsection for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems (as defined under section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water used for bottled drinking water. The effective date for any such standard of quality regulation shall be the same as the effective date for such national primary drinking water regulation, except for any standard of quality of regulation promulgated by the Secretary before August 6, 1996, for which (as of August 6, 1996) an effective date had not been established. In the case of a standard of quality regulation to which such exception applies, the Secretary shall promulgate monitoring requirements for the contaminants covered by the regulation not later than 2 years after August 6, 1996.

(2) A regulation issued by the Secretary as provided in this subsection shall include any monitoring requirements that the Secretary determines appropriate for bottled water.

(3) A regulation issued by the Secretary as provided in this subsection shall require the following:

(A) In the case of contaminants for which a maximum contaminant level is established in a national primary drinking water regulation under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the regulation under this subsection shall establish a maximum contaminant level for the contaminant in bottled water which is no less stringent than the maximum contaminant level provided in the national primary drinking water regulation.

(B) In the case of contaminants for which a treatment technique is established in a national primary drinking water regulation under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the regulation under this subsection shall require that bottled water be subject to requirements no less protective of the public health than those applicable to water provided by public water systems using the treatment technique required by the national primary drinking water regulation.

(4)(A) If the Secretary does not promulgate a regulation under this subsection within the period described in paragraph (1), the national primary drinking water regulation referred to in paragraph (1) shall be considered, as of the date on which the Secretary is required to establish a regulation under paragraph (1), as the regulation applicable under this subsection to bottled water.

(B) In the case of a national primary drinking water regulation that pursuant to subparagraph (A) is considered to be a standard of quality regulation, the Secretary shall, not later than the applicable date referred to in such subparagraph, publish in the Federal Register a notice—

(i) specifying the contents of such regulation, including monitoring requirements; and

(ii) providing that for purposes of this paragraph the effective date for such regulation is the same as the effective date for the regulation for purposes of the Safe Drinking Water Act [42 U.S.C. 300f et seq.] (or, if the exception under paragraph (1) applies to the regulation, that the effective date for the regulation is not later than 2 years and 180 days after August 6, 1996).

(June 25, 1938, ch. 675, §410, as added Pub. L. 93–523, §4, Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104–182, title III, §305, Aug. 6, 1996, 110 Stat. 1684.)

Editorial Notes

References in Text

The Safe Drinking Water Act, referred to in subsec. (b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16, 1974, Pub. L. 93–523, §2(a), 88 Stat. 1660, as amended, which is classified generally to subchapter XII (§300f et seq.) of chapter 6A of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

1996—Pub. L. 104–182 substituted "(a) Except as provided in subsection (b), whenever" for "Whenever" and added subsec. (b).

Statutory Notes and Related Subsidiaries

Bottled Water Study

Pub. L. 104–182, title I, §114(b), Aug. 6, 1996, 110 Stat. 1641, provided that not later than 18 months after Aug. 6, 1996, the Administrator of the Food and Drug Administration would publish for public notice and comment a draft study on the feasibility of appropriate methods, if any, of informing customers of the contents of bottled water, and publish a final study not later than 30 months after Aug. 6, 1996.

§350. Vitamins and minerals

(a) Authority and limitations of Secretary; applicability

(1) Except as provided in paragraph (2)—

(A) the Secretary may not establish, under section 321(n), 341, or 343 of this title, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food to which this section applies;

(B) the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful;

(C) the Secretary may not limit, under section 321(n), 341, or 343 of this title, the combination or number of any synthetic or natural—

(i) vitamin,

(ii) mineral, or

(iii) other ingredient of food,

within a food to which this section applies.

(2) Paragraph (1) shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women. For purposes of this subparagraph,¹ the term "children" means individuals who are under the age of twelve years.

(b) Labeling and advertising requirements for foods

(1) A food to which this section applies shall not be deemed under section 343 of this title to be misbranded solely because its label bears, in accordance with section 343(i)(2) of this title, all the ingredients in the food or its advertising contains references to ingredients in the food which are not vitamins or minerals.

(2) The labeling for any food to which this section applies may not list its ingredients which are not dietary supplement ingredients described in section 321(ff) of this title (i) except as a part of a list of all the ingredients of such food, and (ii) unless such ingredients are listed in accordance with applicable regulations under section 343 of this title. To the extent that compliance with clause (i) of this subparagraph is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.

(c) Definitions

(1) For purposes of this section, the term "food to which this section applies" means a food for humans which is a food for special dietary use—

(A) which is or contains any natural or synthetic vitamin or mineral, and

(B) which—

(i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or

(ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.

(2) For purposes of paragraph (1)(B)(i), a food shall be considered as intended for ingestion in liquid form only if it is formulated in a fluid carrier and it is intended for ingestion in daily quantities measured in drops or similar small units of measure.

(3) For purposes of paragraph (1) and of section 343(j) of this title insofar as that section is applicable to food to which this section applies, the term "special dietary use" as applied to food used by man means a particular use for which a food purports or is represented to be used, including but not limited to the following:

(A) Supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium.

(B) Supplying a vitamin, mineral, or other ingredient for use by man to supplement his diet by increasing the total dietary intake.

(C) Supplying a special dietary need by reason of being a food for use as the sole item of the diet.

(June 25, 1938, ch. 675, §411, as added Pub. L. 94–278, title V, §501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103–417, §§3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)

Editorial Notes

Amendments

1994—Subsec. (b)(2). Pub. L. 103–417, §7(d), redesignated subpar. (A) as par. (2), substituted "dietary supplement ingredients described in section 321(ff) of this title" for "vitamins or minerals", and struck out former subpar. (B), which read as follows: "Notwithstanding the provisions of subparagraph (A), the labeling and advertising for any food to which this section applies may not give prominence to or emphasize ingredients which are not—

"(i) vitamins,

"(ii) minerals, or

"(iii) represented as a source of vitamins or minerals."

Subsec. (c)(1)(B)(i). Pub. L. 103–417, §3(c)(1), inserted "powder, softgel, gelcap," after "capsule,".

Subsec. (c)(1)(B)(ii). Pub. L. 103–417, §3(c)(2), struck out "does not simulate and" after "in such a form,".

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

For provision that dietary supplements may be labeled after Oct. 25, 1994, in accordance with amendments made by section 7(d) of Pub. L. 103–417, and shall be so labeled after Dec. 31, 1996, see section 7(e) of Pub. L. 103–417, set out as a note under section 343 of this title.

Amendment of Inconsistent Regulations by Secretary

Pub. L. 94–278, title V, §501(b), Apr. 22, 1976, 90 Stat. 411, as amended by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, provided that: "The Secretary of Health and Human Services shall amend any regulation promulgated under the Federal Food, Drug, and Cosmetic Act [this chapter] which is inconsistent with section 411 of such Act [section 350 of this title] (as added by subsection (a)) and such amendments shall be promulgated in accordance with section 553 of title 5, United States Code."

¹ So in original. Probably should be "paragraph".

§350a. Infant formulas

(a) Adulteration

An infant formula, including an infant formula powder, shall be deemed to be adulterated if—

(1) such infant formula does not provide nutrients as required by subsection (i),

(2) such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(1), or

(3) the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures prescribed by the Secretary under subsection (b)(2).

(b) Requirements for quality factors, good manufacturing practices, and retention of records

(1) The Secretary shall by regulation establish requirements for quality factors for infant formulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by subsection (i).

(2)(A) The Secretary shall by regulation establish good manufacturing practices for infant formulas, including quality control procedures that the Secretary determines are necessary to assure that an infant formula provides nutrients in accordance with this subsection and subsection (i) and is manufactured in a manner designed to prevent adulteration of the infant formula.

(B) The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for—

(i) the testing, in accordance with paragraph (3) and by the manufacturer of an infant formula or an agent of such manufacturer, of each batch of infant formula for each nutrient required by subsection (i) before the distribution of such batch,

(ii) regularly scheduled testing, by the manufacturer of an infant formula or an agent of such manufacturer, of samples of infant formulas during the shelf life of such formulas to ensure that such formulas are in compliance with this section,

(iii) in-process controls including, where necessary, testing required by good manufacturing practices designed to prevent adulteration of each batch of infant formula, and

(iv) the conduct by the manufacturer of an infant formula or an agent of such manufacturer of regularly scheduled audits to determine that such manufacturer has complied with the regulations prescribed under subparagraph (A).

In prescribing requirements for audits under clause (iv), the Secretary shall provide that such audits be conducted by appropriately trained individuals who do not have any direct responsibility for the manufacture or production of infant formula.

(3)(A) At the final product stage, each batch of infant formula shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E to ensure that such infant formula is in compliance with the requirements of this subsection and subsection (i) relating to such vitamins.

(B) Each nutrient premix used in the manufacture of an infant formula shall be tested for each relied upon nutrient required by subsection (i) which is contained in such premix to ensure that such premix is in compliance with its specifications or certifications by a premix supplier.

(C) During the manufacturing process or at the final product stage and before distribution of an infant formula, an infant formula shall be tested for all nutrients required to be included in such formula by subsection (i) for which testing has not been conducted pursuant to subparagraph (A) or (B). Testing under this subparagraph shall be conducted to—

(i) ensure that each batch of such infant formula is in compliance with the requirements of subsection (i) relating to such nutrients, and

(ii) confirm that nutrients contained in any nutrient premix used in such infant formula are present in each batch of such infant formula in the proper concentration.

(D) If the Secretary adds a nutrient to the list of nutrients in the table in subsection (i), the Secretary shall by regulation require that the manufacturer of an infant formula test each batch of such formula for such new nutrient in accordance with subparagraph (A), (B), or (C).

(E) For purposes of this paragraph, the term "final product stage" means the point in the manufacturing process, before distribution of an infant formula, at which an infant formula is homogenous and is not subject to further degradation.

(4)(A) The Secretary shall by regulation establish requirements respecting the retention of records. Such requirements shall provide for—

(i) the retention of all records necessary to demonstrate compliance with the good manufacturing practices and quality control procedures prescribed by the Secretary under paragraph (2), including records containing the results of all testing required under paragraph (2)(B),

(ii) the retention of all certifications or guarantees of analysis by premix suppliers,

(iii) the retention by a premix supplier of all records necessary to confirm the accuracy of all premix certifications and guarantees of analysis,

(iv) the retention of—

(I) all records pertaining to the microbiological quality and purity of raw materials used in infant formula powder and in finished infant formula, and

(II) all records pertaining to food packaging materials which show that such materials do not cause an infant formula to be adulterated within the meaning of section 342(a)(2)(C) of this title,

(v) the retention of all records of the results of regularly scheduled audits conducted pursuant to the requirements prescribed by the Secretary under paragraph (2)(B)(iv), and

(vi) the retention of all complaints and the maintenance of files with respect to, and the review of, complaints concerning infant formulas which may reveal the possible existence of a hazard to health.

(B)(i) Records required under subparagraph (A) with respect to an infant formula shall be retained for at least one year after the expiration of the shelf life of such infant formula. Except as provided in clause (ii), such records shall be made available to the Secretary for review and duplication upon request of the Secretary.

(ii) A manufacturer need only provide written assurances to the Secretary that the regularly scheduled audits required by paragraph (2)(B)(iv) are being conducted by the manufacturer, and need not make available to the Secretary the actual written reports of such audits.

(c) Registration of persons distributing new infant formula

(1) No person shall introduce or deliver for introduction into interstate commerce any new infant formula unless—

(A) such person has, before introducing such new infant formula, or delivering such new infant formula for introduction, into interstate commerce, registered with the Secretary the name of such person, the place of business of such person, and all establishments at which such person intends to manufacture such new infant formula, and

(B) such person has at least 90 days before marketing such new infant formula, made the submission to the Secretary required by subsection (d)(1).

(2) For purposes of paragraph (1), the term "new infant formula" includes—

(A) an infant formula manufactured by a person which has not previously manufactured an infant formula, and

(B) an infant formula manufactured by a person which has previously manufactured infant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer.

For purposes of this paragraph, the term "major change" has the meaning given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder.

(d) Submission of information about new infant formula required

(1) A person shall, with respect to any infant formula subject to subsection (c), make a submission to the Secretary which shall include—

(A) the quantitative formulation of the infant formula,

(B) a description of any reformulation of the formula or change in processing of the infant formula,

(C) assurances that the infant formula will not be marketed unless it meets the requirements of subsections (b)(1) and (i), as demonstrated by the testing required under subsection (b)(3), and

(D) assurances that the processing of the infant formula complies with subsection (b)(2).

(2) After the first production of an infant formula subject to subsection (c), and before the introduction into interstate commerce of such formula, the manufacturer of such formula shall submit to the Secretary, in such form as may be prescribed by the Secretary, a written verification which summarizes test results and records demonstrating that such formula complies with the requirements of subsections (b)(1), (b)(2)(A), (b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i).

(3) If the manufacturer of an infant formula for commercial or charitable distribution for human consumption determines that a change in the formulation of the formula or a change in the processing of the formula may affect whether the formula is adulterated under subsection (a), the manufacturer shall, before the first processing of such formula, make the submission to the Secretary required by paragraph (1).

(4) The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.

(e) Additional notice requirements for manufacturer

(1) If the manufacturer of an infant formula has knowledge which reasonably supports the conclusion that an infant formula which has been processed by the manufacturer and which has left an establishment subject to the control of the manufacturer—

(A) may not provide the nutrients required by subsection (i), or

(B) may be otherwise adulterated or misbranded,

the manufacturer shall promptly notify the Secretary of such knowledge. If the Secretary determines that the infant formula presents a risk to human health, the manufacturer shall immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary.

(2) For purposes of paragraph (1), the term "knowledge" as applied to a manufacturer means (A) the actual knowledge that the manufacturer had, or (B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.

(f) Procedures applicable to recalls by manufacturer; regulatory oversight

(1) If a recall of infant formula is begun by a manufacturer, the recall shall be carried out in accordance with such requirements as the Secretary shall prescribe under paragraph (2) and—

(A) the Secretary shall, not later than the 15th day after the beginning of such recall and at least once every 15 days thereafter until the recall is terminated, review the actions taken under the recall to determine whether the recall meets the requirements prescribed under paragraph (2), and

(B) the manufacturer shall, not later than the 14th day after the beginning of such recall and at least once every 14 days thereafter until the recall is terminated, report to the Secretary the actions taken to implement the recall.

(2) The Secretary shall by regulation prescribe the scope and extent of recalls of infant formulas necessary and appropriate for the degree of risks to human health presented by the formula subject to the recall.

(3) The Secretary shall by regulation require each manufacturer of an infant formula who begins a recall of such formula because of a risk to human health to request each retail establishment at which such formula is sold or available for sale to post at the point of purchase of such formula a notice of such recall at such establishment for such time that the Secretary determines necessary to inform the public of such recall.

(g) Recordkeeping requirements for manufacturer; regulatory oversight and enforcement

(1) Each manufacturer of an infant formula shall make and retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the formula. Such records shall be retained for at least one year after the expiration of the shelf life of the infant formula.

(2) To the extent that the Secretary determines that records are not being made or maintained in accordance with paragraph (1), the Secretary may by regulation prescribe the records required to be made under paragraph (1) and requirements respecting the retention of such records under such paragraph. Such regulations shall take effect on such date as the Secretary prescribes but not sooner than the 180th day after the date such regulations are promulgated. Such regulations shall apply only with respect to distributions of infant formulas made after such effective date.

(h) Exemptions; regulatory oversight

(1) Any infant formula which is represented and labeled for use by an infant—

(A) who has an inborn error of metabolism or a low birth weight, or

(B) who otherwise has an unusual medical or dietary problem,

is exempt from the requirements of subsections (a), (b), and (c). The manufacturer of an infant formula exempt under this paragraph shall, in the case of the exempt formula, be required to provide the notice required by subsection (e)(1) only with respect to adulteration or misbranding described in subsection (e)(1)(B) and to comply with the regulations prescribed by the Secretary under paragraph (2).

(2) The Secretary may by regulation establish terms and conditions for the exemption of an infant formula from the requirements of subsections (a), (b), and (c). An exemption of an infant formula under paragraph (1) may be withdrawn by the Secretary if such formula is not in compliance with applicable terms and conditions prescribed under this paragraph.

(i) Nutrient requirements

(1) An infant formula shall contain nutrients in accordance with the table set out in this subsection, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table.

(2) The Secretary may by regulation—

(A) revise the list of nutrients in the table in this subsection, and

(B) revise the required level for any nutrient required by the table.

NUTRIENTS

Nutrient		Minimum a	Maximum a
Protein (gm)	1.8 b		4.5.
Fat:
gm	3.3		6.0.
percent cal	30.0		54.0.
Essential fatty acids   (linoleate):
percent cal	2.7
mg	300.0
Vitamins:
A (IU)	250.0	(75 µg)c	750.0 (225 µg).c
D (IU)	40.0		100.0.
K (µg)	4.0
E (IU)	0.7	(with 0.7 IU/gm linoleic acid)
C (ascorbic acid) (mg)	8.0
B1 (thiamine) (µg)	40.0
B2 (riboflavin) (µg)	60.0
B6 (pyridoxine) (µg)	35.0	(with 15 µg/gm of protein in formula)
B12 (µg)	0.15
Niacin (µg)	250.0
Folic acid (µg)	4.0
Pantothenic acid (µg)	300.0
Biotin (µg)	1.5 d
Choline (mg)	7.0 d
Inositol (mg)	4.0 d
Minerals:
Calcium (mg)	50.0 e
Phosphorus (mg)	25.0 e
Magnesium (mg)	6.0
Iron (mg)	0.15
Iodine (µg)	5.0
Zinc (mg)	0.5
Copper (µg)	60.0
Manganese (µg)	5.0
Sodium (mg)	20.0		60.0.
Potassium (mg)	80.0		200.0.
Chloride (mg)	55.0		150.0.

^a Stated per 100 kilocalories.

^b The source of protein shall be at least nutritionally equivalent to casein.

^c Retinol equivalents.

^d Required to be included in this amount only in formulas which are not milk-based.

^e Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0.

(j) Premarket submissions to address shortages

(1) In general

The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket submission requirement for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula.

(2) Effective period

The waiver authority under this subsection shall remain in effect—

(A) for 90 days beginning on the date that the Secretary distributes information under section 350m(a)(2) of this title with respect to a shortage of infant formula; or

(B) such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula.

(k) Congressional notification of recall

(1) In general

Not later than 24 hours after the initiation of a recall of infant formula as described in subsection (e), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a notification of such recall.

(2) Contents

A notification under paragraph (1) shall include the following:

(A) If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health.

(B) If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded.

(C) Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall.

(D) An initial estimate of the disruption in domestic production that may result from the recall.

(l) Annual report to Congress

(1) In general

Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information:

(A) The number of submissions received by the Secretary under subsection (d).

(B) The number of such submissions that included any new ingredients that were not included in any infant formula already on the market.

(C) The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b).

(D) The time between any inspection referred to in subparagraph (C) and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b).

(E) A breakdown of the information described in subparagraphs (A) through (D) between foreign and domestic manufacturers and facilities.

(2) Confidentiality

The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(m) Waiver of requirements for importation of specialty infant formula

(1) In general

The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this chapter applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to—

(A) the importation of specialty infant formula from any country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of this chapter; or

(B) the distribution and sale of such imported specialty infant formula.

(2) Rule of construction

Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to require a recall of, or otherwise impose restrictions and requirements under this chapter with respect to, specialty infant formula that is subject to a waiver under paragraph (1).

(3) Definition of specialty infant formula

In this subsection, the term "specialty infant formula" means infant formula described in subsection (h)(1).

(June 25, 1938, ch. 675, §412, as added Pub. L. 96–359, §2, Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99–570, title IV, §4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207–116, 3207-120; Pub. L. 103–80, §3(l), Aug. 13, 1993, 107 Stat. 777; Pub. L. 117–328, div. FF, title III, §3401(c), (g)(1)–(4), (6), (l), Dec. 29, 2022, 136 Stat. 5838, 5840, 5841, 5845.)

Editorial Notes

Amendments

2022—Subsec. (c)(1)(B). Pub. L. 117–328, §3401(g)(6), substituted "subsection (d)(1)" for "subsection (c)(1)".

Subsec. (d)(4). Pub. L. 117–328, §3401(g)(3), added par. (4).

Subsec. (i)(1). Pub. L. 117–328, §3401(g)(4), substituted ", which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table" for "or, if revised by the Secretary under paragraph (2), as so revised".

Subsec. (j). Pub. L. 117–328, §3401(c), added subsec. (j).

Subsec. (k). Pub. L. 117–328, §3401(g)(1), added subsec. (k).

Subsec. (l). Pub. L. 117–328, §3401(g)(2), added subsec. (l).

Subsec. (m). Pub. L. 117–328, §3401(l), added subsec. (m).

1993—Subsec. (h)(1). Pub. L. 103–80 substituted "(e)(1)(B)" for "(c)(1)(B)," in concluding provisions.

1986—Subsecs. (a) to (d). Pub. L. 99–570, §4014(a)(7), added subsecs. (a) to (d) and struck out former subsecs. (a) relating to adulteration and regulatory oversight, (b) relating to notice to the Secretary by a manufacturer and requirements and scope of that notice, (c) relating to additional notice requirements for the manufacturer, and (d) relating to procedures applicable to recalls by a manufacturer.

Subsecs. (e), (f). Pub. L. 99–570, §4014(a)(1), (7), added subsecs. (e) and (f) and redesignated former subsecs. (e) and (f) as (g) and (h), respectively.

Subsec. (g). Pub. L. 99–570, §4014(a)(1), (2), redesignated subsec. (e) as (g) and substituted "Such records shall be retained for at least one year after the expiration of the shelf life of the infant formula" for "No manufacturer shall be required under this subsection to retain any record respecting the distribution of an infant formula for a period of longer than 2 years from the date the record was made". Former subsec. (g) redesignated (i).

Subsec. (h). Pub. L. 99–570, §4014(a)(1), redesignated subsec. (f) as (h).

Subsec. (h)(1). Pub. L. 99–570, §4014(a)(3), (4), substituted "(a), (b), and (c)" for "(a) and (b)" and "(e)(1)" for "(c)(1)".

Pub. L. 99–570, §4014(a)(5), which directed that "(d)(1)(B)" be substituted for "(e)(1)(B)" in second sentence could not be executed because "(e)(1)(B)" did not appear. See 1993 Amendment note above.

Subsec. (h)(2). Pub. L. 99–570, §4014(a)(6), substituted "(a), (b), and (c)" for "(a) and (b)".

Subsec. (i). Pub. L. 99–570, §4014(a)(1), (b)(1), redesignated subsec. (g) as (i), designated existing provisions as par. (1), substituted "paragraph (2)" for "subsection (a)(2) of this section", substituted a period for the colon after "as so revised", and added par. (2).

Statutory Notes and Related Subsidiaries

Effective Date of 1980 Amendment

Pub. L. 96–359, §6, Sept. 26, 1980, 94 Stat. 1193, provided that: "Section 412 of the Federal Food, Drug, and Cosmetic Act (added by section 2) [this section] shall apply with respect to infant formulas manufactured on or after the 90th day after the date of the enactment of this Act [Sept. 26, 1980]."

§350a–1. Protecting infants and improving formula supply

(a) Definitions

(1) In general

In this section, the term "infant formula" has the meaning given such term in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)).

(2) Omitted

(b) Office of Critical Foods

(1) In general

The Secretary shall establish within the Center for Food Safety and Applied Nutrition an office to be known as the Office of Critical Foods. The Secretary shall appoint a Director to lead such Office.

(2) Duties

The Office of Critical Foods shall be responsible for oversight, coordination, and facilitation of activities related to critical foods, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(ss)], as added by subsection (a)(2).

(c) Omitted

(d) Report

Not later than one year after December 29, 2022, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—

(1) the number of premarket submissions for new infant formula the Secretary has received under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) each year since 2012;

(2) how many of such submissions received requests from the Secretary for additional information;

(3) how long after receiving such submissions the Secretary sent such requests for additional information;

(4) what additional information the Secretary requested of the persons submitting such submissions; and

(5) the date each new infant formula described in subparagraph (A) ¹ was first marketed, if available.

(e) Infant formula flexibilities

The Secretary shall publish a list on the website of the Department of Health and Human Services providing information on how to identify appropriate substitutes for infant formula products in shortage that are relied upon by infants and other individuals with inborn errors of metabolism or other serious health conditions.

(f) International harmonization of infant formula requirements

(1) In general

The Secretary—

(A) shall participate in meetings with representatives from other countries to discuss methods and approaches to harmonizing regulatory requirements for infant formula, including with respect to inspections, labeling, and nutritional requirements; and

(B) may enter into arrangements or agreements regarding such requirements with other countries, as appropriate, including arrangements or agreements with a foreign government or agency of a foreign government to recognize the inspection of foreign establishments that manufacture infant formula for export to the United States.

(2) Study on infant formula

(A) In general

Not later than 60 days after December 29, 2022, the Secretary shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this paragraph as the "National Academies") to examine and report on challenges in supply, market competition, and regulation of infant formula in the United States.

(B) Contents of the report

The report developed pursuant to the agreement under subparagraph (A) shall—

(i) assess and evaluate—

(I) infant formula marketed in the United States;

(II) any challenges in supply, or market competition with respect to such infant formula; and

(III) any differences between infant formula marketed in the United States and infant formula marketed in the European Union, including with respect to nutritional content and applicable labeling and other regulatory requirements; and

(ii) include recommendations, including for infant formula manufacturers, on measures to address supply and market competition in the United States.

(C) Final report

The agreement under subparagraph (A) shall specify that the National Academies shall, not later than 1 year after December 29, 2022, complete such study and submit a report on the results of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(g) Transparency and accountability to support infant formula innovation

(1) to (4) Omitted

(5) Guidance

Not later than 1 year after December 29, 2022, the Secretary shall issue guidance regarding information sponsors may consider including in submissions required under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)), including considerations for meeting each of the requirements of paragraphs (1), (2), and (3) of subsection (d).

(6) Omitted

(h) Response to recall

(1) Manufacturer submission

(A) In general

Promptly after the initiation of a recall of infant formula, the manufacturer of the recalled infant formula shall submit information to the Secretary regarding such recall.

(B) Contents

A submission under subparagraph (A) shall include the following:

(i) A plan (including an estimated timeline, as applicable) of actions the manufacturer will take, suited to the individual circumstances of the particular recall, including—

(I) to identify and address any cause of, and contributing factor in, known or suspected adulteration or known or suspected misbranding; and

(II) if appropriate, to restore operation of the impacted facilities.

(ii) In the case that a recall of the manufacturer's infant formula products, and subsequent actions to respond to such recall, impacts over 10 percent of the production of the infant formula intended for sale in the United States, a plan to backfill the supply of the manufacturer's infant formula supply if the current domestic supply of such infant formula has fallen, or is expected to fall, below the expected demand for the formula.

(2) Report to Congress

(A) In general

Promptly after a submission under paragraph (1) is received, the Secretary shall provide such submission, together with the information specified in subparagraph (B), in a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(B) Contents

A report under subparagraph (A) shall include the following:

(i) Information concerning the current domestic supply of infant formula, including—

(I) a breakdown of the specific types of formula involved; and

(II) an estimate of how long current supplies will last.

(ii) If a submission or submissions under paragraph (1) show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domestic production of infant formula intended for sale in the United States—

(I) actions to work with the impacted manufacturer or other manufacturers to increase production; and

(II) specification of—

(aa) any additional authorities needed regarding production or importation to fill a supply gap; and

(bb) any supplemental funding necessary to address the shortage.

(3) Sunset

This subsection shall cease to have force or effect on September 30, 2026.

(i) Coordination with manufacturer

(1) In general

(A) Communication following inspection

Upon completing an inspection of an infant formula manufacturing facility impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide the manufacturer involved a list of any actions necessary to—

(i) address deficiencies contributing to the potential adulteration or misbranding of product at the facility; and

(ii) safely restart production at the facility.

(B) Response to manufacturer

Not later than 7 days after receiving a written communication from a manufacturer of infant formula containing corrective actions to address manufacturing deficiencies identified during an inspection of a facility engaged in the manufacturing of an infant formula impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide a substantive response to such communication concerning the sufficiency of the proposed corrective actions.

(2) Inspections

The Secretary shall ensure timely communication with a manufacturer of infant formula following an inspection of a facility engaged in the manufacturing of infant formula for consumption in the United States. If a reinspection of a manufacturer of an infant formula is required to ensure that such manufacturer completed any remediation actions or addressed any deficiencies, the Secretary shall reinspect such facility in a timely manner. The Secretary shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an infant formula.

(3) Annual inspections

Not later than 6 months after December 29, 2022, and not less than once per calendar year thereafter, the Secretary shall conduct inspections, including unannounced inspections, of the facilities (including foreign facilities) of each manufacturer of an infant formula required to be registered under section 412(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(A)), in accordance with a risk-based approach and ensure timely and effective internal coordination and alignment among the Office of Regulatory Affairs and the Center for Food Safety and Applied Nutrition. In meeting the inspection requirements under this subsection, the Secretary may rely on inspections conducted by foreign regulatory authorities, under arrangements or agreements, and conducted by State agencies under contract, memoranda of understanding, or any other obligation.

(j) National strategy on infant formula

(1) In general

The Secretary, in consultation with the Secretary of Agriculture and other heads of relevant departments and agencies, shall develop and issue, not later than 90 days after December 29, 2022, a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to infant formula and information they need.

(2) Immediate national strategy

The national strategy under paragraph (1) shall include efforts—

(A) to increase the resiliency of the infant formula supply chain in the short-term by—

(i) assessing causes of any supply disruption or shortage of infant formula in existence as of December 29, 2022, and potential causes of future supply disruptions and shortages;

(ii) assessing and addressing immediate infant formula needs associated with the shortage; and

(iii) developing a plan to increase infant formula supply, including through increased competition; and

(B) to ensure the development and updating of education and communication materials for parents and caregivers that cover—

(i) where and how to find infant formula;

(ii) comparable infant formulas on the market;

(iii) what to do if a specialty infant formula is unavailable;

(iv) safe practices for handling infant formula; and

(v) other topics, as appropriate.

(3) Long-term strategy

Not later than 90 days after the submission of the report described in subsection (f)(2), the Secretary shall update the national strategy under paragraph (1) to include efforts to improve preparedness against infant formula shortages in the long-term by—

(A) outlining methods to improve information-sharing between the Federal Government and State and local governments, and other entities as appropriate, regarding shortages;

(B) recommending measures for protecting the integrity of the infant formula supply and preventing contamination;

(C) outlining methods to incentivize new infant formula manufacturers to increase supply and mitigate future shortages; and

(D) recommending other necessary authorities to gain insight into the supply chain and risk for shortages, and to incentivize new infant formula manufacturers.

(k), (l) Omitted

(m) Importation for personal use

(1) In general

Notwithstanding any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), during the 90-day period beginning on December 29, 2022, an individual may, without prior notice to the Food and Drug Administration, import up to a 3-month supply of infant formula for personal use from—

(A) Canada;

(B) any country in the European Union; or

(C) any other country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(2) Limitations

Infant formula may be imported pursuant to paragraph (1) only if the infant formula—

(A) is exclusively for personal use and will not be commercialized or promoted; and

(B) does not present an unreasonable risk to human health.

(3) Reporting of adverse events

If a health care provider becomes aware of any adverse event which the health care provider reasonably suspects to be associated with infant formula imported pursuant to paragraph (1), the health care provider shall report such adverse event to the Commissioner of Food and Drugs.

(4) Public notice

The Secretary, acting through the Commissioner of Food and Drugs, shall post on the public website of the Food and Drug Administration notice that—

(A) infant formula imported pursuant to paragraph (1) may not have been manufactured in a facility that has been inspected by the Food and Drug Administration;

(B) the labeling of such infant formula may not meet the standards and other requirements applicable with respect to infant formula under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and

(C) the nutritional content of infant formula imported pursuant to paragraph (1) may vary from that of infant formula meeting such standards and other requirements.

(5) Sense of Congress

It is the sense of Congress that persons considering the personal importation of infant formula should consult with their pediatrician about such importation.

(Pub. L. 117–328, div. FF, title III, §3401, Dec. 29, 2022, 136 Stat. 5838.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (m)(1), (4)(B), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Section is comprised of section 3401 of div. FF of Pub. L. 117–328. Subsec. (a)(2) of section 3401 of div. FF of Pub. L. 117–328 amended section 321 of this title. Subsecs. (c), (g)(1)–(4), (6), and (l) of such section 3401 amended section 350a of this title. Subsec. (k) of such section 3401 enacted section 350m of this title.

Statutory Notes and Related Subsidiaries

Definition of "Secretary"

Pub. L. 117–328, div. FF, title III, §3002, Dec. 29, 2022, 136 Stat. 5807, provided that: "In this title [see Short Title of 2022 Amendment note set out under section 301 of this title], except as otherwise specified, the term 'Secretary' means the Secretary of Health and Human Services."

¹ So in original. There is no subparagraph (A).

§350b. New dietary ingredients

(a) In general

A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 342(f) of this title unless it meets one of the following requirements:

(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.

(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.

(b) Petition

Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, the decision of the Secretary shall be considered final agency action.

(c) Notification

(1) In general

If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has.

(2) Definitions

For purposes of this subsection—

(A) the term "anabolic steroid" has the meaning given such term in section 802(41) of this title; and

(B) the term "analogue of an anabolic steroid" means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.

(d) "New dietary ingredient" defined

For purposes of this section, the term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.

(June 25, 1938, ch. 675, §413, as added Pub. L. 103–417, §8, Oct. 25, 1994, 108 Stat. 4331; amended Pub. L. 111–353, title I, §113(a), Jan. 4, 2011, 124 Stat. 3920.)

Editorial Notes

Amendments

2011—Subsecs. (c), (d). Pub. L. 111–353 added subsec. (c) and redesignated former subsec. (c) as (d).

Statutory Notes and Related Subsidiaries

Guidance

Pub. L. 111–353, title I, §113(b), Jan. 4, 2011, 124 Stat. 3921, provided that: "Not later than 180 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350b(a)(2)], the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify [sic] of a new dietary ingredient."

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

§350c. Maintenance and inspection of records

(a) Records inspection

(1) Adulterated food

If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.

(2) Use of or exposure to food of concern

If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.

(3) Application

The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.

(b) Regulations concerning recordkeeping

The Secretary, in consultation and coordination, as appropriate, with other Federal departments and agencies with responsibilities for regulating food safety, may by regulation establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food, which records are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. The Secretary shall take into account the size of a business in promulgating regulations under this section.

(c) Protection of sensitive information

The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section.

(d) Limitations

This section shall not be construed—

(1) to limit the authority of the Secretary to inspect records or to require establishment and maintenance of records under any other provision of this chapter;

(2) to authorize the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);

(3) to have any legal effect on section 552 of title 5 or section 1905 of title 18; or

(4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).

(June 25, 1938, ch. 675, §414, as added Pub. L. 107–188, title III, §306(a), June 12, 2002, 116 Stat. 669; amended Pub. L. 111–353, title I, §101(a), Jan. 4, 2011, 124 Stat. 3886.)

Editorial Notes

References in Text

The Federal Meat Inspection Act, referred to in subsec. (d)(2), is titles I to V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, §11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

The Poultry Products Inspection Act, referred to in subsec. (d)(2), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.

The Egg Products Inspection Act, referred to in subsec. (d)(2), is Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to chapter 15 (§1031 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

2011—Subsec. (a). Pub. L. 111–353 reenacted heading without change, designated existing provisions as par. (1) and inserted heading, substituted "If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is" for "If the Secretary has a reasonable belief that an article of food is", inserted ", and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner," after "relating to such article", struck out at end "The requirement under the preceding sentence applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.", and added pars. (2) and (3).

Statutory Notes and Related Subsidiaries

Expedited Rulemaking

Pub. L. 107–188, title III, §306(d), June 12, 2002, 116 Stat. 670, provided that: "Not later than 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary shall promulgate proposed and final regulations establishing recordkeeping requirements under subsection 414(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350c(b)] (as added by subsection (a))."

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

§350d. Registration of food facilities

(a) Registration

(1) In general

The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered—

(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and

(B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.

(2) Registration

An entity (referred to in this section as the "registrant") shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations, or any other food categories as determined appropriate by the Secretary, including by guidance) of any food manufactured, processed, packed, or held at such facility. The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this chapter. The registrant shall notify the Secretary in a timely manner of changes to such information.

(3) Biennial registration renewal

During the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a renewal registration containing the information described in paragraph (2). The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.

(4) Procedure

Upon receipt of a completed registration described in paragraph (1), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility.

(5) List

The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section. Such list and any registration documents submitted pursuant to this subsection shall not be subject to disclosure under section 552 of title 5. Information derived from such list or registration documents shall not be subject to disclosure under section 552 of title 5 to the extent that it discloses the identity or location of a specific registered person.

(b) Suspension of registration

(1) In general

If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility—

(A) that created, caused, or was otherwise responsible for such reasonable probability; or

(B)(i) that knew of, or had reason to know of, such reasonable probability; and

(ii) packed, received, or held such food.

(2) Hearing on suspension

The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.

(3) Post-hearing corrective action plan; vacating of order

(A) Corrective action plan

If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 days after the submission of the corrective action plan or such other time period as determined by the Secretary.

(B) Vacating of order

Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall promptly vacate the order and reinstate the registration of the facility subject to the order or modify the order, as appropriate.

(4) Effect of suspension

If the registration of a facility is suspended under this subsection, no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States.

(5) Regulations

(A) In general

The Secretary shall promulgate regulations to implement this subsection. The Secretary may promulgate such regulations on an interim final basis.

(B) Registration requirement

The Secretary may require that registration under this section be submitted in an electronic format. Such requirement may not take effect before the date that is 5 years after January 4, 2011.

(6) Application date

Facilities shall be subject to the requirements of this subsection beginning on the earlier of—

(A) the date on which the Secretary issues regulations under paragraph (5); or

(B) 180 days after January 4, 2011.

(7) No delegation

The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.

(c) Facility

For purposes of this section:

(1) The term "facility" includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations).

(2) The term "domestic facility" means a facility located in any of the States or Territories.

(3)(A) The term "foreign facility" means a facility that manufacturers,¹ processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.

(B) A food may not be considered to have undergone further processing or packaging for purposes of subparagraph (A) solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the food.

(d) Rule of construction

Nothing in this section shall be construed to authorize the Secretary to require an application, review, or licensing process for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b).

(June 25, 1938, ch. 675, §415, as added Pub. L. 107–188, title III, §305(a), June 12, 2002, 116 Stat. 667; amended Pub. L. 111–353, title I, §102(a)–(b)(1), (d)(2), Jan. 4, 2011, 124 Stat. 3887, 3889.)

Editorial Notes

Amendments

2011—Subsec. (a)(2). Pub. L. 111–353, §102(a)(1), (b)(1)(A), substituted "conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and" for "conducts business and", inserted ", or any other food categories as determined appropriate by the Secretary, including by guidance" after "Code of Federal Regulations", and inserted after first sentence "The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this chapter."

Subsec. (a)(3) to (5). Pub. L. 111–353, §102(a)(2), (3), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively.

Subsecs. (b), (c). Pub. L. 111–353, §102(b)(1)(B), (C), added subsec. (b) and redesignated former subsec. (b) as (c). Former subsec. (c) redesignated (d).

Subsec. (d). Pub. L. 111–353, §102(b)(1)(B), (d)(2), redesignated subsec. (c) as (d) and inserted "for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)" before period at end.

Statutory Notes and Related Subsidiaries

Regulations

Pub. L. 111–353, title I, §102(c), Jan. 4, 2011, 124 Stat. 3889, provided that:

"(1) Retail food establishment.—The Secretary shall amend the definition of the term 'retail food establishment' in section in [sic] 1.227(b)(11) of title 21, Code of Federal Regulations[,] to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include—

"(A) the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed;

"(B) the sale and distribution of such food through a community supported agriculture program; and

"(C) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.

"(2) Definitions.—For purposes of paragraph (1)—

"(A) the term 'community supported agriculture program' has the same meaning given the term 'community supported agriculture (CSA) program' in section 249.2 of title 7, Code of Federal Regulations (or any successor regulation); and

"(B) the term 'consumer' does not include a business."

Pub. L. 111–353, title I, §103(c), Jan. 4, 2011, 124 Stat. 3896, provided that:

"(1) Proposed rulemaking.—

"(A) In general.—Not later than 9 months after the date of enactment of this Act [Jan. 4, 2011], the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall publish a notice of proposed rulemaking in the Federal Register to promulgate regulations with respect to—

"(i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act; and

"(ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415.

"(B) Clarification.—The rulemaking described under subparagraph (A) shall enhance the implementation of such section 415 and clarify the activities that are included as part of the definition of the term 'facility' under such section 415. Nothing in this Act [see Short Title note set out under section 2201 of this title] authorizes the Secretary to modify the definition of the term 'facility' under such section.

"(C) Science-based risk analysis.—In promulgating regulations under subparagraph (A), the Secretary shall conduct a science-based risk analysis of—

"(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and

"(ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.

"(D) Authority with respect to certain facilities.—

"(i) In general.—In promulgating the regulations under subparagraph (A), the Secretary shall consider the results of the science-based risk analysis conducted under subparagraph (C), and shall exempt certain facilities from the requirements in section 418 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g] (as added by this section), including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of such Act [21 U.S.C. 350j] (as added by section 201), or modify the requirements in such sections 418 or 421, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.

"(ii) Limitation.—The exemptions or modifications under clause (i) shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act, if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added under subsection (a)).

"(2) Final regulations.—Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shall adopt final rules with respect to—

"(A) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act;

"(B) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415; and

"(C) the requirements under sections 418 and 421 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g, 350j], as added by this Act, from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities."

Pub. L. 107–188, title III, §305(e), June 12, 2002, 116 Stat. 669, provided that: "Not later than 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and Human Services shall promulgate proposed and final regulations for the requirement of registration under section 415 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as added by subsection (a) of this section). Such requirement of registration takes effect—

"(1) upon the effective date of such final regulations; or

"(2) upon the expiration of such 18-month period if the final regulations have not been made effective as of the expiration of such period, subject to compliance with the final regulations when the final regulations are made effective."

Construction of 2011 Amendment

Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

Small Entity Compliance Policy Guide

Pub. L. 111–353, title I, §102(b)(2), Jan. 4, 2011, 124 Stat. 3888, provided that: "Not later than 180 days after the issuance of the regulations promulgated under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350d(b)(5)] (as added by this section), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small entities in complying with registration requirements and other activities required under such section."

Electronic Filing

Pub. L. 107–188, title III, §305(d), June 12, 2002, 116 Stat. 668, provided that: "For the purpose of reducing paperwork and reporting burdens, the Secretary of Health and Human Services may provide for, and encourage the use of, electronic methods of submitting to the Secretary registrations required pursuant to this section [enacting this section, amending sections 331 and 381 of this title, and enacting provisions set out as a note under this section]. In providing for the electronic submission of such registrations, the Secretary shall ensure adequate authentication protocols are used to enable identification of the registrant and validation of the data as appropriate."

¹ So in original. Probably should be "manufactures,".

§350e. Sanitary transportation practices

(a) Definitions

In this section:

(1) Bulk vehicle

The term "bulk vehicle" includes a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.

(2) Transportation

The term "transportation" means any movement in commerce by motor vehicle or rail vehicle.

(b) Regulations

The Secretary shall by regulation require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated.

(c) Contents

The regulations under subsection (b) shall—

(1) prescribe such practices as the Secretary determines to be appropriate relating to—

(A) sanitation;

(B) packaging, isolation, and other protective measures;

(C) limitations on the use of vehicles;

(D) information to be disclosed—

(i) to a carrier by a person arranging for the transport of food; and

(ii) to a manufacturer or other person that—

(I) arranges for the transportation of food by a carrier; or

(II) furnishes a tank vehicle or bulk vehicle for the transportation of food; and

(E) recordkeeping; and

(2) include—

(A) a list of nonfood products that the Secretary determines may, if shipped in a bulk vehicle, render adulterated food that is subsequently transported in the same vehicle; and

(B) a list of nonfood products that the Secretary determines may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is simultaneously or subsequently transported in the same vehicle.

(d) Waivers

(1) In general

The Secretary may waive any requirement under this section, with respect to any class of persons, vehicles, food, or nonfood products, if the Secretary determines that the waiver—

(A) will not result in the transportation of food under conditions that would be unsafe for human or animal health; and

(B) will not be contrary to the public interest.

(2) Publication

The Secretary shall publish in the Federal Register any waiver and the reasons for the waiver.

(e) Preemption

(1) In general

A requirement of a State or political subdivision of a State that concerns the transportation of food is preempted if—

(A) complying with a requirement of the State or political subdivision and a requirement of this section, or a regulation prescribed under this section, is not possible; or

(B) the requirement of the State or political subdivision as applied or enforced is an obstacle to accomplishing and carrying out this section or a regulation prescribed under this section.

(2) Applicability

This subsection applies to transportation that occurs on or after the effective date of the regulations promulgated under subsection (b).

(f) Assistance of other agencies

The Secretary of Transportation, the Secretary of Agriculture, the Administrator of the Environmental Protection Agency, and the heads of other Federal agencies, as appropriate, shall provide assistance on request, to the extent resources are available, to the Secretary for the purposes of carrying out this section.

(June 25, 1938, ch. 675, §416, as added Pub. L. 109–59, title VII, §7202(b), Aug. 10, 2005, 119 Stat. 1911.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as an Effective Date of 2005 Amendment note under section 331 of this title.

Regulations

Pub. L. 111–353, title I, §111(a), Jan. 4, 2011, 124 Stat. 3916, provided that: "Not later than 18 months after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall promulgate regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b))."

§350f. Reportable food registry

(a) Definitions

In this section:

(1) Responsible party

The term "responsible party", with respect to an article of food, means a person that submits the registration under section 350d(a) of this title for a food facility that is required to register under section 350d(a) of this title, at which such article of food is manufactured, processed, packed, or held.

(2) Reportable food

The term "reportable food" means an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

(b) Establishment

(1) In general

Not later than 1 year after September 27, 2007, the Secretary shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection (d), via an electronic portal, from—

(A) Federal, State, and local public health officials; or

(B) responsible parties.

(2) Review by Secretary

The Secretary shall promptly review and assess the information submitted under paragraph (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting under subsection (c), and exercising other existing food safety authorities under this chapter to protect the public health.

(c) Issuance of an alert by the Secretary

(1) In general

The Secretary shall issue, or cause to be issued, an alert or a notification with respect to a reportable food using information from the Reportable Food Registry as the Secretary deems necessary to protect the public health.

(2) Effect

Paragraph (1) shall not affect the authority of the Secretary to issue an alert or a notification under any other provision of this chapter.

(d) Reporting and notification

(1) In general

Except as provided in paragraph (2), as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall—

(A) submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) (except the elements described in paragraphs (8), (9), and (10) of such subsection); and

(B) investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.

(2) No report required

A responsible party is not required to submit a report under paragraph (1) if—

(A) the adulteration originated with the responsible party;

(B) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and

(C) the responsible party—

(i) corrected such adulteration; or

(ii) destroyed or caused the destruction of such article of food.

(3) Reports by public health officials

A Federal, State, or local public health official may submit a report about a reportable food to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) that the official is able to provide.

(4) Report number

The Secretary shall ensure that, upon submission of a report under paragraph (1) or (3), a unique number is issued through the electronic portal established under subsection (b) to the person submitting such report, by which the Secretary is able to link reports about the reportable food submitted and amended under this subsection and identify the supply chain for such reportable food.

(5) Review

The Secretary shall promptly review a report submitted under paragraph (1) or (3).

(6) Response to report submitted by a responsible party

After consultation with the responsible party that submitted a report under paragraph (1), the Secretary may require such responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, 1 or more of the following:

(A) Amend the report submitted by the responsible party under paragraph (1) to include the data element described in subsection (e)(9).

(B) Provide a notification—

(i) to the immediate previous source of the article of food, if the Secretary deems necessary;

(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and

(iii) that includes—

(I) the data elements described in subsection (e) that the Secretary deems necessary;

(II) the actions described under paragraph (7) that the recipient of the notification shall perform, as required by the Secretary; and

(III) any other information that the Secretary may require.

(7) Subsequent reports and notifications

Except as provided in paragraph (8), the Secretary may require a responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, after the responsible party receives a notification under subparagraph (C) or paragraph (6)(B), 1 or more of the following:

(A) Submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes those data elements described in subsection (e) and other information that the Secretary deems necessary.

(B) Investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.

(C) Provide a notification—

(i) to the immediate previous source of the article of food, if the Secretary deems necessary;

(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and

(iii) that includes—

(I) the data elements described in subsection (e) that the Secretary deems necessary;

(II) the actions described under this paragraph that the recipient of the notification shall perform, as required by the Secretary; and

(III) any other information that the Secretary may require.

(8) Amended report

If a responsible party receives a notification under paragraph (6)(B) or paragraph (7)(C) with respect to an article of food after the responsible party has submitted a report to the Food and Drug Administration under paragraph (1) with respect to such article of food—

(A) the responsible party is not required to submit an additional report or make a notification under paragraph (7); and

(B) the responsible party shall amend the report submitted by the responsible party under paragraph (1) to include the data elements described in paragraph (9), and, with respect to both such notification and such report, paragraph (11) of subsection (e).

(e) Data elements

The data elements described in this subsection are the following:

(1) The registration numbers of the responsible party under section 350d(a)(3) ¹ of this title.

(2) The date on which an article of food was determined to be a reportable food.

(3) A description of the article of food including the quantity or amount.

(4) The extent and nature of the adulteration.

(5) If the adulteration of the article of food may have originated with the responsible party, the results of the investigation required under paragraph (1)(B) or (7)(B) of subsection (d), as applicable and when known.

(6) The disposition of the article of food, when known.

(7) Product information typically found on packaging including product codes, use-by dates, and names of manufacturers, packers, or distributors sufficient to identify the article of food.

(8) Contact information for the responsible party.

(9) The contact information for parties directly linked in the supply chain and notified under paragraph (6)(B) or (7)(C) of subsection (d), as applicable.

(10) The information required by the Secretary to be included in a notification provided by the responsible party involved under paragraph (6)(B) or (7)(C) of subsection (d) or required in a report under subsection (d)(7)(A).

(11) The unique number described in subsection (d)(4).

(f) Critical information

Except with respect to fruits and vegetables that are raw agricultural commodities, not more than 18 months after January 4, 2011, the Secretary may require a responsible party to submit to the Secretary consumer-oriented information regarding a reportable food, which shall include—

(1) a description of the article of food as provided in subsection (e)(3);

(2) as provided in subsection (e)(7), affected product identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of food;

(3) contact information for the responsible party as provided in subsection (e)(8); and

(4) any other information the Secretary determines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food.

(g) Grocery store notification

(1) Action by Secretary

The Secretary shall—

(A) prepare the critical information described under subsection (f) for a reportable food as a standardized one-page summary;

(B) publish such one-page summary on the Internet website of the Food and Drug Administration in a format that can be easily printed by a grocery store for purposes of consumer notification.

(2) Action by grocery store

A notification described under paragraph (1)(B) shall include the date and time such summary was posted on the Internet website of the Food and Drug Administration.

(h) Consumer notification

(1) In general

If a grocery store sold a reportable food that is the subject of the posting and such establishment is part of ² chain of establishments with 15 or more physical locations, then such establishment shall, not later than 24 hours after a one page summary described in subsection (g) is published, prominently display such summary or the information from such summary via at least one of the methods identified under paragraph (2) and maintain the display for 14 days.

(2) List of conspicuous locations

Not more than 1 year after January 4, 2011, the Secretary shall develop and publish a list of acceptable conspicuous locations and manners, from which grocery stores shall select at least one, for providing the notification required in paragraph (1). Such list shall include—

(A) posting the notification at or near the register;

(B) providing the location of the reportable food;

(C) providing targeted recall information given to customers upon purchase of a food; and

(D) other such prominent and conspicuous locations and manners utilized by grocery stores as of January 4, 2011, to provide notice of such recalls to consumers as considered appropriate by the Secretary.

(i) Coordination of Federal, State, and local efforts

(1) Department of Agriculture

In implementing this section, the Secretary shall—

(A) share information and coordinate regulatory efforts with the Department of Agriculture; and

(B) if the Secretary receives a report submitted about a food within the jurisdiction of the Department of Agriculture, promptly provide such report to the Department of Agriculture.

(2) States and localities

In implementing this section, the Secretary shall work with the State and local public health officials to share information and coordinate regulatory efforts, in order to—

(A) help to ensure coverage of the safety of the food supply chain, including those food establishments regulated by the States and localities that are not required to register under section 350d of this title; and

(B) reduce duplicative regulatory efforts.

(j) Maintenance and inspection of records

The responsible party shall maintain records related to each report received, notification made, and report submitted to the Food and Drug Administration under this section for 2 years. A responsible party shall, at the request of the Secretary, permit inspection of such records as provided for section ³ 350c of this title.

(k) Request for information

Except as provided by section 350d(a)(4) ¹ of this title, section 552 of title 5 shall apply to any request for information regarding a record in the Reportable Food Registry.

(l) Safety report

A report or notification under subsection (d) shall be considered to be a safety report under section 379v of this title and may be accompanied by a statement, which shall be part of any report released for public disclosure, that denies that the report or the notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or serious illness.

(m) Admission

A report or notification under this section shall not be considered an admission that the article of food involved is adulterated or caused or contributed to a death, serious injury, or serious illness.

(n) Homeland Security notification

If, after receiving a report under subsection (d), the Secretary believes such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary of Homeland Security. The Secretary shall make relevant information from the Reportable Food Registry available to the Secretary of Homeland Security.

(June 25, 1938, ch. 675, §417, as added Pub. L. 110–85, title X, §1005(b), Sept. 27, 2007, 121 Stat. 965; amended Pub. L. 111–353, title II, §211(a), Jan. 4, 2011, 124 Stat. 3951.)

Editorial Notes

References in Text

Section 350d(a)(3), (4) of this title, referred to in subsecs. (e)(1) and (k), was redesignated section 350d(a)(4), (5), respectively, of this title by Pub. L. 111–353, title I, §102(a)(2), Jan. 4, 2011, 124 Stat. 3887.

Amendments

2011—Subsecs. (f) to (n). Pub. L. 111–353 added subsecs. (f) to (h) and redesignated former subsecs. (f) to (k) as (i) to (n), respectively.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 110–85, title X, §1005(e), Sept. 27, 2007, 121 Stat. 969, provided that: "The requirements of section 417(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f(d)], as added by subsection (a) [probably should be (b)], shall become effective 1 year after the date of the enactment of this Act [Sept. 27, 2007]."

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Findings

Pub. L. 110–85, title X, §1005(a), Sept. 27, 2007, 121 Stat. 964, provided that: "Congress makes the following findings:

"(1) In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994 (Public Law 103–417) [see Short Title of 1994 Amendments note set out under section 301 of this title] to provide the Food and Drug Administration the legal framework which is intended to ensure that dietary supplements are safe and properly labeled foods.

"(2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462) [see Short Title of 2006 Amendment note set out under section 301 of this title] to establish a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States.

"(3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act is intended to serve as an early warning system for potential public health issues associated with the use of these products.

"(4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health."

Guidance

Pub. L. 110–85, title X, §1005(f), Sept. 27, 2007, 121 Stat. 969, provided that: "Not later than 9 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary [of Health and Human Services] shall issue a guidance to industry about submitting reports to the electronic portal established under section 417 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f] (as added by this section) and providing notifications to other persons in the supply chain of an article of food under such section 417."

¹ See References in Text note below.

² So in original. Probably should be followed by "a".

³ So in original. Probably should be "in section".

§350g. Hazard analysis and risk-based preventive controls

(a) In general

The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 342 of this title or misbranded under section 343(w) of this title, monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.

(b) Hazard analysis

The owner, operator, or agent in charge of a facility shall—

(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including—

(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and

(B) hazards that occur naturally, or may be unintentionally introduced; and

(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and

(3) develop a written analysis of the hazards.

(c) Preventive controls

The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that—

(1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be significantly minimized or prevented;

(2) any hazards identified in the hazard analysis conducted under subsection (b)(2) will be significantly minimized or prevented and addressed, consistent with section 350i of this title, as applicable; and

(3) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(d) Monitoring of effectiveness

The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under subsection (c) to provide assurances that the outcomes described in subsection (c) shall be achieved.

(e) Corrective actions

The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under subsection (c) are not properly implemented or are found to be ineffective—

(1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure;

(2) all affected food is evaluated for safety; and

(3) all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(f) Verification

The owner, operator, or agent in charge of a facility shall verify that—

(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b);

(2) the owner, operator, or agent is conducting monitoring in accordance with subsection (d);

(3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (e);

(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and

(5) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.

(g) Recordkeeping

The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under subsection (c), instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under subsection (f)(4), instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.

(h) Written plan and documentation

The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted under subsection (c) to address those hazards. Such written plan, together with the documentation described in subsection (g), shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.

(i) Requirement to reanalyze

The owner, operator, or agent in charge of a facility shall conduct a reanalysis under subsection (b) whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. Such owner, operator, or agent shall revise the written plan required under subsection (h) if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under this section to respond to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.

(j) Exemption for seafood, juice, and low-acid canned food facilities subject to HACCP

(1) In general

This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:

(A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(B) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(C) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).

(2) Applicability

The exemption under paragraph (1)(C) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter ¹ 21, Code of Federal Regulations (or any successor regulations).

(k) Exception for activities of facilities subject to section 350h of this title

This section shall not apply to activities of a facility that are subject to section 350h of this title.

(l) Modified requirements for qualified facilities

(1) Qualified facilities

(A) In general

A facility is a qualified facility for purposes of this subsection if the facility meets the conditions under subparagraph (B) or (C).

(B) Very small business

A facility is a qualified facility under this subparagraph—

(i) if the facility, including any subsidiary or affiliate of the facility, is, collectively, a very small business (as defined in the regulations promulgated under subsection (n)); and

(ii) in the case where the facility is a subsidiary or affiliate of an entity, if such subsidiaries or affiliates, are, collectively, a very small business (as so defined).

(C) Limited annual monetary value of sales

(i) In general

A facility is a qualified facility under this subparagraph if clause (ii) applies—

(I) to the facility, including any subsidiary or affiliate of the facility, collectively; and

(II) to the subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate.

(ii) Average annual monetary value

This clause applies if—

(I) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as described in clause (i)) that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as so described) sold by such facility (or collectively by any such subsidiary or affiliate) to all other purchasers during such period; and

(II) the average annual monetary value of all food sold by such facility (or the collective average annual monetary value of such food sold by any subsidiary or affiliate, as described in clause (i)) during such period was less than $500,000, adjusted for inflation.

(2) Exemption

A qualified facility—

(A) shall not be subject to the requirements under subsections (a) through (i) and subsection (n) in an applicable calendar year; and

(B) shall submit to the Secretary—

(i)(I) documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective; or

(II) documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the Secretary, that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law; and

(ii) documentation, as specified by the Secretary in a guidance document issued not later than 1 year after January 4, 2011, that the facility is a qualified facility under paragraph (1)(B) or (1)(C).

(3) Withdrawal; rule of construction

(A) In general

In the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Secretary may withdraw the exemption provided to such facility under this subsection.

(B) Rule of construction

Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary.

(4) Definitions

In this subsection:

(A) Affiliate

The term "affiliate" means any facility that controls, is controlled by, or is under common control with another facility.

(B) Qualified end-user

The term "qualified end-user", with respect to a food, means—

(i) the consumer of the food; or

(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 350d of this title) that—

(I) is located—

(aa) in the same State as the qualified facility that sold the food to such restaurant or establishment; or

(bb) not more than 275 miles from such facility; and

(II) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.

(C) Consumer

For purposes of subparagraph (B), the term "consumer" does not include a business.

(D) Subsidiary

The term "subsidiary" means any company which is owned or controlled directly or indirectly by another company.

(5) Study

(A) In general

The Secretary, in consultation with the Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine—

(i) the distribution of food production by type and size of operation, including monetary value of food sold;

(ii) the proportion of food produced by each type and size of operation;

(iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity;

(iv) the incidence of foodborne illness originating from each size and type of operation and the type of food facilities for which no reported or known hazard exists; and

(v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities.

(B) Size

The results of the study conducted under subparagraph (A) shall include the information necessary to enable the Secretary to define the terms "small business" and "very small business", for purposes of promulgating the regulation under subsection (n). In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested.

(C) Submission of report

Not later than 18 months after January 4, 2011, the Secretary shall submit to Congress a report that describes the results of the study conducted under subparagraph (A).

(6) No preemption

Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production of food. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law.

(7) Notification to consumers

(A) In general

A qualified facility that is exempt from the requirements under subsections (a) through (i) and subsection (n) and does not prepare documentation under paragraph (2)(B)(i)(I) shall—

(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this chapter, include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed; or

(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provisions of this chapter, prominently and conspicuously display, at the point of purchase, the name and business address of the facility where the food was manufactured or processed, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.

(B) No additional label

Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this chapter.

(m) Authority with respect to certain facilities

The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment.

(n) Regulations

(1) In general

Not later than 18 months after January 4, 2011, the Secretary shall promulgate regulations—

(A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under this section; and

(B) to define, for purposes of this section, the terms "small business" and "very small business", taking into consideration the study described in subsection (l)(5).

(2) Coordination

In promulgating the regulations under paragraph (1)(A), with regard to hazards that may be intentionally introduced, including by acts of terrorism, the Secretary shall coordinate with the Secretary of Homeland Security, as appropriate.

(3) Content

The regulations promulgated under paragraph (1)(A) shall—

(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm;

(B) comply with chapter 35 of title 44 (commonly known as the "Paperwork Reduction Act"), with special attention to minimizing the burden (as defined in section 3502(2) of such title) on the facility, and collection of information (as defined in section 3502(3) of such title), associated with such regulations;

(C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and

(D) not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party.

(4) Rule of construction

Nothing in this subsection shall be construed to provide the Secretary with the authority to prescribe specific technologies, practices, or critical controls for an individual facility.

(5) Review

In promulgating the regulations under paragraph (1)(A), the Secretary shall review regulatory hazard analysis and preventive control programs in existence on January 4, 2011, including the Grade "A" Pasteurized Milk Ordinance to ensure that such regulations are consistent, to the extent practicable, with applicable domestic and internationally-recognized standards in existence on such date.

(o) Definitions

For purposes of this section:

(1) Critical control point

The term "critical control point" means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.

(2) Facility

The term "facility" means a domestic facility or a foreign facility that is required to register under section 350d of this title.

(3) Preventive controls

The term "preventive controls" means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following:

(A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment.

(B) Supervisor, manager, and employee hygiene training.

(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.

(D) A food allergen control program.

(E) A recall plan.

(F) Current Good Manufacturing Practices (cGMPs) under part 110 of title 21, Code of Federal Regulations (or any successor regulations).

(G) Supplier verification activities that relate to the safety of food.

(June 25, 1938, ch. 675, §418, as added Pub. L. 111–353, title I, §103(a), Jan. 4, 2011, 124 Stat. 3889.)

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 111–353, title I, §103(i), Jan. 4, 2011, 124 Stat. 3898, provided that:

"(1) General rule.—The amendments made by this section [enacting this section and amending section 331 of this title] shall take effect 18 months after the date of enactment of this Act [Jan. 4, 2011].

"(2) Flexibility for small businesses.—Notwithstanding paragraph (1)—

"(A) the amendments made by this section shall apply to a small business (as defined in the regulations promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g(n)] (as added by this section)) beginning on the date that is 6 months after the effective date of such regulations; and

"(B) the amendments made by this section shall apply to a very small business (as defined in such regulations) beginning on the date that is 18 months after the effective date of such regulations."

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Guidance Document

Pub. L. 111–353, title I, §103(b), Jan. 4, 2011, 124 Stat. 3896, provided that: "The Secretary shall issue a guidance document related to the regulations promulgated under subsection (b)(1) [probably means 21 U.S.C. 350g(n)(1)] with respect to the hazard analysis and preventive controls under section 418 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g] (as added by subsection (a))."

Small Entity Compliance Policy Guide

Pub. L. 111–353, title I, §103(d), Jan. 4, 2011, 124 Stat. 3898, provided that: "Not later than 180 days after the issuance of the regulations promulgated under subsection (n) of section 418 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g(n)] (as added by subsection (a)), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 418 and this section [enacting this section, amending section 331 of this title, and enacting provisions set out as notes under this section and sections 342 and 350d of this title] to assist small entities in complying with the hazard analysis and other activities required under such section 418 and this section."

No Effect on HACCP Authorities

Pub. L. 111–353, title I, §103(f), Jan. 4, 2011, 124 Stat. 3898, provided that: "Nothing in the amendments made by this section [enacting this section and amending section 331 of this title] limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce Hazard Analysis Critical Control [Points] programs and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards."

Dietary Supplements

Pub. L. 111–353, title I, §103(g), Jan. 4, 2011, 124 Stat. 3898, provided that: "Nothing in the amendments made by this section [enacting this section and amending section 331 of this title] shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa–1)."

¹ So in original. Probably should be "title".

§350h. Standards for produce safety

(a) Proposed rulemaking

(1) In general

(A) Rulemaking

Not later than 1 year after January 4, 2011, the Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990 [7 U.S.C. 6501 et seq.]), and in consultation with the Secretary of Homeland Security, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.

(B) Determination by Secretary

With respect to small businesses and very small businesses (as such terms are defined in the regulation promulgated under subparagraph (A)) that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the applicable requirements of regulations promulgated pursuant to this section.

(2) Public input

During the comment period on the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.

(3) Content

The proposed rulemaking under paragraph (1) shall—

(A) provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities;

(B) include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water;

(C) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism;

(D) take into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies;

(E) in the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990, while providing the same level of public health protection as the requirements under guidance documents, including guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act; and

(F) define, for purposes of this section, the terms "small business" and "very small business".

(4) Prioritization

The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities based on known risks which may include a history and severity of foodborne illness outbreaks.

(b) Final regulation

(1) In general

Not later than 1 year after the close of the comment period for the proposed rulemaking under subsection (a), the Secretary shall adopt a final regulation to provide for minimum science-based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks.

(2) Final regulation

The final regulation shall—

(A) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States or the appropriate elected State official as recognized by State statute; and

(B) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant.

(3) Flexibility for small businesses

Notwithstanding paragraph (1)—

(A) the regulations promulgated under this section shall apply to a small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 1 year after the effective date of the final regulation under paragraph (1); and

(B) the regulations promulgated under this section shall apply to a very small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 2 years after the effective date of the final regulation under paragraph (1).

(c) Criteria

(1) In general

The regulations adopted under subsection (b) shall—

(A) set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 342 of this title;

(B) provide sufficient flexibility to be practicable for all sizes and types of businesses, including small businesses such as a small food processing facility co-located on a farm;

(C) comply with chapter 35 of title 44 (commonly known as the "Paperwork Reduction Act"), with special attention to minimizing the burden (as defined in section 3502(2) of such title) on the business, and collection of information (as defined in section 3502(3) of such title), associated with such regulations;

(D) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and

(E) not require a business to hire a consultant or other third party to identify, implement, certify, compliance ¹ with these procedures, processes, and practices, except in the case of negotiated enforcement resolutions that may require such a consultant or third party; and

(F) permit States and foreign countries from which food is imported into the United States to request from the Secretary variances from the requirements of the regulations, subject to paragraph (2), where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 342 of this title and to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b).

(2) Variances

(A) Requests for variances

A State or foreign country from which food is imported into the United States may in writing request a variance from the Secretary. Such request shall describe the variance requested and present information demonstrating that the variance does not increase the likelihood that the food for which the variance is requested will be adulterated under section 342 of this title, and that the variance provides the same level of public health protection as the requirements of the regulations adopted under subsection (b). The Secretary shall review such requests in a reasonable timeframe.

(B) Approval of variances

The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons.

(C) Denial of variances

The Secretary may deny a variance request if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 342 of this title and is not reasonably likely to provide the same level of public health protection as the requirements of the regulation adopted under subsection (b). The Secretary shall notify the person requesting such variance of the reasons for the denial.

(D) Modification or revocation of a variance

The Secretary, after notice and an opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 342 of this title and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b).

(d) Enforcement

The Secretary may coordinate with the Secretary of Agriculture and, as appropriate, shall contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.

(e) Guidance

(1) In general

Not later than 1 year after January 4, 2011, the Secretary shall publish, after consultation with the Secretary of Agriculture, representatives of State departments of agriculture, farmer representatives, and various types of entities engaged in the production and harvesting or importing of fruits and vegetables that are raw agricultural commodities, including small businesses, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce under this section.

(2) Public meetings

The Secretary shall conduct not fewer than 3 public meetings in diverse geographical areas of the United States as part of an effort to conduct education and outreach regarding the guidance described in paragraph (1) for persons in different regions who are involved in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including persons that sell directly to consumers and farmer representatives, and for importers of fruits and vegetables that are raw agricultural commodities.

(3) Paperwork reduction

The Secretary shall ensure that any updated guidance under this section will—

(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; and

(B) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods.

(f) Exemption for direct farm marketing

(1) In general

A farm shall be exempt from the requirements under this section in a calendar year if—

(A) during the previous 3-year period, the average annual monetary value of the food sold by such farm directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers during such period; and

(B) the average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation.

(2) Notification to consumers

(A) In general

A farm that is exempt from the requirements under this section shall—

(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this chapter, include prominently and conspicuously on such label the name and business address of the farm where the produce was grown; or

(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provision of this chapter, prominently and conspicuously display, at the point of purchase, the name and business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.

(B) No additional label

Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this chapter.

(3) Withdrawal; rule of construction

(A) In general

In the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such farm, the Secretary may withdraw the exemption provided to such farm under this subsection.

(B) Rule of construction

Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary.

(4) Definitions

(A) Qualified end-user

In this subsection, the term "qualified end-user", with respect to a food means—

(i) the consumer of the food; or

(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 350d of this title) that is located—

(I) in the same State as the farm that produced the food; or

(II) not more than 275 miles from such farm.

(B) Consumer

For purposes of subparagraph (A), the term "consumer" does not include a business.

(5) No preemption

Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production, harvesting, holding, transportation, and sale of fresh fruits and vegetables. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law.

(6) Limitation of effect

Nothing in this subsection shall prevent the Secretary from exercising any authority granted in the other sections of this chapter.

(g) Clarification

This section shall not apply to produce that is produced by an individual for personal consumption.

(h) Exception for activities of facilities subject to section 350g of this title

This section shall not apply to activities of a facility that are subject to section 350g of this title.

(June 25, 1938, ch. 675, §419, as added Pub. L. 111–353, title I, §105(a), Jan. 4, 2011, 124 Stat. 3899.)

Editorial Notes

References in Text

The Organic Foods Production Act of 1990, referred to in subsec. (a)(1)(A), (3)(E), is title XXI of Pub. L. 101–624, Nov. 28, 1990, 104 Stat. 3935, which is classified generally to chapter 94 (§6501 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 6501 of Title 7 and Tables.

The FDA Food Safety Modernization Act, referred to in subsec. (a)(3)(E), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Scientific and Economic Analysis of the FDA Food Safety Modernization Act

Pub. L. 113–79, title XII, §12311(a), Feb. 7, 2014, 128 Stat. 992, provided that: "When publishing a final rule with respect to 'Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption' published by the Department of Health and Human Services on January 16, 2013 (78 Fed. Reg. 3504), the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall ensure that the final rule (referred to in this section as the 'final rule') includes the following information:

"(1) An analysis of the scientific information used to promulgate the final rule, taking into consideration any information about farming and ranching operations of a variety of sizes, with regional differences, and that have a diversity of production practices and methods.

"(2) An analysis of the economic impact of the final rule.

"(3) A plan to systematically—

"(A) evaluate the impact of the final rule on farming and ranching operations; and

"(B) develop an ongoing process to evaluate and respond to business concerns."

Small Entity Compliance Policy Guide

Pub. L. 111–353, title I, §105(b), Jan. 4, 2011, 124 Stat. 3904, provided that: "Not later than 180 days after the issuance of regulations under section 419 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350h] (as added by subsection (a)), the Secretary of Health and Human Services shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 419 and to assist small entities in complying with standards for safe production and harvesting and other activities required under such section."

No Effect on HACCP Authorities

Pub. L. 111–353, title I, §105(d), Jan. 4, 2011, 124 Stat. 3905, provided that: "Nothing in the amendments made by this section [enacting this section and amending section 331 of this title] limits the authority of the Secretary [of Health and Human Services] under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control [Points] Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards."

¹ So in original. Probably should be "or certify compliance".

§350i. Protection against intentional adulteration

(a) Determinations

(1) In general

The Secretary shall—

(A) conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;

(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and

(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.

(2) Limited distribution

In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which determinations made under paragraph (1) are made publicly available.

(b) Regulations

Not later than 18 months after January 4, 2011, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this chapter. Such regulations shall—

(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and

(2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate.

(c) Applicability

Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection (a), that could cause serious adverse health consequences or death to humans or animals and shall include those foods—

(1) for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and

(2) in bulk or batch form, prior to being packaged for the final consumer.

(d) Exception

This section shall not apply to farms, except for those that produce milk.

(e) Definition

For purposes of this section, the term "farm" has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).

(June 25, 1938, ch. 675, §420, as added Pub. L. 111–353, title I, §106(a), Jan. 4, 2011, 124 Stat. 3905.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Guidance Documents

Pub. L. 111–353, title I, §106(b), Jan. 4, 2011, 124 Stat. 3906, provided that:

"(1) In general.—Not later than 1 year after the date of enactment of this Act [Jan. 4, 2011], the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i], as added by subsection (a).

"(2) Content.—The guidance documents issued under paragraph (1) shall—

"(A) include a model assessment for a person to use under subsection (b)(1) of section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);

"(B) include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and

"(C) specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate.

"(3) Limited distribution.—In the interest of national security, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences."

Periodic Review

Pub. L. 111–353, title I, §106(c), Jan. 4, 2011, 124 Stat. 3906, provided that: "The Secretary of Health and Human Services shall periodically review and, as appropriate, update the regulations under section 420(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i(b)], as added by subsection (a), and the guidance documents under subsection (b) [section 106(b) of Pub. L. 111–353, set out above]."

§350j. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

(a) Identification and inspection of facilities

(1) Identification

The Secretary shall identify high-risk facilities and shall allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors:

(A) The known safety risks of the food manufactured, processed, packed, or held at the facility.

(B) The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

(C) The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls.

(D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under section 381(h)(1) of this title.

(E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 381(q) or 384b of this title, as appropriate.

(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

(2) Inspections

(A) In general

Beginning on January 4, 2011, the Secretary shall increase the frequency of inspection of all facilities.

(B) Domestic high-risk facilities

The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities such that each such facility is inspected—

(i) not less often than once in the 5-year period following January 4, 2011; and

(ii) not less often than once every 3 years thereafter.

(C) Domestic non-high-risk facilities

The Secretary shall ensure that each domestic facility that is not identified under paragraph (1) as a high-risk facility is inspected—

(i) not less often than once in the 7-year period following January 4, 2011; and

(ii) not less often than once every 5 years thereafter.

(D) Foreign facilities

(i) Year 1

In the 1-year period following January 4, 2011, the Secretary shall inspect not fewer than 600 foreign facilities.

(ii) Subsequent years

In each of the 5 years following the 1-year period described in clause (i), the Secretary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary during the previous year.

(E) Reliance on Federal, State, or local inspections

In meeting the inspection requirements under this subsection for domestic facilities, the Secretary may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.

(b) Identification and inspection at ports of entry

The Secretary, in consultation with the Secretary of Homeland Security, shall allocate resources to inspect any article of food imported into the United States according to the known safety risks of the article of food, which shall be based on the following factors:

(1) The known safety risks of the food imported.

(2) The known safety risks of the countries or regions of origin and countries through which such article of food is transported.

(3) The compliance history of the importer, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

(4) The rigor and effectiveness of the activities conducted by the importer of such article of food to satisfy the requirements of the foreign supplier verification program under section 384a of this title.

(5) Whether the food importer participates in the voluntary qualified importer program under section 384b of this title.

(6) Whether the food meets the criteria for priority under section 381(h)(1) of this title.

(7) Whether the food or the facility that manufactured, processed, packed, or held such food received a certification as described in section 381(q) or 384b of this title.

(8) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

(c) Interagency agreements with respect to seafood

(1) In general

The Secretary of Health and Human Services, the Secretary of Commerce, the Secretary of Homeland Security, the Chairman of the Federal Trade Commission, and the heads of other appropriate agencies may enter into such agreements as may be necessary or appropriate to improve seafood safety.

(2) Scope of agreements

The agreements under paragraph (1) may include—

(A) cooperative arrangements for examining and testing seafood imports that leverage the resources, capabilities, and authorities of each party to the agreement;

(B) coordination of inspections of foreign facilities to increase the percentage of imported seafood and seafood facilities inspected;

(C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordination;

(D) coordination to detect and investigate violations under applicable Federal law;

(E) a process, including the use or modification of existing processes, by which officers and employees of the National Oceanic and Atmospheric Administration may be duly designated by the Secretary to carry out seafood examinations and investigations under section 381 of this title or section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004;

(F) the sharing of information concerning observed non-compliance with United States food requirements domestically and in foreign nations and new regulatory decisions and policies that may affect the safety of food imported into the United States;

(G) conducting joint training on subjects that affect and strengthen seafood inspection effectiveness by Federal authorities; and

(H) outreach on Federal efforts to enhance seafood safety and compliance with Federal food safety requirements.

(d) Coordination

The Secretary shall improve coordination and cooperation with the Secretary of Agriculture and the Secretary of Homeland Security to target food inspection resources.

(e) Facility

For purposes of this section, the term "facility" means a domestic facility or a foreign facility that is required to register under section 350d of this title.

(June 25, 1938, ch. 675, §421, as added Pub. L. 111–353, title II, §201(a), Jan. 4, 2011, 124 Stat. 3923.)

Editorial Notes

References in Text

Section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004, referred to in subsec. (c)(2)(E), is section 203 of Pub. L. 108–282, Aug. 2, 2004, 118 Stat. 906, which amended sections 321, 343, and 343–1 of this title and enacted provisions set out as notes under sections 321 and 343 of this title.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Advisory Committee Consultation

Pub. L. 111–353, title II, §201(c), Jan. 4, 2011, 124 Stat. 3926, provided that: "In allocating inspection resources as described in section 421 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450j] (as added by subsection (a)), the Secretary may, as appropriate, consult with any relevant advisory committee within the Department of Health and Human Services."

§350k. Laboratory accreditation for analyses of foods

(a) Recognition of laboratory accreditation

(1) In general

Not later than 2 years after January 4, 2011, the Secretary shall—

(A) establish a program for the testing of food by accredited laboratories;

(B) establish a publicly available registry of accreditation bodies recognized by the Secretary and laboratories accredited by a recognized accreditation body, including the name of, contact information for, and other information deemed appropriate by the Secretary about such bodies and laboratories; and

(C) require, as a condition of recognition or accreditation, as appropriate, that recognized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of such accreditation body or the accreditation of such laboratory.

(2) Program requirements

The program established under paragraph (1)(A) shall provide for the recognition of laboratory accreditation bodies that meet criteria established by the Secretary for accreditation of laboratories, including independent private laboratories and laboratories run and operated by a Federal agency (including the Department of Commerce), State, or locality with a demonstrated capability to conduct 1 or more sampling and analytical testing methodologies for food.

(3) Increasing the number of qualified laboratories

The Secretary shall work with the laboratory accreditation bodies recognized under paragraph (1), as appropriate, to increase the number of qualified laboratories that are eligible to perform testing under subparagraph ¹ (b) beyond the number so qualified on January 4, 2011.

(4) Limited distribution

In the interest of national security, the Secretary, in coordination with the Secretary of Homeland Security, may determine the time, manner, and form in which the registry established under paragraph (1)(B) is made publicly available.

(5) Foreign laboratories

Accreditation bodies recognized by the Secretary under paragraph (1) may accredit laboratories that operate outside the United States, so long as such laboratories meet the accreditation standards applicable to domestic laboratories accredited under this section.

(6) Model laboratory standards

The Secretary shall develop model standards that a laboratory shall meet to be accredited by a recognized accreditation body for a specified sampling or analytical testing methodology and included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall consult existing standards for guidance. The model standards shall include—

(A) methods to ensure that—

(i) appropriate sampling, analytical procedures (including rapid analytical procedures), and commercially available techniques are followed and reports of analyses are certified as true and accurate;

(ii) internal quality systems are established and maintained;

(iii) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and

(iv) individuals who conduct the sampling and analyses are qualified by training and experience to do so; and

(B) any other criteria determined appropriate by the Secretary.

(7) Review of recognition

To ensure compliance with the requirements of this section, the Secretary—

(A) shall periodically, and in no case less than once every 5 years, reevaluate accreditation bodies recognized under paragraph (1) and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition; and

(B) shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section, specifying, as appropriate, any terms and conditions necessary for laboratories accredited by such body to continue to perform testing as described in this section.

(b) Testing procedures

(1) In general

Not later than 30 months after January 4, 2011, food testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Secretary under subsection (a)(1)(B) whenever such testing is conducted—

(A) by or on behalf of an owner or consignee—

(i) in response to a specific testing requirement under this chapter or implementing regulations, when applied to address an identified or suspected food safety problem; and

(ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem; or

(B) on behalf of an owner or consignee—

(i) in support of admission of an article of food under section 381(a) of this title; and

(ii) under an Import Alert that requires successful consecutive tests.

(2) Results of testing

The results of any such testing shall be sent directly to the Food and Drug Administration, except the Secretary may by regulation exempt test results from such submission requirement if the Secretary determines that such results do not contribute to the protection of public health. Test results required to be submitted may be submitted to the Food and Drug Administration through electronic means.

(3) Exception

The Secretary may waive requirements under this subsection if—

(A) a new methodology or methodologies have been developed and validated but a laboratory has not yet been accredited to perform such methodology or methodologies; and

(B) the use of such methodology or methodologies are necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak.

(c) Review by Secretary

If food sampling and testing performed by a laboratory run and operated by a State or locality that is accredited by a recognized accreditation body on the registry established by the Secretary under subsection (a) result in a State recalling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities.

(d) No limit on Secretarial authority

Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, including determining the sufficiency of such information and testing.

(June 25, 1938, ch. 675, §422, as added Pub. L. 111–353, title II, §202(a), Jan. 4, 2011, 124 Stat. 3926.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

¹ So in original. Probably should be "subsection".

§350l. Mandatory recall authority

(a) Voluntary procedures

If the Secretary determines, based on information gathered through the reportable food registry under section 350f of this title or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 342 of this title or misbranded under section 343(w) of this title and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 350f of this title) with an opportunity to cease distribution and recall such article.

(b) Prehearing order to cease distribution and give notice

(1) In general

If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to—

(A) immediately cease distribution of such article; and

(B) as applicable, immediately notify all persons—

(i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and

(ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.¹

(2) Required additional information

(A) In general

If an article of food covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based third party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based third party logistics provider to identify the food.

(B) Rules of construction

Nothing in this paragraph shall be construed—

(i) to exempt a warehouse-based third party logistics provider from the requirements of this chapter, including the requirements in this section and section 350c of this title; or

(ii) to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order.

(3) Determination to limit areas affected

If the Secretary requires a responsible party to cease distribution under paragraph (1)(A) of an article of food identified in subsection (a), the Secretary may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health.

(c) Hearing on order

The Secretary shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled.

(d) Post-hearing recall order and modification of order

(1) Amendment of order

If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate—

(A) amend the order to require recall of such article or other appropriate action;

(B) specify a timetable in which the recall shall occur;

(C) require periodic reports to the Secretary describing the progress of the recall; and

(D) provide notice to consumers to whom such article was, or may have been, distributed.

(2) Vacating of order

If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.

(e) Rule regarding alcoholic beverages

The Secretary shall not initiate a mandatory recall or take any other action under this section with respect to any alcohol beverage until the Secretary has provided the Alcohol and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and recall such article under the Alcohol and Tobacco Tax and Trade Bureau authority.

(f) Cooperation and consultation

The Secretary shall work with State and local public health officials in carrying out this section, as appropriate.

(g) Public notification

In conducting a recall under this section, the Secretary shall—

(1) ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification—

(A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and

(B) that includes, at a minimum—

(i) the name of the article of food subject to the recall;

(ii) a description of the risk associated with such article; and

(iii) to the extent practicable, information for consumers about similar articles of food that are not affected by the recall;

(2) consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public, as determined appropriate by the Secretary; and

(3) if available, publish on the Internet Web site of the Food and Drug Administration an image of the article that is the subject of the press release described in (1).²

(h) No delegation

The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.

(i) Effect

Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this chapter or under the Public Health Service Act [42 U.S.C. 201 et seq.].

(j) Coordinated communication

(1) In general

To assist in carrying out the requirements of this subsection, the Secretary shall establish an incident command operation or a similar operation within the Department of Health and Human Services that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health consequences or death to humans or animals.

(2) Requirements

To reduce the potential for miscommunication during recalls or regarding investigations of a food borne illness outbreak associated with a food that is subject to a recall, each incident command operation or similar operation under paragraph (1) shall use regular staff and resources of the Department of Health and Human Services to—

(A) ensure timely and coordinated communication within the Department, including enhanced communication and coordination between different agencies and organizations within the Department;

(B) ensure timely and coordinated communication from the Department, including public statements, throughout the duration of the investigation and related foodborne illness outbreak;

(C) identify a single point of contact within the Department for public inquiries regarding any actions by the Secretary related to a recall;

(D) coordinate with Federal, State, local, and tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall, including notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a commodity intended for use in a child nutrition program (as identified in section 1769f(b) of title 42); and

(E) conclude operations at such time as the Secretary determines appropriate.

(3) Multiple recalls

The Secretary may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks necessitating such action by the Department of Health and Human Services.

(June 25, 1938, ch. 675, §423, as added Pub. L. 111–353, title II, §206(a), Jan. 4, 2011, 124 Stat. 3939.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (i), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

Search Engine

Pub. L. 111–353, title II, §206(b), Jan. 4, 2011, 124 Stat. 3942, provided that: "Not later than 90 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall modify the Internet Web site of the Food and Drug Administration to include a search engine that—

"(1) is consumer-friendly, as determined by the Secretary; and

"(2) provides a means by which an individual may locate relevant information regarding each article of food subject to a recall under section 423 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350l] and the status of such recall (such as whether a recall is ongoing or has been completed)."

¹ So in original. The words "to immediately cease distribution of such article." probably should follow cl. (ii).

² So in original. Probably should be "paragraph (1)."

§350l–1. Annual report to Congress

(1) In general

Not later than 2 years after January 4, 2011, and annually thereafter, the Secretary of Health and Human Services (referred to in this section as the "Secretary") shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the use of recall authority under section 350l of this title (as added by subsection (a)) ¹ and any public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent danger to health.

(2) Content

The report under paragraph (1) shall include, with respect to the report year—

(A) the identity of each article of food that was the subject of a public health advisory described in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 350l of this title, or a mandatory recall order under subsection (b) of such section;

(B) the number of responsible parties, as defined in section 350f of this title, formally given the opportunity to cease distribution of an article of food and recall such article, as described in section 350l(a) of such title;

(C) the number of responsible parties described in subparagraph (B) who did not cease distribution of or recall an article of food after given the opportunity to cease distribution or recall under section 350l(a) of this title;

(D) the number of recall orders issued under section 350l(b) of this title; and

(E) a description of any instances in which there was no testing that confirmed adulteration of an article of food that was the subject of a recall under section 350l(b) of this title or a public health advisory described in paragraph (1).

(Pub. L. 111–353, title II, §206(f), Jan. 4, 2011, 124 Stat. 3943.)

Editorial Notes

References in Text

Subsection (a), referred to in par. (1), means subsec. (a) of section 206 of Pub. L. 111–353.

Codification

Section was enacted as part of the FDA Food Safety Modernization Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

¹ See References in Text note below.

§350m. Requirements for critical food

(a) Notification of meaningful disruption for critical food

(1) In general

A manufacturer of a critical food (as defined in section 321(ss) of this title) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption.

(2) Distribution of information

Not later than 5 calendar days after receiving a notification under paragraph (1), if the Secretary has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage.

(3) Confidentiality

Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(4) Meaningful disruption

In this subsection, the term "meaningful disruption"—

(A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and

(B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.

(b) Risk management plans

Each manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection—

(1) may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment;

(2) may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means; and

(3) shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 374 of this title.

(c) Failure to meet requirements

(1) In general

If a person fails to submit information required under, and in accordance with, subsection (a)—

(A) the Secretary shall issue a letter to such person informing such person of such failure; and

(B) not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)—

(i) the letter issued under subparagraph (A); and

(ii) at the request of such person, any response to such letter such person submitted to the Secretary.

(2) Exception

If the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not submitting a notification as required under subsection (a), the requirements of paragraph (1)(B) shall not apply.

(June 25, 1938, ch. 675, §424, as added Pub. L. 117–328, div. FF, title III, §3401(k), Dec. 29, 2022, 136 Stat. 5844.)

SUBCHAPTER V—DRUGS AND DEVICES

Part A—Drugs and Devices

§351. Adulterated drugs and devices

A drug or device shall be deemed to be adulterated—

(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture

(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e(a) of this title, or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of section 379e(a) of this title; or (5) if it is a new animal drug which is unsafe within the meaning of section 360b of this title; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 360b of this title.

(b) Strength, quality, or purity differing from official compendium

If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.

(c) Misrepresentation of strength, etc., where drug is unrecognized in compendium

If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

(d) Mixture with or substitution of another substance

If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor.

(e) Devices not in conformity with performance standards

(1) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under section 360d of this title unless such device is in all respects in conformity with such standard.

(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under section 360d(c) of this title unless such device is in all respects in conformity with such standard.

(f) Certain class III devices

(1) If it is a class III device—

(A)(i) which is required by an order issued under subsection (b) of section 360e of this title to have an approval under such section of an application for premarket approval and which is not exempt from section 360e of this title under section 360j(g) of this title, and

(ii)(I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the Secretary within the ninety-day period beginning on the date of the issuance of such order, or

(II) for which such an application was filed and approval of the application has been denied, suspended, or withdrawn, or such a notice was filed and has been declared not completed or the approval of the device under the protocol has been withdrawn;

(B)(i) which was classified under section 360c(f) of this title into class III, which under section 360e(a) of this title is required to have in effect an approved application for premarket approval, and which is not exempt from section 360e of this title under section 360j(g) of this title, and

(ii) which has an application which has been suspended or is otherwise not in effect; or

(C) which was classified under section 360j(l) of this title into class III, which under such section is required to have in effect an approved application under section 360e of this title, and which has an application which has been suspended or is otherwise not in effect.

(2)(A) In the case of a device classified under section 360c(f) of this title into class III and intended solely for investigational use, paragraph ¹ (1)(B) shall not apply with respect to such device during the period ending on the ninetieth day after the date of the promulgation of the regulations prescribing the procedures and conditions required by section 360j(g)(2) of this title.

(B) In the case of a device subject to an order issued under subsection (b) of section 360e of this title, paragraph ¹ (1) shall not apply with respect to such device during the period ending—

(i) on the last day of the thirtieth calendar month beginning after the month in which the classification of the device in class III became effective under section 360c of this title, or

(ii) on the ninetieth day after the date of the issuance of such order,

whichever occurs later.

(3) In the case of a device with respect to which a regulation was promulgated under section 360e(b) of this title prior to July 9, 2012, a reference in this subsection to an order issued under section 360e(b) of this title shall be deemed to include such regulation.

(g) Banned devices

If it is a banned device.

(h) Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions

If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under section 360j(f)(1) of this title or an applicable condition prescribed by an order under section 360j(f)(2) of this title.

(i) Failure to comply with requirements under which device was exempted for investigational use

If it is a device for which an exemption has been granted under section 360j(g) of this title for investigational use and the person who was granted such exemption or any investigator who uses such device under such exemption fails to comply with a requirement prescribed by or under such section.

(j) Delayed, denied, or limited inspection; refusal to permit entry or inspection

If it is a drug or device and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.

For purposes of paragraph (a)(2)(B), the term "current good manufacturing practice" includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.

(June 25, 1938, ch. 675, §501, 52 Stat. 1049; Pub. L. 86–618, title I, §102(b)(1), July 12, 1960, 74 Stat. 398; Pub. L. 87–781, title I, §101, Oct. 10, 1962, 76 Stat. 780; Pub. L. 90–399, §101(a), July 13, 1968, 82 Stat. 343; Pub. L. 94–295, §§3(d), 9(b)(1), May 28, 1976, 90 Stat. 576, 583; Pub. L. 101–629, §9(b), Nov. 28, 1990, 104 Stat. 4521; Pub. L. 102–571, title I, §107(8), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105–115, title I, §121(b)(1), title II, §204(c), Nov. 21, 1997, 111 Stat. 2320, 2336; Pub. L. 112–144, title VI, §608(b)(2), title VII, §§707(a), 711, July 9, 2012, 126 Stat. 1058, 1068, 1071; Pub. L. 115–52, title VII, §702(c), Aug. 18, 2017, 131 Stat. 1056.)

Editorial Notes

Amendments

2017—Par. (j). Pub. L. 115–52 inserted "or device" after "drug".

2012—Pub. L. 112–144, §711, inserted concluding provisions.

Par. (f)(1)(A)(i). Pub. L. 112–144, §608(b)(2)(A)(i), substituted "an order issued" for "a regulation promulgated".

Par. (f)(1)(A)(ii)(I). Pub. L. 112–144, §608(b)(2)(A)(ii), substituted "issuance of such order" for "promulgation of such regulation".

Par. (f)(2)(B). Pub. L. 112–144, §608(b)(2)(B), substituted "an order issued" for "a regulation promulgated" in introductory provisions and "issuance of such order" for "promulgation of such regulation" in subcl. (ii).

Par. (f)(3). Pub. L. 112–144, §608(b)(2)(C), added subpar. (3).

Par. (j). Pub. L. 112–144, §707(a), added par. (j).

1997—Par. (a)(2)(C). Pub. L. 105–115, §121(b)(1), inserted "; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess;" before "or (3)".

Par. (e). Pub. L. 105–115, §204(c), designated existing provisions as subpar. (1) and added subpar. (2).

1992—Par. (a)(4). Pub. L. 102–571 substituted "379e(a)" for "376(a)" in cls. (A) and (B).

1990—Par. (f)(1). Pub. L. 101–629, §9(b), which directed the amendment of subpars. (A) to (C) of par. (f), was executed by making the amendments in cls. (A) to (C) of subpar. (1) of par. (f) as follows to reflect the probable intent of Congress: in cl. (A)(ii)(II), substituted ", suspended, or withdrawn" for "or withdrawn"; in cl. (B)(ii), substituted "which has an application which has been suspended or is otherwise not in effect" for "which does not have such an application in effect"; and in cl. (C), substituted "which has an application which has been suspended or is otherwise not in effect" for "which does not have such an application in effect".

1976—Par. (a). Pub. L. 94–295, §9(b)(1), substituted "(3) if its" for "(3) if it is a drug and its" in cl. (3), substituted "(4) if (A) it bears or contains" for "(4) if (A) it is a drug which bears or contains" in cl. (4)(A), and substituted "drugs or devices" for "drugs" in cl. (4)(B).

Pars. (e) to (i). Pub. L. 94–295, §3(d), added pars. (e) to (i).

1968—Par. (a). Pub. L. 90–399 added cls. (5) and (6).

1962—Par. (a). Pub. L. 87–781 designated existing provisions of cl. (2) as (A) and added (B).

1960—Par. (a). Pub. L. 86–618 substituted provisions in cl. (4) relating to unsafe color additives for provisions which related to a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 354 of this title.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1997 Amendment

Pub. L. 105–115, title I, §121(b)(2), Nov. 21, 1997, 111 Stat. 2320, provided that: "Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of enactment of this Act [Nov. 21, 1997] or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in subsection (c)(1)(B) [section 121(c)(1)(B) of Pub. L. 105–115, set out as a note under section 355 of this title], whichever is later."

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Effective Date of 1962 Amendment; Exceptions

Amendment by Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date; Postponement

Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Approval by Regulation Prior to July 9, 2012

Pub. L. 112–144, title VI, §608(b)(3), July 9, 2012, 126 Stat. 1059, provided that: "The amendments made by this subsection [amending this section and section 360e of this title] shall have no effect on a regulation that was promulgated prior to the date of enactment of this Act [July 9, 2012] requiring that a device have an approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval."

Guidance

Pub. L. 112–144, title VII, §707(b), July 9, 2012, 126 Stat. 1068, provided that: "Not later than 1 year after the date of enactment of this section [July 9, 2012], the Secretary of Health and Human Services shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351(j)] (as added by subsection (a))."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original. Probably should be "subparagraph".

§352. Misbranded drugs and devices

A drug or device shall be deemed to be misbranded—

(a) False or misleading label

(1) If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42. The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.

(2)(A) For purposes of this paragraph,¹ the term "health care economic information" means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug or device. Such analysis may be comparative to the use of another drug or device, to another health care intervention, or to no intervention.

(B) Such term does not include any analysis that relates only to an indication that is not approved under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 for such drug or device.

(b) Package form; contents of label

If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

(c) Prominence of information on label

If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(d) Repealed. Pub. L. 105–115, title I, §126(b), Nov. 21, 1997, 111 Stat. 2327

(e) Designation of drugs or devices by established names

(1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula)—

(i) the established name (as defined in subparagraph (3)) of the drug, if there is such a name;

(ii) the established name and quantity or, if determined to be appropriate by the Secretary, the proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not the established name and quantity or if determined to be appropriate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein, except that the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subclause, shall not apply to nonprescription drugs not intended for human use; and

(iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate by the Secretary, on the immediate container, as prescribed in regulation promulgated by the Secretary, except that nothing in this subclause shall be deemed to require that any trade secret be divulged, and except that the requirements of this subclause with respect to alphabetical order shall apply only to nonprescription drugs that are not also cosmetics and that this subclause shall not apply to nonprescription drugs not intended for human use.

(B) For any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) shall be printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient, except that to the extent that compliance with the requirements of subclause (ii) or (iii) of clause (A) or this clause is impracticable, exemptions shall be established by regulations promulgated by the Secretary.

(2) If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name (as defined in subparagraph (4)) prominently printed in type at least half as large as that used thereon for any proprietary name or designation for such device, except that to the extent compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary.

(3) As used in subparagraph (1), the term "established name", with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to section 358 of this title, or (B), if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph applies, then the common or usual name, if any, of such drug or of such ingredient, except that where clause (B) of this subparagraph applies to an article recognized in the United States Pharmacopeia and in the Homoeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopeia shall apply unless it is labeled and offered for sale as a homoeopathic drug, in which case the official title used in the Homoeopathic Pharmacopoeia shall apply.

(4) As used in subparagraph (2), the term "established name" with respect to a device means (A) the applicable official name of the device designated pursuant to section 358 of this title, (B) if there is no such name and such device is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph applies, then any common or usual name of such device.

(f) Directions for use and warnings on label

Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement. Required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost.

(g) Representations as recognized drug; packing and labeling; inconsistent requirements for designation of drug

If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein. The method of packing may be modified with the consent of the Secretary. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States, and not those of the United States Pharmacopoeia, except that in the event of inconsistency between the requirements of this paragraph and those of paragraph (e) as to the name by which the drug or its ingredients shall be designated, the requirements of paragraph (e) shall prevail.

(h) Deteriorative drugs; packing and labeling

If it has been found by the Secretary to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the public health. No such regulation shall be established for any drug recognized in an official compendium until the Secretary shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements.

(i) Drug; misleading container; imitation; offer for sale under another name

(1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.

(j) Health-endangering when used as prescribed

If it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.

(k), (l) Repealed. Pub. L. 105–115, title I, §125(a)(2)(B), (b)(2)(D), Nov. 21, 1997, 111 Stat. 2325

(m) Color additives; packing and labeling

If it is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, as may be contained in regulations issued under section 379e of this title.

(n) Prescription drug advertisements: established name; quantitative formula; side effects, contraindications, and effectiveness; prior approval; false advertising; labeling; construction of the Convention on Psychotropic Substances

In the case of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of (1) the established name as defined in paragraph (e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under paragraph (e), and (3) such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations which shall be issued by the Secretary in accordance with section 371(a) of this title, and in the case of published direct-to-consumer advertisements the following statement printed in conspicuous text: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.", except that (A) except in extraordinary circumstances, no regulation issued under this paragraph shall require prior approval by the Secretary of the content of any advertisement, and (B) no advertisement of a prescription drug, published after the effective date of regulations issued under this paragraph applicable to advertisements of prescription drugs, shall with respect to the matters specified in this paragraph or covered by such regulations, be subject to the provisions of sections 52 to 57 of title 15. This paragraph (n) shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in section 321(m) of this title. Nothing in the Convention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, shall be construed to prevent drug price communications to consumers. In the case of an advertisement for a drug subject to section 353(b)(1) of this title presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.

(o) Drugs or devices from nonregistered establishments

If it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 360 of this title, if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under section 381(s) of this title, if it was not included in a list required by section 360(j) of this title, if a notice or other information respecting it was not provided as required by such section or section 360(k) of this title, or if it does not bear such symbols from the uniform system for identification of devices prescribed under section 360(e) of this title as the Secretary by regulation requires.

(p) Packaging or labeling of drugs in violation of regulations

If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15.

(q) Restricted devices using false or misleading advertising or used in violation of regulations

In the case of any restricted device distributed or offered for sale in any State, if (1) its advertising is false or misleading in any particular, or (2) it is sold, distributed, or used in violation of regulations prescribed under section 360j(e) of this title.

(r) Restricted devices not carrying requisite accompanying statements in advertisements and other descriptive printed matter

In the case of any restricted device distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that device (1) a true statement of the device's established name as defined in subsection (e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications and, in the case of specific devices made subject to a finding by the Secretary after notice and opportunity for comment that such action is necessary to protect the public health, a full description of the components of such device or the formula showing quantitatively each ingredient of such device to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing. Except in extraordinary circumstances, no regulation issued under this paragraph shall require prior approval by the Secretary of the content of any advertisement and no advertisement of a restricted device, published after the effective date of this paragraph shall, with respect to the matters specified in this paragraph or covered by regulations issued hereunder, be subject to the provisions of sections 52 through 55 of title 15. This paragraph shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in section 321(m) of this title.

(s) Devices subject to performance standards not bearing requisite labeling

If it is a device subject to a performance standard established under section 360d of this title, unless it bears such labeling as may be prescribed in such performance standard.

(t) Devices for which there has been a failure or refusal to give required notification or to furnish required material or information

If it is a device and there was a failure or refusal (1) to comply with any requirement prescribed under section 360h of this title respecting the device, (2) to furnish any material or information required by or under section 360i of this title respecting the device, or (3) to comply with a requirement under section 360l of this title.

(u) Identification of manufacturer

(1) Subject to paragraph (2), if it is a reprocessed single-use device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the reprocessed device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer.

(2) If the original device or an attachment thereto does not prominently and conspicuously bear the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, a reprocessed device may satisfy the requirements of paragraph (1) through the use of a detachable label on the packaging that identifies the manufacturer and is intended to be affixed to the medical record of a patient.

(v) Reprocessed single-use devices

If it is a reprocessed single-use device, unless all labeling of the device prominently and conspicuously bears the statement "Reprocessed device for single use. Reprocessed by ____." The name of the manufacturer of the reprocessed device shall be placed in the space identifying the person responsible for reprocessing.

(w) New animal drugs

If it is a new animal drug—

(1) that is conditionally approved under section 360ccc of this title and its labeling does not conform with the approved application or section 360ccc(f) of this title, or that is not conditionally approved under section 360ccc of this title and its label bears the statement set forth in section 360ccc(f)(1)(A) of this title;

(2) that is indexed under section 360ccc–1 of this title and its labeling does not conform with the index listing under section 360ccc–1(e) of this title or 360ccc–1(h) of this title, or that has not been indexed under section 360ccc–1 of this title and its label bears the statement set forth in section 360ccc–1(h) of this title; or

(3) for which an application has been approved under section 360b of this title and the labeling of such drug does not include the application number in the format: "Approved by FDA under (A)NADA # xxx–xxx", except that this subparagraph shall not apply to representative labeling required under section 514.1(b)(3)(v)(b) of title 21, Code of Federal Regulations (or any successor regulation) for animal feed bearing or containing a new animal drug.

(x) Nonprescription drugs

If it is a nonprescription drug (as defined in section 379aa of this title) that is marketed in the United States, unless the label of such drug includes a domestic address or domestic phone number through which the responsible person (as described in section 379aa of this title) may receive a report of a serious adverse event (as defined in section 379aa of this title) with such drug.

(y) Drugs subject to approved risk evaluation and mitigation strategy

If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to section 355(p) of this title and the responsible person (as such term is used in section 355–1 of this title) fails to comply with a requirement of such strategy provided for under subsection (d), (e), or (f) of section 355–1 of this title.

(z) Postmarket studies and clinical trials; new safety information in labeling

If it is a drug, and the responsible person (as such term is used in section 355(o) of this title) is in violation of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or paragraph (4) (relating to labeling) of section 355(o) of this title with respect to such drug.

(aa) Unpaid fees; failure to submit identifying information

If it is a drug, or an active pharmaceutical ingredient, and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 379j–42(a)(4) of this title or for which identifying information required by section 379j–42(f) of this title has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.

(bb) False or misleading advertisement or promotion of compounded drug

If the advertising or promotion of a compounded drug is false or misleading in any particular.

(cc) Failure to bear product identifier

If it is a drug and it fails to bear the product identifier as required by section 360eee–1 of this title.

(dd) Improper labeling of antimicrobial drugs

If it is an antimicrobial drug, as defined in section 360a–2(f) of this title, and its labeling fails to conform with the requirements under section 360a–2(d) of this title.

(ee) Nonprescription drug subject to regulation

If it is a nonprescription drug that is subject to section 355h of this title, is not the subject of an application approved under section 355 of this title, and does not comply with the requirements under section 355h of this title.

(ff) Drugs manufactured, prepared, propagated, compounded, or processed in facilities for which fees have not been paid

If it is a drug and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 379j–72 of this title.

(gg) Product information prior to approval

(1) Unless its labeling bears adequate directions for use in accordance with paragraph (f), except that (in addition to drugs or devices that conform with exemptions pursuant to such paragraph) no drug or device shall be deemed to be misbranded under such paragraph through the provision of truthful and not misleading product information to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investigational use of a drug or device that is approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable), provided—

(A) the product information includes—

(i) a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable) and that the safety and effectiveness of such drug or device for such use has not been established;

(ii) information related to the stage of development of the drug or device involved, such as—

(I) the status of any study or studies in which the investigational drug or device or investigational use is being investigated;

(II) how the study or studies relate to the overall plan for the development of the drug or device; and

(III) whether an application, premarket notification, or request for classification for the investigational drug or device or investigational use has been submitted to the Secretary and when such a submission is planned;

(iii) in the case of information that includes factual presentations of results from studies, which shall not be selectively presented, a description of—

(I) all material aspects of study design, methodology, and results; and

(II) all material limitations related to the study design, methodology, and results;

(iv) where applicable, a prominent statement disclosing the indication or indications for which the Secretary has approved, granted marketing authorization, cleared, or licensed the product pursuant to section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42, and a copy of the most current required labeling; and

(v) updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status; and

(B) the product information does not include—

(i) information that represents that an unapproved product—

(I) has been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable); or

(II) has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied; or

(ii) information that represents that an unapproved use of a drug or device that has been so approved, granted marketing authorization, cleared, or licensed—

(I) is so approved, granted marketing authorization, cleared, or licensed; or

(II) that the product is safe or effective for the use or uses for which the drug or device is being studied.

(2) For purposes of this paragraph, the term "product information" includes—

(A) information describing the drug or device (such as drug class, device description, and features);

(B) information about the indication or indications being investigated;

(C) the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 355, 360(k), 360c, or 360e of this title or section 262 of title 42;

(D) drug or device pricing information;

(E) patient utilization projections;

(F) product-related programs or services; and

(G) factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy.

(June 25, 1938, ch. 675, §502, 52 Stat. 1050; June 23, 1939, ch. 242, §3, 53 Stat. 854; Dec. 22, 1941, ch. 613, §2, 55 Stat. 851; July 6, 1945, ch. 281, §2, 59 Stat. 463; Mar. 10, 1947, ch. 16, §2, 61 Stat. 11; July 13, 1949, ch. 305, §1, 63 Stat. 409; Aug. 5, 1953, ch. 334, §1, 67 Stat. 389; Pub. L. 86–618, title I, §102(b)(2), July 12, 1960, 74 Stat. 398; Pub. L. 87–781, title I, §§105(c), 112(a), (b), 131(a), title III, §305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90–399, §105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91–601, §6(d), formerly §7(d), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, §1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 94–295, §§3(e), 4(b)(2), 5(a), 9(b)(2), May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95–633, title I, §111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102–300, §3(a)(2), June 16, 1992, 106 Stat. 239; Pub. L. 102–571, title I, §107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §3(m), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105–115, title I, §§114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, §412(c), Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107–250, title II, §206, title III, §§301(a), 302(a)(1), Oct. 26, 2002, 116 Stat. 1613, 1616; Pub. L. 108–214, §2(b)(2)(B), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108–282, title I, §102(b)(5)(E), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109–43, §2(c)(1), Aug. 1, 2005, 119 Stat. 441; Pub. L. 109–462, §2(d), Dec. 22, 2006, 120 Stat. 3472; Pub. L. 110–85, title IX, §§901(d)(3)(A), (6), 902(a), 906(a), Sept. 27, 2007, 121 Stat. 940, 942, 943, 949; Pub. L. 112–144, title III, §306, title VII, §§702(a), 714(c), July 9, 2012, 126 Stat. 1024, 1065, 1074; Pub. L. 112–193, §2(a), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 113–54, title I, §103(b), title II, §206(b), Nov. 27, 2013, 127 Stat. 597, 639; Pub. L. 114–255, div. A, title III, §§3037, 3044(b)(2), Dec. 13, 2016, 130 Stat. 1105, 1121; Pub. L. 115–234, title III, §303(a), Aug. 14, 2018, 132 Stat. 2436; Pub. L. 116–136, div. A, title III, §3852, Mar. 27, 2020, 134 Stat. 454; Pub. L. 117–328, div. FF, title III, §3630(a), Dec. 29, 2022, 136 Stat. 5893.)

Editorial Notes

Amendments

2022—Subsec. (a)(1). Pub. L. 117–328, §3630(a)(1)–(3), substituted "drugs or devices for coverage" for "drugs for coverage", "drug or device" for "drug" in two places, "under section 355 of this title or under section 262(a) of title 42" for "under section 355 of this title or under section 262(a) of title 42", "under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42" for "under section 355 of this title or under section 262 of title 42", and "in section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42" for "in section 355(a) of this title or in subsections (a) and (k) of section 262 of title 42".

Subsec. (a)(2)(A). Pub. L. 117–328, §3630(a)(1)(B), substituted "drug or device" for "drug" in two places.

Subsec. (a)(2)(B). Pub. L. 117–328, §3630(a)(1)(B), (2), substituted "drug or device" for "drug" and "under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42" for "under section 355 of this title or under section 262 of title 42".

Subsec. (gg). Pub. L. 117–328, §3630(a)(4), added subsec. (gg).

2020—Subsecs. (ee), (ff). Pub. L. 116–136 added subsecs. (ee) and (ff).

2018—Subsec. (w)(3). Pub. L. 115–234 added par. (3).

2016—Subsec. (a). Pub. L. 114–255, §3037, designated existing provisions as par. (1), substituted "a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement" for "a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations", "relates" for "directly relates", and ", is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section 355 of this title or under section 262 of title 42. The requirements set forth in section 355(a) of this title or in subsections (a) and (k) of section 262 of title 42 shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph" for "and is based on competent and reliable scientific evidence. The requirements set forth in section 355(a) of this title or in section 262(a) of title 42 shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph", struck out "In this paragraph, the term 'health care economic information' means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention." at end, and added par. (2).

Subsec. (dd). Pub. L. 114–255, §3044(b)(2), added subsec. (dd).

2013—Par. (bb). Pub. L. 113–54, §103(b), added par. (bb).

Par. (cc). Pub. L. 113–54, §206(b), added par. (cc).

2012—Par. (o). Pub. L. 112–144, §714(c), inserted "if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under section 381(s) of this title," after "not duly registered under section 360 of this title,".

Pub. L. 112–144, §702(a), struck out "in any State" after "establishment".

Par. (aa). Pub. L. 112–193 substituted "379j–42(a)(4)" for "379j–41(a)(4)".

Pub. L. 112–144, §306, added par. (aa).

2007—Par. (n). Pub. L. 110–85, §906(a), inserted "and in the case of published direct-to-consumer advertisements the following statement printed in conspicuous text: 'You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.'," after "section 371(a) of this title,".

Pub. L. 110–85, §901(d)(6), substituted "section 371(a) of this title" for "the procedure specified in section 371(e) of this title".

Pub. L. 110–85, §901(d)(3)(A), inserted at end "In the case of an advertisement for a drug subject to section 353(b)(1) of this title presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner."

Pars. (y), (z). Pub. L. 110–85, §902(a), added pars. (y) and (z).

2006—Par. (x). Pub. L. 109–462 added par. (x).

2005—Par. (u). Pub. L. 109–43 amended par. (u) generally. Prior to amendment, par. (u) read as follows: "If it is a device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, except that the Secretary may waive any requirement under this paragraph for the device if the Secretary determines that compliance with the requirement is not feasible for the device or would compromise the provision of reasonable assurance of the safety or effectiveness of the device."

2004—Par. (f). Pub. L. 108–214, in last sentence, inserted "or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments" after "in health care facilities", inserted comma after "means", substituted "requirements of law, and that the manufacturer affords such users the opportunity" for "requirements of law and, that the manufacturer affords health care facilities the opportunity", and struck out "the health care facility" after "promptly provides".

Par. (w). Pub. L. 108–282 added par. (w).

2002—Par. (f). Pub. L. 107–250, §206, inserted at end "Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost."

Par. (u). Pub. L. 107–250, §301(a), which directed amendment of section by adding par. (u) at end, was executed by adding par. (u) before par. (v) to reflect the probable intent of Congress.

Par. (v). Pub. L. 107–250, §302(a)(1), added par. (v).

1997—Par. (a). Pub. L. 105–115, §114(a), inserted at end "Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved under section 355 of this title or under section 262(a) of title 42 for such drug and is based on competent and reliable scientific evidence. The requirements set forth in section 355(a) of this title or in section 262(a) of title 42 shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request. In this paragraph, the term 'health care economic information' means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention."

Par. (d). Pub. L. 105–115, §126(b), struck out par. (d) which read as follows: "If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or any chemical derivative of such substance, which derivative has been by the Secretary, after investigation, found to be, and by regulations designated as, habit forming; unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement 'Warning—May be habit forming.' "

Par. (e)(1). Pub. L. 105–115, §412(c), amended subpar. (1) generally. Prior to amendment, subpar. (1) read as follows: "If it is a drug, unless (A) its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in subparagraph (3)) of the drug, if such there be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury ouabain strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; Provided, That the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this paragraph, shall apply only to prescription drugs; and (B) for any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient: Provided, That to the extent that compliance with the requirements of clause (A)(ii) or clause (B) of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary."

Par. (k). Pub. L. 105–115, §125(a)(2)(B), struck out par. (k) which read as follows: "If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 356 of this title, and (2) such certificate or release is in effect with respect to such drug."

Par. (l). Pub. L. 105–115, §125(b)(2)(D), struck out par. (l) which read as follows: "If it is, or purports to be, or is represented as a drug (except a drug for use in animals other than man) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 357 of this title, and (2) such certificate or release is in effect with respect to such drug: Provided, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under section 357(c) or (d) of this title."

1993—Par. (e)(3). Pub. L. 103–80, §3(m)(1), substituted "of such ingredient, except that" for "of such ingredient: Provided, That".

Par. (f). Pub. L. 103–80, §3(m)(2), substituted "users, except that where" for "users: Provided, That where".

Par. (g). Pub. L. 103–80, §3(m)(3), substituted "prescribed therein. The method" for "prescribed therein: Provided, That the method" and "Pharmacopoeia, except that" for "Pharmacopoeia: Provided further, That,".

Par. (n). Pub. L. 103–80, §3(m)(4), substituted ", except that (A)" for ": Provided, That (A)".

1992—Par. (m). Pub. L. 102–571 substituted "379e" for "376".

Par. (t)(3). Pub. L. 102–300 added cl. (3).

1978—Par. (n). Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances.

1976—Par. (e). Pub. L. 94–295, §5(a), substituted "subparagraph (3)" for "subparagraph (2)" in subpar. (1), added subpar. (2), redesignated former subpar. (2) as (3) and in subpar. (3) as so redesignated substituted "subparagraph (1)" for "this paragraph (e)", and added subpar. (4).

Par. (j). Pub. L. 94–295, §3(e)(2), substituted "dosage or manner," for "dosage,".

Par. (m). Pub. L. 94–295, §9(b)(2), substituted "the intended use of which is for" for "the intended use of which in or on drugs is for".

Par. (o). Pub. L. 94–295, §4(b)(2), substituted "If it was manufactured" for "If it is a drug and was manufactured" and inserted ", if it was not included in a list required by section 360(j) of this title, if a notice or other information respecting it was not provided as required by such section or section 360(k) of this title, or if it does not bear such symbols from the uniform system for identification of devices prescribed under section 360(e) of this title as the Secretary by regulation requires".

Pars. (q) to (t). Pub. L. 94–295, §3(e)(1), added pars. (q) to (t).

1970—Par. (p). Pub. L. 91–601 added par. (p).

1968—Par. (l). Pub. L. 90–399 inserted "(except a drug for use in animals other than man)" after "represented as a drug".

1962—Par. (e). Pub. L. 87–781, §112(a), designated existing provisions as subpar. (1), substituted ", unless (A) its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in subparagraph (2) of this subsection) of the drug, if such there be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity" for "and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2), in case it is fabricated from two or more ingredients, the common or usual name", and "the established name" for "the name", provided that the requirement for stating the quantity of active ingredients, other than those specified in this par., applies only to prescription drugs, and that the established name of a drug on a label is to be printed prominently and in type at least half as large as used for any proprietary designation, and added subpar. (2) defining "established name".

Par. (g). Pub. L. 87–781, §112(b), provided that if there is an inconsistency between the provisions of this par. and those of par. (e), as to the name of a drug, the requirements of par. (e) should prevail.

Par. (l). Pub. L. 87–781, §105(c), substituted "bacitracin, or any other antibiotic drug" for "or bacitracin."

Par. (n). Pub. L. 87–781, §131(a), added par. (n).

Par. (o). Pub. L. 87–781, §305, added par. (o).

1960—Par. (m). Pub. L. 86–618 added par. (m).

1953—Par. (l). Act Aug. 5, 1953, substituted "chlortetracycline" for "aureomycin".

1949—Par. (l). Act July 13, 1949, inserted ", aureomycin, chloramphenicol, or bacitracin" after "streptomycin".

1947—Par. (l). Act Mar. 10, 1947, inserted "or streptomycin" after "penicillin".

1945—Par. (l). Act July 6, 1945, added par. (l).

1941—Par. (k). Act Dec. 22, 1941, added par. (k).

1939—Par. (d). Act June 29, 1939, substituted "name, and quality or proportion" for "name, quantity, and percentage".

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Pub. L. 115–234, title III, §303(b), Aug. 14, 2018, 132 Stat. 2436, provided that: "Section 502(w)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(w)(3)], as added by subsection (a), shall apply beginning on September 30, 2023."

Effective Date of 2012 Amendment

Amendment by section 306 of Pub. L. 112–144 effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–41 of this title.

Effective Date of 2007 Amendment

Amendment by Pub. L. 110–85 effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as a note under section 331 of this title.

Effective Date of 2006 Amendment

Pub. L. 109–462, §2(e)(1), (2), Dec. 22, 2006, 120 Stat. 3472, provided that:

"(1) In general.—Except as provided in paragraph (2), the amendments made by this section [enacting section 379aa of this title and amending this section and section 331 of this title] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006].

"(2) Misbranding.—Section 502(x) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(x)] (as added by this section) shall apply to any nonprescription drug (as defined in such section 502(x)) labeled on or after the date that is 1 year after the date of enactment of this Act [Dec. 22, 2006]."

Effective Date of 2002 Amendment

Pub. L. 107–250, title III, §301(b), Oct. 26, 2002, 116 Stat. 1616, as amended by Pub. L. 108–214, §2(c)(1), Apr. 1, 2004, 118 Stat. 575; Pub. L. 109–43, §2(d), Aug. 1, 2005, 119 Stat. 441, provided that: "Section 502(u) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(u)] (as amended by section 2(c) of the Medical Device User Fee Stabilization Act of 2005 [Pub. L. 109–43])—

"(1) shall be effective—

"(A) with respect to devices described under paragraph (1) of such section, 12 months after the date of enactment of the Medical Device User Fee Stabilization Act of 2005 [Aug. 1, 2005], or the date on which the original device first bears the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, whichever is later; and

"(B) with respect to devices described under paragraph (2) of such section 502(u), 12 months after such date of enactment; and

"(2) shall apply only to devices reprocessed and introduced or delivered for introduction in interstate commerce after such applicable effective date."

Pub. L. 107–250, title III, §302(a)(2), Oct. 26, 2002, 116 Stat. 1616, provided that: "The amendment made by paragraph (1) [amending this section] takes effect 15 months after the date of the enactment of this Act [Oct. 26, 2002], and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date."

Effective Date of 1997 Amendment

Amendment by sections 114(a), 126(b), and 412(c) of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Effective Date of 1962 Amendment

Pub. L. 87–781, title I, §112(c), Oct. 10, 1962, 76 Stat. 791, provided that: "This section [amending this section] shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted [October 1962]."

Pub. L. 87–781, title I, §131(b), Oct. 10, 1962, 76 Stat. 792, provided that: "No drug which was being commercially distributed prior to the date of enactment of this Act [Oct. 10, 1962] shall be deemed to be misbranded under paragraph (n) of section 502 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(n)], as added by this section, until the earlier of the following dates: (1) the first day of the seventh month following the month in which this Act is enacted; or (2) the effective date of regulations first issued under clause (3) of such paragraph (n) in accordance with the procedure specified in section 701(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 371(e)]."

Amendment by Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date; Postponement

Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such paragraphs effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers bearing certain labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date: Postponement in Certain Cases note under section 301 of this title.

Regulations

Pub. L. 110–85, title IX, §901(d)(3)(B), Sept. 27, 2007, 121 Stat. 940, provided that: "Not later than 30 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 [Sept. 27, 2007], the Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement relating to side effects and contraindications of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner required under such section."

Construction of 2016 Amendment

Nothing in amendment by section 3044(b)(2) of Pub. L. 114–255 to be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under section 356(h) of this title, by health care professionals, or to limit the practice of health care, see section 3043 of Pub. L. 114–255, set out as a note under section 356 of this title.

Presentation of Prescription Drug Benefit and Risk Information

Pub. L. 111–148, title III, §3507, Mar. 23, 2010, 124 Stat. 530, provided that:

"(a) In General.—The Secretary of Health and Human Services (referred to in this section as the 'Secretary'), acting through the Commissioner of Food and Drugs, shall determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers.

"(b) Review and Consultation.—In making the determination under subsection (a), the Secretary shall review all available scientific evidence and research on decisionmaking and social and cognitive psychology and consult with drug manufacturers, clinicians, patients and consumers, experts in health literacy, representatives of racial and ethnic minorities, and experts in women's and pediatric health.

"(c) Report.—Not later than 1 year after the date of enactment of this Act [Mar. 23, 2010], the Secretary shall submit to Congress a report that provides—

"(1) the determination by the Secretary under subsection (a); and

"(2) the reasoning and analysis underlying that determination.

"(d) Authority.—If the Secretary determines under subsection (a) that the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers, then the Secretary, not later than 3 years after the date of submission of the report under subsection (c), shall promulgate proposed regulations as necessary to implement such format.

"(e) Clarification.—Nothing in this section shall be construed to restrict the existing authorities of the Secretary with respect to benefit and risk information."

Guidance; Misbranded Devices

Pub. L. 109–43, §2(c)(2), Aug. 1, 2005, 119 Stat. 441, provided that: "Not later than 180 days after the date of enactment of this Act [Aug. 1, 2005], the Secretary of Health and Human Services shall issue guidance to identify circumstances in which the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, is not 'prominent and conspicuous', as used in section 502(u) of Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(u)] (as amended by paragraph (1))."

Studies

Pub. L. 110–85, title IX, §906(b), Sept. 27, 2007, 121 Stat. 950, provided that:

"(1) In general.—In the case of direct-to-consumer television advertisements, the Secretary of Health and Human Services, in consultation with the Advisory Committee on Risk Communication under section 567 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–6] (as added by section 917), shall, not later than 6 months after the date of the enactment of this Act [Sept. 27, 2007], conduct a study to determine if the statement in section 502(n) of such Act [21 U.S.C. 352(n)] (as added by subsection (a)) required with respect to published direct-to-consumer advertisements is appropriate for inclusion in such television advertisements.

"(2) Content.—As part of the study under paragraph (1), such Secretary shall consider whether the information in the statement described in paragraph (1) would detract from the presentation of risk information in a direct-to-consumer television advertisement. If such Secretary determines the inclusion of such statement is appropriate in direct-to-consumer television advertisements, such Secretary shall issue regulations requiring the implementation of such statement in direct-to-consumer television advertisements, including determining a reasonable length of time for displaying the statement in such advertisements. The Secretary shall report to the appropriate committees of Congress the findings of such study and any plans to issue regulations under this paragraph."

Pub. L. 108–173, title I, §107(f), Dec. 8, 2003, 117 Stat. 2171, directed the Secretary of Health and Human Services to undertake a study of how to make prescription pharmaceutical information, including drug labels and usage instructions, accessible to blind and visually-impaired individuals, and to submit a report to Congress not later than 18 months after Dec. 8, 2003.

Pub. L. 105–115, title I, §114(b), Nov. 21, 1997, 111 Stat. 2312, provided that: "The Comptroller General of the United States shall conduct a study of the implementation of the provisions added by the amendment made by subsection (a) [amending this section]. Not later than 4 years and 6 months after the date of enactment of this Act [Nov. 21, 1997], the Comptroller General of the United States shall prepare and submit to Congress a report containing the findings of the study."

Counterfeiting of Drugs; Congressional Findings and Declaration of Policy

Pub. L. 89–74, §9(a), July 15, 1965, 79 Stat. 234, provided that: "The Congress finds and declares that there is a substantial traffic in counterfeit drugs simulating the brand or other identifying mark or device of the manufacturer of the genuine article; that such traffic poses a serious hazard to the health of innocent consumers of such drugs because of the lack of proper qualifications, facilities, and manufacturing controls on the part of the counterfeiter, whose operations are clandestine; that, while such drugs are deemed misbranded within the meaning of section 502(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(i)], the controls for the suppression of the traffic in such drugs are inadequate because of the difficulty of determining the place of interstate origin of such drugs and, if that place is discovered, the fact that the implements for counterfeiting are not subject to seizure, and that these factors require enactment of additional controls with respect to such drugs without regard to their interstate or intrastate origins."

Provisions as effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as an Effective Date of 1965 Amendment note under section 321 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original. The term "health care economic information" appears only in par. (1).

§353. Exemptions and consideration for certain drugs, devices, and biological products

(a) Regulations for goods to be processed, labeled, or repacked elsewhere

The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.

(b) Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws

(1) A drug intended for use by man which—

(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or

(B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug;

shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

(2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 352 of this title, except paragraphs (a), (i)(2) and (3), (k), and (l), and the packaging requirements of paragraphs (g), (h), and (p), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection.

(3) The Secretary may by regulation remove drugs subject to section 355 of this title from the requirements of paragraph (1) of this subsection when such requirements are not necessary for the protection of the public health.

(4)(A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing the label of the drug fails to bear, at a minimum, the symbol "Rx only".

(B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing the label of the drug bears the symbol described in subparagraph (A).

(5) Nothing in this subsection shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifications stated in sections 4721, 6001, and 6151 of title 26, or to marihuana as defined in section 4761 of title 26.

(c) Sales restrictions

(1) No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug sample. For purposes of this paragraph and subsection (d), the term "drug sample" means a unit of a drug, subject to subsection (b), which is not intended to be sold and is intended to promote the sale of the drug. Nothing in this paragraph shall subject an officer or executive of a drug manufacturer or distributor to criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade in violation of this paragraph by other employees of the manufacturer or distributor.

(2) No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any coupon. For purposes of this paragraph, the term "coupon" means a form which may be redeemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with subsection (b).

(3)(A) No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug—

(i) which is subject to subsection (b), and

(ii)(I) which was purchased by a public or private hospital or other health care entity, or

(II) which was donated or supplied at a reduced price to a charitable organization described in section 501(c)(3) of title 26.

(B) Subparagraph (A) does not apply to—

(i) the purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities which are members of such organization,

(ii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by an organization described in subparagraph (A)(ii)(II) to a nonprofit affiliate of the organization to the extent otherwise permitted by law,

(iii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities which are under common control,

(iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons, or

(v) a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription executed in accordance with subsection (b).

For purposes of this paragraph, the term "entity" does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law and the term "emergency medical reasons" includes transfers of a drug between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the drug arising from delays in or interruptions of regular distribution schedules.

(d) Distribution of drug samples

(1) Except as provided in paragraphs (2) and (3), no person may distribute any drug sample. For purposes of this subsection, the term "distribute" does not include the providing of a drug sample to a patient by a—

(A) practitioner licensed to prescribe such drug,

(B) health care professional acting at the direction and under the supervision of such a practitioner, or

(C) pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner and that received such sample pursuant to paragraph (2) or (3).

(2)(A) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may, in accordance with this paragraph, distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. Such a distribution of drug samples may only be made—

(i) in response to a written request for drug samples made on a form which meets the requirements of subparagraph (B), and

(ii) under a system which requires the recipient of the drug sample to execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or authorized distributor of record.

(B) A written request for a drug sample required by subparagraph (A)(i) shall contain—

(i) the name, address, professional designation, and signature of the practitioner making the request,

(ii) the identity of the drug sample requested and the quantity requested,

(iii) the name of the manufacturer of the drug sample requested, and

(iv) the date of the request.

(C) Each drug manufacturer or authorized distributor of record which makes distributions by mail or common carrier under this paragraph shall maintain, for a period of 3 years, the request forms submitted for such distributions and the receipts submitted for such distributions and shall maintain a record of distributions of drug samples which identifies the drugs distributed and the recipients of the distributions. Forms, receipts, and records required to be maintained under this subparagraph shall be made available by the drug manufacturer or authorized distributor of record to Federal and State officials engaged in the regulation of drugs and in the enforcement of laws applicable to drugs.

(3) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may, by means other than mail or common carrier, distribute drug samples only if the manufacturer or authorized distributor of record makes the distributions in accordance with subparagraph (A) and carries out the activities described in subparagraphs (B) through (F) as follows:

(A) Drug samples may only be distributed—

(i) to practitioners licensed to prescribe such drugs if they make a written request for the drug samples, or

(ii) at the written request of such a licensed practitioner, to pharmacies of hospitals or other health care entities.

A written request for drug samples shall be made on a form which contains the practitioner's name, address, and professional designation, the identity of the drug sample requested, the quantity of drug samples requested, the name of the manufacturer or authorized distributor of record of the drug sample, the date of the request and signature of the practitioner making the request.

(B) Drug manufacturers or authorized distributors of record shall store drug samples under conditions that will maintain their stability, integrity, and effectiveness and will assure that the drug samples will be free of contamination, deterioration, and adulteration.

(C) Drug manufacturers or authorized distributors of record shall conduct, at least annually, a complete and accurate inventory of all drug samples in the possession of representatives of the manufacturer or authorized distributor of record. Drug manufacturers or authorized distributors of record shall maintain lists of the names and address of each of their representatives who distribute drug samples and of the sites where drug samples are stored. Drug manufacturers or authorized distributors of record shall maintain records for at least 3 years of all drug samples distributed, destroyed, or returned to the manufacturer or authorized distributor of record, of all inventories maintained under this subparagraph, of all thefts or significant losses of drug samples, and of all requests made under subparagraph (A) for drug samples. Records and lists maintained under this subparagraph shall be made available by the drug manufacturer or authorized distributor of record to the Secretary upon request.

(D) Drug manufacturers or authorized distributors of record shall notify the Secretary of any significant loss of drug samples and any known theft of drug samples.

(E) Drug manufacturers or authorized distributors of record shall report to the Secretary any conviction of their representatives for violations of subsection (c)(1) or a State law because of the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample.

(F) Drug manufacturers or authorized distributors of record shall provide to the Secretary the name and telephone number of the individual responsible for responding to a request for information respecting drug samples.

(4) In this subsection, the term "authorized distributors of record" means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products.

(e) Licensing and reporting requirements for wholesale distributors; fees; definitions

(1) Requirement.—Subject to section 360eee–2 of this title:

(A) In general.—No person may engage in wholesale distribution of a drug subject to subsection (b)(1) in any State unless such person—

(i)(I) is licensed by the State from which the drug is distributed; or

(II) if the State from which the drug is distributed has not established a licensure requirement, is licensed by the Secretary; and

(ii) if the drug is distributed interstate, is licensed by the State into which the drug is distributed if the State into which the drug is distributed requires the licensure of a person that distributes drugs into the State.

(B) Standards.—Each Federal and State license described in subparagraph (A) shall meet the standards, terms, and conditions established by the Secretary under section 360eee–2 of this title.

(2) Reporting and database.—

(A) Reporting.—Beginning January 1, 2015, any person who owns or operates an establishment that engages in wholesale distribution shall—

(i) report to the Secretary, on an annual basis pursuant to a schedule determined by the Secretary—

(I) each State by which the person is licensed and the appropriate identification number of each such license; and

(II) the name, address, and contact information of each facility at which, and all trade names under which, the person conducts business; and

(ii) report to the Secretary within a reasonable period of time and in a reasonable manner, as determined by the Secretary, any significant disciplinary actions, such as the revocation or suspension of a wholesale distributor license, taken by a State or the Federal Government during the reporting period against the wholesale distributor.

(B) Database.—Not later than January 1, 2015, the Secretary shall establish a database of authorized wholesale distributors. Such database shall—

(i) identify each authorized wholesale distributor by name, contact information, and each State where such wholesale distributor is appropriately licensed to engage in wholesale distribution;

(ii) be available to the public on the Internet Web site of the Food and Drug Administration; and

(iii) be regularly updated on a schedule determined by the Secretary.

(C) Coordination.—The Secretary shall establish a format and procedure for appropriate State officials to access the information provided pursuant to subparagraph (A) in a prompt and secure manner.

(D) Confidentiality.—Nothing in this paragraph shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(3) Costs.—

(A) Authorized fees of secretary.—If a State does not establish a licensing program for persons engaged in the wholesale distribution of a drug subject to subsection (b), the Secretary shall license a person engaged in wholesale distribution located in such State and may collect a reasonable fee in such amount necessary to reimburse the Secretary for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section. The Secretary shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.

(B) State licensing fees.—Nothing in this chapter shall prohibit States from collecting fees from wholesale distributors in connection with State licensing of such distributors.

(4) For the purposes of this subsection and subsection (d), the term "wholesale distribution" means the distribution of a drug subject to subsection (b) to a person other than a consumer or patient, or receipt of a drug subject to subsection (b) by a person other than the consumer or patient, but does not include—

(A) intracompany distribution of any drug between members of an affiliate or within a manufacturer;

(B) the distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control;

(C) the distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act [42 U.S.C. 247d], except that, for purposes of this paragraph, a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(D) the dispensing of a drug pursuant to a prescription executed in accordance with subsection (b)(1);

(E) the distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use;

(F) the distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

(G) the purchase or other acquisition by a dispenser, hospital, or other health care entity of a drug for use by such dispenser, hospital, or other health care entity;

(H) the distribution of a drug by the manufacturer of such drug;

(I) the receipt or transfer of a drug by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership of the drug;

(J) a common carrier that transports a drug, provided that the common carrier does not take ownership of the drug;

(K) the distribution of a drug, or an offer to distribute a drug by an authorized repackager that has taken ownership or possession of the drug and repacks it in accordance with section 360eee–1(e) of this title;

(L) salable drug returns when conducted by a dispenser;

(M) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this subparagraph as a "medical convenience kit") if—

(i) the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance with section 360(b)(2) of this title;

(ii) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.];

(iii) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit—

(I) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and

(II) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and

(iv) in the case of a medical convenience kit that includes a product, the product is—

(I) an intravenous solution intended for the replenishment of fluids and electrolytes;

(II) a product intended to maintain the equilibrium of water and minerals in the body;

(III) a product intended for irrigation or reconstitution;

(IV) an anesthetic;

(V) an anticoagulant;

(VI) a vasopressor; or

(VII) a sympathomimetic;

(N) the distribution of an intravenous drug that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);

(O) the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;

(P) the distribution of a drug that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;

(Q) the distribution of medical gas, as defined in section 360ddd of this title;

(R) facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments; or

(S) the transfer of a product by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital or other health care entity, to a repackager described in section 360eee(16)(B) of this title and registered under section 360 of this title for the purpose of repackaging the drug for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the drug remains with the hospital or other health care entity at all times.

(5) Third-party logistics providers.—Notwithstanding paragraphs (1) through (4), each entity that meets the definition of a third-party logistics provider under section 360eee(22) of this title shall obtain a license as a third-party logistics provider as described in section 360eee–3(a) of this title and is not required to obtain a license as a wholesale distributor if the entity never assumes an ownership interest in the product it handles.

(6) Affiliate.—For purposes of this subsection, the term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has the power to control, both of the business entities.

(f) Veterinary prescription drugs

(1)(A) A drug intended for use by animals other than man, other than a veterinary feed directive drug intended for use in animal feed or an animal feed bearing or containing a veterinary feed directive drug, which—

(i) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary for its use, is not safe for animal use except under the professional supervision of a licensed veterinarian, or

(ii) is limited by an approved application under subsection (b) of section 360b of this title, a conditionally-approved application under section 360ccc of this title, or an index listing under section 360ccc–1 of this title to use under the professional supervision of a licensed veterinarian,

shall be dispensed only by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian's professional practice.

(B) For purposes of subparagraph (A), an order is lawful if the order—

(i) is a prescription or other order authorized by law,

(ii) is, if an oral order, promptly reduced to writing by the person lawfully filling the order, and filed by that person, and

(iii) is refilled only if authorized in the original order or in a subsequent oral order promptly reduced to writing by the person lawfully filling the order, and filed by that person.

(C) The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

(2) Any drug when dispensed in accordance with paragraph (1) of this subsection—

(A) shall be exempt from the requirements of section 352 of this title, except subsections (a), (g), (h), (i)(2), (i)(3), and (p) of such section, and

(B) shall be exempt from the packaging requirements of subsections (g), (h), and (p) of such section, if—

(i) when dispensed by a licensed veterinarian, the drug bears a label containing the name and address of the practitioner and any directions for use and cautionary statements specified by the practitioner, or

(ii) when dispensed by filling the lawful order of a licensed veterinarian, the drug bears a label containing the name and address of the dispenser, the serial number and date of the order or of its filling, the name of the licensed veterinarian, and the directions for use and cautionary statements, if any, contained in such order.

The preceding sentence shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail.

(3) The Secretary may by regulation exempt drugs for animals other than man subject to section 360b, 360ccc, or 360ccc–1 of this title from the requirements of paragraph (1) when such requirements are not necessary for the protection of the public health.

(4) A drug which is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.". A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the statement specified in the preceding sentence.

(g) Regulation of combination products

(1)(A) The Secretary shall, in accordance with this subsection, assign a primary agency center to regulate products that constitute a combination of a drug, device, or biological product.

(B) The Secretary shall conduct the premarket review of any combination product under a single application, whenever appropriate.

(C) For purposes of this subsection, the term "primary mode of action" means the single mode of action of a combination product expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.

(D) The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—

(i) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction;

(ii) a device, the agency center charged with premarket review of devices shall have primary jurisdiction; or

(iii) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction.

(E) In determining the primary mode of action of a combination product, the Secretary shall not determine that the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body.

(F) If a sponsor of a combination product disagrees with the determination under subparagraph (D)—

(i) such sponsor may request, and the Secretary shall provide, a substantive rationale to such sponsor that references scientific evidence provided by the sponsor and any other scientific evidence relied upon by the Secretary to support such determination; and

(ii)(I) the sponsor of the combination product may propose one or more studies (which may be nonclinical, clinical, or both) to establish the relevance, if any, of the chemical action in achieving the primary mode of action of such product;

(II) if the sponsor proposes any such studies, the Secretary and the sponsor of such product shall collaborate and seek to reach agreement, within a reasonable time of such proposal, not to exceed 90 calendar days, on the design of such studies; and

(III) if an agreement is reached under subclause (II) and the sponsor conducts one or more of such studies, the Secretary shall consider the data resulting from any such study when reevaluating the determination of the primary mode of action of such product, and unless and until such reevaluation has occurred and the Secretary issues a new determination, the determination of the Secretary under subparagraph (D) shall remain in effect.

(2)(A) ¹ (i) To establish clarity and certainty for the sponsor, the sponsor of a combination product may request a meeting on such combination product. If the Secretary concludes that a determination of the primary mode of action pursuant to paragraph (1)(D) is necessary, the sponsor may request such meeting only after the Secretary makes such determination. If the sponsor submits a written meeting request, the Secretary shall, not later than 75 calendar days after receiving such request, meet with the sponsor of such combination product.

(ii) A meeting under clause (i) may—

(I) address the standards and requirements for market approval or clearance of the combination product;

(II) address other issues relevant to such combination product, such as requirements related to postmarket modification of such combination product and good manufacturing practices applicable to such combination product; and

(III) identify elements under subclauses (I) and (II) that may be more appropriate for discussion and agreement with the Secretary at a later date given that scientific or other information is not available, or agreement is otherwise not feasible regarding such elements, at the time a request for such meeting is made.

(iii) Any agreement under this subparagraph shall be in writing and made part of the administrative record by the Secretary.

(iv) Any such agreement shall remain in effect, except—

(I) upon the written agreement of the Secretary and the sponsor or applicant; or

(II) pursuant to a decision by the director of the reviewing division of the primary agency center, or a person more senior than such director, in consultation with consulting centers and the Office, as appropriate, that an issue essential to determining whether the standard for market clearance or other applicable standard under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] applicable to the combination product has been identified since the agreement was reached, or that deviating from the agreement is otherwise justifiable based on scientific evidence, for public health reasons.

(3) For purposes of conducting the premarket review of a combination product that contains an approved constituent part described in paragraph (4), the Secretary may require that the sponsor of such combination product submit to the Secretary only data or information that the Secretary determines is necessary to meet the standard for clearance or approval, as applicable, under this chapter or the Public Health Service Act, including any incremental risks and benefits posed by such combination product, using a risk-based approach and taking into account any prior finding of safety and effectiveness or substantial equivalence for the approved constituent part relied upon by the applicant in accordance with paragraph (5).

(4) For purposes of paragraph (3), an approved constituent part is—

(A) a drug constituent part of a combination product being reviewed in a single application or request under section 360e, 360(k), or 360c(f)(2) of this title (submitted in accordance with paragraph (5)), that is an approved drug, provided such application or request complies with paragraph (5);

(B) a device constituent part approved under section 360e of this title that is referenced by the sponsor and that is available for use by the Secretary under section 360j(h)(4) of this title; or

(C) any constituent part that was previously approved, cleared, or classified under section 355, 360(k), 360c(f)(2), or 360e of this title for which the sponsor has a right of reference or any constituent part that is a nonprescription drug, as defined in section 379aa(a)(2) of this title.

(5)(A) If an application is submitted under section 360e or 360(k) of this title or a request is submitted under section 360c(f)(2) of this title, consistent with any determination made under paragraph (1)(D), for a combination product containing as a constituent part an approved drug—

(i) the application or request shall include the certification or statement described in section 355(b)(2) of this title; and

(ii) the applicant or requester shall provide notice as described in section 355(b)(3) of this title.

(B) For purposes of this paragraph and paragraph (4), the term "approved drug" means an active ingredient—

(i) that was in an application previously approved under section 355(c) of this title;

(ii) where such application is relied upon by the applicant submitting the application or request described in subparagraph (A);

(iii) for which full reports of investigations that have been made to show whether such drug is safe for use and whether such drug is effective in use were not conducted by or for the applicant submitting the application or request described in subparagraph (A); and

(iv) for which the applicant submitting the application or request described in subparagraph (A) has not obtained a right of reference or use from the person by or for whom the investigations described in clause (iii) were conducted.

(C) The following provisions shall apply with respect to an application or request described in subparagraph (A) to the same extent and in the same manner as if such application or request were an application described in section 355(b)(2) of this title that referenced the approved drug:

(i) Subparagraphs (A), (B), (C), and (D) of section 355(c)(3) of this title.

(ii) Clauses (ii), (iii), and (iv) of section 355(c)(3)(E) of this title.

(iii) Subsections (b) and (c) of section 355a of this title.

(iv) Section 355f(a) of this title.

(v) Section 360cc(a) of this title.

(D) Notwithstanding any other provision of this subsection, an application or request for classification for a combination product described in subparagraph (A) shall be considered an application submitted under section 355(b)(2) of this title for purposes of section 271(e)(2)(A) of title 35.

(6) Nothing in this subsection shall be construed as prohibiting a sponsor from submitting separate applications for the constituent parts of a combination product, unless the Secretary determines that a single application is necessary.

(7) Nothing in this subsection shall prevent the Secretary from using any agency resources of the Food and Drug Administration necessary to ensure adequate review of the safety, effectiveness, or substantial equivalence of an article.

(8)(A) Not later than 60 days after October 26, 2002, the Secretary shall establish within the Office of the Commissioner of Food and Drugs an office to ensure the prompt assignment of combination products to agency centers, the timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law. Additionally, the office shall, in determining whether a product is to be designated a combination product, consult with the component within the Office of the Commissioner of Food and Drugs that is responsible for such determinations. Such office (referred to in this paragraph as the "Office") shall have appropriate scientific and medical expertise, and shall be headed by a director.

(B) In carrying out this subsection, the Office shall, for each combination product, promptly assign an agency center with primary jurisdiction in accordance with paragraph (1) for the premarket review of such product.

(C)(i) In carrying out this subsection, the Office shall help to ensure timely and effective premarket review that involves more than one agency center by coordinating such reviews, overseeing the timeliness of such reviews, and overseeing the alignment of feedback regarding such reviews.

(ii) In order to ensure the timeliness and alignment of the premarket review of a combination product, the agency center with primary jurisdiction for the product, and the consulting agency center, shall be responsible to the Office with respect to the timeliness and alignment of the premarket review.

(iii) The Office shall ensure that, with respect to a combination product, a designated person or persons in the primary agency center is the primary point or points of contact for the sponsor of such combination product. The Office shall also coordinate communications to and from any consulting center involved in such premarket review, if requested by such primary agency center or any such consulting center. Agency communications and commitments, to the extent consistent with other provisions of law and the requirements of all affected agency centers, from the primary agency center shall be considered as communication from the Secretary on behalf of all agency centers involved in the review.

(iv) The Office shall, with respect to the premarket review of a combination product—

(I) ensure that any meeting between the Secretary and the sponsor of such product is attended by each agency center involved in the review, as appropriate;

(II) ensure that each consulting agency center has completed its premarket review and provided the results of such review to the primary agency center in a timely manner; and

(III) ensure that each consulting center follows the guidance described in clause (vi) and advises, as appropriate, on other relevant regulations, guidances, and policies.

(v) In seeking agency action with respect to a combination product, the sponsor of such product—

(I) shall identify the product as a combination product; and

(II) may request in writing the participation of representatives of the Office in meetings related to such combination product, or to have the Office otherwise engage on such regulatory matters concerning the combination product.

(vi) Not later than 4 years after December 13, 2016, and after a public comment period of not less than 60 calendar days, the Secretary shall issue a final guidance that describes—

(I) the structured process for managing pre-submission interactions with sponsors developing combination products;

(II) the best practices for ensuring that the feedback in such pre-submission interactions represents the Agency's best advice based on the information provided during such pre-submission interactions; ²

(III) the information that is required to be submitted with a meeting request under paragraph (2), how such meetings relate to other types of meetings in the Food and Drug Administration, and the form and content of any agreement reached through a meeting under such paragraph (2); ³

(D) In carrying out this subsection, the Office shall ensure the consistency and appropriateness of postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law.

(E)(i) Any dispute regarding the timeliness of the premarket review of a combination product may be presented to the Office for resolution, unless the dispute is clearly premature.

(ii) During the review process, any dispute regarding the substance of the premarket review may be presented to the Commissioner of Food and Drugs after first being considered by the agency center with primary jurisdiction of the premarket review, under the scientific dispute resolution procedures for such center. The Commissioner of Food and Drugs shall consult with the Director of the Office in resolving the substantive dispute.

(F) The Secretary, acting through the Office, shall review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers and shall determine whether the agreement, guidance, or practice is consistent with the requirements of this subsection. In carrying out such review, the Secretary shall consult with stakeholders and the directors of the agency centers. After such consultation, the Secretary shall determine whether to continue in effect, modify, revise, or eliminate such agreement, guidance, or practice, and shall publish in the Federal Register a notice of the availability of such modified or revised agreement, guidance or practice. Nothing in this paragraph shall be construed as preventing the Secretary from following each agreement, guidance, or practice until continued, modified, revised, or eliminated.

(G) Not later than one year after October 26, 2002 (except with respect to clause (iv), beginning not later than one year after December 13, 2016), and annually thereafter, the Secretary shall report to the appropriate committees of Congress on the activities and impact of the Office. The report shall include provisions—

(i) describing the numbers and types of combination products under review and the timeliness in days of such assignments, reviews, and dispute resolutions;

(ii) identifying the number of premarket reviews of such products that involved a consulting agency center;

(iii) describing improvements in the consistency of postmarket regulation of combination products; and

(iv) identifying the percentage of combination products for which a dispute resolution, with respect to premarket review, was requested by the combination product's sponsor.

(H) Nothing in this paragraph shall be construed to limit the regulatory authority of any agency center.

(9) As used in this subsection:

(A) The term "agency center" means a center or alternative organizational component of the Food and Drug Administration.

(B) The term "biological product" has the meaning given the term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).

(C) The term "market clearance" includes—

(i) approval of an application under section 355, 357,⁴ 360e, or 360j(g) of this title;

(ii) a finding of substantial equivalence under this part;

(iii) approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act (42 U.S.C. 262); and

(iv) de novo classification under section 360c(a)(1) of this title.

(D) The terms "premarket review" and "reviews" include all activities of the Food and Drug Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section 355, 360(k), 360c(f)(2), 360e, or 360j of this title or under section 351 of the Public Health Service Act [42 U.S.C. 262], including with respect to investigational use of the product.

(h) Regulation of certain products as drugs

(1) Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under section 321(g) of this title and not a device under section 321(h) of this title.

(2) For purposes of this subsection:

(A) The term "contrast agent" means an article that is intended for use in conjunction with a medical imaging device, and—

(i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.

(B) The term "radioactive drug" has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regulations), except that such term does not include—

(i) an implant or article similar to an implant;

(ii) an article that applies radiation from outside of the body; or

(iii) the radiation source of an article described in clause (i) or (ii).

(C) The term "OTC monograph drug" has the meaning given such term in section 379j–71 of this title.

(3) Nothing in this subsection shall be construed as allowing for the classification of a product as a drug (as defined in section 321(g) of this title) if such product—

(A) is not described in paragraph (1); and

(B) meets the definition of a device under section 321(h) of this title,

unless another provision of this chapter otherwise indicates a different classification.

(4) The Secretary shall waive the application fee under sections 379h and 379j–42 of this title for applications for drugs that are—

(A) on September 30, 2022, legally marketed as devices; and

(B) deemed drugs pursuant to paragraph (1) ⁵

(June 25, 1938, ch. 675, §503, 52 Stat. 1051; Oct. 26, 1951, ch. 578, §1, 65 Stat. 648; Pub. L. 87–781, title I, §104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91–601, §6(e), formerly §7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, §1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 100–293, §§4–6, Apr. 22, 1988, 102 Stat. 96–98; Pub. L. 100–670, title I, §105, Nov. 16, 1988, 102 Stat. 3983; Pub. L. 101–629, §16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102–108, §2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102–300, §6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102–353, §§2(a)–(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104–250, §5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105–115, title I, §§123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324, 2327, 2328; Pub. L. 107–250, title II, §204, Oct. 26, 2002, 116 Stat. 1611; Pub. L. 108–282, title I, §102(b)(5)(F), Aug. 2, 2004, 118 Stat. 903; Pub. L. 113–54, title II, §204(a)(1)–(4), (b), Nov. 27, 2013, 127 Stat. 630–635; Pub. L. 114–255, div. A, title III, §3038(a), Dec. 13, 2016, 130 Stat. 1105; Pub. L. 117–328, div. FF, title III, §3621, Dec. 29, 2022, 136 Stat. 5877.)

Editorial Notes

References in Text

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in subsec. (e)(4)(M)(ii), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to chapter 13 (§801 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Public Health Service Act, referred to in subsec. (g)(2)(A)(iv)(II), (3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Section 357 of this title, referred to in subsec. (g)(9)(C)(i), was repealed by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

Codification

In subsec. (b)(5), "sections 4721, 6001, and 6151 of title 26" and "section 4761 of title 26" substituted for "section 3220 of the Internal Revenue Code (26 U.S.C. 3220)" and "section 3238(b) of the Internal Revenue Code (26 U.S.C. 3238(b))", respectively, on authority of section 7852(b) of Title 26, Internal Revenue Code.

Amendments

2022—Subsec. (h). Pub. L. 117–328 added subsec. (h).

2016—Subsec. (g)(1). Pub. L. 114–255, §3038(a)(4), added par. (1) and struck out former par. (1) which read as follows: "The Secretary shall in accordance with this subsection assign an agency center to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—

"(A) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction,

"(B) a device, the agency center charged with premarket review of devices shall have primary jurisdiction, or

"(C) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction."

Subsec. (g)(2). Pub. L. 114–255, §3038(a)(4), added par. (2). Former par. (2) redesignated (7).

Subsec. (g)(3). Pub. L. 114–255, §3038(a)(1), (4), added par. (3) and struck out former par. (3) which read as follows: "The Secretary shall promulgate regulations to implement market clearance procedures in accordance with paragraphs (1) and (2) not later than 1 year after November 28, 1990."

Subsec. (g)(4) to (6). Pub. L. 114–255, §3038(a)(4), added pars. (4) to (6). Former pars. (4) and (5) redesignated (8) and (9), respectively.

Subsec. (g)(7). Pub. L. 114–255, §3038(a)(2), redesignated par. (2) as (7).

Subsec. (g)(8). Pub. L. 114–255, §3038(a)(3), redesignated par. (4) as (8).

Subsec. (g)(8)(C)(i). Pub. L. 114–255, §3038(a)(5)(A)(i), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "In carrying out this subsection, the Office shall ensure timely and effective premarket reviews by overseeing the timeliness of and coordinating reviews involving more than one agency center."

Subsec. (g)(8)(C)(ii). Pub. L. 114–255, §3038(a)(5)(A)(ii), inserted "and alignment" after "the timeliness" in two places.

Subsec. (g)(8)(C)(iii) to (vi). Pub. L. 114–255, §3038(a)(5)(A)(iii), added cls. (iii) to (vi).

Subsec. (g)(8)(G). Pub. L. 114–255, §3038(a)(5)(B)(i), inserted "(except with respect to clause (iv), beginning not later than one year after December 13, 2016)" after "October 26, 2002" in introductory provisions.

Subsec. (g)(8)(G)(iv). Pub. L. 114–255, §3038(a)(5)(B)(ii)–(iv), added cl. (iv).

Subsec. (g)(9). Pub. L. 114–255, §3038(a)(3), redesignated par. (5) as (9).

Subsec. (g)(9)(C). Pub. L. 114–255, §3038(a)(6)(A), substituted semicolon for comma at end of cl. (i), semicolon for ", and" at end of cl. (ii), and "; and" for period at end of cl. (iii), and added cl. (iv).

Subsec. (g)(9)(D). Pub. L. 114–255, §3038(a)(6)(B), added subpar. (D).

2013—Subsec. (d)(4). Pub. L. 113–54, §204(b), added par. (4).

Subsec. (e). Pub. L. 113–54, §204(a)(1)–(4), added pars. (1) to (6) and struck out former pars. (1) to (3). Prior to amendment, pars. (1) to (3) set out certain disclosure and licensing requirements for wholesale distributors and defined "authorized distributors of record" and "wholesale distribution".

2004—Subsec. (f)(1)(A)(ii). Pub. L. 108–282, §102(b)(5)(F)(i), substituted "360b of this title, a conditionally-approved application under section 360ccc of this title, or an index listing under section 360ccc–1 of this title" for "360b of this title".

Subsec. (f)(3). Pub. L. 108–282, §102(b)(5)(F)(ii), substituted "section 360b, 360ccc, or 360ccc–1" for "section 360b".

2002—Subsec. (g)(1). Pub. L. 107–250, §204(1)(A), substituted "shall in accordance with this subsection assign an agency center" for "shall designate a component of the Food and Drug Administration" in first sentence of introductory provisions.

Subsec. (g)(1)(A) to (C). Pub. L. 107–250, §204(1)(B), substituted "the agency center charged" for "the persons charged".

Subsec. (g)(4). Pub. L. 107–250, §204(3), added par. (4). Former par. (4) redesignated (5).

Subsec. (g)(5). Pub. L. 107–250, §204(2), (4), redesignated par. (4) as (5), added subpar. (A), and redesignated former subpars. (A) and (B) as (B) and (C), respectively.

1997—Subsec. (b)(1)(A) to (C). Pub. L. 105–115, §126(c)(1), redesignated subpars. (B) and (C) as (A) and (B), respectively, and struck out former subpar. (A), which read as follows: "is a habit-forming drug to which section 352(d) of this title applies; or".

Subsec. (b)(3). Pub. L. 105–115, §126(c)(2), struck out reference to section 352(d) of this title before "355".

Subsec. (b)(4). Pub. L. 105–115, §126(a), amended par. (4) generally. Prior to amendment, par. (4) read as follows: "A drug which is subject to paragraph (1) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement 'Caution: Federal law prohibits dispensing without prescription'. A drug to which paragraph (1) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence."

Subsec. (g)(4)(A). Pub. L. 105–115, §123(e)(1), substituted "section 351(i)" for "section 351(a)" and "262(i)" for "262(a)".

Subsec. (g)(4)(B)(iii). Pub. L. 105–115, §123(e)(2), substituted "biologics license application under subsection (a)" for "product or establishment license under subsection (a) or (d)".

1996—Subsec. (f)(1)(A). Pub. L. 104–250 inserted ", other than a veterinary feed directive drug intended for use in animal feed or an animal feed bearing or containing a veterinary feed directive drug," after "other than man" in introductory provisions.

1992—Subsec. (d)(1). Pub. L. 102–353, §4(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Except as provided in paragraphs (2) and (3), no representative of a drug manufacturer or distributor may distribute any drug sample."

Subsec. (d)(2). Pub. L. 102–353, §4(2), substituted "authorized distributor of record" for "distributor" wherever appearing.

Subsec. (d)(3). Pub. L. 102–353, §4(2), substituted "authorized distributor of record" for "distributor" and "authorized distributors of record" for "distributors" wherever appearing.

Subsec. (e)(1). Pub. L. 102–353, §4(3), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Each person who is engaged in the wholesale distribution of drugs subject to subsection (b) of this section and who is not an authorized distributor of record of such drugs shall provide to each wholesale distributor of such drugs a statement identifying each sale of the drug (including the date of the sale) before the sale to such wholesale distributor. Each manufacturer shall maintain at its corporate offices a current list of such authorized distributors."

Subsec. (e)(2)(A). Pub. L. 102–353, §2(a), (d), temporarily inserted "or has registered with the Secretary in accordance with paragraph (3)". See Termination Date of 1992 Amendment note below.

Subsec. (e)(3). Pub. L. 102–353, §2(b), (d), temporarily added par. (3). Former par. (3) redesignated (4). See Termination Date of 1992 Amendment note below.

Subsec. (e)(4). Pub. L. 102–353, §4(4), inserted "and subsection (d) of this section" after "For the purposes of this subsection".

Pub. L. 102–353, §2(b), (d), temporarily redesignated par. (3) as (4). See Termination Date of 1992 Amendment note below.

Subsec. (f)(1)(B). Pub. L. 102–353, §2(c), which directed the substitution of "an order" for "and order", could not be executed because "and order" did not appear in subpar. (B).

Subsec. (g)(3). Pub. L. 102–300 substituted "clearance" for "approval".

1991—Subsec. (c). Pub. L. 102–108, §2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f). Former subsec. (f) redesignated (g).

Subsec. (c)(2), (3)(B)(v). Pub. L. 102–108, §2(d)(1), made technical amendment to reference to subsection (b) of this section involving corresponding provision of original act.

Subsec. (d)(3)(E). Pub. L. 102–108, §2(d)(2), made technical amendment to reference to subsection (c)(1) of this section involving corresponding provision of original act.

Subsec. (f). Pub. L. 102–108, §2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).

Pub. L. 102–108, §2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f).

Subsec. (g). Pub. L. 102–108, §2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).

1990—Pub. L. 101–629, §16(a)(1), substituted "Exemptions and consideration for certain drugs, devices, and biological products" for "Exemptions in case of drugs and devices" in section catchline.

Subsec. (f). Pub. L. 101–629, §16(a)(2), added subsec. (f).

1988—Subsec. (c). Pub. L. 100–670 added subsec. (c) relating to veterinary prescription drugs.

Pub. L. 100–293, §4, added subsec. (c) relating to sales restrictions.

Subsec. (d). Pub. L. 100–293, §5, added subsec. (d).

Subsec. (e). Pub. L. 100–293, §6, added subsec. (e).

1970—Subsec. (b)(2). Pub. L. 91–601 included exemption from packaging requirements of subsec. (p) of section 352 of this title.

1962—Subsec. (b)(1)(C). Pub. L. 87–781 substituted "approved" for "effective".

1951—Subsec. (b). Act Oct. 26, 1951, amended subsec. (b) generally to protect the public from abuses in the sale of potent prescription drugs, and to relieve retail pharmacists and the public from unnecessary restrictions on the dispensation of drugs that are safe to use without supervision of a doctor.

Statutory Notes and Related Subsidiaries

Effective Date of 2013 Amendment

Pub. L. 113–54, title II, §204(c), Nov. 27, 2013, 127 Stat. 636, provided that: "The amendments made by subsections (a) and (b) [enacting section 360eee–2 of this title and amending this section] shall take effect on January 1, 2015."

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Termination Date of 1992 Amendment

Pub. L. 102–353, §2(d), Aug. 26, 1992, 106 Stat. 941, provided that: "Effective September 14, 1994, the amendments made by subsections (a) and (b) [amending this section] shall no longer be in effect."

Effective Date of 1988 Amendment

Pub. L. 100–293, §8, Apr. 22, 1988, 102 Stat. 100, provided that:

"(a) General Rule.—Except as provided in subsection (b), this Act and the amendments made by this Act [amending this section and sections 331, 333, and 381 of this title and enacting provisions set out as notes under this section and section 301 of this title] shall take effect upon the expiration of 90 days after the date of the enactment of this Act [Apr. 22, 1988].

"(b) Exception.—

"(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take effect upon the expiration of 180 days after the date of the enactment of this Act [Apr. 22, 1988].

"(2) The Secretary of Health and Human Services shall by regulation issue the guidelines required by section 503(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(e)(2)(B)] (as added by section 6 of this Act) not later than 180 days after the date of the enactment of this Act. Section 503(e)(2)(A) of such Act shall take effect upon the expiration of 2 years after the date such regulations are promulgated and take effect."

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1951 Amendment

Amendment by act Oct. 26, 1951, effective six months after Oct. 26, 1951, see section 3 of act Oct. 26, 1951, set out as a note under section 333 of this title.

Effective Medication Guides

Pub. L. 104–180, title VI, §601, Aug. 6, 1996, 110 Stat. 1593, provided that:

"(a) In General.—Not later than 30 days after the date of enactment of this Act [Aug. 6, 1996], the Secretary of the Department of Health and Human Services shall request that national organizations representing health care professionals, consumer organizations, voluntary health agencies, the pharmaceutical industry, drug wholesalers, patient drug information database companies, and other relevant parties collaborate to develop a long-range comprehensive action plan to achieve goals consistent with the goals of the proposed rule of the Food and Drug Administration on 'Prescription Drug Product Labeling: Medication Guide Requirements' (60 Fed. Reg. 44182; relating to the provision of oral and written prescription information to consumers).

"(b) Goals.—Goals consistent with the proposed rule described in subsection (a) are the distribution of useful written information to 75 percent of individuals receiving new precriptions [sic] by the year 2000 and to 95 percent by the year 2006.

"(c) Plan.—The plan described in subsection (a) shall—

"(1) identify the plan goals;

"(2) assess the effectiveness of the current private-sector approaches used to provide oral and written prescription information to consumers;

"(3) develop guidelines for providing effective oral and written prescription information consistent with the findings of any such assessment;

"(4) contain elements necessary to ensure the transmittal of useful information to the consuming public, including being scientifically accurate, non-promotional in tone and content, sufficiently specific and comprehensive as to adequately inform consumers about the use of the product, and in an understandable, legible format that is readily comprehensible and not confusing to consumers expected to use the product.[;]

"(5) develop a mechanism to assess periodically the quality of the oral and written prescription information and the frequency with which the information is provided to consumers; and

"(6) provide for compliance with relevant State board regulations.

"(d) Limitation on the Authority of the Secretary.—The Secretary of the Department of Health and Human Services shall have no authority to implement the proposed rule described in subsection (a), or to develop any similar regulation, policy statement, or other guideline specifying a uniform content or format for written information voluntarily provided to consumers about prescription drugs if, (1) not later than 120 days after the date of enactment of this Act [Aug. 6, 1996], the national organizations described in subsection (a) develop and submit to the Secretary for Health and Human Services a comprehensive, long-range action plan (as described in subsection (a)) which shall be acceptable to the Secretary of Health and Human Services; (2) the aforementioned plan is submitted to the Secretary of Health and Human Services for review and acceptance: Provided, That the Secretary shall give due consideration to the submitted plan and that any such acceptance shall not be arbitrarily withheld; and (3) the implementation of (a) a plan accepted by the Secretary commences within 30 days of the Secretary's acceptance of such plan, or (b) the plan submitted to the Secretary commences within 60 days of the submission of such plan if the Secretary fails to take any action on the plan within 30 days of the submission of the plan. The Secretary shall accept, reject or suggest modifications to the plan submitted within 30 days of its submission. The Secretary may confer with and assist private parties in the development of the plan described in subsections (a) and (b).

"(e) Secretary Review.—Not later than January 1, 2001, the Secretary of the Department of Health and Human Services shall review the status of private-sector initiatives designed to achieve the goals of the plan described in subsection (a), and if such goals are not achieved, the limitation in subsection (d) shall not apply, and the Secretary shall seek public comment on other initiatives that may be carried out to meet such goals."

Congressional Findings

Pub. L. 100–293, §2, Apr. 22, 1988, 102 Stat. 95, provided that: "The Congress finds the following:

"(1) American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective.

"(2) The integrity of the distribution system for prescription drugs is insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit drugs.

"(3) The existence and operation of a wholesale submarket, commonly known as the 'diversion market', prevents effective control over or even routine knowledge of the true sources of prescription drugs in a significant number of cases.

"(4) Large amounts of drugs are being reimported to the United States as American goods returned. These imports are a health and safety risk to American consumers because they may have become subpotent or adulterated during foreign handling and shipping.

"(5) The ready market for prescription drug reimports has been the catalyst for a continuing series of frauds against American manufacturers and has provided the cover for the importation of foreign counterfeit drugs.

"(6) The existing system of providing drug samples to physicians through manufacturer's representatives has been abused for decades and has resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals.

"(7) The bulk resale of below wholesale priced prescription drugs by health care entities, for ultimate sale at retail, helps fuel the diversion market and is an unfair form of competition to wholesalers and retailers that must pay otherwise prevailing market prices.

"(8) The effect of these several practices and conditions is to create an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs will be sold to American consumers."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original. No subpar. (B) has been enacted.

² So in original. The word "and" probably should appear.

³ So in original. The semicolon probably should be a period.

⁴ See References in Text note below.

⁵ So in original. Probably should be followed by a period.

§353a. Pharmacy compounding

(a) In general

Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding—

(1) is by—

(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or

(B) a licensed physician,

on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or

(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and

(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between—

(i) the licensed pharmacist or licensed physician; and

(ii)(I) such individual patient for whom the prescription order will be provided; or

(II) the physician or other licensed practitioner who will write such prescription order.

(b) Compounded drug

(1) Licensed pharmacist and licensed physician

A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician—

(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations—

(i) that—

(I) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;

(II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or

(III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (c);

(ii) that are manufactured by an establishment that is registered under section 360 of this title (including a foreign establishment that is registered under section 360(i) of this title); and

(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;

(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;

(C) does not compound a drug product that appears on a list published by the Secretary in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective; and

(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.

(2) Definition

For purposes of paragraph (1)(D), the term "essentially a copy of a commercially available drug product" does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.

(3) Drug product

A drug product may be compounded under subsection (a) only if—

(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product; and

(B) such drug product is compounded in a State—

(i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or

(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.

The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the States in complying with subparagraph (B)(i).

(c) Regulations

(1) In general

The Secretary shall issue regulations to implement this section. Before issuing regulations to implement subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Secretary shall convene and consult an advisory committee on compounding unless the Secretary determines that the issuance of such regulations before consultation is necessary to protect the public health. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy, physician, and consumer organizations, and other experts selected by the Secretary.

(2) Limiting compounding

The Secretary, in consultation with the United States Pharmacopoeia Convention, Incorporated, shall promulgate regulations identifying drug substances that may be used in compounding under subsection (b)(1)(A)(i)(III) for which a monograph does not exist or which are not components of drug products approved by the Secretary. The Secretary shall include in the regulation the criteria for such substances, which shall include historical use, reports in peer reviewed medical literature, or other criteria the Secretary may identify.

(d) Application

This section shall not apply to—

(1) compounded positron emission tomography drugs as defined in section 321(ii) of this title; or

(2) radiopharmaceuticals.

(e) "Compounding" defined

As used in this section, the term "compounding" does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.

(June 25, 1938, ch. 675, §503A, as added Pub. L. 105–115, title I, §127(a), Nov. 21, 1997, 111 Stat. 2328; amended Pub. L. 113–54, title I, §106(a), Nov. 27, 2013, 127 Stat. 598.)

Editorial Notes

Amendments

2013—Subsec. (a). Pub. L. 113–54, §106(a)(1), struck out "unsolicited" before "receipt of a valid prescription" in introductory provisions.

Subsec. (b)(1)(A)(i)(III). Pub. L. 113–54, §106(a)(4), substituted "subsection (c)" for "subsection (d)".

Subsecs. (c) to (f). Pub. L. 113–54, §106(a)(2), (3), redesignated subsecs. (d) to (f) as (c) to (e), respectively, and struck out former subsec. (c). Prior to amendment, subsec. (c) read as follows: "A drug may be compounded under subsection (a) of this section only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and promote the compounding service provided by the licensed pharmacist or licensed physician."

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 105–115, title I, §127(b), Nov. 21, 1997, 111 Stat. 2330, provided that: "Section 503A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by subsection (a), shall take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act [Nov. 21, 1997]."

§353a–1. Enhanced communication

(a) Submissions from State boards of pharmacy

In a manner specified by the Secretary of Health and Human Services (referred to in this section as the "Secretary"), the Secretary shall receive submissions from State boards of pharmacy—

(1) describing actions taken against compounding pharmacies, as described in subsection (b); or

(2) expressing concerns that a compounding pharmacy may be acting contrary to section 353a of this title.

(b) Content of submissions from State boards of pharmacy

An action referred to in subsection (a)(1) is, with respect to a pharmacy that compounds drugs, any of the following:

(1) The issuance of a warning letter, or the imposition of sanctions or penalties, by a State for violations of a State's pharmacy regulations pertaining to compounding.

(2) The suspension or revocation of a State-issued pharmacy license or registration for violations of a State's pharmacy regulations pertaining to compounding.

(3) The recall of a compounded drug due to concerns relating to the quality or purity of such drug.

(c) Consultation

The Secretary shall implement subsection (a) in consultation with the National Association of Boards of Pharmacy.

(d) Notifying State boards of pharmacy

The Secretary shall immediately notify State boards of pharmacy when—

(1) the Secretary receives a submission under subsection (a)(1); or

(2) the Secretary makes a determination that a pharmacy is acting contrary to section 353a of this title.

(Pub. L. 113–54, title I, §105, Nov. 27, 2013, 127 Stat. 597.)

Editorial Notes

Codification

Section was enacted as part of the Compounding Quality Act and also as part of the Drug Quality and Security Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§353b. Outsourcing facilities

(a) In general

Sections 352(f)(1), 355, and 360eee–1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met:

(1) Registration and reporting

The drug is compounded in an outsourcing facility that is in compliance with the requirements of subsection (b).

(2) Bulk drug substances

The drug is compounded in an outsourcing facility that does not compound using bulk drug substances (as defined in section 207.3(a)(4) of title 21, Code of Federal Regulations (or any successor regulation)), unless—

(A)(i) the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need, by—

(I) publishing a notice in the Federal Register proposing bulk drug substances to be included on the list, including the rationale for such proposal;

(II) providing a period of not less than 60 calendar days for comment on the notice; and

(III) publishing a notice in the Federal Register designating bulk drug substances for inclusion on the list; or

(ii) the drug compounded from such bulk drug substance appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing;

(B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph;

(C) the bulk drug substances are each manufactured by an establishment that is registered under section 360 of this title (including a foreign establishment that is registered under section 360(i) of this title); and

(D) the bulk drug substances are each accompanied by a valid certificate of analysis.

(3) Ingredients (other than bulk drug substances)

If any ingredients (other than bulk drug substances) are used in compounding the drug, such ingredients comply with the standards of the applicable United States Pharmacopeia or National Formulary monograph, if such monograph exists, or of another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph if any.

(4) Drugs withdrawn or removed because unsafe or not effective

The drug does not appear on a list published by the Secretary of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective.

(5) Essentially a copy of an approved drug

The drug is not essentially a copy of one or more approved drugs.

(6) Drugs presenting demonstrable difficulties for compounding

The drug—

(A) is not identified (directly or as part of a category of drugs) on a list published by the Secretary, through the process described in subsection (c), of drugs or categories of drugs that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients; or

(B) is compounded in accordance with all applicable conditions identified on the list described in subparagraph (A) as conditions that are necessary to prevent the drug or category of drugs from presenting the demonstrable difficulties described in subparagraph (A).

(7) Elements to assure safe use

In the case of a drug that is compounded from a drug that is the subject of a risk evaluation and mitigation strategy approved with elements to assure safe use pursuant to section 355–1 of this title, or from a bulk drug substance that is a component of such drug, the outsourcing facility demonstrates to the Secretary prior to beginning compounding that such facility will utilize controls comparable to the controls applicable under the relevant risk evaluation and mitigation strategy.

(8) Prohibition on wholesaling

The drug will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug. This paragraph does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 353(b)(1) of this title.

(9) Fees

The drug is compounded in an outsourcing facility that has paid all fees owed by such facility pursuant to section 379j–62 of this title.

(10) Labeling of drugs

(A) Label

The label of the drug includes—

(i) the statement "This is a compounded drug." or a reasonable comparable alternative statement (as specified by the Secretary) that prominently identifies the drug as a compounded drug;

(ii) the name, address, and phone number of the applicable outsourcing facility; and

(iii) with respect to the drug—

(I) the lot or batch number;

(II) the established name of the drug;

(III) the dosage form and strength;

(IV) the statement of quantity or volume, as appropriate;

(V) the date that the drug was compounded;

(VI) the expiration date;

(VII) storage and handling instructions;

(VIII) the National Drug Code number, if available;

(IX) the statement "Not for resale", and, if the drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement "Office Use Only"; and

(X) subject to subparagraph (B)(i), a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.

(B) Container

The container from which the individual units of the drug are removed for dispensing or for administration (such as a plastic bag containing individual product syringes) shall include—

(i) the information described under subparagraph (A)(iii)(X), if there is not space on the label for such information;

(ii) the following information to facilitate adverse event reporting: www.fda.gov/medwatch and 1–800–FDA–1088 (or any successor Internet Web site or phone number); and

(iii) directions for use, including, as appropriate, dosage and administration.

(C) Additional information

The label and labeling of the drug shall include any other information as determined necessary and specified in regulations promulgated by the Secretary.

(11) Outsourcing facility requirement

The drug is compounded in an outsourcing facility in which the compounding of drugs occurs only in accordance with this section.

(b) Registration of outsourcing facilities and reporting of drugs

(1) Registration of outsourcing facilities

(A) Annual registration

Upon electing and in order to become an outsourcing facility, and during the period beginning on October 1 and ending on December 31 of each year thereafter, a facility—

(i) shall register with the Secretary its name, place of business, and unique facility identifier (which shall conform to the requirements for the unique facility identifier established under section 360 of this title), and a point of contact email address; and

(ii) shall indicate whether the outsourcing facility intends to compound a drug that appears on the list in effect under section 356e of this title during the subsequent calendar year.

(B) Availability of registration for inspection; list

(i) Registrations

The Secretary shall make available for inspection, to any person so requesting, any registration filed pursuant to this paragraph.

(ii) List

The Secretary shall make available on the public Internet Web site of the Food and Drug Administration a list of the name of each facility registered under this subsection as an outsourcing facility, the State in which each such facility is located, whether the facility compounds from bulk drug substances, and whether any such compounding from bulk drug substances is for sterile or nonsterile drugs.

(2) Drug reporting by outsourcing facilities

(A) In general

Upon initially registering as an outsourcing facility, once during the month of June of each year, and once during the month of December of each year, each outsourcing facility that registers with the Secretary under paragraph (1) shall submit to the Secretary a report—

(i) identifying the drugs compounded by such outsourcing facility during the previous 6-month period; and

(ii) with respect to each drug identified under clause (i), providing the active ingredient, the source of such active ingredient, the National Drug Code number of the source drug or bulk active ingredient, if available, the strength of the active ingredient per unit, the dosage form and route of administration, the package description, the number of individual units produced, and the National Drug Code number of the final product, if assigned.

(B) Form

Each report under subparagraph (A) shall be prepared in such form and manner as the Secretary may prescribe by regulation or guidance.

(C) Confidentiality

Reports submitted under this paragraph shall be exempt from inspection under paragraph (1)(B)(i), unless the Secretary finds that such an exemption would be inconsistent with the protection of the public health.

(3) Electronic registration and reporting

Registrations and drug reporting under this subsection (including the submission of updated information) shall be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting waiver.

(4) Risk-based inspection frequency

(A) In general

Outsourcing facilities—

(i) shall be subject to inspection pursuant to section 374 of this title; and

(ii) shall not be eligible for the exemption under section 374(a)(2)(A) of this title.

(B) Risk-based schedule

The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect outsourcing facilities in accordance with a risk-based schedule established by the Secretary.

(C) Risk factors

In establishing the risk-based schedule, the Secretary shall inspect outsourcing facilities according to the known safety risks of such outsourcing facilities, which shall be based on the following factors:

(i) The compliance history of the outsourcing facility.

(ii) The record, history, and nature of recalls linked to the outsourcing facility.

(iii) The inherent risk of the drugs compounded at the outsourcing facility.

(iv) The inspection frequency and history of the outsourcing facility, including whether the outsourcing facility has been inspected pursuant to section 374 of this title within the last 4 years.

(v) Whether the outsourcing facility has registered under this paragraph as an entity that intends to compound a drug that appears on the list in effect under section 356e of this title.

(vi) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

(5) Adverse event reporting

Outsourcing facilities shall submit adverse event reports to the Secretary in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).

(c) Regulations

(1) In general

The Secretary shall implement the list described in subsection (a)(6) through regulations.

(2) Advisory committee on compounding

Before issuing regulations to implement subsection (a)(6), the Secretary shall convene and consult an advisory committee on compounding. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations.

(3) Interim list

(A) In general

Before the effective date of the regulations finalized to implement subsection (a)(6), the Secretary may designate drugs, categories of drugs, or conditions as described such ¹ subsection by—

(i) publishing a notice of such substances, drugs, categories of drugs, or conditions proposed for designation, including the rationale for such designation, in the Federal Register;

(ii) providing a period of not less than 60 calendar days for comment on the notice; and

(iii) publishing a notice in the Federal Register designating such drugs, categories of drugs, or conditions.

(B) Sunset of notice

Any notice provided under subparagraph (A) shall not be effective after the earlier of—

(i) the date that is 5 years after November 27, 2013; or

(ii) the effective date of the final regulations issued to implement subsection (a)(6).

(4) Updates

The Secretary shall review, and update as necessary, the regulations containing the lists of drugs, categories of drugs, or conditions described in subsection (a)(6) regularly, but not less than once every 4 years. Nothing in the previous sentence prohibits submissions to the Secretary, before or during any 4-year period described in such sentence, requesting updates to such lists.

(d) ² Definitions

In this section:

(1) The term "compounding" includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.

(2) The term "essentially a copy of an approved drug" means—

(A) a drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 353(b) of this title and not subject to approval in an application submitted under section 355 of this title, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing; or

(B) a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject to section 353(b) of this title and not subject to approval in an application submitted under section 355 of this title, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.

(3) The term "approved drug" means a drug that is approved under section 355 of this title and does not appear on the list described in subsection (a)(4) of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective.

(4)(A) The term "outsourcing facility" means a facility at one geographic location or address that—

(i) is engaged in the compounding of sterile drugs;

(ii) has elected to register as an outsourcing facility; and

(iii) complies with all of the requirements of this section.

(B) An outsourcing facility is not required to be a licensed pharmacy.

(C) An outsourcing facility may or may not obtain prescriptions for identified individual patients.

(5) The term "sterile drug" means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law.

(d) ² Obligation to pay fees

Payment of the fee under section 379j–62 of this title, as described in subsection (a)(9), shall not relieve an outsourcing facility that is licensed as a pharmacy in any State that requires pharmacy licensing fees of its obligation to pay such State fees.

(June 25, 1938, ch. 675, §503B, as added Pub. L. 113–54, title I, §102(a)(2), Nov. 27, 2013, 127 Stat. 588.)

Editorial Notes

Prior Provisions

A prior section 503B of act June 25, 1938, ch. 675, was renumbered section 503C by Pub. L. 113–54, §102(a)(1), Nov. 27, 2013, 127 Stat. 587, and transferred to section 353c of this title.

¹ So in original.

² So in original. Two subsecs. (d) have been enacted.

§353c. Prereview of television advertisements

(a) In general

The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement.

(b) Review

In conducting a review of a television advertisement under this section, the Secretary may make recommendations with respect to information included in the label of the drug—

(1) on changes that are—

(A) necessary to protect the consumer good and well-being; or

(B) consistent with prescribing information for the product under review; and

(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the drug as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities.

(c) No authority to require changes

Except as provided by subsection (e), this section does not authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).

(d) Elderly populations, children, racially and ethnically diverse communities

In formulating recommendations under subsection (b), the Secretary shall take into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically diverse communities.

(e) Specific disclosures

(1) Serious risk; safety protocol

In conducting a review of a television advertisement under this section, if the Secretary determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.

(2) Date of approval

In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug under section 355 of this title or section 262 of title 42, a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading.

(f) Rule of construction

Nothing in this section may be construed as having any effect on requirements under section 352(n) of this title or on the authority of the Secretary under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).

(June 25, 1938, ch. 675, §503C, formerly §503B, as added Pub. L. 110–85, title IX, §901(d)(2), Sept. 27, 2007, 121 Stat. 939, renumbered §503C, Pub. L. 113–54, title I, §102(a)(1), Nov. 27, 2013, 127 Stat. 587.)

Editorial Notes

Codification

Section was formerly classified to section 353b of this title prior to renumbering by Pub. L. 113–54.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as an Effective Date of 2007 Amendment note under section 331 of this title.

§353d. Process to update labeling for certain generic drugs

(a) Definitions

For purposes of this section:

(1) The term "covered drug" means a drug approved under section 355(c) of this title—

(A) for which there are no unexpired patents included in the list under section 355(j)(7) of this title and no unexpired period of exclusivity;

(B) for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and

(C) for which—

(i)(I) there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling;

(II) the approved labeling does not reflect current legal and regulatory requirements for content or format; or

(III) there is a relevant accepted use in clinical practice that is not reflected in the approved labeling; and

(ii) updating the approved labeling would benefit the public health.

(2) The term "period of exclusivity", with respect to a drug approved under section 355(c) of this title, means any period of exclusivity under clause (ii), (iii), or (iv) of section 355(c)(3)(E) of this title, clause (ii), (iii), or (iv) of section 355(j)(5)(F) of this title, or section 355a, 355f, or 360cc of this title.

(3) The term "generic version" means a drug approved under section 355(j) of this title whose reference listed drug is a covered drug.

(4) The term "relevant accepted use" means a use for a drug in clinical practice that is supported by scientific evidence that appears to the Secretary to meet the standards for approval under section 355 of this title.

(5) The term "selected drug" means a covered drug for which the Secretary has determined through the process under subsection (c) that the labeling should be changed.

(b) Identification of covered drugs

The Secretary may identify covered drugs for which labeling updates would provide a public health benefit. To assist in identifying covered drugs, the Secretary may do one or both of the following:

(1) Enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs.

(2) Seek public input concerning such drugs, including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling of such drugs or whether new scientific evidence is available regarding the conditions of use for such drug, by—

(A) holding one or more public meetings;

(B) opening a public docket for the submission of public comments; or

(C) other means, as the Secretary determines appropriate.

(c) Selection of drugs for updating

If the Secretary determines, with respect to a covered drug, that the available scientific evidence meets the standards under section 355 of this title for adding or modifying information to the labeling or providing supplemental information to the labeling regarding the use of the covered drug, the Secretary may initiate the process under subsection (d).

(d) Initiation of the process of updating

If the Secretary determines that labeling changes are appropriate for a selected drug pursuant to subsection (c), the Secretary shall provide notice to the holders of approved applications for a generic version of such drug that—

(1) summarizes the findings supporting the determination of the Secretary that the available scientific evidence meets the standards under section 355 of this title for adding or modifying information or providing supplemental information to the labeling of the covered drug pursuant to subsection (c);

(2) provides a clear statement regarding the additional, modified, or supplemental information for such labeling, according to the determination by the Secretary (including, as applicable, modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug); and

(3) states whether the statement under paragraph (2) applies to the selected drug as a class of covered drugs or only to a specific drug product.

(e) Response to notification

Within 30 days of receipt of notification provided by the Secretary pursuant to subsection (d), the holder of an approved application for a generic version of the selected drug shall—

(1) agree to change the approved labeling to reflect the additional, modified, or supplemental information the Secretary has determined to be appropriate; or

(2) notify the Secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted.

(f) Review of application holder's response

(1) In general

Upon receipt of the application holder's response, the Secretary shall promptly review each statement received under subsection (e)(2) and determine which labeling changes pursuant to the Secretary's notice under subsection (d) are appropriate, if any. If the Secretary disagrees with the reasons why such labeling changes are not warranted, the Secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect available scientific evidence, and if so, the content of such labeling changes.

(2) Changes to labeling

After considering all responses from the holder of an approved application under paragraph (1) or (2) of subsection (e), and any discussion under paragraph (1), the Secretary may order such holder to make the labeling changes the Secretary determines are appropriate. Such holder of an approved application shall—

(A) update its paper labeling for the drug at the next printing of that labeling;

(B) update any electronic labeling for the drug within 30 days of such order; and

(C) submit the revised labeling through the form, "Supplement—Changes Being Effected".

(g) Violation

If the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection (f)(2), such generic version of the selected drug shall be deemed to be misbranded under section 352 of this title.

(h) Limitations; generic drugs

(1) In general

With respect to any labeling change required under this section, the generic version shall be deemed to have the same conditions of use and the same labeling as its reference listed drug for purposes of clauses (i) and (v) of section 355(j)(2)(A) of this title. Any labeling change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved to conform the labeling of the generic version to a change in the labeling of the reference drug.

(2) Supplemental applications

Changes to labeling made in accordance with this section shall not be eligible for an exclusivity period under this chapter.

(3) Selection of drugs

The Secretary shall not identify a drug as a covered drug or select a drug label for updating under subsection (b) or (c) solely based on the availability of new safety information. Upon identification of a drug as a covered drug under subsection (b), the Secretary may then consider the availability of new safety information (as defined in section 355–1(b) of this title) in determining whether the drug is a selected drug and in determining what labeling changes are appropriate.

(i) Rules of construction

(1) Approval standards

This section shall not be construed as altering the applicability of the standards for approval of an application under section 355 of this title. No order shall be issued under this subsection unless the scientific evidence supporting the changed labeling meets the standards for approval applicable to any change to labeling under section 355 of this title.

(2) Removal of information

Nothing in this section shall be construed to give the Secretary additional authority to remove approved indications for drugs, other than the authority described in this section.

(3) Secretary authority

Nothing in this section shall be construed to limit the authority of the Secretary to require labeling changes under section 355(o) of this title.

(4) Maintenance of labeling

Nothing in this section shall be construed to affect the responsibility of the holder of an approved application under section 355(j) of this title to maintain its labeling in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 314.97 of title 21, Code of Federal Regulations (or any successor regulations).

(j) Reports

Not later than 4 years after December 27, 2020, and every 4 years thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report that—

(1) describes the actions of the Secretary under this section, including—

(A) the number of covered drugs and description of the types of drugs the Secretary has selected for labeling changes and the rationale for such recommended changes; and

(B) the number of times the Secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change, if any; and

(2) includes any recommendations of the Secretary for modifying the program under this section.

(June 25, 1938, ch. 675, §503D, as added Pub. L. 116–260, div. BB, title III, §324, Dec. 27, 2020, 134 Stat. 2933.)

§354. Veterinary feed directive drugs

(a) Lawful veterinary feed directive requirement

(1) A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 360b(b) of this title, a conditionally-approved application filed pursuant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title to use under the professional supervision of a licensed veterinarian is a veterinary feed directive drug. Any animal feed bearing or containing a veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice. When labeled, distributed, held, and used in accordance with this section, a veterinary feed directive drug and any animal feed bearing or containing a veterinary feed directive drug shall be exempt from section 352(f) of this title.

(2) A veterinary feed directive is lawful if it—

(A) contains such information as the Secretary may by general regulation or by order require; and

(B) is in compliance with the conditions and indications for use of the drug set forth in the notice published pursuant to section 360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title.

(3)(A) Any persons involved in the distribution or use of animal feed bearing or containing a veterinary feed directive drug and the licensed veterinarian issuing the veterinary feed directive shall maintain a copy of the veterinary feed directive applicable to each such feed, except in the case of a person distributing such feed to another person for further distribution. Such person distributing the feed shall maintain a written acknowledgment from the person to whom the feed is shipped stating that that person shall not ship or move such feed to an animal production facility without a veterinary feed directive or ship such feed to another person for further distribution unless that person has provided the same written acknowledgment to its immediate supplier.

(B) Every person required under subparagraph (A) to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(C) Any person who distributes animal feed bearing or containing a veterinary feed directive drug shall upon first engaging in such distribution notify the Secretary of that person's name and place of business. The failure to provide such notification shall be deemed to be an act which results in the drug being misbranded.

(b) Labeling and advertising

A veterinary feed directive drug and any feed bearing or containing a veterinary feed directive drug shall be deemed to be misbranded if their labeling fails to bear such cautionary statement and such other information as the Secretary may by general regulation or by order prescribe, or their advertising fails to conform to the conditions and indications for use published pursuant to section 360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title or fails to contain the general cautionary statement prescribed by the Secretary.

(c) Nonprescription status

Neither a drug subject to this section, nor animal feed bearing or containing such a drug, shall be deemed to be a prescription article under any Federal or State law.

(June 25, 1938, ch. 675, §504, as added Pub. L. 104–250, §5(b), Oct. 9, 1996, 110 Stat. 3155; amended Pub. L. 108–282, title I, §102(b)(5)(G), (H), Aug. 2, 2004, 118 Stat. 903.)

Editorial Notes

Prior Provisions

A prior section 354, act June 25, 1938, ch. 675, §504, 52 Stat. 1052, which directed Secretary to promulgate regulations for listing of coal-tar colors, was repealed effective July 12, 1960, subject to provisions of section 203 of Pub. L. 86–618, by Pub. L. 86–618, title I, §103(a)(2), title II, §202, July 12, 1960, 74 Stat. 398, 404.

Amendments

2004—Subsec. (a)(1). Pub. L. 108–282, §102(b)(5)(G), substituted "360b(b) of this title, a conditionally-approved application filed pursuant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title" for "360b(b) of this title".

Subsecs. (a)(2)(B), (b). Pub. L. 108–282, §102(b)(5)(H), substituted "360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title" for "360b(i) of this title".

§355. New drugs

(a) Necessity of effective approval of application

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.

(b) Filing application; contents

(1)(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—

(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;

(ii) a full list of the articles used as components of such drug;

(iii) a full statement of the composition of such drug;

(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;

(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;

(vi) specimens of the labeling proposed to be used for such drug;

(vii) any assessments required under section 355c of this title; and

(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—

(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or

(II) claims a method of using such drug for which approval is sought or has been granted in the application.

(B) If an application is filed under this subsection for a drug, and a patent of the type described in subparagraph (A)(viii) is issued after the filing date but before approval of the application, the applicant shall amend the application to include the patent number and expiration date.

(2) An application submitted under paragraph (1) for a drug for which the investigations described in clause (A) of such paragraph and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted shall also include—

(A) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under paragraph (1) or subsection (c)—

(i) that such patent information has not been filed,

(ii) that such patent has expired,

(iii) of the date on which such patent will expire, or

(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and

(B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted information was filed under paragraph (1) or subsection (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use.

(3) Notice of opinion that patent is invalid or will not be infringed.—

(A) Agreement to give notice.—An applicant that makes a certification described in paragraph (2)(A)(iv) shall include in the application a statement that the applicant will give notice as required by this paragraph.

(B) Timing of notice.—An applicant that makes a certification described in paragraph (2)(A)(iv) shall give notice as required under this paragraph—

(i) if the certification is in the application, not later than 20 days after the date of the postmark on the notice with which the Secretary informs the applicant that the application has been filed; or

(ii) if the certification is in an amendment or supplement to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether the applicant has already given notice with respect to another such certification contained in the application or in an amendment or supplement to the application.

(C) Recipients of notice.—An applicant required under this paragraph to give notice shall give notice to—

(i) each owner of the patent that is the subject of the certification (or a representative of the owner designated to receive such a notice); and

(ii) the holder of the approved application under this subsection for the drug that is claimed by the patent or a use of which is claimed by the patent (or a representative of the holder designated to receive such a notice).

(D) Contents of notice.—A notice required under this paragraph shall—

(i) state that an application that contains data from bioavailability or bioequivalence studies has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and

(ii) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed.

(4)(A) An applicant may not amend or supplement an application referred to in paragraph (2) to seek approval of a drug that is a different drug than the drug identified in the application as submitted to the Secretary.

(B) With respect to the drug for which such an application is submitted, nothing in this subsection or subsection (c)(3) prohibits an applicant from amending or supplementing the application to seek approval of a different strength.

(5)(A) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph (1) or under section 262 of title 42, which shall relate to promptness in conducting the review, technical excellence, lack of bias and conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply equally to all individuals who review such applications.

(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under this subsection or section 262 of title 42 if the sponsor or applicant makes a reasonable written request for a meeting for the purpose of reaching agreement on the design and size—

(i)(I) of clinical trials intended to form the primary basis of an effectiveness claim; or

(II) in the case where human efficacy studies are not ethical or feasible, of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim; or

(ii) with respect to an application for approval of a biological product under section 262(k) of title 42, of any necessary clinical study or studies.

The sponsor or applicant shall provide information necessary for discussion and agreement on the design and size of the clinical trials. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant upon request.

(C) Any agreement regarding the parameters of the design and size of clinical trials of a new drug under this paragraph that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Such agreement shall not be changed after the testing begins, except—

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after the testing has begun.

(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant will be present and at which the director will document the scientific issue involved.

(E) The written decisions of the reviewing division shall be binding upon, and may not directly or indirectly be changed by, the field or compliance division personnel unless such field or compliance division personnel demonstrate to the reviewing division why such decision should be modified.

(F) No action by the reviewing division may be delayed because of the unavailability of information from or action by field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe and effective drug.

(G) For purposes of this paragraph, the reviewing division is the division responsible for the review of an application for approval of a drug under this subsection or section 262 of title 42 (including all scientific and medical matters, chemistry, manufacturing, and controls).

(6) An application submitted under this subsection shall be accompanied by the certification required under section 282(j)(5)(B) of title 42. Such certification shall not be considered an element of such application.

(c) Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order

(1) Within one hundred and eighty days after the filing of an application under subsection (b), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either—

(A) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or

(B) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs.

(2) Not later than 30 days after the date of approval of an application submitted under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subsection (b)(1)(A)(viii), except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application. If a patent described in subsection (b)(1)(A)(viii) is issued after the date of approval of an application submitted under subsection (b), the holder of the approved application shall, not later than 30 days after the date of issuance of the patent, file the patent number and the expiration date of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application. If the patent information described in subsection (b) could not be filed with the submission of an application under subsection (b) because the application was filed before the patent information was required under subsection (b) or a patent was issued after the application was approved under such subsection, the holder of an approved application shall file with the Secretary the patent number and the expiration date of any patent described in subsection (b)(1)(A)(viii). If the holder of an approved application could not file patent information under subsection (b) because it was not required at the time the application was approved, the holder shall file such information under this subsection not later than thirty days after September 24, 1984, and if the holder of an approved application could not file patent information under subsection (b) because no patent of the type for which information is required to be submitted in subsection (b)(1)(A)(viii) had been issued when an application was filed or approved, the holder shall file such information under this subsection not later than thirty days after the date the patent involved is issued. Upon the submission of patent information under this subsection, the Secretary shall publish it. Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph.

(3) The approval of an application filed under subsection (b) which contains a certification required by paragraph (2) of such subsection shall be made effective on the last applicable date determined by applying the following to each certification made under subsection (b)(2)(A):

(A) If the applicant only made a certification described in clause (i) or (ii) of subsection (b)(2)(A) or in both such clauses, the approval may be made effective immediately.

(B) If the applicant made a certification described in clause (iii) of subsection (b)(2)(A), the approval may be made effective on the date certified under clause (iii).

(C) If the applicant made a certification described in clause (iv) of subsection (b)(2)(A), the approval shall be made effective immediately unless, before the expiration of 45 days after the date on which the notice described in subsection (b)(3) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) before the date on which the application (excluding an amendment or supplement to the application) was submitted. If such an action is brought before the expiration of such days, the approval may be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under subsection (b)(3) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that—

(i) if before the expiration of such period the district court decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity), the approval shall be made effective on—

(I) the date on which the court enters judgment reflecting the decision; or

(II) the date of a settlement order or consent decree signed and entered by the court stating that the patent that is the subject of the certification is invalid or not infringed;

(ii) if before the expiration of such period the district court decides that the patent has been infringed—

(I) if the judgment of the district court is appealed, the approval shall be made effective on—

(aa) the date on which the court of appeals decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity); or

(bb) the date of a settlement order or consent decree signed and entered by the court of appeals stating that the patent that is the subject of the certification is invalid or not infringed; or

(II) if the judgment of the district court is not appealed or is affirmed, the approval shall be made effective on the date specified by the district court in a court order under section 271(e)(4)(A) of title 35;

(iii) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective as provided in clause (i); or

(iv) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent has been infringed, the approval shall be made effective as provided in clause (ii).

In such an action, each of the parties shall reasonably cooperate in expediting the action.

(D) Civil action to obtain patent certainty.—

(i) Declaratory judgment absent infringement action.—

(I) In general.—No action may be brought under section 2201 of title 28 by an applicant referred to in subsection (b)(2) for a declaratory judgment with respect to a patent which is the subject of the certification referred to in subparagraph (C) unless—

(aa) the 45-day period referred to in such subparagraph has expired;

(bb) neither the owner of such patent nor the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent brought a civil action against the applicant for infringement of the patent before the expiration of such period; and

(cc) in any case in which the notice provided under paragraph (2)(B) relates to noninfringement, the notice was accompanied by a document described in subclause (III).

(II) Filing of civil action.—If the conditions described in items (aa), (bb), and as applicable, (cc) of subclause (I) have been met, the applicant referred to in such subclause may, in accordance with section 2201 of title 28, bring a civil action under such section against the owner or holder referred to in such subclause (but not against any owner or holder that has brought such a civil action against the applicant, unless that civil action was dismissed without prejudice) for a declaratory judgment that the patent is invalid or will not be infringed by the drug for which the applicant seeks approval, except that such civil action may be brought for a declaratory judgment that the patent will not be infringed only in a case in which the condition described in subclause (I)(cc) is applicable. A civil action referred to in this subclause shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.

(III) Offer of confidential access to application.—For purposes of subclause (I)(cc), the document described in this subclause is a document providing an offer of confidential access to the application that is in the custody of the applicant referred to in subsection (b)(2) for the purpose of determining whether an action referred to in subparagraph (C) should be brought. The document providing the offer of confidential access shall contain such restrictions as to persons entitled to access, and on the use and disposition of any information accessed, as would apply had a protective order been entered for the purpose of protecting trade secrets and other confidential business information. A request for access to an application under an offer of confidential access shall be considered acceptance of the offer of confidential access with the restrictions as to persons entitled to access, and on the use and disposition of any information accessed, contained in the offer of confidential access, and those restrictions and other terms of the offer of confidential access shall be considered terms of an enforceable contract. Any person provided an offer of confidential access shall review the application for the sole and limited purpose of evaluating possible infringement of the patent that is the subject of the certification under subsection (b)(2)(A)(iv) and for no other purpose, and may not disclose information of no relevance to any issue of patent infringement to any person other than a person provided an offer of confidential access. Further, the application may be redacted by the applicant to remove any information of no relevance to any issue of patent infringement.

(ii) Counterclaim to infringement action.—

(I) In general.—If an owner of the patent or the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or this subsection on the ground that the patent does not claim either—

(aa) the drug for which the application was approved; or

(bb) an approved method of using the drug.

(II) No independent cause of action.—Subclause (I) does not authorize the assertion of a claim described in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I).

(iii) No damages.—An applicant shall not be entitled to damages in a civil action under clause (i) or a counterclaim under clause (ii).

(E)(i) Repealed. Pub. L. 117–9, §1(b)(1)(A), Apr. 23, 2021, 135 Stat. 258.

(ii) If an application submitted under subsection (b) for a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under subsection (b), is approved after September 24, 1984, no application which refers to the drug for which the subsection (b) application was submitted and for which the investigations described in subsection (b)(1)(A)(i) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted may be submitted under subsection (b) before the expiration of five years from the date of the approval of the application under subsection (b), except that such an application may be submitted under subsection (b) after the expiration of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in clause (iv) of subsection (b)(2)(A). The approval of such an application shall be made effective in accordance with this paragraph except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (C) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application.

(iii) If an application submitted under subsection (b) for a drug, which includes an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in another application approved under subsection (b), is approved after September 24, 1984, and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under subsection (b) for the conditions of approval of such drug in the approved subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) if the investigations described in subsection (b)(1)(A)(i) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.

(iv) If a supplement to an application approved under subsection (b) is approved after September 24, 1984, and the supplement contains reports of new clinical investigations (other than bioavailabilty ¹ studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under subsection (b) for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b) if the investigations described in subsection (b)(1)(A)(i) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.

(v) If an application (or supplement to an application) submitted under subsection (b) for a drug, which includes an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in another application under subsection (b), was approved during the period beginning January 1, 1982, and ending on September 24, 1984, the Secretary may not make the approval of an application submitted under this subsection and for which the investigations described in subsection (b)(1)(A)(i) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted and which refers to the drug for which the subsection (b) application was submitted effective before the expiration of two years from September 24, 1984.

(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.

(5)(A) The Secretary may rely upon qualified data summaries to support the approval of a supplemental application, with respect to a qualified indication for a drug, submitted under subsection (b), if such supplemental application complies with subparagraph (B).

(B) A supplemental application is eligible for review as described in subparagraph (A) only if—

(i) there is existing data available and acceptable to the Secretary demonstrating the safety of the drug; and

(ii) all data used to develop the qualified data summaries are submitted to the Secretary as part of the supplemental application.

(C) The Secretary shall post on the Internet website of the Food and Drug Administration and update annually—

(i) the number of applications reviewed solely under subparagraph (A) or section 262(a)(2)(E) of title 42;

(ii) the average time for completion of review under subparagraph (A) or section 262(a)(2)(E) of title 42;

(iii) the average time for review of supplemental applications where the Secretary did not use review flexibility under subparagraph (A) or section 262(a)(2)(E) of title 42; and

(iv) the number of applications reviewed under subparagraph (A) or section 262(a)(2)(E) of title 42 for which the Secretary made use of full data sets in addition to the qualified data summary.

(D) In this paragraph—

(i) the term "qualified indication" means an indication for a drug that the Secretary determines to be appropriate for summary level review under this paragraph; and

(ii) the term "qualified data summary" means a summary of clinical data that demonstrates the safety and effectiveness of a drug with respect to a qualified indication.

(d) Grounds for refusing application; approval of application; "substantial evidence" defined

If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a hearing, in accordance with said subsection, that (1) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; or (5) evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) the application failed to contain the patent information prescribed by subsection (b); or (7) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that clauses (1) through (6) do not apply, he shall issue an order approving the application. As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for purposes of the preceding sentence. The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs. Nothing in the preceding sentence shall alter the criteria for evaluating an application for marketing approval of a drug.

(e) Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to public health

The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary finds (1) that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved; (2) that new evidence of clinical experience, not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved; or (3) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) the patent information prescribed by subsection (c) was not filed within thirty days after the receipt of written notice from the Secretary specifying the failure to file such information; or (5) that the application contains any untrue statement of a material fact: Provided, That if the Secretary (or in his absence the officer acting as Secretary) finds that there is an imminent hazard to the public health, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this proviso to suspend the approval of an application shall not be delegated. The Secretary may also, after due notice and opportunity for hearing to the applicant, withdraw the approval of an application submitted under subsection (b) or (j) with respect to any drug under this section if the Secretary finds (1) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports, in accordance with a regulation or order under subsection (k) or to comply with the notice requirements of section 360(k)(2) of this title, or the applicant has refused to permit access to, or copying or verification of, such records as required by paragraph (2) of such subsection; or (2) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. Any order under this subsection shall state the findings upon which it is based. The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 355–1(g)(2)(D) of this title.

(f) Revocation of order refusing, withdrawing or suspending approval of application

Whenever the Secretary finds that the facts so require, he shall revoke any previous order under subsection (d) or (e) refusing, withdrawing, or suspending approval of an application and shall approve such application or reinstate such approval, as may be appropriate.

(g) Service of orders

Orders of the Secretary issued under this section shall be served (1) in person by any officer or employee of the department designated by the Secretary or (2) by mailing the order by registered mail or by certified mail addressed to the applicant or respondent at his last-known address in the records of the Secretary.

(h) Appeal from order

An appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application under this section. Such appeal shall be taken by filing in the United States court of appeals for the circuit wherein such applicant resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within sixty days after the entry of such order, a written petition praying that the order of the Secretary be set aside. A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall certify and file in the court the record upon which the order complained of was entered, as provided in section 2112 of title 28. Upon the filing of such petition such court shall have exclusive jurisdiction to affirm or set aside such order, except that until the filing of the record the Secretary may modify or set aside his order. No objection to the order of the Secretary shall be considered by the court unless such objection shall have been urged before the Secretary or unless there were reasonable grounds for failure so to do. The finding of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive. If any person shall apply to the court for leave to adduce additional evidence, and shall show to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence to be taken before the Secretary and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts by reason of the additional evidence so taken, and he shall file with the court such modified findings which, if supported by substantial evidence, shall be conclusive, and his recommendation, if any, for the setting aside of the original order. The judgment of the court affirming or setting aside any such order of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28. The commencement of proceedings under this subsection shall not, unless specifically ordered by the court to the contrary, operate as a stay of the Secretary's order.

(i) Exemptions of drugs for research; discretionary and mandatory conditions; direct reports to Secretary

(1) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. Such regulations may, within the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon—

(A) the submission to the Secretary, before any clinical testing of a new drug is undertaken, of reports, by the manufacturer or the sponsor of the investigation of such drug, of nonclinical tests of such drug adequate to justify the proposed clinical testing;

(B) the manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of such investigators that patients to whom the drug is administered will be under his personal supervision, or under the supervision of investigators responsible to him, and that he will not supply such drug to any other investigator, or to clinics, for administration to human beings;

(C) the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such drug, of data (including but not limited to analytical reports by investigators) obtained as the result of such investigational use of such drug, as the Secretary finds will enable him to evaluate the safety and effectiveness of such drug in the event of the filing of an application pursuant to subsection (b); and

(D) the submission to the Secretary by the manufacturer or the sponsor of the investigation of a new drug of a statement of intent regarding whether the manufacturer or sponsor has plans for assessing pediatric safety and efficacy.

(2) Subject to paragraph (3), a clinical investigation of a new drug may begin 30 days after the Secretary has received from the manufacturer or sponsor of the investigation a submission containing such information about the drug and the clinical investigation, including—

(A) information on design of the investigation and adequate reports of basic information, certified by the applicant to be accurate reports, necessary to assess the safety of the drug for use in clinical investigation; and

(B) adequate information on the chemistry and manufacturing of the drug, controls available for the drug, and primary data tabulations from nonclinical tests or human studies.

(3)(A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a "clinical hold") if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing.

(B) For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is that—

(i) the drug involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the drug, the design of the clinical investigation, the condition for which the drug is to be investigated, and the health status of the subjects involved; or

(ii) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish (including reasons established by regulation before November 21, 1997).

(C) Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold.

(4) Regulations under paragraph (1) shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs. The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 282 of title 42.

(j) Abbreviated new drug applications

(1) Any person may file with the Secretary an abbreviated application for the approval of a new drug.

(2)(A) An abbreviated application for a new drug shall contain—

(i) information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a drug listed under paragraph (7) (hereinafter in this subsection referred to as a "listed drug");

(ii)(I) if the listed drug referred to in clause (i) has only one active ingredient, information to show that the active ingredient of the new drug is the same as that of the listed drug;

(II) if the listed drug referred to in clause (i) has more than one active ingredient, information to show that the active ingredients of the new drug are the same as those of the listed drug, or

(III) if the listed drug referred to in clause (i) has more than one active ingredient and if one of the active ingredients of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the other active ingredients of the new drug are the same as the active ingredients of the listed drug, information to show that the different active ingredient is an active ingredient of a listed drug or of a drug which does not meet the requirements of section 321(p) of this title, and such other information respecting the different active ingredient with respect to which the petition was filed as the Secretary may require;

(iii) information to show that the route of administration, the dosage form, and the strength of the new drug are the same as those of the listed drug referred to in clause (i) or, if the route of administration, the dosage form, or the strength of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require;

(iv) information to show that the new drug is bioequivalent to the listed drug referred to in clause (i), except that if the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in clause (i) and the new drug can be expected to have the same therapeutic effect as the listed drug when administered to patients for a condition of use referred to in clause (i);

(v) information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug referred to in clause (i) except for changes required because of differences approved under a petition filed under subparagraph (C) or because the new drug and the listed drug are produced or distributed by different manufacturers;

(vi) the items specified in clauses (ii) through (vi) of subsection (b)(1)(A);

(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug referred to in clause (i) or which claims a use for such listed drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b) or (c)—

(I) that such patent information has not been filed,

(II) that such patent has expired,

(III) of the date on which such patent will expire, or

(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and

(viii) if with respect to the listed drug referred to in clause (i) information was filed under subsection (b) or (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use.

The Secretary may not require that an abbreviated application contain information in addition to that required by clauses (i) through (viii).

(B) Notice of opinion that patent is invalid or will not be infringed.—

(i) Agreement to give notice.—An applicant that makes a certification described in subparagraph (A)(vii)(IV) shall include in the application a statement that the applicant will give notice as required by this subparagraph.

(ii) Timing of notice.—An applicant that makes a certification described in subparagraph (A)(vii)(IV) shall give notice as required under this subparagraph—

(I) if the certification is in the application, not later than 20 days after the date of the postmark on the notice with which the Secretary informs the applicant that the application has been filed; or

(II) if the certification is in an amendment or supplement to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether the applicant has already given notice with respect to another such certification contained in the application or in an amendment or supplement to the application.

(iii) Recipients of notice.—An applicant required under this subparagraph to give notice shall give notice to—

(I) each owner of the patent that is the subject of the certification (or a representative of the owner designated to receive such a notice); and

(II) the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent (or a representative of the holder designated to receive such a notice).

(iv) Contents of notice.—A notice required under this subparagraph shall—

(I) state that an application that contains data from bioavailability or bioequivalence studies has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and

(II) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed.

(C) If a person wants to submit an abbreviated application for a new drug which has a different active ingredient or whose route of administration, dosage form, or strength differ from that of a listed drug, such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve or disapprove a petition submitted under this subparagraph within ninety days of the date the petition is submitted. The Secretary shall approve such a petition unless the Secretary finds—

(i) that investigations must be conducted to show the safety and effectiveness of the drug or of any of its active ingredients, the route of administration, the dosage form, or strength which differ from the listed drug; or

(ii) that any drug with a different active ingredient may not be adequately evaluated for approval as safe and effective on the basis of the information required to be submitted in an abbreviated application.

(D)(i) An applicant may not amend or supplement an application to seek approval of a drug referring to a different listed drug from the listed drug identified in the application as submitted to the Secretary.

(ii) With respect to the drug for which an application is submitted, nothing in this subsection prohibits an applicant from amending or supplementing the application to seek approval of a different strength.

(iii) Within 60 days after December 8, 2003, the Secretary shall issue guidance defining the term "listed drug" for purposes of this subparagraph.

(3)(A) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph (1), which shall relate to promptness in conducting the review, technical excellence, lack of bias and conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply equally to all individuals who review such applications.

(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under this subsection if the sponsor or applicant makes a reasonable written request for a meeting for the purpose of reaching agreement on the design and size of bioavailability and bioequivalence studies needed for approval of such application. The sponsor or applicant shall provide information necessary for discussion and agreement on the design and size of such studies. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant.

(C) Any agreement regarding the parameters of design and size of bioavailability and bioequivalence studies of a drug under this paragraph that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Such agreement shall not be changed after the testing begins, except—

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after the testing has begun.

(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant will be present and at which the director will document the scientific issue involved.

(E) The written decisions of the reviewing division shall be binding upon, and may not directly or indirectly be changed by, the field or compliance office personnel unless such field or compliance office personnel demonstrate to the reviewing division why such decision should be modified.

(F) No action by the reviewing division may be delayed because of the unavailability of information from or action by field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe and effective drug.

(G) For purposes of this paragraph, the reviewing division is the division responsible for the review of an application for approval of a drug under this subsection (including scientific matters, chemistry, manufacturing, and controls).

(4) Subject to paragraph (5), the Secretary shall approve an application for a drug unless the Secretary finds—

(A) the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity;

(B) information submitted with the application is insufficient to show that each of the proposed conditions of use have been previously approved for the listed drug referred to in the application;

(C)(i) if the listed drug has only one active ingredient, information submitted with the application is insufficient to show that the active ingredient is the same as that of the listed drug;

(ii) if the listed drug has more than one active ingredient, information submitted with the application is insufficient to show that the active ingredients are the same as the active ingredients of the listed drug, or

(iii) if the listed drug has more than one active ingredient and if the application is for a drug which has an active ingredient different from the listed drug, information submitted with the application is insufficient to show—

(I) that the other active ingredients are the same as the active ingredients of the listed drug, or

(II) that the different active ingredient is an active ingredient of a listed drug or a drug which does not meet the requirements of section 321(p) of this title,

or no petition to file an application for the drug with the different ingredient was approved under paragraph (2)(C);

(D)(i) if the application is for a drug whose route of administration, dosage form, or strength of the drug is the same as the route of administration, dosage form, or strength of the listed drug referred to in the application, information submitted in the application is insufficient to show that the route of administration, dosage form, or strength is the same as that of the listed drug, or

(ii) if the application is for a drug whose route of administration, dosage form, or strength of the drug is different from that of the listed drug referred to in the application, no petition to file an application for the drug with the different route of administration, dosage form, or strength was approved under paragraph (2)(C);

(E) if the application was filed pursuant to the approval of a petition under paragraph (2)(C), the application did not contain the information required by the Secretary respecting the active ingredient, route of administration, dosage form, or strength which is not the same;

(F) information submitted in the application is insufficient to show that the drug is bioequivalent to the listed drug referred to in the application or, if the application was filed pursuant to a petition approved under paragraph (2)(C), information submitted in the application is insufficient to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in paragraph (2)(A)(i) and that the new drug can be expected to have the same therapeutic effect as the listed drug when administered to patients for a condition of use referred to in such paragraph;

(G) information submitted in the application is insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the listed drug referred to in the application except for changes required because of differences approved under a petition filed under paragraph (2)(C) or because the drug and the listed drug are produced or distributed by different manufacturers;

(H) information submitted in the application or any other information available to the Secretary shows that (i) the inactive ingredients of the drug are unsafe for use under the conditions prescribed, recommended, or suggested in the labeling proposed for the drug, or (ii) the composition of the drug is unsafe under such conditions because of the type or quantity of inactive ingredients included or the manner in which the inactive ingredients are included;

(I) the approval under subsection (c) of the listed drug referred to in the application under this subsection has been withdrawn or suspended for grounds described in the first sentence of subsection (e), the Secretary has published a notice of opportunity for hearing to withdraw approval of the listed drug under subsection (c) for grounds described in the first sentence of subsection (e), the approval under this subsection of the listed drug referred to in the application under this subsection has been withdrawn or suspended under paragraph (6), or the Secretary has determined that the listed drug has been withdrawn from sale for safety or effectiveness reasons;

(J) the application does not meet any other requirement of paragraph (2)(A); or

(K) the application contains an untrue statement of material fact.

(5)(A) Within one hundred and eighty days of the initial receipt of an application under paragraph (2) or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application.

(B) The approval of an application submitted under paragraph (2) shall be made effective on the last applicable date determined by applying the following to each certification made under paragraph (2)(A)(vii):

(i) If the applicant only made a certification described in subclause (I) or (II) of paragraph (2)(A)(vii) or in both such subclauses, the approval may be made effective immediately.

(ii) If the applicant made a certification described in subclause (III) of paragraph (2)(A)(vii), the approval may be made effective on the date certified under subclause (III).

(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that—

(I) if before the expiration of such period the district court decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity), the approval shall be made effective on—

(aa) the date on which the court enters judgment reflecting the decision; or

(bb) the date of a settlement order or consent decree signed and entered by the court stating that the patent that is the subject of the certification is invalid or not infringed;

(II) if before the expiration of such period the district court decides that the patent has been infringed—

(aa) if the judgment of the district court is appealed, the approval shall be made effective on—

(AA) the date on which the court of appeals decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity); or

(BB) the date of a settlement order or consent decree signed and entered by the court of appeals stating that the patent that is the subject of the certification is invalid or not infringed; or

(bb) if the judgment of the district court is not appealed or is affirmed, the approval shall be made effective on the date specified by the district court in a court order under section 271(e)(4)(A) of title 35;

(III) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective as provided in subclause (I); or

(IV) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent has been infringed, the approval shall be made effective as provided in subclause (II).

In such an action, each of the parties shall reasonably cooperate in expediting the action.

(iv) 180-day exclusivity period.—

(I) Effectiveness of application.—Subject to subparagraph (D), if the application contains a certification described in paragraph (2)(A)(vii)(IV) and is for a drug for which a first applicant has submitted an application containing such a certification, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant.

(II) Definitions.—In this paragraph:

(aa) 180-day exclusivity period.—The term "180-day exclusivity period" means the 180-day period ending on the day before the date on which an application submitted by an applicant other than a first applicant could become effective under this clause.

(bb) First applicant.—As used in this subsection, the term "first applicant" means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug.

(cc) Substantially complete application.—As used in this subsection, the term "substantially complete application" means an application under this subsection that on its face is sufficiently complete to permit a substantive review and contains all the information required by paragraph (2)(A).

(dd) Tentative approval.—

(AA) In general.—The term "tentative approval" means notification to an applicant by the Secretary that an application under this subsection meets the requirements of paragraph (2)(A), but cannot receive effective approval because the application does not meet the requirements of this subparagraph, there is a period of exclusivity for the listed drug under subparagraph (F) or section 355a of this title, or there is a 7-year period of exclusivity for the listed drug under section 360cc of this title.

(BB) Limitation.—A drug that is granted tentative approval by the Secretary is not an approved drug and shall not have an effective approval until the Secretary issues an approval after any necessary additional review of the application.

(v) 180-day exclusivity period for competitive generic therapies.—

(I) Effectiveness of application.—Subject to subparagraph (D)(iv), if the application is for a drug that is the same as a competitive generic therapy for which any first approved applicant has commenced commercial marketing, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.

(II) Limitation.—The exclusivity period under subclause (I) shall not apply with respect to a competitive generic therapy that has previously received an exclusivity period under subclause (I).

(III) Definitions.—In this clause and subparagraph (D)(iv):

(aa) The term "competitive generic therapy" means a drug—

(AA) that is designated as a competitive generic therapy under section 356h of this title; and

(BB) for which there are no unexpired patents or exclusivities on the list of products described in section 355(j)(7)(A) of this title at the time of submission.

(bb) The term "first approved applicant" means any applicant that has submitted an application that—

(AA) is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved;

(BB) is not eligible for a 180-day exclusivity period under clause (iv) for the drug that is the subject of the application for the competitive generic therapy; and

(CC) is not for a drug for which all drug versions have forfeited eligibility for a 180-day exclusivity period under clause (iv) pursuant to subparagraph (D).

(C) Civil action to obtain patent certainty.—

(i) Declaratory judgment absent infringement action.—

(I) In general.—No action may be brought under section 2201 of title 28 by an applicant under paragraph (2) for a declaratory judgment with respect to a patent which is the subject of the certification referred to in subparagraph (B)(iii) unless—

(aa) the 45-day period referred to in such subparagraph has expired;

(bb) neither the owner of such patent nor the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent brought a civil action against the applicant for infringement of the patent before the expiration of such period; and

(cc) in any case in which the notice provided under paragraph (2)(B) relates to noninfringement, the notice was accompanied by a document described in subclause (III).

(II) Filing of civil action.—If the conditions described in items (aa), (bb), and as applicable, (cc) of subclause (I) have been met, the applicant referred to in such subclause may, in accordance with section 2201 of title 28, bring a civil action under such section against the owner or holder referred to in such subclause (but not against any owner or holder that has brought such a civil action against the applicant, unless that civil action was dismissed without prejudice) for a declaratory judgment that the patent is invalid or will not be infringed by the drug for which the applicant seeks approval, except that such civil action may be brought for a declaratory judgment that the patent will not be infringed only in a case in which the condition described in subclause (I)(cc) is applicable. A civil action referred to in this subclause shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.

(III) Offer of confidential access to application.—For purposes of subclause (I)(cc), the document described in this subclause is a document providing an offer of confidential access to the application that is in the custody of the applicant under paragraph (2) for the purpose of determining whether an action referred to in subparagraph (B)(iii) should be brought. The document providing the offer of confidential access shall contain such restrictions as to persons entitled to access, and on the use and disposition of any information accessed, as would apply had a protective order been entered for the purpose of protecting trade secrets and other confidential business information. A request for access to an application under an offer of confidential access shall be considered acceptance of the offer of confidential access with the restrictions as to persons entitled to access, and on the use and disposition of any information accessed, contained in the offer of confidential access, and those restrictions and other terms of the offer of confidential access shall be considered terms of an enforceable contract. Any person provided an offer of confidential access shall review the application for the sole and limited purpose of evaluating possible infringement of the patent that is the subject of the certification under paragraph (2)(A)(vii)(IV) and for no other purpose, and may not disclose information of no relevance to any issue of patent infringement to any person other than a person provided an offer of confidential access. Further, the application may be redacted by the applicant to remove any information of no relevance to any issue of patent infringement.

(ii) Counterclaim to infringement action.—

(I) In general.—If an owner of the patent or the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) on the ground that the patent does not claim either—

(aa) the drug for which the application was approved; or

(bb) an approved method of using the drug.

(II) No independent cause of action.—Subclause (I) does not authorize the assertion of a claim described in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I).

(iii) No damages.—An applicant shall not be entitled to damages in a civil action under clause (i) or a counterclaim under clause (ii).

(D) Forfeiture of 180-day exclusivity period.—

(i) Definition of forfeiture event.—In this subparagraph, the term "forfeiture event", with respect to an application under this subsection, means the occurrence of any of the following:

(I) Failure to market.—The first applicant fails to market the drug by the later of—

(aa) the earlier of the date that is—

(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or

(BB) 30 months after the date of submission of the application of the first applicant; or

(bb) with respect to the first applicant or any other applicant (which other applicant has received tentative approval), the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a certification qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at least 1 of the following has occurred:

(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.

(BB) In an infringement action or a declaratory judgment action described in subitem (AA), a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed.

(CC) The patent information submitted under subsection (b) or (c) is withdrawn by the holder of the application approved under subsection (b).

(II) Withdrawal of application.—The first applicant withdraws the application or the Secretary considers the application to have been withdrawn as a result of a determination by the Secretary that the application does not meet the requirements for approval under paragraph (4).

(III) Amendment of certification.—The first applicant amends or withdraws the certification for all of the patents with respect to which that applicant submitted a certification qualifying the applicant for the 180-day exclusivity period.

(IV) Failure to obtain tentative approval.—The first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.

(V) Agreement with another applicant, the listed drug application holder, or a patent owner.—The first applicant enters into an agreement with another applicant under this subsection for the drug, the holder of the application for the listed drug, or an owner of the patent that is the subject of the certification under paragraph (2)(A)(vii)(IV), the Federal Trade Commission or the Attorney General files a complaint, and there is a final decision of the Federal Trade Commission or the court with regard to the complaint from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the agreement has violated the antitrust laws (as defined in section 12 of title 15, except that the term includes section 45 of title 15 to the extent that that section applies to unfair methods of competition).

(VI) Expiration of all patents.—All of the patents as to which the applicant submitted a certification qualifying it for the 180-day exclusivity period have expired.

(ii) Forfeiture.—The 180-day exclusivity period described in subparagraph (B)(iv) shall be forfeited by a first applicant if a forfeiture event occurs with respect to that first applicant.

(iii) Subsequent applicant.—If all first applicants forfeit the 180-day exclusivity period under clause (ii)—

(I) approval of any application containing a certification described in paragraph (2)(A)(vii)(IV) shall be made effective in accordance with subparagraph (B)(iii); and

(II) no applicant shall be eligible for a 180-day exclusivity period.

(iv) Special forfeiture rule for competitive generic therapy.—The 180-day exclusivity period described in subparagraph (B)(v) shall be forfeited by a first approved applicant if the applicant fails to market the competitive generic therapy within 75 days after the date on which the approval of the first approved applicant's application for the competitive generic therapy is made effective.

(E) If the Secretary decides to disapprove an application, the Secretary shall give the applicant notice of an opportunity for a hearing before the Secretary on the question of whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs.

(F)(i) Repealed. Pub. L. 117–9, §1(b)(1)(B), Apr. 23, 2021, 135 Stat. 258.

(ii) If an application submitted under subsection (b) for a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under subsection (b), is approved after September 24, 1984, no application may be submitted under this subsection which refers to the drug for which the subsection (b) application was submitted before the expiration of five years from the date of the approval of the application under subsection (b), except that such an application may be submitted under this subsection after the expiration of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in subclause (IV) of paragraph (2)(A)(vii). The approval of such an application shall be made effective in accordance with subparagraph (B) except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (B)(iii) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application.

(iii) If an application submitted under subsection (b) for a drug, which includes an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in another application approved under subsection (b), is approved after September 24, 1984, and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under this subsection for the conditions of approval of such drug in the subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) for such drug.

(iv) If a supplement to an application approved under subsection (b) is approved after September 24, 1984, and the supplement contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under this subsection for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b).

(v) If an application (or supplement to an application) submitted under subsection (b) for a drug, which includes an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in another application under subsection (b), was approved during the period beginning January 1, 1982, and ending on September 24, 1984, the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted or which refers to a change approved in a supplement to the subsection (b) application effective before the expiration of two years from September 24, 1984.

(6) If a drug approved under this subsection refers in its approved application to a drug the approval of which was withdrawn or suspended for grounds described in the first sentence of subsection (e) or was withdrawn or suspended under this paragraph or which, as determined by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the approval of the drug under this subsection shall be withdrawn or suspended—

(A) for the same period as the withdrawal or suspension under subsection (e) or this paragraph, or

(B) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons.

(7)(A)(i) Within sixty days of September 24, 1984, the Secretary shall publish and make available to the public—

(I) a list in alphabetical order of the official and proprietary name of each drug which has been approved for safety and effectiveness under subsection (c) before September 24, 1984;

(II) the date of approval if the drug is approved after 1981 and the number of the application which was approved; and

(III) whether in vitro or in vivo bioequivalence studies, or both such studies, are required for applications filed under this subsection which will refer to the drug published.

(ii) Every thirty days after the publication of the first list under clause (i) the Secretary shall revise the list to include each drug which has been approved for safety and effectiveness under subsection (c) or approved under this subsection during the thirty-day period.

(iii) When patent information submitted under subsection (c) respecting a drug included on the list is to be published by the Secretary, the Secretary shall, in revisions made under clause (ii), include such information for such drug.

(iv) For each drug included on the list, the Secretary shall specify any exclusivity period that is applicable, for which the Secretary has determined the expiration date, and for which such period has not yet expired, under—

(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E);

(II) clause (iv) or (v) of paragraph (5)(B);

(III) clause (ii), (iii), or (iv) of paragraph (5)(F);

(IV) section 355a of this title;

(V) section 355f of this title;

(VI) section 360cc(a) of this title; or

(VII) subsection (u).

(v)(I) With respect to an application submitted pursuant to subsection (b)(2) for a drug that is subject to section 353(b) of this title for which the sole difference from a listed drug relied upon in the application is a difference in inactive ingredients not permitted under clause (iii) or (iv) of section 314.94(a)(9) of title 21, Code of Federal Regulations (or any successor regulations), the Secretary shall make an evaluation with respect to whether such drug is a therapeutic equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to another approved drug product in the prescription drug product section of the list under this paragraph as follows:

(aa) With respect to such an application submitted after December 29, 2022, the evaluation shall be made with respect to a listed drug relied upon in the application pursuant to subsection (b)(2) that is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug in the application pursuant to subsection (b)(2) at the time of approval of such application or not later than 180 days after the date of such approval, provided that the request for such an evaluation is made in the original application (or in a resubmission to a complete response letter), and all necessary data and information are submitted in the original application (or in a resubmission in response to a complete response letter) for the therapeutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Secretary.

(bb) With respect to such an application approved prior to or on December 29, 2022, the evaluation shall be made not later than 180 days after receipt of a request for a therapeutic equivalence evaluation submitted as part of a supplement to such application; or with respect to an application that was submitted prior to December 29, 2022, but not approved as of December 29, 2022, the evaluation shall be made not later than 180 days after the date of approval of such application if a request for such evaluation is submitted as an amendment to the application, provided that—

(AA) such request for a therapeutic equivalence evaluation is being sought with respect to a listed drug relied upon in the application, and the relied upon listed drug is in the prescription drug product section of the list under this paragraph and is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug for which a therapeutic equivalence evaluation is sought; and

(BB) the amendment or supplement, as applicable, containing such request, or the relevant application, includes all necessary data and information for the therapeutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Secretary.

(II) When the Secretary makes an evaluation under subclause (I), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug.

(B) A drug approved for safety and effectiveness under subsection (c) or approved under this subsection shall, for purposes of this subsection, be considered to have been published under subparagraph (A) on the date of its approval or September 24, 1984, whichever is later.

(C) If the approval of a drug was withdrawn or suspended for grounds described in the first sentence of subsection (e) or was withdrawn or suspended under paragraph (6) or if the Secretary determines that a drug has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its publication in such list, it shall be immediately removed from such list—

(i) for the same period as the withdrawal or suspension under subsection (e) or paragraph (6), or

(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons.

A notice of the removal shall be published in the Federal Register.

(D) In the case of a listed drug for which the list under subparagraph (A)(i) includes a patent for such drug, and any claim of the patent has been cancelled or invalidated pursuant to a final decision issued by the Patent Trial and Appeal Board of the United States Patent and Trademark Office or by a court, from which no appeal has been, or can be, taken, if the holder of the applicable application approved under subsection (c) determines that a patent for such drug, or any patent information for such drug, no longer meets the listing requirements under this section—

(i) the holder of such approved application shall notify the Secretary, in writing, within 14 days of such decision of such cancellation or invalidation and request that such patent or patent information, as applicable, be amended or withdrawn in accordance with the decision issued by the Patent Trial and Appeal Board or a court;

(ii) the holder of such approved application shall include in any notification under clause (i) information related to such patent cancellation or invalidation decision and submit such information, including a copy of such decision, to the Secretary; and

(iii) the Secretary shall, in response to a notification under clause (i), amend or remove patent or patent information in accordance with the relevant decision from the Patent Trial and Appeals Board or court, as applicable, except that the Secretary shall not remove from the list any patent or patent information before the expiration of any 180-day exclusivity period under paragraph (5)(B)(iv) that relies on a certification described in paragraph (2)(A)(vii)(IV).

(8) For purposes of this subsection:

(A)(i) The term "bioavailability" means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action.

(ii) For a drug that is not intended to be absorbed into the bloodstream, the Secretary may assess bioavailability by scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or therapeutic ingredient becomes available at the site of drug action.

(B) A drug shall be considered to be bioequivalent to a listed drug if—

(i) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses; or

(ii) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses and the difference from the listed drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug.

(C) For a drug that is not intended to be absorbed into the bloodstream, the Secretary may establish alternative, scientifically valid methods to show bioequivalence if the alternative methods are expected to detect a significant difference between the drug and the listed drug in safety and therapeutic effect.

(9) The Secretary shall, with respect to each application submitted under this subsection, maintain a record of—

(A) the name of the applicant,

(B) the name of the drug covered by the application,

(C) the name of each person to whom the review of the chemistry of the application was assigned and the date of such assignment, and

(D) the name of each person to whom the bioequivalence review for such application was assigned and the date of such assignment.

The information the Secretary is required to maintain under this paragraph with respect to an application submitted under this subsection shall be made available to the public after the approval of such application.

(10)(A) If the proposed labeling of a drug that is the subject of an application under this subsection differs from the listed drug due to a labeling revision described under clause (i), the drug that is the subject of such application shall, notwithstanding any other provision of this chapter, be eligible for approval and shall not be considered misbranded under section 352 of this title if—

(i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for approval under this subsection;

(ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application;

(iii) the labeling revision described under clause (i) does not include a change to the "Warnings" section of the labeling; and

(iv) such application otherwise meets the applicable requirements for approval under this subsection.

(B) If, after a labeling revision described in subparagraph (A)(i), the Secretary determines that the continued presence in interstate commerce of the labeling of the listed drug (as in effect before the revision described in subparagraph (A)(i)) adversely impacts the safe use of the drug, no application under this subsection shall be eligible for approval with such labeling.

(11)(A) Subject to subparagraph (B), the Secretary shall prioritize the review of, and act within 8 months of the date of the submission of, an original abbreviated new drug application submitted for review under this subsection that is for a drug—

(i) for which there are not more than 3 approved drug products listed under paragraph (7) and for which there are no blocking patents and exclusivities; or

(ii) that has been included on the list under section 356e of this title.

(B) To qualify for priority review under this paragraph, not later than 60 days prior to the submission of an application described in subparagraph (A) or that the Secretary may prioritize pursuant to subparagraph (D), the applicant shall provide complete, accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application, including facilities in corresponding Type II active pharmaceutical ingredients drug master files referenced in an application and sites or organizations involved in bioequivalence and clinical studies used to support the application, to enable the Secretary to make a determination regarding whether an inspection of a facility is necessary. Such information shall include the relevant (as determined by the Secretary) sections of such application, which shall be unchanged relative to the date of the submission of such application, except to the extent that a change is made to such information to exclude a facility that was not used to generate data to meet any application requirements for such submission and that is not the only facility intended to conduct one or more unit operations in commercial production. Information provided by an applicant under this subparagraph shall not be considered the submission of an application under this subsection.

(C) The Secretary may expedite an inspection or reinspection under section 374 of this title of an establishment that proposes to manufacture a drug described in subparagraph (A).

(D) Nothing in this paragraph shall prevent the Secretary from prioritizing the review of other applications as the Secretary determines appropriate.

(12) The Secretary shall publish on the internet website of the Food and Drug Administration, and update at least once every 6 months, a list of all drugs approved under subsection (c) for which all patents and periods of exclusivity under this chapter have expired and for which no application has been approved under this subsection.

(13) Upon the request of an applicant regarding one or more specified pending applications under this subsection, the Secretary shall, as appropriate, provide review status updates indicating the categorical status of the applications by each relevant review discipline.

(k) Records and reports; required information; regulations and orders; access to records

(1) In the case of any drug for which an approval of an application filed under subsection (b) or (j) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, of data relating to clinical experience and other data or information, received or otherwise obtained by such applicant with respect to such drug, as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e). Regulations and orders issued under this subsection and under subsection (i) shall have due regard for the professional ethics of the medical profession and the interests of patients and shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulations or orders are applicable, of similar information received or otherwise obtained by the Secretary.

(2) Every person required under this section to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(3) Active postmarket risk identification.—

(A) Definition.—In this paragraph, the term "data" refers to information with respect to a drug approved under this section or under section 262 of title 42, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, and any other data deemed appropriate by the Secretary.

(B) Development of postmarket risk identification and analysis methods.—The Secretary shall, not later than 2 years after September 27, 2007, in collaboration with public, academic, and private entities—

(i) develop methods to obtain access to disparate data sources including the data sources specified in subparagraph (C);

(ii) develop validated methods for the establishment of a postmarket risk identification and analysis system to link and analyze safety data from multiple sources, with the goals of including, in aggregate—

(I) at least 25,000,000 patients by July 1, 2010; and

(II) at least 100,000,000 patients by July 1, 2012; and

(iii) convene a committee of experts, including individuals who are recognized in the field of protecting data privacy and security, to make recommendations to the Secretary on the development of tools and methods for the ethical and scientific uses for, and communication of, postmarketing data specified under subparagraph (C), including recommendations on the development of effective research methods for the study of drug safety questions.

(C) Establishment of the postmarket risk identification and analysis system.—

(i) In general.—The Secretary shall, not later than 1 year after the development of the risk identification and analysis methods under subparagraph (B), establish and maintain procedures—

(I) for risk identification and analysis based on electronic health data, in compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, and in a manner that does not disclose individually identifiable health information in violation of paragraph (4)(B);

(II) for the reporting (in a standardized form) of data on all serious adverse drug experiences (as defined in section 355–1(b) of this title) submitted to the Secretary under paragraph (1), and those adverse events submitted by patients, providers, and drug sponsors, when appropriate;

(III) to provide for active adverse event surveillance using the following data sources, as available:

(aa) Federal health-related electronic data (such as data from the Medicare program and the health systems of the Department of Veterans Affairs);

(bb) private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); and

(cc) other data as the Secretary deems necessary to create a robust system to identify adverse events and potential drug safety signals;

(IV) to identify certain trends and patterns with respect to data accessed by the system;

(V) to provide regular reports to the Secretary concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative national adverse event trends; and

(VI) to enable the program to export data in a form appropriate for further aggregation, statistical analysis, and reporting.

(ii) Timeliness of reporting.—The procedures established under clause (i) shall ensure that such data are accessed, analyzed, and reported in a timely, routine, and systematic manner, taking into consideration the need for data completeness, coding, cleansing, and standardized analysis and transmission.

(iii) Private sector resources.—To ensure the establishment of the active postmarket risk identification and analysis system under this subsection not later than 1 year after the development of the risk identification and analysis methods under subparagraph (B), as required under clause (i), the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities.

(iv) Complementary approaches.—To the extent the active postmarket risk identification and analysis system under this subsection is not sufficient to gather data and information relevant to a priority drug safety question, the Secretary shall develop, support, and participate in complementary approaches to gather and analyze such data and information, including—

(I) approaches that are complementary with respect to assessing the safety of use of a drug in domestic populations not included, or underrepresented, in the trials used to approve the drug (such as older people, people with comorbidities, pregnant women, or children); and

(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or successor databases.

(v) Authority for contracts.—The Secretary may enter into contracts with public and private entities to fulfill the requirements of this subparagraph.

(4) Advanced analysis of drug safety data.—

(A) Purpose.—The Secretary shall establish collaborations with public, academic, and private entities, which may include the Centers for Education and Research on Therapeutics under section 299b–1 of title 42, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other information that is publicly available or is provided by the Secretary, in order to—

(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;

(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety questions; and

(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data.

(B) Privacy.—Such analysis shall not disclose individually identifiable health information when presenting such drug safety signals and trends or when responding to inquiries regarding such drug safety signals and trends.

(C) Public process for priority questions.—At least biannually, the Secretary shall seek recommendations from the Drug Safety and Risk Management Advisory Committee (or any successor committee) and from other advisory committees, as appropriate, to the Food and Drug Administration on—

(i) priority drug safety questions; and

(ii) mechanisms for answering such questions, including through—

(I) active risk identification under paragraph (3); and

(II) when such risk identification is not sufficient, postapproval studies and clinical trials under subsection (o)(3).

(D) Procedures for the development of drug safety collaborations.—

(i) In general.—Not later than 180 days after the date of the establishment of the active postmarket risk identification and analysis system under this subsection, the Secretary shall establish and implement procedures under which the Secretary may routinely contract with one or more qualified entities to—

(I) classify, analyze, or aggregate data described in paragraph (3)(C) and information that is publicly available or is provided by the Secretary;

(II) allow for prompt investigation of priority drug safety questions, including—

(aa) unresolved safety questions for drugs or classes of drugs; and

(bb) for a newly-approved drugs,² safety signals from clinical trials used to approve the drug and other preapproval trials; rare, serious drug side effects; and the safety of use in domestic populations not included, or underrepresented, in the trials used to approve the drug (such as older people, people with comorbidities, pregnant women, or children);

(III) perform advanced research and analysis on identified drug safety risks;

(IV) focus postapproval studies and clinical trials under subsection (o)(3) more effectively on cases for which reports under paragraph (1) and other safety signal detection is not sufficient to resolve whether there is an elevated risk of a serious adverse event associated with the use of a drug; and

(V) carry out other activities as the Secretary deems necessary to carry out the purposes of this paragraph.

(ii) Request for specific methodology.—The procedures described in clause (i) shall permit the Secretary to request that a specific methodology be used by the qualified entity. The qualified entity shall work with the Secretary to finalize the methodology to be used.

(E) Use of analyses.—The Secretary shall provide the analyses described in this paragraph, including the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug.

(F) Qualified entities.—

(i) In general.—The Secretary shall enter into contracts with a sufficient number of qualified entities to develop and provide information to the Secretary in a timely manner.

(ii) Qualification.—The Secretary shall enter into a contract with an entity under clause (i) only if the Secretary determines that the entity has a significant presence in the United States and has one or more of the following qualifications:

(I) The research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this paragraph, including the capability and expertise to provide the Secretary de-identified data consistent with the requirements of this subsection.

(II) An information technology infrastructure in place to support electronic data and operational standards to provide security for such data.

(III) Experience with, and expertise on, the development of drug safety and effectiveness research using electronic population data.

(IV) An understanding of drug development or risk/benefit balancing in a clinical setting.

(V) Other expertise which the Secretary deems necessary to fulfill the activities under this paragraph.

(G) Contract requirements.—Each contract with a qualified entity under subparagraph (F)(i) shall contain the following requirements:

(i) Ensuring privacy.—The qualified entity shall ensure that the entity will not use data under this subsection in a manner that—

(I) violates the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996;

(II) violates sections 552 or 552a of title 5 with regard to the privacy of individually-identifiable beneficiary health information; or

(III) discloses individually identifiable health information when presenting drug safety signals and trends or when responding to inquiries regarding drug safety signals and trends.

Nothing in this clause prohibits lawful disclosure for other purposes.

(ii) Component of another organization.—If a qualified entity is a component of another organization—

(I) the qualified entity shall establish appropriate security measures to maintain the confidentiality and privacy of such data; and

(II) the entity shall not make an unauthorized disclosure of such data to the other components of the organization in breach of such confidentiality and privacy requirement.

(iii) Termination or nonrenewal.—If a contract with a qualified entity under this subparagraph is terminated or not renewed, the following requirements shall apply:

(I) Confidentiality and privacy protections.—The entity shall continue to comply with the confidentiality and privacy requirements under this paragraph with respect to all data disclosed to the entity.

(II) Disposition of data.—The entity shall return any data disclosed to such entity under this subsection to which it would not otherwise have access or, if returning the data is not practicable, destroy the data.

(H) Competitive procedures.—The Secretary shall use competitive procedures (as defined in section 132 of title 41) to enter into contracts under subparagraph (G).

(I) Review of contract in the event of a merger or acquisition.—The Secretary shall review the contract with a qualified entity under this paragraph in the event of a merger or acquisition of the entity in order to ensure that the requirements under this paragraph will continue to be met.

(J) Coordination.—In carrying out this paragraph, the Secretary shall provide for appropriate communications to the public, scientific, public health, and medical communities, and other key stakeholders, and to the extent practicable shall coordinate with the activities of private entities, professional associations, or other entities that may have sources of drug safety data.

(5) The Secretary shall—

(A) conduct regular screenings of the Adverse Event Reporting System database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse ³ Event Reporting System within the last quarter; and ⁴

(B) on an annual basis, review the entire backlog of postmarket safety commitments to determine which commitments require revision or should be eliminated, report to the Congress on these determinations, and assign start dates and estimated completion dates for such commitments; and

(C) make available on the Internet website of the Food and Drug Administration—

(i) guidelines, developed with input from experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that detail best practices for drug safety surveillance using the Adverse Event Reporting System; and

(ii) criteria for public posting of adverse event signals.

(l) Public disclosure of safety and effectiveness data and action package

(1) Safety and effectiveness data and information which has been submitted in an application under subsection (b) for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown—

(A) if no work is being or will be undertaken to have the application approved,

(B) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted,

(C) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted,

(D) if the Secretary has determined that such drug is not a new drug, or

(E) upon the effective date of the approval of the first application under subsection (j) which refers to such drug or upon the date upon which the approval of an application under subsection (j) which refers to such drug could be made effective if such an application had been submitted.

(2) Action Package for Approval.—

(A) Action package.—The Secretary shall publish the action package for approval of an application under subsection (b) or section 262 of title 42 on the Internet Web site of the Food and Drug Administration—

(i) not later than 30 days after the date of approval of such applications—

(I) for a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under this section; or

(II) for a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42; and

(ii) not later than 30 days after the third request for such action package for approval received under section 552 of title 5 for any other drug or biological product.

(B) Immediate publication of summary review.—Notwithstanding subparagraph (A), the Secretary shall publish, on the Internet Web site of the Food and Drug Administration, the materials described in subparagraph (C)(iv) not later than 48 hours after the date of approval of the drug, except where such materials require redaction by the Secretary.

(C) Contents.—An action package for approval of an application under subparagraph (A) shall be dated and shall include the following:

(i) Documents generated by the Food and Drug Administration related to review of the application.

(ii) Documents pertaining to the format and content of the application generated during drug development.

(iii) Labeling submitted by the applicant.

(iv) A summary review that documents conclusions from all reviewing disciplines about the drug, noting any critical issues and disagreements with the applicant and within the review team and how they were resolved, recommendations for action, and an explanation of any nonconcurrence with review conclusions.

(v) The Division Director and Office Director's decision document which includes—

(I) a brief statement of concurrence with the summary review;

(II) a separate review or addendum to the review if disagreeing with the summary review; and

(III) a separate review or addendum to the review to add further analysis.

(vi) Identification by name of each officer or employee of the Food and Drug Administration who—

(I) participated in the decision to approve the application; and

(II) consents to have his or her name included in the package.

(D) Review.—A scientific review of an application is considered the work of the reviewer and shall not be altered by management or the reviewer once final.

(E) Confidential information.—This paragraph does not authorize the disclosure of any trade secret, confidential commercial or financial information, or other matter listed in section 552(b) of title 5.

(m) "Patent" defined

For purposes of this section, the term "patent" means a patent issued by the United States Patent and Trademark Office.

(n) Scientific advisory panels

(1) For the purpose of providing expert scientific advice and recommendations to the Secretary regarding a clinical investigation of a drug or the approval for marketing of a drug under this section or section 262 of title 42, the Secretary shall establish panels of experts or use panels of experts established before November 21, 1997, or both.

(2) The Secretary may delegate the appointment and oversight authority granted under section 394 of this title to a director of a center or successor entity within the Food and Drug Administration.

(3) The Secretary shall make appointments to each panel established under paragraph (1) so that each panel shall consist of—

(A) members who are qualified by training and experience to evaluate the safety and effectiveness of the drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the development, manufacture, or utilization of such drugs;

(B) members with diverse expertise in such fields  as  clinical  and  administrative  medicine, pharmacy, pharmacology, pharmacoeconomics, biological and physical sciences, and other related professions;

(C) a representative of consumer interests, and a representative of interests of the drug manufacturing industry not directly affected by the matter to be brought before the panel; and

(D) two or more members who are specialists or have other expertise in the particular disease or condition for which the drug under review is proposed to be indicated.

Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in the administration of this chapter may be a voting member of any panel. The Secretary shall designate one of the members of each panel to serve as chairman thereof.

(4) The Secretary shall, as appropriate, provide education and training to each new panel member before such member participates in a panel's activities, including education regarding requirements under this chapter and related regulations of the Secretary, and the administrative processes and procedures related to panel meetings.

(5) Panel members (other than officers or employees of the United States), while attending meetings or conferences of a panel or otherwise engaged in its business, shall be entitled to receive compensation for each day so engaged, including traveltime, at rates to be fixed by the Secretary, but not to exceed the daily equivalent of the rate in effect for positions classified above grade GS–15 of the General Schedule. While serving away from their homes or regular places of business, panel members may be allowed travel expenses (including per diem in lieu of subsistence) as authorized by section 5703 of title 5, for persons in the Government service employed intermittently.

(6) The Secretary shall ensure that scientific advisory panels meet regularly and at appropriate intervals so that any matter to be reviewed by such a panel can be presented to the panel not more than 60 days after the matter is ready for such review. Meetings of the panel may be held using electronic communication to convene the meetings.

(7) Within 90 days after a scientific advisory panel makes recommendations on any matter under its review, the Food and Drug Administration official responsible for the matter shall review the conclusions and recommendations of the panel, and notify the affected persons of the final decision on the matter, or of the reasons that no such decision has been reached. Each such final decision shall be documented including the rationale for the decision.

(o) Postmarket studies and clinical trials; labeling

(1) In general

A responsible person may not introduce or deliver for introduction into interstate commerce the new drug involved if the person is in violation of a requirement established under paragraph (3) or (4) with respect to the drug.

(2) Definitions

For purposes of this subsection:

(A) Responsible person

The term "responsible person" means a person who—

(i) has submitted to the Secretary a covered application that is pending; or

(ii) is the holder of an approved covered application.

(B) Covered application

The term "covered application" means—

(i) an application under subsection (b) for a drug that is subject to section 353(b) of this title; and

(ii) an application under section 262 of title 42.

(C) New safety information; serious risk

The terms "new safety information", "serious risk", and "signal of a serious risk" have the meanings given such terms in section 355–1(b) of this title.

(3) Studies and clinical trials

(A) In general

For any or all of the purposes specified in subparagraph (B), the Secretary may, subject to subparagraph (D), require a responsible person for a drug to conduct a postapproval study or studies of the drug, or a postapproval clinical trial or trials of the drug, on the basis of scientific data deemed appropriate by the Secretary, including information regarding chemically-related or pharmacologically-related drugs.

(B) Purposes of study or clinical trial

The purposes referred to in this subparagraph with respect to a postapproval study or postapproval clinical trial are the following:

(i) To assess a known serious risk related to the use of the drug involved.

(ii) To assess signals of serious risk related to the use of the drug.

(iii) To identify an unexpected serious risk when available data indicates the potential for a serious risk.

(C) Establishment of requirement after approval of covered application

The Secretary may require a postapproval study or studies or postapproval clinical trial or trials for a drug for which an approved covered application is in effect as of the date on which the Secretary seeks to establish such requirement only if the Secretary becomes aware of new safety information.

(D) Determination by Secretary

(i) Postapproval studies

The Secretary may not require the responsible person to conduct a study under this paragraph, unless the Secretary makes a determination that the reports under subsection (k)(1) and the active postmarket risk identification and analysis system as available under subsection (k)(3) will not be sufficient to meet the purposes set forth in subparagraph (B).

(ii) Postapproval clinical trials

The Secretary may not require the responsible person to conduct a clinical trial under this paragraph, unless the Secretary makes a determination that a postapproval study or studies will not be sufficient to meet the purposes set forth in subparagraph (B).

(E) Notification; timetables; periodic reports

(i) Notification

The Secretary shall notify the responsible person regarding a requirement under this paragraph to conduct a postapproval study or clinical trial by the target dates for communication of feedback from the review team to the responsible person regarding proposed labeling and postmarketing study commitments as set forth in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.

(ii) Timetable; periodic reports

For each study or clinical trial required to be conducted under this paragraph, the Secretary shall require that the responsible person submit a timetable for completion of the study or clinical trial. With respect to each study required to be conducted under this paragraph or otherwise undertaken by the responsible person to investigate a safety issue, the Secretary shall require the responsible person to periodically report to the Secretary on the status of such study including whether any difficulties in completing the study have been encountered. With respect to each clinical trial required to be conducted under this paragraph or otherwise undertaken by the responsible person to investigate a safety issue, the Secretary shall require the responsible person to periodically report to the Secretary on the status of such clinical trial including whether enrollment has begun, the number of participants enrolled, the expected completion date, whether any difficulties completing the clinical trial have been encountered, and registration information with respect to the requirements under section 282(j) of title 42. If the responsible person fails to comply with such timetable or violates any other requirement of this subparagraph, the responsible person shall be considered in violation of this subsection, unless the responsible person demonstrates good cause for such noncompliance or such other violation. The Secretary shall determine what constitutes good cause under the preceding sentence.

(F) Dispute resolution

The responsible person may appeal a requirement to conduct a study or clinical trial under this paragraph using dispute resolution procedures established by the Secretary in regulation and guidance.

(4) Safety labeling changes requested by Secretary

(A) New safety or new effectiveness information

If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug, the Secretary shall promptly notify the responsible person or, if the same drug approved under subsection (b) is not currently marketed, the holder of an approved application under subsection (j).

(B) Response to notification

Following notification pursuant to subparagraph (A), the responsible person or the holder of the approved application under subsection (j) shall within 30 days—

(i) submit a supplement proposing changes to the approved labeling to reflect the new safety information, including changes to boxed warnings, contraindications, warnings, precautions, or adverse reactions, or new effectiveness information; or

(ii) notify the Secretary that the responsible person or the holder of the approved application under subsection (j) does not believe a labeling change is warranted and submit a statement detailing the reasons why such a change is not warranted.

(C) Review

Upon receipt of such supplement, the Secretary shall promptly review and act upon such supplement. If the Secretary disagrees with the proposed changes in the supplement or with the statement setting forth the reasons why no labeling change is necessary, the Secretary shall initiate discussions to reach agreement on whether the labeling for the drug should be modified to reflect the new safety or new effectiveness information, and if so, the contents of such labeling changes.

(D) Discussions

Such discussions shall not extend for more than 30 days after the response to the notification under subparagraph (B), unless the Secretary determines an extension of such discussion period is warranted.

(E) Order

Within 15 days of the conclusion of the discussions under subparagraph (D), the Secretary may issue an order directing the responsible person or the holder of the approved application under subsection (j) to make such a labeling change as the Secretary deems appropriate to address the new safety or new effectiveness information. Within 15 days of such an order, the responsible person or the holder of the approved application under subsection (j) shall submit a supplement containing the labeling change.

(F) Dispute resolution

Within 5 days of receiving an order under subparagraph (E), the responsible person or the holder of the approved application under subsection (j) may appeal using dispute resolution procedures established by the Secretary in regulation and guidance.

(G) Violation

If the responsible person or the holder of the approved application under subsection (j) has not submitted a supplement within 15 days of the date of such order under subparagraph (E), and there is no appeal or dispute resolution proceeding pending, the responsible person or holder shall be considered to be in violation of this subsection. If at the conclusion of any dispute resolution procedures the Secretary determines that a supplement must be submitted and such a supplement is not submitted within 15 days of the date of that determination, the responsible person or holder shall be in violation of this subsection.

(H) Public health threat

Notwithstanding subparagraphs (A) through (F), if the Secretary concludes that such a labeling change is necessary to protect the public health, the Secretary may accelerate the timelines in such subparagraphs.

(I) Rule of construction

This paragraph shall not be construed to affect the responsibility of the responsible person or the holder of the approved application under subsection (j) to maintain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations).

(5) Non-delegation

Determinations by the Secretary under this subsection for a drug shall be made by individuals at or above the level of individuals empowered to approve a drug (such as division directors within the Center for Drug Evaluation and Research).

(p) Risk evaluation and mitigation strategy

(1) In general

A person may not introduce or deliver for introduction into interstate commerce a new drug if—

(A)(i) the application for such drug is approved under subsection (b) or (j) and is subject to section 353(b) of this title; or

(ii) the application for such drug is approved under section 262 of title 42; and

(B) a risk evaluation and mitigation strategy is required under section 355–1 of this title with respect to the drug and the person fails to maintain compliance with the requirements of the approved strategy or with other requirements under section 355–1 of this title, including requirements regarding assessments of approved strategies.

(2) Certain postmarket studies

The failure to conduct a postmarket study under section 356 of this title, subpart H of part 314, or subpart E of part 601 of title 21, Code of Federal Regulations (or any successor regulations), is deemed to be a violation of paragraph (1).

(q) Petitions and civil actions regarding approval of certain applications

(1) In general

(A) Determination

The Secretary shall not delay approval of a pending application submitted under subsection (b)(2) or (j) of this section or section 262(k) of title 42 because of any request to take any form of action relating to the application, either before or during consideration of the request, unless—

(i) the request is in writing and is a petition submitted to the Secretary pursuant to section 10.30 or 10.35 of title 21, Code of Federal Regulations (or any successor regulations); and

(ii) the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health.

Consideration of the petition shall be separate and apart from review and approval of any application.

(B) Notification

If the Secretary determines under subparagraph (A) that a delay is necessary with respect to an application, the Secretary shall provide to the applicant, not later than 30 days after making such determination, the following information:

(i) Notification of the fact that a determination under subparagraph (A) has been made.

(ii) If applicable, any clarification or additional data that the applicant should submit to the docket on the petition to allow the Secretary to review the petition promptly.

(iii) A brief summary of the specific substantive issues raised in the petition which form the basis of the determination.

(C) Format

The information described in subparagraph (B) shall be conveyed via either, at the discretion of the Secretary—

(i) a document; or

(ii) a meeting with the applicant involved.

(D) Public disclosure

Any information conveyed by the Secretary under subparagraph (C) shall be considered part of the application and shall be subject to the disclosure requirements applicable to information in such application.

(E) Denial based on intent to delay

If the Secretary determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, the Secretary may deny the petition at any point based on such determination. The Secretary may issue guidance to describe the factors that will be used to determine under this subparagraph whether a petition is submitted with the primary purpose of delaying the approval of an application.

(F) Final agency action

The Secretary shall take final agency action on a petition not later than 150 days after the date on which the petition is submitted. The Secretary shall not extend such period for any reason, including—

(i) any determination made under subparagraph (A);

(ii) the submission of comments relating to the petition or supplemental information supplied by the petitioner; or

(iii) the consent of the petitioner.

(G) Extension of 30-month period

If the filing of an application resulted in first-applicant status under subsection (j)(5)(D)(i)(IV) and approval of the application was delayed because of a petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether the Secretary grants, in whole or in part, or denies, in whole or in part, the petition.

(H) Certification

The Secretary shall not consider a petition for review unless the party submitting such petition does so in written form and the subject document is signed and contains the following certification: "I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or information which are unfavorable to the petition were disclosed to me. I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is submitted on or about the following date: ____________________. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: __________________________. I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition.", with the date on which such information first became known to such party and the names of such persons or organizations inserted in the first and second blank space, respectively.

(I) Verification

The Secretary shall not accept for review any supplemental information or comments on a petition unless the party submitting such information or comments does so in written form and the subject document is signed and contains the following verification: "I certify that, to my best knowledge and belief: (a) I have not intentionally delayed submission of this document or its contents; and (b) the information upon which I have based the action requested herein first became known to me on or about ____________________. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: __________. I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition.", with the date on which such information first became known to the party and the names of such persons or organizations inserted in the first and second blank space, respectively.

(2) Exhaustion of administrative remedies

(A) Final agency action within 150 days

The Secretary shall be considered to have taken final agency action on a petition if—

(i) during the 150-day period referred to in paragraph (1)(F), the Secretary makes a final decision within the meaning of section 10.45(d) of title 21, Code of Federal Regulations (or any successor regulation); or

(ii) such period expires without the Secretary having made such a final decision.

(B) Dismissal of certain civil actions

If a civil action is filed against the Secretary with respect to any issue raised in the petition before the Secretary has taken final agency action on the petition within the meaning of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.

(C) Administrative record

For purposes of judicial review related to the approval of an application for which a petition under paragraph (1) was submitted, the administrative record regarding any issue raised by the petition shall include—

(i) the petition filed under paragraph (1) and any supplements and comments thereto;

(ii) the Secretary's response to such petition, if issued; and

(iii) other information, as designated by the Secretary, related to the Secretary's determinations regarding the issues raised in such petition, as long as the information was considered by the agency no later than the date of final agency action as defined under subparagraph (2)(A), and regardless of whether the Secretary responded to the petition at or before the approval of the application at issue in the petition.

(3) Annual report on delays in approvals per petitions

The Secretary shall annually submit to the Congress a report that specifies—

(A) the number of applications that were approved during the preceding 12-month period;

(B) the number of such applications whose effective dates were delayed by petitions referred to in paragraph (1) during such period;

(C) the number of days by which such applications were so delayed; and

(D) the number of such petitions that were submitted during such period.

(4) Exceptions

(A) This subsection does not apply to—

(i) a petition that relates solely to the timing of the approval of an application pursuant to subsection (j)(5)(B)(iv); or

(ii) a petition that is made by the sponsor of an application and that seeks only to have the Secretary take or refrain from taking any form of action with respect to that application.

(B) Paragraph (2) does not apply to a petition addressing issues concerning an application submitted pursuant to section 262(k) of title 42.

(5) Definitions

(A) Application

For purposes of this subsection, the term "application" means an application submitted under subsection (b)(2) or (j) of this section or section 262(k) of title 42.

(B) Petition

For purposes of this subsection, other than paragraph (1)(A)(i), the term "petition" means a request described in paragraph (1)(A)(i).

(r) Postmarket drug safety information for patients and providers

(1) Establishment

Not later than 1 year after September 27, 2007, the Secretary shall improve the transparency of information about drugs and allow patients and health care providers better access to information about drugs by developing and maintaining an Internet Web site that—

(A) provides links to drug safety information listed in paragraph (2) for prescription drugs that are approved under this section or licensed under section 262 of title 42; and

(B) improves communication of drug safety information to patients and providers.

(2) Internet Web site

The Secretary shall carry out paragraph (1) by—

(A) developing and maintaining an accessible, consolidated Internet Web site with easily searchable drug safety information, including the information found on United States Government Internet Web sites, such as the United States National Library of Medicine's Daily Med and Medline Plus Web sites, in addition to other such Web sites maintained by the Secretary;

(B) ensuring that the information provided on the Internet Web site is comprehensive and includes, when available and appropriate—

(i) patient labeling and patient packaging inserts;

(ii) a link to a list of each drug, whether approved under this section or licensed under such section 262, for which a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations), is required;

(iii) a link to the registry and results data bank provided for under subsections (i) and (j) of section 282 of title 42;

(iv) the most recent safety information and alerts issued by the Food and Drug Administration for drugs approved by the Secretary under this section, such as product recalls, warning letters, and import alerts;

(v) publicly available information about implemented RiskMAPs and risk evaluation and mitigation strategies under subsection (o);

(vi) guidance documents and regulations related to drug safety; and

(vii) other material determined appropriate by the Secretary;

(C) providing access to summaries of the assessed and aggregated data collected from the active surveillance infrastructure under subsection (k)(3) to provide information of known and serious side-effects for drugs approved under this section or licensed under such section 262;

(D) preparing and making publicly available on the Internet website established under paragraph (1) best practices for drug safety surveillance activities for drugs approved under this section or section 262 of title 42;

(E) enabling patients, providers, and drug sponsors to submit adverse event reports through the Internet Web site;

(F) providing educational materials for patients and providers about the appropriate means of disposing of expired, damaged, or unusable medications; and

(G) supporting initiatives that the Secretary determines to be useful to fulfill the purposes of the Internet Web site.

(3) Posting of drug labeling

The Secretary shall post on the Internet Web site established under paragraph (1) the approved professional labeling and any required patient labeling of a drug approved under this section or licensed under such section 262 not later than 21 days after the date the drug is approved or licensed, including in a supplemental application with respect to a labeling change.

(4) Private sector resources

To ensure development of the Internet Web site by the date described in paragraph (1), the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities.

(5) Authority for contracts

The Secretary may enter into contracts with public and private entities to fulfill the requirements of this subsection.

(6) Review

The Advisory Committee on Risk Communication under section 360bbb–6 of this title shall, on a regular basis, perform a comprehensive review and evaluation of the types of risk communication information provided on the Internet Web site established under paragraph (1) and, through other means, shall identify, clarify, and define the purposes and types of information available to facilitate the efficient flow of information to patients and providers, and shall recommend ways for the Food and Drug Administration to work with outside entities to help facilitate the dispensing of risk communication information to patients and providers.

(s) Referral to advisory committee

The Secretary shall—

(1) refer a drug or biological product to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee prior to the approval of such drug or biological if it is—

(A) a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under this section; or

(B) a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42; or

(2) if the Secretary does not refer a drug or biological product described in paragraph (1) to a Food and Drug Administration advisory committee prior to such approval, provide in the action letter on the application for the drug or biological product a summary of the reasons why the Secretary did not refer the drug or biological product to an advisory committee prior to approval.

(t) Database for authorized generic drugs

(1) In general

(A) Publication

The Commissioner shall—

(i) not later than 9 months after September 27, 2007, publish a complete list on the Internet Web site of the Food and Drug Administration of all authorized generic drugs (including drug trade name, brand company manufacturer, and the date the authorized generic drug entered the market); and

(ii) update the list quarterly to include each authorized generic drug included in an annual report submitted to the Secretary by the sponsor of a listed drug during the preceding 3-month period.

(B) Notification

The Commissioner shall notify relevant Federal agencies, including the Centers for Medicare & Medicaid Services and the Federal Trade Commission, when the Commissioner first publishes the information described in subparagraph (A) that the information has been published and that the information will be updated quarterly.

(2) Inclusion

The Commissioner shall include in the list described in paragraph (1) each authorized generic drug included in an annual report submitted to the Secretary by the sponsor of a listed drug after January 1, 1999.

(3) Authorized generic drug

In this section, the term "authorized generic drug" means a listed drug (as that term is used in subsection (j)) that—

(A) has been approved under subsection (c); and

(B) is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed drug.

(u) Certain drugs containing single enantiomers

(1) In general

For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted under subsection (b) for a non-racemic drug containing as an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) a single enantiomer that is contained in a racemic drug approved in another application under subsection (b), the applicant may, in the application for such non-racemic drug, elect to have the single enantiomer not be considered the same active moiety as that contained in the approved racemic drug, if—

(A)(i) the single enantiomer has not been previously approved except in the approved racemic drug; and

(ii) the application submitted under subsection (b) for such non-racemic drug—

(I) includes full reports of new clinical investigations (other than bioavailability studies)—

(aa) necessary for the approval of the application under subsections (c) and (d); and

(bb) conducted or sponsored by the applicant; and

(II) does not rely on any clinical investigations (other than bioavailability studies) that are part of an application submitted under subsection (b) for approval of the approved racemic drug; and

(B) the application submitted under subsection (b) for such non-racemic drug is not submitted for approval of a condition of use—

(i) in a therapeutic category in which the approved racemic drug has been approved; or

(ii) for which any other enantiomer of the racemic drug has been approved.

(2) Limitation

(A) No approval in certain therapeutic categories

Until the date that is 10 years after the date of approval of a non-racemic drug described in paragraph (1) and with respect to which the applicant has made the election provided for by such paragraph, the Secretary shall not approve such non-racemic drug for any condition of use in the therapeutic category in which the racemic drug has been approved.

(B) Labeling

If applicable, the labeling of a non-racemic drug described in paragraph (1) and with respect to which the applicant has made the election provided for by such paragraph shall include a statement that the non-racemic drug is not approved, and has not been shown to be safe and effective, for any condition of use of the racemic drug.

(3) Definition

(A) In general

For purposes of this subsection, the term "therapeutic category" means a therapeutic category identified in the list developed by the United States Pharmacopeia pursuant to section 1395w–104(b)(3)(C)(ii) of title 42 and as in effect on September 27, 2007.

(B) Publication by Secretary

The Secretary shall publish the list described in subparagraph (A) and may amend such list by regulation.

(4) Availability

The election referred to in paragraph (1) may be made only in an application that is submitted to the Secretary after September 27, 2007, and before October 1, 2027.

(v) Antibiotic drugs submitted before November 21, 1997

(1) Antibiotic drugs approved before November 21, 1997

(A) In general

Notwithstanding any provision of the Food and Drug Administration Modernization Act of 1997 or any other provision of law, a sponsor of a drug that is the subject of an application described in subparagraph (B)(i) shall be eligible for, with respect to the drug, the 3-year exclusivity period referred to under clauses (iii) and (iv) of subsection (c)(3)(E) and under clauses (iii) and (iv) of subsection (j)(5)(F), subject to the requirements of such clauses, as applicable.

(B) Application; antibiotic drug described

(i) Application

An application described in this clause is an application for marketing submitted under this section after October 8, 2008, in which the drug that is the subject of the application contains an antibiotic drug described in clause (ii).

(ii) Antibiotic drug

An antibiotic drug described in this clause is an antibiotic drug that was the subject of an application approved by the Secretary under section 357 of this title (as in effect before November 21, 1997).

(2) Antibiotic drugs submitted before November 21, 1997, but not approved

(A) In general

Notwithstanding any provision of the Food and Drug Administration Modernization Act of 1997 or any other provision of law, a sponsor of a drug that is the subject of an application described in subparagraph (B)(i) may elect to be eligible for, with respect to the drug—

(i)(I) the 3-year exclusivity period referred to under clauses (iii) and (iv) of subsection (c)(3)(E) and under clauses (iii) and (iv) of subsection (j)(5)(F), subject to the requirements of such clauses, as applicable; and

(II) the 5-year exclusivity period referred to under clause (ii) of subsection (c)(3)(E) and under clause (ii) of subsection (j)(5)(F), subject to the requirements of such clauses, as applicable; or

(ii) a patent term extension under section 156 of title 35, subject to the requirements of such section.

(B) Application; antibiotic drug described

(i) Application

An application described in this clause is an application for marketing submitted under this section after October 8, 2008, in which the drug that is the subject of the application contains an antibiotic drug described in clause (ii).

(ii) Antibiotic drug

An antibiotic drug described in this clause is an antibiotic drug that was the subject of 1 or more applications received by the Secretary under section 357 of this title (as in effect before November 21, 1997), none of which was approved by the Secretary under such section.

(3) Limitations

(A) Exclusivities and extensions

Paragraphs (1)(A) and (2)(A) shall not be construed to entitle a drug that is the subject of an approved application described in subparagraphs ⁵ (1)(B)(i) or (2)(B)(i), as applicable, to any market exclusivities or patent extensions other than those exclusivities or extensions described in paragraph (1)(A) or (2)(A).

(B) Conditions of use

Paragraphs (1)(A) and (2)(A)(i) shall not apply to any condition of use for which the drug referred to in subparagraph (1)(B)(i) or (2)(B)(i), as applicable, was approved before October 8, 2008.

(4) Application of certain provisions

Notwithstanding section 125, or any other provision, of the Food and Drug Administration Modernization Act of 1997, or any other provision of law, and subject to the limitations in paragraphs (1), (2), and (3), the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 shall apply to any drug subject to paragraph (1) or any drug with respect to which an election is made under paragraph (2)(A).

(w) Deadline for determination on certain petitions

The Secretary shall issue a final, substantive determination on a petition submitted pursuant to subsection (b) of section 314.161 of title 21, Code of Federal Regulations (or any successor regulations), no later than 270 days after the date the petition is submitted.

(x) Date of approval in the case of recommended controls under the CSA

(1) In general

In the case of an application under subsection (b) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].

(2) Date of approval

For purposes of this section, with respect to an application described in paragraph (1), the term "date of approval" shall mean the later of—

(A) the date an application under subsection (b) is approved under subsection (c); or

(B) the date of issuance of the interim final rule controlling the drug.

(y) Contrast agents intended for use with applicable medical imaging devices

(1) In general

The sponsor of a contrast agent for which an application has been approved under this section may submit a supplement to the application seeking approval for a new use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section 360j(p)(1) of this title.

(2) Review of supplement

In reviewing a supplement submitted under this subsection, the agency center charged with the premarket review of drugs may—

(A) consult with the center charged with the premarket review of devices; and

(B) review information and data submitted to the Secretary by the sponsor of an applicable medical imaging device pursuant to section 360e, 360(k), or 360c(f)(2) of this title so long as the sponsor of such applicable medical imaging device has provided to the sponsor of the contrast agent a right of reference.

(3) Definitions

For purposes of this subsection—

(A) the term "new use" means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 360j(p) of this title, but that is not described in the approved labeling of the contrast agent; and

(B) the terms "applicable medical imaging device" and "contrast agent" have the meanings given such terms in section 360j(p) of this title.

(z) ⁶ Nonclinical test defined

For purposes of this section, the term "nonclinical test" means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test may include the following:

(1) Cell-based assays.

(2) Organ chips and microphysiological systems.

(3) Computer modeling.

(4) Other nonhuman or human biology-based test methods, such as bioprinting.

(5) Animal tests.

(z) ⁶ Diversity action plan for clinical studies ⁷

(1) With respect to a clinical investigation of a new drug that is a phase 3 study, as defined in section 312.21(c) of title 21, Code of Federal Regulations (or successor regulations), or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies), the sponsor of such drug shall submit to the Secretary a diversity action plan.

(2) Such diversity action plan shall include—

(A) the sponsor's goals for enrollment in such clinical study;

(B) the sponsor's rationale for such goals; and

(C) an explanation of how the sponsor intends to meet such goals.

(3) The sponsor shall submit to the Secretary such diversity action plan, in the form and manner specified by the Secretary in guidance, as soon as practicable but not later than the date on which the sponsor submits the protocol to the Secretary for such a phase 3 study or other pivotal study of the drug. The sponsor may submit modifications to the diversity action plan. Any such modifications shall be in the form and manner specified by the Secretary in guidance.

(4)(A) On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any requirement in paragraph (1), (2), or (3) if the Secretary determines that a waiver is necessary based on what is known or what can be determined about the prevalence or incidence of the disease or condition for which the new drug is under investigation (including in terms of the patient population that may use the drug), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency.

(B) The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request.

(5) No diversity action plan shall be required for a submission described in section 360bbb of this title.

(June 25, 1938, ch. 675, §505, 52 Stat. 1052; Pub. L. 86–507, §1(18), June 11, 1960, 74 Stat. 201; Pub. L. 87–781, title I, §§102(b)–(d), 103(a), (b), 104(a)–(d)(2), Oct. 10, 1962, 76 Stat. 781–783, 784, 785; Pub. L. 92–387, §4(d), Aug. 16, 1972, 86 Stat. 562; Pub. L. 98–417, title I, §§101, 102(a)–(b)(5), 103, 104, Sept. 24, 1984, 98 Stat. 1585, 1592, 1593, 1597; Pub. L. 102–282, §5, May 13, 1992, 106 Stat. 161; Pub. L. 103–80, §3(n), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105–115, title I, §§115, 117, 119, 120, 124(a), Nov. 21, 1997, 111 Stat. 2313, 2315, 2316, 2318, 2324; Pub. L. 106–113, div. B, §1000(a)(9) [title IV, §4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584; Pub. L. 107–109, §15(c)(1), Jan. 4, 2002, 115 Stat. 1420; Pub. L. 108–155, §2(b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108–173, title XI, §§1101(a), (b), 1102(a), 1103(a), Dec. 8, 2003, 117 Stat. 2448, 2452, 2457, 2460; Pub. L. 110–85, title VII, §701(b), title VIII, §801(b)(3)(A), (B), title IX, §§901(a), 903, 905(a), 914(a), 915, 916, 918, 920, 921, title XI, §1113, Sept. 27, 2007, 121 Stat. 903, 921, 922, 943, 944, 953, 957, 958, 960-962, 976; Pub. L. 110–316, title III, §301, Aug. 14, 2008, 122 Stat. 3524; Pub. L. 110–379, §4(a), Oct. 8, 2008, 122 Stat. 4076; Pub. L. 111–31, div. A, title I, §103(e), June 22, 2009, 123 Stat. 1837; Pub. L. 111–148, title VII, §7002(d)(1), title X, §10609, Mar. 23, 2010, 124 Stat. 816, 1014; Pub. L. 112–144, title IX, §905, title XI, §§1101, 1134(a), 1135, July 9, 2012, 126 Stat. 1092, 1108, 1123; Pub. L. 113–5, title III, §301, Mar. 13, 2013, 127 Stat. 179; Pub. L. 114–89, §2(a)(1), Nov. 25, 2015, 129 Stat. 698; Pub. L. 114–255, div. A, title III, §§3024(b), 3031(a), 3075(a), (b), 3101(a)(2)(B), 3102(1), Dec. 13, 2016, 130 Stat. 1099, 1138, 1152, 1156; Pub. L. 115–52, title VI, §601, title VII, §706(b), title VIII, §§801, 802, 808, title IX, §901(a), Aug. 18, 2017, 131 Stat. 1048, 1059, 1068, 1069, 1074, 1076; Pub. L. 115–271, title III, §3041(b), Oct. 24, 2018, 132 Stat. 3942; Pub. L. 116–290, §2(a)–(d)(1), (g), Jan. 5, 2021, 134 Stat. 4889–4892; Pub. L. 117–9, §1(a)(1), (b)(1), Apr. 23, 2021, 135 Stat. 256, 258; Pub. L. 117–180, div. F, title V, §5004, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, §305, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, §§3105, 3209(a), 3222, 3224, 3601(a), Dec. 29, 2022, 136 Stat. 5807, 5821, 5829, 5831, 5860.)

Delayed Applicability of Amendment

For delayed applicability of subsection (z) of this section as added by section 3601(a) of Pub. L. 117–328, see Effective Date of 2022 Amendment note below.

Editorial Notes

References in Text

Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (k)(3)(C)(i)(I), (4)(G)(i)(I), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of Title 42, The Public Health and Welfare.

The General Schedule, referred to in subsec. (n)(5), is set out under section 5332 of Title 5, Government Organization and Employees.

Section 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. (o)(3)(E)(i), is section 101(c) of Pub. L. 110–85, which is set out as a note under section 379g of this title.

The Food and Drug Administration Modernization Act of 1997, referred to in subsec. (v)(1)(A), (2)(A), (4), is Pub. L. 105–115, Nov. 21, 1997, 111 Stat. 2296. Section 125 of the Act amended sections 321, 331, 335a, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381, and 382 of this title, section 45C of Title 26, Internal Revenue Code, section 156 of Title 35, Patents, and section 8126 of Title 38, Veterans' Benefits, repealed sections 356 and 357 of this title, and enacted provisions set out as a note under this section. For complete classification of this Act to the Code, see Short Title of 1997 Amendment note set out under section 301 of this title and Tables.

The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (v)(4), is Pub. L. 98–417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables.

The Controlled Substances Act, referred to in subsec. (x)(1), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Codification

In subsec. (k)(4)(H), "section 132 of title 41" substituted for "section 4(5) of the Federal Procurement Policy Act" on authority of Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

2022—Subsec. (i)(1)(A). Pub. L. 117–328, §3209(a)(1)(A), substituted "nonclinical tests" for "preclinical tests (including tests on animals)".

Subsec. (i)(2)(B). Pub. L. 117–328, §3209(a)(1)(B), substituted "nonclinical tests" for "animal".

Subsec. (j)(7)(A)(v). Pub. L. 117–328, §3222, added cl. (v).

Subsec. (j)(10)(A)(i) to (iii). Pub. L. 117–328, §3224, added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows:

"(i) the application is otherwise eligible for approval under this subsection but for expiration of patent, an exclusivity period, or of a delay in approval described in paragraph (5)(B)(iii), and a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of such expiration;

"(ii) the labeling revision described under clause (i) does not include a change to the 'Warnings' section of the labeling;

"(iii) the sponsor of the application under this subsection agrees to submit revised labeling of the drug that is the subject of such application not later than 60 days after the notification of any changes to such labeling required by the Secretary; and".

Subsec. (u)(1)(A)(ii)(II). Pub. L. 117–328, §3105(1), inserted "(other than bioavailability studies)" after "any clinical investigations".

Subsec. (u)(4). Pub. L. 117–328, §3105(2), substituted "October 1, 2027" for "December 24, 2022".

Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022".

Pub. L. 117–180 substituted "December 17" for "October 1".

Subsec. (z). Pub. L. 117–328, §3601(a), added subsec. (z) relating to diversity action plan for clinical studies.

Pub. L. 117–328, §3209(a)(2), added subsec. (z) defining nonclinical test.

2021—Subsec. (b)(1). Pub. L. 116–290, §2(a)(1), amended par. (1) generally. Prior to amendment, par. (1) related to requirements for filing an application with respect to any drug subject to the provisions of subsec. (a).

Subsec. (c)(2). Pub. L. 116–290, §2(b)(1), inserted at beginning "Not later than 30 days after the date of approval of an application submitted under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subsection (b)(1)(A)(viii), except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application. If a patent described in subsection (b)(1)(A)(viii) is issued after the date of approval of an application submitted under subsection (b), the holder of the approved application shall, not later than 30 days after the date of issuance of the patent, file the patent number and the expiration date of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application."; substituted "described in subsection (b)(1)(A)(viii)." for "which claims the drug for which the application was submitted or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug."; inserted "of the type for which information is required to be submitted in subsection (b)(1)(A)(viii)" after "could not file patent information under subsection (b) because no patent"; and inserted at end "Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph."

Subsec. (c)(3)(E). Pub. L. 117–9, §1(a)(1)(A), substituted "active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))" for "active ingredient (including any ester or salt of the active ingredient)" wherever appearing.

Pub. L. 116–290, §2(g)(1), substituted "subsection (b)(1)(A)(i)" for "clause (A) of subsection (b)(1)" wherever appearing.

Subsec. (c)(3)(E)(i). Pub. L. 117–9, §1(b)(1)(A), struck out cl. (i) which read as follows: "If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning January 1, 1982, and ending on September 24, 1984, the Secretary may not make the approval of another application for a drug for which the investigations described in subsection (b)(1)(A)(i) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted effective before the expiration of ten years from the date of the approval of the application previously approved under subsection (b)."

Subsec. (j)(2)(A)(vi). Pub. L. 116–290, §2(g)(2), substituted "clauses (ii) through (vi) of subsection (b)(1)(A)" for "clauses (B) through (F) of subsection (b)(1)".

Subsec. (j)(5)(F). Pub. L. 117–9, §1(a)(1)(B), substituted "active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))" for "active ingredient (including any ester or salt of the active ingredient)" wherever appearing.

Subsec. (j)(5)(F)(i). Pub. L. 117–9, §1(b)(1)(B), struck out cl. (i) which read as follows: "If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning January 1, 1982, and ending on September 24, 1984, the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted effective before the expiration of ten years from the date of the approval of the application under subsection (b)."

Subsec. (j)(7)(A)(iii). Pub. L. 116–290, §2(b)(2), struck out "(b) or" before "(c)".

Subsec. (j)(7)(A)(iv). Pub. L. 116–290, §2(c), added cl. (iv).

Subsec. (j)(7)(D). Pub. L. 116–290, §2(d)(1), added subpar. (D).

Subsec. (l)(2)(A)(i). Pub. L. 117–9, §1(a)(1)(C)(i), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "not later than 30 days after the date of approval of such application for a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 262 of title 42; and".

Subsec. (l)(2)(A)(ii). Pub. L. 117–9, §1(a)(1)(C)(ii), inserted "or biological product" before period at end.

Subsec. (s). Pub. L. 117–9, §1(a)(1)(D), amended subsec. (s) generally. Prior to amendment, text read as follows: "Prior to the approval of a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 262 of title 42, the Secretary shall—

"(1) refer such drug to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee; or

"(2) if the Secretary does not refer such a drug to a Food and Drug Administration advisory committee prior to the approval of the drug, provide in the action letter on the application for the drug a summary of the reasons why the Secretary did not refer the drug to an advisory committee prior to approval."

Subsec. (u)(1). Pub. L. 117–9, §1(a)(1)(E), in introductory provisions, substituted "active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))" for "active ingredient (including any ester or salt of the active ingredient)" and "same active moiety" for "same active ingredient".

2018—Subsec. (o)(4)(A). Pub. L. 115–271, §3041(b)(1), substituted "safety or new effectiveness information" for "safety information" in heading and "If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug" for "If the Secretary becomes aware of new safety information that the Secretary believes should be included in the labeling of the drug" in text. Amendment to heading was executed to reflect the probable intent of Congress, notwithstanding error in text directed to be stricken.

Subsec. (o)(4)(B)(i). Pub. L. 115–271, §3041(b)(2), inserted ", or new effectiveness information" after "adverse reactions".

Subsec. (o)(4)(C). Pub. L. 115–271, §3041(b)(3), substituted "safety or new effectiveness information" for "safety information".

Subsec. (o)(4)(E). Pub. L. 115–271, §3041(b)(4), substituted "safety or new effectiveness information" for "safety information".

2017—Subsec. (j)(5)(B)(v). Pub. L. 115–52, §808(1), added cl. (v).

Subsec. (j)(5)(D)(iv). Pub. L. 115–52, §808(2), added cl. (iv).

Subsec. (j)(11), (12). Pub. L. 115–52, §801, added pars. (11) and (12).

Subsec. (j)(13). Pub. L. 115–52, §802, added par. (13).

Subsec. (k)(5). Pub. L. 115–52, §901(a), made technical amendments to directory language of Pub. L. 114–255, §3075(a). See 2016 Amendment notes below.

Subsec. (u)(4). Pub. L. 115–52, §601, substituted "2022" for "2017".

Subsec. (y). Pub. L. 115–52, §706(b), added subsec. (y).

2016—Subsec. (c)(5). Pub. L. 114–255, §3031(a), added par. (5).

Subsec. (d). Pub. L. 114–255, §3101(a)(2)(B)(i), substituted "marketing approval" for "premarket approval" in last sentence.

Subsec. (i)(4). Pub. L. 114–255, §3024(b), substituted "except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings" for "except where it is not feasible or it is contrary to the best interests of such human beings".

Subsec. (k)(5)(A). Pub. L. 114–255, §3075(a)(1), as amended by Pub. L. 115–52, §901(a)(1), substituted "screenings" for ", bi-weekly screening".

Pub. L. 114–255, §3102(1)(A), inserted "and" after the semicolon.

Subsec. (k)(5)(B). Pub. L. 114–255, §3075(a)(2), as amended by Pub. L. 115–52, §901(a), substituted "; and" for period at end.

Pub. L. 114–255, §3102(1)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: "report to Congress not later than 2 year after September 27, 2007, on procedures and processes of the Food and Drug Administration for addressing ongoing post market safety issues identified by the Office of Surveillance and Epidemiology and how recommendations of the Office of Surveillance and Epidemiology are handled within the agency; and".

Subsec. (k)(5)(C). Pub. L. 114–255, §3075(a)(3), as amended by Pub. L. 115–52, §901(a)(1), added subpar. (C).

Pub. L. 114–255, §3102(1)(C), redesignated subpar. (C) as (B).

Subsec. (q)(5)(A). Pub. L. 114–255, §3101(a)(2)(B)(ii), substituted "subsection (b)(2) or (j) of this section or section 262(k) of title 42" for "subsection (b)(2) or (j) of the Act or 262(k) of title 42".

Subsec. (r)(2)(D). Pub. L. 114–255, §3075(b), substituted "and making publicly available on the Internet website established under paragraph (1) best practices for drug safety surveillance activities for drugs approved under this section or section 262 of title 42" for ", by 18 months after approval of a drug or after use of the drug by 10,000 individuals, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number;".

2015—Subsec. (x). Pub. L. 114–89 added subsec. (x).

2013—Subsec. (b)(5)(B). Pub. L. 113–5 substituted "size—" for "size of clinical trials intended to form the primary basis of an effectiveness claim or, with respect to an applicant for approval of a biological product under section 262(k) of title 42, any necessary clinical study or studies.", added cls. (i) and (ii), and designated last two sentences as concluding provisions.

2012—Subsec. (d). Pub. L. 112–144, §905, inserted at end "The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs. Nothing in the preceding sentence shall alter the criteria for evaluating an application for premarket approval of a drug."

Subsec. (q)(1)(A). Pub. L. 112–144, §1135(1)(A), substituted "subsection (b)(2) or (j) of this section or section 262(k) of title 42" for "subsection (b)(2) or (j)" in introductory provisions.

Subsec. (q)(1)(F). Pub. L. 112–144, §1135(1)(B), substituted "150 days" for "180 days" in introductory provisions.

Subsec. (q)(2)(A). Pub. L. 112–144, §1135(2)(A), substituted "150" for "180" in heading.

Subsec. (q)(2)(A)(i). Pub. L. 112–144, §1135(2)(B), substituted "150-day" for "180-day".

Subsec. (q)(4). Pub. L. 112–144, §1135(3), designated existing provisions as subpar. (A), redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), and added subpar. (B).

Subsec. (q)(5)(A). Pub. L. 112–144, §1135(4), substituted "subsection (b)(2) or (j) of the Act or 262(k) of title 42" for "subsection (b)(2) or (j)".

Subsec. (u)(1)(A)(ii)(II). Pub. L. 112–144, §1101(b), inserted "clinical" after "any".

Subsec. (u)(4). Pub. L. 112–144, §1101(a), substituted "2017" for "2012".

Subsec. (w). Pub. L. 112–144, §1134(a), added subsec. (w).

2010—Subsec. (b)(5)(B). Pub. L. 111–148, §7002(d)(1), inserted "or, with respect to an applicant for approval of a biological product under section 262(k) of title 42, any necessary clinical study or studies" before period at end of first sentence.

Subsec. (j)(10). Pub. L. 111–148, §10609, added par. (10).

2009—Subsec. (n)(2). Pub. L. 111–31 made technical amendment to reference in original act which appears in text as reference to section 394 of this title.

2008—Subsec. (q)(1)(A). Pub. L. 110–316, §301, inserted concluding provisions.

Subsec. (v). Pub. L. 110–379 added subsec. (v).

2007—Subsec. (b)(6). Pub. L. 110–85, §801(b)(3)(B), added par. (6).

Subsec. (e). Pub. L. 110–85, §903, inserted at end "The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 355–1(g)(2)(D) of this title."

Subsec. (i)(4). Pub. L. 110–85, §801(b)(3)(A), inserted at end "The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 282 of title 42."

Subsec. (k)(3), (4). Pub. L. 110–85, §905(a), added pars. (3) and (4).

Subsec. (k)(5). Pub. L. 110–85, §921, added par. (5).

Subsec. (l). Pub. L. 110–85, §916, designated existing provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), and added par. (2).

Subsec. (n)(4) to (8). Pub. L. 110–85, §701(b), redesignated pars. (5) to (8) as (4) to (7), respectively, and struck out former par. (4) which read as follows: "Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate family of such member could gain financially from the advice given to the Secretary. The Secretary may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary may not grant a waiver for a member of a panel when the member's own scientific work is involved."

Subsecs. (o), (p). Pub. L. 110–85, §901(a), added subsecs. (o) and (p).

Subsec. (q). Pub. L. 110–85, §914(a), added subsec. (q).

Subsec. (r). Pub. L. 110–85, §915, added subsec. (r).

Subsec. (s). Pub. L. 110–85, §918, added subsec. (s).

Subsec. (t). Pub. L. 110–85, §920, added subsec. (t).

Subsec. (u). Pub. L. 110–85, §1113, added subsec. (u).

2003—Subsec. (b)(1). Pub. L. 108–155, in second sentence, substituted "(F)" for "and (F)" and inserted ", and (G) any assessments required under section 355c of this title" before period at end.

Subsec. (b)(3). Pub. L. 108–173, §1101(b)(1)(A), added par. (3) and struck out former par. (3) which, in subpar. (A), required an applicant making a certification under par. (2)(A)(iv) to include statement that applicant will give notice to each owner of the patent which is the subject of the certification and to the holder of the approved application, in subpar. (B), directed that notice state that an application has been submitted and include a detailed statement of the applicant's opinion that the patent is not valid or will not be infringed, and, in subpar. (C), provided that if an application is amended, notice shall be given when the amended application is submitted.

Subsec. (b)(4), (5). Pub. L. 108–173, §1101(b)(1)(B), added par. (4) and redesignated former par. (4) as (5).

Subsec. (c)(3). Pub. L. 108–173, §1101(b)(2)(A), substituted "by applying the following to each certification made under subsection (b)(2)(A)" for "under the following" in introductory provisions.

Subsec. (c)(3)(C). Pub. L. 108–173, §1101(b)(2)(B)(iii), which directed the substitution of "subsection (b)(3)" for "paragraph (3)(B)" in third sentence, could not be executed because such words do not appear. See note below.

Pub. L. 108–173, §1101(b)(2)(B)(ii)(VI), in concluding provisions, struck out "Until the expiration of forty-five days from the date the notice made under paragraph (3)(B) is received, no action may be brought under section 2201 of title 28 for a declaratory judgment with respect to the patent. Any action brought under such section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business." after "expediting the action."

Pub. L. 108–173, §1101(b)(2)(B)(i), (ii)(I), in first sentence of introductory provisions, substituted "unless, before the expiration of 45 days after the date on which the notice described in subsection (b)(3) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) before the date on which the application (excluding an amendment or supplement to the application) was submitted" for "unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (3)(B) is received" and, in second sentence of introductory provisions, substituted "subsection (b)(3)" for "paragraph (3)(B)".

Subsec. (c)(3)(C)(i). Pub. L. 108–173, §1101(b)(2)(B)(ii)(II), added cl. (i) and struck out former cl. (i) which read as follows: "if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval may be made effective on the date of the court decision,".

Subsec. (c)(3)(C)(ii). Pub. L. 108–173, §1101(b)(2)(B)(ii)(III), added cl. (ii) and struck out former cl. (ii) which read as follows: "if before the expiration of such period the court decides that such patent has been infringed, the approval may be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, or".

Subsec. (c)(3)(C)(iii). Pub. L. 108–173, §1101(b)(2)(B)(ii)(IV), substituted "as provided in clause (i); or" for "on the date of such court decision."

Subsec. (c)(3)(C)(iv). Pub. L. 108–173, §1101(b)(2)(B)(ii)(V), added cl. (iv).

Subsec. (c)(3)(D), (E). Pub. L. 108–173, §1101(b)(2)(C), (D), added subpar. (D) and redesignated former subpar. (D) as (E).

Subsec. (j)(2)(B). Pub. L. 108–173, §1101(a)(1)(A), added subpar. (B) and struck out former subpar. (B) which, in cl. (i), required that an applicant making a certification under subpar. (A)(vii)(IV) include in the application a statement that notice would be given to each owner of the patent and the holder of the approved application, in cl. (ii), required that notice would state that an application had been submitted and that it would include a detailed statement of the basis of the applicant's opinion, and, in cl. (iii), directed that notice of an amended application be given when the amended application had been submitted.

Subsec. (j)(2)(D). Pub. L. 108–173, §1101(a)(1)(B), added subpar. (D).

Subsec. (j)(5)(B). Pub. L. 108–173, §1101(a)(2)(A)(i), substituted "by applying the following to each certification made under paragraph (2)(A)(vii)" for "under the following" in introductory provisions.

Subsec. (j)(5)(B)(iii). Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second sentence of subsec. (j)(5)(B)(iii) by striking "Until the expiration" and all that follows in the matter after and below subclause (IV), was executed by striking "Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under section 2201 of title 28, for a declaratory judgment with respect to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business." after "expediting the action." in concluding provisions, to reflect the probable intent of Congress.

Pub. L. 108–173, §1101(a)(2)(A)(ii)(I), in introductory provisions, substituted "unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted" for "unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received".

Subsec. (j)(5)(B)(iii)(I). Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former subcl. (I) which read as follows: "if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision,".

Subsec. (j)(5)(B)(iii)(II). Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former subcl. (II) which read as follows: "if before the expiration of such period the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, or".

Subsec. (j)(5)(B)(iii)(III). Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(cc), substituted "as provided in subclause (I); or" for "on the date of such court decision."

Subsec. (j)(5)(B)(iii)(IV). Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV).

Subsec. (j)(5)(B)(iv). Pub. L. 108–173, §1102(a)(1), added cl. (iv) and struck out former cl. (iv) which read as follows: "If the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this subsection continuing such a certification, the application shall be made effective not earlier than one hundred and eighty days after—

"(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or

"(II) the date of a decision of a court in an action described in clause (iii) holding the patent which is the subject of the certification to be invalid or not infringed,

whichever is earlier."

Subsec. (j)(5)(C). Pub. L. 108–173, §1101(a)(2)(B), (C), added subpar. (C). Former subpar. (C) redesignated (E).

Subsec. (j)(5)(D). Pub. L. 108–173, §1102(a)(2), added subpar. (D).

Pub. L. 108–173, §1101(a)(2)(B), redesignated subpar. (D) as (F).

Subsec. (j)(5)(E), (F). Pub. L. 108–173, §1101(a)(2)(B), redesignated subpars. (C) and (D) as (E) and (F), respectively.

Subsec. (j)(8)(A). Pub. L. 108–173, §1103(a)(1), added subpar. (A) and struck out former subpar. (A) which read as follows: "The term 'bioavailability' means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action."

Subsec. (j)(8)(C). Pub. L. 108–173, §1103(a)(2), added subpar. (C).

2002—Subsec. (i)(1)(D). Pub. L. 107–109 added subpar. (D).

1999—Subsec. (m). Pub. L. 106–113 substituted "United States Patent and Trademark Office" for "Patent and Trademark Office of the Department of Commerce".

1997—Subsec. (b)(1). Pub. L. 105–115, §115(b), inserted at end "The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A)."

Subsec. (b)(4). Pub. L. 105–115, §119(a), added par. (4).

Subsec. (c)(4). Pub. L. 105–115, §124(a), added par. (4).

Subsec. (d). Pub. L. 105–115, §115(a), inserted at end "If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for purposes of the preceding sentence."

Subsec. (i). Pub. L. 105–115, §117, inserted "(1)" after "(i)", redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1), added pars. (2) to (4), and struck out closing provisions which read as follows: "Such regulations shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs."

Subsec. (j)(2)(A)(i). Pub. L. 105–115, §119(b)(2)(A), substituted "paragraph (7)" for "paragraph (6)".

Subsec. (j)(3). Pub. L. 105–115, §119(b)(1)(B), added par. (3). Former par. (3) redesignated (4).

Subsec. (j)(4). Pub. L. 105–115, §119(b)(1)(A), (2)(B), redesignated par. (3) as (4) and in introductory provisions substituted "paragraph (5)" for "paragraph (4)". Former par. (4) redesignated (5).

Subsec. (j)(4)(I). Pub. L. 105–115, §119(b)(2)(C), substituted "paragraph (6)" for "paragraph (5)".

Subsec. (j)(5), (6). Pub. L. 105–115, §119(b)(1)(A), redesignated pars. (4) and (5) as (5) and (6), respectively. Former par. (6) redesignated (7).

Subsec. (j)(7). Pub. L. 105–115, §119(b)(1)(A), (2)(D), redesignated par. (6) as (7) and in subpar. (C) substituted "paragraph (6)" for "paragraph (5)" in two places. Former par. (7) redesignated (8).

Subsec. (j)(8), (9). Pub. L. 105–115, §119(b)(1)(A), redesignated pars. (7) and (8) as (8) and (9), respectively.

Subsec. (n). Pub. L. 105–115, §120, added subsec. (n).

1993—Subsec. (j)(6)(A)(ii). Pub. L. 103–80, §3(n)(1)(A), substituted "Secretary" for "Secretry".

Subsec. (j)(6)(A)(iii). Pub. L. 103–80, §3(n)(1)(B), inserted comma after "published by the Secretary".

Subsec. (k)(1). Pub. L. 103–80, §3(n)(2), substituted "section. Regulations" for "section: Provided, however, That regulations".

1992—Subsec. (j)(8). Pub. L. 102–282 added par. (8).

1984—Subsec. (a). Pub. L. 98–417, §102(b)(1), inserted "or (j)" after "subsection (b)".

Subsec. (b). Pub. L. 98–417, §§102(a)(1), 103(a), designated existing provisions of subsec. (b) as par. (1) thereof and redesignated existing cls. (1) through (6) of such par. (1) as cls. (A) through (F) thereof, respectively, inserted requirement that the applicant file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably by asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, that the applicant amend the application to include such information if an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, and that upon approval of the application, the Secretary publish the information submitted, and added pars. (2) and (3).

Subsec. (c). Pub. L. 98–417, §§102(a)(2), (b)(2), 103(b), designated existing provisions of subsec. (c) as par. (1) thereof and in par. (1) as so designated substituted "subsection (b)" for "this subsection" and redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, and added pars. (2) and (3).

Subsec. (d)(6), (7). Pub. L. 98–417, §102(a)(3)(A), added cl. (6) relating to the failure of the application to contain the patent information prescribed by subsec. (b) of this section, and redesignated former cl. (6) as (7).

Subsec. (e). Pub. L. 98–417, §102(a)(3)(B), in first sentence, added a new cl. (4) relating to the failure to file the patent information prescribed by subsec. (c) of this section within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information, and redesignated former cl. (4) as (5).

Pub. L. 98–417, §102(b)(3), (4), in second sentence, inserted in provisions preceding cl. (1) "submitted under subsection (b) or (j)" and in cl. (1) substituted "under subsection (k) or to comply with the notice requirements of section 360(k)(2) of this title" for "under subsection (j) or to comply with the notice requirements of section 360(j)(2) of this title".

Subsecs. (j), (k). Pub. L. 98–417, §101, added subsec. (j) and redesignated former subsec. (j) as (k).

Subsec. (k)(1). Pub. L. 98–417, §102(b)(5), substituted "under subsection (b) or (j)" for "pursuant to this section".

Subsecs. (l), (m). Pub. L. 98–417, §104, added subsecs. (l) and (m).

1972—Subsec. (e). Pub. L. 92–387 inserted "or to comply with the notice requirements of section 360(j)(2) of this title" in cl. (1) of second sentence relating to the maintenance of records.

1962—Subsec. (a). Pub. L. 87–781, §104(a), inserted "an approval of" before "an application".

Subsec. (b). Pub. L. 87–781, §102(b), inserted "and whether such drug is effective in use" after "is safe for use".

Subsec. (c). Pub. L. 87–781, §104(b), substituted provisions requiring the Secretary, within 180 days after filing an application, or such additional period as the Secretary and the applicant agree upon, to either approve the application, if meeting the requirements of subsec. (d) of this section, or give notice of opportunity for hearing on question of whether such application is approvable, and providing that if applicant requests hearing in writing within 30 days, the hearing shall begin within 90 days after expiration of said 30 days, unless the Secretary and applicant agree otherwise, that such hearing shall be expedited, and that the Secretary's order shall be issued within 90 days after date for filing final briefs, for provisions which had an application become effective on the sixtieth day after filing thereof unless prior thereto the Secretary postponed the date by written notice to such time, but not more than 180 days after filing, as the Secretary deemed necessary to study and investigate the application.

Subsec. (d). Pub. L. 87–781, §102(c), inserted references to subsec. (c), added cls. (5) and (6), provided that if after notice and opportunity for hearing, the Secretary finds that cls. (1) to (6) do not apply, he shall approve the application, and defined "substantial evidence" as used in this subsection and subsec. (e) of this section.

Subsec. (e). Pub. L. 87–781, §102(d), amended subsec. (e) generally, and among other changes, directed the Secretary to withdraw approval of an application if by tests, other scientific data or experience, or new evidence of clinical experience not contained in the application or available at the time of its approval, the drug is shown to be unsafe, or on the basis of new information, there is shown a lack of substantial evidence that the drug has the effect it is represented to have, and provided that if the Secretary, or acting Secretary, finds there is an imminent hazard to the public health, he may suspend approval immediately, notify the applicant, and give him opportunity for an expedited hearing, that the Secretary may withdraw approval if the applicant fails to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain records and make reports, or has refused access to, or copying or verification of such records, or if the Secretary finds on new evidence that the methods, facilities and controls in the manufacturing, processing, and packing are inadequate to assure and preserve the drugs' identity, strength, quality and purity, and were not made adequate within a reasonable time after receipt of written notice thereof, or finds on new evidence, that the labeling is false or misleading and was not corrected within a reasonable time after receipt of written notice thereof.

Subsec. (f). Pub. L. 87–781, §104(c), substituted provisions requiring the Secretary to revoke any previous order under subsecs. (d) or (e) of this section refusing, withdrawing, or suspending approval of an application and to approve such application or reinstate such approval, for provisions which required him to revoke an order refusing effectiveness to an application.

Subsec. (h). Pub. L. 87–781, §104(d)(1), (2), inserted "as provided in section 2112 of title 28", and "except that until the filing of the record the Secretary may modify or set aside his order", substituted "or withdrawing approval of an application under this section" for "to permit the application to become effective, or suspending the effectiveness of the application", "United States court of appeals for the circuit" for "district court of the United States within any district", "Court of Appeals for the District of Columbia Circuit" for "District Court for the District of Columbia", "transmitted by the clerk of the court to" for "served upon", and "by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28" for "as provided in sections 225, 346, and 347 of title 28, as amended, and in section 7, as amended, of the Act entitled 'An Act to establish a Court of Appeals for the District of Columbia', approved February 9, 1893", and eliminated "upon" before "any officer designated", "a transcript of" before "the record" and "and decree" before "of the court affirming".

Subsec. (i). Pub. L. 87–781, §103(b), inserted "the foregoing subsections of" after "operation of", and "and effectiveness" after "safety", and provided that the regulations may condition exemptions upon the submission of reports of preclinical tests to justify the proposed clinical testing, upon the obtaining by the manufacturer or sponsor of the investigation of a new drug of a signed agreement from each of the investigators that patients to whom the drug is administered will be under his supervision or under investigators responsible to him, and that he will not supply such drug to any other investigator, or to clinics, for administration to human beings, or upon the establishment and maintenance of records and reports of data obtained by the investigational use of such drug, as the Secretary finds will enable him to evaluate the safety and effectiveness of such drug, and provided that the regulations shall condition an exemption upon the manufacturer or sponsor of the investigation requiring that experts using such drugs certify that they will inform humans to whom such drugs or any controls connected therewith are administered, or their representatives, and will obtain the consent of such people where feasible and not contrary to the best interests of such people, and that reports on the investigational use of drugs are not required to be submitted directly to the Secretary.

Subsec. (j). Pub. L. 87–781, §103(a), added subsec. (j).

1960—Subsec. (g). Pub. L. 86–507 inserted "or by certified mail" after "registered mail".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3602(c), Dec. 29, 2022, 136 Stat. 5863, provided that: "Sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(z), 360j(g)(9)], as added by section 3601, shall apply only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under this section [see section 3602(a), (b) of Pub. L. 117–328, set out below]."

Effective Date of 2021 Amendment

Pub. L. 116–290, §2(d)(2), Jan. 5, 2021, 134 Stat. 4891, provided that: "Subparagraph (D) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), as added by paragraph (1), applies only with respect to a decision described in such subparagraph that is issued on or after the date of enactment of this Act [Jan. 5, 2021]."

Effective Date of 2012 Amendment

Pub. L. 112–144, title XI, §1134(b), July 9, 2012, 126 Stat. 1123, provided that: "The amendment made by subsection (a) [amending this section] shall apply to any petition that is submitted pursuant to subsection (b) of section 314.161 of title 21, Code of Federal Regulations (or any successor regulations), on or after the date of enactment of this Act [July 9, 2012]."

Effective Date of 2007 Amendment

Pub. L. 110–85, title VII, §701(c), Sept. 27, 2007, 121 Stat. 904, provided that: "The amendments made by this section [enacting section 379d–1 of this title and amending this section] shall take effect on October 1, 2007."

Amendment by sections 901(a), 903, and 905(a) of Pub. L. 110–85 effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as a note under section 331 of this title.

Effective Date of 2003 Amendments

Pub. L. 108–173, title XI, §1101(c), Dec. 8, 2003, 117 Stat. 2456, provided that:

"(1) In general.—Except as provided in paragraphs (2) and (3), the amendments made by subsections (a) and (b) [amending this section] apply to any proceeding under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending on or after the date of the enactment of this Act [Dec. 8, 2003] regardless of the date on which the proceeding was commenced or is commenced.

"(2) Notice of opinion that patent is invalid or will not be infringed.—The amendments made by subsections (a)(1) and (b)(1) apply with respect to any certification under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) submitted on or after August 18, 2003, in an application filed under subsection (b) or (j) of that section or in an amendment or supplement to an application filed under subsection (b) or (j) of that section.

"(3) Effective date of approval.—The amendments made by subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with respect to any patent information submitted under subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) on or after August 18, 2003."

Pub. L. 108–173, title XI, §1102(b), Dec. 8, 2003, 117 Stat. 2460, provided that:

"(1) In general.—Except as provided in paragraph (2), the amendment made by subsection (a) [amending this section] shall be effective only with respect to an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date of the enactment of this Act [Dec. 8, 2003] for a listed drug for which no certification under section 505(j)(2)(A)(vii)(IV) of that Act was made before the date of the enactment of this Act.

"(2) Collusive agreements.—If a forfeiture event described in section 505(j)(5)(D)(i)(V) of that Act occurs in the case of an applicant, the applicant shall forfeit the 180-day period under section 505(j)(5)(B)(iv) of that Act without regard to when the first certification under section 505(j)(2)(A)(vii)(IV) of that Act for the listed drug was made.

"(3) Decision of a court when the 180-day exclusivity period has not been triggered.—With respect to an application filed before, on, or after the date of the enactment of this Act [Dec. 8, 2003] for a listed drug for which a certification under section 505(j)(2)(A)(vii)(IV) of that Act was made before the date of the enactment of this Act and for which neither of the events described in subclause (I) or (II) of section 505(j)(5)(B)(iv) of that Act (as in effect on the day before the date of the enactment of this Act) has occurred on or before the date of the enactment of this Act, the term 'decision of a court' as used in clause (iv) of section 505(j)(5)(B) of that Act means a final decision of a court from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken."

Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of this title.

Effective Date of 1999 Amendment

Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, §4731] of Pub. L. 106–113, set out as a note under section 1 of Title 35, Patents.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1984 Amendment

Pub. L. 98–417, title I, §105, Sept. 24, 1984, 98 Stat. 1597, provided that:

"(a) The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 505 of the Federal Food, Drug, and Cosmetic Act [this section], as amended by sections 101, 102, and 103 of this Act, within one year of the date of enactment of this Act [Sept. 24, 1984].

"(b) During the period beginning sixty days after the date of the enactment of this Act [Sept. 24, 1984], and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new drug applications may be submitted in accordance with the provisions of section 314.2 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 505(c) of the Federal Food, Drug, and Cosmetic Act [subsec. (c) of this section] before the date of the enactment of this Act. If any such provision is inconsistent with the requirements of section 505(j) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall consider the application under the applicable requirements of such section. The Secretary of Health and Human Services may not approve such an abbreviated new drug application which is filed for a drug which is described in sections 505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and Cosmetic Act, except in accordance with such section."

Effective Date of 1972 Amendment

Amendment by Pub. L. 92–387 effective on first day of sixth month beginning after Aug. 16, 1972, see section 5 of Pub. L. 92–387, set out as a note under section 360 of this title.

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Construction of Amendment by Pub. L. 110–85

Pub. L. 110–85, title IX, §905(b), Sept. 27, 2007, 121 Stat. 949, provided that: "Nothing in this section [amending this section] or the amendment made by this section shall be construed to prohibit the lawful disclosure or use of data or information by an entity other than as described in paragraph (4)(B) or (4)(G) of section 505(k) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(k)], as added by subsection (a)."

Construction of Amendments by Pub. L. 102–282

Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.

Extending Expiration Dates for Certain Drugs

Pub. L. 117–328, div. FF, title II, §2512(a), Dec. 29, 2022, 136 Stat. 5804, provided that: "Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall issue draft guidance, or revise existing guidance, to address recommendations for sponsors of applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) regarding—

"(1) the submission of stability testing data in such applications, including considerations for data requirements that could be streamlined or reduced to facilitate faster review of longer proposed expiration dates;

"(2) establishing in the labeling of drugs the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may—

"(A) help prevent or mitigate drug shortages; and

"(B) affect product quality; and

"(3) the use of innovative approaches for drug and combination product stability modeling to support initial product expiration dates and expiration date extensions."

Antifungal Research and Development

Pub. L. 117–328, div. FF, title III, §3211, Dec. 29, 2022, 136 Stat. 5825, provided that:

"(a) Draft Guidance.—Not later than 3 years after the date of enactment of this Act [Dec. 29, 2022], the Secretary [of Health and Human Services], acting through the Commissioner of Food and Drugs, shall issue draft guidance for industry for the purposes of assisting entities seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensure under section 351 of the Public Health Service Act (42 U.S.C. 262) of antifungal therapies designed to treat coccidioidomycosis (commonly known as Valley Fever).

"(b) Final Guidance.—Not later than 18 months after the close of the public comment period on the draft guidance issued pursuant to subsection (a), the Secretary, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance.

"(c) Workshop.—To assist entities developing preventive vaccines for fungal infections and coccidioidomycosis, the Secretary shall hold a public workshop."

Guidance on Diversity Action Plans for Clinical Studies

Pub. L. 117–328, div. FF, title III, §3602(a), (b), Dec. 29, 2022, 136 Stat. 5861, 5862, provided that:

"(a) In General.—The Secretary [of Health and Human Services] shall update or issue guidance relating to—

"(1) the format and content of the diversity action plans required by sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z); 360j(g)(9)) (as amended by section 3601) pertaining to the sponsor's goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations, and may include characteristics such as geographic location and socioeconomic status, including with respect to—

"(A) the rationale for the sponsor's enrollment goals, which may include—

"(i) the estimated prevalence or incidence in the United States of the disease or condition for which the drug or device is being investigated in the relevant clinical trial, if such estimated prevalence or incidence is known or can be determined based on available data;

"(ii) what is known about the disease or condition for which the drug or device is being investigated;

"(iii) any relevant pharmacokinetic or pharmacogenomic data;

"(iv) what is known about the patient population for such disease or condition, including, to the extent data is available—

     "(I) demographic information, which may include age group, sex, race, geographic location, socioeconomic status, and ethnicity;

     "(II) non-demographic factors, including co-morbidities affecting the patient population; and

     "(III) potential barriers to enrolling diverse participants, such as patient population size, geographic location, and socioeconomic status; and

"(v) any other data or information relevant to selecting appropriate enrollment goals, disaggregated by demographic subgroup, such as the inclusion of pregnant and lactating women; and

"(B) an explanation for how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical study inclusion and exclusion practices, and any diversity training for study personnel;

"(2) submission of any modifications to the diversity action plan;

"(3) considerations for the public posting by a sponsor of key information from the diversity action plan that would be useful to patients and providers on the sponsor's website, as appropriate;

"(4) criteria that the Secretary will consider in assessing whether to grant a sponsor's request to waive the requirement to submit a diversity action plan under section 505(z)(4) or 520(g)(9)(C) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(z)(4), 360j(g)(9)(C)] (as amended by section 3601); and

"(5) how sponsors may include in regular reports otherwise required by the Secretary—

"(A) the sponsor's progress in meeting the goals referred to in paragraph (1)(A); and

"(B) any updates needed to be made to a diversity action plan referred to in paragraph (1) to help meet goals referred to in paragraph (1)(A); and

"(C) if the sponsor does not expect to meet goals referred to in paragraph (1)(A), the sponsor's reasons for why the sponsor does not expect to meet such goals.

"(b) Issuance.—The Secretary shall—

"(1) not later than 12 months after the date of enactment of this Act [Dec. 29, 2022], issue new draft guidance or update existing draft guidance described in subsection (a); and

"(2) not later than 9 months after closing the comment period on such draft guidance, finalize such guidance."

Annual Summary Report on Progress To Increase Diversity in Clinical Studies

Pub. L. 117–328, div. FF, title III, §3604, Dec. 29, 2022, 136 Stat. 5864, provided that:

"(a) In General.—Beginning not later than 2 years after the date of enactment of this Act [Dec. 29, 2022], and each year thereafter, the Secretary [of Health and Human Services] shall submit to the Congress, and publish on the public website of the Food and Drug Administration, a report that—

"(1) summarizes, in aggregate, the diversity action plans received pursuant to section 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(z), 360j(g)(9)], as added by section 3601; and

"(2) contains information, in the aggregate, on—

"(A) for drugs, biological products, and devices approved, licensed, cleared, or classified under section 505, 515, 510(k), or 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355; 360e; 360(k); and 360(f)(2) [probably means "360c(f)(2)"]), or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), whether the clinical studies conducted with respect to such applications met the demographic subgroup enrollment goals from the diversity action plan submitted for such applications; and

"(B) the reasons provided, if any, for why enrollment goals from submitted diversity action plans were not met.

"(b) Confidentiality.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code."

Facilitating the Use of Real World Evidence

Pub. L. 117–328, div. FF, title III, §3629, Dec. 29, 2022, 136 Stat. 5891, provided that:

"(a) Guidance.—Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary [of Health and Human Services] shall issue or revise existing guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making, as follows:

"(1) With respect to drugs, such guidance shall address the use of such data and evidence to support the approval of a drug application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological product application under section 351 of the Public Health Service Act (42 U.S.C. 262), and to support an investigational use exemption submission under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a)(3) of the Public Health Service Act (42 U.S.C. 262(a)(3)). Such guidance shall include considerations for the inclusion, in such applications and submissions, of real world data and real world evidence obtained as a result of the use of drugs authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications and submissions, as appropriate.

"(2) With respect to devices, such guidance shall address the use of such data and evidence to support the approval, clearance, or classification of a device pursuant to an application or submission submitted under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 360e), to support an investigational use exemption submission under section 520(g) of such Act (21 U.S.C. 360j(g)), and to support a determination by the Secretary for purposes of section 353 of the Public Health Service Act (42 U.S.C. 263a) (including the category described under subsection (d)(3) of such section). Such guidance shall include considerations for the inclusion, in such applications and submissions, of real world data and real world evidence obtained as a result of the use of devices authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), including considerations related to a determination under section 353(d)(3) of the Public Health Service Act (42 U.S.C. 263a(d)(3)), and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications, submissions, or determinations, as appropriate.

"(b) Report to Congress.—Not later than 2 years after the end of the public health emergency declared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) on January 31, 2020, with respect to COVID–19, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—

"(1) the number of applications, submissions, or requests submitted for clearance, approval, or authorization under section 505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262), for which an authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) was previously granted;

"(2) of the number of applications so submitted, the number of such applications—

"(A) for which real world evidence was submitted and used to support a regulatory decision; and

"(B) for which real world evidence was submitted and determined to be insufficient to support a regulatory decision; and

"(3) a summary explanation of why, in the case of applications described in paragraph (2)(B), real world evidence could not be used to support regulatory decisions.

"(c) Information Disclosure.—Nothing in this section shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 1905 of title 18, United States Code, or subject to withholding under subsection (b)(4) of section 552 of title 5, United States Code (commonly referred to as the 'Freedom of Information Act')."

Clarifying FDA Regulation of Non-Addictive Pain Products

Pub. L. 115–271, title III, §3001, Oct. 24, 2018, 132 Stat. 3932, provided that:

"(a) Public Meetings.—Not later than one year after the date of enactment of this Act [Oct. 24, 2018], the Secretary of Health and Human Services (referred to in this section as the 'Secretary'), acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction, which may include—

"(1) the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable;

"(2) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255) [set out as a note below]), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction;

"(3) the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and

"(4) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction.

"(b) Guidance.—Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding—

"(1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary—

"(A) may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction;

"(B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and

"(C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition;

"(2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence;

"(3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including—

"(A) alternative data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255) [set out as a note below]) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), including patient registries and patient reported outcomes, as appropriate, to support product labeling;

"(B) ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit;

"(C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use;

"(D) best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and

"(E) the appropriate format in which to submit such data results to the Secretary; and

"(4) the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section.

"(c) Definitions.—In this section—

"(1) the term 'medical product' means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and

"(2) the term 'opioid-sparing' means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain."

Guidance Regarding Reduction in Drug Effectiveness

Pub. L. 115–271, title III, §3041(c), Oct. 24, 2018, 132 Stat. 3943, provided that: "Not less than one year after the date of enactment of this Act [Oct. 24, 2018], the Secretary of Health and Human Services shall issue guidance regarding the circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. Such guidance shall also address how the Food and Drug Administration may apply this section [amending this section and section 355–1 of this title] and the amendments made thereby with respect to circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials and safety labeling changes related to the use of controlled substances for acute or chronic pain."

Annual Report on Inspections

Pub. L. 115–52, title IX, §902, Aug. 18, 2017, 131 Stat. 1077, as amended by Pub. L. 117–328, div. FF, title III, §3617, Dec. 29, 2022, 136 Stat. 5876, provided that: "Not later than 120 days after the end of each fiscal year, the Secretary of Health and Human Services shall post on the website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or approval of a device under section 515 of such Act (21 U.S.C. 360e) that were conducted during the previous fiscal year. Such information shall include the following:

"(1) The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, including—

"(A) the median time for drugs described in 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));

"(B) the median time for drugs for which a notification has been submitted in accordance with section 506C(a) of such Act (21 U.S.C. 356c(a)) during the previous fiscal year; and

"(C) the median time for drugs on the drug shortage list in effect under section 506E of such Act (21 U.S.C. 356e) at the time of such request.

"(2) The median time from the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).

"(3) The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting related to conditions observed by the Secretary during an inspection, to the time at which the Secretary concludes that corrective actions to resolve such conditions have been taken.

"(4) The number of facilities that failed to implement adequate corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold recommendation for an application under review, including the number of such facilities manufacturing each category of drugs listed in subparagraphs (A) through (C) of paragraph (1)."

Report on Patient Experience Drug Development

Pub. L. 114–255, div. A, title III, §3004, Dec. 13, 2016, 130 Stat. 1085, provided that: "Not later than June 1 of 2021, 2026, and 2031, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall prepare and publish on the Internet website of the Food and Drug Administration a report assessing the use of patient experience data in regulatory decisionmaking, in particular with respect to the review of patient experience data and information on patient-focused drug development tools as part of applications approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a))."

Novel Clinical Trial Designs

Pub. L. 114–255, div. A, title III, §3021, Dec. 13, 2016, 130 Stat. 1095, provided that:

"(a) Proposals for Use of Novel Clinical Trial Designs for Drugs and Biological Products.—For purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall conduct a public meeting and issue guidance in accordance with subsection (b).

"(b) Guidance Addressing Use of Novel Clinical Trial Designs.—

"(1) In general.—The Secretary, acting through the Commissioner of Food and Drugs, shall update or issue guidance addressing the use of complex adaptive and other novel trial design in the development and regulatory review and approval or licensure for drugs and biological products.

"(2) Contents.—The guidance under paragraph (1) shall address—

"(A) the use of complex adaptive and other novel trial designs, including how such clinical trials proposed or submitted help to satisfy the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));

"(B) how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to—

"(i) completion of such modeling or simulations; or

"(ii) the submission of resulting information to the Secretary;

"(C) the types of quantitative and qualitative information that should be submitted for review; and

"(D) recommended analysis methodologies.

"(3) Public meeting.—Prior to updating or issuing the guidance required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, consumer groups, and disease research foundations, through a public meeting to be held not later than 18 months after the date of enactment of this Act [Dec. 13, 2016].

"(4) Timing.—The Secretary shall update or issue a draft version of the guidance required by paragraph (1) not later than 18 months after the date of the public meeting required by paragraph (3) and finalize such guidance not later than 1 year after the date on which the public comment period for the draft guidance closes."

Variations From CGMP Streamlined Approach

Pub. L. 114–255, div. A, title III, §3038(c), Dec. 13, 2016, 130 Stat. 1110, provided that: "Not later than 18 months after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall identify types of combination products and manufacturing processes with respect to which the Secretary proposes that good manufacturing processes may be adopted that vary from the requirements set forth in section 4.4 of title 21, Code of Federal Regulations (or any successor regulations) or that the Secretary proposes can satisfy the requirements in section 4.4 through alternative or streamlined mechanisms. The Secretary shall identify such types, variations from such requirements, and such mechanisms, in a proposed list published in the Federal Register. After a public comment period regarding the appropriate good manufacturing practices for such types, the Secretary shall publish a final list in the Federal Register, notwithstanding section 553 of title 5, United States Code. The Secretary shall evaluate such types, variations, and mechanisms using a risk-based approach. The Secretary shall periodically review such final list."

FDA Opioid Action Plan

Pub. L. 114–198, title I, §106(a), July 22, 2016, 130 Stat. 702, provided that:

"(1) New drug application.—

"(A) In general.—Subject to subparagraph (B), prior to the approval pursuant to an application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) of a new drug that is an opioid, the Secretary of Health and Human Services (referred to in this section [enacting provisions set out as notes under this section and section 355–1 of this title] as the 'Secretary') shall refer the application to an advisory committee of the Food and Drug Administration to seek recommendations from such advisory committee.

"(B) Public health exemption.—A referral to an advisory committee under subparagraph (A) is not required with respect to a new opioid drug or drugs if the Secretary—

"(i) finds that such a referral is not in the interest of protecting and promoting public health;

"(ii) finds that such a referral is not necessary based on a review of the relevant scientific information; and

"(iii) submits a notice containing the rationale for such findings to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

"(2) Pediatric opioid labeling.—The Secretary shall convene the Pediatric Advisory Committee of the Food and Drug Administration to seek recommendations from such Committee regarding a framework for the inclusion of information in the labeling of drugs that are opioids relating to the use of such drugs in pediatric populations before the Secretary approves any labeling or change to labeling for any drug that is an opioid intended for use in a pediatric population.

"(3) Sunset.—The requirements of paragraphs (1) and (2) shall cease to be effective on October 1, 2022."

Guidance on Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products

Pub. L. 114–198, title I, §106(c), July 22, 2016, 130 Stat. 703, provided that: "Not later than 18 months after the end of the period for public comment on the draft guidance entitled 'General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products' issued by the Center for Drug Evaluation and Research of the Food and Drug Administration in March 2016, the Commissioner of Food and Drugs shall publish in the Federal Register a final version of such guidance."

Guidance on Pathogen-Focused Antibacterial Drug Development

Pub. L. 112–144, title VIII, §806, July 9, 2012, 126 Stat. 1082, provided that:

"(a) Draft Guidance.—Not later than June 30, 2013, in order to facilitate the development of antibacterial drugs for serious or life-threatening bacterial infections, particularly in areas of unmet need, the Secretary of Health and Human Services shall publish draft guidance that—

"(1) specifies how preclinical and clinical data can be utilized to inform an efficient and streamlined pathogen-focused antibacterial drug development program that meets the approval standards of the Food and Drug Administration; and

"(2) provides advice on approaches for the development of antibacterial drugs that target a more limited spectrum of pathogens.

"(b) Final Guidance.—Not later than December 31, 2014, after notice and opportunity for public comment on the draft guidance under subsection (a), the Secretary of Health and Human Services shall publish final guidance consistent with this section."

Guidance on Abuse-Deterrent Products

Pub. L. 112–144, title XI, §1122(c), July 9, 2012, 126 Stat. 1113, as amended by Pub. L. 114–255, div. A, title III, §3101(b)(3)(B), Dec. 13, 2016, 130 Stat. 1156, provided that: "Not later than 6 months after the date of enactment of this Act [July 9, 2012], the Secretary [of Health and Human Services] shall issue guidance on the development of abuse-deterrent drug products."

Extension of Period for First Applicant To Obtain Tentative Approval Without Forfeiting 180-Day-Exclusivity Period

Pub. L. 112–144, title XI, §1133, July 9, 2012, 126 Stat. 1122, provided that:

"(a) Extension.—

"(1) In general.—If a first applicant files an application during the 30-month period ending on the date of enactment of this Act [July 9, 2012] and such application initially contains a certification described in paragraph (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), or if a first applicant files an application and the application is amended during such period to first contain such a certification, the phrase '30 months' in paragraph (5)(D)(i)(IV) of such section shall, with respect to such application, be read as meaning—

"(A) during the period beginning on the date of enactment of this Act, and ending on September 30, 2015, '40 months'; and

"(B) during the period beginning on October 1, 2015, and ending on September 30, 2016, '36 months'.

"(2) Conforming amendment.—In the case of an application to which an extended period under paragraph (1) applies, the reference to the 30-month period under section 505(q)(1)(G) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)(G)) shall be read to be the applicable period under paragraph (1).

"(b) Period for Obtaining Tentative Approval of Certain Applications.—If an application is filed on or before the date of enactment of this Act [July 9, 2012] and such application is amended during the period beginning on the day after the date of enactment of this Act and ending on September 30, 2017, to first contain a certification described in paragraph (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), the date of the filing of such amendment (rather than the date of the filing of such application) shall be treated as the beginning of the 30-month period described in paragraph (5)(D)(i)(IV) of such section 505(j).

"(c) Definitions.—For the purposes of this section, the terms 'application' and 'first applicant' mean application and first applicant, as such terms are used in section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV))."

Effect of Amendments by Pub. L. 110–85 on Veterinary Medicine

Pub. L. 110–85, title IX, §907, Sept. 27, 2007, 121 Stat. 950, provided that: "This subtitle [subtitle A (§§901–909) of title IX of Pub. L. 110–85, enacting sections 353c and 355–1 of this title, amending this section and sections 331, 333, and 352 of this title and section 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under this section and sections 331, 352, and 355a of this title], and the amendments made by this subtitle, shall have no effect on the use of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] by, or on the lawful written or oral order of, a licensed veterinarian within the context of a veterinarian-client-patient relationship, as provided for under section 512(a)(5) of such Act [21 U.S.C. 360b(a)(5)]."

Effect of Amendment by Pub. L. 108–173 on Abbreviated New Drug Applications

Pub. L. 108–173, title XI, §1103(b), Dec. 8, 2003, 117 Stat. 2461, provided that: "The amendment made by subsection (a) [amending this section] does not alter the standards for approval of drugs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))."

Federal Trade Commission Review

Pub. L. 108–173, title XI, subtitle B, Dec. 8, 2003, 117 Stat. 2461, as amended by Pub. L. 115–263, §3, Oct. 10, 2018, 132 Stat. 3673; Pub. L. 115–271, title IV, §4004, Oct. 24, 2018, 132 Stat. 3960, provided that:

"SEC. 1111. DEFINITIONS.

"In this subtitle:

"(1) ANDA.—The term 'ANDA' means an abbreviated drug application, as defined under section 201(aa) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(aa)].

"(2) Assistant attorney general.—The term 'Assistant Attorney General' means the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice.

"(3) Biosimilar biological product.—The term 'biosimilar biological product' means a biological product for which a biosimilar biological product application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)] is approved.

"(4) Biosimilar biological product applicant.—The term 'biosimilar biological product applicant' means a person who has filed or received approval for a biosimilar biological product application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)].

"(5) Biosimilar biological product application.—The term 'biosimilar biological product application' means an application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)] for licensure of a biological product as biosimilar to, or interchangeable with, a reference product.

"(6) Brand name drug.—The term 'brand name drug' means a drug for which an application is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)], including an application referred to in section 505(b)(2) of such Act [21 U.S.C. 355(b)(2)], or a biological product for which an application is approved under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)].

"(7) Brand name drug company.—The term 'brand name drug company' means the party that holds the approved application referred to in paragraph (6) for a brand name drug that is a listed drug in an ANDA or a reference product in a biosimilar biological product application, or a party that is the owner of a patent for which information is submitted for such drug under subsection (b) or (c) of section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b), (c)] or the owner, or exclusive licensee, of a patent included in a list provided under section 351(l)(3) of the Public Health Service Act [42 U.S.C. 262(l)(3)].

"(8) Commission.—The term 'Commission' means the Federal Trade Commission.

"(9) Generic drug.—The term 'generic drug' means a drug for which an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)] is approved.

"(10) Generic drug applicant.—The term 'generic drug applicant' means a person who has filed or received approval for an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)].

"(11) Listed drug.—The term 'listed drug' means a brand name drug that is listed under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(7)].

"(12) Reference product.—The term 'reference product' has the meaning given such term in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].

"SEC. 1112. NOTIFICATION OF AGREEMENTS.

"(a) Agreement With Brand Name Drug Company.—

"(1) Requirement.—A generic drug applicant that has submitted an ANDA containing a certification under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(2)(A)(vii)(IV)] or a biosimilar biological product applicant who has submitted a biosimilar biological product application and a brand name drug company that enter into an agreement described in paragraph (2) shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of the generic drug that is the subject of the ANDA or the biosimilar biological product that is the subject of the biosimilar biological product application, as applicable.

"(2) Subject matter of agreement.—An agreement described in this paragraph between a generic drug applicant or a biosimilar biological product applicant and a brand name drug company is an agreement regarding—

"(A) the manufacture, marketing, or sale of the brand name drug that is the listed drug in the ANDA or the reference product in the biosimilar biological product application involved;

"(B) the manufacture, marketing, or sale of the generic drug for which the ANDA was submitted or of the biosimilar biological product for which the biosimilar biological product application was submitted; or

"(C) as applicable—

"(i) the 180-day period referred to in section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(5)(B)(iv)] as it applies to such ANDA or to any other ANDA based on the same listed drug; or

"(ii) any of the time periods referred to in section 351(k)(6) of the Public Health Service Act [42 U.S.C. 262(k)(6)] as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product.

"(b) Agreement With Another Generic Drug Applicant or Biosimilar Biological Product Applicant.—

"(1) Requirement.—

"(A) Generic drugs.—A generic drug applicant that has submitted an ANDA containing a certification under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(2)(A)(vii)(IV)] with respect to a listed drug and another generic drug applicant that has submitted an ANDA containing such a certification for the same listed drug shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of either of the generic drugs for which such ANDAs were submitted.

"(B) Biosimilar biological products.—A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of either of the biosimilar biological products for which such biosimilar biological product applications were submitted.

"(2) Subject matter of agreement.—An agreement described in this paragraph is, as applicable, an agreement between 2 or more generic drug applicants regarding the 180-day period referred to in section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(5)(B)(iv)] as it applies to the ANDAs with which the agreement is concerned,, [sic] an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act [42 U.S.C. 262(k)(6)] as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product.

"(c) Filing.—

"(1) Agreement.—The parties that are required in subsection (a) or (b) to file an agreement in accordance with this subsection shall file with the Assistant Attorney General and the Commission the text of any such agreement, except that such parties are not required to file an agreement that solely concerns—

"(A) purchase orders for raw material supplies;

"(B) equipment and facility contracts;

"(C) employment or consulting contracts; or

"(D) packaging and labeling contracts.

"(2) Other agreements.—The parties that are required in subsection (a) or (b) to file an agreement in accordance with this subsection shall file with the Assistant Attorney General and the Commission the text of any agreements between the parties that are not described in such subsections and are contingent upon, provide a contingent condition for, were entered into within 30 days of, or are otherwise related to an agreement that is required in subsection (a) or (b) to be filed in accordance with this subsection.

"(3) Description.—In the event that any agreement required in subsection (a) or (b) to be filed in accordance with this subsection has not been reduced to text, each of the parties involved shall file written descriptions of such agreement that are sufficient to disclose all the terms and conditions of the agreement.

"SEC. 1113. FILING DEADLINES.

"Any filing required under section 1112 shall be filed with the Assistant Attorney General and the Commission not later than 10 business days after the date the agreements are executed.

"SEC. 1114. DISCLOSURE EXEMPTION.

"Any information or documentary material filed with the Assistant Attorney General or the Commission pursuant to this subtitle shall be exempt from disclosure under section 552 of title 5, United States Code, and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding. Nothing in this section is intended to prevent disclosure to either body of the Congress or to any duly authorized committee or subcommittee of the Congress.

"SEC. 1115. ENFORCEMENT.

"(a) Civil Penalty.—Any brand name drug company, generic drug applicant, or biosimilar biological product applicant which fails to comply with any provision of this subtitle shall be liable for a civil penalty of not more than $11,000, for each day during which such entity is in violation of this subtitle. Such penalty may be recovered in a civil action brought by the United States, or brought by the Commission in accordance with the procedures established in section 16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a) [15 U.S.C. 56(a)(1)]).

"(b) Compliance and Equitable Relief.—If any brand name drug company, generic drug applicant, or biosimilar biological product applicant fails to comply with any provision of this subtitle, the United States district court may order compliance, and may grant such other equitable relief as the court in its discretion determines necessary or appropriate, upon application of the Assistant Attorney General or the Commission.

"SEC. 1116. RULEMAKING.

"The Commission, with the concurrence of the Assistant Attorney General and by rule in accordance with section 553 of title 5, United States Code, consistent with the purposes of this subtitle—

"(1) may define the terms used in this subtitle;

"(2) may exempt classes of persons or agreements from the requirements of this subtitle; and

"(3) may prescribe such other rules as may be necessary and appropriate to carry out the purposes of this subtitle.

"SEC. 1117. SAVINGS CLAUSE.

"Any action taken by the Assistant Attorney General or the Commission, or any failure of the Assistant Attorney General or the Commission to take action, under this subtitle shall not at any time bar any proceeding or any action with respect to any agreement between a brand name drug company and a generic drug applicant or a biosimilar biological product applicant, any agreement between generic drug applicants, or any agreement between biosimilar biological product applicants, under any other provision of law, nor shall any filing under this subtitle constitute or create a presumption of any violation of any competition laws.

"SEC. 1118. EFFECTIVE DATE.

"This subtitle shall—

"(1) take effect 30 days after the date of the enactment of this Act [Dec. 8, 2003]; and

"(2) shall apply to agreements described in section 1112 that are entered into 30 days after the date of the enactment of this Act."

Report on Patient Access to New Therapeutic Agents for Pediatric Cancer

Pub. L. 107–109, §15(d), Jan. 4, 2002, 115 Stat. 1421, provided that: "Not later than January 31, 2003, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs and in consultation with the Director of the National Institutes of Health, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on patient access to new therapeutic agents for pediatric cancer, including access to single patient use of new therapeutic agents."

Data Requirements for Drugs and Biologics

Pub. L. 105–115, title I, §118, Nov. 21, 1997, 111 Stat. 2316, provided that: "Within 12 months after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue guidance that describes when abbreviated study reports may be submitted, in lieu of full reports, with a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and with a biologics license application under section 351 of the Public Health Service Act (42 U.S.C. 262) for certain types of studies. Such guidance shall describe the kinds of studies for which abbreviated reports are appropriate and the appropriate abbreviated report formats."

Requirements for Review of Approval Procedures and Current Good Manufacturing Practices for Positron Emission Technology

Pub. L. 105–115, title I, §121(c), Nov. 21, 1997, 111 Stat. 2321, provided that:

"(1) Procedures and requirements.—

"(A) In general.—In order to take account of the special characteristics of positron emission tomography drugs and the special techniques and processes required to produce these drugs, not later than 2 years after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall establish—

"(i) appropriate procedures for the approval of positron emission tomography drugs pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and

"(ii) appropriate current good manufacturing practice requirements for such drugs.

"(B) Considerations and consultation.—In establishing the procedures and requirements required by subparagraph (A), the Secretary of Health and Human Services shall take due account of any relevant differences between not-for-profit institutions that compound the drugs for their patients and commercial manufacturers of the drugs. Prior to establishing the procedures and requirements, the Secretary of Health and Human Services shall consult with patient advocacy groups, professional associations, manufacturers, and physicians and scientists licensed to make or use positron emission tomography drugs.

"(2) Submission of new drug applications and abbreviated new drug applications.—

"(A) In general.—Except as provided in subparagraph (B), the Secretary of Health and Human Services shall not require the submission of new drug applications or abbreviated new drug applications under subsection (b) or (j) of section 505 (21 U.S.C. 355), for compounded positron emission tomography drugs that are not adulterated drugs described in section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a period of 4 years after the date of enactment of this Act [Nov. 21, 1997], or for 2 years after the date on which the Secretary establishes procedures and requirements under paragraph (1), whichever is longer.

"(B) Exception.—Nothing in this Act [see Short Title of 1997 Amendment note set out under section 301 of this title] shall prohibit the voluntary submission of such applications or the review of such applications by the Secretary of Health and Human Services. Nothing in this Act shall constitute an exemption for a positron emission tomography drug from the requirements of regulations issued under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i))."

"Compounded Positron Emission Topography Drug" Defined

Pub. L. 105–115, title I, §121(e), Nov. 21, 1997, 111 Stat. 2322, provided that: "As used in this section [amending sections 321 and 351 of this title and enacting provisions set out as notes under this section and section 351 of this title], the term 'compounded positron emission tomography drug' has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)."

Requirements for Radiopharmaceuticals

Pub. L. 105–115, title I, §122, Nov. 21, 1997, 111 Stat. 2322, provided that:

"(a) Requirements.—

"(1) Regulations.—

"(A) Proposed regulations.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services, after consultation with patient advocacy groups, associations, physicians licensed to use radiopharmaceuticals, and the regulated industry, shall issue proposed regulations governing the approval of radiopharmaceuticals. The regulations shall provide that the determination of the safety and effectiveness of such a radiopharmaceutical under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) shall include consideration of the proposed use of the radiopharmaceutical in the practice of medicine, the pharmacological and toxicological activity of the radiopharmaceutical (including any carrier or ligand component of the radiopharmaceutical), and the estimated absorbed radiation dose of the radiopharmaceutical.

"(B) Final regulations.—Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate final regulations governing the approval of the radiopharmaceuticals.

"(2) Special rule.—In the case of a radiopharmaceutical, the indications for which such radiopharmaceutical is approved for marketing may, in appropriate cases, refer to manifestations of disease (such as biochemical, physiological, anatomic, or pathological processes) common to, or present in, one or more disease states.

"(b) Definition.—In this section, the term 'radiopharmaceutical' means—

"(1) an article—

"(A) that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans; and

"(B) that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or

"(2) any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of any such article."

Special Rule

Pub. L. 105–115, title I, §123(f), Nov. 21, 1997, 111 Stat. 2324, provided that: "The Secretary of Health and Human Services shall take measures to minimize differences in the review and approval of products required to have approved biologics license applications under section 351 of the Public Health Service Act (42 U.S.C. 262) and products required to have approved new drug applications under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1))."

Transition

Pub. L. 110–379, §4(b), Oct. 8, 2008, 122 Stat. 4077, provided that:

"(1) With respect to a patent issued on or before the date of the enactment of this Act [Oct. 8, 2008], any patent information required to be filed with the Secretary of Health and Human Services under subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) to be listed on a drug to which subsection (v)(1) of such section 505 (as added by this section) applies shall be filed with the Secretary not later than 60 days after the date of the enactment of this Act.

"(2) With respect to any patent information referred to in paragraph (1) of this subsection that is filed with the Secretary within the 60-day period after the date of the enactment of this Act [Oct. 8, 2008], the Secretary shall publish such information in the electronic version of the list referred to at section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) as soon as it is received, but in no event later than the date that is 90 days after the enactment of this Act.

"(3) With respect to any patent information referred to in paragraph (1) that is filed with the Secretary within the 60-day period after the date of enactment of this Act [Oct. 8, 2008], each applicant that, not later than 120 days after the date of the enactment of this Act, amends an application that is, on or before the date of the enactment of this Act, a substantially complete application (as defined in paragraph (5)(B)(iv) of section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))) to contain a certification described in paragraph (2)(A)(vii)(IV) of such section 505(j) with respect to that patent shall be deemed to be a first applicant (as defined in paragraph (5)(B)(iv) of such section 505(j))."

Pub. L. 105–115, title I, §125(d), Nov. 21, 1997, 111 Stat. 2326, provided that:

"(1) In general.—An application that was approved by the Secretary of Health and Human Services before the date of the enactment of this Act [Nov. 21, 1997] for the marketing of an antibiotic drug under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357), as in effect on the day before the date of the enactment of this Act, shall, on and after such date of enactment, be considered to be an application that was submitted and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and approved for safety and effectiveness under section 505(c) of such Act (21 U.S.C. 355(c)), except that if such application for marketing was in the form of an abbreviated application, the application shall be considered to have been filed and approved under section 505(j) of such Act (21 U.S.C. 355(j)).

"(2) Exception.—The following subsections of section 505 (21 U.S.C. 355) shall not apply to any application for marketing in which the drug that is the subject of the application contains an antibiotic drug and the antibiotic drug was the subject of any application for marketing received by the Secretary of Health and Human Services under section 507 of such Act (21 U.S.C. 357) before the date of the enactment of this Act [Nov. 21, 1997]:

"(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii), (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and

"(ii) The third and fourth sentences of subsection (b)(1) (regarding the filing and publication of patent information); and

"(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if the investigations relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.

"(3) Publication.—For purposes of this section, the Secretary is authorized to make available to the public the established name of each antibiotic drug that was the subject of any application for marketing received by the Secretary for Health and Human Services under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357) before the date of enactment of this Act [Nov. 21, 1997]."

Termination of Advisory Panels

Advisory panels established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a panel established by the President or an officer of the Federal Government, such panel is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a panel established by Congress, its duration is otherwise provided for by law. See sections 1001(2) and 1013 of Title 5, Government Organization and Employees.

Appeals Taken Prior to October 10, 1962

Pub. L. 87–781, title I, §104(d)(3), Oct. 10, 1962, 76 Stat. 785, made amendments to subsec. (h) of this section inapplicable to any appeal taken prior to Oct. 10, 1962.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original. Probably should be "bioavailability".

² So in original. Probably should be "drug,".

³ So in original. Probably should be preceded by "the".

⁴ So in original. The word "and" probably should not appear.

⁵ So in original. Probably should be "subparagraph".

⁶ So in original. Two subsecs. (z) have been enacted.

⁷ See Delayed Applicability of Amendment note below.

§355–1. Risk evaluation and mitigation strategies

(a) Submission of proposed strategy

(1) Initial approval

If the Secretary, in consultation with the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug, determines that a risk evaluation and mitigation strategy is necessary to ensure that the benefits of the drug outweigh the risks of the drug, and informs the person who submits such application of such determination, then such person shall submit to the Secretary as part of such application a proposed risk evaluation and mitigation strategy. In making such a determination, the Secretary shall consider the following factors:

(A) The estimated size of the population likely to use the drug involved.

(B) The seriousness of the disease or condition that is to be treated with the drug.

(C) The expected benefit of the drug with respect to such disease or condition.

(D) The expected or actual duration of treatment with the drug.

(E) The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug.

(F) Whether the drug is a new molecular entity.

(2) Postapproval requirement

(A) In general

If the Secretary has approved a covered application (including an application approved before the effective date of this section) and did not when approving the application require a risk evaluation and mitigation strategy under paragraph (1), the Secretary, in consultation with the offices described in paragraph (1), may subsequently require such a strategy for the drug involved (including when acting on a supplemental application seeking approval of a new indication for use of the drug) if the Secretary becomes aware of new safety information and makes a determination that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks of the drug.

(B) Submission of proposed strategy

Not later than 120 days after the Secretary notifies the holder of an approved covered application that the Secretary has made a determination under subparagraph (A) with respect to the drug involved, or within such other reasonable time as the Secretary requires to protect the public health, the holder shall submit to the Secretary a proposed risk evaluation and mitigation strategy.

(3) Abbreviated new drug applications

The applicability of this section to an application under section 355(j) of this title is subject to subsection (i).

(4) Non-delegation

Determinations by the Secretary under this subsection for a drug shall be made by individuals at or above the level of individuals empowered to approve a drug (such as division directors within the Center for Drug Evaluation and Research).

(b) Definitions

For purposes of this section:

(1) Adverse drug experience

The term "adverse drug experience" means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including—

(A) an adverse event occurring in the course of the use of the drug in professional practice;

(B) an adverse event occurring from an overdose of the drug, whether accidental or intentional;

(C) an adverse event occurring from abuse of the drug;

(D) an adverse event occurring from withdrawal of the drug; and

(E) any failure of expected pharmacological action of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling.

(2) Covered application

The term "covered application" means an application referred to in section 355(p)(1)(A) of this title.

(3) New safety information

The term "new safety information", with respect to a drug, means information derived from a clinical trial, an adverse event report, a postapproval study (including a study under section 355(o)(3) of this title), or peer-reviewed biomedical literature; data derived from the postmarket risk identification and analysis system under section 355(k) of this title; or other scientific data deemed appropriate by the Secretary about—

(A) a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of (that may be based on a new analysis of existing information) since the drug was approved, since the risk evaluation and mitigation strategy was required, or since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or

(B) the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained since the last assessment of such strategy.

(4) Serious adverse drug experience

The term "serious adverse drug experience" is an adverse drug experience that—

(A) results in—

(i) death;

(ii) an adverse drug experience that places the patient at immediate risk of death from the adverse drug experience as it occurred (not including an adverse drug experience that might have caused death had it occurred in a more severe form);

(iii) inpatient hospitalization or prolongation of existing hospitalization;

(iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or

(v) a congenital anomaly or birth defect; or

(B) based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described under subparagraph (A).

(5) Serious risk

The term "serious risk" means a risk of a serious adverse drug experience.

(6) Signal of a serious risk

The term "signal of a serious risk" means information related to a serious adverse drug experience associated with use of a drug and derived from—

(A) a clinical trial;

(B) adverse event reports;

(C) a postapproval study, including a study under section 355(o)(3) of this title;

(D) peer-reviewed biomedical literature;

(E) data derived from the postmarket risk identification and analysis system under section 355(k)(4) of this title; or

(F) other scientific data deemed appropriate by the Secretary.

(7) Responsible person

The term "responsible person" means the person submitting a covered application or the holder of the approved such application.

(8) Unexpected serious risk

The term "unexpected serious risk" means a serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically and pathophysiologically related to an adverse drug experience identified in the labeling, but differs from such adverse drug experience because of greater severity, specificity, or prevalence.

(c) Contents

A proposed risk evaluation and mitigation strategy under subsection (a) shall—

(1) include the timetable required under subsection (d); and

(2) to the extent required by the Secretary, in consultation with the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug, include additional elements described in subsections (e) and (f).

(d) Minimal strategy

For purposes of subsection (c)(1), the risk evaluation and mitigation strategy for a drug shall require a timetable for submission of assessments of the strategy that—

(1) includes an assessment, by the date that is 18 months after the strategy is initially approved;

(2) includes an assessment by the date that is 3 years after the strategy is initially approved;

(3) includes an assessment in the seventh year after the strategy is so approved; and

(4) subject to paragraphs (1), (2), and (3)—

(A) is at a frequency specified in the strategy;

(B) is increased or reduced in frequency as necessary as provided for in subsection (g)(4)(A); and

(C) is eliminated after the 3-year period described in paragraph (1) if the Secretary determines that serious risks of the drug have been adequately identified and assessed and are being adequately managed.

(e) Additional potential elements of strategy

(1) In general

The Secretary, in consultation with the offices described in subsection (c)(2), may under such subsection require that the risk evaluation and mitigation strategy for a drug include 1 or more of the additional elements described in this subsection if the Secretary makes the determination required with respect to each element involved.

(2) Medication Guide; patient package insert

The risk evaluation and mitigation strategy for a drug may require that, as applicable, the responsible person develop for distribution to each patient when the drug is dispensed—

(A) a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations); and

(B) a patient package insert, if the Secretary determines that such insert may help mitigate a serious risk of the drug.

(3) Communication plan

The risk evaluation and mitigation strategy for a drug may require that the responsible person conduct a communication plan to health care providers, if, with respect to such drug, the Secretary determines that such plan may support implementation of an element of the strategy (including under this paragraph). Such plan may include—

(A) sending letters to health care providers;

(B) disseminating information about the elements of the risk evaluation and mitigation strategy to encourage implementation by health care providers of components that apply to such health care providers, or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests) ¹

(C) disseminating information to health care providers through professional societies about any serious risks of the drug and any protocol to assure safe use; or

(D) disseminating information to health care providers about drug formulations or properties, including information about the limitations or patient care implications of such formulations or properties, and how such formulations or properties may be related to serious adverse drug events associated with use of the drug.

(4) Packaging and disposal

The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph (B) or (C) of subsection (b)(1), taking into consideration the factors described in subparagraphs (C) and (D) of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug disposal packaging, which may include requiring that—

(A) the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or

(B) the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system if the Secretary determines that such safe disposal packaging or system may mitigate such serious risk and is sufficiently available.

(f) Providing safe access for patients to drugs with known serious risks that would otherwise be unavailable

(1) Allowing safe access to drugs with known serious risks

The Secretary, in consultation with the offices described in subsection (c)(2), may require that the risk evaluation and mitigation strategy for a drug include such elements as are necessary to assure safe use of the drug, because of its inherent toxicity or potential harmfulness, if the Secretary determines that—

(A) the drug, which has been shown to be effective, but is associated with a serious adverse drug experience, can be approved only if, or would be withdrawn unless, such elements are required as part of such strategy to mitigate a specific serious risk listed in the labeling of the drug; and

(B) for a drug initially approved without elements to assure safe use, other elements under subsections (c), (d), and (e) are not sufficient to mitigate such serious risk.

(2) Assuring access and minimizing burden

Such elements to assure safe use under paragraph (1) shall—

(A) be commensurate with the specific serious risk listed in the labeling of the drug;

(B) within 30 days of the date on which any element under paragraph (1) is imposed, be posted publicly by the Secretary with an explanation of how such elements will mitigate the observed safety risk;

(C) considering such risk, not be unduly burdensome on patient access to the drug, considering in particular—

(i) patients with serious or life-threatening diseases or conditions;

(ii) patients who have difficulty accessing health care (such as patients in rural or medically underserved areas); and

(iii) patients with functional limitations; and

(D) to the extent practicable, so as to minimize the burden on the health care delivery system—

(i) conform with elements to assure safe use for other drugs with similar, serious risks; and

(ii) be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.

(3) Elements to assure safe use

The elements to assure safe use under paragraph (1) shall include 1 or more goals to mitigate a specific serious risk listed in the labeling of the drug and, to mitigate such risk, may require that—

(A) health care providers who prescribe the drug have particular training or experience, or are specially certified (the opportunity to obtain such training or certification with respect to the drug shall be available to any willing provider from a frontier area in a widely available training or certification method (including an on-line course or via mail) as approved by the Secretary at reasonable cost to the provider);

(B) pharmacies, practitioners, or health care settings that dispense the drug are specially certified (the opportunity to obtain such certification shall be available to any willing provider from a frontier area);

(C) the drug be dispensed to patients only in certain health care settings, such as hospitals;

(D) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results;

(E) each patient using the drug be subject to certain monitoring; or

(F) each patient using the drug be enrolled in a registry.

(4) Implementation system

The elements to assure safe use under paragraph (1) that are described in subparagraphs (B), (C), and (D) of paragraph (3) may include a system through which the applicant is able to take reasonable steps to—

(A) monitor and evaluate implementation of such elements by health care providers, pharmacists, and other parties in the health care system who are responsible for implementing such elements; and

(B) work to improve implementation of such elements by such persons.

(5) Evaluation of elements to assure safe use

The Secretary, through the Drug Safety and Risk Management Advisory Committee (or successor committee) or other advisory committee of the Food and Drug Administration, shall—

(A) seek input from patients, physicians, pharmacists, and other health care providers about how elements to assure safe use under this subsection for 1 or more drugs may be standardized so as not to be—

(i) unduly burdensome on patient access to the drug; and

(ii) to the extent practicable, minimize ² the burden on the health care delivery system;

(B) periodically evaluate, for 1 or more drugs, the elements to assure safe use of such drug to assess whether the elements—

(i) assure safe use of the drug;

(ii) are not unduly burdensome on patient access to the drug; and

(iii) to the extent practicable, minimize the burden on the health care delivery system; and

(C) considering such input and evaluations—

(i) issue or modify agency guidance about how to implement the requirements of this subsection; and

(ii) modify elements under this subsection for 1 or more drugs as appropriate.

(6) Additional mechanisms to assure access

The mechanisms under section 360bbb of this title to provide for expanded access for patients with serious or life-threatening diseases or conditions may be used to provide access for patients with a serious or life-threatening disease or condition, the treatment of which is not an approved use for the drug, to a drug that is subject to elements to assure safe use under this subsection. The Secretary shall promulgate regulations for how a physician may provide the drug under the mechanisms of section 360bbb of this title.

(7) Repealed. Pub. L. 113–5, title III, §302(c)(1), Mar. 13, 2013, 127 Stat. 185

(8) Limitation

No holder of an approved covered application shall use any element to assure safe use required by the Secretary under this subsection to block or delay approval of an application under section 355(b)(2) or (j) of this title or to prevent application of such element under subsection (i)(1)(B) to a drug that is the subject of an abbreviated new drug application.

(g) Assessment and modification of approved strategy

(1) Voluntary assessments

After the approval of a risk evaluation and mitigation strategy under subsection (a), the responsible person involved may, subject to paragraph (2), submit to the Secretary an assessment of the approved strategy for the drug involved at any time.

(2) Required assessments

A responsible person shall submit an assessment of the approved risk evaluation and mitigation strategy for a drug—

(A) when submitting a supplemental application for a new indication for use under section 355(b) of this title or under section 262 of title 42, unless the drug is not subject to section 353(b) of this title and the risk evaluation and mitigation strategy for the drug includes only the timetable under subsection (d);

(B) when required by the strategy, as provided for in such timetable under subsection (d);

(C) within a time period to be determined by the Secretary, if the Secretary, in consultation with the offices described in subsection (c)(2), determines that an assessment is needed to evaluate whether the approved strategy should be modified to—

(i) ensure the benefits of the drug outweigh the risks of the drug; or

(ii) minimize the burden on the health care delivery system of complying with the strategy.

(3) Requirements for assessments

An assessment under paragraph (1) or (2) of an approved risk evaluation and mitigation strategy for a drug shall include, with respect to each goal included in the strategy, an assessment of the extent to which the approved strategy, including each element of the strategy, is meeting the goal or whether 1 or more such goals or such elements should be modified.

(4) Modification

(A) On initiative of responsible person

After the approval of a risk evaluation and mitigation strategy by the Secretary, the responsible person may, at any time, submit to the Secretary a proposal to modify the approved strategy. Such proposal may propose the addition, modification, or removal of any goal or element of the approved strategy and shall include an adequate rationale to support such proposed addition, modification, or removal of any goal or element of the strategy.

(B) On initiative of Secretary

After the approval of a risk evaluation and mitigation strategy by the Secretary, the Secretary may, at any time, require a responsible person to submit a proposed modification to the strategy within 120 days or within such reasonable time as the Secretary specifies, if the Secretary, in consultation with the offices described in subsection (c)(2), determines that 1 or more goals or elements should be added, modified, or removed from the approved strategy to—

(i) ensure the benefits of the drug outweigh the risks of the drug;

(ii) minimize the burden on the health care delivery system of complying with the strategy; or

(iii) accommodate different, comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section 355(j) of this title, and the applicable listed drug.

(h) Review of proposed strategies; review of assessments and modifications of approved strategies

(1) In general

The Secretary, in consultation with the offices described in subsection (c)(2), shall promptly review each proposed risk evaluation and mitigation strategy for a drug submitted under subsection (a) and each assessment of and proposed modification to an approved risk evaluation and mitigation strategy for a drug submitted under subsection (g), and, if necessary, promptly initiate discussions with the responsible person about such proposed strategy, assessment, or modification.

(2) Action

(A) In general

(i) Timeframe

Unless the dispute resolution process described under paragraph (3) or (4) applies, and, except as provided in clause (ii) or clause (iii) below, the Secretary, in consultation with the offices described in subsection (c)(2), shall review and act on the proposed risk evaluation and mitigation strategy for a drug or any proposed modification to any required strategy within 180 days of receipt of the proposed strategy or modification.

(ii) Minor modifications

The Secretary shall review and act on a proposed minor modification, as defined by the Secretary in guidance, within 60 days of receipt of such modification.

(iii) REMS modification due to safety labeling changes

Not later than 60 days after the Secretary receives a proposed modification to an approved risk evaluation and mitigation strategy to conform the strategy to approved safety labeling changes, including safety labeling changes initiated by the responsible person in accordance with FDA regulatory requirements, or to a safety labeling change that the Secretary has directed the holder of the application to make pursuant to section 355(o)(4) of this title, the Secretary shall review and act on such proposed modification to the approved strategy.

(iv) Guidance

The Secretary shall establish, through guidance, that responsible persons may implement certain modifications to an approved risk evaluation and mitigation strategy following notification to the Secretary.

(B) Inaction

An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided under subparagraph (A).

(C) Public availability

Upon acting on a proposed risk evaluation and mitigation strategy or proposed modification to a risk evaluation and mitigation strategy under subparagraph (A), the Secretary shall make publicly available an action letter describing the actions taken by the Secretary under such subparagraph (A).

(3) Dispute resolution at initial approval

If a proposed risk evaluation and mitigation strategy is submitted under subsection (a)(1) in an application for initial approval of a drug and there is a dispute about the strategy, the responsible person shall use the major dispute resolution procedures as set forth in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.

(4) Dispute resolution in all other cases

(A) Request for review

(i) In general

The responsible person may, after the sponsor is required to make a submission under subsection (a)(2) or (g), request in writing that a dispute about the strategy be reviewed by the Drug Safety Oversight Board under subsection (j), except that the determination of the Secretary to require a risk evaluation and mitigation strategy is not subject to review under this paragraph. The preceding sentence does not prohibit review under this paragraph of the particular elements of such a strategy.

(ii) Scheduling

Upon receipt of a request under clause (i), the Secretary shall schedule the dispute involved for review under subparagraph (B) and, not later than 5 business days of ³ scheduling the dispute for review, shall publish by posting on the Internet or otherwise a notice that the dispute will be reviewed by the Drug Safety Oversight Board.

(B) Scheduling review

If a responsible person requests review under subparagraph (A), the Secretary—

(i) shall schedule the dispute for review at 1 of the next 2 regular meetings of the Drug Safety Oversight Board, whichever meeting date is more practicable; or

(ii) may convene a special meeting of the Drug Safety Oversight Board to review the matter more promptly, including to meet an action deadline on an application (including a supplemental application).

(C) Agreement after discussion or administrative appeals

(i) Further discussion or administrative appeals

A request for review under subparagraph (A) shall not preclude further discussions to reach agreement on the risk evaluation and mitigation strategy, and such a request shall not preclude the use of administrative appeals within the Food and Drug Administration to reach agreement on the strategy, including appeals as described in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 for procedural or scientific matters involving the review of human drug applications and supplemental applications that cannot be resolved at the divisional level. At the time a review has been scheduled under subparagraph (B) and notice of such review has been posted, the responsible person shall either withdraw the request under subparagraph (A) or terminate the use of such administrative appeals.

(ii) Agreement terminates dispute resolution

At any time before a decision and order is issued under subparagraph (G), the Secretary (in consultation with the offices described in subsection (c)(2)) and the responsible person may reach an agreement on the risk evaluation and mitigation strategy through further discussion or administrative appeals, terminating the dispute resolution process, and the Secretary shall issue an action letter or order, as appropriate, that describes the strategy.

(D) Meeting of the Board

At a meeting of the Drug Safety Oversight Board described in subparagraph (B), the Board shall—

(i) hear from both parties via written or oral presentation; and

(ii) review the dispute.

(E) Record of proceedings

The Secretary shall ensure that the proceedings of any such meeting are recorded, transcribed, and made public within 90 days of the meeting. The Secretary shall redact the transcript to protect any trade secrets and other information that is exempted from disclosure under section 552 of title 5 or section 552a of title 5.

(F) Recommendation of the Board

Not later than 5 days after any such meeting, the Drug Safety Oversight Board shall provide a written recommendation on resolving the dispute to the Secretary. Not later than 5 days after the Board provides such written recommendation to the Secretary, the Secretary shall make the recommendation available to the public.

(G) Action by the Secretary

(i) Action letter

With respect to a proposal or assessment referred to in paragraph (1), the Secretary shall issue an action letter that resolves the dispute not later than the later of—

(I) the action deadline for the action letter on the application; or

(II) 7 days after receiving the recommendation of the Drug Safety Oversight Board.

(ii) Order

With respect to an assessment of an approved risk evaluation and mitigation strategy under subsection (g)(1) or under any of subparagraphs (B) through (D) of subsection (g)(2), the Secretary shall issue an order, which shall be made public, that resolves the dispute not later than 7 days after receiving the recommendation of the Drug Safety Oversight Board.

(H) Inaction

An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided for under subparagraph (G).

(I) Effect on action deadline

With respect to a proposal or assessment referred to in paragraph (1), the Secretary shall be considered to have met the action deadline for the action letter on the application if the responsible person requests the dispute resolution process described in this paragraph and if the Secretary has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively.

(J) Disqualification

No individual who is an employee of the Food and Drug Administration and who reviews a drug or who participated in an administrative appeal under subparagraph (C)(i) with respect to such drug may serve on the Drug Safety Oversight Board at a meeting under subparagraph (D) to review a dispute about the risk evaluation and mitigation strategy for such drug.

(K) Additional expertise

The Drug Safety Oversight Board may add members with relevant expertise from the Food and Drug Administration, including the Office of Pediatrics, the Office of Women's Health, or the Office of Rare Diseases, or from other Federal public health or health care agencies, for a meeting under subparagraph (D) of the Drug Safety Oversight Board.

(5) Use of advisory committees

The Secretary may convene a meeting of 1 or more advisory committees of the Food and Drug Administration to—

(A) review a concern about the safety of a drug or class of drugs, including before an assessment of the risk evaluation and mitigation strategy or strategies of such drug or drugs is required to be submitted under subparagraph (B) or (C) of subsection (g)(2);

(B) review the risk evaluation and mitigation strategy or strategies of a drug or group of drugs; or

(C) review a dispute under paragraph (3) or (4).

(6) Process for addressing drug class effects

(A) In general

When a concern about a serious risk of a drug may be related to the pharmacological class of the drug, the Secretary, in consultation with the offices described in subsection (c)(2), may defer assessments of the approved risk evaluation and mitigation strategies for such drugs until the Secretary has convened 1 or more public meetings to consider possible responses to such concern.

(B) Notice

If the Secretary defers an assessment under subparagraph (A), the Secretary shall—

(i) give notice of the deferral to the holder of the approved covered application not later than 5 days after the deferral;

(ii) publish the deferral in the Federal Register; and

(iii) give notice to the public of any public meetings to be convened under subparagraph (A), including a description of the deferral.

(C) Public meetings

Such public meetings may include—

(i) 1 or more meetings of the responsible person for such drugs;

(ii) 1 or more meetings of 1 or more advisory committees of the Food and Drug Administration, as provided for under paragraph (6); ⁴ or

(iii) 1 or more workshops of scientific experts and other stakeholders.

(D) Action

After considering the discussions from any meetings under subparagraph (A), the Secretary may—

(i) announce in the Federal Register a planned regulatory action, including a modification to each risk evaluation and mitigation strategy, for drugs in the pharmacological class;

(ii) seek public comment about such action; and

(iii) after seeking such comment, issue an order addressing such regulatory action.

(7) International coordination

The Secretary, in consultation with the offices described in subsection (c)(2), may coordinate the timetable for submission of assessments under subsection (d), or a study or clinical trial under section 355(o)(3) of this title, with efforts to identify and assess the serious risks of such drug by the marketing authorities of other countries whose drug approval and risk management processes the Secretary deems comparable to the drug approval and risk management processes of the United States. If the Secretary takes action to coordinate such timetable, the Secretary shall give notice to the responsible person.

(8) Effect

Use of the processes described in paragraphs (6) and (7) shall not be the sole source of delay of action on an application or a supplement to an application for a drug.

(i) Abbreviated new drug applications

(1) In general

A drug that is the subject of an abbreviated new drug application under section 355(j) of this title is subject to only the following elements of the risk evaluation and mitigation strategy required under subsection (a) for the applicable listed drug:

(A) A Medication Guide or patient package insert, if required under subsection (e) for the applicable listed drug.

(B) A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug.

(C)(i) Elements to assure safe use, if required under subsection (f) for the listed drug, which, subject to clause (ii), for a drug that is the subject of an application under section 355(j) of this title may use—

(I) a single, shared system with the listed drug under subsection (f); or

(II) a different, comparable aspect of the elements to assure safe use under subsection (f).

(ii) The Secretary may require a drug that is the subject of an application under section 355(j) of this title and the listed drug to use a single, shared system under subsection (f), if the Secretary determines that no different, comparable aspect of the elements to assure safe use could satisfy the requirements of subsection (f).

(2) Action by Secretary

For an applicable listed drug for which a drug is approved under section 355(j) of this title, the Secretary—

(A) shall undertake any communication plan to health care providers required under subsection (e)(3) for the applicable listed drug;

(B) shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and

(C) shall inform the responsible person for the drug that is so approved if the risk evaluation and mitigation strategy for the applicable listed drug is modified.

(3) Shared REMS

If the Secretary approves, in accordance with paragraph (1)(C)(i)(II), a different, comparable aspect of the elements to assure safe use under subsection (f) for a drug that is the subject of an abbreviated new drug application under section 355(j) of this title, the Secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section 355(j) or 355(b) of this title that references the same listed drug.

(j) Drug Safety Oversight Board

(1) In general

There is established a Drug Safety Oversight Board.

(2) Composition; meetings

The Drug Safety Oversight Board shall—

(A) be composed of scientists and health care practitioners appointed by the Secretary, each of whom is an employee of the Federal Government;

(B) include representatives from offices throughout the Food and Drug Administration, including the offices responsible for postapproval safety of drugs;

(C) include at least 1 representative each from the National Institutes of Health and the Department of Health and Human Services (other than the Food and Drug Administration);

(D) include such representatives as the Secretary shall designate from other appropriate agencies that wish to provide representatives; and

(E) meet at least monthly to provide oversight and advice to the Secretary on the management of important drug safety issues.

(k) Waiver in public health emergencies

The Secretary may waive any requirement of this section with respect to a qualified countermeasure (as defined in section 247d–6a(a)(2) of title 42) to which a requirement under this section has been applied, if the Secretary determines that such waiver is required to mitigate the effects of, or reduce the severity of, the circumstances under which—

(1) a determination described in subparagraph (A), (B), or (C) of section 360bbb–3(b)(1) of this title has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or

(2) the identification of a material threat described in subparagraph (D) of section 360bbb–3(b)(1) of this title has been made pursuant to section 247d–6b of title 42.

(l) Provision of samples not a violation of strategy

The provision of samples of a covered product to an eligible product developer (as those terms are defined in section 355–2(a) of this title) shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug.

(m) Separate REMS

When used in this section, the term "different, comparable aspect of the elements to assure safe use" means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 355(j) of this title that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 355(j) of this title with the same such listed drug, but achieves the same level of safety as such strategy.

(June 25, 1938, ch. 675, §505–1, as added Pub. L. 110–85, title IX, §901(b), Sept. 27, 2007, 121 Stat. 926; amended Pub. L. 112–144, title XI, §1132(a), (b), July 9, 2012, 126 Stat. 1119, 1120; Pub. L. 113–5, title III, §302(c), Mar. 13, 2013, 127 Stat. 185; Pub. L. 114–255, div. A, title III, §§3075(c), 3101(a)(2)(C), Dec. 13, 2016, 130 Stat. 1139, 1153; Pub. L. 115–52, title VI, §606, Aug. 18, 2017, 131 Stat. 1049; Pub. L. 115–271, title III, §§3032(a)–(c), 3041(a), Oct. 24, 2018, 132 Stat. 3940–3942; Pub. L. 116–94, div. N, title I, §610(d), (f), Dec. 20, 2019, 133 Stat. 3135, 3136; Pub. L. 117–328, div. FF, title III, §3221, Dec. 29, 2022, 136 Stat. 5829.)

Editorial Notes

References in Text

For the effective date of this section, referred to in subsec. (a)(2)(A), see Effective Date note below.

Section 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. (h)(3), (4)(C)(i), is section 101(c) of Pub. L. 110–85, which is set out as a note under section 379g of this title.

Paragraph (6), referred to in subsec. (h)(6)(C)(ii), was redesignated par. (5) of subsec. (h) of this section by Pub. L. 112–144, title XI, §1132(b)(4), July 9, 2012, 126 Stat. 1120.

Amendments

2022—Subsec. (e)(4)(B). Pub. L. 117–328 struck out "for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation))" before "if the Secretary determines".

2019—Subsec. (g)(4)(B)(iii). Pub. L. 116–94, §610(f)(1), added cl. (iii).

Subsec. (i)(1)(C). Pub. L. 116–94, §610(f)(2), added subpar. (C) and struck out former subpar. (C) which read as follows: "Elements to assure safe use, if required under subsection (f) for the listed drug. A drug that is the subject of an abbreviated new drug application and the listed drug shall use a single, shared system under subsection (f). The Secretary may waive the requirement under the preceding sentence for a drug that is the subject of an abbreviated new drug application, and permit the applicant to use a different, comparable aspect of the elements to assure safe use, if the Secretary determines that—

"(i) the burden of creating a single, shared system outweighs the benefit of a single, system, taking into consideration the impact on health care providers, patients, the applicant for the abbreviated new drug application, and the holder of the reference drug product; or

"(ii) an aspect of the elements to assure safe use for the applicable listed drug is claimed by a patent that has not expired or is a method or process that, as a trade secret, is entitled to protection, and the applicant for the abbreviated new drug application certifies that it has sought a license for use of an aspect of the elements to assure safe use for the applicable listed drug and that it was unable to obtain a license.

A certification under clause (ii) shall include a description of the efforts made by the applicant for the abbreviated new drug application to obtain a license. In a case described in clause (ii), the Secretary may seek to negotiate a voluntary agreement with the owner of the patent, method, or process for a license under which the applicant for such abbreviated new drug application may use an aspect of the elements to assure safe use, if required under subsection (f) for the applicable listed drug, that is claimed by a patent that has not expired or is a method or process that as a trade secret is entitled to protection."

Subsec. (i)(3). Pub. L. 116–94, §610(f)(3), added par. (3).

Subsec. (l). Pub. L. 116–94, §610(d), added subsec. (l).

Subsec. (m). Pub. L. 116–94, §610(f)(4), added subsec. (m).

2018—Subsec. (b)(1)(E). Pub. L. 115–271, §3041(a), substituted "of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling" for "of the drug".

Subsec. (e)(4). Pub. L. 115–271, §3032(a), added par. (4).

Subsec. (f)(2)(C)(iii). Pub. L. 115–271, §3032(b), added cl. (iii).

Subsec. (i)(1)(B), (C). Pub. L. 115–271, §3032(c)(1), added subpar. (B) and redesignated former subpar. (B) as (C).

Subsec. (i)(2)(B), (C). Pub. L. 115–271, §3032(c)(2), added subpar. (B) and redesignated former subpar. (B) as (C).

2017—Subsec. (e)(3)(B). Pub. L. 115–52, §606(1), struck out "; or" at end.

Subsec. (e)(3)(D). Pub. L. 115–52, §606(2), (3), added subpar. (D).

2016—Subsec. (f)(5). Pub. L. 114–255, §3075(c)(1), inserted "or other advisory committee" after "(or successor committee)" in introductory provisions.

Subsec. (f)(5)(B). Pub. L. 114–255, §3075(c)(2), substituted "periodically" for "at least annually," in introductory provisions.

Subsec. (h)(2)(A)(iii). Pub. L. 114–255, §3101(a)(2)(C)(i), substituted, in heading, "labeling" for "label" and in text, "approved safety labeling changes" for "approved safety label changes", "responsible person" for "sponsor", and "a safety labeling change" for "a safety label change".

Subsec. (h)(8). Pub. L. 114–255, §3101(a)(2)(C)(ii), struck out period after "(7)".

2013—Subsec. (f)(7). Pub. L. 113–5, §302(c)(1), struck out par. (7) which related to waiver of subsec. (f) requirements in public health emergencies.

Subsec. (k). Pub. L. 113–5, §302(c)(2), added subsec. (k).

2012—Subsec. (g)(1). Pub. L. 112–144, §1132(a)(1), struck out ", and propose a modification to," after "an assessment of".

Subsec. (g)(2). Pub. L. 112–144, §1132(a)(2)(A), in introductory provisions, struck out ", subject to paragraph (5)," after "shall" and ", and may propose a modification to," after "an assessment of".

Subsec. (g)(2)(C). Pub. L. 112–144, §1132(a)(2)(B), substituted "an assessment is needed to evaluate whether the approved strategy should be modified to—" and cls. (i) and (ii) for "new safety or effectiveness information indicates that—

"(i) an element under subsection (d) or (e) should be modified or included in the strategy; or

"(ii) an element under subsection (f) should be modified or included in the strategy; or".

Subsec. (g)(2)(D). Pub. L. 112–144, §1132(a)(2)(C), struck out subpar. (D) which read as follows: "within 15 days when ordered by the Secretary, in consultation with the offices described in subsection (c)(2), if the Secretary determines that there may be a cause for action by the Secretary under section 355(e) of this title."

Subsec. (g)(3). Pub. L. 112–144, §1132(a)(3), substituted "for a drug shall include, with respect to each goal included in the strategy, an assessment of the extent to which the approved strategy, including each element of the strategy, is meeting the goal or whether 1 or more such goals or such elements should be modified." for "for a drug shall include—" and struck out subpars. (A) to (C) which related to assessment of elements to assure safe use, postapproval studies, and postapproval clinical trials.

Subsec. (g)(4). Pub. L. 112–144, §1132(a)(4), amended par. (4) generally. Prior to amendment, text read as follows: "A modification (whether an enhancement or a reduction) to the approved risk evaluation and mitigation strategy for a drug may include the addition or modification of any element under subsection (d) or the addition, modification, or removal of any element under subsection (e) or (f), such as—

"(A) modifying the timetable for assessments of the strategy as provided in subsection (d)(3), including to eliminate assessments; or

"(B) adding, modifying, or removing an element to assure safe use under subsection (f)."

Subsec. (h). Pub. L. 112–144, §1132(b)(1), inserted "and modifications" after "review of assessments" in heading.

Subsec. (h)(1). Pub. L. 112–144, §1132(b)(2), inserted "and proposed modification to" after "under subsection (a) and each assessment of" and ", and, if necessary, promptly initiate discussions with the responsible person about such proposed strategy, assessment, or modification" after "subsection (g)".

Subsec. (h)(2). Pub. L. 112–144, §1132(b)(3), (4), redesignated par. (3) as (2) and struck out former par. (2). Prior to amendment, text of par. (2) read as follows: "The Secretary, in consultation with the offices described in subsection (c)(2), shall initiate discussions with the responsible person for purposes of this subsection to determine a strategy not later than 60 days after any such assessment is submitted or, in the case of an assessment submitted under subsection (g)(2)(D), not later than 30 days after such assessment is submitted."

Subsec. (h)(2)(A). Pub. L. 112–144, §1132(b)(5)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) related to Secretary's description of any required risk evaluation and mitigation strategy for a drug as part of the action letter on the application or in an order.

Subsec. (h)(2)(C). Pub. L. 112–144, §1132(b)(5)(B), amended subpar. (C) generally. Prior to amendment, text read as follows: "Any action letter described in subparagraph (A)(i) or order described in subparagraph (A)(ii) shall be made publicly available."

Subsec. (h)(3), (4). Pub. L. 112–144, §1132(b)(4), redesignated pars. (4) and (5) as (3) and (4), respectively. Former par. (3) redesignated (2).

Subsec. (h)(4)(A)(i). Pub. L. 112–144, §1132(b)(6)(A), substituted "The responsible" for "Not earlier than 15 days, and not later than 35 days, after discussions under paragraph (2) have begun, the responsible" and inserted ", after the sponsor is required to make a submission under subsection (a)(2) or (g)," before "request in writing".

Subsec. (h)(4)(I). Pub. L. 112–144, §1132(b)(6)(B), substituted "if the Secretary has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively." for "if the Secretary—" and struck out cls. (i) and (ii) which read as follows:

"(i) has initiated the discussions described under paragraph (2) not less than 60 days before such action deadline; and

"(ii) has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively."

Subsec. (h)(5). Pub. L. 112–144, §1132(b)(4), (7), redesignated par. (6) as (5) and substituted "subparagraph (B) or (C)" for "any of subparagraphs (B) through (D)" in subpar. (A) and "paragraph (3) or (4)" for "paragraph (4) or (5)" in subpar. (C). Former par. (5) redesignated (4).

Subsec. (h)(6), (7). Pub. L. 112–144, §1132(b)(4), redesignated pars. (7) and (8) as (6) and (7), respectively. Former par. (6) redesignated (5).

Subsec. (h)(8), (9). Pub. L. 112–144, §1132(b)(4), (8), redesignated par. (9) as (8) and substituted "paragraphs (6) and (7)." for "paragraphs (7) and (8)". Former par. (8) redesignated (7).

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as an Effective Date of 2007 Amendment note under section 331 of this title.

Evidence-Based Opioid Analgesic Prescribing Guidelines and Report

Pub. L. 115–271, title III, §3002, Oct. 24, 2018, 132 Stat. 3934, provided that:

"(a) Guidelines.—The Commissioner of Food and Drugs shall develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain only for the relevant therapeutic areas where such guidelines do not exist.

"(b) Public Input.—In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall—

"(1) consult with stakeholders, which may include conducting a public meeting of medical professional societies (including any State-based societies), health care providers, State medical boards, medical specialties including pain medicine specialty societies, patient groups, pharmacists, academic or medical research entities, and other entities with experience in health care, as appropriate;

"(2) collaborate with the Director of the Centers for Disease Control and Prevention, as applicable and appropriate, and other Federal agencies with relevant expertise as appropriate; and

"(3) provide for a notice and comment period consistent with section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)) for the submission of comments by the public.

"(c) Report.—Not later than 1 year after the date of enactment of this Act [Oct. 24, 2018], or, if earlier, at the time the guidelines under subsection (a) are finalized, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the Food and Drug Administration will utilize the guidelines under subsection (a) to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline.

"(d) Updates.—The Commissioner of Food and Drugs shall periodically—

"(1) update the guidelines under subsection (a), informed by public input described in subsection (b); and

"(2) submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under such subsection.

"(e) Statement To Accompany Guidelines and Recommendations.—The Commissioner of Food and Drugs shall ensure that opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable—

"(1) are intended to help inform clinical decisionmaking by prescribers and patients; and

"(2) are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice."

Prescriber Education

Pub. L. 114–198, title I, §106(b), July 22, 2016, 130 Stat. 703, provided that: "Not later than 1 year after the date of the enactment of this Act [July 22, 2016], the Secretary [of Health and Human Services], acting through the Commissioner of Food and Drugs, as part of the Food and Drug Administration's evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, and in consultation with relevant stakeholders, shall develop recommendations regarding education programs for prescribers of opioids pursuant to section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), including recommendations on—

"(1) which prescribers should participate in such programs; and

"(2) how often participation in such programs is necessary."

Guidance

Pub. L. 112–144, title XI, §1132(c), July 9, 2012, 126 Stat. 1122, provided that: "Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall issue guidance that, for purposes of section 505–1(h)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(h)(2)(A)), describes the types of modifications to approved risk evaluation and mitigation strategies that shall be considered to be minor modifications of such strategies."

¹ So in original. Probably should be followed by a semicolon.

² So in original. Does not follow from introductory provisions.

³ So in original.

⁴ See References in Text note below.

§355–2. Actions for delays of generic drugs and biosimilar biological products

(a) Definitions

In this section—

(1) the term "commercially reasonable, market-based terms" means—

(A) a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in section 1395w–3a(c)(6)(B) of title 42;

(B) a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and

(C) no additional conditions are imposed on the sale of the covered product;

(2) the term "covered product"—

(A) means—

(i) any drug approved under subsection (c) or (j) of section 355 of this title or biological product licensed under subsection (a) or (k) of section 262 of title 42;

(ii) any combination of a drug or biological product described in clause (i); or

(iii) when reasonably necessary to support approval of an application under section 355 of this title, or section 262 of title 42, as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and

(B) does not include any drug or biological product that appears on the drug shortage list in effect under section 356e of this title, unless—

(i) the drug or biological product has been on the drug shortage list in effect under such section 356e of this title continuously for more than 6 months; or

(ii) the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage.

(3) the term "device" has the meaning given the term in section 321 of this title;

(4) the term "eligible product developer" means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 355 of this title or for licensing pursuant to an application under section 262(k) of title 42;

(5) the term "license holder" means the holder of an application approved under subsection (c) or (j) of section 355 of this title or the holder of a license under subsection (a) or (k) of section 262 of title 42 for a covered product;

(6) the term "REMS" means a risk evaluation and mitigation strategy under section 355–1 of this title;

(7) the term "REMS with ETASU" means a REMS that contains elements to assure safe use under section 355–1(f) of this title;

(8) the term "Secretary" means the Secretary of Health and Human Services;

(9) the term "single, shared system of elements to assure safe use" means a single, shared system of elements to assure safe use under section 355–1(f) of this title; and

(10) the term "sufficient quantities" means an amount of a covered product that the eligible product developer determines allows it to—

(A) conduct testing to support an application under—

(i) subsection (b)(2) or (j) of section 355 of this title; or

(ii) section 262(k) of title 42; and

(B) fulfill any regulatory requirements relating to approval of such an application.

(b) Civil action for failure to provide sufficient quantities of a covered product

(1) In general

An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms.

(2) Elements

(A) In general

To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence—

(i) that—

(I) the covered product is not subject to a REMS with ETASU; or

(II) if the covered product is subject to a REMS with ETASU—

(aa) the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and

(bb) the eligible product developer has provided a copy of the covered product authorization to the license holder;

(ii) that, as of the date on which the civil action is filed, the eligible product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms;

(iii) that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder, and such request—

(I) was sent to a named corporate officer of the license holder;

(II) was made by certified or registered mail with return receipt requested;

(III) specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual; and

(IV) specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product; and

(iv) that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms—

(I) for a covered product that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered product; and

(II) for a covered product that is subject to a REMS with ETASU, by 31 days after the later of—

(aa) the date on which the license holder received the request for the covered product; or

(bb) the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with subparagraph (B).

(B) Authorization for covered product subject to a REMS with ETASU

(i) Request

An eligible product developer may submit to the Secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU.

(ii) Authorization

Not later than 120 days after the date on which a request under clause (i) is received, the Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of—

(I) development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or

(II) development and testing that involves human clinical trials, if the eligible product developer has—

(aa)(AA) submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or

(BB) otherwise satisfied the Secretary that such protections will be provided; and

(bb) met any other requirements the Secretary may establish.

(iii) Notice

A covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the REMS for the covered product.

(3) Affirmative defense

In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence—

(A) that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder—

(i) neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and

(ii) neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms;

(B) that—

(i) the license holder sells the covered product through agents, distributors, or wholesalers;

(ii) the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and

(iii) the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder; or

(C) that the license holder made an offer to the individual specified pursuant to paragraph (2)(A)(iii)(III), by a means of communication (electronic, written, or both) specified pursuant to such paragraph, to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms—

(i) for a covered product that is not subject to a REMS with ETASU, by the date that is 14 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 7 days after the date on which the eligible product developer received such offer from the license holder; or

(ii) for a covered product that is subject to a REMS with ETASU, by the date that is 20 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 10 days after the date on which the eligible product developer received such offer from the license holder.

(4) Remedies

(A) In general

If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall—

(i) order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms;

(ii) award to the eligible product developer reasonable attorney's fees and costs of the civil action; and

(iii) award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence—

(I) that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or

(II) that the license holder failed to comply with an order issued under clause (i).

(B) Maximum monetary amount

A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period—

(i) beginning on—

(I) for a covered product that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or

(II) for a covered product that is subject to a REMS with ETASU, the date that is 31 days after the later of—

(aa) the date on which the license holder received the request; or

(bb) the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with paragraph (2)(B); and

(ii) ending on the date on which the eligible product developer received sufficient quantities of the covered product.

(C) Avoidance of delay

The court may issue an order under subparagraph (A)(i) before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause (ii) or (iii) of subparagraph (A), or the amount of any such award.

(c) Limitation of liability

A license holder for a covered product shall not be liable for any claim under Federal, State, or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section, including transportation, handling, use, or disposal of the covered product by the eligible product developer.

(d) Omitted

(e) Rule of construction

(1) Definition

In this subsection, the term "antitrust laws"—

(A) has the meaning given the term in subsection (a) of section 12 of title 15; and

(B) includes section 45 of title 15 to the extent that such section applies to unfair methods of competition.

(2) Antitrust laws

Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.

(f) Omitted

(g) Rule of construction

Nothing in this section, the amendments made by this section, or in section 355–1 of this title, shall be construed as—

(1) prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this section; or

(2) in any way negating the applicability of a REMS with ETASU, as otherwise required under such section 355–1 of this title, with respect to such covered product.

(Pub. L. 116–94, div. N, title I, §610, Dec. 20, 2019, 133 Stat. 3130.)

Editorial Notes

Codification

Section was enacted as part of the Further Consolidated Appropriations Act, 2020, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Section is comprised of section 610 of Pub. L. 116–94. Subsecs. (d) and (f) of section 610 of Pub. L. 116–94 amended section 355–1 of this title.

§355a. Pediatric studies of drugs

(a) Definitions

As used in this section, the term "pediatric studies" or "studies" means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies.

(b) Market exclusivity for new drugs

(1) In general

Except as provided in paragraph (2), if, prior to approval of an application that is submitted under section 355(b)(1) of this title, the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(4)—

(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) of section 355 of this title, and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively; or

(II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months rather than three years; and

(ii) if the drug is designated under section 360bb of this title for a rare disease or condition, the period referred to in section 360cc(a) of this title is deemed to be seven years and six months rather than seven years; and

(B)(i) if the drug is the subject of—

(I) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 355 of this title and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or

(II) a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 355 of this title,

the period during which an application may not be approved under section 355(c)(3) of this title or section 355(j)(5)(B) of this title shall be extended by a period of six months after the date the patent expires (including any patent extensions); or

(ii) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 355(c)(3) of this title or section 355(j)(5)(B) of this title shall be extended by a period of six months after the date the patent expires (including any patent extensions).

(2) Exception

The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(4) is made later than 9 months prior to the expiration of such period.

(c) Market exclusivity for already-marketed drugs

(1) In general

Except as provided in paragraph (2), if the Secretary determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and makes a written request to the holder of an approved application under section 355(b)(1) of this title for pediatric studies (which shall include a timeframe for completing such studies), the holder agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(4)—

(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) of section 355 of this title, and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectiv ely; or

(II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months rather than three years; and

(ii) if the drug is designated under section 360bb of this title for a rare disease or condition, the period referred to in section 360cc(a) of this title is deemed to be seven years and six months rather than seven years; and

(B)(i) if the drug is the subject of—

(I) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 355 of this title and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or

(II) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 355 of this title,

the period during which an application may not be approved under section 355(c)(3) of this title or section 355(j)(5)(B)(ii) of this title shall be extended by a period of six months after the date the patent expires (including any patent extensions); or

(ii) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 355(c)(3) of this title or section 355(j)(5)(B) of this title shall be extended by a period of six months after the date the patent expires (including any patent extensions).

(2) Exception

The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(4) is made later than 9 months prior to the expiration of such period.

(d) Conduct of pediatric studies

(1) Request for studies

(A) In general

The Secretary may, after consultation with the sponsor of an application for an investigational new drug under section 355(i) of this title, the sponsor of an application for a new drug under section 355(b)(1) of this title, or the holder of an approved application for a drug under section 355(b)(1) of this title, issue to the sponsor or holder a written request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take into account adequate representation of children of ethnic and racial minorities. Such request to conduct pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the sponsor or holder to propose pediatric labeling resulting from such studies. If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not requesting studies in neonates.

(B) Single written request

A single written request—

(i) may relate to more than one use of a drug; and

(ii) may include uses that are both approved and unapproved.

(2) Written request for pediatric studies

(A) Request and response

(i) In general

If the Secretary makes a written request for pediatric studies (including neonates, as appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after receiving the written request, shall respond to the Secretary as to the intention of the applicant or holder to act on the request by—

(I) indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the request; or

(II) indicating that the applicant or holder does not agree to the request and stating the reasons for declining the request.

(ii) Disagree with request

If, on or after September 27, 2007, the applicant or holder does not agree to the request on the grounds that it is not possible to develop the appropriate pediatric formulation, the applicant or holder shall submit to the Secretary the reasons such pediatric formulation cannot be developed.

(B) Adverse event reports

An applicant or holder that, on or after September 27, 2007, agrees to the request for such studies shall provide the Secretary, at the same time as the submission of the reports of such studies, with all postmarket adverse event reports regarding the drug that is the subject of such studies and are available prior to submission of such reports.

(3) Action on submissions

The Secretary shall review and act upon a submission by a sponsor or holder of a proposed pediatric study request or a proposed amendment to a written request for pediatric studies within 120 calendar days of the submission.

(4) Meeting the studies requirement

Not later than 180 days after the submission of the reports of the studies, the Secretary shall accept or reject such reports and so notify the sponsor or holder. The Secretary's only responsibility in accepting or rejecting the reports shall be to determine, within the 180-day period, whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the requirements of the Secretary for filing.

(5) Effect of subsection

Nothing in this subsection alters or amends section 331(j) of this title or section 552 of title 5 or section 1905 of title 18.

(6) Consultation

With respect to a drug that is a qualified countermeasure (as defined in section 247d–6a of title 42), a security countermeasure (as defined in section 247d–6b of title 42), or a qualified pandemic or epidemic product (as defined in section 247d–6d of title 42), the Secretary shall solicit input from the Assistant Secretary for Preparedness and Response regarding the need for and, from the Director of the Biomedical Advanced Research and Development Authority regarding the conduct of, pediatric studies under this section.

(e) Notice of determinations on studies requirement

(1) In general

The Secretary shall publish a notice of any determination, made on or after September 27, 2007, that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section 355 of this title for a drug will be subject to the provisions of this section. Such notice shall be published not later than 30 days after the date of the Secretary's determination regarding market exclusivity and shall include a copy of the written request made under subsection (b) or (c).

(2) Identification of certain drugs

The Secretary shall publish a notice identifying any drug for which, on or after September 27, 2007, a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population (or specified subpopulation) if the pediatric formulation for such drug is not introduced onto the market within one year after the date that the Secretary publishes the notice described in paragraph (1). Such notice identifying such drug shall be published not later than 30 days after the date of the expiration of such one year period.

(f) Internal review of written requests and pediatric studies

(1) Internal review

The Secretary shall utilize the internal review committee established under section 355d of this title to review all written requests issued on or after September 27, 2007, in accordance with paragraph (2).

(2) Review of written requests

The committee referred to in paragraph (1) shall review all written requests issued pursuant to this section prior to being issued.

(3) Review of pediatric studies

The committee referred to in paragraph (1) may review studies conducted pursuant to this section to make a recommendation to the Secretary whether to accept or reject such reports under subsection (d)(4).

(4) Activity by committee

The committee referred to in paragraph (1) may operate using appropriate members of such committee and need not convene all members of the committee.

(5) Documentation of committee action

For each drug, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (2) or (3), which members of the committee participated in such activity.

(6) Tracking pediatric studies and labeling changes

The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make available to the public, in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration—

(A) the number of studies conducted under this section and under section 284m of title 42;

(B) the specific drugs and drug uses, including labeled and off-labeled indications, studied under such sections;

(C) the types of studies conducted under such sections, including trial design, the number of pediatric patients studied, and the number of centers and countries involved;

(D) the number of pediatric formulations developed and the number of pediatric formulations not developed and the reasons such formulations were not developed;

(E) the labeling changes made as a result of studies conducted under such sections;

(F) an annual summary of labeling changes made as a result of studies conducted under such sections for distribution pursuant to subsection (k)(2); and

(G) information regarding reports submitted on or after September 27, 2007.

(7) Informing internal review committee

The Secretary shall provide to the committee referred to in paragraph (1) any response issued to an applicant or holder with respect to a proposed pediatric study request.

(g) Limitations

Notwithstanding subsection (c)(2), a drug to which the six-month period under subsection (b) or (c) has already been applied—

(1) may receive an additional six-month period under subsection (c)(1)(A)(i)(II) for a supplemental application if all other requirements under this section are satisfied, except that such drug may not receive any additional such period under subsection (c)(1)(B); and

(2) may not receive any additional such period under subsection (c)(1)(A)(ii).

(h) Relationship to pediatric research requirements

Exclusivity under this section shall only be granted for the completion of a study or studies that are the subject of a written request and for which reports are submitted and accepted in accordance with subsection (d)(4). Written requests under this section may consist of a study or studies required under section 355c of this title.

(i) Labeling changes

(1) Priority status for pediatric applications and supplements

Any application or supplement to an application under section 355 of this title proposing a labeling change as a result of any pediatric study conducted pursuant to this section—

(A) shall be considered to be a priority application or supplement; and

(B) shall be subject to the performance goals established by the Commissioner for priority drugs.

(2) Dispute resolution

(A) Request for labeling change and failure to agree

If, on or after September 27, 2007, the Commissioner determines that the sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the labeling for the drug that is the subject of the application, not later than 180 days after the date of submission of the application—

(i) the Commissioner shall request that the sponsor of the application make any labeling change that the Commissioner determines to be appropriate; and

(ii) if the sponsor of the application does not agree within 30 days after the Commissioner's request to make a labeling change requested by the Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Committee.

(B) Action by the Pediatric Advisory Committee

Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory Committee shall—

(i) review the pediatric study reports; and

(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any.

(C) Consideration of recommendations

The Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not later than 30 days after receiving the recommendation, make a request to the sponsor of the application to make any labeling change that the Commissioner determines to be appropriate.

(D) Misbranding

If the sponsor of the application, within 30 days after receiving a request under subparagraph (C), does not agree to make a labeling change requested by the Commissioner, the Commissioner may deem the drug that is the subject of the application to be misbranded.

(E) No effect on authority

Nothing in this subsection limits the authority of the United States to bring an enforcement action under this chapter when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.

(j) Other labeling changes

If, on or after September 27, 2007, the Secretary determines that a pediatric study conducted under this section does or does not demonstrate that the drug that is the subject of the study is safe and effective, including whether such study results are inconclusive, in pediatric populations or subpopulations, the Secretary shall order the labeling of such product to include information about the results of the study and a statement of the Secretary's determination.

(k) Dissemination of pediatric information

(1) In general

Not later than 210 days after the date of submission of a report on a pediatric study under this section, the Secretary shall make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted under subsection (b) or (c).

(2) Dissemination of information regarding labeling changes

Beginning on September 27, 2007, the Secretary shall include as a requirement of a written request that the sponsors of the studies that result in labeling changes that are reflected in the annual summary developed pursuant to subsection (f)(6)(F) distribute, at least annually (or more frequently if the Secretary determines that it would be beneficial to the public health), such information to physicians and other health care providers.

(3) Effect of subsection

Nothing in this subsection alters or amends section 331(j) of this title or section 552 of title 5 or section 1905 of title 18.

(l) Adverse event reporting

(1) Reporting in first 18-month period

Beginning on September 27, 2007, during the 18-month period beginning on the date a labeling change is approved pursuant to subsection (i), the Secretary shall ensure that all adverse event reports that have been received for such drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics established under section 393a of this title. In considering the reports, the Director of such Office shall provide for the review of the reports by the Pediatric Advisory Committee, including obtaining any recommendations of such Committee regarding whether the Secretary should take action under this chapter in response to such reports.

(2) Reporting in subsequent periods

Following the 18-month period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such Committee regarding whether the Secretary should take action in response to such reports.

(3) Preservation of authority

Nothing in this subsection shall prohibit the Office of Pediatric Therapeutics from providing for the review of adverse event reports by the Pediatric Advisory Committee prior to the 18-month period referred to in paragraph (1), if such review is necessary to ensure safe use of a drug in a pediatric population.

(4) Effect

The requirements of this subsection shall supplement, not supplant, other review of such adverse event reports by the Secretary.

(m) Clarification of interaction of market exclusivity under this section and market exclusivity awarded to an applicant for approval of a drug under section 355(j) of this title

If a 180-day period under section 355(j)(5)(B)(iv) of this title overlaps with a 6-month exclusivity period under this section, so that the applicant for approval of a drug under section 355(j) of this title entitled to the 180-day period under that section loses a portion of the 180-day period to which the applicant is entitled for the drug, the 180-day period shall be extended from—

(1) the date on which the 180-day period would have expired by the number of days of the overlap, if the 180-day period would, but for the application of this subsection, expire after the 6-month exclusivity period; or

(2) the date on which the 6-month exclusivity period expires, by the number of days of the overlap if the 180-day period would, but for the application of this subsection, expire during the six-month exclusivity period.

(n) Referral if pediatric studies not submitted

(1) In general

Beginning on September 27, 2007, if pediatric studies of a drug have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request under subsection (d) and if the Secretary, through the committee established under section 355d of this title, determines that there is a continuing need for information relating to the use of the drug in the pediatric population (including neonates, as appropriate), the Secretary shall carry out the following:

(A) For a drug for which a listed patent has not expired, or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 has not ended, make a determination regarding whether an assessment shall be required to be submitted under section 355c(b) of this title.

(B) For a drug that has no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 apply, the Secretary shall refer the drug for inclusion on the list established under section 284m of title 42 for the conduct of studies.

(C) For a drug that is a qualified countermeasure (as defined in section 247d–6a of title 42), a security countermeasure (as defined in section 247d–6b of title 42), or a qualified pandemic or epidemic product (as defined in section 247d–6d of title 42), in addition to any action with respect to such drug under subparagraph (A) or (B), the Secretary shall notify the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority of all pediatric studies in the written request issued by the Commissioner of Food and Drugs.

(2) Public notice

The Secretary shall give the public notice of a decision under paragraph (1)(A) not to require an assessment under section 355c of this title and the basis for such decision.

(3) Effect of subsection

Nothing in this subsection alters or amends section 331(j) of this title or section 552 of title 5 or section 1905 of title 18.

(o) Prompt approval of drugs when pediatric information is added to labeling

(1) General rule

A drug for which an application has been submitted or approved under subsection (b)(2) or (j) of section 355 of this title shall not be considered ineligible for approval under that section or misbranded under section 352 of this title on the basis that the labeling of the drug omits a pediatric indication or any other aspect of labeling pertaining to pediatric use when the omitted indication or other aspect is protected by patent, or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title, clause (iii) or (iv) of section 355(c)(3)(E) of this title, or section 360cc(a) of this title, or by an extension of such exclusivity under this section or section 355f of this title.

(2) Labeling

Notwithstanding clauses (iii) and (iv) of section 355(j)(5)(F) of this title, clauses (iii) and (iv) of section 355(c)(3)(E) of this title, or section 360cc of this title, the Secretary may require that the labeling of a drug approved pursuant to an application submitted under subsection (b)(2) or (j) of section 355 of this title that omits a pediatric indication or other aspect of labeling as described in paragraph (1) include—

(A) a statement that, because of marketing exclusivity for a manufacturer—

(i) the drug is not labeled for pediatric use; or

(ii) in the case of a drug for which there is an additional pediatric use not referred to in paragraph (1), the drug is not labeled for the pediatric use under paragraph (1); and

(B) a statement of any appropriate pediatric contraindications, warnings, precautions, or other information that the Secretary considers necessary to assure safe use.

(3) Preservation of pediatric exclusivity and extensions

This subsection does not affect—

(A) the availability or scope of exclusivity under—

(i) this section;

(ii) section 355 of this title for pediatric formulations; or

(iii) section 360cc of this title;

(B) the availability or scope of an extension to any such exclusivity, including an extension under this section or section 355f of this title;

(C) the question of the eligibility for approval under section 355 of this title of any application described in subsection (b)(2) or (j) of such section that omits any other aspect of labeling protected by exclusivity under—

(i) clause (iii) or (iv) of section 355(j)(5)(F) of this title;

(ii) clause (iii) or (iv) of section 355(c)(3)(E) of this title; or

(iii) section 360cc(a) of this title; or

(D) except as expressly provided in paragraphs (1) and (2), the operation of section 355 of this title or section 360cc of this title.

(June 25, 1938, ch. 675, §505A, as added Pub. L. 105–115, title I, §111, Nov. 21, 1997, 111 Stat. 2305; amended Pub. L. 107–109, §§2, 4, 5(b)(2), 7–11(a), 18(a), 19, Jan. 4, 2002, 115 Stat. 1408, 1411, 1413-1415, 1423, 1424; Pub. L. 108–155, §§2(b)(2), 3(a), (b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108–173, title XI, §1104, Dec. 8, 2003, 117 Stat. 2461; Pub. L. 110–85, title V, §502(a)(1), Sept. 27, 2007, 121 Stat. 876; Pub. L. 111–148, title VII, §7002(g)(2)(B), Mar. 23, 2010, 124 Stat. 820; Pub. L. 112–144, title V, §§501(a), 502(a)(1), (b), 509(a), July 9, 2012, 126 Stat. 1039, 1040, 1047; Pub. L. 113–5, title III, §307(a), Mar. 13, 2013, 127 Stat. 191; Pub. L. 114–255, div. A, title III, §3102(2), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title V, §505(a)–(b)(2)(A), title VI, §608, Aug. 18, 2017, 131 Stat. 1046, 1050; Pub. L. 117–9, §1(b)(2), Apr. 23, 2021, 135 Stat. 258.)

Editorial Notes

Amendments

2021—Subsec. (c)(1)(A)(i)(II). Pub. L. 117–9 substituted "(c)(3)(E)" for "(c)(3)(D)".

2017—Subsecs. (b), (c). Pub. L. 115–52, §505(b)(2)(A), substituted "subsection (d)(4)" for "subsection (d)(3)" in introductory provisions of par. (1) and in par. (2).

Subsec. (d)(3) to (6). Pub. L. 115–52, §505(b)(1), added par. (3) and redesignated former pars. (3) to (5) as (4) to (6), respectively.

Subsec. (f)(3). Pub. L. 115–52, §505(b)(2)(A), substituted "subsection (d)(4)" for "subsection (d)(3)".

Subsec. (f)(7). Pub. L. 115–52, §505(a), added par. (7).

Subsec. (h). Pub. L. 115–52, §505(b)(2)(A), substituted "subsection (d)(4)" for "subsection (d)(3)".

Subsec. (o). Pub. L. 115–52, §608(1), struck out "under section 355(j)" after "approval of drugs" in heading.

Subsec. (o)(1). Pub. L. 115–52, §608(2), substituted "under subsection (b)(2) or (j) of section 355 of this title" for "under section 355(j) of this title" and ", or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title, clause (iii) or (iv) of section 355(c)(3)(E) of this title, or section 360cc(a) of this title, or by an extension of such exclusivity under this section or section 355f of this title" for "or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title".

Subsec. (o)(2). Pub. L. 115–52, §608(3), in introductory provisions, inserted "clauses (iii) and (iv) of section 355(c)(3)(E) of this title, or section 360cc of this title," after "section 355(j)(5)(F) of this title," and substituted "drug approved pursuant to an application submitted under subsection (b)(2) or (j) of section 355 of this title" for "drug approved under section 355(j) of this title".

Subsec. (o)(3). Pub. L. 115–52, §608(4), amended par. (3) generally. Prior to amendment, text read as follows: "This subsection does not affect—

"(A) the availability or scope of exclusivity under this section;

"(B) the availability or scope of exclusivity under section 355 of this title for pediatric formulations;

"(C) the question of the eligibility for approval of any application under section 355(j) of this title that omits any other conditions of approval entitled to exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title; or

"(D) except as expressly provided in paragraphs (1) and (2), the operation of section 355 of this title."

2016—Subsec. (p). Pub. L. 114–255 struck out subsec. (p) which related to Institute of Medicine study.

2013—Subsec. (d)(5). Pub. L. 113–5, §307(a)(1), added par. (5).

Subsec. (n)(1)(C). Pub. L. 113–5, §307(a)(2), added subpar. (C).

2012—Subsec. (d)(1)(A). Pub. L. 112–144, §502(b), inserted at end "If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not requesting studies in neonates."

Subsec. (h). Pub. L. 112–144, §502(a)(1), amended subsec. (h) generally. Prior to amendment, text read as follows: "Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including a regulation) other than this section and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section."

Subsec. (k)(2). Pub. L. 112–144, §509(a)(1), substituted "subsection (f)(6)(F)" for "subsection (f)(3)(F)".

Subsec. (l)(1). Pub. L. 112–144, §509(a)(2)(A), substituted "first 18-month period" for "year one" in heading and "18-month" for "one-year" in text.

Subsec. (l)(2). Pub. L. 112–144, §509(a)(2)(B), substituted "periods" for "years" in heading and "18-month period" for "one-year period" in text.

Subsec. (l)(3), (4). Pub. L. 112–144, §509(a)(2)(C), (D), added par. (3) and redesignated former par. (3) as (4).

Subsec. (n). Pub. L. 112–144, §509(a)(3)(A), substituted "submitted" for "completed" in heading.

Subsec. (n)(1). Pub. L. 112–144, §509(a)(3)(B)(i), substituted "have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request" for "have not been completed" in introductory provisions.

Subsec. (n)(1)(A). Pub. L. 112–144, §509(a)(3)(B)(ii), inserted ", or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 has not ended" after "expired" and struck out at end "Prior to making such a determination, the Secretary may not take more than 30 days to certify whether the Foundation for the National Institutes of Health has sufficient funding at the time of such certification to initiate and fund all of the studies in the written request in their entirety within the timeframes specified within the written request. Only if the Secretary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for the National Institutes of Health for the conduct of such studies, and such Foundation shall fund such studies. If no certification has been made at the end of the 30-day period, or if the Secretary certifies that funds are not sufficient to initiate and fund all the studies in their entirety, the Secretary shall consider whether assessments shall be required under section 355c(b) of this title for such drug."

Subsec. (n)(1)(B). Pub. L. 112–144, §509(a)(3)(B)(iii), substituted "no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 apply," for "no listed patents or has 1 or more listed patents that have expired,".

Subsec. (o)(2)(B). Pub. L. 112–144, §509(a)(4), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "a statement of any appropriate pediatric contraindications, warnings, or precautions that the Secretary considers necessary."

Subsec. (q). Pub. L. 112–144, §501(a), struck out subsec. (q). Text read as follows: "A drug may not receive any 6-month period under subsection (b) or (c) unless—

"(1) on or before October 1, 2012, the Secretary makes a written request for pediatric studies of the drug;

"(2) on or before October 1, 2012, an application for the drug is accepted for filing under section 355(b) of this title; and

"(3) all requirements of this section are met."

2010—Subsec. (p)(4) to (6). Pub. L. 111–148 added pars. (4) to (6) and struck out former pars. (4) and (5) which read as follows:

"(4) review and assess the pediatric studies of biological products as required under subsections (a) and (b) of section 355c of this title; and

"(5) make recommendations regarding appropriate incentives for encouraging pediatric studies of biologics."

2007—Pub. L. 110–85 amended section generally. Prior to amendment, text consisted of subsecs. (a) to (n) relating to pediatric studies of drugs, including market exclusivity, conduct of pediatric studies, delay of effective date for certain applications, notice of determinations on studies requirement, limitations, research requirements, labeling supplements, dissemination of information, prompt approval of drugs, report to Congress not later than Jan. 1, 2001, and sunset provisions.

2003—Subsec. (b)(1)(A)(i). Pub. L. 108–173, §1104(1), substituted "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places.

Subsec. (b)(1)(A)(ii). Pub. L. 108–173, §1104(2), substituted "(j)(5)(F)" for "(j)(5)(D)".

Subsec. (b)(2). Pub. L. 108–155, §3(a), substituted "355(j)(5)(B)" for "355(j)(4)(B)" in two places.

Subsec. (c)(1)(A)(i). Pub. L. 108–173, §1104(1), substituted "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places.

Subsec. (c)(1)(A)(ii). Pub. L. 108–173, §1104(2), substituted "(j)(5)(F)" for "(j)(5)(D)".

Subsec. (c)(2). Pub. L. 108–155, §3(a), substituted "355(j)(5)(B)" for "355(j)(4)(B)" in two places.

Subsec. (e). Pub. L. 108–173, §1104(3), substituted "355(j)(5)(F)" for "355(j)(5)(D)".

Subsec. (h). Pub. L. 108–155, §2(b)(2), substituted "pediatric research requirements" for "regulations" in heading and "by a provision of law (including a regulation) other than this section" for "pursuant to regulations promulgated by the Secretary" in text.

Subsec. (i)(2). Pub. L. 108–155, §3(b)(1), struck out "Advisory Subcommittee of the Anti-Infective Drugs" before "Advisory Committee" wherever appearing.

Subsec. (l). Pub. L. 108–173, §1104(3), substituted "355(j)(5)(F)" for "355(j)(5)(D)" wherever appearing.

2002—Subsec. (a). Pub. L. 107–109, §19(2), (3), redesignated subsec. (g) as (a). Former subsec. (a) redesignated (b).

Subsec. (a)(1)(A). Pub. L. 107–109, §19(1)(A), (B), substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii).

Subsec. (b). Pub. L. 107–109, §19(2), (3), redesignated subsec. (a) as (b).

Pub. L. 107–109, §2(1), struck out heading and text of subsec. (b). Text read as follows: "Not later than 180 days after November 21, 1997, the Secretary, after consultation with experts in pediatric research shall develop, prioritize, and publish an initial list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. The Secretary shall annually update the list."

Subsec. (c). Pub. L. 107–109, §2(2), in introductory provisions, inserted "determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and" after "the Secretary" and struck out "concerning a drug identified in the list described in subsection (b) of this section" after "such studies)".

Subsec. (c)(1)(A). Pub. L. 107–109, §19(1)(A), (B), substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii).

Subsec. (d)(1). Pub. L. 107–109, §19(4), substituted "subsection (b) or (c)" for "subsection (a) or (c)" in introductory provisions.

Subsec. (d)(2). Pub. L. 107–109, §§18(a), 19(4), substituted "subsection (b) or (c)" for "subsection (a) or (c)" and inserted "In reaching an agreement regarding written protocols, the Secretary shall take into account adequate representation of children of ethnic and racial minorities." after first sentence.

Subsec. (d)(3). Pub. L. 107–109, §19(4), substituted "subsection (b) or (c)" for "subsection (a) or (c)".

Subsec. (d)(4). Pub. L. 107–109, §4, added par. (4).

Subsec. (e). Pub. L. 107–109, §19(1)(C), (4), substituted "section 355(j)(5)(D)" for "section 355(j)(4)(D)" and "subsection (b) or (c)" for "subsection (a) or (c)".

Subsec. (g). Pub. L. 107–109, §19(2), (3), (5), redesignated subsec. (h) as (g) and substituted "subsection (b) or (c)" for "subsection (a) or (b)" in introductory provisions. Former subsec. (g) redesignated (a).

Pub. L. 107–109, §7, inserted "(including neonates in appropriate cases)" after "pediatric age groups".

Subsec. (h). Pub. L. 107–109, §19(2), (3), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g).

Subsec. (i). Pub. L. 107–109, §19(2), (3), redesignated subsec. (l) as (i). Former subsec. (i) redesignated (h).

Subsec. (j). Pub. L. 107–109, §19(2), (3), redesignated subsec. (m) as (j). Former subsec. (j) redesignated (n).

Pub. L. 107–109, §8, added subsec. (j) and struck out heading and text of former subsec. (j). Text read as follows: "A drug may not receive any six-month period under subsection (a) or (c) of this section unless the application for the drug under section 355(b)(1) of this title is submitted on or before January 1, 2002. After January 1, 2002, a drug shall receive a six-month period under subsection (c) of this section if—

"(1) the drug was in commercial distribution as of November 21, 1997;

"(2) the drug was included by the Secretary on the list under subsection (b) of this section as of January 1, 2002;

"(3) the Secretary determines that there is a continuing need for information relating to the use of the drug in the pediatric population and that the drug may provide health benefits in that population; and

"(4) all requirements of this section are met."

Subsec. (k). Pub. L. 107–109, §19(2), (3), redesignated subsec. (n) as (k). Former subsec. (k) redesignated (m).

Subsec. (l). Pub. L. 107–109, §19(2), (3), redesignated subsec. (o) as (l). Former subsec. (l) redesignated (i).

Pub. L. 107–109, §5(b)(2), added subsec. (l).

Subsec. (m). Pub. L. 107–109, §19(2), (3), redesignated subsec. (k) as (m). Former subsec. (m) redesignated (j).

Pub. L. 107–109, §9, added subsec. (m).

Subsec. (n). Pub. L. 107–109, §19(4), which directed substitution of "subsection (b) or (c)" for "subsection (a) or (c)" in subsec. (m), was executed by making the substitution in introductory provisions of subsec. (n), to reflect the probable intent of Congress.

Pub. L. 107–109, §19(2), (3), redesignated subsec. (j) as (n). Former subsec. (n) redesignated (k).

Pub. L. 107–109, §10, added subsec. (n).

Subsec. (o). Pub. L. 107–109, §19(2), (3), redesignated subsec. (o) as (l).

Pub. L. 107–109, §11(a), added subsec. (o).

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Pub. L. 112–144, title V, §509(g), July 9, 2012, 126 Stat. 1050, provided that:

"(1) Application.—Notwithstanding any provision of section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) stating that a provision applies beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 [Sept. 27, 2007] or the date of the enactment of the Pediatric Research Equity Act of 2007 [Sept. 27, 2007], any amendment made by this Act to such a provision applies beginning on the date of the enactment of this Act [July 9, 2012].

"(2) Transitional rule for adverse event reporting.—With respect to a drug for which a labeling change described under section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved or made, respectively, during the one-year period that ends on the day before the date of enactment of this Act [July 9, 2012], the Secretary [of Health and Human Services] shall apply section 505A(l) and section 505B(i), as applicable, to such drug, as such sections were in effect on such day."

Effective Date of 2007 Amendment

Pub. L. 110–85, title V, §502(a)(2), Sept. 27, 2007, 121 Stat. 885, provided that:

"(A) In general.—The amendment made by this subsection [amending this section] shall apply to written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) issued on or after the date of the enactment of this Act [Sept. 27, 2007].

"(B) Certain written requests.—A written request issued under section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this Act, which has been accepted and for which no determination under subsection (d)(2) of such section has been made before such date of enactment, shall be subject to such section 505A, except that such written requests shall be subject to subsections (d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on or after the date of the enactment of this Act."

Effective Date of 2003 Amendment

Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of this title.

Effective Date of 2002 Amendment

Pub. L. 107–109, §11(b), Jan. 4, 2002, 115 Stat. 1416, provided that: "The amendment made by subsection (a) [amending this section] takes effect on the date of enactment of this Act [Jan. 4, 2002], including with respect to applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that are approved or pending on that date."

Construction of 2007 Amendments on Pediatric Studies

Pub. L. 110–85, title IX, §901(e), Sept. 27, 2007, 121 Stat. 942, provided that: "This title [enacting sections 353c, 355–1, 355e, 360a, and 360bbb–6 of this title, amending sections 331, 333, 334, 352, 355, and 381 of this title and section 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 331, 352, and 355 of this title] and the amendments made by this title may not be construed as affecting the authority of the Secretary of Health and Human Services to request pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a] or to require such studies under section 505B of such Act [21 U.S.C. 355c]."

Plan for Earlier Submission of Pediatric Studies

Pub. L. 115–52, title V, §505(c), Aug. 18, 2017, 131 Stat. 1046, provided that: "The Secretary of Health and Human Services, acting through the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) shall, not later than one year after the date of enactment of this Act [Aug. 18, 2017], develop and implement a plan to achieve, when appropriate, earlier submission of pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)). Such plan shall include recommendations to achieve—

"(1) earlier discussion of proposed pediatric study requests and written requests with sponsors, and if appropriate, discussion of such requests at the meeting required under section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a);

"(2) earlier issuance of written requests for a pediatric study under such section 505A, including for investigational new drugs prior to the submission of an application under section 505(b)(1) of such Act (21 U.S.C. 355(b)(1)); and

"(3) shorter timelines, when appropriate, for the completion of studies pursuant to a written request under such section 505A or such section 351(m)."

Draft Guidance for Neonatal Studies

Pub. L. 115–52, title V, §505(d)(2), Aug. 18, 2017, 131 Stat. 1047, provided that: "Not later than 2 years after the date of enactment of this Act [Aug. 18, 2017], the Secretary shall issue draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products."

Communication With Pediatric Review Committee

Pub. L. 112–144, title V, §503, July 9, 2012, 126 Stat. 1040, provided that: "Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services (referred to in this title [see Tables for classification] as the 'Secretary') shall issue internal standard operating procedures that provide for the review by the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) of any significant modifications to initial pediatric study plans, agreed initial pediatric study plans, and written requests under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c). Such internal standard operating procedures shall be made publicly available on the Internet Web site of the Food and Drug Administration."

Access to Data

Pub. L. 112–144, title V, §504, July 9, 2012, 126 Stat. 1040, provided that: "Not later than 3 years after the date of enactment of this Act [July 9, 2012], the Secretary [of Health and Human Services] shall make available to the public, including through posting on the Internet Web site of the Food and Drug Administration, the medical, statistical, and clinical pharmacology reviews of, and corresponding written requests issued to an applicant, sponsor, or holder for, pediatric studies submitted between January 4, 2002, and September 27, 2007, under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 months of market exclusivity was granted and that resulted in a labeling change. The Secretary shall make public the information described in the preceding sentence in a manner consistent with how the Secretary releases information under section 505A(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k))."

Report on Pediatric Exclusivity Program

Pub. L. 107–109, §16, Jan. 4, 2002, 115 Stat. 1421, as amended by Pub. L. 108–155, §3(b)(4), Dec. 3, 2003, 117 Stat. 1942, required the Comptroller General, not later than Oct. 1, 2006, and in consultation with the Secretary of Health and Human Services, to submit to Congress a report on specified issues concerning the effectiveness of the pediatric exclusivity program.

Study by General Accounting Office

Pub. L. 107–109, §18(b), Jan. 4, 2002, 115 Stat. 1423, required the Comptroller General, not later than Jan. 10, 2003, to conduct a study relating to the representation of children of ethnic and racial minorities in studies under section 355a of this title and to submit a report to Congress describing the findings of the study.

§355b. Adverse-event reporting

(a) Toll-free number in labeling

Not later than one year after January 4, 2002, the Secretary of Health and Human Services shall promulgate a final rule requiring that the labeling of each drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (regardless of the date on which approved) include the toll-free number maintained by the Secretary for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With respect to the final rule:

(1) The rule shall provide for the implementation of such labeling requirement in a manner that the Secretary considers to be most likely to reach the broadest consumer audience.

(2) In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession.

(3) The rule shall take effect not later than 60 days after the date on which the rule is promulgated.

(b) Drugs with pediatric market exclusivity

(1) In general

During the one year beginning on the date on which a drug receives a period of market exclusivity under 505A ¹ of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], any report of an adverse event regarding the drug that the Secretary of Health and Human Services receives shall be referred to the Office of Pediatric Therapeutics established under section 393a of this title. In considering the report, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such subcommittee ² regarding whether the Secretary should take action under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] in response to the report.

(2) Rule of construction

Paragraph (1) may not be construed as restricting the authority of the Secretary of Health and Human Services to continue carrying out the activities described in such paragraph regarding a drug after the one-year period described in such paragraph regarding the drug has expired.

(Pub. L. 107–109, §17, Jan. 4, 2002, 115 Stat. 1422; Pub. L. 108–155, §3(b)(5), Dec. 3, 2003, 117 Stat. 1942.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

2003—Subsec. (b)(1). Pub. L. 108–155 struck out "Advisory Subcommittee of the Anti-Infective Drugs" before "Advisory Committee".

Statutory Notes and Related Subsidiaries

Effective Date of 2003 Amendment

Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of this title.

¹ So in original. Probably should be preceded by "section".

² So in original. Probably should be "Committee".

§355c. Research into pediatric uses for drugs and biological products

(a) New drugs and biological products

(1) In general

(A) General requirements

Except with respect to an application for which subparagraph (B) applies, a person that submits, on or after September 27, 2007, an application (or supplement to an application) for a drug—

(i) under section 355 of this title for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; or

(ii) under section 262 of title 42 for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration,

shall submit with the application the assessments described in paragraph (2).

(B) Certain molecularly targeted cancer indications

A person that submits, on or after the date that is 3 years after August 18, 2017, an original application for a new active ingredient under section 355 of this title or section 262 of title 42, shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is—

(i) intended for the treatment of an adult cancer; and

(ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.

(2) Assessments

(A) In general

The assessments referred to in paragraph (1)(A) shall contain data, gathered using appropriate formulations for each age group for which the assessment is required, that are adequate—

(i) to assess the safety and effectiveness of the drug or the biological product for the claimed indications in all relevant pediatric subpopulations; and

(ii) to support dosing and administration for each pediatric subpopulation for which the drug or the biological product is safe and effective.

(B) Similar course of disease or similar effect of drug or biological product

(i) In general

If the course of the disease and the effects of the drug are sufficiently similar in adults and pediatric patients, the Secretary may conclude that pediatric effectiveness can be extrapolated from adequate and well-controlled studies in adults, usually supplemented with other information obtained in pediatric patients, such as pharmacokinetic studies.

(ii) Extrapolation between age groups

A study may not be needed in each pediatric age group if data from one age group can be extrapolated to another age group.

(iii) Information on extrapolation

A brief documentation of the scientific data supporting the conclusion under clauses (i) and (ii) shall be included in any pertinent reviews for the application under section 355 of this title or section 262 of title 42.

(3) Molecularly targeted pediatric cancer investigation

(A) In general

With respect to a drug or biological product described in paragraph (1)(B), the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation, which shall be designed to yield clinically meaningful pediatric study data, gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.

(B) Extrapolation of data

Paragraph (2)(B) shall apply to investigations described in this paragraph to the same extent and in the same manner as paragraph (2)(B) applies with respect to the assessments required under paragraph (1)(A).

(C) Deferrals and waivers

Deferrals and waivers under paragraphs (4) and (5) shall apply to investigations described in this paragraph to the same extent and in the same manner as such deferrals and waivers apply with respect to the assessments under paragraph (2)(B).

(4) Deferral

(A) In general

On the initiative of the Secretary or at the request of the applicant, the Secretary may defer submission of some or all assessments required under paragraph (1)(A) or reports on the investigation required under paragraph (1)(B) until a specified date after approval of the drug or issuance of the license for a biological product if—

(i) the Secretary finds that—

(I) the drug or biological product is ready for approval for use in adults before pediatric studies are complete;

(II) pediatric studies should be delayed until additional safety or effectiveness data have been collected; or

(III) there is another appropriate reason for deferral; and

(ii) the applicant submits to the Secretary—

(I) certification of the grounds for deferring the assessments or reports on the investigation;

(II) a pediatric study plan as described in subsection (e);

(III) evidence that the studies are being conducted or will be conducted with due diligence and at the earliest possible time; and

(IV) a timeline for the completion of such studies.

(B) Deferral extension

(i) In general

On the initiative of the Secretary or at the request of the applicant, the Secretary may grant an extension of a deferral approved under subparagraph (A) for submission of some or all assessments required under paragraph (1)(A) or reports on the investigation required under paragraph (1)(B) if—

(I) the Secretary determines that the conditions described in subclause (II) or (III) of subparagraph (A)(i) continue to be met; and

(II) the applicant submits a new timeline under subparagraph (A)(ii)(IV) and any significant updates to the information required under subparagraph (A)(ii).

(ii) Timing and information

If the deferral extension under this subparagraph is requested by the applicant, the applicant shall submit the deferral extension request containing the information described in this subparagraph not less than 90 days prior to the date that the deferral would expire. The Secretary shall respond to such request not later than 45 days after the receipt of such letter. If the Secretary grants such an extension, the specified date shall be the extended date. The sponsor of the required assessment under paragraph (1)(A) or reports on the investigation under paragraph (1)(B) shall not be issued a letter described in subsection (d) unless the specified or extended date of submission for such required studies has passed or if the request for an extension is pending. For a deferral that has expired prior to July 9, 2012, or that will expire prior to 270 days after July 9, 2012, a deferral extension shall be requested by an applicant not later than 180 days after July 9, 2012. The Secretary shall respond to any such request as soon as practicable, but not later than 1 year after July 9, 2012. Nothing in this clause shall prevent the Secretary from updating the status of a study or studies publicly if components of such study or studies are late or delayed.

(C) Annual review

(i) In general

On an annual basis following the approval of a deferral under subparagraph (A), the applicant shall submit to the Secretary the following information:

(I) Information detailing the progress made in conducting pediatric studies.

(II) If no progress has been made in conducting such studies, evidence and documentation that such studies will be conducted with due diligence and at the earliest possible time.

(III) Projected completion date for pediatric studies.

(IV) The reason or reasons why a deferral or deferral extension continues to be necessary.

(ii) Public availability

Not later than 90 days after the submission to the Secretary of the information submitted through the annual review under clause (i), the Secretary shall make available to the public in an easily accessible manner, including through the Internet Web site of the Food and Drug Administration—

(I) such information;

(II) the name of the applicant for the product subject to the assessment or investigation;

(III) the date on which the product was approved; and

(IV) the date of each deferral or deferral extension under this paragraph for the product.

(5) Waivers

(A) Full waiver

On the initiative of the Secretary or at the request of an applicant, the Secretary shall grant a full waiver, as appropriate, of the requirement to submit assessments or reports on the investigation for a drug or biological product under this subsection if the applicant certifies and the Secretary finds that—

(i) necessary studies are impossible or highly impracticable (because, for example, the number of patients is so small or the patients are geographically dispersed);

(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in all pediatric age groups; or

(iii) the drug or biological product—

(I) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients; and

(II) is not likely to be used in a substantial number of pediatric patients.

(B) Partial waiver

On the initiative of the Secretary or at the request of an applicant, the Secretary shall grant a partial waiver, as appropriate, of the requirement to submit assessments or reports on the investigation for a drug or biological product under this subsection with respect to a specific pediatric age group if the applicant certifies and the Secretary finds that—

(i) necessary studies are impossible or highly impracticable (because, for example, the number of patients in that age group is so small or patients in that age group are geographically dispersed);

(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in that age group;

(iii) the drug or biological product—

(I) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in that age group; and

(II) is not likely to be used by a substantial number of pediatric patients in that age group; or

(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age group have failed.

(C) Pediatric formulation not possible

If a partial waiver is granted on the ground that it is not possible to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that formulation. An applicant seeking such a partial waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed and, if the waiver is granted, the applicant's submission shall promptly be made available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration.

(D) Labeling requirement

If the Secretary grants a full or partial waiver because there is evidence that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be included in the labeling for the drug or biological product.

(b) Marketed drugs and biological products

(1) In general

The Secretary may (by order in the form of a letter) require the sponsor or holder of an approved application for a drug under section 355 of this title or the holder of a license for a biological product under section 262 of title 42 to submit by a specified date the assessments described in subsection (a)(2), if the Secretary finds that—

(A)(i) the drug or biological product is used for a substantial number of pediatric patients for the labeled indications; and

(ii) adequate pediatric labeling could confer a benefit on pediatric patients;

(B) there is reason to believe that the drug or biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients for 1 or more of the claimed indications; or

(C) the absence of adequate pediatric labeling could pose a risk to pediatric patients.

(2) Waivers

(A) Full waiver

At the request of an applicant, the Secretary shall grant a full waiver, as appropriate, of the requirement to submit assessments under this subsection if the applicant certifies and the Secretary finds that—

(i) necessary studies are impossible or highly impracticable (because, for example, the number of patients in that age group is so small or patients in that age group are geographically dispersed); or

(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in all pediatric age groups.

(B) Partial waiver

At the request of an applicant, the Secretary shall grant a partial waiver, as appropriate, of the requirement to submit assessments under this subsection with respect to a specific pediatric age group if the applicant certifies and the Secretary finds that—

(i) necessary studies are impossible or highly impracticable (because, for example, the number of patients in that age group is so small or patients in that age group are geographically dispersed);

(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in that age group;

(iii)(I) the drug or biological product—

(aa) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in that age group; and

(bb) is not likely to be used in a substantial number of pediatric patients in that age group; and

(II) the absence of adequate labeling could not pose significant risks to pediatric patients; or

(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age group have failed.

(C) Pediatric formulation not possible

If a waiver is granted on the ground that it is not possible to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that formulation. An applicant seeking either a full or partial waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed and, if the waiver is granted, the applicant's submission shall promptly be made available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration.

(D) Labeling requirement

If the Secretary grants a full or partial waiver because there is evidence that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be included in the labeling for the drug or biological product.

(3) Effect of subsection

Nothing in this subsection alters or amends section 331(j) of this title or section 552 of title 5 or section 1905 of title 18.

(c) Meaningful therapeutic benefit

For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and paragraphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or biological product shall be considered to represent a meaningful therapeutic benefit over existing therapies if the Secretary determines that—

(1) if approved, the drug or biological product could represent an improvement in the treatment, diagnosis, or prevention of a disease, compared with marketed products adequately labeled for that use in the relevant pediatric population; or

(2) the drug or biological product is in a class of products or for an indication for which there is a need for additional options.

(d) Submission of assessments and reports on the investigation

If a person fails to submit a required assessment described in subsection (a)(2) or the investigation described in subsection (a)(3), fails to meet the applicable requirements in subsection (a)(4), or fails to submit a request for approval of a pediatric formulation described in subsection (a) or (b), in accordance with applicable provisions of subsections (a) and (b), the following shall apply:

(1) Beginning 270 days after July 9, 2012, the Secretary shall issue a non-compliance letter to such person informing them of such failure to submit or meet the requirements of the applicable subsection. Such letter shall require the person to respond in writing within 45 calendar days of issuance of such letter. Such response may include the person's request for a deferral extension if applicable. Such letter and the person's written response to such letter shall be made publicly available on the Internet Web site of the Food and Drug Administration 60 calendar days after issuance, with redactions for any trade secrets and confidential commercial information. If the Secretary determines that the letter was issued in error, the requirements of this paragraph shall not apply. The Secretary shall inform the Pediatric Advisory Committee of letters issued under this paragraph and responses to such letters.

(2) The drug or biological product that is the subject of an assessment described in subsection (a)(2) or the investigation described in subsection (a)(3), applicable requirements in subsection (a)(4), or request for approval of a pediatric formulation, may be considered misbranded solely because of that failure and subject to relevant enforcement action (except that the drug or biological product shall not be subject to action under section 333 of this title), but such failure shall not be the basis for a proceeding—

(A) to withdraw approval for a drug under section 355(e) of this title; or

(B) to revoke the license for a biological product under section 262 of title 42.

(e) Pediatric study plans

(1) In general

An applicant subject to subsection (a) shall submit to the Secretary an initial pediatric study plan prior to the submission of the assessments described under subsection (a)(2) or the investigation described in subsection (a)(3).

(2) Timing; content; meetings

(A) Timing

An applicant shall submit the initial pediatric study plan under paragraph (1)—

(i) before the date on which the applicant submits the assessments under subsection (a)(2) or the investigation described in subsection (a)(3); and

(ii) not later than—

(I) 60 calendar days after the date of the end-of-Phase 2 meeting (as such term is used in section 312.47 of title 21, Code of Federal Regulations, or successor regulations); or

(II) such other time as may be agreed upon between the Secretary and the applicant.

Nothing in this section shall preclude the Secretary from accepting the submission of an initial pediatric study plan earlier than the date otherwise applicable under this subparagraph.

(B) Content of initial pediatric study plan

The initial pediatric study plan shall include—

(i) an outline of the pediatric study or studies that the applicant plans to conduct (including, to the extent practicable study objectives and design, age groups, relevant endpoints, and statistical approach);

(ii) any request for a deferral, partial waiver, or waiver under this section, if applicable, along with any supporting information; and

(iii) other information specified in the regulations promulgated under paragraph (7).

(C) Meetings

The Secretary—

(i) shall meet with the applicant—

(I) if requested by the applicant with respect to a drug or biological product that is intended to treat a serious or life-threatening disease or condition, to discuss preparation of the initial pediatric study plan, not later than the end-of-Phase 1 meeting (as such term is used in section 312.82(b) of title 21, Code of Federal Regulations, or successor regulations) or within 30 calendar days of receipt of such request, whichever is later;

(II) to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A); and

(III) to discuss the bases for the deferral under subsection (a)(4) or a full or partial waiver under subsection (a)(5);

(ii) may determine that a written response to the initial pediatric study plan is sufficient to communicate comments on the initial pediatric study plan, and that no meeting under clause (i)(II) is necessary; and

(iii) if the Secretary determines that no meeting under clause (i)(II) is necessary, shall so notify the applicant and provide written comments of the Secretary as soon as practicable, but not later than 90 calendar days after the receipt of the initial pediatric study plan.

(3) Agreed initial pediatric study plan

Not later than 90 calendar days following the meeting under paragraph (2)(C)(i)(II) or the receipt of a written response from the Secretary under paragraph (2)(C)(iii), the applicant shall document agreement on the initial pediatric study plan in a submission to the Secretary marked "Agreed Initial Pediatric Study Plan", and the Secretary shall confirm such agreement to the applicant in writing not later than 30 calendar days of receipt of such agreed initial pediatric study plan.

(4) Deferral and waiver

If the agreed initial pediatric study plan contains a request from the applicant for a deferral, partial waiver, or waiver under this section, the written confirmation under paragraph (3) shall include a recommendation from the Secretary as to whether such request meets the standards under paragraphs (3) or (4) of subsection (a).

(5) Amendments to the agreed initial pediatric study plan

At the initiative of the Secretary or the applicant, the agreed initial pediatric study plan may be amended at any time. The requirements of paragraph (2)(C) shall apply to any such proposed amendment in the same manner and to the same extent as such requirements apply to an initial pediatric study plan under paragraph (1). The requirements of paragraphs (3) and (4) shall apply to any agreement resulting from such proposed amendment in the same manner and to the same extent as such requirements apply to an agreed initial pediatric study plan.

(6) Internal committee

The Secretary shall consult the internal committee under section 355d of this title on the review of the initial pediatric study plan, agreed initial pediatric study plan, and any significant amendments to such plans.

(7) Required rulemaking

Not later than 1 year after July 9, 2012, the Secretary shall promulgate proposed regulations and issue guidance to implement the provisions of this subsection.

(f) Review of pediatric study plans, assessments, deferrals, deferral extensions, and waivers

(1) Review

Beginning not later than 30 days after September 27, 2007, the Secretary shall utilize the internal committee established under section 355d of this title to provide consultation to reviewing divisions on initial pediatric study plans, agreed initial pediatric study plans, and any significant amendments to such plans, and assessments prior to approval of an application or supplement for which a pediatric assessment is required under this section and all deferral, deferral extension, and waiver requests granted pursuant to this section.

(2) Activity by committee

The committee referred to in paragraph (1) may operate using appropriate members of such committee and need not convene all members of the committee.

(3) Documentation of committee action

For each drug or biological product, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (4) or (5), which members of the committee participated in such activity.

(4) Review of pediatric study plans, assessments, deferrals, deferral extensions, and waivers

Consultation on initial pediatric study plans, agreed initial pediatric study plans, and assessments by the committee referred to in paragraph (1) pursuant to this section shall occur prior to approval of an application or supplement for which a pediatric assessment is required under this section. The committee shall review all requests for deferrals, deferral extensions, and waivers from the requirement to submit a pediatric assessment granted under this section and shall provide recommendations as needed to reviewing divisions, including with respect to whether such a supplement, when submitted, shall be considered for priority review.

(5) Retrospective review of pediatric assessments, deferrals, and waivers

Not later than 1 year after September 27, 2007, the committee referred to in paragraph (1) shall conduct a retrospective review and analysis of a representative sample of assessments submitted and deferrals and waivers approved under this section since December 3, 2003. Such review shall include an analysis of the quality and consistency of pediatric information in pediatric assessments and the appropriateness of waivers and deferrals granted. Based on such review, the Secretary shall issue recommendations to the review divisions for improvements and initiate guidance to industry related to the scope of pediatric studies required under this section.

(6) Tracking of assessments and labeling changes

The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration—

(A) the number of assessments conducted under this section;

(B) the specific drugs and biological products and their uses assessed under this section;

(C) the types of assessments conducted under this section, including trial design, the number of pediatric patients studied, and the number of centers and countries involved;

(D) aggregated on an annual basis—

(i) the total number of deferrals and deferral extensions requested and granted under this section and, if granted, the reasons for each such deferral or deferral extension;

(ii) the timeline for completion of the assessments;

(iii) the number of assessments completed and pending; and

(iv) the number of postmarket non-compliance letters issued pursuant to subsection (d), and the recipients of such letters;

(E) the number of waivers requested and granted under this section and, if granted, the reasons for the waivers;

(F) the number of pediatric formulations developed and the number of pediatric formulations not developed and the reasons any such formulation was not developed;

(G) the labeling changes made as a result of assessments conducted under this section;

(H) an annual summary of labeling changes made as a result of assessments conducted under this section for distribution pursuant to subsection (h)(2);

(I) an annual summary of information submitted pursuant to subsection (a)(4)(C); and

(J) the number of times the committee referred to in paragraph (1) made a recommendation to the Secretary under paragraph (4) regarding priority review, the number of times the Secretary followed or did not follow such a recommendation, and, if not followed, the reasons why such a recommendation was not followed.

(g) Labeling changes

(1) Dispute resolution

(A) Request for labeling change and failure to agree

If, on or after September 27, 2007, the Commissioner determines that a sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the labeling for the drug that is the subject of the application or supplement, not later than 180 days after the date of the submission of the application or supplement that receives a priority review or 330 days after the date of the submission of an application or supplement that receives a standard review—

(i) the Commissioner shall request that the sponsor of the application make any labeling change that the Commissioner determines to be appropriate; and

(ii) if the sponsor does not agree within 30 days after the Commissioner's request to make a labeling change requested by the Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Committee.

(B) Action by the Pediatric Advisory Committee

Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory Committee shall—

(i) review the pediatric study reports; and

(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any.

(C) Consideration of recommendations

The Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not later than 30 days after receiving the recommendation, make a request to the sponsor of the application or supplement to make any labeling changes that the Commissioner determines to be appropriate.

(D) Misbranding

If the sponsor of the application or supplement, within 30 days after receiving a request under subparagraph (C), does not agree to make a labeling change requested by the Commissioner, the Commissioner may deem the drug that is the subject of the application or supplement to be misbranded.

(E) No effect on authority

Nothing in this subsection limits the authority of the United States to bring an enforcement action under this chapter when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.

(2) Other labeling changes

If, on or after September 27, 2007, the Secretary makes a determination that a pediatric assessment conducted under this section does or does not demonstrate that the drug that is the subject of such assessment is safe and effective in pediatric populations or subpopulations, including whether such assessment results are inconclusive, the Secretary shall order the labeling of such product to include information about the results of the assessment and a statement of the Secretary's determination.

(h) Dissemination of pediatric information

(1) In general

Not later than 210 days after the date of submission of an application (or supplement to an application) that contains a pediatric assessment under this section, if the application (or supplement) receives a priority review, or not later than 330 days after the date of submission of an application (or supplement to an application) that contains a pediatric assessment under this section, if the application (or supplement) receives a standard review, the Secretary shall make available to the public in an easily accessible manner the medical, statistical, and clinical pharmacology reviews of such pediatric assessments, and shall post such assessments on the Web site of the Food and Drug Administration.

(2) Dissemination of information regarding labeling changes

Beginning on September 27, 2007, the Secretary shall require that the sponsors of the assessments that result in labeling changes that are reflected in the annual summary developed pursuant to subsection (f)(6)(H) distribute such information to physicians and other health care providers.

(3) Effect of subsection

Nothing in this subsection shall alter or amend section 331(j) of this title or section 552 of title 5 or section 1905 of title 18.

(i) Adverse event reporting

(1) Reporting in first 18-month period

Beginning on September 27, 2007, during the 18-month period beginning on the date a labeling change is made pursuant to subsection (g), the Secretary shall ensure that all adverse event reports that have been received for such drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics. In considering such reports, the Director of such Office shall provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action under this chapter in response to such reports.

(2) Reporting in subsequent periods

Following the 18-month period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such Committee regarding whether the Secretary should take action in response to such reports.

(3) Preservation of authority

Nothing in this subsection shall prohibit the Office of Pediatric Therapeutics from providing for the review of adverse event reports by the Pediatric Advisory Committee prior to the 18-month period referred to in paragraph (1), if such review is necessary to ensure safe use of a drug in a pediatric population.

(4) Effect

The requirements of this subsection shall supplement, not supplant, other review of such adverse event reports by the Secretary.

(j) Scope of authority

Nothing in this section provides to the Secretary any authority to require a pediatric assessment of any drug or biological product, or any assessment regarding other populations or uses of a drug or biological product, other than the pediatric assessments described in this section.

(k) Relation to orphan drugs

(1) In general; exemption for orphan indications

Unless the Secretary requires otherwise by regulation and except as provided in paragraph (2), this section does not apply to any drug or biological product for an indication for which orphan designation has been granted under section 360bb of this title.

(2) Applicability despite orphan designation of certain indications

This section shall apply with respect to a drug or biological product for which an indication has been granted orphan designation under 360bb ¹ of this title if the investigation described in subsection (a)(3) applies to the drug or biological product as described in subsection (a)(1)(B).

(l) New active ingredient

(1) Non-interchangeable biosimilar biological product

A biological product that is biosimilar to a reference product under section 262 of title 42, and that the Secretary has not determined to meet the standards described in subsection (k)(4) of such section for interchangeability with the reference product, shall be considered to have a new active ingredient under this section.

(2) Interchangeable biosimilar biological product

A biological product that is interchangeable with a reference product under section 262 of title 42 shall not be considered to have a new active ingredient under this section.

(m) List of primary molecular targets

(1) In general

Within one year of August 18, 2017, the Secretary shall establish and update regularly, and shall publish on the internet website of the Food and Drug Administration—

(A) a list of molecular targets considered, on the basis of data the Secretary determines to be adequate, to be substantially relevant to the growth and progression of a pediatric cancer, and that may trigger the requirements under this section; and

(B) a list of molecular targets of new cancer drugs and biological products in development for which pediatric cancer study requirements under this section will be automatically waived.

(2) Consultation

In establishing the lists described in paragraph (1), the Secretary shall consult the National Cancer Institute, members of the internal committee under section 355d of this title, and the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, and shall take into account comments from the meeting under subsection (c).

(3) Rule of construction

Nothing in paragraph (1) shall be construed—

(A) to require the inclusion of a molecular target on the list published under such paragraph as a condition for triggering the requirements under subsection (a)(1)(B) with respect to a drug or biological product directed at such molecular target; or

(B) to authorize the disclosure of confidential commercial information, as prohibited under section 331(j) of this title or section 1905 of title 18.

(June 25, 1938, ch. 675, §505B, as added Pub. L. 108–155, §2(a), Dec. 3, 2003, 117 Stat. 1936; amended Pub. L. 110–85, title IV, §402(a), Sept. 27, 2007, 121 Stat. 866; Pub. L. 111–148, title VII, §7002(d)(2), Mar. 23, 2010, 124 Stat. 816; Pub. L. 112–144, title V, §§501(b), 505–506(b), 509(b), July 9, 2012, 126 Stat. 1040–1044, 1048; Pub. L. 114–255, div. A, title III, §§3101(a)(2)(D), 3102(3), Dec. 13, 2016, 130 Stat. 1153, 1156; Pub. L. 115–52, title V, §§503–504(b), 505(e), Aug. 18, 2017, 131 Stat. 1038–1041, 1047; Pub. L. 117–328, div. FF, title II, §2515(c), Dec. 29, 2022, 136 Stat. 5806.)

Editorial Notes

Amendments

2022—Subsec. (f)(6)(I). Pub. L. 117–328 substituted "subsection (a)(4)(C)" for "subsection (a)(3)(B)".

2017—Subsec. (a)(1). Pub. L. 115–52, §504(a)(1)(A), designated existing provisions as subpar. (A) and inserted heading, substituted "Except with respect to an application for which subparagraph (B) applies, a person" for "A person", redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A) and realigned margins, substituted "; or" for ", or" at end of subpar. (A)(i), and added subpar. (B).

Subsec. (a)(2)(A). Pub. L. 115–52, §504(a)(1)(B), substituted "paragraph (1)(A)" for "paragraph (1)" in introductory provisions.

Subsec. (a)(3). Pub. L. 115–52, §504(a)(1)(D), added par. (3). Former par. (3) redesignated (4).

Subsec. (a)(4). Pub. L. 115–52, §504(a)(1)(C), redesignated par. (3) as (4). Former par. (4) redesignated (5).

Subsec. (a)(4)(A). Pub. L. 115–52, §504(a)(1)(E)(i), substituted "assessments required under paragraph (1)(A) or reports on the investigation required under paragraph (1)(B)" for "assessments required under paragraph (1)" in introductory provisions.

Subsec. (a)(4)(A)(ii)(I). Pub. L. 115–52, §504(a)(1)(E)(ii), inserted "or reports on the investigation" after "assessments".

Subsec. (a)(4)(B)(i). Pub. L. 115–52, §504(a)(1)(E)(i), substituted "assessments required under paragraph (1)(A) or reports on the investigation required under paragraph (1)(B)" for "assessments required under paragraph (1)" in introductory provisions.

Subsec. (a)(4)(B)(ii). Pub. L. 115–52, §504(a)(1)(E)(iii), substituted "assessment under paragraph (1)(A) or reports on the investigation under paragraph (1)(B)" for "assessment under paragraph (1)".

Subsec. (a)(4)(C)(ii)(II). Pub. L. 115–52, §504(a)(1)(E)(iv), inserted "or investigation" after "assessment".

Subsec. (a)(5). Pub. L. 115–52, §504(a)(1)(C), redesignated par. (4) as (5).

Subsec. (a)(5)(A), (B). Pub. L. 115–52, §504(a)(1)(F), inserted "or reports on the investigation" after "assessments" in introductory provisions.

Subsec. (d). Pub. L. 115–52, §504(a)(2), inserted "and reports on the investigation" after "Submission of assessments" in heading and, in introductory provisions, inserted "or the investigation described in subsection (a)(3)" after "assessment described in subsection (a)(2)" and substituted "subsection (a)(4)" for "subsection (a)(3)".

Subsec. (d)(1). Pub. L. 115–52, §505(e), inserted at end "The Secretary shall inform the Pediatric Advisory Committee of letters issued under this paragraph and responses to such letters."

Subsec. (d)(2). Pub. L. 115–52, §504(a)(2)(A), (C), in introductory provisions, inserted "or the investigation described in subsection (a)(3)" after "assessment described in subsection (a)(2)" and substituted "subsection (a)(4)" for "subsection (a)(3)".

Subsec. (e)(1). Pub. L. 115–52, §504(a)(3)(A), inserted "or the investigation described in subsection (a)(3)" after "under subsection (a)(2)".

Subsec. (e)(2). Pub. L. 115–52, §503(b)(1), substituted "meetings" for "meeting" in heading.

Subsec. (e)(2)(A)(i). Pub. L. 115–52, §504(a)(3)(B), inserted "or the investigation described in subsection (a)(3)" after "under subsection (a)(2)".

Subsec. (e)(2)(C). Pub. L. 115–52, §503(b)(2), substituted "Meetings" for "Meeting" in heading.

Subsec. (e)(2)(C)(i). Pub. L. 115–52, §503(a), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "shall meet with the applicant to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A);".

Subsec. (e)(2)(C)(ii), (iii). Pub. L. 115–52, §503(b)(3), substituted "no meeting under clause (i)(II)" for "no meeting".

Subsec. (e)(3). Pub. L. 115–52, §503(b)(4), substituted "meeting under paragraph (2)(C)(i)(II)" for "meeting under paragraph (2)(C)(i)".

Subsec. (k). Pub. L. 115–52, §504(b), amended subsec. (k) generally. Prior to amendment, text read as follows: "Unless the Secretary requires otherwise by regulation, this section does not apply to any drug for an indication for which orphan designation has been granted under section 360bb of this title."

Subsec. (m). Pub. L. 115–52, §504(a)(4), added subsec. (m).

2016—Subsec. (e)(2)(A). Pub. L. 114–255, §3101(a)(2)(D)(i)(I)(aa), inserted "study" after "initial pediatric" in introductory and concluding provisions.

Subsec. (e)(2)(B). Pub. L. 114–255, §3101(a)(2)(D)(i)(I)(bb), substituted "Content of initial pediatric study plan" for "Content of initial plan" in heading.

Subsec. (e)(5). Pub. L. 114–255, §3101(a)(2)(D)(i)(II), inserted "agreed initial pediatric study" before "plan" in heading.

Subsec. (e)(6). Pub. L. 114–255, §3101(a)(2)(D)(i)(III), substituted "agreed initial pediatric study plan" for "agreed initial pediatric plan".

Subsec. (f)(1). Pub. L. 114–255, §3101(a)(2)(D)(ii), inserted "and any significant amendments to such plans," after "agreed initial pediatric study plans,".

Subsecs. (l), (m). Pub. L. 114–255, §3102(3), redesignated subsec. (m) as (l) and struck out former subsec. (l) which related to Institute of Medicine study.

2012—Subsec. (a)(1). Pub. L. 112–144, §509(b)(1)(A), inserted "for a drug" after "(or supplement to an application)" in introductory provisions.

Subsec. (a)(3)(A)(ii)(II). Pub. L. 112–144, §506(b)(1), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: "a description of the planned or ongoing studies;".

Subsec. (a)(3)(B), (C). Pub. L. 112–144, §505(a)(1)(A), (B), added subpar. (B) and redesignated former subpar. (B) as (C).

Subsec. (a)(3)(C)(i)(III), (IV). Pub. L. 112–144, §505(a)(1)(C)(i), added subcls. (III) and (IV).

Subsec. (a)(3)(C)(ii). Pub. L. 112–144, §505(a)(1)(C)(ii), amended cl. (ii) generally. Prior to amendment, text read as follows: "The information submitted through the annual review under clause (i) shall promptly be made available to the public in an easily accessible manner, including through the Web site of the Food and Drug Administration."

Subsec. (a)(4)(C). Pub. L. 112–144, §509(b)(1)(B), inserted "partial" after "If a" in first sentence and substituted "such a" for "either a full or" in second sentence.

Subsec. (b)(1). Pub. L. 112–144, §509(b)(2), substituted "The" for "After providing notice in the form of a letter (that, for a drug approved under section 355 of this title, references a declined written request under section 355a of this title for a labeled indication which written request is not referred under section 355a(n)(1)(A) of this title to the Foundation of the National Institutes of Health for the pediatric studies), the" in introductory provisions.

Subsec. (d). Pub. L. 112–144, §505(c)(1), amended subsec. (d) generally. Prior to amendment, subsec. (d) related to submission of assessments.

Subsec. (e). Pub. L. 112–144, §506(a), amended subsec. (e) generally. Prior to amendment, text read as follows: "Before and during the investigational process for a new drug or biological product, the Secretary shall meet at appropriate times with the sponsor of the new drug or biological product to discuss—

"(1) information that the sponsor submits on plans and timelines for pediatric studies; or

"(2) any planned request by the sponsor for waiver or deferral of pediatric studies."

Subsec. (f). Pub. L. 112–144, §506(b)(2)(A), substituted "pediatric study plans," for "pediatric plans," in heading.

Pub. L. 112–144, §505(a)(2)(A), inserted "deferral extensions," after "deferrals," in heading.

Subsec. (f)(1). Pub. L. 112–144, §506(b)(2)(B), substituted "initial pediatric study plans, agreed initial pediatric study plans," for "all pediatric plans".

Pub. L. 112–144, §505(a)(2)(B), inserted ", deferral extension," after "deferral".

Subsec. (f)(4). Pub. L. 112–144, §506(b)(2)(C), substituted "pediatric study plans," for "pediatric plans," in heading and "initial pediatric study plans, agreed initial pediatric study plans," for "pediatric plans" in text.

Pub. L. 112–144, §505(a)(2)(C), inserted "deferral extensions," after "deferrals," in heading and ", deferral extensions," after "deferrals" in text.

Subsec. (f)(6)(D). Pub. L. 112–144, §505(b), amended subpar. (D) generally. Prior to amendment, subpar. (D) read as follows: "the total number of deferrals requested and granted under this section and, if granted, the reasons for such deferrals, the timeline for completion, and the number completed and pending by the specified date, as outlined in subsection (a)(3);".

Subsec. (f)(6)(D)(iv). Pub. L. 112–144, §505(c)(2), added cl. (iv).

Subsec. (g)(1)(A). Pub. L. 112–144, §509(b)(3)(A), inserted "that receives a priority review or 330 days after the date of the submission of an application or supplement that receives a standard review" after "after the date of the submission of the application or supplement" in introductory provisions.

Subsec. (g)(2). Pub. L. 112–144, §509(b)(3)(B), substituted "the labeling of such product" for "the label of such product".

Subsec. (h)(1). Pub. L. 112–144, §509(b)(4), inserted "an application (or supplement to an application) that contains" after "date of submission of" and "if the application (or supplement) receives a priority review, or not later than 330 days after the date of submission of an application (or supplement to an application) that contains a pediatric assessment under this section, if the application (or supplement) receives a standard review," after "under this section,".

Subsec. (i)(1). Pub. L. 112–144, §509(b)(5)(A), substituted "first 18-month period" for "year one" in heading and "18-month" for "one-year" in text.

Subsec. (i)(2). Pub. L. 112–144, §509(b)(5)(B), substituted "periods" for "years" in heading and "18-month period" for "one-year period" in text.

Subsec. (i)(3), (4). Pub. L. 112–144, §509(b)(5)(C), (D), added par. (3) and redesignated former par. (3) as (4).

Subsecs. (m), (n). Pub. L. 112–144, §501(b), redesignated subsec. (n) as (m) and struck out former subsec. (m). Prior to amendment, text of subsec. (m) read as follows: "The authority under this section shall remain in effect so long as an application subject to this section may be accepted for filing by the Secretary on or before the date specified in section 355a(q) of this title."

2010—Subsec. (n). Pub. L. 111–148 added subsec. (n).

2007—Pub. L. 110–85 amended section generally. Prior to amendment, section related to required submission of assessments with an application for a new drug or new biological product and by order of the Secretary for certain marketed drugs and biological products used for pediatric patients, a definition of meaningful therapeutic benefit, consequences of failure to submit required assessments, meetings of the Secretary and the sponsor of a new drug or biological product, a limitation of the scope of the Secretary's authority, application to orphan drugs, and integration with other pediatric studies.

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Pub. L. 112–144, title V, §506(c), July 9, 2012, 126 Stat. 1045, provided that:

"(1) In general.—Subject to paragraph (2), the amendments made by this section [amending this section] shall take effect 180 calendar days after the date of enactment of this Act [July 9, 2012], irrespective of whether the Secretary [of Health and Human Services] has promulgated final regulations to carry out such amendments.

"(2) Rule of construction.—Paragraph (1) shall not be construed to affect the deadline for promulgation of proposed regulations under section 505B(e)(7) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(e)(7)], as added by subsection (a) of this section."

Notwithstanding any provision of this section stating that a provision applies beginning on Sept. 27, 2007, any amendment made by Pub. L. 112–144 to such a provision applies beginning on July 9, 2012, subject to a transitional rule, see section 509(g) of Pub. L. 112–144, set out as a note under section 355a of this title.

Effective Date of 2007 Amendment

Pub. L. 110–85, title IV, §402(b), Sept. 27, 2007, 121 Stat. 875, provided that:

"(1) In general.—Notwithstanding subsection (h) of section 505B of the Federal Food, Drug and Cosmetic Act [21 U.S.C. 355c(h)], as in effect on the day before the date of the enactment of this Act [Sept. 27, 2007], a pending assessment, including a deferred assessment, required under such section 505B shall be deemed to have been required under section 505B of the Federal Food, Drug and Cosmetic Act as in effect on or after the date of the enactment of this Act.

"(2) Certain assessments and waiver requests.—An assessment pending on or after the date that is 1 year prior to the date of the enactment of this Act shall be subject to the tracking and disclosure requirements established under such section 505B, as in effect on or after such date of enactment, except that any such assessments submitted or waivers of such assessments requested before such date of enactment shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) of such section 505B."

Effective Date

Pub. L. 108–155, §4, Dec. 3, 2003, 117 Stat. 1942, provided that:

"(a) In General.—Subject to subsection (b), this Act [enacting this section, amending sections 355, 355a, and 355b of this title and sections 262 and 284m of Title 42, The Public Health and Welfare, enacting provisions set out as a note under section 301 of this title, and amending provisions set out as notes under section 355a of this title and section 284m of Title 42] and the amendments made by this Act take effect on the date of enactment of this Act [Dec. 3, 2003].

"(b) Applicability to New Drugs and Biological Products.—

"(1) In general.—Subsection (a) of section 505B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(a)] (as added by section 2) shall apply to an application described in paragraph (1) of that subsection submitted to the Secretary of Health and Human Services on or after April 1, 1999.

"(2) Waivers and deferrals.—

"(A) Waiver or deferral granted.—If, with respect to an application submitted to the Secretary of Health and Human Services between April 1, 1999, and the date of enactment of this Act [Dec. 3, 2003], a waiver or deferral of pediatric assessments was granted under regulations of the Secretary then in effect, the waiver or deferral shall be a waiver or deferral under subsection (a) of section 505B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(a)], except that any date specified in such a deferral shall be extended by the number of days that is equal to the number of days between October 17, 2002, and the date of enactment of this Act.

"(B) Waiver and deferral not granted.—If, with respect to an application submitted to the Secretary of Health and Human Services between April 1, 1999, and the date of enactment of this Act [Dec. 3, 2003], neither a waiver nor deferral of pediatric assessments was granted under regulations of the Secretary then in effect, the person that submitted the application shall be required to submit assessments under subsection (a)(2) of section 505B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(a)(2)] on the date that is the later of—

"(i) the date that is 1 year after the date of enactment of this Act; or

"(ii) such date as the Secretary may specify under subsection (a)(3) of that section;

  unless the Secretary grants a waiver under subsection (a)(4) of that section.

"(c) No Limitation of Authority.—Neither the lack of guidance or regulations to implement this Act or the amendments made by this Act nor the pendency of the process for issuing guidance or regulations shall limit the authority of the Secretary of Health and Human Services under, or defer any requirement under, this Act or those amendments."

Rule of Construction

Pub. L. 115–52, title V, §504(e), Aug. 18, 2017, 131 Stat. 1045, provided that: "Nothing in this section [amending this section and section 355c–1 of this title and enacting provisions set out as a note below], including the amendments made by this section, shall limit the authority of the Secretary of Health and Human Services to issue written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)), or to negotiate or implement amendments to such requests proposed by the an [sic] applicant."

Meeting, Consultation, and Guidance

Pub. L. 115–52, title V, §504(c), Aug. 18, 2017, 131 Stat. 1041, provided that:

"(1) Meeting.—The Secretary of Health and Human Services (referred to in this subsection as the 'Secretary'), acting through the Commissioner of Food and Drugs and in collaboration with the Director of the National Cancer Institute, shall convene a public meeting not later than 1 year after the date of enactment of this Act [Aug. 18, 2017] to solicit feedback from physicians and researchers (including pediatric oncologists and rare disease specialists), patients, and other stakeholders to provide input on development of the guidance under paragraph (2) and the list under subsection (m) of section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as added by subsection (a). The Secretary shall seek input at such meeting on—

"(A) the data necessary to determine that there is scientific evidence that a drug or biological product is directed at a molecular target that is considered to be substantially relevant to the growth or progression of a pediatric cancer;

"(B) the data necessary to determine that there is scientific evidence that a molecular target is considered to be substantially relevant to the growth or progression of a pediatric cancer;

"(C) the data needed to meet the requirement of conducting an investigation described in section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(a)(3)], as amended by subsection (a);

"(D) considerations when developing the list under section 505B(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(m)] that contains molecular targets shared between different tumor types;

"(E) the process the Secretary shall utilize to update regularly a list of molecular targets that may trigger a pediatric study under section 505B of the Federal Food, Drug, and Cosmetic Act, as so amended, and how often such updates shall occur;

"(F) how to overcome the challenges related to pediatric cancer drug and biological product development, including issues related to the ethical, practical, and other barriers to conducting clinical trials in pediatric cancer with small patient populations;

"(G) scientific or operational challenges associated with performing an investigation described in section 505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(a)(1)(B)], including the effect on pediatric studies currently underway in a pediatric patient population, treatment of a pediatric patient population, and the ability to complete adult clinical trials;

"(H) the advantages and disadvantages of innovative clinical trial designs in addressing the development of cancer drugs or biological products directed at molecular targets in pediatric cancer patients;

"(I) the ways in which the Secretary can improve the current process outlined under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) to encourage additional research and development of pediatric cancer treatments;

"(J) the ways in which the Secretary might streamline and improve the written request process, including when studies contained in a request under such section 505A are not feasible due to the ethical, practical, or other barriers to conducting clinical trials in pediatric cancer populations;

"(K) how the Secretary will facilitate collaboration among pediatric networks, academic centers and experts in pediatric cancer to conduct an investigation described in such section 505B(a)(3);

"(L) how the Secretary may facilitate collaboration among sponsors of same-in-class drugs and biological products that would be subject to the requirements for an investigation under such section 505B based on shared molecular targets; and

"(M) the ways in which the Secretary will help to mitigate the risks, if any, of discouraging the research and development of orphan drugs when implementing such section 505B as amended.

"(2) Guidance.—Not later than 2 years after the date of enactment of this Act [Aug. 18, 2017], the Secretary, acting through the Commissioner of Food and Drugs, shall issue final guidance on implementation of the amendments to section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) regarding molecularly targeted cancer drugs made by this section, including—

"(A) the scientific criteria, types of data, and regulatory considerations for determining whether a molecular target is substantially relevant to the growth or progression of a pediatric cancer and would trigger an investigation under section 505B of the Federal Food, Drug, and Cosmetic Act, as amended;

"(B) the process by which the Secretary will engage with sponsors to discuss determinations, investigation requirements, deferrals, waivers, and any other issues that need to be resolved to ensure that any required investigation based on a molecular target can be reasonably conducted;

"(C) the scientific or operational challenges for which the Secretary may issue deferrals or waivers for an investigation described in subsection (a)(3) of such section 505B, including adverse impacts on current pediatric studies underway in a pediatric patient population, studies involving drugs designated as orphan drugs, treatment of a pediatric patient population, or the ability to complete adult clinical trials;

"(D) how the Secretary and sponsors will facilitate collaboration among pediatric networks, academic centers, and experts in pediatric cancer to conduct an investigation described in subsection (a)(3) of such section 505B;

"(E) scientific and regulatory considerations for study designs, including the applicability of innovative clinical trial designs for pediatric cancer drug and biological product developments under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c);

"(F) approaches to streamline and improve the amendment process, including when studies contained in a request under such section 505A are not feasible due to the ethical, practical, or other barriers to conducting clinical trials in pediatric cancer populations;

"(G) the process for submission of an initial pediatric study plan for the investigation described in section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)), including the process for a sponsor to meet and reach agreement with the Secretary on the initial pediatric study plan; and

"(H) considerations for implementation of such section 505B, as so amended, and waivers of the requirements of such section 505B with regard to molecular targets for which several drugs or biological products may be under investigation."

¹ So in original. Probably should be preceded by "section".

§355c–1. Report

(a) In general

Not later than four years after July 9, 2012, and every five years thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting on the Internet Web site of the Food and Drug Administration, a report on the implementation of sections 355a and 355c of this title.

(b) Contents

Each report under subsection (a) shall include—

(1) an assessment of the effectiveness of sections 355a and 355c of this title in improving information about pediatric uses for approved drugs and biological products, including the number and type of labeling changes made since July 9, 2012, and the importance of such uses in the improvement of the health of children;

(2) the number of required studies under such section 355c of this title that have not met the initial deadline provided under such section 355c of this title, including—

(A) the number of deferrals and deferral extensions granted and the reasons such extensions were granted;

(B) the number of waivers and partial waivers granted; and

(C) the number of letters issued under subsection (d) of such section 355c of this title;

(3) an assessment of the timeliness and effectiveness of pediatric study planning since July 9, 2012, including the number of initial pediatric study plans not submitted in accordance with the requirements of subsection (e) of such section 355c of this title and any resulting rulemaking;

(4) the number of written requests issued, accepted, and declined under such section 355a of this title since July 9, 2012, and a listing of any important gaps in pediatric information as a result of such declined requests;

(5) a description and current status of referrals made under subsection (n) of such section 355a of this title;

(6) an assessment of the effectiveness of studying biological products in pediatric populations under such sections 355a and 355c of this title and section 284m of title 42;

(7)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonatal population (including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of the studies ethical and safe); and

(B) the results of such efforts;

(8)(A) the number and importance of drugs and biological products for children with cancer that are being tested as a result of the programs under such sections 355a and 355c of this title and under section 284m of title 42; and

(B) any recommendations for modifications to such programs that would lead to new and better therapies for children with cancer, including a detailed rationale for each recommendation;

(9) any recommendations for modification to such programs that would improve pediatric drug research and increase pediatric labeling of drugs and biological products;

(10) an assessment of the successes of and limitations to studying drugs for rare diseases under such sections 355a and 355c of this title;

(11) an assessment of the impact of the amendments to such section 355c of this title made by the FDA Reauthorization Act of 2017 on pediatric research and labeling of drugs and biological products and pediatric labeling of molecularly targeted drugs and biological products for the treatment of cancer;

(12) an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act,¹ regarding earlier submission of pediatric studies under sections 355a and 355c of this title and section 262(m) of title 42, including—

(A) the average length of time after the approval of an application under section 355(b)(1) of this title or section 262(a) of title 42 before studies conducted pursuant to such section 355a of this title, 355c of this title, or section 262(m) of title 42 are completed, submitted, and incorporated into labeling;

(B) the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request;

(C) the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies;

(D) the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under section 355(b)(1) of this title or section 262(a) of title 42; and

(E) the average number, and range of numbers, of amendments to written requests issued, and the time the Secretary requires to review and act on proposed amendments to written requests;

(13) a list of sponsors of applications or holders of approved applications who received exclusivity under such section 355a of this title or such section 262(m) of title 42 after receiving a letter issued under such section 355c(d)(1) of this title for any drug or biological product before the studies referred to in such letter were completed and submitted;

(14) a list of assessments and investigations required under such section 355c of this title;

(15) how many requests under such section 355a of this title for molecular targeted cancer drugs, as defined by subsection (a)(1)(B) of such section 355c of this title, approved prior to 3 years after August 18, 2017, have been issued by the Food and Drug Administration, and how many such requests have been completed; and

(16) the Secretary's assessment of the overall impact of the amendments made by section 504 of the FDA Reauthorization Act of 2017 on the conduct and effectiveness of pediatric cancer research and the orphan drug program, as well any subsequent recommendations.

(c) Stakeholder comment

At least 180 days prior to the submission of each report under subsection (a), the Secretary shall consult with representatives of patient groups (including pediatric patient groups), consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report including suggestions for modifications that would improve pediatric drug research and pediatric labeling of drugs and biological products.

(Pub. L. 112–144, title V, §508, July 9, 2012, 126 Stat. 1045; Pub. L. 115–52, title V, §504(d), Aug. 18, 2017, 131 Stat. 1044.)

Editorial Notes

References in Text

The FDA Reauthorization Act of 2017, referred to in subsec. (b)(11), (16), is Pub. L. 115–52, Aug. 18, 2017, 131 Stat. 1005. Section 504 of the Act amended this section and section 355c of this title. For complete classification of this Act to the Code, see Short Title of 2017 Amendment note set out under section 301 of this title and Tables.

Section 505C–1 of the Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(12), probably means section 505(c) of Pub. L. 115–52, the FDA Reauthorization Act of 2017, which is set out as a note under section 355a of this title. The Federal Food, Drug, and Cosmetic Act does not contain a section 505C–1, and section 505(c) of the FDA Reauthorization Act of 2017 relates to the development and implementation of a plan for earlier submission of pediatric studies under sections 355a and 355c of this title and section 262(m) of Title 42, The Public Health and Welfare.

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

2017—Subsec. (b)(11) to (16). Pub. L. 115–52 added pars. (11) to (16) and struck out former par. (11) which read as follows: "an assessment of the Secretary's efforts to address the suggestions and options described in any prior report issued by the Comptroller General, Institute of Medicine, or the Secretary, and any subsequent reports, including recommendations therein, regarding the topics addressed in the reports under this section, including with respect to—

"(A) improving public access to information from pediatric studies conducted under such sections 355a and 355c of this title; and

"(B) improving the timeliness of pediatric studies and pediatric study planning under such sections 355a and 355c of this title."

Statutory Notes and Related Subsidiaries

Rule of Construction

Nothing in amendment by Pub. L. 115–52 to limit the authority of the Secretary of Health and Human Services to issue written requests under section 355a of this title or section 262(m) of Title 42, The Public Health and Welfare, or to negotiate or implement amendments to such requests proposed by applicants, see section 504(e) of Pub. L. 115–52, set out as a note under section 355c of this title.

Definition of "Secretary"

The term "Secretary" as used in this section means the Secretary of Health and Human Services, see section 503 of Pub. L. 112–144, set out as a note under section 355a of this title.

¹ See References in Text note below.

§355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such internal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry or pediatric rare diseases, and other individuals designated by the Secretary.

(June 25, 1938, ch. 675, §505C, as added Pub. L. 110–85, title IV, §403, Sept. 27, 2007, 121 Stat. 875; amended Pub. L. 112–144, title V, §509(c), July 9, 2012, 126 Stat. 1049; Pub. L. 115–52, title V, §505(f), Aug. 18, 2017, 131 Stat. 1047.)

Editorial Notes

Amendments

2017—Pub. L. 115–52 inserted "or pediatric rare diseases" after "psychiatry".

2012—Pub. L. 112–144 inserted "deferral extensions," after "deferrals," in section catchline and "neonatology," after "pediatric ethics," in text.

§355e. Pharmaceutical security

(a) In general

The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.

(b) Standards development

(1) In general

The Secretary shall, in consultation with the agencies specified in paragraph (4), manufacturers, distributors, pharmacies, and other supply chain stakeholders, prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.

(2) Standardized numeral identifier

Not later than 30 months after September 27, 2007, the Secretary shall develop a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug.

(3) Promising technologies

The standards developed under this subsection shall address promising technologies, which may include—

(A) radio frequency identification technology;

(B) nanotechnology;

(C) encryption technologies; and

(D) other track-and-trace or authentication technologies.

(4) Interagency collaboration

In carrying out this subsection, the Secretary shall consult with Federal health and security agencies, including—

(A) the Department of Justice;

(B) the Department of Homeland Security;

(C) the Department of Commerce; and

(D) other appropriate Federal and State agencies.

(c) Inspection and enforcement

(1) In general

The Secretary shall expand and enhance the resources and facilities of agency components of the Food and Drug Administration involved with regulatory and criminal enforcement of this chapter to secure the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs including biological products and active pharmaceutical ingredients from domestic and foreign sources.

(2) Activities

The Secretary shall undertake enhanced and joint enforcement activities with other Federal and State agencies, and establish regional capacities for the validation of prescription drugs and the inspection of the prescription drug supply chain.

(d) Definition

In this section, the term "prescription drug" means a drug subject to section 353(b)(1) of this title.

(June 25, 1938, ch. 675, §505D, as added Pub. L. 110–85, title IX, §913, Sept. 27, 2007, 121 Stat. 952.)

§355f. Extension of exclusivity period for new qualified infectious disease products

(a) Extension

If the Secretary approves an application pursuant to section 355 of this title for a drug that has been designated as a qualified infectious disease product under subsection (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 355 of this title, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 355 of this title, or the 7-year period described in section 360cc of this title, as applicable, shall be extended by 5 years.

(b) Relation to pediatric exclusivity

Any extension under subsection (a) of a period shall be in addition to any extension of the period under section 355a of this title with respect to the drug.

(c) Limitations

Subsection (a) does not apply to the approval of—

(1) a supplement to an application under section 355(b) of this title for any qualified infectious disease product for which an extension described in subsection (a) is in effect or has expired;

(2) a subsequent application filed with respect to a product approved under section 355 of this title for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength;

(3) a product that does not meet the definition of a qualified infectious disease product under subsection (g) based upon its approved uses; or

(4) an application pursuant to section 262(a) of title 42.

(d) Designation

(1) In general

The manufacturer or sponsor of a drug may request the Secretary to designate a drug as a qualified infectious disease product at any time before the submission of an application under section 355(b) of this title or section 262(a) of title 42 for such drug. The Secretary shall, not later than 60 days after the submission of such a request, determine whether the drug is a qualified infectious disease product.

(2) Limitation

Except as provided in paragraph (3), a designation under this subsection shall not be withdrawn for any reason, including modifications to the list of qualifying pathogens under subsection (f)(2)(C).

(3) Revocation of designation

The Secretary may revoke a designation of a drug as a qualified infectious disease product if the Secretary finds that the request for such designation contained an untrue statement of material fact.

(e) Regulations

(1) In general

Not later than 2 years after July 9, 2012, the Secretary shall adopt final regulations implementing this section, including developing the list of qualifying pathogens described in subsection (f).

(2) Procedure

In promulgating a regulation implementing this section, the Secretary shall—

(A) issue a notice of proposed rulemaking that includes the proposed regulation;

(B) provide a period of not less than 60 days for comments on the proposed regulation; and

(C) publish the final regulation not less than 30 days before the effective date of the regulation.

(3) Restrictions

Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraph (2), except that the Secretary may issue interim guidance for sponsors seeking designation under subsection (d) prior to the promulgation of such regulations.

(4) Designation prior to regulations

The Secretary shall designate drugs as qualified infectious disease products under subsection (d) prior to the promulgation of regulations under this subsection, if such drugs meet the definition of a qualified infectious disease product described in subsection (g).

(f) Qualifying pathogen

(1) Definition

In this section, the term "qualifying pathogen" means a pathogen identified and listed by the Secretary under paragraph (2) that has the potential to pose a serious threat to public health, such as—

(A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus;

(B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;

(C) multi-drug resistant tuberculosis; and

(D) Clostridium difficile.

(2) List of qualifying pathogens

(A) In general

The Secretary shall establish and maintain a list of qualifying pathogens, and shall make public the methodology for developing such list.

(B) Considerations

In establishing and maintaining the list of pathogens described under this section, the Secretary shall—

(i) consider—

(I) the impact on the public health due to drug-resistant organisms in humans;

(II) the rate of growth of drug-resistant organisms in humans;

(III) the increase in resistance rates in humans; and

(IV) the morbidity and mortality in humans; and

(ii) consult with experts in infectious diseases and antibiotic resistance, including the Centers for Disease Control and Prevention, the Food and Drug Administration, medical professionals, and the clinical research community.

(C) Review

Every 5 years, or more often as needed, the Secretary shall review, provide modifications to, and publish the list of qualifying pathogens under subparagraph (A) and shall by regulation revise the list as necessary, in accordance with subsection (e).

(g) Qualified infectious disease product

The term "qualified infectious disease product" means a drug (including a biological product), including an antibacterial or antifungal drug, for human use that—

(1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and

(2) is intended to treat a serious or life-threatening infection, including such an infection caused by—

(A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

(B) qualifying pathogens listed by the Secretary under subsection (f).

(June 25, 1938, ch. 675, §505E, as added Pub. L. 112–144, title VIII, §801(a), July 9, 2012, 126 Stat. 1077; amended Pub. L. 117–328, div. FF, title III, §3212(a), Dec. 29, 2022, 136 Stat. 5826.)

Editorial Notes

Amendments

2022—Subsec. (c)(4). Pub. L. 117–328, §3212(a)(1), added par. (4).

Subsec. (d)(1). Pub. L. 117–328, §3212(a)(2), inserted "or section 262(a) of title 42" after "section 355(b) of this title".

Subsec. (g). Pub. L. 117–328, §3212(a)(3), amended subsec. (g) generally. Prior to amendment, text read as follows: "The term 'qualified infectious disease product' means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—

"(1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

"(2) qualifying pathogens listed by the Secretary under subsection (f)."

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 112–144, title VIII, §801(b), July 9, 2012, 126 Stat. 1079, provided that: "Section 505E of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f], as added by subsection (a), applies only with respect to a drug that is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act [July 9, 2012]."

§355g. Utilizing real world evidence

(a) In general

The Secretary shall establish a program to evaluate the potential use of real world evidence—

(1) to help to support the approval of a new indication for a drug approved under section 355(c) of this title; and

(2) to help to support or satisfy postapproval study requirements.

(b) Real world evidence defined

In this section, the term "real world evidence" means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.

(c) Program framework

(1) In general

Not later than 2 years after December 13, 2016, the Secretary shall establish a draft framework for implementation of the program under this section.

(2) Contents of framework

The framework shall include information describing—

(A) the sources of real world evidence, including ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities;

(B) the gaps in data collection activities;

(C) the standards and methodologies for collection and analysis of real world evidence; and

(D) the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.

(3) Consultation

(A) In general

In developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties.

(B) Process

The consultation under subparagraph (A) may be carried out through approaches such as—

(i) a public-private partnership with the entities described in such subparagraph in which the Secretary may participate;

(ii) a contract, grant, or other arrangement, as the Secretary determines appropriate, with such a partnership or an independent research organization; or

(iii) public workshops with the entities described in such subparagraph.

(d) Program implementation

The Secretary shall, not later than 3 years after December 13, 2016, and in accordance with the framework established under subsection (c), implement the program to evaluate the potential use of real world evidence.

(e) Guidance for industry

The Secretary shall—

(1) utilize the program established under subsection (a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on—

(A) the circumstances under which sponsors of drugs and the Secretary may rely on real world evidence for the purposes described in paragraphs (1) and (2) of subsection (a); and

(B) the appropriate standards and methodologies for collection and analysis of real world evidence submitted for such purposes;

(2) not later than 5 years after December 13, 2016, issue draft guidance for industry as described in paragraph (1); and

(3) not later than 18 months after the close of the public comment period for the draft guidance described in paragraph (2), issue revised draft guidance or final guidance.

(f) Rule of construction

(1) In general

Subject to paragraph (2), nothing in this section prohibits the Secretary from using real world evidence for purposes not specified in this section, provided the Secretary determines that sufficient basis exists for any such nonspecified use.

(2) Standards of evidence and Secretary's authority

This section shall not be construed to alter—

(A) the standards of evidence under—

(i) subsection (c) or (d) of section 355 of this title, including the substantial evidence standard in such subsection (d); or

(ii) section 262(a) of title 42; or

(B) the Secretary's authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.

(June 25, 1938, ch. 675, §505F, as added Pub. L. 114–255, div. A, title III, §3022, Dec. 13, 2016, 130 Stat. 1096; amended Pub. L. 115–52, title IX, §901(c), (d), Aug. 18, 2017, 131 Stat. 1076.)

Editorial Notes

Amendments

2017—Subsec. (b). Pub. L. 115–52, §901(c), substituted "traditional" for "randomized".

Subsec. (d). Pub. L. 115–52, §901(d), substituted "3 years" for "2 years".

§355h. Regulation of certain nonprescription drugs that are marketed without an approved drug application

(a) Nonprescription drugs marketed without an approved application

Nonprescription drugs marketed without an approved drug application under section 355 of this title, as of March 27, 2020, shall be treated in accordance with this subsection.

(1) Drugs subject to a final monograph; category I drugs subject to a tentative final monograph

A drug is deemed to be generally recognized as safe and effective under section 321(p)(1) of this title, not a new drug under section 321(p) of this title, and not subject to section 353(b)(1) of this title, if—

(A) the drug is—

(i) in conformity with the requirements for nonprescription use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in paragraph (2)), the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and

(ii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title; or

(B) the drug is—

(i) classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations;

(ii) in conformity with the proposed requirements for nonprescription use of such tentative final monograph, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and

(iii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title.

(2) Treatment of sunscreen drugs

With respect to sunscreen drugs subject to this section, the applicable requirements in terms of conformity with a final monograph, for purposes of paragraph (1)(A)(i), shall be the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.

(3) Category III drugs subject to a tentative final monograph; category I drugs subject to proposed monograph or advance notice of proposed rulemaking

A drug that is not described in paragraph (1), (2), or (4) is not required to be the subject of an application approved under section 355 of this title, and is not subject to section 353(b)(1) of this title, if—

(A) the drug is—

(i) classified in category III for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such drug issued under part 330 of title 21, Code of Federal Regulations;

(ii) in conformity with—

(I) the conditions of use, including indication and dosage strength, if any, described for such category III drug in such preamble or in an applicable subsequent proposed rule;

(II) the proposed requirements for drugs classified in such tentative final monograph in category I in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the drug; and

(III) the general requirements for nonprescription drugs and conditions or requirements under subsection (b) or (k); and

(iii) in a dosage form that, immediately prior to March 27, 2020, had been used to a material extent and for a material time under section 321(p)(2) of this title; or

(B) the drug is—

(i) classified in category I for safety and effectiveness under a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination for such drug issued under part 330 of title 21, Code of Federal Regulations;

(ii) in conformity with the requirements for nonprescription use of such proposed monograph or advance notice of proposed rulemaking, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsection (b) or (k); and

(iii) in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title.

(4) Category II drugs deemed new drugs

A drug that is classified in category II for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as safe and effective in a proposed rule that is the most recently applicable proposal issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 321(p) of this title, misbranded under section 352(ee) of this title, and subject to the requirement for an approved new drug application under section 355 of this title beginning on the day that is 180 calendar days after March 27, 2020, unless, before such day, the Secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application.

(5) Drugs not GRASE deemed new drugs

A drug that the Secretary has determined not to be generally recognized as safe and effective under section 321(p)(1) of this title under a final determination issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 321(p) of this title, misbranded under section 352(ee) of this title, and subject to the requirement for an approved new drug application under section 355 of this title.

(6) Other drugs deemed new drugs

Except as provided in subsection (m), a drug is deemed to be a new drug under section 321(p) of this title and misbranded under section 352(ee) of this title if the drug—

(A) is not subject to section 353(b)(1) of this title; and

(B) is not described in paragraph (1), (2), (3), (4), or (5), or subsection (b)(1)(B).

(b) Administrative orders

(1) In general

(A) Determination

The Secretary may, on the initiative of the Secretary or at the request of one or more requestors, issue an administrative order determining whether there are conditions under which a specific drug, a class of drugs, or a combination of drugs, is determined to be—

(i) not subject to section 353(b)(1) of this title; and

(ii) generally recognized as safe and effective under section 321(p)(1) of this title.

(B) Effect

A drug or combination of drugs shall be deemed to not require approval under section 355 of this title if such drug or combination of drugs—

(i) is determined by the Secretary to meet the conditions specified in clauses (i) and (ii) of subparagraph (A);

(ii) is marketed in conformity with an administrative order under this subsection;

(iii) meets the general requirements for nonprescription drugs; and

(iv) meets the requirements under subsections (c) and (k).

(C) Standard

The Secretary shall find that a drug is not generally recognized as safe and effective under section 321(p)(1) of this title if—

(i) the evidence shows that the drug is not generally recognized as safe and effective under section 321(p)(1) of this title; or

(ii) the evidence is inadequate to show that the drug is generally recognized as safe and effective under section 321(p)(1) of this title.

(2) Administrative orders initiated by the Secretary

(A) In general

In issuing an administrative order under paragraph (1) upon the Secretary's initiative, the Secretary shall—

(i) make reasonable efforts to notify informally, not later than 2 business days before the issuance of the proposed order, the sponsors of drugs who have a listing in effect under section 360(j) of this title for the drugs or combination of drugs that will be subject to the administrative order;

(ii) after any such reasonable efforts of notification—

(I) issue a proposed administrative order by publishing it on the website of the Food and Drug Administration and include in such order the reasons for the issuance of such order; and

(II) publish a notice of availability of such proposed order in the Federal Register;

(iii) except as provided in subparagraph (B), provide for a public comment period with respect to such proposed order of not less than 45 calendar days; and

(iv) if, after completion of the proceedings specified in clauses (i) through (iii), the Secretary determines that it is appropriate to issue a final administrative order—

(I) issue the final administrative order, together with a detailed statement of reasons, which order shall not take effect until the time for requesting judicial review under paragraph (3)(D)(ii) has expired;

(II) publish a notice of such final administrative order in the Federal Register;

(III) afford requestors of drugs that will be subject to such order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which initially must be requested within 45 calendar days of the issuance of the order, and, for subsequent levels of appeal, within 30 calendar days of the prior decision; and

(IV) except with respect to drugs described in paragraph (3)(B), upon completion of the formal dispute resolution procedure, inform the persons which sought such dispute resolution of their right to request a hearing.

(B) Exceptions

When issuing an administrative order under paragraph (1) on the Secretary's initiative proposing to determine that a drug described in subsection (a)(3) is not generally recognized as safe and effective under section 321(p)(1) of this title, the Secretary shall follow the procedures in subparagraph (A), except that—

(i) the proposed order shall include notice of—

(I) the general categories of data the Secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section 321(p)(1) of this title; and

(II) the format for submissions by interested persons;

(ii) the Secretary shall provide for a public comment period of no less than 180 calendar days with respect to such proposed order, except when the Secretary determines, for good cause, that a shorter period is in the interest of public health; and

(iii) any person who submits data in such comment period shall include a certification that the person has submitted all evidence created, obtained, or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section 321(p)(1) of this title.

(3) Hearings; judicial review

(A) In general

Only a person who participated in each stage of formal dispute resolution under subclause (III) of paragraph (2)(A)(iv) of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under such paragraph with respect to such drug. If a hearing is sought, such person must submit a request for a hearing, which shall be based solely on information in the administrative record, to the Secretary not later than 30 calendar days after receiving notice of the final decision of the formal dispute resolution procedure.

(B) No hearing required with respect to orders relating to certain drugs

(i) In general

The Secretary shall not be required to provide notice and an opportunity for a hearing pursuant to paragraph (2)(A)(iv) if the final administrative order involved relates to a drug—

(I) that is described in subsection (a)(3)(A); and

(II) with respect to which no human or non-human data studies relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug.

(ii) Human data studies and non-human data defined

In this subparagraph:

(I) The term "human data studies" means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies.

(II) The term "non-human data" means data from testing other than with human subjects which provides information concerning safety or effectiveness.

(C) Hearing procedures

(i) Denial of request for hearing

If the Secretary determines that information submitted in a request for a hearing under subparagraph (A) with respect to a final administrative order issued under paragraph (2)(A)(iv) does not identify the existence of a genuine and substantial question of material fact, the Secretary may deny such request. In making such a determination, the Secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies.

(ii) Single hearing for multiple related requests

If more than one request for a hearing is submitted with respect to the same administrative order under subparagraph (A), the Secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate.

(iii) Presiding officer

The presiding officer of a hearing requested under subparagraph (A) shall—

(I) be designated by the Secretary;

(II) not be an employee of the Center for Drug Evaluation and Research; and

(III) not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order.

(iv) Rights of parties to hearing

The parties to a hearing requested under subparagraph (A) shall have the right to present testimony, including testimony of expert witnesses, and to cross-examine witnesses presented by other parties. Where appropriate, the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication.

(v) Final decision

(I) At the conclusion of a hearing requested under subparagraph (A), the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law. The decision of the presiding officer shall be final.

(II) The final decision may not take effect until the period under subparagraph (D)(ii) for submitting a request for judicial review of such decision expires.

(D) Judicial review of final administrative order

(i) In general

The procedures described in section 355(h) of this title shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the United States in lieu of the appellate courts specified in such section.

(ii) Period to submit a request for judicial review

A person eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file such request for judicial review not later than 60 calendar days after the latest of—

(I) the date on which notice of such order is published;

(II) the date on which a hearing with respect to such order is denied under subparagraph (B) or (C)(i);

(III) the date on which a final decision is made following a hearing under subparagraph (C)(v); or

(IV) if no hearing is requested, the date on which the time for requesting a hearing expires.

(4) Expedited procedure with respect to administrative orders initiated by the Secretary

(A) Imminent hazard to the public health

(i) In general

In the case of a determination by the Secretary that a drug, class of drugs, or combination of drugs subject to this section poses an imminent hazard to the public health, the Secretary, after first making reasonable efforts to notify, not later than 48 hours before issuance of such order under this subparagraph, sponsors who have a listing in effect under section 360(j) of this title for such drug or combination of drugs—

(I) may issue an interim final administrative order for such drug, class of drugs, or combination of drugs under paragraph (1), together with a detailed statement of the reasons for such order;

(II) shall publish in the Federal Register a notice of availability of any such order; and

(III) shall provide for a public comment period of at least 45 calendar days with respect to such interim final order.

(ii) Nondelegation

The Secretary may not delegate the authority to issue an interim final administrative order under this subparagraph.

(B) Safety labeling changes

(i) In general

In the case of a determination by the Secretary that a change in the labeling of a drug, class of drugs, or combination of drugs subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug, the Secretary may—

(I) make reasonable efforts to notify informally, not later than 48 hours before the issuance of the interim final order, the sponsors of drugs who have a listing in effect under section 360(j) of this title for such drug or combination of drugs;

(II) after reasonable efforts of notification, issue an interim final administrative order in accordance with paragraph (1) to require such change, together with a detailed statement of the reasons for such order;

(III) publish in the Federal Register a notice of availability of such order; and

(IV) provide for a public comment period of at least 45 calendar days with respect to such interim final order.

(ii) Content of order

An interim final order issued under this subparagraph with respect to the labeling of a drug may provide for new warnings and other information required for safe use of the drug.

(C) Effective date

An order under subparagraph (A) or (B) shall take effect on a date specified by the Secretary.

(D) Final order

After the completion of the proceedings in subparagraph (A) or (B), the Secretary shall—

(i) issue a final order in accordance with paragraph (1);

(ii) publish a notice of availability of such final administrative order in the Federal Register; and

(iii) afford sponsors of such drugs that will be subject to such an order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which must initially be within 45 calendar days of the issuance of the order, and for subsequent levels of appeal, within 30 calendar days of the prior decision.

(E) Hearings

A sponsor of a drug subject to a final order issued under subparagraph (D) and that participated in each stage of formal dispute resolution under clause (iii) of such subparagraph may request a hearing on such order. The provisions of subparagraphs (A), (B), and (C) of paragraph (3), other than paragraph (3)(C)(v)(II), shall apply with respect to a hearing on such order in the same manner and to the same extent as such provisions apply with respect to a hearing on an administrative order issued under paragraph (2)(A)(iv).

(F) Timing

(i) Final order and hearing

The Secretary shall—

(I) not later than 6 months after the date on which the comment period closes under subparagraph (A) or (B), issue a final order in accordance with paragraph (1); and

(II) not later than 12 months after the date on which such final order is issued, complete any hearing under subparagraph (E).

(ii) Dispute resolution request

The Secretary shall specify in an interim final order issued under subparagraph (A) or (B) such shorter periods for requesting dispute resolution under subparagraph (D)(iii) as are necessary to meet the requirements of this subparagraph.

(G) Judicial review

A final order issued pursuant to subparagraph (F) shall be subject to judicial review in accordance with paragraph (3)(D).

(5) Administrative order initiated at the request of a requestor

(A) In general

In issuing an administrative order under paragraph (1) at the request of a requestor with respect to certain drugs, classes of drugs, or combinations of drugs—

(i) the Secretary shall, after receiving a request under this subparagraph, determine whether the request is sufficiently complete and formatted to permit a substantive review;

(ii) if the Secretary determines that the request is sufficiently complete and formatted to permit a substantive review, the Secretary shall—

(I) file the request; and

(II) initiate proceedings with respect to issuing an administrative order in accordance with paragraphs (2) and (3); and

(iii) except as provided in paragraph (6), if the Secretary determines that a request does not meet the requirements for filing or is not sufficiently complete and formatted to permit a substantive review, the requestor may demand that the request be filed over protest, and the Secretary shall initiate proceedings to review the request in accordance with paragraph (2)(A).

(B) Request to initiate proceedings

(i) In general

A requestor seeking an administrative order under paragraph (1) with respect to certain drugs, classes of drugs, or combinations of drugs, shall submit to the Secretary a request to initiate proceedings for such order in the form and manner as specified by the Secretary. Such requestor may submit a request under this subparagraph for the issuance of an administrative order—

(I) determining whether a drug is generally recognized as safe and effective under section 321(p)(1) of this title, exempt from section 353(b)(1) of this title, and not required to be the subject of an approved application under section 355 of this title; or

(II) determining whether a change to a condition of use of a drug is generally recognized as safe and effective under section 321(p)(1) of this title, exempt from section 353(b)(1) of this title, and not required to be the subject of an approved application under section 355 of this title, if, absent such a changed condition of use, such drug is—

(aa) generally recognized as safe and effective under section 321(p)(1) of this title in accordance with subsection (a)(1), (a)(2), or an order under this subsection; or

(bb) subject to subsection (a)(3), but only if such requestor initiates such request in conjunction with a request for the Secretary to determine whether such drug is generally recognized as safe and effective under section 321(p)(1) of this title, which is filed by the Secretary under subparagraph (A)(ii).

(ii) Exception

The Secretary is not required to complete review of a request for a change described in clause (i)(II) if the Secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective under section 321(p)(1) of this title under paragraph (1) and issues a final order announcing that determination.

(iii) Withdrawal

The requestor may withdraw a request under this paragraph, according to the procedures set forth pursuant to subsection (d)(2)(B). Notwithstanding any other provision of this section, if such request is withdrawn, the Secretary may cease proceedings under this subparagraph.

(C) Exclusivity

(i) In general

A final administrative order issued in response to a request under this section shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such order), for a period of 18 months following the effective date of such final order and beginning on the date the requestor may lawfully market such drugs pursuant to the order, to market drugs—

(I) incorporating changes described in clause (ii); and

(II) subject to the limitations under clause (iv).

(ii) Changes described

A change described in this clause is a change subject to an order specified in clause (i), which—

(I) provides for a drug to contain an active ingredient (including any ester or salt of the active ingredient) not previously incorporated in a drug described in clause (iii); or

(II) provides for a change in the conditions of use of a drug, for which new human data studies conducted or sponsored by the requestor (or for which the requestor has an exclusive right of reference) were essential to the issuance of such order.

(iii) Drugs described

The drugs described in this clause are drugs—

(I) specified in subsection (a)(1), (a)(2), or (a)(3);

(II) subject to a final order issued under this section;

(III) subject to a final sunscreen order (as defined in section 360fff(2)(A) of this title); or

(IV) described in subsection (m)(1), other than drugs subject to an active enforcement action under subchapter III of this chapter.

(iv) Limitations on exclusivity

(I) In general

Only one 18-month period under this subparagraph shall be granted, under each order described in clause (i), with respect to changes (to the drug subject to such order) which are either—

(aa) changes described in clause (ii)(I), relating to active ingredients; or

(bb) changes described in clause (ii)(II), relating to conditions of use.

(II) No exclusivity allowed

No exclusivity shall apply to changes to a drug which are—

(aa) the subject of a Tier 2 OTC monograph order request (as defined in section 379j–71 of this title);

(bb) safety-related changes, as defined by the Secretary, or any other changes the Secretary considers necessary to assure safe use; or

(cc) changes related to methods of testing safety or efficacy.

(v) New human data studies defined

In this subparagraph, the term "new human data studies" means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies, the results of which—

(I) have not been relied on by the Secretary to support—

(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title; or

(bb) approval of a drug that was approved under section 355 of this title; and

(II) do not duplicate the results of another study that was relied on by the Secretary to support—

(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title; or

(bb) approval of a drug that was approved under section 355 of this title.

(vi) Notification of drug not available for sale

A requestor that is granted exclusivity with respect to a drug under this subparagraph shall notify the Secretary in writing within 1 year of the issuance of the final administrative order if the drug that is the subject of such order will not be available for sale within 1 year of the date of issuance of such order. The requestor shall include with such notice the—

(I) identity of the drug by established name and by proprietary name, if any;

(II) strength of the drug;

(III) date on which the drug will be available for sale, if known; and

(IV) reason for not marketing the drug after issuance of the order.

(6) Information regarding safe nonprescription marketing and use as condition for filing a generally recognized as safe and effective request

(A) In general

In response to a request under this section that a drug described in subparagraph (B) be generally recognized as safe and effective, the Secretary—

(i) may file such request, if the request includes information specified under subparagraph (C) with respect to safe nonprescription marketing and use of such drug; or

(ii) if the request fails to include information specified under subparagraph (C), shall refuse to file such request and require that nonprescription marketing of the drug be pursuant to a new drug application as described in subparagraph (D).

(B) Drug described

A drug described in this subparagraph is a nonprescription drug which contains an active ingredient not previously incorporated in a drug—

(i) specified in subsection (a)(1), (a)(2), or (a)(3);

(ii) subject to a final order under this section; or

(iii) subject to a final sunscreen order (as defined in section 360fff(2)(A) of this title).

(C) Information demonstrating prima facie safe nonprescription marketing and use

Information specified in this subparagraph, with respect to a request described in subparagraph (A)(i), is—

(i) information sufficient for a prima facie demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the United States as a nonprescription drug under comparable conditions of use;

(ii) if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section 382(b)(1)(A) of this title or designated by the Secretary in accordance with section 382(b)(1)(B) of this title—

(I) for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and

(II) during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the Secretary for such monitoring purposes, including for adverse events associated with nonprescription use of the drug; or

(iii) if the Secretary determines that information described in clause (i) or (ii) is not needed to provide a prima facie demonstration that the drug can be safely marketed and used as a nonprescription drug, such other information the Secretary determines is sufficient for such purposes.

(D) Marketing pursuant to new drug application

In the case of a request described in subparagraph (A)(ii), the drug subject to such request may be resubmitted for filing only if—

(i) the drug is marketed as a nonprescription drug, under conditions of use comparable to the conditions specified in the request, for such period as the Secretary determines appropriate (not to exceed 5 consecutive years) pursuant to an application approved under section 355 of this title; and

(ii) during such period, 1,000,000 retail packages of the drug, or an equivalent quantity as determined by the Secretary, were distributed for retail sale, as determined in such manner as the Secretary finds appropriate.

(E) Rule of application

Except in the case of a request involving a drug described in section 360fff(9) of this title, as in effect on January 1, 2017, if the Secretary refuses to file a request under this paragraph, the requestor may not file such request over protest under paragraph (5)(A)(iii).

(7) Packaging

An administrative order issued under paragraph (2), (4)(A), or (5) may include requirements for the packaging of a drug to encourage use in accordance with labeling. Such requirements may include unit dose packaging, requirements for products intended for use by pediatric populations, requirements to reduce risk of harm from unsupervised ingestion, and other appropriate requirements. This paragraph does not authorize the Food and Drug Administration to require standards or testing procedures as described in part 1700 of title 16, Code of Federal Regulations.

(8) Final and tentative final monographs for category I drugs deemed final administrative orders

(A) In general

A final monograph or tentative final monograph described in subparagraph (B) shall be deemed to be a final administrative order under this subsection and may be amended, revoked, or otherwise modified in accordance with the procedures of this subsection.

(B) Monographs described

For purposes of subparagraph (A), a final monograph or tentative final monograph is described in this subparagraph if it—

(i) establishes conditions of use for a drug described in paragraph (1) or (2) of subsection (a); and

(ii) represents the most recently promulgated version of such conditions, including as modified, in whole or in part, by any proposed or final rule.

(C) Deemed orders include harmonizing technical amendments

The deemed establishment of a final administrative order under subparagraph (A) shall be construed to include any technical amendments to such order as the Secretary determines necessary to ensure that such order is appropriately harmonized, in terms of terminology or cross-references, with the applicable provisions of this chapter (and regulations thereunder) and any other orders issued under this section.

(c) Procedure for minor changes

(1) In general

Minor changes in the dosage form of a drug that is described in paragraph (1) or (2) of subsection (a) or the subject of an order issued under subsection (b) may be made by a requestor without the issuance of an order under subsection (b) if—

(A) the requestor maintains such information as is necessary to demonstrate that the change—

(i) will not affect the safety or effectiveness of the drug; and

(ii) will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product; and

(B) the change is in conformity with the requirements of an applicable administrative order issued by the Secretary under paragraph (3).

(2) Additional information

(A) Access to records

A sponsor shall submit records requested by the Secretary relating to such a minor change under section 374(a)(4) of this title, within 15 business days of receiving such a request, or such longer period as the Secretary may provide.

(B) Insufficient information

If the Secretary determines that the information contained in such records is not sufficient to demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient, the Secretary—

(i) may so inform the sponsor of the drug in writing; and

(ii) if the Secretary so informs the sponsor, shall provide the sponsor of the drug with a reasonable opportunity to provide additional information.

(C) Failure to submit sufficient information

If the sponsor fails to provide such additional information within a time prescribed by the Secretary, or if the Secretary determines that such additional information does not demonstrate that the change does not—

(i) affect the safety or effectiveness of the drug; or

(ii) materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product,

the drug as modified is a new drug under section 321(p) of this title and shall be deemed to be misbranded under section 352(ee) of this title.

(3) Determining whether a change will affect safety or effectiveness

(A) In general

The Secretary shall issue one or more administrative orders specifying requirements for determining whether a minor change made by a sponsor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product, together with guidance for applying those orders to specific dosage forms.

(B) Standard practices

The orders and guidance issued by the Secretary under subparagraph (A) shall take into account relevant public standards and standard practices for evaluating the quality of drugs, and may take into account the special needs of populations, including children.

(d) Confidentiality of information submitted to the Secretary

(1) In general

Subject to paragraph (2), any information, including reports of testing conducted on the drug or drugs involved, that is submitted by a requestor in connection with proceedings on an order under this section (including any minor change under subsection (c)) and is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18 shall not be disclosed to the public unless the requestor consents to that disclosure.

(2) Public availability

(A) In general

Except as provided in subparagraph (B), the Secretary shall—

(i) make any information submitted by a requestor in support of a request under subsection (b)(5)(A) available to the public not later than the date on which the proposed order is issued; and

(ii) make any information submitted by any other person with respect to an order requested (or initiated by the Secretary) under subsection (b), available to the public upon such submission.

(B) Limitations on public availability

Information described in subparagraph (A) shall not be made public if—

(i) the information pertains to pharmaceutical quality information, unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section 321(p)(1) of this title;

(ii) the information is submitted in a requestor-initiated request, but the requestor withdraws such request, in accordance with withdrawal procedures established by the Secretary, before the Secretary issues the proposed order;

(iii) the Secretary requests and obtains the information under subsection (c) and such information is not submitted in relation to an order under subsection (b); or

(iv) the information is of the type contained in raw datasets.

(e) Updates to drug listing information

A sponsor who makes a change to a drug subject to this section shall submit updated drug listing information for the drug in accordance with section 360(j) of this title within 30 calendar days of the date when the drug is first commercially marketed, except that a sponsor who was the order requestor with respect to an order subject to subsection (b)(5)(C) (or a licensee, assignee, or successor in interest of such requestor) shall submit updated drug listing information on or before the date when the drug is first commercially marketed.

(f) Approvals under section 355 of this title

The provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections 355(b)(1), 355(b)(2), and 355(j) of this title. A determination under this section that a drug is not subject to section 353(b)(1) of this title, is generally recognized as safe and effective under section 321(p)(1) of this title, and is not a new drug under section 321(p) of this title shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section 355(b)(2) of this title, so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the drug that is not covered by such determination under this section.

(g) Public availability of administrative orders

The Secretary shall establish, maintain, update (as determined necessary by the Secretary but no less frequently than annually), and make publicly available, with respect to orders issued under this section—

(1) a repository of each final order and interim final order in effect, including the complete text of the order; and

(2) a listing of all orders proposed and under development under subsection (b)(2), including—

(A) a brief description of each such order; and

(B) the Secretary's expectations, if resources permit, for issuance of proposed orders over a 3-year period.

(h) Development advice to sponsors or requestors

The Secretary shall establish procedures under which sponsors or requestors may meet with appropriate officials of the Food and Drug Administration to obtain advice on the studies and other information necessary to support submissions under this section and other matters relevant to the regulation of nonprescription drugs and the development of new nonprescription drugs under this section.

(i) Participation of multiple sponsors or requestors

The Secretary shall establish procedures to facilitate efficient participation by multiple sponsors or requestors in proceedings under this section, including provision for joint meetings with multiple sponsors or requestors or with organizations nominated by sponsors or requestors to represent their interests in a proceeding.

(j) Electronic format

All submissions under this section shall be in electronic format.

(k) Effect on existing regulations governing nonprescription drugs

(1) Regulations of general applicability to nonprescription drugs

Except as provided in this subsection, nothing in this section supersedes regulations establishing general requirements for nonprescription drugs, including regulations of general applicability contained in parts 201, 250, and 330 of title 21, Code of Federal Regulations, or any successor regulations. The Secretary shall establish or modify such regulations by means of rulemaking in accordance with section 553 of title 5.

(2) Regulations establishing requirements for specific nonprescription drugs

(A) The provisions of section 310.545 of title 21, Code of Federal Regulations, as in effect on the day before March 27, 2020, shall be deemed to be a final order under subsection (b).

(B) Regulations in effect on the day before March 27, 2020, establishing requirements for specific nonprescription drugs marketed pursuant to this section (including such requirements in parts 201 and 250 of title 21, Code of Federal Regulations), shall be deemed to be final orders under subsection (b), only as they apply to drugs—

(i) subject to paragraph (1), (2), (3), or (4) of subsection (a); or

(ii) otherwise subject to an order under this section.

(3) Withdrawal of regulations

The Secretary shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter drug review under part 330 and other relevant parts of title 21, Code of Federal Regulations (as in effect on the day before March 27, 2020), or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references. Notwithstanding subchapter II of chapter 5 of title 5, any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the Federal Register (or upon such date as specified in such notice).

(l) Guidance

The Secretary shall issue guidance that specifies—

(1) the procedures and principles for formal meetings between the Secretary and sponsors or requestors for drugs subject to this section;

(2) the format and content of data submissions to the Secretary under this section;

(3) the format of electronic submissions to the Secretary under this section;

(4) consolidated proceedings for appeal and the procedures for such proceedings where appropriate; and

(5) for minor changes in drugs, recommendations on how to comply with the requirements in orders issued under subsection (c)(3).

(m) Rule of construction

(1) In general

This section shall not affect the treatment or status of a nonprescription drug—

(A) that is marketed without an application approved under section 355 of this title as of March 27, 2020;

(B) that is not subject to an order issued under this section; and

(C) to which paragraph (1), (2), (3), (4), or (5) of subsection (a) do not apply.

(2) Treatment of products previously found to be subject to time and extent requirements

(A) Notwithstanding subsection (a), a drug described in subparagraph (B) may only be lawfully marketed, without an application approved under section 355 of this title, pursuant to an order issued under this section.

(B) A drug described in this subparagraph is a drug which, prior to March 27, 2020, the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review (as such phrase "OTC drug review" was used in section 330.14 of title 21, Code of Federal Regulations, as in effect on the day before March 27, 2020).

(3) Preservation of authority

(A) Nothing in paragraph (1) shall be construed to preclude or limit the applicability of any provision of this chapter other than this section.

(B) Nothing in subsection (a) shall be construed to prohibit the Secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective under section 321(p)(1) of this title, as the Secretary determines appropriate.

(n) Investigational new drugs

A drug is not subject to this section if an exemption for investigational use under section 355(i) of this title is in effect for such drug.

(o) Inapplicability of Paperwork Reduction Act

Chapter 35 of title 44 shall not apply to collections of information made under this section.

(p) Inapplicability of notice and comment rulemaking and other requirements

The requirements of subsection (b) shall apply with respect to orders issued under this section instead of the requirements of subchapter II of chapter 5 of title 5.

(q) Definitions

In this section:

(1) The term "nonprescription drug" refers to a drug not subject to the requirements of section 353(b)(1) of this title.

(2) The term "sponsor" refers to any person marketing, manufacturing, or processing a drug that—

(A) is listed pursuant to section 360(j) of this title; and

(B) is or will be subject to an administrative order under this section of the Food and Drug Administration.

(3) The term "requestor" refers to any person or group of persons marketing, manufacturing, processing, or developing a drug.

(June 25, 1938, ch. 675, §505G, as added Pub. L. 116–136, div. A, title III, §3851(a), Mar. 27, 2020, 134 Stat. 435.)

Statutory Notes and Related Subsidiaries

Drugs Excluded From the Over-the-Counter Drug Review

Pub. L. 116–136, div. A, title III, §3853, Mar. 27, 2020, 134 Stat. 454, provided that:

"(a) In General.—Nothing in this Act [probably should be "this subtitle", meaning subtitle F (§§3851–3862) of title III of div. A of Pub. L. 116–136, enacting this section, section 360fff–8 of this title, and subpart 10 of part C of subchapter VII of this chapter, amending sections 352, 360fff–3, 379j–52, 379r, and 381 of this title, repealing section 360fff–5 of this title, and enacting provisions set out as notes under this section and sections 360fff–3, 360fff–6, 379j–52, and 379j–71 of this title] (or the amendments made by this Act) shall apply to any nonprescription drug (as defined in section 505G(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(q)], as added by section 3851 of this subtitle) which was excluded by the Food and Drug Administration from the Over-the-Counter Drug Review in accordance with the paragraph numbered 25 on page 9466 of volume 37 of the Federal Register, published on May 11, 1972.

"(b) Rule of Construction.—Nothing in this section shall be construed to preclude or limit the applicability of any other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)."

Treatment of Authority Regarding Finalization of Sunscreen Monograph

Pub. L. 116–136, div. A, title III, §3854(c), Mar. 27, 2020, 134 Stat. 456, provided that:

"(1) In general.—

"(A) Revision of final sunscreen order.—The Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall amend and revise the final administrative order concerning nonprescription sunscreen (referred to in this subsection as the 'sunscreen order') for which the content, prior to the date of enactment of this Act [Mar. 27, 2020], was represented by the final monograph for sunscreen drug products set forth in part 352 of title 21, Code of Federal Regulations (as in effect on May 21, 1999).

"(B) Issuance of revised sunscreen order; effective date.—A revised sunscreen order described in subparagraph (A) shall be—

"(i) issued in accordance with the procedures described in section 505G(b)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)(2)];

"(ii) issued in proposed form not later than 18 months after the date of enactment of this Act; and

"(iii) issued by the Secretary at least 1 year prior to the effective date of the revised order.

"(2) Reports.—If a revised sunscreen order issued under paragraph (1) does not include provisions related to the effectiveness of various sun protection factor levels, and does not address all dosage forms known to the Secretary to be used in sunscreens marketed in the United States without a new drug application approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the rationale for omission of such provisions from such order, and a plan and timeline to compile any information necessary to address such provisions through such order."

Annual Update to Congress on Appropriate Pediatric Indication for Certain OTC Cough and Cold Drugs

Pub. L. 116–136, div. A, title III, §3855, Mar. 27, 2020, 134 Stat. 457, provided that:

"(a) In General.—Subject to subsection (c), the Secretary of Health and Human Services shall, beginning not later than 1 year after the date of enactment of this Act [Mar. 27, 2020], annually submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a letter describing the progress of the Food and Drug Administration—

"(1) in evaluating the cough and cold monograph described in subsection (b) with respect to children under age 6; and

"(2) as appropriate, revising such cough and cold monograph to address such children through the order process under section 505G(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)], as added by section 3851 of this subtitle.

"(b) Cough and Cold Monograph Described.—The cough and cold monograph described in this subsection consists of the conditions under which nonprescription drugs containing antitussive, expectorant, nasal decongestant, or antihistamine active ingredients (or combinations thereof) are generally recognized as safe and effective, as specified in part 341 of title 21, Code of Federal Regulations (as in effect immediately prior to the date of enactment of this Act), and included in an order deemed to be established under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle.

"(c) Duration of Authority.—The requirement under subsection (a) shall terminate as of the date of a letter submitted by the Secretary of Health and Human Services pursuant to such subsection in which the Secretary indicates that the Food and Drug Administration has completed its evaluation and revised, in a final order, as applicable, the cough and cold monograph as described in subsection (a)(2)."

§356. Expedited approval of drugs for serious or life-threatening diseases or conditions

(a) Designation of a drug as a breakthrough therapy

(1) In general

The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a "breakthrough therapy".)

(2) Request for designation

The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(3) Designation

(A) In general

Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug.

(B) Actions

The actions to expedite the development and review of an application under subparagraph (A) may include, as appropriate—

(i) holding meetings with the sponsor and the review team throughout the development of the drug;

(ii) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable;

(iii) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

(iv) assigning a cross-disciplinary project lead for the Food and Drug Administration review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; and

(v) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment.

(b) Designation of drug as fast track product

(1) In general

The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition, or if the Secretary designates the drug as a qualified infectious disease product under section 355f(d) of this title. (In this section, such a drug is referred to as a "fast track product".)

(2) Request for designation

The sponsor of a new drug may request the Secretary to designate the drug as a fast track product. A request for the designation may be made concurrently with, or at any time after, submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(3) Designation

Within 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a fast track product and shall take such actions as are appropriate to expedite the development and review of the application for approval of such product.

(c) Accelerated approval of a drug for a serious or life-threatening disease or condition, including a fast track product

(1) In general

(A) Accelerated approval

The Secretary may approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 355(c) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. The approval described in the preceding sentence is referred to in this section as "accelerated approval".

(B) Evidence

The evidence to support that an endpoint is reasonably likely to predict clinical benefit under subparagraph (A) may include epidemiological, pathophysiological, therapeutic, pharmacologic, or other evidence developed using biomarkers, for example, or other scientific methods or tools.

(2) Limitation

(A) In general

Approval of a product under this subsection may be subject to 1 or both of the following requirements:

(i) That the sponsor conduct an appropriate postapproval study or studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit.

(ii) That the sponsor submit copies of all promotional materials related to the product during the preapproval review period and, following approval and for such period thereafter as the Secretary determines to be appropriate, at least 30 days prior to dissemination of the materials.

(B) Studies not required

If the Secretary does not require that the sponsor of a product approved under accelerated approval conduct a postapproval study under this paragraph, the Secretary shall publish on the website of the Food and Drug Administration the rationale for why such study is not appropriate or necessary.

(C) Postapproval study conditions

Not later than the date of approval of a product under accelerated approval, the Secretary shall specify the conditions for a postapproval study or studies required to be conducted under this paragraph with respect to such product, which may include enrollment targets, the study protocol, and milestones, including the target date of study completion.

(D) Studies begun before approval

The Secretary may require, as appropriate, a study or studies to be underway prior to approval, or within a specified time period after the date of approval, of the applicable product.

(3) Expedited withdrawal of approval

(A) In general

The Secretary may withdraw approval of a product approved under accelerated approval using expedited procedures described in subparagraph (B) if—

(i) the sponsor fails to conduct any required postapproval study of the product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C);

(ii) a study required to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit of the product fails to verify and describe such effect or benefit;

(iii) other evidence demonstrates that the product is not shown to be safe or effective under the conditions of use; or

(iv) the sponsor disseminates false or misleading promotional materials with respect to the product.

(B) Expedited procedures described

Expedited procedures described in this subparagraph shall consist of, prior to the withdrawal of accelerated approval—

(i) providing the sponsor with—

(I) due notice;

(II) an explanation for the proposed withdrawal;

(III) an opportunity for a meeting with the Commissioner or the Commissioner's designee; and

(IV) an opportunity for written appeal to—

(aa) the Commissioner; or

(bb) a designee of the Commissioner who has not participated in the proposed withdrawal of approval (other than a meeting pursuant to subclause (III)) and is not subordinate of an individual (other than the Commissioner) who participated in such proposed withdrawal;

(ii) providing an opportunity for public comment on the proposal to withdraw approval;

(iii) the publication of a summary of the public comments received, and the Secretary's response to such comments, on the website of the Food and Drug Administration; and

(iv) convening and consulting an advisory committee on issues related to the proposed withdrawal, if requested by the sponsor and if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor's request.

(d) Review of incomplete applications for approval of a fast track product

(1) In general

If the Secretary determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective, the Secretary shall evaluate for filing, and may commence review of portions of, an application for the approval of the product before the sponsor submits a complete application. The Secretary shall commence such review only if the applicant—

(A) provides a schedule for submission of information necessary to make the application complete; and

(B) pays any fee that may be required under section 379h of this title.

(2) Exception

Any time period for review of human drug applications that has been agreed to by the Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use of fees collected under section 379h of this title to expedite the drug development process and the review of human drug applications) shall not apply to an application submitted under paragraph (1) until the date on which the application is complete.

(e) Construction

(1) Purpose

The amendments made by the Food and Drug Administration Safety and Innovation Act and the 21st Century Cures Act to this section are intended to encourage the Secretary to utilize innovative and flexible approaches to the assessment of products under accelerated approval for treatments for patients with serious or life-threatening diseases or conditions and unmet medical needs.

(2) Construction

Nothing in this section shall be construed to alter the standards of evidence under subsection (c) or (d) of section 355 of this title (including the substantial evidence standard in section 355(d) of this title) or under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]. Such sections and standards of evidence apply to the review and approval of products under this section, including whether a product is safe and effective. Nothing in this section alters the ability of the Secretary to rely on evidence that does not come from adequate and well-controlled investigations for the purpose of determining whether an endpoint is reasonably likely to predict clinical benefit as described in subsection (b)(1)(B).

(f) Awareness efforts

The Secretary shall—

(1) develop and disseminate to physicians, patient organizations, pharmaceutical and biotechnology companies, and other appropriate persons a description of the provisions of this section applicable to breakthrough therapies, accelerated approval, and and ¹ fast track products; and

(2) establish a program to encourage the development of surrogate and clinical endpoints, including biomarkers, and other scientific methods and tools that can assist the Secretary in determining whether the evidence submitted in an application is reasonably likely to predict clinical benefit for serious or life-threatening conditions for which significant unmet medical needs exist.

(g) Regenerative advanced therapy

(1) In general

The Secretary, at the request of the sponsor of a drug, shall facilitate an efficient development program for, and expedite review of, such drug if the drug qualifies as a regenerative advanced therapy under the criteria described in paragraph (2).

(2) Criteria

A drug is eligible for designation as a regenerative advanced therapy under this subsection if—

(A) the drug is a regenerative medicine therapy (as defined in paragraph (8));

(B) the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and

(C) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition.

(3) Request for designation

The sponsor of a drug may request the Secretary to designate the drug as a regenerative advanced therapy concurrently with, or at any time after, submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(4) Designation

Not later than 60 calendar days after the receipt of a request under paragraph (3), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (2). If the Secretary determines that the drug meets the criteria, the Secretary shall designate the drug as a regenerative advanced therapy and shall take such actions as are appropriate under paragraph (1). If the Secretary determines that a drug does not meet the criteria for such designation, the Secretary shall include with the determination a written description of the rationale for such determination.

(5) Actions

The sponsor of a regenerative advanced therapy shall be eligible for the actions to expedite development and review of such therapy under subsection (a)(3)(B), including early interactions to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval of an application for the product under subsection (c).

(6) Access to expedited approval pathways

An application for a regenerative advanced therapy under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] may be—

(A) eligible for priority review, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012; and

(B) eligible for accelerated approval under subsection (c), as agreed upon pursuant to subsection (a)(3)(B), through, as appropriate—

(i) surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; or

(ii) reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate.

(7) Postapproval requirements

The sponsor of a regenerative advanced therapy that is granted accelerated approval and is subject to the postapproval requirements under subsection (c) may, as appropriate, fulfill such requirements, as the Secretary may require, through—

(A) the submission of clinical evidence, clinical studies, patient registries, or other sources of real world evidence, such as electronic health records;

(B) the collection of larger confirmatory data sets, as agreed upon pursuant to subsection (a)(3)(B); or

(C) postapproval monitoring of all patients treated with such therapy prior to approval of the therapy.

(8) Definition

For purposes of this section, the term "regenerative medicine therapy" includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act [42 U.S.C. 264] and part 1271 of title 21, Code of Federal Regulations.

(h) Limited population pathway for antibacterial and antifungal drugs

(1) In general

The Secretary may approve an antibacterial or antifungal drug, alone or in combination with one or more other drugs, as a limited population drug pursuant to this subsection only if—

(A) the drug is intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs;

(B) the standards for approval under section 355(c) and (d) of this title, or the standards for licensure under section 351 of the Public Health Service Act [42 U.S.C. 262], as applicable, are met; and

(C) the Secretary receives a written request from the sponsor to approve the drug as a limited population drug pursuant to this subsection.

(2) Benefit-risk consideration

The Secretary's determination of safety and effectiveness of an antibacterial or antifungal drug shall reflect the benefit-risk profile of such drug in the intended limited population, taking into account the severity, rarity, or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment in such limited population. Such drug may be approved under this subsection notwithstanding a lack of evidence to fully establish a favorable benefit-risk profile in a population that is broader than the intended limited population.

(3) Additional requirements

A drug approved under this subsection shall be subject to the following requirements, in addition to any other applicable requirements of this chapter:

(A) Labeling

To indicate that the safety and effectiveness of a drug approved under this subsection has been demonstrated only with respect to a limited population—

(i) all labeling and advertising of an antibacterial or antifungal drug approved under this subsection shall contain the statement "Limited Population" in a prominent manner and adjacent to, and not more prominent than—

(I) the proprietary name of such drug, if any; or

(II) if there is no proprietary name, the established name of the drug, if any, as defined in section 353(e)(3) of this title, or, in the case of a drug that is a biological product, the proper name, as defined by regulation; and

(ii) the prescribing information for the drug required by section 201.57 of title 21, Code of Federal Regulations (or any successor regulation) shall also include the following statement: "This drug is indicated for use in a limited and specific population of patients.".

(B) Promotional material

The sponsor of an antibacterial or antifungal drug subject to this subsection shall submit to the Secretary copies of all promotional materials related to such drug at least 30 calendar days prior to dissemination of the materials.

(4) Other programs

A sponsor of a drug that seeks approval of a drug under this subsection may also seek designation or approval, as applicable, of such drug under other applicable sections or subsections of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.].

(5) Guidance

Not later than 18 months after December 13, 2016, the Secretary shall issue draft guidance describing criteria, processes, and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs. The Secretary shall publish final guidance within 18 months of the close of the public comment period on such draft guidance. The Secretary may approve antibacterial and antifungal drugs under this subsection prior to issuing guidance under this paragraph.

(6) Advice

The Secretary shall provide prompt advice to the sponsor of a drug for which the sponsor seeks approval under this subsection to enable the sponsor to plan a development program to obtain the necessary data for such approval, and to conduct any additional studies that would be required to gain approval of such drug for use in a broader population.

(7) Termination of limitations

If, after approval of a drug under this subsection, the Secretary approves a broader indication for such drug under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], the Secretary may remove any postmarketing conditions, including requirements with respect to labeling and review of promotional materials under paragraph (3), applicable to the approval of the drug under this subsection.

(8) Rules of construction

Nothing in this subsection shall be construed to alter the authority of the Secretary to approve drugs pursuant to this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262], including the standards of evidence and applicable conditions for approval under such chapter or Act, the standards of approval of a drug under such chapter or Act, or to alter the authority of the Secretary to monitor drugs pursuant to such chapter or Act.

(9) Reporting and accountability

(A) Biennial reporting

The Secretary shall report to Congress not less often than once every 2 years on the number of requests for approval, and the number of approvals, of an antibacterial or antifungal drug under this subsection.

(B) GAO report

Not later than December 2021, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the coordination of activities required under section 319E of the Public Health Service Act [42 U.S.C. 247d–5]. Such report shall include a review of such activities, and the extent to which the use of the pathway established under this subsection has streamlined premarket approval for antibacterial or antifungal drugs for limited populations, if such pathway has functioned as intended, if such pathway has helped provide for safe and effective treatment for patients, if such premarket approval would be appropriate for other categories of drugs, and if the authorities under this subsection have affected antibacterial or antifungal resistance.

(June 25, 1938, ch. 675, §506, as added Pub. L. 105–115, title I, §112(a), Nov. 21, 1997, 111 Stat. 2309; amended Pub. L. 112–144, title VIII, §803, title IX, §§901(b), 902(a), July 9, 2012, 126 Stat. 1079, 1083, 1086; Pub. L. 114–255, div. A, title III, §§3033(a), (c), 3042, Dec. 13, 2016, 130 Stat. 1101, 1103, 1112; Pub. L. 117–328, div. FF, title III, §3210(a), Dec. 29, 2022, 136 Stat. 5822.)

Editorial Notes

References in Text

The Food and Drug Administration Safety and Innovation Act, referred to in subsec. (e)(1), is Pub. L. 112–144. For the amendments made to this section by the Act, see 2012 Amendment notes below.

The 21st Century Cures Act, referred to in subsec. (e)(1), is Pub. L. 114–255. For the amendments made to this section by the Act, see 2016 Amendment notes below.

Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsec. (g)(6)(A), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

The Public Health Service Act, referred to in subsec. (h)(4), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Prior Provisions

A prior section 356, act June 25, 1938, ch. 675, §506, as added Dec. 22, 1941, ch. 613, §3, 55 Stat. 851; amended Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(o), Aug. 13, 1993, 107 Stat. 777, related to certification of drugs containing insulin, prior to repeal by Pub. L. 105–115, title I, §125(a)(1), Nov. 21, 1997, 111 Stat. 2325.

Amendments

2022—Subsec. (c)(2). Pub. L. 117–328, §3210(a)(1)(A), (B), (D), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A) and realigned margins, and added subpars. (B) to (D).

Subsec. (c)(2)(A)(i). Pub. L. 117–328, §3210(a)(1)(C), substituted "an appropriate postapproval study or studies" for "appropriate postapproval studies".

Subsec. (c)(3). Pub. L. 117–328, §3210(a)(2)(B), (C), (F), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) to (D) as cls. (i) to (iv), respectively, of subpar. (A) and realigned margins, and added subpar. (B).

Pub. L. 117–328, §3210(a)(2)(A), substituted "described in subparagraph (B)" for "(as prescribed by the Secretary in regulations which shall include an opportunity for an informal hearing)" in introductory provisions.

Subsec. (c)(3)(A)(i). Pub. L. 117–328, §3210(a)(2)(D), substituted "product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C)" for "drug with due diligence".

Subsec. (c)(3)(A)(iii). Pub. L. 117–328, §3210(a)(2)(E), inserted "shown to be" after "product is not".

2016—Subsec. (e). Pub. L. 114–255, §3033(a)(1), transferred subsec. (e) to appear before subsec. (f).

Subsec. (e)(1). Pub. L. 114–255, §3033(c), inserted "and the 21st Century Cures Act" after "Food and Drug Administration Safety and Innovation Act".

Subsec. (g). Pub. L. 114–255, §3033(a)(2), added subsec. (g).

Subsec. (h). Pub. L. 114–255, §3042, added subsec. (h).

2012—Pub. L. 112–144, §901(b), amended section generally. Prior to amendment, section consisted of subsecs. (a) to (d) relating to designation of drugs as fast track products, approval of applications for fast track products, review of incomplete applications for approval of fast track products, and awareness efforts, respectively.

Subsec. (a). Pub. L. 112–144, §902(a)(3), added subsec. (a). Former subsec. (a) redesignated (b).

Subsec. (a)(1). Pub. L. 112–144, §803, amended subsec. (a)(1), as amended by Pub. L. 112–144, §901(b), by inserting ", or if the Secretary designates the drug as a qualified infectious disease product under section 355f(d) of this title" after "such a disease or condition".

Subsecs. (b) to (d). Pub. L. 112–144, §902(a)(1), redesignated subsecs. (a) to (c) as (b) to (d), respectively. Former subsec. (d) relating to awareness efforts redesignated (f).

Subsec. (f). Pub. L. 112–144, §902(a)(2), which directed the redesignation of subsec. (d) as (f), was executed by redesignating the subsec. (d) relating to awareness efforts as (f), to reflect the probable intent of Congress and the subsequent amendment by Pub. L. 114–255, §3033(a)(1), which transferred subsec. (e) to appear before subsec. (f) "relating to awareness efforts".

Subsec. (f)(1). Pub. L. 112–144, §902(a)(4), substituted "applicable to breakthrough therapies, accelerated approval, and" for "applicable to accelerated approval".

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Construction of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3210(f), Dec. 29, 2022, 136 Stat. 5825, provided that: "Nothing in this section [enacting section 356–2 of this title, amending this section and sections 331 and 356b of this title, and enacting provisions set out as a note under this section] (including the amendments made by this section) shall be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for which a notice of proposed withdrawal has been published in the Federal Register prior to the date of enactment of this Act [Dec. 29, 2022]. Such proceedings may continue under procedures in effect prior to the date of enactment of this Act."

Construction of 2016 Amendments

Pub. L. 114–255, div. A, title III, §3033(b), Dec. 13, 2016, 130 Stat. 1103, provided that: "Nothing in this section [amending this section] and the amendments made by this section shall be construed to alter the authority of the Secretary of Health and Human Services—

"(1) to approve drugs pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the Public Health Service Act (42 U.S.C. 262) as authorized prior to the date of enactment of the 21st Century Cures Act [Dec. 13, 2016], including the standards of evidence, and applicable conditions, for approval under such Acts; or

"(2) to alter the authority of the Secretary to require postapproval studies pursuant to such Acts, as authorized prior to the date of enactment of the 21st Century Cures Act."

Pub. L. 114–255, div. A, title III, §3043, Dec. 13, 2016, 130 Stat. 1114, provided that: "Nothing in this subtitle [subtitle E (§§3041–3044) of title III of div. A of Pub. L. 114–255, enacting section 360a–2 of this title, amending this section, sections 352 and 360d of this title, and section 247d–5 of Title 42, The Public Health and Welfare, repealing section 247d–5a of Title 42, and enacting provisions set out as notes under section 360a–2 of this title and section 247d–5 of Title 42], or an amendment made by this subtitle, shall be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under subsection (h) of section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356[(h)]) (as added by section 3042), by health care professionals, or to limit the practice of health care."

Guidance

Pub. L. 117–328, div. FF, title III, §3210(d), Dec. 29, 2022, 136 Stat. 5824, provided that:

"(1) In general.—The Secretary [of Health and Human Services] shall issue guidance describing—

"(A) how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early-stage development meetings with the Food and Drug Administration;

"(B) the use of novel clinical trial designs that may be used to conduct appropriate postapproval studies as may be required under section 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)(2)(A)), as amended by subsection (a);

"(C) the expedited procedures described in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)(3)(B)); and

"(D) considerations related to the use of surrogate or intermediate clinical endpoints that may support the accelerated approval of an application under 506(c)(1)(A) of such Act (21 U.S.C. 356(c)(1)(A)), including considerations in evaluating the evidence related to any such endpoints.

"(2) Final guidance.—The Secretary shall issue—

"(A) draft guidance under paragraph (1) not later than 18 months after the date of enactment of this Act [Dec. 29, 2022]; and

"(B) final guidance not later than 1 year after the close of the public comment period on such draft guidance."

Report on Regenerative Advanced Therapies

Pub. L. 114–255, div. A, title III, §3035, Dec. 13, 2016, 130 Stat. 1103, provided that:

"(a) Report to Congress.—Before March 1 of each calendar year, the Secretary of Health and Human Services shall, with respect to the previous calendar year, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—

"(1) the number and type of applications for approval of regenerative advanced therapies filed, approved or licensed as applicable, withdrawn, or denied; and

"(2) how many of such applications or therapies, as applicable, were granted accelerated approval or priority review.

"(b) Regenerative Advanced Therapy.—In this section, the term 'regenerative advanced therapy' has the meaning given such term in section 506(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356(g)], as added by section 3033 of this Act."

Findings and Sense of Congress on Enhancement of Accelerated Patient Access to New Medical Treatments

Pub. L. 112–144, title IX, §901(a), July 9, 2012, 126 Stat. 1082, as amended by Pub. L. 114–255, div. A, title III, §3101(b)(1), Dec. 13, 2016, 130 Stat. 1156, provided that:

"(1) Findings.—Congress finds as follows:

"(A) The Food and Drug Administration (referred to in this section as the 'FDA') serves a critical role in helping to assure that new medicines are safe and effective. Regulatory innovation is 1 element of the Nation's strategy to address serious or life-threatening diseases or conditions by promoting investment in and development of innovative treatments for unmet medical needs.

"(B) During the 2 decades following the establishment of the accelerated approval mechanism, advances in medical sciences, including genomics, molecular biology, and bioinformatics, have provided an unprecedented understanding of the underlying biological mechanism and pathogenesis of disease. A new generation of modern, targeted medicines is under development to treat serious and life-threatening diseases, some applying drug development strategies based on biomarkers or pharmacogenomics, predictive toxicology, clinical trial enrichment techniques, and novel clinical trial designs, such as adaptive clinical trials.

"(C) As a result of these remarkable scientific and medical advances, the FDA should be encouraged to implement more broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases or conditions, including those for rare diseases or conditions, using a broad range of surrogate or clinical endpoints and modern scientific tools earlier in the drug development cycle when appropriate. This may result in fewer, smaller, or shorter clinical trials for the intended patient population or targeted subpopulation without compromising or altering the high standards of the FDA for the approval of drugs.

"(D) Patients benefit from expedited access to safe and effective innovative therapies to treat unmet medical needs for serious or life-threatening diseases or conditions.

"(E) For these reasons, the statutory authority in effect on the day before the date of enactment of this Act [July 9, 2012] governing expedited approval of drugs for serious or life-threatening diseases or conditions should be amended in order to enhance the authority of the FDA to consider appropriate scientific data, methods, and tools, and to expedite development and access to novel treatments for patients with a broad range of serious or life-threatening diseases or conditions.

"(2) Sense of congress.—It is the sense of Congress that the Food and Drug Administration should apply the accelerated approval and fast track provisions set forth in section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), as amended by this section, to help expedite the development and availability to patients of treatments for serious or life-threatening diseases or conditions while maintaining safety and effectiveness standards for such treatments."

Guidance; Amended Regulations

Pub. L. 112–144, title IX, §901(c), July 9, 2012, 126 Stat. 1085, provided that:

"(1) Draft guidance.—Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall issue draft guidance to implement the amendments made by this section [amending this section]. In developing such guidance, the Secretary shall specifically consider issues arising under the accelerated approval and fast track processes under section 506 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356], as amended by subsection (b), for drugs designated for a rare disease or condition under section 526 of such Act (21 U.S.C. 360bb) and shall also consider any unique issues associated with very rare diseases.

"(2) Final guidance.—Not later than 1 year after the issuance of draft guidance under paragraph (1), and after an opportunity for public comment, the Secretary shall—

"(A) issue final guidance; and

"(B) amend the regulations governing accelerated approval in parts 314 and 601 of title 21, Code of Federal Regulations, as necessary to conform such regulations with the amendment made by subsection (b).

"(3) Consideration.—In developing the guidance under paragraphs (1) and (2)(A) and the amendments under paragraph (2)(B), the Secretary shall consider how to incorporate novel approaches to the review of surrogate endpoints based on pathophysiologic and pharmacologic evidence in such guidance, especially in instances where the low prevalence of a disease renders the existence or collection of other types of data unlikely or impractical.

"(4) Conforming changes.—The Secretary shall issue, as necessary, conforming amendments to the applicable regulations under title 21, Code of Federal Regulations, governing accelerated approval.

"(5) No effect of inaction on requests.—The issuance (or nonissuance) of guidance or conforming regulations implementing the amendment made by subsection (b) shall not preclude the review of, or action on, a request for designation or an application for approval submitted pursuant to section 506 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356], as amended by subsection (b)."

Pub. L. 112–144, title IX, §902(b), July 9, 2012, 126 Stat. 1087, provided that:

"(1) In general.—

"(A) Guidance.—Not later than 18 months after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall issue draft guidance on implementing the requirements with respect to breakthrough therapies, as set forth in section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), as amended by this section. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.

"(B) Amended regulations.—

"(i) In general.—If the Secretary determines that it is necessary to amend the regulations under title 21, Code of Federal Regulations in order to implement the amendments made by this section to section 506(a) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall amend such regulations not later than 2 years after the date of enactment of this Act.

"(ii) Procedure.—In amending regulations under clause (i), the Secretary shall—

"(I) issue a notice of proposed rulemaking that includes the proposed regulation;

"(II) provide a period of not less than 60 days for comments on the proposed regulation; and

"(III) publish the final regulation not less than 30 days before the effective date of the regulation.

"(iii) Restrictions.—Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing the amendments made by this section only as described in clause (ii).

"(2) Requirements.—Guidance issued under this section shall—

"(A) specify the process and criteria by which the Secretary makes a designation under section 506(a)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356(a)(3)]; and

"(B) specify the actions the Secretary shall take to expedite the development and review of a breakthrough therapy pursuant to such designation under such section 506(a)(3), including updating good review management practices to reflect breakthrough therapies."

Pub. L. 105–115, title I, §112(b), Nov. 21, 1997, 111 Stat. 2310, provided that: "Within 1 year after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall issue guidance for fast track products (as defined in [former] section 506(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356(a)(1)]) that describes the policies and procedures that pertain to section 506 of such Act."

¹ So in original.

§356–1. Accelerated approval of priority countermeasures

(a) In general

The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section 356 of this title or as a device granted review priority pursuant to section 360e(d)(5) ¹ of this title. Such a designation may be made prior to the submission of—

(1) a request for designation by the sponsor or applicant; or

(2) an application for the investigation of the drug under section 355(i) of this title or section 262(a)(3) of title 42.

Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.

(b) Use of animal trials

A drug for which approval is sought under section 355(b) of this title or section 262 of title 42 on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123 ¹ may be designated as a fast track product for purposes of this section.

(c) Priority review of drugs and biological products

A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.

(d) Definitions

For purposes of this title: ¹

(1) The term "priority countermeasure" has the meaning given such term in section 247d–6(h)(4) ¹ of title 42.

(2) The term "priority drugs or biological products" means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

(Pub. L. 107–188, title I, §122, June 12, 2002, 116 Stat. 613.)

Editorial Notes

References in Text

Section 360e(d)(5) of this title, referred to in subsec. (a), was struck out and former subsec. (d)(6) redesignated subsec. (d)(5) of section 360e by Pub. L. 114–255, div. A, title III, §3051(c)(1), Dec. 13, 2016, 130 Stat. 1124. Section 360e(d)(5) no longer relates to grants of review priority.

Section 123, referred to in subsec. (b), is section 123 of Pub. L. 107–188, title I, June 12, 2002, 116 Stat. 613, which is not classified to the Code.

This title, referred to in subsec. (d), is title I of Pub. L. 107–188, June 12, 2002, 116 Stat. 596, which enacted this section, section 669a of Title 29, Labor, and sections 244, 245, 247d–3a, 247d–3b, 247d–7a to 247d–7d, 300hh, 300hh–11 to 300hh–13, 1320b–5, and 7257d of Title 42, The Public Health and Welfare, amended sections 247d to 247d–6, 264, 266, 290hh–1, and 5196b of Title 42, and enacted provisions set out as notes preceding section 8101 of Title 38, Veterans' Benefits, and under sections 201, 244, 247d, 247d–6, 300hh, 300hh–12, and 1320b–5 of Title 42. For complete classification of this title to the Code, see Tables.

Section 247d–6(h)(4) of title 42, referred to in subsec. (d)(1), was redesignated section 247d–6(e)(4) by Pub. L. 109–417, title III, §304(3), Dec. 19, 2006, 120 Stat. 2861.

Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in subsec. (d)(2), is section 101(4) of Pub. L. 105–115, which is set out as a note under section 379g of this title.

Codification

Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

¹ See References in Text note below.

§356–2. Accelerated approval Council

(1) In general

Not later than 1 year after December 29, 2022, the Secretary shall establish an intra-agency coordinating council (referred to in this subsection as the "Council") within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated approval across the Food and Drug Administration, pursuant to section 356(c) of this title.

(2) Membership

The members of the Council shall consist of the following senior officials, or a designee of such official, from the Food and Drug Administration and relevant Centers:

(A) The Director of the Center for Drug Evaluation and Research.

(B) The Director of the Center for Biologics Evaluation and Research.

(C) The Director of the Oncology Center of Excellence.

(D) The Director of the Office of New Drugs.

(E) The Director of the Office of Orphan Products Development.

(F) The Director of the Office of Tissues and Advanced Therapies.

(G) The Director of the Office of Medical Policy.

(H) At least 3 directors of review divisions or offices overseeing products approved under accelerated approval, including at least one director within the Office of Neuroscience.

(3) Duties of the Council

(A) Meetings

The Council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval.

(B) Policy development

The Council shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the Food and Drug Administration. Such engagement may include—

(i) developing guidance for Food and Drug Administration staff and best practices for, and across, product review teams, including with respect to communication between sponsors and the Food and Drug Administration and the review of products under accelerated approval;

(ii) providing training for product review teams; and

(iii) advising review divisions on best practices with respect to product-specific development, review, and withdrawal of products under accelerated approval.

(4) Publication of a report

Not later than 1 year after December 29, 2022, and annually thereafter, the Council shall publish on the public website of the Food and Drug Administration a report on the activities of the Council.

(Pub. L. 117–328, div. FF, title III, §3210(e), Dec. 29, 2022, 136 Stat. 5824.)

Editorial Notes

Codification

Section was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Construction

Nothing in section 3210(e) of Pub. L. 117–328, which enacted this section, to be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 356(c) of this title for which a notice of proposed withdrawal has been published in the Federal Register prior to Dec. 29, 2022, see section 3210(f) of Pub. L. 117–328, set out as a Construction of 2022 Amendment note under section 356 of this title.

Definition of "Secretary"

Secretary as used in this section means the Secretary of Health and Human Services, see section 3002 of div. FF of Pub. L. 117–328, set out as a note under section 350a–1 of this title.

§356a. Manufacturing changes

(a) In general

With respect to a drug for which there is in effect an approved application under section 355 or 360b of this title or a license under section 262 of title 42, a change from the manufacturing process approved pursuant to such application or license may be made, and the drug as made with the change may be distributed, if—

(1) the holder of the approved application or license (referred to in this section as a "holder") has validated the effects of the change in accordance with subsection (b); and

(2)(A) in the case of a major manufacturing change, the holder has complied with the requirements of subsection (c); or

(B) in the case of a change that is not a major manufacturing change, the holder complies with the applicable requirements of subsection (d).

(b) Validation of effects of changes

For purposes of subsection (a)(1), a drug made with a manufacturing change (whether a major manufacturing change or otherwise) may be distributed only if, before distribution of the drug as so made, the holder involved validates the effects of the change on the identity, strength, quality, purity, and potency of the drug as the identity, strength, quality, purity, and potency may relate to the safety or effectiveness of the drug.

(c) Major manufacturing changes

(1) Requirement of supplemental application

For purposes of subsection (a)(2)(A), a drug made with a major manufacturing change may be distributed only if, before the distribution of the drug as so made, the holder involved submits to the Secretary a supplemental application for such change and the Secretary approves the application. The application shall contain such information as the Secretary determines to be appropriate, and shall include the information developed under subsection (b) by the holder in validating the effects of the change.

(2) Changes qualifying as major changes

For purposes of subsection (a)(2)(A), a major manufacturing change is a manufacturing change that is determined by the Secretary to have substantial potential to adversely affect the identity, strength, quality, purity, or potency of the drug as they may relate to the safety or effectiveness of a drug. Such a change includes a change that—

(A) is made in the qualitative or quantitative formulation of the drug involved or in the specifications in the approved application or license referred to in subsection (a) for the drug (unless exempted by the Secretary by regulation or guidance from the requirements of this subsection);

(B) is determined by the Secretary by regulation or guidance to require completion of an appropriate clinical study demonstrating equivalence of the drug to the drug as manufactured without the change; or

(C) is another type of change determined by the Secretary by regulation or guidance to have a substantial potential to adversely affect the safety or effectiveness of the drug.

(d) Other manufacturing changes

(1) In general

For purposes of subsection (a)(2)(B), the Secretary may regulate drugs made with manufacturing changes that are not major manufacturing changes as follows:

(A) The Secretary may in accordance with paragraph (2) authorize holders to distribute such drugs without submitting a supplemental application for such changes.

(B) The Secretary may in accordance with paragraph (3) require that, prior to the distribution of such drugs, holders submit to the Secretary supplemental applications for such changes.

(C) The Secretary may establish categories of such changes and designate categories to which subparagraph (A) applies and categories to which subparagraph (B) applies.

(2) Changes not requiring supplemental application

(A) Submission of report

A holder making a manufacturing change to which paragraph (1)(A) applies shall submit to the Secretary a report on the change, which shall contain such information as the Secretary determines to be appropriate, and which shall include the information developed under subsection (b) by the holder in validating the effects of the change. The report shall be submitted by such date as the Secretary may specify.

(B) Authority regarding annual reports

In the case of a holder that during a single year makes more than one manufacturing change to which paragraph (1)(A) applies, the Secretary may in carrying out subparagraph (A) authorize the holder to comply with such subparagraph by submitting a single report for the year that provides the information required in such subparagraph for all the changes made by the holder during the year.

(3) Changes requiring supplemental application

(A) Submission of supplemental application

The supplemental application required under paragraph (1)(B) for a manufacturing change shall contain such information as the Secretary determines to be appropriate, which shall include the information developed under subsection (b) by the holder in validating the effects of the change.

(B) Authority for distribution

In the case of a manufacturing change to which paragraph (1)(B) applies:

(i) The holder involved may commence distribution of the drug involved 30 days after the Secretary receives the supplemental application under such paragraph, unless the Secretary notifies the holder within such 30-day period that prior approval of the application is required before distribution may be commenced.

(ii) The Secretary may designate a category of such changes for the purpose of providing that, in the case of a change that is in such category, the holder involved may commence distribution of the drug involved upon the receipt by the Secretary of a supplemental application for the change.

(iii) If the Secretary disapproves the supplemental application, the Secretary may order the manufacturer to cease the distribution of the drugs that have been made with the manufacturing change.

(June 25, 1938, ch. 675, §506A, as added Pub. L. 105–115, title I, §116(a), Nov. 21, 1997, 111 Stat. 2313.)

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 105–115, title I, §116(b), Nov. 21, 1997, 111 Stat. 2315, provided that: "The amendment made by subsection (a) [enacting this section] takes effect upon the effective date of regulations promulgated by the Secretary of Health and Human Services to implement such amendment, or upon the expiration of the 24-month period beginning on the date of the enactment of this Act [Nov. 21, 1997], whichever occurs first."

§356b. Reports of postmarketing studies

(a) Submission

(1) In general

A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approval of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary.

(2) Accelerated approval

Notwithstanding paragraph (1), a sponsor of a drug approved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under section 356(c) of this title, including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.

(3) Agreements prior to effective date

Any agreement entered into between the Secretary and a sponsor of a drug, prior to November 21, 1997, to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1).

(b) Consideration of information as public information

Any information pertaining to a report described in subsection (a) shall be considered to be public information to the extent that the information is necessary—

(1) to identify the sponsor; and

(2) to establish the status of a study described in subsection (a) and the reasons, if any, for any failure to carry out the study.

(c) Status of studies and reports

The Secretary shall annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies—

(1) that sponsors have entered into agreements to conduct; and

(2) for which reports have been submitted under subsection (a)(1).

(d) Disclosure

If a sponsor fails to complete an agreed upon study required by this section by its original or otherwise negotiated deadline, the Secretary shall publish a statement on the Internet site of the Food and Drug Administration stating that the study was not completed and, if the reasons for such failure to complete the study were not satisfactory to the Secretary, a statement that such reasons were not satisfactory to the Secretary.

(e) Notification

With respect to studies of the type required under section 356(c)(2)(A) of this title or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as each of such sections was in effect on the day before the effective date of this subsection, the Secretary may require that a sponsor who, for reasons not satisfactory to the Secretary, fails to complete by its deadline a study under any of such sections of such type for a drug or biological product (including such a study conducted after such effective date) notify practitioners who prescribe such drug or biological product of the failure to complete such study and the questions of clinical benefit, and, where appropriate, questions of safety, that remain unanswered as a result of the failure to complete such study. Nothing in this subsection shall be construed as altering the requirements of the types of studies required under section 356(c)(2)(A) of this title or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for studies in addition to those of such type.

(June 25, 1938, ch. 675, §506B, as added Pub. L. 105–115, title I, §130(a), Nov. 21, 1997, 111 Stat. 2331; amended Pub. L. 107–188, title V, §506, June 12, 2002, 116 Stat. 693; Pub. L. 112–144, title IX, §902(c), July 9, 2012, 126 Stat. 1088; Pub. L. 117–328, div. FF, title III, §3210(b), Dec. 29, 2022, 136 Stat. 5823.)

Editorial Notes

References in Text

The effective date of this subsection, referred to in subsec. (e), is Oct. 1, 2002, see Effective Date of 2002 Amendment note set out below.

Amendments

2022—Subsec. (a)(2), (3). Pub. L. 117–328 added par. (2) and redesignated former par. (2) as (3).

2012—Subsec. (e). Pub. L. 112–144 substituted "section 356(c)(2)(A) of this title" for "section 356(b)(2)(A) of this title" in two places.

2002—Subsecs. (d), (e). Pub. L. 107–188 added subsecs. (d) and (e).

Statutory Notes and Related Subsidiaries

Effective Date of 2002 Amendment

Pub. L. 107–188, title V, §508, June 12, 2002, 116 Stat. 694, provided that: "The amendments made by this subtitle [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending this section and sections 379g and 379h of this title] shall take effect October 1, 2002."

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Construction of 2022 Amendment

Nothing in amendment made by Pub. L. 117–328 to be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 356(c) of this title for which a notice of proposed withdrawal has been published in the Federal Register prior to Dec. 29, 2022, see section 3210(f) of Pub. L. 117–328, set out as a note under section 356 of this title.

Report to Congressional Committees

Pub. L. 105–115, title I, §130(b), Nov. 21, 1997, 111 Stat. 2331, provided that not later than Oct. 1, 2001, the Secretary was to submit to Congress a report containing a summary of the reports submitted under section 356b of this title and an evaluation and legislative recommendations relating to postmarketing studies of drugs.

§356c. Discontinuance or interruption in the production of life-saving drugs

(a) In general

A manufacturer of a drug—

(1) that is—

(A) life-supporting;

(B) life-sustaining; or

(C) intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 247d of title 42; and

(2) that is not a radio pharmaceutical drug product or any other product as designated by the Secretary,

shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or a permanent discontinuance in the manufacture of an active pharmaceutical ingredient or an interruption in the manufacture of the active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug, and the reasons for such discontinuance or interruption. Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, and if applicable, an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuation or interruption; the expected duration of the interruption; and such other information as the Secretary may require.

(b) Timing

A notice required under subsection (a) shall be submitted to the Secretary—

(1) at least 6 months prior to the date of the discontinuance or interruption; or

(2) if compliance with paragraph (1) is not possible, as soon as practicable.

(c) Distribution

To the maximum extent practicable, the Secretary shall distribute, through such means as the Secretary deems appropriate, information on the discontinuance or interruption of the manufacture of the drugs described in subsection (a) to appropriate organizations, including physician, health provider, and patient organizations, as described in section 356e of this title.

(d) Confidentiality

Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(e) Coordination with Attorney General

Not later than 30 days after the receipt of a notification described in subsection (a), the Secretary shall—

(1) determine whether the notification pertains to a controlled substance subject to a production quota under section 826 of this title; and

(2) if necessary, as determined by the Secretary—

(A) notify the Attorney General that the Secretary has received such a notification;

(B) request that the Attorney General increase the aggregate and individual production quotas under section 826 of this title applicable to such controlled substance and any ingredient therein to a level the Secretary deems necessary to address a shortage of a controlled substance based on the best available market data; and

(C) if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide to the Secretary a written response detailing the basis for the Attorney General's determination.

The Secretary shall make the written response provided under subparagraph (C) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Failure to meet requirements

If a person fails to submit information required under subsection (a) in accordance with subsection (b)—

(1) the Secretary shall issue a letter to such person informing such person of such failure;

(2) not later than 30 calendar days after the issuance of a letter under paragraph (1), the person who receives such letter shall submit to the Secretary a written response to such letter setting forth the basis for noncompliance and providing information required under subsection (a); and

(3) not later than 45 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter and any response to such letter under paragraph (2) available to the public on the Internet Web site of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (d), except that, if the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not notifying as required under subsection (a), the requirements of this paragraph shall not apply.

(g) Expedited inspections and reviews

If, based on notifications described in subsection (a) or any other relevant information, the Secretary concludes that there is, or is likely to be, a drug shortage of a drug described in subsection (a), the Secretary shall, as appropriate—

(1) prioritize and expedite the review of a supplement to a new drug application submitted under section 355(b) of this title, an abbreviated new drug application submitted under section 355(j) of this title, or a supplement to such an application submitted under section 355(j) of this title, that could help mitigate or prevent such shortage; or

(2) prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent such drug shortage.

(h) Definitions

For purposes of this section—

(1) the term "drug"—

(A) means a drug (as defined in section 321(g) of this title) that is intended for human use and that is subject to section 353(b)(1) of this title; and

(B) does not include biological products (as defined in section 262 of title 42), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i);

(2) the term "drug shortage" or "shortage", with respect to a drug, means a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug; and

(3) the term "meaningful disruption"—

(A) means a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product; and

(B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.

(i) Regulations

(1) In general

Not later than 18 months after July 9, 2012, the Secretary shall adopt a final regulation implementing this section.

(2) Contents

Such regulation shall define, for purposes of this section, the terms "life-supporting", "life-sustaining", and "intended for use in the prevention or treatment of a debilitating disease or condition".

(3) Inclusion of biological products

(A) In general

The Secretary may by regulation apply this section to biological products (as defined in section 262 of title 42), including plasma products derived from human plasma protein and their recombinant analogs, if the Secretary determines such inclusion would benefit the public health. Such regulation shall take into account any supply reporting programs and shall aim to reduce duplicative notification.

(B) Rule for vaccines

If the Secretary applies this section to vaccines pursuant to subparagraph (A), the Secretary shall—

(i) consider whether the notification requirement under subsection (a) may be satisfied by submitting a notification to the Centers for Disease Control and Prevention under the vaccine shortage notification program of such Centers; and

(ii) explain the determination made by the Secretary under clause (i) in the regulation.

(4) Procedure

In promulgating a regulation implementing this section, the Secretary shall—

(A) issue a notice of proposed rulemaking that includes the proposed regulation;

(B) provide a period of not less than 60 days for comments on the proposed regulation; and

(C) publish the final regulation not less than 30 days before the regulation's effective date.

(5) Restrictions

Notwithstanding any other provision of Federal law, in implementing this section, the Secretary shall only promulgate regulations as described in paragraph (4).

(j) Risk management plans

Each manufacturer of a drug described in subsection (a) or of any active pharmaceutical ingredient or any associated medical device used for preparation or administration included in the drug, shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which such drug or active pharmaceutical ingredient of such drug is manufactured. A risk management plan under this section shall be subject to inspection and copying by the Secretary pursuant to an inspection or a request under section 374(a)(4) of this title.

(June 25, 1938, ch. 675, §506C, as added Pub. L. 105–115, title I, §131(a), Nov. 21, 1997, 111 Stat. 2332; amended Pub. L. 112–144, title X, §1001(a), July 9, 2012, 126 Stat. 1099; Pub. L. 114–255, div. A, title III, §3101(a)(2)(E), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, §§3111–3112(b), Mar. 27, 2020, 134 Stat. 361, 362; Pub. L. 117–328, div. FF, title II, §2515(a)(1), (b)(1), Dec. 29, 2022, 136 Stat. 5806.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328, §2515(b)(1), substituted "in the United States," for "in the United States,," in concluding provisions.

Subsec. (g). Pub. L. 117–328, §2515(a)(1), made technical amendment to directory language of Pub. L. 116–136, §3111(1). See 2020 Amendment note below.

2020—Subsec. (a). Pub. L. 116–136, §3112(a)(2), in concluding provisions, inserted ", or a permanent discontinuance in the manufacture of an active pharmaceutical ingredient or an interruption in the manufacture of the active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug," before "and the reasons" and inserted at end "Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, and if applicable, an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuation or interruption; the expected duration of the interruption; and such other information as the Secretary may require."

Subsec. (a)(1)(C). Pub. L. 116–136, §3112(a)(1), inserted "or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 247d of title 42" after "during surgery".

Subsec. (g). Pub. L. 116–136, §3111(1), as amended by Pub. L. 117–328, §2515(a)(1), substituted "the Secretary shall, as appropriate" for "the Secretary may" in introductory provisions.

Subsec. (g)(1). Pub. L. 116–136, §3111(2), inserted "prioritize and" before "expedite the review".

Subsec. (g)(2). Pub. L. 116–136, §3111(3), inserted "prioritize and" before "expedite an inspection".

Subsec. (j). Pub. L. 116–136, §3112(b), added subsec. (j).

2016—Subsec. (c). Pub. L. 114–255, §3101(a)(2)(E)(i), substituted "discontinuance" for "discontinuation".

Subsec. (g)(1). Pub. L. 114–255, §3101(a)(2)(E)(ii), substituted "section 355(j) of this title, that could help" for "section 355(j) of this title that could help".

2012—Pub. L. 112–144 amended section generally. Prior to amendment, section related to discontinuance of life saving products.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title II, §2515(b)(2), Dec. 29, 2022, 136 Stat. 5806, provided that: "The amendment made by paragraph (1) [amending this section] shall take effect as if included in section 3112 of division A of the CARES Act (Public Law 116–136)."

Effective Date of 2020 Amendment

Pub. L. 116–136, div. A, title III, §3112(g), Mar. 27, 2020, 134 Stat. 363, provided that: "The amendments made by this section [amending this section and sections 356e, 360, and 374 of this title] and section 3111 [amending this section] shall take effect on the date that is 180 days after the date of enactment of this Act [Mar. 27, 2020]."

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Construction of 2020 Amendment: Confidentiality

Pub. L. 116–136, div. A, title III, §3112(f), Mar. 27, 2020, 134 Stat. 363, provided that: "Nothing in the amendments made by this section [see Effective Date of 2020 Amendment note set out above] shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code."

Effect of Notification

Pub. L. 112–144, title X, §1001(b), July 9, 2012, 126 Stat. 1101, provided that: "The submission of a notification to the Secretary of Health and Human Services (referred to in this title [see Tables for classification] as the 'Secretary') for purposes of complying with the requirement in section 506C(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356c(a)] (as amended by subsection (a)) shall not be construed—

"(1) as an admission that any product that is the subject of such notification violates any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or

"(2) as evidence of an intention to promote or market the product for an indication or use for which the product has not been approved by the Secretary."

Executive Documents

Ex. Ord. No. 13588. Reducing Prescription Drug Shortages

Ex. Ord. No. 13588, Oct. 31, 2011, 76 F.R. 68295, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. Shortages of pharmaceutical drugs pose a serious and growing threat to public health. While a very small number of drugs in the United States experience a shortage in any given year, the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent. The affected medicines include cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment and prevention of serious diseases and life-threatening conditions.

For example, over approximately the last 5 years, data indicates that the use of sterile injectable cancer treatments has increased by about 20 percent, without a corresponding increase in production capacity. While manufacturers are currently in the process of expanding capacity, it may be several years before production capacity has been significantly increased. Interruptions in the supplies of these drugs endanger patient safety and burden doctors, hospitals, pharmacists, and patients. They also increase health care costs, particularly because some participants in the market may use shortages as opportunities to hoard scarce drugs or charge exorbitant prices.

The Food and Drug Administration (FDA) in the Department of Health and Human Services has been working diligently to address this problem through its existing regulatory framework. While the root problems and many of their solutions are outside of the FDA's control, the agency has worked cooperatively with manufacturers to prevent or mitigate shortages by expediting review of certain regulatory submissions and adopting a flexible approach to drug manufacturing and importation regulations where appropriate. As a result, the FDA prevented 137 drug shortages in 2010 and 2011. Despite these successes, however, the problem of drug shortages has continued to grow.

Many different factors contribute to drug shortages, and solving this critical public health problem will require a multifaceted approach. An important factor in many of the recent shortages appears to be an increase in demand that exceeds current manufacturing capacity. While manufacturers are in the process of expanding capacity, one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible. The FDA cannot begin to work with manufacturers or use the other tools at its disposal until it knows there is a potential problem. Similarly, early disclosure of a shortage can help hospitals, doctors, and patients make alternative arrangements before a shortage becomes a crisis. However, drug manufacturers have not consistently provided the FDA with adequate notice of potential shortages.

As part of my Administration's broader effort to work with manufacturers, health care providers, and other stakeholders to prevent drug shortages, this order directs the FDA to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines.

Sec. 2. Broader Reporting of Manufacturing Discontinuances. To the extent permitted by law, the FDA shall use all appropriate administrative tools, including its authority to interpret and administer the reporting requirements in 21 U.S.C. 356c, to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life-supporting or life-sustaining, or that prevent debilitating disease.

Sec. 3. Expedited Regulatory Review. To the extent practicable, and consistent with its statutory responsibility to ensure the safety and effectiveness of the drug supply, the FDA shall take steps to expand its current efforts to expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages. In prioritizing and allocating its limited resources, the FDA should consider both the severity of the shortage and the importance of the affected drug to public health.

Sec. 4. Review of Certain Behaviors by Market Participants. The FDA shall communicate to the Department of Justice (DOJ) any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices. The DOJ shall then determine whether these activities are consistent with applicable law. Based on its determination, DOJ, in coordination with other State and Federal regulatory agencies as appropriate, should undertake whatever enforcement actions, if any, it deems appropriate.

Sec. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) authority granted by law to an agency, or the head thereof; or

(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

Barack Obama.      

§356c–1. Annual reporting on drug shortages

(a) Annual reports to Congress

Not later than March 31 of each calendar year, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report, with respect to the preceding calendar year, on drug shortages that—

(1) specifies the number of manufacturers that submitted a notification to the Secretary under section 356c(a) of this title during such calendar year;

(2) describes the communication between the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program, including the Food and Drug Administration's procedures for enabling and ensuring such communication;

(3) describes the coordination and alignment activities undertaken pursuant to section 356d(g) of this title;

(4) provides the number of reports that were required under section 374(b)(2) of this title to be sent to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages, and the number of such reports that were sent;

(5)(A) lists the major actions taken by the Secretary to prevent or mitigate the drug shortages described in paragraph (9);

(B) in the list under subparagraph (A), includes—

(i) the number of applications and supplements for which the Secretary expedited review under section 356c(g)(1) of this title during such calendar year; and

(ii) the number of establishment inspections or reinspections that the Secretary expedited under section 356c(g)(2) of this title during such calendar year;

(6) describes the coordination between the Food and Drug Administration and the Drug Enforcement Administration on efforts to prevent or alleviate drug shortages;

(7) identifies the number of and describes the instances in which the Food and Drug Administration exercised regulatory flexibility and discretion to prevent or alleviate a drug shortage;

(8) lists the names of manufacturers that were issued letters under section 356c(f) of this title; and

(9) specifies the number of drug shortages occurring during such calendar year, as identified by the Secretary.

(b) Trend analysis

The Secretary is authorized to retain a third party to conduct a study, if the Secretary believes such a study would help clarify the causes, trends, or solutions related to drug shortages.

(c) Definition

In this section, the term "drug shortage" or "shortage" has the meaning given such term in section 356c of this title.

(June 25, 1938, ch. 675, §506C–1, as added Pub. L. 112–144, title X, §1002, July 9, 2012, 126 Stat. 1102; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(F), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 117–328, div. FF, title III, §3616(b)(1), Dec. 29, 2022, 136 Stat. 5875.)

Applicability of Amendment

Amendment of section by Pub. L. 117–328 applicable with respect to reports submitted under section 356c–1 of this title on or after Mar. 31, 2024. See 2022 Amendment notes below.

Editorial Notes

Amendments

2022—Subsec. (a)(3) to (5). Pub. L. 117–328, §3616(b)(1)(A), (B), added pars. (3) and (4) and redesignated former par. (3) as (5). Former pars. (4) and (5) redesignated (6) and (7), respectively.

Subsec. (a)(5)(A). Pub. L. 117–328, §3616(b)(1)(C), substituted "paragraph (9)" for "paragraph (7)".

Subsec. (a)(6) to (9). Pub. L. 117–328, §3616(b)(1)(A), redesignated pars. (4) to (7) as (6) to (9), respectively.

2016—Subsec. (a). Pub. L. 114–255, in introductory provisions, substituted "Not later than March 31 of each calendar year," for "Not later than the end of calendar year 2013, and not later than the end of each calendar year thereafter," and inserted ", with respect to the preceding calendar year," after "a report".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3616(b)(2), Dec. 29, 2022, 136 Stat. 5875, provided that: "The amendments made by paragraph (1) [amending this section] shall apply with respect to reports submitted under section 506C–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c–1) on or after March 31, 2024."

§356d. Coordination; task force and strategic plan

(a) Task force and strategic plan

(1) In general

(A) Task force

As soon as practicable after July 9, 2012, the Secretary shall establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages.

(B) Strategic plan

The strategic plan described in subparagraph (A) shall include—

(i) plans for enhanced interagency and intra-agency coordination, communication, and decisionmaking;

(ii) plans for ensuring that drug shortages are considered when the Secretary initiates a regulatory action that could precipitate a drug shortage or exacerbate an existing drug shortage;

(iii) plans for effective communication with outside stakeholders, including who the Secretary should alert about potential or actual drug shortages, how the communication should occur, and what types of information should be shared;

(iv) plans for considering the impact of drug shortages on research and clinical trials; and

(v) an examination of whether to establish a "qualified manufacturing partner program", as described in subparagraph (C).

(C) Description of program

In conducting the examination of a "qualified manufacturing partner program" under subparagraph (B)(v), the Secretary—

(i) shall take into account that—

(I) a "qualified manufacturer", for purposes of such program, would need to have the capability and capacity to supply products determined or anticipated to be in shortage; and

(II) in examining the capability and capacity to supply products in shortage, the "qualified manufacturer" could have a site that manufactures a drug listed under section 356e of this title or have the capacity to produce drugs in response to a shortage within a rapid timeframe; and

(ii) shall examine whether incentives are necessary to encourage the participation of "qualified manufacturers" in such a program.

(D) Consultation

In carrying out this paragraph, the task force shall ensure consultation with the appropriate offices within the Food and Drug Administration, including the Office of the Commissioner, the Center for Drug Evaluation and Research, the Office of Regulatory Affairs, and employees within the Department of Health and Human Services with expertise regarding drug shortages. The Secretary shall engage external stakeholders and experts as appropriate.

(2) Timing

Not later than 1 year after July 9, 2012, the task force shall—

(A) publish the strategic plan described in paragraph (1); and

(B) submit such plan to Congress.

(b) Communication

The Secretary shall ensure that, prior to any enforcement action or issuance of a warning letter that the Secretary determines could reasonably be anticipated to lead to a meaningful disruption in the supply in the United States of a drug described under section 356c(a) of this title, there is communication with the appropriate office of the Food and Drug Administration with expertise regarding drug shortages regarding whether the action or letter could cause, or exacerbate, a shortage of the drug.

(c) Action

If the Secretary determines, after the communication described in subsection (b), that an enforcement action or a warning letter could reasonably cause or exacerbate a shortage of a drug described under section 356c(a) of this title, then the Secretary shall evaluate the risks associated with the impact of such shortage upon patients and those risks associated with the violation involved before taking such action or issuing such letter, unless there is imminent risk of serious adverse health consequences or death to humans.

(d) Reporting by other entities

The Secretary shall identify or establish a mechanism by which health care providers and other third-party organizations may report to the Secretary evidence of a drug shortage.

(e) Review and construction

No determination, finding, action, or omission of the Secretary under this section shall—

(1) be subject to judicial review; or

(2) be construed to establish a defense to an enforcement action by the Secretary.

(f) Temporary sunset

Subsection (a) shall cease to be effective on the date that is 5 years after July 9, 2012. Subsections (b), (c), and (e) shall not be in effect during the period beginning 5 years after July 9, 2012, and ending on December 29, 2022. Subsections (b), (c), and (e) shall be in effect beginning on December 29, 2022.

(g) Coordination

The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program regarding—

(1) the reviews of reports shared pursuant to section 374(b)(2) of this title; and

(2) any feedback or corrective or preventive actions in response to such reports.

(June 25, 1938, ch. 675, §506D, as added Pub. L. 112–144, title X, §1003, July 9, 2012, 126 Stat. 1103; amended Pub. L. 117–328, div. FF, title III, §3616(a), Dec. 29, 2022, 136 Stat. 5874.)

Editorial Notes

Amendments

2022—Subsec. (f). Pub. L. 117–328, §3616(a)(2), amended subsec. (f) generally. Prior to amendment, text read as follows: "Subsections (a), (b), (c), and (e) shall cease to be effective on the date that is 5 years after July 9, 2012."

Subsec. (g). Pub. L. 117–328, §3616(a)(1), added subsec. (g).

§356e. Drug shortage list

(a) Establishment

The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.

(b) Contents

For each drug on such list, the Secretary shall include the following information:

(1) The name of the drug in shortage, including the National Drug Code number for such drug.

(2) The name of each manufacturer of such drug.

(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories:

(A) Requirements related to complying with good manufacturing practices.

(B) Regulatory delay.

(C) Shortage of an active ingredient.

(D) Shortage of an inactive ingredient component.

(E) Discontinuance of the manufacture of the drug.

(F) Delay in shipping of the drug.

(G) Demand increase for the drug.

(4) The estimated duration of the shortage as determined by the Secretary.

(c) Public availability

(1) In general

Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.

(2) Trade secrets and confidential information

Nothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5.

(3) Public health exception

The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or section 356c(c) of this title if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients).

(d) Interagency notification

Not later than 180 days after March 27, 2020, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.

(June 25, 1938, ch. 675, §506E, as added Pub. L. 112–144, title X, §1004, July 9, 2012, 126 Stat. 1104; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(G), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, §3112(c), Mar. 27, 2020, 134 Stat. 362.)

Editorial Notes

Amendments

2020—Subsec. (d). Pub. L. 116–136 added subsec. (d).

2016—Subsec. (b)(3)(E). Pub. L. 114–255, which directed substitution of "discontinuance" for "discontinuation", was executed by substituting "Discontinuance" for "Discontinuation" to reflect the probable intent of Congress.

Statutory Notes and Related Subsidiaries

Effective Date of 2020 Amendment

Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.

§356f. Hospital repackaging of drugs in shortage

(a) Definitions

In this section:

(1) Drug

The term "drug" excludes any controlled substance (as such term is defined in section 802 of this title).

(2) Health system

The term "health system" means a collection of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients.

(3) Repackage

For the purposes of this section only, the term "repackage", with respect to a drug, means to divide the volume of a drug into smaller amounts in order to—

(A) extend the supply of a drug in response to the placement of the drug on a drug shortage list under section 356e of this title; and

(B) facilitate access to the drug by hospitals within the same health system.

(b) Exclusion from registration

Notwithstanding any other provision of this chapter, a hospital shall not be considered an establishment for which registration is required under section 360 of this title solely because it repackages a drug and transfers it to another hospital within the same health system in accordance with the conditions in subsection (c)—

(1) during any period in which the drug is listed on the drug shortage list under section 356e of this title; or

(2) during the 60-day period following any period described in paragraph (1).

(c) Conditions

Subsection (b) shall only apply to a hospital, with respect to the repackaging of a drug for transfer to another hospital within the same health system, if the following conditions are met:

(1) Drug for intrasystem use only

In no case may a drug that has been repackaged in accordance with this section be sold or otherwise distributed by the health system or a hospital within the system to an entity or individual that is not a hospital within such health system.

(2) Compliance with State rules

Repackaging of a drug under this section shall be done in compliance with applicable State requirements of each State in which the drug is repackaged and received.

(d) Termination

This section shall not apply on or after the date on which the Secretary issues final guidance that clarifies the policy of the Food and Drug Administration regarding hospital pharmacies repackaging and safely transferring repackaged drugs to other hospitals within the same health system during a drug shortage.

(June 25, 1938, ch. 675, §506F, as added Pub. L. 112–144, title X, §1007, July 9, 2012, 126 Stat. 1106.)

§356g. Standards for regenerative medicine and regenerative advanced therapies

(a) In general

Not later than 2 years after December 13, 2016, the Secretary, in consultation with the National Institute of Standards and Technology and stakeholders (including regenerative medicine and advanced therapies manufacturers and clinical trial sponsors, contract manufacturers, academic institutions, practicing clinicians, regenerative medicine and advanced therapies industry organizations, and standard setting organizations), shall facilitate an effort to coordinate and prioritize the development of standards and consensus definition of terms, through a public process, to support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to the manufacturing processes and controls of such products.

(b) Activities

(1) In general

In carrying out this section, the Secretary shall continue to—

(A) identify opportunities to help advance the development of regenerative medicine therapies and regenerative advanced therapies;

(B) identify opportunities for the development of laboratory regulatory science research and documentary standards that the Secretary determines would help support the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies through regulatory predictability; and

(C) work with stakeholders, such as those described in subsection (a), as appropriate, in the development of such standards.

(2) Regulations and guidance

Not later than 1 year after the development of standards as described in subsection (a), the Secretary shall review relevant regulations and guidance and, through a public process, update such regulations and guidance as the Secretary determines appropriate.

(c) Definitions

For purposes of this section, the terms "regenerative medicine therapy" and "regenerative advanced therapy" have the meanings given such terms in section 356(g) of this title.

(June 25, 1938, ch. 675, §506G, as added Pub. L. 114–255, div. A, title III, §3036, Dec. 13, 2016, 130 Stat. 1104; amended Pub. L. 115–52, title IX, §901(b), Aug. 18, 2017, 131 Stat. 1076.)

Editorial Notes

Amendments

2017—Subsec. (b)(1)(A). Pub. L. 115–52 substituted "identify" for "identity".

Statutory Notes and Related Subsidiaries

Guidance Regarding Devices Used in the Recovery, Isolation, or Delivery of Regenerative Advanced Therapies

Pub. L. 114–255, div. A, title III, §3034, Dec. 13, 2016, 130 Stat. 1103, provided that:

"(a) Draft Guidance.—Not later than 1 year after the date of enactment of the 21st Century Cures Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. In doing so, the Secretary shall specifically address—

"(1) how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination device and cell or tissue products;

"(2) what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device;

"(3) when the Food and Drug Administration considers it is necessary, if ever, for the intended use of a device to be limited to a specific intended use with only one particular type of cell; and

"(4) application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.

"(b) Final Guidance.—Not later than 12 months after the close of the period for public comment on the draft guidance under subsection (a), the Secretary of Health and Human Services shall finalize such guidance."

§356h. Competitive generic therapies

(a) In general

The Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under section 355(j) of this title for such drug.

(b) Designation process

(1) Request

The applicant may request the Secretary to designate the drug as a competitive generic therapy.

(2) Timing

A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 355(j) of this title.

(3) Criteria

A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.

(4) Designation

Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may—

(A) determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and

(B) if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.

(c) Actions

In expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:

(1) Hold meetings with the applicant and the review team throughout the development of the drug prior to submission of the application for such drug under section 355(j) of this title.

(2) Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.

(3) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to drug-device combination products and other complex products.

(4) Assign a cross-disciplinary project lead—

(A) to facilitate an efficient review of the development program and application, including manufacturing inspections; and

(B) to serve as a scientific liaison between the review team and the applicant.

(d) Reporting requirement

Not later than one year after the date of the approval of an application under section 355(j) of this title with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval.

(e) Definitions

In this section:

(1) The term "generic drug" means a drug that is approved pursuant to section 355(j) of this title.

(2) The term "inadequate generic competition" means, with respect to a drug, there is not more than one approved drugs ¹ on the list of drugs described in section 355(j)(7)(A) of this title (not including drugs on the discontinued section of such list) that is—

(A) the reference listed drug; or

(B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.

(3) The term "reference listed drug" means the listed drug (as such term is used in section 355(j) of this title) for the drug involved.

(June 25, 1938, ch. 675, §506H, as added Pub. L. 115–52, title VIII, §803(a), Aug. 18, 2017, 131 Stat. 1070.)

Statutory Notes and Related Subsidiaries

Guidance; Amended Regulations

Pub. L. 115–52, title VIII, §803(b), Aug. 18, 2017, 131 Stat. 1071, provided that:

"(1) In general.—

"(A) Issuance.—The Secretary of Health and Human Services shall—

"(i) not later than 18 months after the date of enactment of this Act [Aug. 18, 2017], issue draft guidance on section 506H of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356h], as added by subsection (a); and

"(ii) not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H.

"(B) Contents.—The guidance issued under this paragraph shall—

"(i) specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);

"(ii) specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and

"(iii) include good review management practices for competitive generic therapies.

"(2) Amended regulations.—The Secretary of Health and Human Services shall issue or revise any regulations as may be necessary to carry out this section not later than 2 years after the date of enactment of this Act [Aug. 18, 2017]."

¹ So in original. Probably should be "drug".

§356i. Prompt reports of marketing status

(a) Notification of withdrawal

The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall notify the Secretary in writing 180 days prior to withdrawing the approved drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall include with such notice the—

(1) National Drug Code;

(2) identity of the drug by established name (or, in the case of a biological product, the proper name) and by proprietary name, if any;

(3) new drug application number, abbreviated application number, or biologics license application number;

(4) strength of the drug;

(5) date on which the drug is expected to no longer be available for sale; and

(6) reason for withdrawal of the drug.

(b) Notification of drug not available for sale

The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall notify the Secretary in writing within 180 calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of such date of approval. The holder shall include with such notice the—

(1) identity of the drug by established name (or, in the case of a biological product, the proper name) and by proprietary name, if any;

(2) new drug application number, abbreviated application number, or biologics license application number;

(3) strength of the drug;

(4) date on which the drug will be available for sale, if known; and

(5) reason for not marketing the drug after approval.

(c) Additional one-time report

Within 180 days of December 29, 2022, all holders of applications approved under subsection (a) or (k) of section 262 of title 42 shall review the information in the list published under section 262(k)(9)(A) of title 42 and shall submit a written notice to the Secretary—

(1) stating that all of the application holder's biological products in the list published under such section 262(k)(9)(A) of title 42 that are not listed as discontinued are available for sale; or

(2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder's biological products that are in the list published under such section 262(k)(9)(A) of title 42 and not listed as discontinued, but have been discontinued from sale or never have been available for sale.

(d) Failure to meet requirements

If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may—

(1) move the application holder's drugs from the active section of the list published under section 355(j)(7)(A) of this title to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with section 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness; and

(2) identify the application holder's biological products as discontinued in the list published under section 262(k)(9)(A) of title 42, except that the Secretary shall remove from the list in accordance with section 262(k)(9)(B) of such title biological products for which the license has been revoked or suspended for reasons of safety, purity, or potency.

(e) Updates

The Secretary shall update the list published under section 355(j)(7)(A) of this title based on the information provided under subsections (a), (b), and (c) by moving drugs that are not available for sale from the active section to the discontinued section of the list, except that drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with section 355(j)(7)(C) of this title. The Secretary shall update the list published under section 262(k)(9)(A) of title 42 based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that biological products for which the license has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in accordance with section 262(k)(9)(B) of title 42. The Secretary shall make monthly updates to the lists referred to in the preceding sentences based on the information provided pursuant to subsections (a) and (b), and shall update such lists based on the information provided under subsection (c) as soon as practicable.

(f) Limitation on use of notices

Any notice submitted under this section shall not be made public by the Secretary and shall be used solely for the purpose of the updates described in subsection (e).

(June 25, 1938, ch. 675, §506I, as added Pub. L. 115–52, title VIII, §804, Aug. 18, 2017, 131 Stat. 1071; amended Pub. L. 117–328, div. FF, title III, §3201, Dec. 29, 2022, 136 Stat. 5808.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328, §3201(a)(1)(A), substituted "The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42" for "The holder of an application approved under subsection (c) or (j) of section 355 of this title" in introductory provisions.

Subsec. (a)(2). Pub. L. 117–328, §3201(a)(1)(B), substituted "established name (or, in the case of a biological product, the proper name)" for "established name".

Subsec. (a)(3). Pub. L. 117–328, §3201(a)(1)(C), substituted ", abbreviated application number, or biologics license application number" for "or abbreviated application number".

Subsec. (b). Pub. L. 117–328, §3201(a)(2)(A), substituted "The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42" for "The holder of an application approved under subsection (c) or (j)" in introductory provisions.

Subsec. (b)(1). Pub. L. 117–328, §3201(a)(2)(B), substituted "established name (or, in the case of a biological product, the proper name)" for "established name".

Subsec. (b)(2). Pub. L. 117–328, §3201(a)(2)(C), substituted ", abbreviated application number, or biologics license application number" for "or abbreviated application number".

Subsec. (c). Pub. L. 117–328, §3201(b), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to an additional one-time report to be done within 180 days of Aug. 18, 2017.

Subsec. (d). Pub. L. 117–328, §3201(c)(1), added subsec. (d) and struck out former subsec. (d). Prior to amendment, text read as follows: "If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may move the application holder's drugs from the active section of the list published under subsection 355(j)(7)(A) of this title to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with subsection 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety of effectiveness."

Subsec. (e). Pub. L. 117–328, §3201(d), substituted "section 355(j)(7)(A) of this title" for "subsection 355(j)(7)(A) of this title" and "section 355(j)(7)(C) of this title" for "subsection 355(j)(7)(C) of this title".

Pub. L. 117–328, §3201(c)(2), inserted "The Secretary shall update the list published under section 262(k)(9)(A) of title 42 based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that biological products for which the license has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in accordance with section 262(k)(9)(B) of title 42." before "The Secretary shall make monthly updates" and substituted "monthly updates to the lists referred to in the preceding sentences" for "monthly updates to the list" and "and shall update such lists based on" for "and shall update the list based on".

§356j. Discontinuance or interruption in the production of medical devices

(a) In general

A manufacturer of a device that—

(1) is critical to public health during a public health emergency, including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery; or

(2) for which the Secretary determines that information on potential meaningful supply disruptions of such device is needed during, or in advance of, a public health emergency;

shall, during, or in advance of, a public health emergency declared by the Secretary under section 247d of title 42, notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the device (except for discontinuances as a result of an approved modification of the device) or an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States, and the reasons for such discontinuance or interruption.

(b) Timing

A notice required under subsection (a) shall be submitted to the Secretary—

(1) at least 6 months prior to the date of the discontinuance or interruption; or

(2) if compliance with paragraph (1) is not possible, as soon as practicable.

(c) Distribution

(1) Public availability

To the maximum extent practicable, subject to paragraph (2), the Secretary shall distribute, through such means as the Secretary determines appropriate, information on the discontinuance or interruption of the manufacture of devices reported under subsection (a) to appropriate organizations, including physician, health provider, patient organizations, and supply chain partners, as appropriate and applicable, as described in subsection (g).

(2) Public health exception

The Secretary may choose not to make information collected under this section publicly available pursuant to this section if the Secretary determines that disclosure of such information would adversely affect the public health, such as by increasing the possibility of unnecessary over purchase of product, component parts, or other disruption of the availability of medical products to patients.

(d) Confidentiality

Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(e) Failure to meet requirements

If a person fails to submit information required under subsection (a) in accordance with subsection (b)—

(1) the Secretary shall issue a letter to such person informing such person of such failure;

(2) not later than 30 calendar days after the issuance of a letter under paragraph (1), the person who receives such letter shall submit to the Secretary a written response to such letter setting forth the basis for noncompliance and providing information required under subsection (a); and

(3) not later than 45 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter and any response to such letter under paragraph (2) available to the public on the internet website of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (d), except that, if the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not notifying as required under subsection (a), the requirements of this paragraph shall not apply.

(f) Expedited inspections and reviews

If, based on notifications described in subsection (a) or (h) or any other relevant information, the Secretary concludes that there is, or is likely to be, a shortage of an ¹ device, the Secretary shall, as appropriate—

(1) prioritize and expedite the review of a submission under section 360c(f)(2) of this title, 360e of this title, review of a notification under section 360(k) of this title, or 360j(m) of this title for a device that could help mitigate or prevent such shortage; or

(2) prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent such shortage.

(g) Device shortage list

(1) Establishment

The Secretary shall establish and maintain an up-to-date list of devices that are determined by the Secretary to be in shortage in the United States.

(2) Contents

For each device included on the list under paragraph (1), the Secretary shall include the following information:

(A) The category or name of the device in shortage.

(B) The name of each manufacturer of such device.

(C) The reason for the shortage, as determined by the Secretary, selecting from the following categories:

(i) Requirements related to complying with good manufacturing practices.

(ii) Regulatory delay.

(iii) Shortage or discontinuance of a component or part.

(iv) Discontinuance of the manufacture of the device.

(v) Delay in shipping of the device.

(vi) Delay in sterilization of the device.

(vii) Demand increase for the device.

(viii) Facility closure.

(D) The estimated duration of the shortage as determined by the Secretary.

(3) Public availability

(A) In general

Subject to subparagraphs (B) and (C), the Secretary shall make the information in the list under paragraph (1) publicly available.

(B) Trade secrets and confidential information

Nothing in this subsection shall be construed to alter or amend section 1905 of title 18 or section 552(b)(4) of title 5.

(C) Public health exception

The Secretary may elect not to make information collected under this subsection publicly available if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of the device to patients).

(h) Additional notifications

The Secretary may receive voluntary notifications from a manufacturer of a device that is life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery, or any other device the Secretary determines to be critical to the public health, pertaining to a permanent discontinuance in the manufacture of the device (except for any discontinuance as a result of an approved modification of the device) or an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States, and the reasons for such discontinuance or interruption.

(i) Rule of construction

Nothing in this section shall be construed to affect the authority of the Secretary on March 27, 2020, to expedite the review of devices under section 360e of this title, section 360e–3 of this title relating to the priority review program for devices, and section 360bbb–3 of this title relating to the emergency use authorization authorities.

(j) Definitions

In this section:

(1) Meaningful disruption

The term "meaningful disruption"—

(A) means a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product;

(B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time, not to exceed 6 months;

(C) does not include interruptions in manufacturing of components or raw materials so long as such interruptions do not result in a shortage of the device and the manufacturer expects to resume operations in a reasonable period of time; and

(D) does not include interruptions in manufacturing that do not lead to a reduction in procedures or diagnostic tests associated with a medical device designed to perform more than one procedure or diagnostic test.

(2) Shortage

The term "shortage", with respect to a device, means a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.

(June 25, 1938, ch. 675, §506J, as added Pub. L. 116–136, div. A, title III, §3121, Mar. 27, 2020, 134 Stat. 363; amended Pub. L. 117–328, div. FF, title II, §2514(a), Dec. 29, 2022, 136 Stat. 5805.)

Editorial Notes

Amendments

2022—Subsec. (f). Pub. L. 117–328, §2514(a)(1), inserted "or (h)" after "subsection (a)" in introductory provisions.

Subsecs. (h) to (j). Pub. L. 117–328, §2514(a)(2), (3), added subsec. (h) and redesignated former subsecs. (h) and (i) as (i) and (j), respectively.

Statutory Notes and Related Subsidiaries

Guidance on Voluntary Notifications of Discontinuance or Interruption of Device Manufacture

Pub. L. 117–328, div. FF, title II, §2514(b), Dec. 29, 2022, 136 Stat. 5806, provided that: "Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall issue draft guidance to facilitate voluntary notifications under subsection (h) of section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j), as added by subsection (a). Such guidance shall include a description of circumstances in which a voluntary notification under such subsection (h) may be appropriate, recommended timeframes for such a notification, the process for receiving such a notification, and actions the Secretary may take to mitigate or prevent a shortage resulting from a discontinuance or interruption in the manufacture of a device for which such notification is received. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance."

Guidance on Device Shortage Notification Requirement

Pub. L. 117–328, div. FF, title II, §2514(c), Dec. 29, 2022, 136 Stat. 5806, provided that: "Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall issue or revise draft guidance regarding requirements under section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j). Such guidance shall include a list of each device product code for which a manufacturer of such device is required to notify the Secretary in accordance with section 506J."

¹ So in original. Probably should be "a".

§356k. Platform technologies

(a) In general

The Secretary shall establish a program for the designation of platform technologies that meet the criteria described in subsection (b).

(b) Criteria

A platform technology incorporated within or utilized by a drug or biological product is eligible for designation as a designated platform technology under this section if—

(1) the platform technology is incorporated in, or utilized by, a drug approved under section 355 of this title or a biological product licensed under section 351 of the Public Health Service Act [42 U.S.C. 262];

(2) preliminary evidence submitted by the sponsor of the approved or licensed drug described in paragraph (1), or a sponsor that has been granted a right of reference to data submitted in the application for such drug, demonstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse effect on quality, manufacturing, or safety; and

(3) data or information submitted by the applicable person under paragraph (2) indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the drug development or manufacturing process and to the review process.

(c) Request for designation

A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)] for the investigation of a drug that incorporates or utilizes the platform technology that is the subject of the request.

(d) Designation

(1) In general

Not later than 90 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the platform technology that is the subject of the request meets the criteria described in subsection (b).

(2) Designation

If the Secretary determines that the platform technology meets the criteria described in subsection (b), the Secretary shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate.

(3) Determination not to designate

If the Secretary determines that the platform technology does not meet the criteria under subsection (b), the Secretary shall include with the determination not to designate the technology a written description of the rationale for such determination.

(4) Revocation of designation

The Secretary may revoke a designation made under paragraph (2), if the Secretary determines that the designated platform technology no longer meets the criteria described in subsection (b). The Secretary shall communicate the determination to revoke a designation to the requesting sponsor in writing, including a description of the rationale for such determination.

(5) Applicability

Nothing in this section shall prevent a product that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eligible under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.].

(e) Actions

The Secretary may take actions to expedite the development and review of an application for a drug that incorporates or utilizes a designated platform technology, including—

(1) engaging in early interactions with the sponsor to discuss the use of the designated platform technology and what is known about such technology, including data previously submitted that is relevant to establishing, as applicable, safety or efficacy under section 355(b) of this title or safety, purity, or potency under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)];

(2) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug that proposes to use the designated platform technology to ensure that the development program designed to gather data necessary for approval or licensure is as efficient as practicable, which may include holding meetings with the sponsor and the review team throughout the development of the drug; and

(3) considering inspectional findings, including prior findings, related to the manufacture of a drug that incorporates or utilizes the designated platform technology.

(f) Leveraging data from designated platform technologies

The Secretary shall, consistent with applicable standards for approval, authorization, or licensure under this chapter and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under section 355(b) of this title or section 351(a) of the Public Health Service Act or a request for emergency use authorization under section 360bbb–3 of this title, in order to support approval, licensure, or authorization, to reference or rely upon data and information within an application or request for a drug or biological product that incorporates or utilizes the same platform technology designated under subsection (d), provided that—

(1) such data and information was submitted by the same sponsor, pursuant to the application for the drug with respect to which designation of the designated platform technology under subsection (d) was granted; or

(2) the sponsor relying on such data and information received a right of reference to such data and information from the sponsor described in paragraph (1).

(g) Changes to a designated platform technology

A sponsor of more than one application approved under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for drugs that incorporate or utilize a designated platform technology may submit a single supplemental application for proposed changes to the designated platform technology that may be applicable to more than one such drug that incorporates or utilizes the same designated platform technology. Such supplemental application may cross-reference data and information submitted in other applications and may include one or more comparability protocols regarding how such changes to the platform technology would be made for each applicable drug or biological product.

(h) Definitions

For purposes of this section:

(1) The term "platform technology" means a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of any such technologies that the Secretary determines to be appropriate, that the sponsor demonstrates—

(A) is incorporated in or utilized by a drug or biological product and is essential to the structure or function of such drug or biological product;

(B) can be adapted for, incorporated into, or utilized by, more than one drug or biological product sharing common structural elements; and

(C) facilitates the manufacture or development of more than one drug or biological product through a standardized production or manufacturing process or processes.

(2) The term "designated platform technology" means a platform technology that is designated as a platform technology under subsection (d).

(i) Rule of construction

Nothing in this section shall be construed to—

(1) alter the authority of the Secretary to approve drugs pursuant to section 505 of this Act [21 U.S.C. 355] or license biological products pursuant to section 351 of the Public Health Service Act [42 U.S.C. 262], including standards of evidence and applicable conditions for approval or licensure under the applicable Act; or

(2) confer any new rights with respect to the permissibility of a sponsor of an application for a drug product or biological product referencing information contained in another application submitted by the holder of an approved application under section 355(c) of this title or of a license under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)].

(June 25, 1938, ch. 675, §506K, as added Pub. L. 117–328, div. FF, title II, §2503(a), Dec. 29, 2022, 136 Stat. 5798.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (d)(5), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Statutory Notes and Related Subsidiaries

Guidance

Pub. L. 117–328, div. FF, title II, §2503(b), Dec. 29, 2022, 136 Stat. 5801, provided that: "Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall issue draft guidance on the implementation of this section. Such guidance shall include examples of drugs that can be manufactured using platform technologies, including drugs that contain or consist of vectors and nucleic acids, information about the Secretary's review of platform technologies, information regarding submitting for designation, considerations for persons submitting a request for designation who have been granted a right of reference, the implementation of the designated platform technology designation program, efficiencies that may be achieved in the development and review of products that incorporate or utilize designated platform technologies, and recommendations and requirements for making and reporting manufacturing changes to a designated platform technology in accordance with section 506K(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356k(g)] (as added by subsection (a)) and section 506A of such Act (21 U.S.C. 356a), as applicable."

§356l. Advanced manufacturing technologies designation program

(a) In general

Not later than 1 year after December 29, 2022, the Secretary shall initiate a program under which persons may request designation of an advanced manufacturing technology as described in subsection (b).

(b) Designation process

The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such drugs, as advanced manufacturing technologies. A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug while maintaining equivalent, or providing superior, drug quality, including by—

(1) reducing development time for a drug using the designated manufacturing method; or

(2) increasing or maintaining the supply of—

(A) a drug that is life-supporting, life-sustaining, or of critical importance to providing health care; or

(B) a drug that is on the drug shortage list under section 356e of this title.

(c) Evaluation and designation of an advanced manufacturing technology

(1) Submission

A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection (b) in a particular context of use. The Secretary may facilitate the development and review of such data or information by—

(A) providing timely advice to, and interactive communication with, such person regarding the development of the method of manufacturing; and

(B) involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable.

(2) Evaluation and designation

Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under paragraph (1) and the criteria described in subsection (b).

(d) Review of advanced manufacturing technologies

If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall—

(1) expedite the development and review of an application submitted under section 355 of this title or section 262 of title 42, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology; and

(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under section 355 of this title or section 262 of title 42, including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted.

(e) Implementation and evaluation of advanced manufacturing technologies program

(1) Public meeting

The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after December 29, 2022, to discuss, and obtain input and recommendations from relevant stakeholders regarding—

(A) the goals and scope of the program under this section, and the framework, procedures, and requirements suitable for such program; and

(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs.

(2) Program guidance

(A) In general

The Secretary shall—

(i) not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and implementation of the program under this section; and

(ii) not later than 2 years after December 29, 2022, issue final guidance regarding the implementation of such program.

(B) Content

The guidance described in subparagraph (A) shall address—

(i) the process by which a person may request a designation under subsection (b);

(ii) the data and information that a person requesting such a designation is required to submit under subsection (c), and how the Secretary intends to evaluate such submissions;

(iii) the process to expedite the development and review of applications under subsection (d); and

(iv) the criteria described in subsection (b) for eligibility for such a designation.

(3) Report

Not later than 3 years after December 29, 2022, and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing a description and evaluation of the program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following:

(A) The number of persons that have requested designations and that have been granted designations.

(B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.

(C) The average number of calendar days for completion of evaluations under subsection (c)(2).

(D) An analysis of the factors in data submissions that result in determinations to designate and not to designate after evaluation under subsection (c)(2).

(E) The number of applications received under section 355 of this title or section 262 of title 42, including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.

(f) Sunset

The Secretary—

(1) may not consider any requests for designation submitted under subsection (c) after October 1, 2032; and

(2) may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection (b) prior to such date, if the Secretary determines such activities are in the interest of the public health.

(June 25, 1938, ch. 675, §506L, as added Pub. L. 117–328, div. FF, title III, §3213, Dec. 29, 2022, 136 Stat. 5826.)

§357. Qualification of drug development tools

(a) Process for qualification

(1) In general

The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—

(A)(i) a requestor initiates such process by submitting a letter of intent to the Secretary; and

(ii) the Secretary accepts or declines to accept such letter of intent;

(B)(i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and

(ii) the Secretary accepts or declines to accept the qualification plan; and

(C)(i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;

(ii) the Secretary determines whether to accept such qualification package for review; and

(iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.

(2) Acceptance and review of submissions

(A) In general

Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as "qualification submissions").

(B) Acceptance factors; nonacceptance

The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.

(C) Prioritization of qualification review

The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including—

(i) as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and

(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.

(D) Engagement of external experts

The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3).

(3) Review of full qualification package

The Secretary shall—

(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and

(B) determine whether the drug development tool at issue is qualified for its proposed context of use.

(4) Qualification

The Secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3).

(b) Effect of qualification

(1) In general

A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2).

(2) Use of a drug development tool

Subject to paragraph (3), a drug development tool qualified under this section may be used for—

(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or

(B) supporting the investigational use of a drug or biological product under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(3) Rescission or modification

(A) In general

The Secretary may rescind or modify a determination under this section to qualify a drug development tool if the Secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a determination may be based on new information that calls into question the basis for such qualification.

(B) Meeting for review

If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall, on request, be granted a meeting with the Secretary to discuss the basis of the Secretary's decision to rescind or modify the determination before the effective date of the rescission or modification.

(c) Transparency

(1) In general

Subject to paragraph (3), the Secretary shall make publicly available, and update on at least a biannual basis, on the Internet website of the Food and Drug Administration the following:

(A) Information with respect to each qualification submission under the qualification process under subsection (a), including—

(i) the stage of the review process applicable to the submission;

(ii) the date of the most recent change in stage status;

(iii) whether external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package; and

(iv) submissions from requestors under the qualification process under subsection (a), including any data and evidence contained in such submissions, and any updates to such submissions.

(B) The Secretary's formal written determinations in response to such qualification submissions.

(C) Any rescissions or modifications under subsection (b)(3) of a determination to qualify a drug development tool.

(D) Summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection (a).

(E) A comprehensive list of—

(i) all drug development tools qualified under subsection (a); and

(ii) all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(2) Relation to Trade Secrets Act

Information made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18.

(3) Applicability

(A) In general

Nothing in this section shall be construed as authorizing or directing the Secretary to disclose—

(i) any information contained in an application submitted under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] that is confidential commercial or trade secret information subject to section 552(b)(4) of title 5 or section 1905 of title 18; or

(ii) in the case of a drug development tool that may be used to support the development of a qualified countermeasure, security countermeasure, or qualified pandemic or epidemic product, as defined in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [42 U.S.C. 247d–6a, 247d–6b, 247d–6d], any information that the Secretary determines has a significant potential to affect national security.

(B) Public acknowledgment

In the case that the Secretary, pursuant to subparagraph (A)(ii), does not make information publicly available, the Secretary shall provide on the internet website of the Food and Drug Administration an acknowledgment of the information that has not been disclosed, pursuant to subparagraph (A)(ii).

(d) Rule of construction

Nothing in this section shall be construed—

(1) to alter the standards of evidence under subsection (c) or (d) of section 355 of this title, including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act [42 U.S.C. 262] (as applicable); or

(2) to limit the authority of the Secretary to approve or license products under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], as applicable (as in effect before December 13, 2016).

(e) Definitions

In this section:

(1) Biomarker

The term "biomarker"—

(A) means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and

(B) includes a surrogate endpoint.

(2) Biomedical research consortia

The term "biomedical research consortia" means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 1001(a) of title 20), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.

(3) Clinical outcome assessment

The term "clinical outcome assessment" means—

(A) a measurement of a patient's symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and

(B) includes a patient-reported outcome.

(4) Context of use

The term "context of use" means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review.

(5) Drug development tool

The term "drug development tool" includes—

(A) a biomarker;

(B) a clinical outcome assessment; and

(C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.

(6) Patient-reported outcome

The term "patient-reported outcome" means a measurement based on a report from a patient regarding the status of the patient's health condition without amendment or interpretation of the patient's report by a clinician or any other person.

(7) Qualification

The terms "qualification" and "qualified" mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this chapter.

(8) Requestor

The term "requestor" means an entity or entities, including a drug sponsor or a biomedical research consortia, seeking to qualify a drug development tool for a proposed context of use under this section.

(9) Surrogate endpoint

The term "surrogate endpoint" means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—

(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or

(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 356(c) of this title.

(June 25, 1938, ch. 675, §507, as added Pub. L. 114–255, div. A, title III, §3011(a), Dec. 13, 2016, 130 Stat. 1086; amended Pub. L. 116–22, title VII, §705(e), June 24, 2019, 133 Stat. 964.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (d)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Prior Provisions

A prior section 357, act June 25, 1938, ch. 675, §507, as added July 6, 1945, ch. 281, §3, 59 Stat. 463; amended Mar. 10, 1947, ch. 16, §3, 61 Stat. 12; July 13, 1949, ch. 305, §2, 63 Stat. 409; Aug. 5, 1953, ch. 334, §2, 67 Stat. 389; Pub. L. 87–781, title I, §§105(a), (b), (d)–(f), 106(a), (b), Oct. 10, 1962, 76 Stat. 785, 786, 787; Pub. L. 90–399, §105(b), July 13, 1968, 82 Stat. 352; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(p), Aug. 13, 1993, 107 Stat. 777, related to certification of drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, prior to repeal by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

Amendments

2019—Subsec. (c)(3). Pub. L. 116–22 designated existing provisions as subpar. (A), inserted heading and "or directing" after "authorizing" in text, substituted "disclose—" for "disclose", designated remainder of existing provisions as cl. (i) of subpar. (A), substituted ";or" for period at end, and added cl. (ii) of subpar. (A) and subpar. (B).

Statutory Notes and Related Subsidiaries

Guidance

Pub. L. 114–255, div. A, title III, §3011(b), Dec. 13, 2016, 130 Stat. 1089, provided that:

"(1) In general.—The Secretary of Health and Human Services (referred to in this section [this note] as the 'Secretary') shall, in consultation with biomedical research consortia (as defined in subsection (e) of section 507 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 357] (as added by subsection (a)) and other interested parties through a collaborative public process, issue guidance to implement such section 507 that—

"(A) provides a conceptual framework describing appropriate standards and scientific approaches to support the development of biomarkers delineated under the taxonomy established under paragraph (3);

"(B) with respect to the qualification process under such section 507—

"(i) describes the requirements that entities seeking to qualify a drug development tool under such section shall observe when engaging in such process;

"(ii) outlines reasonable timeframes for the Secretary's review of letters, qualification plans, or full qualification packages submitted under such process; and

"(iii) establishes a process by which such entities or the Secretary may consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the Secretary in the review of qualification plans and full qualification submissions under such section; and

"(C) includes such other information as the Secretary determines appropriate.

"(2) Timing.—Not later than 3 years after the date of the enactment of this Act [Dec. 13, 2016], the Secretary shall issue draft guidance under paragraph (1) on the implementation of section 507 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 357] (as added by subsection (a)). The Secretary shall issue final guidance on the implementation of such section not later than 6 months after the date on which the comment period for the draft guidance closes.

"(3) Taxonomy.—

"(A) In general.—For purposes of informing guidance under this subsection, the Secretary shall, in consultation with biomedical research consortia and other interested parties through a collaborative public process, establish a taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug development.

"(B) Public availability.—Not later than 2 years after the date of the enactment of this Act, the Secretary shall make such taxonomy publicly available in draft form for public comment. The Secretary shall finalize the taxonomy not later than 1 year after the close of the public comment period."

§358. Authority to designate official names

(a) Necessity or desirability; use in official compendiums; infringement of trademarks

The Secretary may designate an official name for any drug or device if he determines that such action is necessary or desirable in the interest of usefulness and simplicity. Any official name designated under this section for any drug or device shall be the only official name of that drug or device used in any official compendium published after such name has been prescribed or for any other purpose of this chapter. In no event, however, shall the Secretary establish an official name so as to infringe a valid trademark.

(b) Review of names in official compendiums

Within a reasonable time after October 10, 1962, and at such other times as he may deem necessary, the Secretary shall cause a review to be made of the official names by which drugs are identified in the official United States Pharmacopoeia, the official Homoeopathic Pharmacopoeia of the United States, and the official National Formulary, and all supplements thereto, and at such times as he may deem necessary shall cause a review to be made of the official names by which devices are identified in any official compendium (and all supplements thereto) to determine whether revision of any of those names is necessary or desirable in the interest of usefulness and simplicity.

(c) Determinations of complexity, usefulness, multiplicity, or lack of name; designation by Secretary

Whenever he determines after any such review that (1) any such official name is unduly complex or is not useful for any other reason, (2) two or more official names have been applied to a single drug or device, or to two or more drugs which are identical in chemical structure and pharmacological action and which are substantially identical in strength, quality, and purity, or to two or more devices which are substantially equivalent in design and purpose or (3) no official name has been applied to a medically useful drug or device, he shall transmit in writing to the compiler of each official compendium in which that drug or drugs or device are identified and recognized his request for the recommendation of a single official name for such drug or drugs or device which will have usefulness and simplicity. Whenever such a single official name has not been recommended within one hundred and eighty days after such request, or the Secretary determines that any name so recommended is not useful for any reason, he shall designate a single official name for such drug or drugs or device. Whenever he determines that the name so recommended is useful, he shall designate that name as the official name of such drug or drugs or device. Such designation shall be made as a regulation upon public notice and in accordance with the procedure set forth in section 553 of title 5.

(d) Revised official names; compilation, publication, and public distribution of listings

After each such review, and at such other times as the Secretary may determine to be necessary or desirable, the Secretary shall cause to be compiled, published, and publicly distributed a list which shall list all revised official names of drugs or devices designated under this section and shall contain such descriptive and explanatory matter as the Secretary may determine to be required for the effective use of those names.

(e) Request by compiler of official compendium for designation of name

Upon a request in writing by any compiler of an official compendium that the Secretary exercise the authority granted to him under subsection (a), he shall upon public notice and in accordance with the procedure set forth in section 553 of title 5 designate the official name of the drug or device for which the request is made.

(June 25, 1938, ch. 675, §508, as added Pub. L. 87–781, title I, §111(a), Oct. 10, 1962, 76 Stat. 789; amended Pub. L. 94–295, §5(b), May 28, 1976, 90 Stat. 581; Pub. L. 103–80, §3(q), Aug. 13, 1993, 107 Stat. 777.)

Editorial Notes

Amendments

1993—Subsecs. (c), (e). Pub. L. 103–80 substituted reference to section 553 of title 5 for "section 4 of the Administrative Procedure Act (5 U.S.C. 1003)".

1976—Subsec. (a). Pub. L. 94–295 substituted "drug or device" for "drug" wherever appearing.

Subsec. (b). Pub. L. 94–295 substituted "National Formulary, and all supplements thereto, and at such times as he may deem necessary shall cause a review to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)" for "National Formulary, and all supplements thereto,".

Subsec. (c)(2). Pub. L. 94–295 inserted "or device" after "single drug", and "or to two or more devices which are substantially equivalent in design and purpose" after "purity,".

Subsec. (c)(3). Pub. L. 94–295 inserted "or device" after "useful drug" and after "drug or drugs" wherever appearing.

Subsec. (d). Pub. L. 94–295 inserted "or devices" after "drugs".

Subsec. (e). Pub. L. 94–295 substituted "drug or device" for "drug".

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 87–781, title I, §111(b), Oct. 10, 1962, 76 Stat. 790, provided that: "This section [enacting this section] shall take effect on the date of its enactment [Oct. 10, 1962]."

§359. Nonapplicability of subchapter to cosmetics

This subchapter, as amended by the Drug Amendments of 1962, shall not apply to any cosmetic unless such cosmetic is also a drug or device or component thereof.

(June 25, 1938, ch. 675, §509, as added Pub. L. 87–781, title I, §113, Oct. 10, 1962, 76 Stat. 791.)

Editorial Notes

References in Text

This subchapter, as amended by the Drug Amendments of 1962, referred to in text, means the amendment of this subchapter by Pub. L. 87–781 which enacted sections 358 to 360 of this title, amended sections 351 to 353, 355, and 357 of this title, and enacted provisions set out as notes under sections 352, 355, 358, and 360 of this title.

The Drug Amendments of 1962, referred to in text, is Pub. L. 87–781, Oct. 10, 1962, 76 Stat. 780, as amended. For complete classification of this Act to the Code, see Short Title of 1962 Amendment note set out under section 301 of this title and Tables.

§360. Registration of producers of drugs or devices

(a) Definitions

As used in this section—

(1) the term "manufacture, preparation, propagation, compounding, or processing" shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user; and

(2) the term "name" shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.

(b) Annual registration

(1) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.

(2) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments.

(3) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.

(c) New producers

Every person upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices in any establishment which he owns or operates in any State shall immediately register with the Secretary—

(1) with respect to drugs, the information described under subsection (b)(1); and

(2) with respect to devices, the information described under subsection (b)(2)..¹

(d) Additional establishments

Every person duly registered in accordance with the foregoing subsections of this section shall immediately register with the Secretary any additional establishment which he owns or operates in any State and in which he begins the manufacture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices.

(e) Registration number; uniform system for identification of devices intended for human use

The Secretary may assign a registration number to any person or any establishment registered in accordance with this section. The Secretary may also assign a listing number to each drug or class of drugs listed under subsection (j). Any number assigned pursuant to the preceding sentence shall be the same as that assigned pursuant to the National Drug Code. The Secretary may by regulation prescribe a uniform system for the identification of devices intended for human use and may require that persons who are required to list such devices pursuant to subsection (j) shall list such devices in accordance with such system.

(f) Availability of registrations for inspection

The Secretary shall make available for inspection, to any person so requesting, any registration filed pursuant to this section; except that any list submitted pursuant to paragraph (3) of subsection (j) and the information accompanying any list or notice filed under paragraph (1) or (2) of that subsection shall be exempt from such inspection unless the Secretary finds that such an exemption would be inconsistent with protection of the public health.

(g) Exclusions from application of section

The foregoing subsections of this section shall not apply to—

(1) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail;

(2) practitioners licensed by law to prescribe or administer drugs or devices and who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice;

(3) persons who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in research, teaching, or chemical analysis and not for sale;

(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or

(5) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that registration by such classes of persons in accordance with this section is not necessary for the protection of the public health.

In this subsection, the term "wholesale distributor" means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.

(h) Inspections

(1) In general

Every establishment that is required to be registered with the Secretary under this section shall be subject to inspection pursuant to section 374 of this title.

(2) Risk-based schedule for devices

(A) In general

The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph (1) that are engaged in the manufacture, propagation, compounding, or processing of a device or devices (referred to in this subsection as "device establishments") in accordance with a risk-based schedule established by the Secretary.

(B) Factors and considerations

In establishing the risk-based schedule under subparagraph (A), the Secretary shall—

(i) apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and

(ii) consider the participation of the device establishment, as applicable, in international device audit programs in which the United States participates or the United States recognizes for purposes of inspecting device establishments.

(3) Risk-based schedule for drugs

The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph (1) that are engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs (referred to in this subsection as "drug establishments") in accordance with a risk-based schedule established by the Secretary.

(4) Risk factors

In establishing a risk-based schedule under paragraph (2) or (3), the Secretary shall inspect establishments according to the known safety risks of such establishments, which shall be based on the following factors:

(A) The compliance history of the establishment.

(B) The record, history, and nature of recalls linked to the establishment.

(C) The inherent risk of the drug or device manufactured, prepared, propagated, compounded, or processed at the establishment.

(D) The inspection frequency and history of the establishment, including whether the establishment has been inspected pursuant to section 374 of this title within the last 4 years.

(E) Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under section 384e of this title.

(F) The compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this chapter, including the history of violations related to products exported from such country or region that are subject to such regulation.

(G) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

(5) Effect of status

In determining the risk associated with an establishment for purposes of establishing a risk-based schedule under paragraph (3), the Secretary shall not consider whether the drugs manufactured, prepared, propagated, compounded, or processed by such establishment are drugs described in section 353(b) of this title.

(6) Annual report on inspections of establishments

Not later than May 1 of each year, the Secretary shall make available on the Internet Web site of the Food and Drug Administration a report regarding—

(A)(i) the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year;

(ii) the number of such registered establishments in each region of interest;

(iii) the number of such domestic establishments and the number of such foreign establishments, including the number of establishments in each region of interest, that the Secretary inspected in the previous fiscal year;

(iv) the number of inspections to support actions by the Secretary on applications under section 355 of this title or section 262 of title 42, including the number of inspections to support actions by the Secretary on supplemental applications, including changes to manufacturing processes, the Secretary conducted in the previous fiscal year;

(v) the number of routine surveillance inspections the Secretary conducted in the previous fiscal year, including in each region of interest;

(vi) the number of for-cause inspections the Secretary conducted in the previous fiscal year, not including inspections described in clause (iv), including in each region of interest; and

(vii) the number of inspections the Secretary has recognized pursuant to an agreement entered into pursuant to section 384e of this title, or otherwise recognized, for each of the types of inspections described in clauses (v) and (vi), including for inspections of establishments in each region of interest.²

(B) with respect to establishments that manufacture, prepare, propagate, compound, or process an active ingredient of a drug or a finished drug product, the number of each such type of establishment;

(C) the percentage of the budget of the Food and Drug Administration used to fund the inspections described under subparagraph (A); and

(D) the status of the efforts of the Food and Drug Administration to expand its recognition of inspections conducted or recognized by foreign regulatory authorities under section 384e of this title, including any obstacles to expanding the use of such recognition.

(7) Region of interest

For purposes of paragraph (6)(A), the term "region of interest" means a foreign geographic region or country, including the People's Republic of China, India, the European Union, the United Kingdom, and any other country or geographic region, as the Secretary determines appropriate.

(i) Registration of foreign establishments

(1) Every person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—

(A) upon first engaging in any such activity, immediately submit a registration to the Secretary that includes—

(i) with respect to drugs, the name and place of business of such person, all such establishments, the unique facility identifier of each such establishment, a point of contact e-mail address, the name of the United States agent of each such establishment, the name of each importer of such drug in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug to the United States for purposes of importation; and

(ii) with respect to devices, the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such device in the United States that is known to the establishment, and the name of each person who imports or offers for import such device to the United States for purposes of importation; and

(B) each establishment subject to the requirements of subparagraph (A) shall thereafter register with the Secretary during the period beginning on October 1 and ending on December 31 of each year.

(2) The establishment shall also provide the information required by subsection (j).

(3) The Secretary is authorized to enter into cooperative arrangements with officials of foreign countries to ensure that adequate and effective means are available for purposes of determining, from time to time, whether drugs or devices manufactured, prepared, propagated, compounded, or processed by an establishment described in paragraph (1), if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.

(4) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1) with respect to drugs. The requirement to include a unique facility identifier in a registration under paragraph (1) with respect to drugs shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.

(5) The requirements of paragraphs (1) and (2) shall apply regardless of whether the drug or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or offered for import into the United States.

(j) Filing of lists of drugs and devices manufactured, prepared, propagated and compounded by registrants; statements; accompanying disclosures

(1) Every person who registers with the Secretary under subsection (b), (c), (d), or (i) shall, at the time of registration under any such subsection, file with the Secretary a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by its established name (as defined in section 352(e) of this title) and by any proprietary name) which are being manufactured, prepared, propagated, compounded, or processed by him for commercial distribution and which he has not included in any list of drugs or devices filed by him with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by—

(A) in the case of a drug contained in the applicable list and subject to section 355 or 360b of this title, or a device intended for human use contained in the applicable list with respect to which a performance standard has been established under section 360d of this title or which is subject to section 360e of this title, a reference to the authority for the marketing of such drug or device and a copy of all labeling for such drug or device;

(B) in the case of any other drug or device contained in an applicable list—

(i) which drug is subject to section 353(b)(1) of this title, or which device is a restricted device, a copy of all labeling for such drug or device, a representative sampling of advertisements for such drug or device, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product or device, or

(ii) which drug is not subject to section 353(b)(1) of this title or which device is not a restricted device, the label and package insert for such drug or device and a representative sampling of any other labeling for such drug or device;

(C) in the case of any drug contained in an applicable list which is described in subparagraph (B), a quantitative listing of its active ingredient or ingredients, except that with respect to a particular drug product the Secretary may require the submission of a quantitative listing of all ingredients if he finds that such submission is necessary to carry out the purposes of this chapter;

(D) if the registrant filing a list has determined that a particular drug product or device contained in such list is not subject to section 355 or 360b of this title, or the particular device contained in such list is not subject to a performance standard established under section 360d of this title or to section 360e of this title or is not a restricted device a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular drug product or device; and

(E) in the case of a drug contained in the applicable list, the name and place of business of each manufacturer of an excipient of the listed drug with which the person listing the drug conducts business, including all establishments used in the production of such excipient, the unique facility identifier of each such establishment, and a point of contact e-mail address for each such excipient manufacturer.

(2) Each person who registers with the Secretary under this section shall report to the Secretary, with regard to drugs once during the month of June of each year and once during the month of December of each year, and with regard to devices once each year during the period beginning on October 1 and ending on December 31, the following information:

(A) A list of each drug or device introduced by the registrant for commercial distribution which has not been included in any list previously filed by him with the Secretary under this subparagraph or paragraph (1) of this subsection. A list under this subparagraph shall list a drug or device by its established name (as defined in section 352(e) of this title), and by any proprietary name it may have and shall be accompanied by the other information required by paragraph (1).

(B) If since the date the registrant last made a report under this paragraph (or if he has not made a report under this paragraph, since February 1, 1973) he has discontinued the manufacture, preparation, propagation, compounding, or processing for commercial distribution of a drug or device included in a list filed by him under subparagraph (A) or paragraph (1); notice of such discontinuance, the date of such discontinuance, and the identity (by established name (as defined in section 352(e) of this title) and by any proprietary name) of such drug or device.

(C) If since the date the registrant reported pursuant to subparagraph (B) a notice of discontinuance he has resumed the manufacture, preparation, propagation, compounding, or processing for commercial distribution of the drug or device with respect to which such notice of discontinuance was reported; notice of such resumption, the date of such resumption, the identity of such drug or device (each by established name (as defined in section 352(e) of this title) and by any proprietary name), and the other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary pursuant to this subparagraph.

(D) Any material change in any information previously submitted pursuant to this paragraph or paragraph (1).

(3)(A) Each person who registers with the Secretary under this section with regard to a drug shall report annually to the Secretary on the amount of each drug listed under paragraph (1) that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. Such information may be required to be submitted in an electronic format as determined by the Secretary. The Secretary may require that information required to be reported under this paragraph be submitted at the time a public health emergency is declared by the Secretary under section 247d of title 42.

(B) By order of the Secretary, certain biological products or categories of biological products regulated under section 262 of title 42 may be exempt from some or all of the reporting requirements under subparagraph (A), if the Secretary determines that applying such reporting requirements to such biological products or categories of biological products is not necessary to protect the public health.

(4) The Secretary may also require each registrant under this section to submit a list of each drug product which (A) the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial distribution, and (B) contains a particular ingredient. The Secretary may not require the submission of such a list unless he has made a finding that the submission of such a list is necessary to carry out the purposes of this chapter.

(5) The Secretary shall require persons subject to this subsection to use, for purposes of this subsection, the unique facility identifier systems specified under subsections (b)(3) and (i)(4) with respect to drugs. Such requirement shall not apply until the date that the identifier system under subsection (b)(3) or (i)(4), as applicable, is specified by the Secretary.

(k) Report preceding introduction of devices into interstate commerce

Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or delivery, report to the Secretary or person who is accredited under section 360m(a) of this title (in such form and manner as the Secretary shall by regulation prescribe)—

(1) the class in which the device is classified under section 360c of this title or if such person determines that the device is not classified under such section, a statement of that determination and the basis for such person's determination that the device is or is not so classified, and

(2) action taken by such person to comply with requirements under section 360d or 360e of this title which are applicable to the device.

A notification submitted under this subsection that contains clinical trial data for an applicable device clinical trial (as defined in section 282(j)(1) of title 42) shall be accompanied by the certification required under section 282(j)(5)(B) of such title. Such certification shall not be considered an element of such notification.

(l) Exemption from reporting requirements

(1) A report under subsection (k) is not required for a device intended for human use that is exempted from the requirements of this subsection under subsection (m) or is within a type that has been classified into class I under section 360c of this title, or with respect to a change that is consistent with a predetermined change control plan cleared under section 360e–4 of this title. The exception established in the preceding sentence does not apply to any class I device that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.

(2) Not later than 120 calendar days after December 13, 2016, and at least once every 5 years thereafter, as the Secretary determines appropriate, the Secretary shall identify, through publication in the Federal Register, any type of class I device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Upon such publication—

(A) each type of class I device so identified shall be exempt from the requirement for a report under subsection (k); and

(B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.

(m) List of exempt class II devices; initial and final determinations by Secretary; publication in Federal Register

(1) The Secretary shall—

(A) not later than 90 days after December 13, 2016, and at least once every 5 years thereafter, as the Secretary determines appropriate—

(i) publish in the Federal Register a notice that contains a list of each type of class II device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness; and

(ii) provide for a period of not less than 60 calendar days for public comment beginning on the date of the publication of such notice; and

(B) not later than 210 calendar days after December 13, 2016, publish in the Federal Register a list representing the Secretary's final determination with respect to the devices contained in the list published under subparagraph (A).

(2) Beginning on the date that is 1 calendar day after the date of publication of the final list under paragraph (1)(B), the Secretary may exempt a class II device from the requirement to submit a report under subsection (k), upon the Secretary's own initiative or a petition of an interested person, if the Secretary determines that such report is not necessary to assure the safety and effectiveness of the device. The Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the device, or of the petition, and provide a 60-calendar-day period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice. If the Secretary fails to respond to a petition within 180 days of receiving it, the petition shall be deemed to be granted.

(3) Upon the publication of the final list under paragraph (1)(B)—

(A) each type of class II device so listed shall be exempt from the requirement for a report under subsection (k); and

(B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.

(n) Review of report; time for determination by Secretary

(1) The Secretary shall review the report required in subsection (k) and make a determination under section 360c(f)(1) of this title not later than 90 days after receiving the report.

(2)(A) Not later than 18 months after July 9, 2012, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report regarding when a premarket notification under subsection (k) should be submitted for a modification or change to a legally marketed device. The report shall include the Secretary's interpretation of the following terms: "could significantly affect the safety or effectiveness of the device", "a significant change or modification in design, material, chemical composition, energy source, or manufacturing process", and "major change or modification in the intended use of the device". The report also shall discuss possible processes for industry to use to determine whether a new submission under subsection (k) is required and shall analyze how to leverage existing quality system requirements to reduce premarket burden, facilitate continual device improvement, and provide reasonable assurance of safety and effectiveness of modified devices. In developing such report, the Secretary shall consider the input of interested stakeholders.

(B) The Secretary shall withdraw the Food and Drug Administration draft guidance entitled "Guidance for Industry and FDA Staff—510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011, and shall not use this draft guidance as part of, or for the basis of, any premarket review or any compliance or enforcement decisions or actions. The Secretary shall not issue—

(i) any draft guidance or proposed regulation that addresses when to submit a premarket notification submission for changes and modifications made to a manufacturer's previously cleared device before the receipt by the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the report required in subparagraph (A); and

(ii) any final guidance or regulation on that topic for one year after date of receipt of such report by the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.

(C) The Food and Drug Administration guidance entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device", dated January 10, 1997, shall be in effect until the subsequent issuance of guidance or promulgation, if appropriate, of a regulation described in subparagraph (B), and the Secretary shall interpret such guidance in a manner that is consistent with the manner in which the Secretary has interpreted such guidance since 1997.

(o) Reprocessed single-use devices

(1) With respect to reprocessed single-use devices for which reports are required under subsection (k):

(A) The Secretary shall identify such devices or types of devices for which reports under such subsection must, in order to ensure that the device is substantially equivalent to a predicate device, include validation data, the types of which shall be specified by the Secretary, regarding cleaning and sterilization, and functional performance demonstrating that the single-use device will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification. Within six months after October 26, 2002, the Secretary shall publish in the Federal Register a list of the types so identified, and shall revise the list as appropriate. Reports under subsection (k) for devices or types of devices within a type included on the list are, upon publication of the list, required to include such validation data.

(B) In the case of each report under subsection (k) that was submitted to the Secretary before the publication of the initial list under subparagraph (A), or any revision thereof, and was for a device or type of device included on such list, the person who submitted the report under subsection (k) shall submit validation data as described in subparagraph (A) to the Secretary not later than nine months after the publication of the list. During such nine-month period, the Secretary may not take any action under this chapter against such device solely on the basis that the validation data for the device have not been submitted to the Secretary. After the submission of the validation data to the Secretary, the Secretary may not determine that the device is misbranded under section 352(o) of this title or adulterated under section 351(f)(1)(B) of this title, or take action against the device under section 331(p) of this title for failure to provide any information required by subsection (k) until (i) the review is terminated by withdrawal of the submission of the report under subsection (k); (ii) the Secretary finds the data to be acceptable and issues a letter; or (iii) the Secretary determines that the device is not substantially equivalent to a predicate device. Upon a determination that a device is not substantially equivalent to a predicate device, or if such submission is withdrawn, the device can no longer be legally marketed.

(C) In the case of a report under subsection (k) for a device identified under subparagraph (A) that is of a type for which the Secretary has not previously received a report under such subsection, the Secretary may, in advance of revising the list under subparagraph (A) to include such type, require that the report include the validation data specified in subparagraph (A).

(D) Section 352(o) of this title applies with respect to the failure of a report under subsection (k) to include validation data required under subparagraph (A).

(2) With respect to critical or semi-critical reprocessed single-use devices that, under subsection (l) or (m), are exempt from the requirement of submitting reports under subsection (k):

(A) The Secretary shall identify such devices or types of devices for which such exemptions should be terminated in order to provide a reasonable assurance of the safety and effectiveness of the devices. The Secretary shall publish in the Federal Register a list of the devices or types of devices so identified, and shall revise the list as appropriate. The exemption for each device or type included on the list is terminated upon the publication of the list. For each report under subsection (k) submitted pursuant to this subparagraph the Secretary shall require the validation data described in paragraph (1)(A).

(B) For each device or type of device included on the list under subparagraph (A), a report under subsection (k) shall be submitted to the Secretary not later than 15 months after the publication of the initial list, or a revision of the list, whichever terminates the exemption for the device. During such 15-month period, the Secretary may not take any action under this chapter against such device solely on the basis that such report has not been submitted to the Secretary. After the submission of the report to the Secretary the Secretary may not determine that the device is misbranded under section 352(o) of this title or adulterated under section 351(f)(1)(B) of this title, or take action against the device under section 331(p) of this title for failure to provide any information required by subsection (k) until (i) the review is terminated by withdrawal of the submission; (ii) the Secretary determines by order that the device is substantially equivalent to a predicate device; or (iii) the Secretary determines by order that the device is not substantially equivalent to a predicate device. Upon a determination that a device is not substantially equivalent to a predicate device, the device can no longer be legally marketed.

(C) In the case of semi-critical devices, the initial list under subparagraph (A) shall be published not later than 18 months after the effective date of this subsection. In the case of critical devices, the initial list under such subparagraph shall be published not later than six months after such effective date.

(D) Section 352(o) of this title applies with respect to the failure to submit a report under subsection (k) that is required pursuant to subparagraph (A), including a failure of the report to include validation data required in such subparagraph.

(E) The termination under subparagraph (A) of an exemption under subsection (l) or (m) for a critical or semi-critical reprocessed single-use device does not terminate the exemption under subsection (l) or (m) for the original device.

(p) Electronic registration and listing

(1) In general

Registrations and listings under this section (including the submission of updated information) shall be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver.

(2) Electronic database

Not later than 2 years after the Secretary specifies a unique facility identifier system under subsections (b) and (i), the Secretary shall maintain an electronic database, which shall not be subject to inspection under subsection (f), populated with the information submitted as described under paragraph (1) that—

(A) enables personnel of the Food and Drug Administration to search the database by any field of information submitted in a registration described under paragraph (1), or combination of such fields; and

(B) uses the unique facility identifier system to link with other relevant databases within the Food and Drug Administration, including the database for submission of information under section 381(r) of this title.

(3) Risk-based information and coordination

The Secretary shall ensure the accuracy and coordination of relevant Food and Drug Administration databases in order to identify and inform risk-based inspections under subsection (h).

(q) Reusable medical devices

(1) In general

Not later than 180 days after December 13, 2016, the Secretary shall identify and publish a list of reusable device types for which reports under subsection (k) are required to include—

(A) instructions for use, which have been validated in a manner specified by the Secretary; and

(B) validation data, the types of which shall be specified by the Secretary;

regarding cleaning, disinfection, and sterilization, and for which a substantial equivalence determination may be based.

(2) Revision of list

The Secretary shall revise the list under paragraph (2),³ as the Secretary determines appropriate, with notice in the Federal Register.

(3) Content of reports

Reports under subsection (k) that are submitted after the publication of the list described in paragraph (1), for devices or types of devices included on such list, shall include such instructions for use and validation data.

(June 25, 1938, ch. 675, §510, as added Pub. L. 87–781, title III, §302, Oct. 10, 1962, 76 Stat. 794; amended Pub. L. 89–74, §4, July 15, 1965, 79 Stat. 231; Pub. L. 91–513, title II, §701(e), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 92–387, §§3, 4(a)–(c), Aug. 16, 1972, 86 Stat. 560–562; Pub. L. 94–295, §4(a), May 28, 1976, 90 Stat. 579; Pub. L. 105–115, title I, §125(a)(2)(C), title II, §§206(a), 209(a), 213(b), title IV, §417, Nov. 21, 1997, 111 Stat. 2325, 2338, 2341, 2347, 2379; Pub. L. 107–188, title III, §321(a), June 12, 2002, 116 Stat. 675; Pub. L. 107–250, title II, §§201(e), 207, 211, title III, §302(b), Oct. 26, 2002, 116 Stat. 1609, 1613, 1614, 1616; Pub. L. 108–214, §2(c)(2), Apr. 1, 2004, 118 Stat. 576; Pub. L. 110–85, title II, §§222–224, title VIII, §801(b)(3)(C), Sept. 27, 2007, 121 Stat. 853, 921; Pub. L. 112–144, title VI, §604, title VII, §§701, 702(b)–705, July 9, 2012, 126 Stat. 1052, 1064-1066; Pub. L. 114–255, div. A, title III, §§3054, 3059(a), 3101(a)(2)(H), Dec. 13, 2016, 130 Stat. 1126, 1130, 1154; Pub. L. 115–52, title VII, §701(a), title IX, §901(e), Aug. 18, 2017, 131 Stat. 1054, 1076; Pub. L. 116–136, div. A, title III, §3112(e), Mar. 27, 2020, 134 Stat. 363; Pub. L. 117–328, div. FF, title II, §§2511(a), 2515(a)(3), title III, §§3308(b)(1), 3613(a), 3616(c), Dec. 29, 2022, 136 Stat. 5803, 5806, 5836, 5872, 5875.)

Editorial Notes

References in Text

The effective date of this subsection, referred to in subsec. (o)(2)(C), probably means the date of the enactment of Pub. L. 107–250, which enacted subsec. (o) of this section and was approved Oct. 26, 2002.

Amendments

2022—Subsec. (h)(4)(F), (G). Pub. L. 117–328, §3613(a), added subpar. (F) and redesignated former subpar. (F) as (G).

Subsec. (h)(6). Pub. L. 117–328, §3616(c)(1)(A), substituted "Not" for "Beginning in 2014, not" in introductory provisions.

Subsec. (h)(6)(A). Pub. L. 117–328, §3616(c)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows:

"(A)(i) the number of domestic and foreign establishments registered pursuant to this section in the previous calendar year; and

"(ii) the number of such domestic establishments and the number of such foreign establishments that the Secretary inspected in the previous calendar year;".

Subsec. (h)(6)(D). Pub. L. 117–328, §3616(c)(1)(C)–(E), added subpar. (D).

Subsec. (h)(7). Pub. L. 117–328, §3616(c)(2), added par. (7).

Subsec. (i)(5). Pub. L. 117–328, §2511(a), added par. (5).

Subsec. (j)(3) to (5). Pub. L. 117–328, §2515(a)(3), made technical amendment to directory language of Pub. L. 116–136, §3112(e). See 2020 Amendment note below.

Subsec. (l)(1). Pub. L. 117–328, §3308(b)(1), inserted ", or with respect to a change that is consistent with a predetermined change control plan cleared under section 360e–4 of this title" after "section 360c of this title".

2020—Subsec. (j)(3) to (5). Pub. L. 116–136, §3112(e), as amended by Pub. L. 117–328, §2515(a)(3), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively.

2017—Subsec. (h)(2). Pub. L. 115–52, §701(a)(1), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: "Every establishment described in paragraph (1), in any State, that is engaged in the manufacture, propagation, compounding, or processing of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive 2-year period thereafter."

Subsec. (h)(4). Pub. L. 115–52, §701(a)(2)(A), substituted "paragraph (2) or (3)" for "paragraph (3)" in introductory provisions.

Subsec. (h)(4)(C). Pub. L. 115–52, §701(a)(2)(B), inserted "or device" after "drug".

Subsec. (h)(6). Pub. L. 115–52, §901(e), substituted "May 1" for "February 1" in introductory provisions.

2016—Subsec. (h)(4). Pub. L. 114–255, §3101(a)(2)(H)(i), substituted "establishing a risk-based schedule" for "establishing the risk-based scheduled" in introductory provisions.

Subsec. (h)(6)(A). Pub. L. 114–255, §3101(a)(2)(H)(ii)(I), substituted "calendar" for "fiscal" in cls. (i) and (ii).

Subsec. (h)(6)(B). Pub. L. 114–255, §3101(a)(2)(H)(ii)(II), substituted "an active ingredient of a drug or a finished drug product" for "an active ingredient of a drug, a finished drug product, or an excipient of a drug".

Subsec. (l). Pub. L. 114–255, §3054(a), designated existing provisions as par. (1) and added par. (2).

Subsec. (m)(1). Pub. L. 114–255, §3054(b)(1), added par. (1) and struck out former par. (1) which read as follows: "Not later than 60 days after November 21, 1997, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Each type of class II device identified by the Secretary as not requiring the report shall be exempt from the requirement to provide a report under subsection (k) as of the date of the publication of the list in the Federal Register. The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary."

Subsec. (m)(2). Pub. L. 114–255, §3054(b)(2)(B), substituted "60-calendar-day period" for "30-day period".

Pub. L. 114–255, §3054(b)(2)(A), which directed the substitution of "1 calendar day after the date of publication of the final list under paragraph (1)(B)," for "1 day after the date of publication of a list under this subsection,", was executed by making the substitution for "1 day after the date of the publication of a list under this subsection," to reflect the probable intent of Congress.

Subsec. (m)(3). Pub. L. 114–255, §3054(b)(2)(C), added par. (3).

Subsec. (q). Pub. L. 114–255, §3059(a), added subsec. (q).

2012—Subsec. (b)(1). Pub. L. 112–144, §701(1)(A), which directed amendment of par. (1) by "striking 'On or before' and all that follows through the period at the end and inserting the following: 'During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.; and", was executed as if an end quotation mark for the inserted material followed "address.", to reflect the probable intent of Congress. Prior to amendment, stricken text read as follows: "On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary his name, places of business, and all such establishments."

Subsec. (b)(3). Pub. L. 112–144, §701(1)(B), added par. (3).

Subsec. (c). Pub. L. 112–144, §701(2), substituted "with the Secretary—" and pars. (1) and (2) for "with the Secretary his name, place of business, and such establishment".

Subsec. (h). Pub. L. 112–144, §705, amended subsec. (h) generally. Prior to amendment, text read as follows: "Every establishment in any State registered with the Secretary pursuant to this section shall be subject to inspection pursuant to section 374 of this title and every such establishment engaged in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the two-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive two-year period thereafter."

Subsec. (i)(1). Pub. L. 112–144, §702(b)(1)(A), amended introductory provisions generally. Prior to amendment, text read as follows: "Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—".

Subsec. (i)(1)(A). Pub. L. 112–144, §702(b)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "upon first engaging in any such activity, immediately register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation; and".

Subsec. (i)(1)(B). Pub. L. 112–144, §702(b)(1)(C), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "each establishment subject to the requirements of subparagraph (A) shall thereafter—

"(i) with respect to drugs, register with the Secretary on or before December 31 of each year; and

"(ii) with respect to devices, register with the Secretary during the period beginning on October 1 and ending on December 31 of each year."

Subsec. (i)(4). Pub. L. 112–144, §702(b)(2), added par. (4).

Subsec. (j)(1)(E). Pub. L. 112–144, §703(1), added subpar. (E).

Subsec. (j)(4). Pub. L. 112–144, §703(2), added par. (4).

Subsec. (n). Pub. L. 112–144, §604, designated existing provisions as par. (1) and added par. (2).

Subsec. (p). Pub. L. 112–144, §704, inserted subsec. heading, designated existing provisions as par. (1) and inserted par. heading, and added pars. (2) and (3).

2007—Subsec. (b). Pub. L. 110–85, §222(a), designated existing provisions as par. (1), struck out "or a device or devices" after "drug or drugs", and added par. (2).

Subsec. (i)(1). Pub. L. 110–85, §222(b), inserted text of par. (1) and struck out former text of par. (1) which related to registration requirement for foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device to be imported or offered for import into the United States.

Subsec. (j)(2). Pub. L. 110–85, §223, in introductory provisions, substituted "Each person who registers with the Secretary under this section shall report to the Secretary, with regard to drugs once during the month of June of each year and once during the month of December of each year, and with regard to devices once each year during the period beginning on October 1 and ending on December 31, the following information:" for "Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following information:".

Subsec. (k). Pub. L. 110–85, §801(b)(3)(C), inserted concluding provisions.

Subsec. (p). Pub. L. 110–85, §224, amended subsec. (p) generally. Prior to amendment, subsec. (p) read as follows: "Registrations under subsections (b), (c), (d), and (i) of this section (including the submission of updated information) shall be submitted to the Secretary by electronic means, upon a finding by the Secretary that the electronic receipt of such registrations is feasible, unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver."

2004—Subsec. (o)(1)(B), (2)(B). Pub. L. 108–214, §2(c)(2)(A), (B)(i), substituted "or adulterated" for ", adulterated".

Subsec. (o)(2)(E). Pub. L. 108–214, §2(c)(2)(B)(ii), substituted "semi-critical" for "semicritical".

2002—Subsec. (h). Pub. L. 107–250, §201(e), inserted ", or by persons accredited to conduct inspections under section 374(g) of this title," after "duly designated by the Secretary".

Subsec. (i)(1). Pub. L. 107–188, §321(a)(1), substituted "On or before December 31 of each year, any establishment" for "Any establishment" and "shall, through electronic means in accordance with the criteria of the Secretary, register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation" for "shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment".

Subsec. (j)(1). Pub. L. 107–188, §321(a)(2), substituted "subsection (b), (c), (d), or (i)" for "subsection (b), (c), or (d)" in first sentence.

Subsec. (m)(1). Pub. L. 107–250, §211, inserted at end "The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary."

Subsec. (o). Pub. L. 107–250, §302(b), added subsec. (o).

Subsec. (p). Pub. L. 107–250, §207, added subsec. (p).

1997—Subsec. (g). Pub. L. 105–115, §213(b)(3), inserted at end "In this subsection, the term 'wholesale distributor' means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user."

Subsec. (g)(4), (5). Pub. L. 105–115, §213(b)(1), (2), added par. (4) and redesignated former par. (4) as (5).

Subsec. (i). Pub. L. 105–115, §417, amended subsec. (i) generally. Prior to amendment, subsec. (i) read as follows: "Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs, or a device or devices, shall be permitted to register under this section pursuant to regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (j) of this section and shall require such establishment to provide the information required by subsection (j) of this section in the case of a device or devices and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether drugs or devices manufactured, prepared, propagated, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title."

Subsec. (j)(1)(A), (D). Pub. L. 105–115, §125(a)(2)(C), struck out ", 356, 357," before "or 360b of this title".

Subsec. (k). Pub. L. 105–115, §206(a)(1), inserted "or person who is accredited under section 360m(a) of this title" after "report to the Secretary".

Subsecs. (l), (m). Pub. L. 105–115, §206(a)(2), added subsecs. (l) and (m).

Subsec. (n). Pub. L. 105–115, §209(a), added subsec. (n).

1976—Subsec. (a)(1). Pub. L. 94–295, §4(a)(2), substituted "drug package or device package" for "drug package", "distribution of the drug or device" for "distribution of the drug", and "ultimate consumer or user" for "ultimate consumer".

Subsecs. (b) to (d). Pub. L. 94–295, §4(a)(3), inserted "or a device or devices" after "drug or drugs".

Subsec. (e). Pub. L. 94–295, §4(a)(4), authorized the Secretary to prescribe by regulation a uniform system for the identification of devices intended for human use and authorized him, in addition, to require that persons who are required to list devices pursuant to subsec. (j) also list such devices in accordance with the system.

Subsec. (g)(1) to (3). Pub. L. 94–295, §4(a)(5), substituted "drugs or devices" for "drugs".

Subsec. (h). Pub. L. 94–295, §4(a)(6), inserted reference to establishments engaged in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device or devices classified in class II or III.

Subsec. (i). Pub. L. 94–295, §4(a)(7), inserted reference to devices and inserted requirement that regulations require establishments to provide the information required by subsection (j) of this section in the case of a device or devices.

Subsec. (j)(1). Pub. L. 94–295, §4(a)(8)(A), in introductory provisions substituted "a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by its established name" for "a list of all drugs (by established name" and "drugs or devices filed" for "drugs filed".

Subsec. (j)(1)(A). Pub. L. 94–295, §4(a)(8)(B), substituted "the applicable list" for "such list", inserted "or a device intended for human use contained in the applicable list with respect to which a performance standard has been established under section 360d of this title or which is subject to section 360e of this title," after "360b of this title,", and substituted "such drug or device" for "such drug" wherever appearing.

Subsec. (j)(1)(B). Pub. L. 94–295, §4(a)(8)(C), in introductory provisions substituted "drug or device contained in an applicable list" for "drug contained in such list".

Subsec. (j)(1)(B)(i). Pub. L. 94–295, §4(a)(8)(D), substituted "which drug is subject to section 353(b)(1) of this title, or which device is a restricted device, a copy of all labeling for such drug or device, a representative sampling of advertisements for such drug or device, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product or device, or" for "which is subject to section 353(b)(1) of this title, a copy of all labeling for such drug, a representative sampling of advertisements for such drug, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product, or".

Subsec. (j)(1)(B)(ii). Pub. L. 94–295, §4(a)(8)(E), substituted "which drug is not subject to section 353(b)(1) of this title or which device is not a restricted device, the label and package insert for such drug or device and a representative sampling of any other labeling for such drug or device" for "which is not subject to section 353(b)(1) of this title, the label and package insert for such drug and a representative sampling of any other labeling for such drug".

Subsec. (j)(1)(C). Pub. L. 94–295, §4(a)(8)(F), substituted "an applicable list" for "such list".

Subsec. (j)(1)(D). Pub. L. 94–295, §4(a)(8)(G), substituted "a list" for "the list", inserted "or the particular device contained in such list is not subject to a performance standard established under section 360d of this title or to section 360e of this title or is not a restricted device" after "or 360b of this title,", and substituted "particular drug product or device" for "particular drug product" wherever appearing.

Subsec. (j)(2). Pub. L. 94–295, §4(a)(8)(H), substituted "drug or device" for "drug" in subpars. (A), (B), and (C), and substituted "(each by established name" for "(by established name" in subpar. (C).

Subsec. (k). Pub. L. 94–295, §4(a)(9), added subsec. (k).

1972—Subsec. (e). Pub. L. 92–387, §4(a), inserted provision that the Secretary may assign a listing number to each drug or class of drugs listed under subsec. (j).

Subsec. (f). Pub. L. 92–387, §4(b), inserted exception that the list submitted under subsec. (j)(3) and information submitted under subsec. (j)(1), (2) shall be exempt from inspection unless the Secretary determines otherwise.

Subsec. (i). Pub. L. 92–387, §4(c), inserted provision that the regulations shall require such establishment to provide the information required by subsec. (j).

Subsec. (j). Pub. L. 92–387, §3, added subsec. (j).

1970—Subsec. (a). Pub. L. 91–513 struck out provisions defining the wholesaling, jobbing, or distributing of depressant or stimulant drugs.

Subsec. (b). Pub. L. 91–513 struck out provisions covering establishments engaged in the wholesaling, jobbing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the annual registration.

Subsec. (c). Pub. L. 91–513 struck out provisions covering new registrations of persons first engaging in the wholesaling, jobbing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the registration.

Subsec. (d). Pub. L. 91–513 struck out number designation "(1)" preceding first sentence, struck out portion of such redesignated provisions covering the wholesaling, jobbing, or distributing of depressant or stimulant drugs, and struck out par. (2) covering the filing of supplemental registration whenever a person not previously engaged or involved with depressant or stimulant drugs goes into the manufacturing, preparation, or processing thereof.

1965—Pub. L. 89–74, §4(e), included certain wholesalers in section catchline.

Subsec. (a)(2), (3). Pub. L. 89–74, §4(a), added par. (2) and redesignated former par. (2) as (3).

Subsecs. (b), (c). Pub. L. 89–74, §4(b), (c), inserted "or in the wholesaling, jobbing, or distributing of any depressant or stimulant drug" after "drug or drugs" and inserted requirement that establishment indicate activity in depressant or stimulant drugs at time of registration.

Subsec. (d). Pub. L. 89–74 §4(d), designated existing provisions as par. (1), inserted "or the wholesaling, jobbing, or distributing of any depressant or stimulant drug" and the requirement that the additional establishment indicate activity in depressant or stimulant drugs at time of registration, and added par. (2).

Statutory Notes and Related Subsidiaries

Effective Date of 2020 Amendment

Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.

Effective Date of 2002 Amendment

Amendment by Pub. L. 107–188 effective upon the expiration of the 180-day period beginning June 12, 2002, see section 321(c) of Pub. L. 107–188, set out as a note under section 331 of this title.

Effective Date of 1997 Amendment

Amendment by sections 206(a), 209(a), 213(b), and 417 of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1972 Amendment

Pub. L. 92–387, §5, Aug. 16, 1972, 86 Stat. 562, provided that: "The amendments made by this Act [amending this section and sections 331 and 335 of this title and enacting provisions set out below] shall take effect on the first day of the sixth month beginning after the date of enactment of this Act [Aug. 16, 1972]."

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1965 Amendment

Amendment by Pub. L. 89–74 effective Feb. 1, 1966, subject to registration with Secretary of names, places of business, establishments, and other prescribed information prior to Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

Updating Regulations

Pub. L. 117–328, div. FF, title II, §2511(b), Dec. 29, 2022, 136 Stat. 5804, provided that: "Not later than 2 years after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services shall update regulations, as appropriate, to implement the amendment made by subsection (a) [amending this section]."

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Device Modifications

Pub. L. 114–255, div. A, title III, §3059(b), Dec. 13, 2016, 130 Stat. 1130, provided that: "The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject."

Declaration of Policy of Drug Listing Act of 1972

Pub. L. 92–387, §2, Aug. 16, 1972, 86 Stat. 559, provided that: "The Federal Government which is responsible for regulating drugs has no ready means of determining what drugs are actually being manufactured or packed by establishments registered under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] except by periodic inspection of such registered establishments. Knowledge of which particular drugs are being manufactured or packed by each registered establishment would substantially assist in the enforcement of Federal laws requiring that such drugs be pure, safe, effective, and properly labeled. Information on the discontinuance of a particular drug could serve to alleviate the burden of reviewing and implementing enforcement actions against drugs which, although commercially discontinued, remain active for regulatory purposes. Information on the type and number of different drugs being manufactured or packed by drug establishments could permit more effective and timely regulation by the agencies of the Federal Government responsible for regulating drugs, including identification of which drugs in interstate commerce are subject to section 505 or 507 [21 U.S.C. 355, 357], or to other provisions of the Federal Food, Drug, and Cosmetic Act."

Congressional Declaration of Need for Registration and Inspection of Drug Establishments

Pub. L. 87–781, title III, §301, Oct. 10, 1962, 76 Stat. 793, provided that: "The Congress hereby finds and declares that in order to make regulation of interstate commerce in drugs effective, it is necessary to provide for registration and inspection of all establishments in which drugs are manufactured, prepared, propagated, compounded, or processed; that the products of all such establishments are likely to enter the channels of interstate commerce and directly affect such commerce; and that the regulation of interstate commerce in drugs without provision for registration and inspection of establishments that may be engaged only in intrastate commerce in such drugs would discriminate against and depress interstate commerce in such drugs, and adversely burden, obstruct, and affect such interstate commerce."

Registration of Certain Persons Owning or Operating Drug Establishments Prior to Oct. 10, 1962

Pub. L. 87–781, title III, §303, Oct. 10, 1962, 76 Stat. 795, provided that any person who, on the day immediately preceding Oct. 10, 1962, owned or operated an establishment which manufactured or processed drugs, registered before the first day of the seventh month following October, 1962, would be deemed to be registered in accordance with subsec. (b) of this section for the calendar year 1962 and if registered within this period and effected in 1963, be deemed in compliance for that calendar year.

¹ So in original.

² So in original. The period probably should be a semicolon.

³ So in original. Probably should be "paragraph (1),".

§360a. Clinical trial guidance for antibiotic drugs

(a) In general

Not later than 1 year after September 27, 2007, the Secretary shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidance shall indicate the appropriate models and valid surrogate markers.

(b) Review

Not later than 5 years after September 27, 2007, the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.

(June 25, 1938, ch. 675, §511, as added Pub. L. 110–85, title IX, §911, Sept. 27, 2007, 121 Stat. 951.)

Editorial Notes

Prior Provisions

A prior section 360a, act June 25, 1938, ch. 675, §511, as added July 15, 1965, Pub. L. 89–74, §3(b), 79 Stat. 227; amended Oct. 24, 1968, Pub. L. 90–639, §2(a), 82 Stat. 1361, regulated the manufacture, compounding, and processing of depressant and stimulant drugs and their sale, delivery, disposal, possession, and recordkeeping activities connected therewith, prior to repeal by Pub. L. 91–513, title II, §§701(a), 704, Oct. 27, 1970, 84 Stat. 1281, 1284, effective on the first day of the seventh calendar month that began after Oct. 26, 1970.

§360a–1. Clinical trials

(a) Review and revision of guidance documents

(1) In general

The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall review and, as appropriate, revise not fewer than 3 guidance documents per year, which shall include—

(A) reviewing the guidance documents of the Food and Drug Administration for the conduct of clinical trials with respect to antibacterial and antifungal drugs; and

(B) as appropriate, revising such guidance documents to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of antibacterial and antifungal drugs under chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.).

(2) Issues for review

At a minimum, the review under paragraph (1) shall address the appropriate animal models of infection, in vitro techniques, valid microbiological surrogate markers, the use of noninferiority versus superiority trials, trial enrollment, data requirements, and appropriate delta values for noninferiority trials.

(3) Rule of construction

Except to the extent to which the Secretary makes revisions under paragraph (1)(B), nothing in this section shall be construed to repeal or otherwise effect the guidance documents of the Food and Drug Administration.

(b) Recommendations for investigations

(1) Request

The sponsor of a drug intended to be designated as a qualified infectious disease product may request that the Secretary provide written recommendations for nonclinical and clinical investigations which the Secretary believes may be necessary to be conducted with the drug before such drug may be approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in treating, detecting, preventing, or identifying a qualifying pathogen, as defined in section 505E of such Act [21 U.S.C. 355f].

(2) Recommendations

If the Secretary has reason to believe that a drug for which a request is made under this subsection is a qualified infectious disease product, the Secretary shall provide the person making the request written recommendations for the nonclinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request, would be necessary for approval under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use described in paragraph (1).

(c) Qualified infectious disease product

For purposes of this section, the term "qualified infectious disease product" has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f(g)], as added by section 801 of this Act.

(Pub. L. 112–144, title VIII, §804, July 9, 2012, 126 Stat. 1080.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1)(B), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. Chapter V of the Act is classified generally to this subchapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This Act, referred to in subsec. (c), is Pub. L. 112–144, July 9, 2012, 126 Stat. 993, known as the Food and Drug Administration Safety and Innovation Act. For complete classification of this Act to the Code, see Tables.

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Decentralized Clinical Studies

Pub. L. 117–328, div. FF, title III, §3606, Dec. 29, 2022, 136 Stat. 5865, provided that:

"(a) Guidance.—The Secretary [of Health and Human Services] shall—

"(1) not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices, including recommendations for how to advance the use of flexible and novel clinical trial designs and to help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse clinical population, including with respect to race, ethnicity, age, sex, and geographic location, when appropriate; and

"(2) not later than 1 year after closing the comment period on such draft guidance, finalize such guidance.

"(b) Content of Guidance.—The guidance under subsection (a) shall address the following:

"(1) Recommendations related to digital health technology or other assessment options, such as telehealth, local laboratories, local health care providers, or other options for remote data collection, could support decentralized clinical studies, including guidance on considerations for selecting technological platforms and mediums, data collection and use, data integrity and security, and communication to study participants through digital technology.

"(2) Recommendations for subject recruitment, retention, and engagement, including considerations for sponsors to minimize or reduce burdens for clinical study participants through the use of digital health technology, telehealth, local health care providers and laboratories, health care provider home visits, direct-to-participant engagement, electronic informed consent, or other means, as appropriate.

"(3) Recommendations with respect to the evaluation of data collected within a decentralized clinical study setting.

"(4) Recommendations for methods of remote data collection, including clinical trial participant experience data, through the use of digital health technologies, telemedicine, local laboratories, local health care providers, or other options for data collection.

"(5) Considerations for sponsors to minimize or reduce burdens for clinical trial participants associated with participating in a clinical trial, such as the use of digital technologies, telemedicine, local laboratories, local health care providers, or other data collection or assessment options, health care provider home visits, direct-to-participant shipping of investigational drugs and devices, and electronic informed consent, as appropriate.

"(6) Recommendations regarding conducting decentralized clinical trials to facilitate and encourage meaningful diversity among clinical trial participants, including with respect to race, ethnicity, age, sex, and geographic location, as appropriate.

"(7) Recommendations for strategies and methods for recruiting, retaining, and engaging with clinical trial participants, including communication regarding the role of clinical trial participants and community partners to facilitate clinical trial recruitment and engagement, including with respect to diverse and underrepresented populations, as appropriate.

"(8) Considerations for review and oversight by sponsors and institutional review boards, including remote trial oversight.

"(9) Recommendations for decentralized clinical trial protocol designs and processes for evaluating such proposed clinical trial designs.

"(10) Recommendations related to digital health technology and other remote assessment tools that may support decentralized clinical trials, including guidance on appropriate technological platforms and tools, data collection and use, data integrity, and communication to clinical trial participants through such technology.

"(11) A description of the manner in which the Secretary will assess or evaluate data collected within a decentralized clinical trial to support the development of the drug or device, if the manner is different from that used for a nondecentralized trial.

"(12) Considerations for sponsors to validate digital technologies and establish appropriate clinical endpoints for use in decentralized trials.

"(13) Considerations for privacy and security of personally identifiable information of trial participants.

"(14) Considerations for conducting clinical trials using centralized approaches in conjunction with decentralized approaches.

"(c) Definition.—In this section, the term 'decentralized clinical study' means a clinical study in which some or all of the study-related activities occur at a location separate from the investigator's location."

Modernizing Clinical Trials

Pub. L. 117–328, div. FF, title III, §3607, Dec. 29, 2022, 136 Stat. 5866, provided that:

"(a) Clarifying the Use of Digital Health Technologies in Clinical Trials.—

"(1) In general.—Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary [of Health and Human Services] shall issue or revise draft guidance regarding the appropriate use of digital health technologies in clinical trials to help improve recruitment for, retention in, participation in, and data collection during, clinical trials, and provide for novel clinical trial designs utilizing such technology for purposes of supporting the development of, and review of applications for, drugs and devices. Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

"(2) Content.—The guidance described in paragraph (1) shall include—

"(A) recommendations for data collection methodologies by which sponsors may incorporate the use of digital health technologies in clinical trials to collect data remotely from trial participants;

"(B) considerations for privacy and security protections for data collected during a clinical trial, including—

"(i) recommendations for the protection of trial participant data that are collected or used in research using digital health technologies;

"(ii) compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ([Pub. L. 104–191;] 42 U.S.C. 1320d–2 note), subpart B of part 50 of title 21, Code of Federal Regulations, subpart C of part 56 of title 21, Code of Federal Regulations, the Federal policy for the protection of human subjects under subpart A of part 46 of title 45, Code of Federal Regulations (commonly known as the 'Common Rule'), and part 2 of title 42, Code of Federal Regulations (or any successor regulations); and

"(iii) recommendations for the protection of clinical trial participant data against cybersecurity threats, as applicable;

"(C) considerations on data collection methods to help increase recruitment of clinical trial participants and the level of participation of such participants, reduce burden on clinical trial participants, and optimize data quality;

"(D) recommendations for the use of electronic methods to obtain informed consent from clinical trial participants, taking into consideration applicable Federal law, including subpart B of part 50 of title 21, Code of Federal Regulations (or successor regulations), and, as appropriate, State law;

"(E) best practices for communication between sponsors and the Secretary on the development of data collection methods;

"(F) the appropriate format to submit such data to the Secretary;

"(G) a description of the manner in which the Secretary may assess or evaluate data collected through digital health technologies to support the development of the drug or device;

"(H) recommendations regarding the data and information needed to demonstrate that a digital health technology is fit-for-purpose for a clinical trial, and a description of how the Secretary will evaluate such data and information; and

"(I) recommendations for increasing access to, and the use of, digital health technologies in clinical trials to facilitate the inclusion of diverse and underrepresented populations, as appropriate, including considerations for access to, and the use of, digital health technologies in clinical trials by people with disabilities and pediatric populations.

"(b) Seamless and Concurrent Clinical Trials.—

"(1) In general.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance on the use of seamless, concurrent, and other innovative clinical trial designs to support the expedited development and review of applications for drugs, as appropriate. Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

"(2) Content.—The guidance described in paragraph (1) shall include—

"(A) recommendations on the use of expansion cohorts and other seamless clinical trial designs to assess different aspects of product candidates in one continuous trial, including how such clinical trial designs can be used as part of meeting the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));

"(B) recommendations on the use of clinical trial designs that involve the concurrent conduct of different or multiple clinical trial phases, and the concurrent conduct of preclinical testing, to expedite the development of new drugs and facilitate the timely collection of data;

"(C) recommendations for how to streamline trial logistics and facilitate the efficient collection and analysis of clinical trial data, including any planned interim analyses and how such analyses could be used to streamline the product development and review processes;

"(D) considerations to assist sponsors in ensuring the rights, safety, and welfare of clinical trial participants, maintaining compliance with good clinical practice regulations, minimizing risks to clinical trial data integrity, and ensuring the reliability of clinical trial results;

"(E) recommendations for communication between sponsors and the Food and Drug Administration on the development of seamless, concurrent, or other adaptive clinical trial designs, including review of, and feedback on, clinical trial protocols; and

"(F) a description of the manner in which the Secretary will assess or evaluate data collected through seamless, concurrent, or other adaptive clinical trial designs to support the development of drugs.

"(c) International Harmonization.—The Secretary shall, as appropriate, work with foreign regulators pursuant to memoranda of understanding or other arrangements governing the exchange of information to facilitate international harmonization of the regulation and use of decentralized clinical trials, digital technology in clinical trials, and seamless, concurrent, and other adaptive or innovative clinical trial designs."

§360a–2. Susceptibility test interpretive criteria for microorganisms

(a) Purpose; identification of criteria

(1) Purpose

The purpose of this section is to clarify the Secretary's authority to—

(A) efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health, due to, among other things, the constant evolution of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients, which warrants unique management of antimicrobial drugs that is inappropriate for most other drugs in order to delay or prevent the development of further resistance to existing therapies;

(B) provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards; and

(C) clear under section 360(k) of this title, classify under section 360c(f)(2) of this title, or approve under section 360e of this title, antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms, as applicable, to antimicrobial drugs.

(2) Identification of criteria

The Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs—

(A) if such criteria are available on the date of approval of the drug under section 355 of this title or licensure of the drug under section 262 of title 42 (as applicable), upon such approval or licensure; or

(B) if such criteria are unavailable on such date, on the date on which such criteria are available for such drug.

(3) Bases for initial identification

The Secretary shall identify appropriate susceptibility test interpretive criteria under paragraph (2), based on the Secretary's review of, to the extent available and relevant—

(A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;

(B) the relationship of susceptibility test interpretive criteria to morbidity and mortality associated with the disease or condition for which such drug is used; and

(C) such other evidence and information as the Secretary considers appropriate.

(b) Susceptibility test Interpretive Criteria Website

(1) In general

Not later than 1 year after December 13, 2016, the Secretary shall establish, and maintain thereafter, on the website of the Food and Drug Administration, a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards and interpretive criteria in accordance with paragraph (2) (referred to in this section as the "Interpretive Criteria Website").

(2) Listing of susceptibility test interpretive criteria standards and interpretive criteria

(A) In general

The list described in paragraph (1) shall consist of any new or updated susceptibility test interpretive criteria standards that are—

(i) established by a nationally or internationally recognized standard development organization that—

(I) establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking;

(II) holds open meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and

(III) permits its standards to be made publicly available, through the National Library of Medicine or another similar source acceptable to the Secretary; and

(ii) recognized in whole, or in part, by the Secretary under subsection (c).

(B) Other list

The Interpretive Criteria Website shall, in addition to the list described in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs, where—

(i) the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph (A) otherwise applicable to such a drug;

(ii) the Secretary withdraws under subsection (c)(1)(A) recognition of a standard, in whole or in part, otherwise applicable to such a drug;

(iii) the Secretary approves an application under section 355 of this title or section 262 of title 42, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or

(iv) because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug—

(I) differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph (A) or interpretive criteria otherwise listed under this subparagraph; and

(II) are determined by the Secretary to be appropriate for the drug.

(C) Required statements

The Interpretive Criteria Website shall include statements conveying—

(i) that the website provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to a certain drug (or drugs);

(ii) that—

(I) the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the susceptibility information described in clause (i) to be included on the website; and

(II) the clinical significance of such susceptibility information in such instances is unknown;

(iii) that the approved product labeling for specific drugs provides the uses for which the Secretary has approved the product; and

(iv) any other information that the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria included on the website.

(3) Notice

Not later than the date on which the Interpretive Criteria Website is established, the Secretary shall publish a notice of that establishment in the Federal Register.

(4) Inapplicability of misbranding provision

The inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the Interpretive Criteria Website, in and of itself, shall not cause the drug to be misbranded in violation of section 352 of this title.

(5) Trade secrets and confidential information

Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5.

(c) Recognition of susceptibility test interpretive criteria

(1) Evaluation and publication

(A) In general

Beginning on the date of the establishment of the Interpretive Criteria Website, and at least every 6 months thereafter, the Secretary shall—

(i) evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection (b)(2)(A)(i); and

(ii) publish on the public website of the Food and Drug Administration a notice—

(I) withdrawing recognition of any different susceptibility test interpretive criteria standard, in whole or in part;

(II) recognizing the new or updated standards;

(III) recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard; and

(IV) making any necessary updates to the lists under subsection (b)(2).

(B) Upon approval of a drug

Upon the approval of an initial or supplemental application for an antimicrobial drug under section 355 of this title or section 262 of title 42, as applicable, where such approval is based on susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to this subsection, or for which there are no relevant interpretive criteria standards recognized, or interpretive criteria otherwise listed, by the Secretary pursuant to this subsection, the Secretary shall update the lists under subparagraphs (A) and (B) of subsection (b)(2) to include the susceptibility test interpretive criteria upon which such approval was based.

(2) Bases for updating interpretive criteria standards

In evaluating new or updated susceptibility test interpretive criteria standards under paragraph (1)(A), the Secretary may consider—

(A) the Secretary's determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient;

(B) information provided by interested third parties, including public comment on the annual compilation of notices published under paragraph (3);

(C) any bases used to identify susceptibility test interpretive criteria under subsection (a)(2); and

(D) such other information or factors as the Secretary determines appropriate.

(3) Annual compilation of notices

Each year, the Secretary shall compile the notices published under paragraph (1)(A) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards or criteria—

(A) recognized by the Secretary under this subsection; or

(B) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

(4) Relation to section 360d(c) of this title

Any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection (b)(2)(B) shall be deemed to be recognized as a standard by the Secretary under section 360d(c)(1) of this title.

(5) Voluntary use of interpretive criteria

Nothing in this section prohibits a person from seeking approval or clearance of a drug or device, or changes to the drug or the device, on the basis of susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to subsection (b)(2).

(d) Antimicrobial drug labeling

(1) Drugs marketed prior to establishment of Interpretive Criteria Website

(A) In general

With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 355 of this title or section 262 of title 42, as applicable, for each such drug, not later than 1 year after establishment of the Interpretive Criteria Website described in subsection (b)(1), shall remove susceptibility test interpretive criteria, if any, and related information from the approved drug labeling and replace it with a reference to the Interpretive Criteria Website.

(B) Labeling changes

The labeling changes required by this section shall be considered a minor change under section 314.70 of title 21, Code of Federal Regulations (or any successor regulations) that may be implemented through documentation in the next applicable annual report.

(2) Drugs marketed subsequent to establishment of Interpretive Criteria Website

With respect to antimicrobial drugs approved on or after the date of the establishment of the Interpretive Criteria Website described in subsection (b)(1), the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website.

(e) Special condition for marketing of antimicrobial susceptibility testing devices

(1) In general

Notwithstanding sections 351, 352, 355, 360, 360c, and 360e of this title, if the conditions specified in paragraph (2) are met (in addition to other applicable provisions under this subchapter) with respect to an antimicrobial susceptibility testing device described in subsection (f)(1), the Secretary may authorize the marketing of such device for a use described in such subsection.

(2) Conditions applicable to antimicrobial susceptibility testing devices

The conditions specified in this paragraph are the following:

(A) The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are—

(i) included in a standard recognized by the Secretary under subsection (c); or

(ii) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

(B) The labeling of such device includes statements conveying—

(i) that the device provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to antimicrobial drugs;

(ii) that—

(I) the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the device to report the susceptibility of such bacteria, fungi, or other microorganisms, as applicable, to such drugs; and

(II) the clinical significance of such susceptibility information in those instances is unknown;

(iii) that the approved labeling for drugs tested using such a device provides the uses for which the Secretary has approved such drugs; and

(iv) any other information the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria described in subparagraph (A).

(C) The antimicrobial susceptibility testing device meets all other requirements to be cleared under section 360(k) of this title, classified under section 360c(f)(2) of this title, or approved under section 360e of this title.

(f) Definitions

In this section:

(1) The term "antimicrobial susceptibility testing device" means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).

(2) The term "qualified infectious disease product" means a qualified infectious disease product designated under section 355f(d) of this title.

(3) The term "susceptibility test interpretive criteria" means—

(A) one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and

(B) related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate.

(4)(A) The term "antimicrobial drug" means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that—

(i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus;

(ii) may include a qualified infectious disease product designated under section 355f(d) of this title; and

(iii) is subject to section 353(b)(1) of this title.

(B) If provided by the Secretary through regulations, such term may include—

(i) drugs other than systemic antibacterial and antifungal drugs; and

(ii) biological products (as such term is defined in section 262 of title 42) to the extent such products exhibit antimicrobial activity.

(5) The term "interpretive criteria standard" means a compilation of susceptibility test interpretive criteria developed by a standard development organization that meets the criteria set forth in subsection (b)(2)(A)(i).

(g) Rule of construction

Nothing in this section shall be construed to—

(1) alter the standards of evidence under subsection (c) or (d) of section 355 of this title (including the substantial evidence standard under section 355(d) of this title) or under section 262 of title 42 (as applicable); or

(2) with respect to clearing devices under section 360(k) of this title, classifying devices under section 360c(f)(2) of this title, or approving devices under section 360e of this title—

(A) apply with respect to any drug, device, or biological product, in any context other than an antimicrobial drug and an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the susceptibility of certain bacteria, fungi, or other microorganisms, as applicable, to such drug to reflect patient morbidity and mortality in accordance with this section; or

(B) unless specifically stated, have any effect on authorities provided under other sections of this chapter, including any regulations issued under such sections.

(June 25, 1938, ch. 675, §511A, as added Pub. L. 114–255, div. A, title III, §3044(a), Dec. 13, 2016, 130 Stat. 1114.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under section 356(h) of this title, by health care professionals, or to limit the practice of health care, see section 3043 of Pub. L. 114–255, set out as a Construction of 2016 Amendments note under section 356 of this title.

Requests for Updates to Interpretive Criteria Website

Pub. L. 114–255, div. A, title III, §3044(d), Dec. 13, 2016, 130 Stat. 1121, provided that: "Chapter 35 of title 44, United States Code, shall not apply to the collection of information from interested parties regarding updating the lists established under section 511A(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360a–2(b)] and posted on the Interpretive Criteria Website established under section 511A(c) [probably means section 511A(b)] of such Act."

§360b. New animal drugs

(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances

(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of section 351(a)(5) of this title and section 342(a)(2)(C)(ii) of this title unless—

(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application;

(B) there is in effect a conditional approval of an application filed pursuant to section 360ccc of this title with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved application;

(C) there is in effect an index listing pursuant to section 360ccc–1 of this title with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing; or

(D) there is in effect an authorization pursuant to section 360bbb–3 of this title with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to any conditions of such authorization.

A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee (i) holds a license issued under subsection (m) and has in its possession current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under subsection (m).

(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed be deemed unsafe for purposes of section 351(a)(6) of this title unless—

(A) there is in effect—

(i) an approval of an application filed pursuant to subsection (b) with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such approved application;

(ii) a conditional approval of an application filed pursuant to section 360ccc of this title with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such conditionally approved application; or

(iii) an index listing pursuant to section 360ccc–1 of this title with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such index listing; and

(B) such animal feed is manufactured at a site for which there is in effect a license issued pursuant to subsection (m)(1) to manufacture such animal feed.

(3) A new animal drug or an animal feed bearing or containing a new animal drug shall not be deemed unsafe for the purposes of section 351(a)(5) or (6) of this title if such article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under subsection (j).

(4)(A) Except as provided in subparagraph (B), if an approval of an application filed under subsection (b) is in effect with respect to a particular use or intended use of a new animal drug, the drug shall not be deemed unsafe for the purposes of paragraph (1) and shall be exempt from the requirements of section 352(f) of this title with respect to a different use or intended use of the drug, other than a use in or on animal feed, if such use or intended use—

(i) is by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship, as defined by the Secretary; and

(ii) is in compliance with regulations promulgated by the Secretary that establish the conditions for such different use or intended use.

The regulations promulgated by the Secretary under clause (ii) may prohibit particular uses of an animal drug and shall not permit such different use of an animal drug if the labeling of another animal drug that contains the same active ingredient and which is in the same dosage form and concentration provides for such different use.

(B) If the Secretary finds that there is a reasonable probability that a use of an animal drug authorized under subparagraph (A) may present a risk to the public health, the Secretary may—

(i) establish a safe level for a residue of an animal drug when it is used for such different use authorized by subparagraph (A); and

(ii) require the development of a practical, analytical method for the detection of residues of such drug above the safe level established under clause (i).

The use of an animal drug that results in residues exceeding a safe level established under clause (i) shall be considered an unsafe use of such drug under paragraph (1). Safe levels may be established under clause (i) either by regulation or order.

(C) The Secretary may by general regulation provide access to the records of veterinarians to ascertain any use or intended use authorized under subparagraph (A) that the Secretary has determined may present a risk to the public health.

(D) If the Secretary finds, after affording an opportunity for public comment, that a use of an animal drug authorized under subparagraph (A) presents a risk to the public health or that an analytical method required under subparagraph (B) has not been developed and submitted to the Secretary, the Secretary may, by order, prohibit any such use.

(5) If the approval of an application filed under section 355 of this title is in effect, the drug under such application shall not be deemed unsafe for purposes of paragraph (1) and shall be exempt from the requirements of section 352(f) of this title with respect to a use or intended use of the drug in animals if such use or intended use—

(A) is by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship, as defined by the Secretary; and

(B) is in compliance with regulations promulgated by the Secretary that establish the conditions for the use or intended use of the drug in animals.

(6) For purposes of section 342(a)(2)(D) ¹ of this title, a use or intended use of a new animal drug shall not be deemed unsafe under this section if the Secretary establishes a tolerance for such drug and any edible portion of any animal imported into the United States does not contain residues exceeding such tolerance. In establishing such tolerance, the Secretary shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used by the Secretary to establish tolerances for applications for new animal drugs filed under subsection (b)(1). The Secretary may consider and rely on data submitted by the drug manufacturer, including data submitted to appropriate regulatory authorities in any country where the new animal drug is lawfully used or data available from a relevant international organization, to the extent such data are not inconsistent with the criteria used by the Secretary to establish a tolerance for applications for new animal drugs filed under subsection (b)(1). For purposes of this paragraph, "relevant international organization" means the Codex Alimenterius ² Commission or other international organization deemed appropriate by the Secretary. The Secretary may, under procedures specified by regulation, revoke a tolerance established under this paragraph if information demonstrates that the use of the new animal drug under actual use conditions results in food being imported into the United States with residues exceeding the tolerance or if scientific evidence shows the tolerance to be unsafe.

(b) Filing application for uses of new animal drug; contents; patent information; abbreviated application; presubmission conference

(1) Any person may file with the Secretary an application with respect to any intended use or uses of a new animal drug. Such person shall submit to the Secretary as a part of the application (A) full reports of investigations which have been made to show whether or not such drug is safe and effective for use; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof, of any animal feed for use in or on which such drug is intended, and of the edible portions or products (before or after slaughter) of animals to which such drug (directly or in or on animal feed) is intended to be administered, as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug, or in case such drug is intended for use in animal feed, proposed labeling appropriate for such use, and specimens of the labeling for the drug to be manufactured, packed, or distributed by the applicant; (G) a description of practicable methods for determining the quantity, if any, of such drug in or on food, and any substance formed in or on food, because of its use; and (H) the proposed tolerance or withdrawal period or other use restrictions for such drug if any tolerance or withdrawal period or other use restrictions are required in order to assure that the proposed use of such drug will be safe. The applicant shall file with the application the patent number and the expiration date of any patent which claims the new animal drug for which the applicant filed the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the information required by the preceding sentence. Upon approval of the application, the Secretary shall publish information submitted under the two preceding sentences.

(2) Any person may file with the Secretary an abbreviated application for the approval of a new animal drug. An abbreviated application shall contain the information required by subsection (n).

(3) Any person intending to file an application under paragraph (1), section 360ccc of this title, or a request for an investigational exemption under subsection (j) shall be entitled to one or more conferences prior to such submission to reach an agreement acceptable to the Secretary establishing a submission or an investigational requirement, which may include a requirement for a field investigation. A decision establishing a submission or an investigational requirement shall bind the Secretary and the applicant or requestor unless (A) the Secretary and the applicant or requestor mutually agree to modify the requirement, or (B) the Secretary by written order determines that a substantiated scientific requirement essential to the determination of safety or effectiveness of the animal drug involved has appeared after the conference. No later than 25 calendar days after each such conference, the Secretary shall provide a written order setting forth a scientific justification specific to the animal drug and intended uses under consideration if the agreement referred to in the first sentence requires more than one field investigation as being essential to provide substantial evidence of effectiveness for the intended uses of the drug. Nothing in this paragraph shall be construed as compelling the Secretary to require a field investigation.

(4) Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require.

(c) Period for submission and approval of application; period for notice and expedition of hearing; period for issuance of order; abbreviated applications; withdrawal periods; effective date of approval; relationship to other applications; withdrawal or suspension of approval; bioequivalence; filing of additional patent information

(1) Within one hundred and eighty days after the filing of an application pursuant to subsection (b), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (A) issue an order approving the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or (B) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. If the applicant elects to accept the opportunity for a hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs.

(2)(A) Subject to subparagraph (C), the Secretary shall approve an abbreviated application for a drug unless the Secretary finds—

(i) the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity;

(ii) the conditions of use prescribed, recommended, or suggested in the proposed labeling are not reasonably certain to be followed in practice or, except as provided in subparagraph (B), information submitted with the application is insufficient to show that each of the proposed conditions of use or similar limitations (whether in the labeling or published pursuant to subsection (i)) have been previously approved for the approved new animal drug referred to in the application;

(iii) information submitted with the application is insufficient to show that the active ingredients are the same as those of the approved new animal drug referred to in the application;

(iv)(I) if the application is for a drug whose active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is the same as the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed of the approved new animal drug referred to in the application, information submitted in the application is insufficient to show that the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is the same as that of the approved new animal drug, or

(II) if the application is for a drug whose active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is different from that of the approved new animal drug referred to in the application, no petition to file an application for the drug with the different active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed was approved under subsection (n)(3);

(v) if the application was filed pursuant to the approval of a petition under subsection (n)(3), the application did not contain the information required by the Secretary respecting the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed which is not the same;

(vi) information submitted in the application is insufficient to show that the drug is bioequivalent to the approved new animal drug referred to in the application, or if the application is filed under a petition approved pursuant to subsection (n)(3), information submitted in the application is insufficient to show that the active ingredients of the new animal drug are of the same pharmacological or therapeutic class as the pharmacological or therapeutic class of the approved new animal drug and that the new animal drug can be expected to have the same therapeutic effect as the approved new animal drug when used in accordance with the labeling;

(vii) information submitted in the application is insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the approved new animal drug referred to in the application except for changes required because of differences approved under a petition filed under subsection (n)(3), because of a different withdrawal period, or because the drug and the approved new animal drug are produced or distributed by different manufacturers;

(viii) information submitted in the application or any other information available to the Secretary shows that (I) the inactive ingredients of the drug are unsafe for use under the conditions prescribed, recommended, or suggested in the labeling proposed for the drug, (II) the composition of the drug is unsafe under such conditions because of the type or quantity of inactive ingredients included or the manner in which the inactive ingredients are included, or (III) in the case of a drug for food producing animals, the inactive ingredients of the drug or its composition may be unsafe with respect to human food safety;

(ix) the approval under subsection (b)(1) of the approved new animal drug referred to in the application filed under subsection (b)(2) has been withdrawn or suspended for grounds described in paragraph (1) of subsection (e), the Secretary has published a notice of a hearing to withdraw approval of the approved new animal drug for such grounds, the approval under this paragraph of the new animal drug for which the application under subsection (b)(2) was filed has been withdrawn or suspended under subparagraph (G) for such grounds, or the Secretary has determined that the approved new animal drug has been withdrawn from sale for safety or effectiveness reasons;

(x) the application does not meet any other requirement of subsection (n); or

(xi) the application contains an untrue statement of material fact.

(B) If the Secretary finds that a new animal drug for which an application is submitted under subsection (b)(2) is bioequivalent to the approved new animal drug referred to in such application and that residues of the new animal drug are consistent with the tolerances established for such approved new animal drug but at a withdrawal period which is different than the withdrawal period approved for such approved new animal drug, the Secretary may establish, on the basis of information submitted, such different withdrawal period as the withdrawal period for the new animal drug for purposes of the approval of such application for such drug.

(C) Within 180 days of the initial receipt of an application under subsection (b)(2) or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application.

(D) The approval of an application filed under subsection (b)(2) shall be made effective on the last applicable date determined under the following:

(i) If the applicant only made a certification described in clause (i) or (ii) of subsection (n)(1)(G) or in both such clauses, the approval may be made effective immediately.

(ii) If the applicant made a certification described in clause (iii) of subsection (n)(1)(G), the approval may be made effective on the date certified under clause (iii).

(iii) If the applicant made a certification described in clause (iv) of subsection (n)(1)(G), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of 45 days from the date the notice provided under subsection (n)(2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the 30 month period beginning on the date of the receipt of the notice provided under subsection (n)(2)(B) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that if before the expiration of such period—

(I) the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision,

(II) the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, or

(III) the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision.

In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of 45 days from the date the notice made under subsection (n)(2)(B) is received, no action may be brought under section 2201 of title 28 for a declaratory judgment with respect to the patent. Any action brought under section 2201 of title 28 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.

(iv) If the application contains a certification described in clause (iv) of subsection (n)(1)(G) and is for a drug for which a previous application has been filed under this subsection containing such a certification, the application shall be made effective not earlier than 180 days after—

(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or

(II) the date of a decision of a court in an action described in subclause (III) ³ holding the patent which is the subject of the certification to be invalid or not infringed,

whichever is earlier.

(E) If the Secretary decides to disapprove an application, the Secretary shall give the applicant notice of an opportunity for a hearing before the Secretary on the question of whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after such notice, such hearing shall commence not more than 90 days after the expiration of such 30 days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within 90 days after the date fixed by the Secretary for filing final briefs.

(F)(i) If an application submitted under subsection (b)(1) for a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under subsection (b)(1), is approved after November 16, 1988, no application may be submitted under subsection (b)(2) which refers to the drug for which the subsection (b)(1) application was submitted before the expiration of 5 years from the date of the approval of the application under subsection (b)(1), except that such an application may be submitted under subsection (b)(2) after the expiration of 4 years from the date of the approval of the subsection (b)(1) application if it contains a certification of patent invalidity or noninfringement described in clause (iv) of subsection (n)(1)(G). The approval of such an application shall be made effective in accordance with subparagraph (B) except that, if an action for patent infringement is commenced during the one-year period beginning 48 months after the date of the approval of the subsection (b) application, the 30 month period referred to in subparagraph (D)(iii) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application.

(ii) If an application submitted under subsection (b)(1) for a drug, which includes an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in another application approved under such subsection, is approved after November 16, 1988, and if such application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or, in the case of food producing animals, human food safety studies (other than bioequivalence studies or residue depletion studies, except residue depletion studies for minor uses or minor species) required for the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under subsection (b)(2) for the conditions of approval of such drug in the subsection (b)(1) application effective before the expiration of 3 years from the date of the approval of the application under subsection (b)(1) for such drug.

(iii) If a supplement to an application approved under subsection (b)(1) is approved after November 16, 1988, and the supplement contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or, in the case of food producing animals, human food safety studies (other than bioequivalence studies or residue depletion studies, except residue depletion studies for minor uses or minor species) required for the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under subsection (b)(2) for a change approved in the supplement effective before the expiration of 3 years from the date of the approval of the supplement.

(iv) An applicant under subsection (b)(1) who comes within the provisions of clause (i) of this subparagraph as a result of an application which seeks approval for a use solely in non-food producing animals, may elect, within 10 days of receiving such approval, to waive clause (i) of this subparagraph, in which event the limitation on approval of applications submitted under subsection (b)(2) set forth in clause (ii) of this subparagraph shall be applicable to the subsection (b)(1) application.

(v) If an application (including any supplement to a new animal drug application) submitted under subsection (b)(1) for a new animal drug for a food-producing animal use, which includes an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) which has been the subject of a waiver under clause (iv) is approved after November 16, 1988, and if the application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or human food safety studies (other than bioequivalence studies or residue depletion studies, except residue depletion studies for minor uses or minor species) required for the new approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application (including any supplement to such application) submitted under subsection (b)(2) for the new conditions of approval of such drug in the subsection (b)(1) application effective before the expiration of five years from the date of approval of the application under subsection (b)(1) for such drug. The provisions of this paragraph shall apply only to the first approval for a food-producing animal use for the same applicant after the waiver under clause (iv).

(G) If an approved application submitted under subsection (b)(2) for a new animal drug refers to a drug the approval of which was withdrawn or suspended for grounds described in paragraph (1) or (2) of subsection (e) or was withdrawn or suspended under this subparagraph or which, as determined by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the approval of the drug under this paragraph shall be withdrawn or suspended—

(i) for the same period as the withdrawal or suspension under subsection (e) or this subparagraph, or

(ii) if the approved new animal drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons.

(H) For purposes of this paragraph:

(i) The term "bioequivalence" means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a new animal drug and becomes available at the site of drug action.

(ii) A new animal drug shall be considered to be bioequivalent to the approved new animal drug referred to in its application under subsection (n) if—

(I) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the approved new animal drug referred to in the application when administered at the same dose of the active ingredient under similar experimental conditions in either a single dose or multiple doses;

(II) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the approved new animal drug referred to in the application when administered at the same dose of the active ingredient under similar experimental conditions in either a single dose or multiple doses and the difference from the approved new animal drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective drug concentrations in use, and is considered scientifically insignificant for the drug in attaining the intended purposes of its use and preserving human food safety; or

(III) in any case in which the Secretary determines that the measurement of the rate and extent of absorption or excretion of the new animal drug in biological fluids is inappropriate or impractical, an appropriate acute pharmacological effects test or other test of the new animal drug and, when deemed scientifically necessary, of the approved new animal drug referred to in the application in the species to be tested or in an appropriate animal model does not show a significant difference between the new animal drug and such approved new animal drug when administered at the same dose under similar experimental conditions.

If the approved new animal drug referred to in the application for a new animal drug under subsection (n) is approved for use in more than one animal species, the bioequivalency information described in subclauses (I), (II), and (III) shall be obtained for one species, or if the Secretary deems appropriate based on scientific principles, shall be obtained for more than one species. The Secretary may prescribe the dose to be used in determining bioequivalency under subclause (I), (II), or (III). To assure that the residues of the new animal drug will be consistent with the established tolerances for the approved new animal drug referred to in the application under subsection (b)(2) upon the expiration of the withdrawal period contained in the application for the new animal drug, the Secretary shall require bioequivalency data or residue depletion studies of the new animal drug or such other data or studies as the Secretary considers appropriate based on scientific principles. If the Secretary requires one or more residue studies under the preceding sentence, the Secretary may not require that the assay methodology used to determine the withdrawal period of the new animal drug be more rigorous than the methodology used to determine the withdrawal period for the approved new animal drug referred to in the application. If such studies are required and if the approved new animal drug, referred to in the application for the new animal drug for which such studies are required, is approved for use in more than one animal species, such studies shall be conducted for one species, or if the Secretary deems appropriate based on scientific principles, shall be conducted for more than one species.

(3) If the patent information described in subsection (b)(1) could not be filed with the submission of an application under subsection (b)(1) because the application was filed before the patent information was required under subsection (b)(1) or a patent was issued after the application was approved under such subsection, the holder of an approved application shall file with the Secretary the patent number and the expiration date of any patent which claims the new animal drug for which the application was filed or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of an approved application could not file patent information under subsection (b)(1) because it was not required at the time the application was approved, the holder shall file such information under this subsection not later than 30 days after November 16, 1988, and if the holder of an approved application could not file patent information under subsection (b)(1) because no patent had been issued when an application was filed or approved, the holder shall file such information under this subsection not later than 30 days after the date the patent involved is issued. Upon the submission of patent information under this subsection, the Secretary shall publish it.

(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.

(d) Grounds for refusing application; approval of application; factors; "substantial evidence" defined; combination drugs

(1) If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a hearing, in accordance with said subsection, that—

(A) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;

(B) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions;

(C) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity;

(D) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions;

(E) evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof;

(F) upon the basis of information submitted to the Secretary as part of the application or any other information before the Secretary with respect to such drug, any use prescribed, recommended, or suggested in labeling proposed for such drug will result in a residue of such drug in excess of a tolerance found by the Secretary to be safe for such drug;

(G) the application failed to contain the patent information prescribed by subsection (b)(1);

(H) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; or

(I) such drug induces cancer when ingested by man or animal or, after tests which are appropriate for the evaluation of the safety of such drug, induces cancer in man or animal, except that the foregoing provisions of this subparagraph shall not apply with respect to such drug if the Secretary finds that, under the conditions of use specified in proposed labeling and reasonably certain to be followed in practice (i) such drug will not adversely affect the animals for which it is intended, and (ii) no residue of such drug will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (c), (d), and (h)), in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animals;

he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearings, the Secretary finds that subparagraphs (A) through (I) do not apply, he shall issue an order approving the application.

(2) In determining whether such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Secretary shall consider, among other relevant factors, (A) the probable consumption of such drug and of any substance formed in or on food because of the use of such drug, (B) the cumulative effect on man or animal of such drug, taking into account any chemically or pharmacologically related substance, (C) safety factors which in the opinion of experts, qualified by scientific training and experience to evaluate the safety of such drugs, are appropriate for the use of animal experimentation data, and (D) whether the conditions of use prescribed, recommended, or suggested in the proposed labeling are reasonably certain to be followed in practice. Any order issued under this subsection refusing to approve an application shall state the findings upon which it is based.

(3) As used in this section, the term "substantial evidence" means evidence consisting of one or more adequate and well controlled investigations, such as—

(A) a study in a target species;

(B) a study in laboratory animals;

(C) any field investigation that may be required under this section and that meets the requirements of subsection (b)(3) if a presubmission conference is requested by the applicant;

(D) a bioequivalence study; or

(E) an in vitro study;

by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.

(4) In a case in which an animal drug contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved pursuant to an application submitted under subsection (b)(1) for particular uses and conditions of use for which they are intended for use in the combination—

(A) the Secretary shall not issue an order under paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the application for such combination on human food safety grounds unless the Secretary finds that the application fails to establish that—

(i) none of the active ingredients or drugs intended for use in the combination, respectively, at the longest withdrawal time of any of the active ingredients or drugs in the combination, respectively, exceeds its established tolerance; or

(ii) none of the active ingredients or drugs in the combination interferes with the methods of analysis for another of the active ingredients or drugs in the combination, respectively;

(B) the Secretary shall not issue an order under paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the application for such combination on target animal safety grounds unless the Secretary finds that—

(i)(I) there is a substantiated scientific issue, specific to one or more of the active ingredients or animal drugs in the combination, that cannot adequately be evaluated based on information contained in the application for the combination (including any investigations, studies, or tests for which the applicant has a right of reference or use from the person by or for whom the investigations, studies, or tests were conducted); or

(II) there is a scientific issue raised by target animal observations contained in studies submitted to the Secretary as part of the application; and

(ii) based on the Secretary's evaluation of the information contained in the application with respect to the issues identified in clauses (i)(I) and (II), paragraph (1)(A), (B), or (D) apply;

(C) except in the case of a combination that contains a nontopical antibacterial ingredient or animal drug, the Secretary shall not issue an order under paragraph (1)(E) refusing to approve an application for a combination animal drug intended for use other than in animal feed or drinking water unless the Secretary finds that the application fails to demonstrate that—

(i) there is substantial evidence that any active ingredient or animal drug intended only for the same use as another active ingredient or animal drug in the combination makes a contribution to labeled effectiveness;

(ii) each active ingredient or animal drug intended for at least one use that is different from all other active ingredients or animal drugs used in the combination provides appropriate concurrent use for the intended target population; or

(iii) where based on scientific information the Secretary has reason to believe the active ingredients or animal drugs may be physically incompatible or have disparate dosing regimens, such active ingredients or animal drugs are physically compatible or do not have disparate dosing regimens; and

(D) the Secretary shall not issue an order under paragraph (1)(E) refusing to approve an application for a combination animal drug intended for use in animal feed or drinking water unless the Secretary finds that the application fails to demonstrate that—

(i) there is substantial evidence that any active ingredient or animal drug intended only for the same use as another active ingredient or animal drug in the combination makes a contribution to the labeled effectiveness;

(ii) each of the active ingredients or animal drugs intended for at least one use that is different from all other active ingredients or animal drugs used in the combination provides appropriate concurrent use for the intended target population;

(iii) where a combination contains more than one nontopical antibacterial ingredient or animal drug, there is substantial evidence that each of the nontopical antibacterial ingredients or animal drugs makes a contribution to the labeled effectiveness, except that for purposes of this clause, antibacterial ingredient or animal drug does not include the ionophore or arsenical classes of animal drugs; or

(iv) where based on scientific information the Secretary has reason to believe the active ingredients or animal drugs intended for use in drinking water may be physically incompatible, such active ingredients or animal drugs intended for use in drinking water are physically compatible.

(5) In reviewing an application that proposes a change to add an intended use for a minor use or a minor species to an approved new animal drug application, the Secretary shall reevaluate only the relevant information in the approved application to determine whether the application for the minor use or minor species can be approved. A decision to approve the application for the minor use or minor species is not, implicitly or explicitly, a reaffirmation of the approval of the original application.

(e) Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to health of man or animals

(1) The Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to subsection (b) with respect to any new animal drug if the Secretary finds—

(A) that experience or scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved or the condition of use authorized under subsection (a)(4)(A);

(B) that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved or that subparagraph (I) of paragraph (1) of subsection (d) applies to such drug;

(C) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence that such drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

(D) the patent information prescribed by subsection (c)(3) was not filed within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information;

(E) that the application contains any untrue statement of a material fact; or

(F) that the applicant has made any changes from the standpoint of safety or effectiveness beyond the variations provided for in the application unless he has supplemented the application by filing with the Secretary adequate information respecting all such changes and unless there is in effect an approval of the supplemental application. The supplemental application shall be treated in the same manner as the original application.

If the Secretary (or in his absence the officer acting as Secretary) finds that there is an imminent hazard to the health of man or of the animals for which such drug is intended, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this sentence to suspend the approval of an application shall not be delegated.

(2) The Secretary may also, after due notice and opportunity for hearing to the applicant, issue an order withdrawing the approval of an application with respect to any new animal drug under this section if the Secretary finds—

(A) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports in accordance with a regulation or order under subsection (l), or the applicant has refused to permit access to, or copying or verification of, such records as required by paragraph (2) of such subsection;

(B) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or

(C) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of.

(3) Any order under this subsection shall state the findings upon which it is based.

(f) Revocation of order refusing, withdrawing or suspending approval of application

Whenever the Secretary finds that the facts so require, he shall revoke any previous order under subsection (d), (e), or (m), or section 360ccc(c), (d), or (e) of this title refusing, withdrawing, or suspending approval of an application and shall approve such application or reinstate such approval, as may be appropriate.

(g) Service of orders

Orders of the Secretary issued under this section, or section 360ccc of this title (other than orders issuing, amending, or repealing regulations) shall be served (1) in person by any officer or employee of the department designated by the Secretary or (2) by mailing the order by registered mail or by certified mail addressed to the applicant or respondent at his last known address in the records of the Secretary.

(h) Appeal from order

An appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application filed under subsection (b) or (m) of this section. The provisions of subsection (h) of section 355 of this title shall govern any such appeal.

(i) Publication in Federal Register; effective date and revocation or suspension of regulation

When a new animal drug application filed pursuant to subsection (b) or section 360ccc of this title is approved, the Secretary shall by notice, which upon publication shall be effective as a regulation, publish in the Federal Register the name and address of the applicant and the conditions and indications of use of the new animal drug covered by such application, including any tolerance and withdrawal period or other use restrictions and, if such new animal drug is intended for use in animal feed, appropriate purposes and conditions of use (including special labeling requirements and any requirement that an animal feed bearing or containing the new animal drug be limited to use under the professional supervision of a licensed veterinarian) applicable to any animal feed for use in which such drug is approved, and such other information, upon the basis of which such application was approved, as the Secretary deems necessary to assure the safe and effective use of such drug. Upon withdrawal of approval of such new animal drug application or upon its suspension or upon failure to renew a conditional approval under section 360ccc of this title, the Secretary shall forthwith revoke or suspend, as the case may be, the regulation published pursuant to this subsection (i) insofar as it is based on the approval of such application.

(j) Exemption of drugs for research; discretionary and mandatory conditions

To the extent consistent with the public health, the Secretary shall promulgate regulations for exempting from the operation of this section new animal drugs, and animal feeds bearing or containing new animal drugs, intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs. Such regulations may, in the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such article, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of such article, as the Secretary finds will enable him to evaluate the safety and effectiveness of such article in the event of the filing of an application pursuant to this section. Such regulations, among other things, shall set forth the conditions (if any) upon which animals treated with such articles, and any products of such animals (before or after slaughter), may be marketed for food use.

(k) Food containing new animal drug considered unadulterated while approval of application for such drug is effective

While approval of an application for a new animal drug is effective, a food shall not, by reason of bearing or containing such drug or any substance formed in or on the food because of its use in accordance with such application (including the conditions and indications of use prescribed pursuant to subsection (i)), be considered adulterated within the meaning of clause (1) of section 342(a) of this title.

(l) Records and reports; required information; regulations and orders; examination of data; access to records

(1) In the case of any new animal drug for which an approval of an application filed pursuant to subsection (b) or section 360ccc of this title is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, of data relating to experience, including experience with uses authorized under subsection (a)(4)(A), and other data or information, received or otherwise obtained by such applicant with respect to such drug, or with respect to animal feeds bearing or containing such drug, as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e) or subsection (m)(4) of this section. Such regulation or order shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulation or order is applicable, of similar information received or otherwise obtained by the Secretary.

(2) Every person required under this subsection to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(3)(A) In the case of each new animal drug described in paragraph (1) that contains an antimicrobial active ingredient, the sponsor of the drug shall submit an annual report to the Secretary on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product.

(B) Each report under this paragraph shall specify the amount of each antimicrobial active ingredient—

(i) by container size, strength, and dosage form;

(ii) by quantities distributed domestically and quantities exported; and

(iii) by dosage form, including, for each such dosage form, a listing of the target animals, indications, and production classes that are specified on the approved label of the product.

(C) Each report under this paragraph shall—

(i) be submitted not later than March 31 each year;

(ii) cover the period of the preceding calendar year; and

(iii) include separate information for each month of such calendar year.

(D) The Secretary may share information reported under this paragraph with the Antimicrobial Resistance Task Force established under section 247d–5 of title 42.

(E) The Secretary shall make summaries of the information reported under this paragraph publicly available, except that—

(i) the summary data shall be reported by antimicrobial class, and no class with fewer than 3 distinct sponsors of approved applications shall be independently reported; and

(ii) the data shall be reported in a manner consistent with protecting both national security and confidential business information.

(m) Feed mill licenses

(1) Any person may file with the Secretary an application for a license to manufacture animal feeds bearing or containing new animal drugs. Such person shall submit to the Secretary as part of the application (A) a full statement of the business name and address of the specific facility at which the manufacturing is to take place and the facility's registration number, (B) the name and signature of the responsible individual or individuals for that facility, (C) a certification that the animal feeds bearing or containing new animal drugs are manufactured and labeled in accordance with the applicable regulations published pursuant to subsection (i) or for indexed new animal drugs in accordance with the index listing published pursuant to section 360ccc–1(e)(2) of this title and the labeling requirements set forth in section 360ccc–1(h) of this title, and (D) a certification that the methods used in, and the facilities and controls used for, manufacturing, processing, packaging, and holding such animal feeds are in conformity with current good manufacturing practice as described in section 351(a)(2)(B) of this title.

(2) Within 90 days after the filing of an application pursuant to paragraph (1), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall (A) issue an order approving the application if the Secretary then finds that none of the grounds for denying approval specified in paragraph (3) applies, or (B) give the applicant notice of an opportunity for a hearing before the Secretary under paragraph (3) on the question whether such application is approvable. The procedure governing such a hearing shall be the procedure set forth in the last two sentences of subsection (c)(1).

(3) If the Secretary, after due notice to the applicant in accordance with paragraph (2) and giving the applicant an opportunity for a hearing in accordance with such paragraph, finds, on the basis of information submitted to the Secretary as part of the application, on the basis of a preapproval inspection, or on the basis of any other information before the Secretary—

(A) that the application is incomplete, false, or misleading in any particular;

(B) that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such animal feed are inadequate to preserve the identity, strength, quality, and purity of the new animal drug therein; or

(C) that the facility manufactures animal feeds bearing or containing new animal drugs in a manner that does not accord with the specifications for manufacture or labels animal feeds bearing or containing new animal drugs in a manner that does not accord with the conditions or indications of use that are published pursuant to subsection (i) or an index listing pursuant to section 360ccc–1(e) of this title,

the Secretary shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that subparagraphs (A) through (C) do not apply, the Secretary shall issue an order approving the application. An order under this subsection approving an application for a license to manufacture animal feeds bearing or containing new animal drugs shall permit a facility to manufacture only those animal feeds bearing or containing new animal drugs for which there are in effect regulations pursuant to subsection (i) or an index listing pursuant to section 360ccc–1(e) of this title relating to the use of such drugs in or on such animal feed.

(4)(A) The Secretary shall, after due notice and opportunity for hearing to the applicant, revoke a license to manufacture animal feeds bearing or containing new animal drugs under this subsection if the Secretary finds—

(i) that the application for such license contains any untrue statement of a material fact; or

(ii) that the applicant has made changes that would cause the application to contain any untrue statements of material fact or that would affect the safety or effectiveness of the animal feeds manufactured at the facility unless the applicant has supplemented the application by filing with the Secretary adequate information respecting all such changes and unless there is in effect an approval of the supplemental application.

If the Secretary (or in the Secretary's absence the officer acting as the Secretary) finds that there is an imminent hazard to the health of humans or of the animals for which such animal feed is intended, the Secretary may suspend the license immediately, and give the applicant prompt notice of the action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this sentence shall not be delegated.

(B) The Secretary may also, after due notice and opportunity for hearing to the applicant, revoke a license to manufacture animal feed under this subsection if the Secretary finds—

(i) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports in accordance with a regulation or order under paragraph (5)(A) of this subsection or section 354(a)(3)(A) of this title, or the applicant has refused to permit access to, or copying or verification of, such records as required by subparagraph (B) of such paragraph or section 354(a)(3)(B) of this title;

(ii) that on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such license was issued, the methods used in, or the facilities and controls used for, the manufacture, processing, packing, and holding of such animal feed are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drug therein, and were not made adequate within a reasonable time after receipt of written notice from the Secretary, specifying the matter complained of;

(iii) that on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such license was issued, the labeling of any animal feeds, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or

(iv) that on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such license was issued, the facility has manufactured, processed, packed, or held animal feed bearing or containing a new animal drug adulterated under section 351(a)(6) of this title and the facility did not discontinue the manufacture, processing, packing, or holding of such animal feed within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of.

(C) The Secretary may also revoke a license to manufacture animal feeds under this subsection if an applicant gives notice to the Secretary of intention to discontinue the manufacture of all animal feed covered under this subsection and waives an opportunity for a hearing on the matter.

(D) Any order under this paragraph shall state the findings upon which it is based.

(5) When a license to manufacture animal feeds bearing or containing new animal drugs has been issued—

(A) the applicant shall establish and maintain such records, and make such reports to the Secretary, or (at the option of the Secretary) to the appropriate person or persons holding an approved application filed under subsection (b), as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e) or paragraph (4); and

(B) every person required under this subsection to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(6) To the extent consistent with the public health, the Secretary may promulgate regulations for exempting from the operation of this subsection facilities that manufacture, process, pack, or hold animal feeds bearing or containing new animal drugs.

(n) Abbreviated applications for new animal drugs; contents, filing, etc.; lists of approved drugs

(1) An abbreviated application for a new animal drug shall contain—

(A)(i) except as provided in clause (ii), information to show that the conditions of use or similar limitations (whether in the labeling or published pursuant to subsection (i)) prescribed, recommended, or suggested in the labeling proposed for the new animal drug have been previously approved for a new animal drug listed under paragraph (4) (hereinafter in this subsection referred to as an "approved new animal drug"), and

(ii) information to show that the withdrawal period at which residues of the new animal drug will be consistent with the tolerances established for the approved new animal drug is the same as the withdrawal period previously established for the approved new animal drug or, if the withdrawal period is proposed to be different, information showing that the residues of the new animal drug at the proposed different withdrawal period will be consistent with the tolerances established for the approved new animal drug;

(B)(i) information to show that the active ingredients of the new animal drug are the same as those of the approved new animal drug, and

(ii) if the approved new animal drug has more than one active ingredient, and if one of the active ingredients of the new animal drug is different from one of the active ingredients of the approved new animal drug and the application is filed pursuant to the approval of a petition filed under paragraph (3)—

(I) information to show that the other active ingredients of the new animal drug are the same as the active ingredients of the approved new animal drug,

(II) information to show either that the different active ingredient is an active ingredient of another approved new animal drug or of an animal drug which does not meet the requirements of section 321(v) of this title, and

(III) such other information respecting the different active ingredients as the Secretary may require;

(C)(i) if the approved new animal drug is permitted to be used with one or more animal drugs in animal feed, information to show that the proposed uses of the new animal drug with other animal drugs in animal feed are the same as the uses of the approved new animal drug, and

(ii) if the approved new animal drug is permitted to be used with one or more other animal drugs in animal feed, and one of the other animal drugs proposed for use with the new animal drug in animal feed is different from one of the other animal drugs permitted to be used in animal feed with the approved new animal drug, and the application is filed pursuant to the approval of a petition filed under paragraph (3)—

(I) information to show either that the different animal drug proposed for use with the approved new animal drug in animal feed is an approved new animal drug permitted to be used in animal feed or does not meet the requirements of section 321(v) of this title when used with another animal drug in animal feed,

(II) information to show that other animal drugs proposed for use with the new animal drug in animal feed are the same as the other animal drugs permitted to be used with the approved new animal drug, and

(III) such other information respecting the different animal drug or combination with respect to which the petition was filed as the Secretary may require,

(D) information to show that the route of administration, the dosage form, and the strength of the new animal drug are the same as those of the approved new animal drug or, if the route of administration, the dosage form, or the strength of the new animal drug is different and the application is filed pursuant to the approval of a petition filed under paragraph (3), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require;

(E) information to show that the new animal drug is bioequivalent to the approved new animal drug, except that if the application is filed pursuant to the approval of a petition filed under paragraph (3) for the purposes described in subparagraph (B) or (C), information to show that the active ingredients of the new animal drug are of the same pharmacological or therapeutic class as the pharmacological or therapeutic class of the approved new animal drug and that the new animal drug can be expected to have the same therapeutic effect as the approved new animal drug when used in accordance with the labeling;

(F) information to show that the labeling proposed for the new animal drug is the same as the labeling approved for the approved new animal drug except for changes required because of differences approved under a petition filed under paragraph (3), because of a different withdrawal period, or because the new animal drug and the approved new animal drug are produced or distributed by different manufacturers;

(G) the items specified in clauses (B) through (F) of subsection (b)(1);

(H) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the approved new animal drug or which claims a use for such approved new animal drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b)(1) or (c)(3)—

(i) that such patent information has not been filed,

(ii) that such patent has expired,

(iii) of the date on which such patent will expire, or

(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new animal drug for which the application is filed; and

(I) if with respect to the approved new animal drug information was filed under subsection (b)(1) or (c)(3) for a method of use patent which does not claim a use for which the applicant is seeking approval of an application under subsection (c)(2), a statement that the method of use patent does not claim such a use.

The Secretary may not require that an abbreviated application contain information in addition to that required by subparagraphs (A) through (I).

(2)(A) An applicant who makes a certification described in paragraph (1)(G)(iv) shall include in the application a statement that the applicant will give the notice required by subparagraph (B) to—

(i) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and

(ii) the holder of the approved application under subsection (c)(1) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice.

(B) The notice referred to in subparagraph (A) shall state that an application, which contains data from bioequivalence studies, has been filed under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed.

(C) If an application is amended to include a certification described in paragraph (1)(G)(iv), the notice required by subparagraph (B) shall be given when the amended application is filed.

(3) If a person wants to submit an abbreviated application for a new animal drug—

(A) whose active ingredients, route of administration, dosage form, or strength differ from that of an approved new animal drug, or

(B) whose use with other animal drugs in animal feed differs from that of an approved new animal drug,

such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve a petition for a new animal drug unless the Secretary finds that—

(C) investigations must be conducted to show the safety and effectiveness, in animals to be treated with the drug, of the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed which differ from the approved new animal drug, or

(D) investigations must be conducted to show the safety for human consumption of any residues in food resulting from the proposed active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed for the new animal drug which is different from the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed of the approved new animal drug.

The Secretary shall approve or disapprove a petition submitted under this paragraph within 90 days of the date the petition is submitted.

(4)(A)(i) Within 60 days of November 16, 1988, the Secretary shall publish and make available to the public a list in alphabetical order of the official and proprietary name of each new animal drug which has been approved for safety and effectiveness before November 16, 1988.

(ii) Every 30 days after the publication of the first list under clause (i) the Secretary shall revise the list to include each new animal drug which has been approved for safety and effectiveness under subsection (c) during the 30 day period.

(iii) When patent information submitted under subsection (b)(1) or (c)(3) respecting a new animal drug included on the list is to be published by the Secretary, the Secretary shall, in revisions made under clause (ii), include such information for such drug.

(B) A new animal drug approved for safety and effectiveness before November 16, 1988, or approved for safety and effectiveness under subsection (c) shall, for purposes of this subsection, be considered to have been published under subparagraph (A) on the date of its approval or November 16, 1988, whichever is later.

(C) If the approval of a new animal drug was withdrawn or suspended under subsection (c)(2)(G) or for grounds described in subsection (e) or if the Secretary determines that a drug has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its publication in such list, it shall be immediately removed from such list—

(i) for the same period as the withdrawal or suspension under subsection (c)(2)(G) or (e), or

(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons.

A notice of the removal shall be published in the Federal Register.

(5) If an application contains the information required by clauses (A), (G), and (H) of subsection (b)(1) and such information—

(A) is relied on by the applicant for the approval of the application, and

(B) is not information derived either from investigations, studies, or tests conducted by or for the applicant or for which the applicant had obtained a right of reference or use from the person by or for whom the investigations, studies, or tests were conducted,

such application shall be considered to be an application filed under subsection (b)(2).

(o) "Patent" defined

For purposes of this section, the term "patent" means a patent issued by the United States Patent and Trademark Office.

(p) Safety and effectiveness data

(1) Safety and effectiveness data and information which has been submitted in an application filed under subsection (b)(1) or section 360ccc(a) of this title for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown—

(A) if no work is being or will be undertaken to have the application approved,

(B) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted,

(C) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted,

(D) if the Secretary has determined that such drug is not a new drug, or

(E) upon the effective date of the approval of the first application filed under subsection (b)(2) which refers to such drug or upon the date upon which the approval of an application filed under subsection (b)(2) which refers to such drug could be made effective if such an application had been filed.

(2) Any request for data and information pursuant to paragraph (1) shall include a verified statement by the person making the request that any data or information received under such paragraph shall not be disclosed by such person to any other person—

(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the application filed under subsection (b)(1) or section 360ccc(a) of this title, and

(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Secretary, which meets the requirements of this paragraph.

(q) Date of approval in the case of recommended controls under the CSA

(1) In general

In the case of an application under subsection (b) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].

(2) Date of approval

For purposes of this section, with respect to an application described in paragraph (1), the term "date of approval" shall mean the later of—

(A) the date an application under subsection (b) is approved under subsection (c); or

(B) the date of issuance of the interim final rule controlling the drug.

(June 25, 1938, ch. 675, §512, as added Pub. L. 90–399, §101(b), July 13, 1968, 82 Stat. 343; amended Pub. L. 100–670, title I, §§101, 102, 104, 107(a)(2), Nov. 16, 1988, 102 Stat. 3971, 3981, 3982, 3984; Pub. L. 102–108, §2(e), Aug. 17, 1991, 105 Stat. 550; Pub. L. 103–80, §3(r), Aug. 13, 1993, 107 Stat. 777; Pub. L. 103–396, §2(a), (b)(2), (3), Oct. 22, 1994, 108 Stat. 4153, 4154; Pub. L. 104–250, §§2(a)–(d), 3, 4, 5(c), 6(a), (b), Oct. 9, 1996, 110 Stat. 3151–3153, 3155-3157; Pub. L. 105–115, title I, §124(b), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 105–277, div. A, §101(a) [title VII, §737], Oct. 21, 1998, 112 Stat. 2681, 2681-30; Pub. L. 106–113, div. B, §1000(a)(9) [title IV, §4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584; Pub. L. 108–282, title I, §102(b)(2), (3), (5)(I)–(S), Aug. 2, 2004, 118 Stat. 892, 903, 904; Pub. L. 110–316, title I, §105(a), Aug. 14, 2008, 122 Stat. 3513; Pub. L. 114–89, §2(a)(3)(A), Nov. 25, 2015, 129 Stat. 699; Pub. L. 114–255, div. A, title III, §3088(b), Dec. 13, 2016, 130 Stat. 1149; Pub. L. 115–234, title III, §301(a), Aug. 14, 2018, 132 Stat. 2436; Pub. L. 117–9, §1(a)(2), Apr. 23, 2021, 135 Stat. 257.)

Editorial Notes

References in Text

Section 342(a)(2) of this title, referred to in subsec. (a)(6), was amended by Pub. L. 104–170, title IV, §404, Aug. 3, 1996, 110 Stat. 1514, and, as so amended, no longer contains a subcl. (D). See section 342(a)(2)(C)(ii) of this title.

The Controlled Substances Act, referred to in subsec. (q)(1), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Amendments

2021—Subsec. (c)(2)(F). Pub. L. 117–9 substituted "active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))" for "active ingredient (including any ester or salt of the active ingredient)" in cls. (i), (ii), and (v).

2018—Subsec. (b)(4). Pub. L. 115–234 added par. (4).

2016—Subsec. (a)(1)(D). Pub. L. 114–255 added subpar. (D).

2015—Subsec. (q). Pub. L. 114–89 added subsec. (q).

2008—Subsec. (l)(3). Pub. L. 110–316 added par. (3).

2004—Subsec. (a)(1), (2). Pub. L. 108–282, §102(b)(5)(I), added pars. (1) and (2) and struck out former pars. (1) and (2) which deemed as unsafe new animal drugs and animal feed bearing or containing a new animal drug which did not have in effect certain approvals.

Subsec. (b)(3). Pub. L. 108–282, §102(b)(5)(J), substituted "under paragraph (1), section 360ccc of this title, or a request for an investigational exemption under subsection (j)" for "under paragraph (1) or a request for an investigational exemption under subsection (j)".

Subsec. (c)(2)(F)(ii), (iii), (v). Pub. L. 108–282, §102(b)(2), substituted "(other than bioequivalence studies or residue depletion studies, except residue depletion studies for minor uses or minor species)" for "(other than bioequivalence or residue studies)".

Subsec. (d)(4). Pub. L. 108–282, §102(b)(5)(K), substituted "have previously been separately approved pursuant to an application submitted under subsection (b)(1)" for "have previously been separately approved" in introductory provisions.

Subsec. (d)(5). Pub. L. 108–282, §102(b)(3), added par. (5).

Subsec. (f). Pub. L. 108–282, §102(b)(5)(L), substituted "subsection (d), (e), or (m), or section 360ccc(c), (d), or (e) of this title" for "subsection (d), (e), or (m)".

Subsec. (g). Pub. L. 108–282, §102(b)(5)(M), substituted "this section, or section 360ccc of this title" for "this section".

Subsec. (i). Pub. L. 108–282, §102(b)(5)(N), substituted "subsection (b) or section 360ccc of this title" for "subsection (b)" and inserted "or upon failure to renew a conditional approval under section 360ccc of this title" after "or upon its suspension".

Subsec. (l)(1). Pub. L. 108–282, §102(b)(5)(O), substituted "subsection (b) or section 360ccc of this title" for "subsection (b)".

Subsec. (m)(1)(C). Pub. L. 108–282, §102(b)(5)(P), substituted "applicable regulations published pursuant to subsection (i) or for indexed new animal drugs in accordance with the index listing published pursuant to section 360ccc–1(e)(2) of this title and the labeling requirements set forth in section 360ccc–1(h) of this title" for "applicable regulations published pursuant to subsection (i)".

Subsec. (m)(3). Pub. L. 108–282, §102(b)(5)(Q), inserted "or an index listing pursuant to section 360ccc–1(e) of this title" after "subsection (i)" in subpar. (C) and concluding provisions.

Subsec. (p)(1), (2)(A). Pub. L. 108–282, §102(b)(5)(R), (S), substituted "subsection (b)(1) or section 360ccc(a) of this title" for "subsection (b)(1)".

1999—Subsec. (o). Pub. L. 106–113 substituted "United States Patent and Trademark Office" for "Patent and Trademark Office of the Department of Commerce".

1998—Subsec. (d)(4)(D)(iii). Pub. L. 105–277 inserted before semicolon ", except that for purposes of this clause, antibacterial ingredient or animal drug does not include the ionophore or arsenical classes of animal drugs".

1997—Subsec. (c)(4). Pub. L. 105–115 added par. (4).

1996—Subsec. (a)(1). Pub. L. 104–250, §6(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 351(a)(5) and section 342(a)(2)(D) of this title unless—

"(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such use or intended use of such drug, and

"(B) such drug, its labeling, and such use conform to such approved application.

A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee—

"(i) is the holder of an approved application under subsection (m) of this section; or

"(ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under subsection (m) of this section."

Subsec. (a)(2). Pub. L. 104–250, §6(a), amended par. (2) generally. Prior to amendment, par. (2) read as follows: "An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of section 351(a)(6) of this title unless—

"(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such drugs, as used in such animal feed,

"(B) there is in effect an approval of an application pursuant to subsection (m)(1) of this section with respect to such animal feed, and

"(C) such animal feed, its labeling, and such use conform to the conditions and indications of use published pursuant to subsection (i) of this section and to the application with respect thereto approved under subsection (m) of this section."

Subsec. (a)(6). Pub. L. 104–250, §4, added par. (6).

Subsec. (b)(3). Pub. L. 104–250, §2(d), added par. (3).

Subsec. (c)(2)(F)(ii), (iii). Pub. L. 104–250, §2(b)(1), substituted "substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or," for "reports of new clinical or field investigations (other than bioequivalence or residue studies) and," and "required for the approval" for "essential to the approval".

Subsec. (c)(2)(F)(v). Pub. L. 104–250, §2(b)(2), substituted "clause (iv)" for "subparagraph (B)(iv)" in two places, "substantial evidence of the effectiveness of the drug involved, any studies of animal safety," for "reports of clinical or field investigations" and "required for the new approval" for "essential to the new approval".

Subsec. (d)(1)(F). Pub. L. 104–250, §3, amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: "upon the basis of the information submitted to him as part of the application or any other information before him with respect to such drug, the tolerance limitation proposed, if any, exceeds that reasonably required to accomplish the physical or other technical effect for which the drug is intended;".

Subsec. (d)(3). Pub. L. 104–250, §2(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: "As used in this subsection and subsection (e) of this section, the term 'substantial evidence' means evidence consisting of adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof."

Subsec. (d)(4). Pub. L. 104–250, §2(c), added par. (4).

Subsec. (i). Pub. L. 104–250, §5(c), inserted "and any requirement that an animal feed bearing or containing the new animal drug be limited to use under the professional supervision of a licensed veterinarian" after "(including special labeling requirements".

Subsec. (m). Pub. L. 104–250, §6(b), amended subsec. (m) generally, substituting provisions relating to application for feed mill licenses, including approval, refusal, revocation, and suspension of such licenses, and provisions for record and reporting requirements for, as well as exemption from, such licenses, for provisions relating to application for uses of animal feed containing new animal drug, including required contents, approval, refusal, and withdrawal of approval or suspension of such usage applications, and provisions for record and reporting requirements of such usage applications.

1994—Subsec. (a)(4), (5). Pub. L. 103–396, §2(a), added pars. (4) and (5).

Subsec. (e)(1)(A). Pub. L. 103–396, §2(b)(2), inserted before semicolon at end "or the condition of use authorized under subsection (a)(4)(A)".

Subsec. (l)(1). Pub. L. 103–396, §2(b)(3), substituted "relating to experience, including experience with uses authorized under subsection (a)(4)(A)," for "relating to experience".

1993—Subsec. (c)(2)(A)(ii). Pub. L. 103–80, §3(r)(1), inserted "in" after "except as provided".

Subsec. (c)(2)(F)(i). Pub. L. 103–80, §3(r)(2), substituted "subparagraph (D)(iii)" for "subparagraph (C)(iii)".

Subsec. (c)(2)(H)(ii). Pub. L. 103–80, §3(r)(3), substituted "subclauses" for "subclause" after "bioequivalency information described in" in concluding provisions.

Subsec. (d)(1). Pub. L. 103–80, §3(r)(4), substituted "subparagraphs (A) through (I)" for "subparagraphs (A) through (G)" in concluding provisions.

Subsec. (n)(1). Pub. L. 103–80, §3(r)(5), substituted "section 321(v) of this title" for "section 321(w) of this title" in subpars. (B)(ii)(II) and (C)(ii)(I) and substituted "through (I)" for "through (H)" in concluding provisions.

1991—Subsec. (e)(1)(B). Pub. L. 102–108 substituted "(I)" for "(H)".

1988—Subsec. (a)(1)(C). Pub. L. 100–670, §107(a)(2), struck out subpar. (C) which read as follows: "in the case of a new animal drug subject to subsection (n) of this section and not exempted therefrom by regulations it is from a batch with respect to which a certificate or release issued pursuant to subsection (n) of this section is in effect with respect to such drug."

Subsec. (b). Pub. L. 100–670, §§101(a), 102(a), designated existing provisions as par. (1), redesignated cls. (1) to (8) as cls. (A) to (H), respectively, added par. (2), and inserted provisions at end of par. (1) which require applicant to file with application, patent number and expiration date of any patent which claims new animal drug, to amend application to include such information if patent which claims such drug or method of using such drug is issued after filing date but before approval of application, and to publish such information upon approval.

Subsec. (c). Pub. L. 100–670, §§101(c), 102(b)(1), designated existing provisions as par. (1), redesignated cls. (1) and (2) as cls. (A) and (B), respectively, and added pars. (2) and (3).

Subsec. (d)(1). Pub. L. 100–670, §102(b)(3), substituted "(G)" for "(H)" in last sentence.

Subsec. (d)(1)(G) to (I). Pub. L. 100–670, §102(b)(2), added subpar. (G) and redesignated former subpars. (G) and (H) as (H) and (I), respectively.

Subsec. (e)(1)(D) to (F). Pub. L. 100–670, §102(b)(4), added subpar. (D) and redesignated former subpars. (D) and (E) as (E) and (F), respectively.

Subsecs. (n), (o). Pub. L. 100–670, §101(b), added subsecs. (n) and (o) and struck out former subsec. (n) which related to certification of new drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, and release prior to certification.

Subsec. (p). Pub. L. 100–670, §104, added subsec. (p).

Statutory Notes and Related Subsidiaries

Effective Date of 1999 Amendment

Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, §4731] of Pub. L. 106–113, set out as a note under section 1 of Title 35, Patents.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1994 Amendment

Pub. L. 103–396, §2(d), Oct. 22, 1994, 108 Stat. 4154, provided that: "The amendments made by this section [amending this section and section 331 of this title] shall take effect upon the adoption of the final regulations under subsection (c) [set out below]." [Final regulations were dated Oct. 22, 1996, filed Nov. 6, 1996, published Nov. 7, 1996, 61 F.R. 57732, and effective Dec. 9, 1996.]

Effective Date of 1988 Amendment

Pub. L. 100–670, title I, §108, Nov. 16, 1988, 102 Stat. 3984, provided that: "The Secretary of Health and Human Services may not make an approval of an application submitted under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before January 1, 1991."

Effective Date and Transitional Provisions

Pub. L. 90–399, §108, July 13, 1968, 82 Stat. 353, as amended by Pub. L. 108–282, title I, §102(b)(5)(T), Aug. 2, 2004, 118 Stat. 905, provided that:

"(a) Except as otherwise provided in this section, the amendments made by the foregoing sections [see Short Title of 1968 Amendment note set out under section 301 of this title] shall take effect on the first day of the thirteenth calendar month which begins after the date of enactment of this Act [July 13, 1968].

"(b)(1) As used in this subsection, the term 'effective date' means the effective date specified in subsection (a) of this section; the term 'basic Act' means the Federal Food, Drug, and Cosmetic Act [this chapter]; and other terms used both in this section and the basic Act shall have the same meaning as they have, or had, at the time referred to in the context, under the basic Act.

"(2) Any approval, prior to the effective date, of a new animal drug or of an animal feed bearing or containing a new animal drug, whether granted by approval of a new-drug application, master file, antibiotic regulation, or food additive regulations, shall continue in effect, and shall be subject to change in accordance with the provisions of the basic Act as amended by this Act [see Short Title of 1968 Amendment note set out under section 301 of this title].

"(3) In the case of any drug (other than a drug subject to section 512(n) of the basic Act as amended by this Act) [subsection (n) of this section] intended for use in animals other than man which, on October 9, 1962, (A) was commercially used or sold in the United States, (B) was not a new drug as defined by section 201(p) of the basic Act [section 321(p) of this title] as then in force, and (C) was not covered by an effective application under section 505 of that Act [section 355 of this title], the words 'effectiveness' and 'effective' contained in section 201(v) to the basic Act [sic] [section 321(v) of this title] shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.

"(4) Regulations providing for fees (and advance deposits to cover fees) which on the day preceding the effective date applicable under subsection (a) of this section were in effect pursuant to section 507 of the basic Act [section 357 of this title] shall, except as the Secretary may otherwise prescribe, be deemed to apply also under section 512(n) of the basic Act [subsection (n) of this section], and appropriations of fees (and of advance deposits to cover fees) available for the purposes specified in such section 507 [section 357 of this title] as in effect prior to the effective date shall also be available for the purposes specified in section 512(n) [subsection (n) of this section], including preparatory work or proceedings prior to that date."

Regulations

Pub. L. 104–250, §2(e), Oct. 9, 1996, 110 Stat. 3154, provided that:

"(1) In general.—Not later than 6 months after the date of enactment of this Act [Oct. 9, 1996], the Secretary of Health and Human Services shall issue proposed regulations implementing the amendments made by this Act as described in paragraph (2)(A) of this subsection, and not later than 18 months after the date of enactment of this Act, the Secretary shall issue final regulations implementing such amendments. Not later than 12 months after the date of enactment of this Act, the Secretary shall issue proposed regulations implementing the other amendments made by this Act as described in paragraphs (2)(B) and (2)(C) of this subsection, and not later than 24 months after the date of enactment of this Act, the Secretary shall issue final regulations implementing such amendments.

"(2) Contents.—In issuing regulations implementing the amendments made by this Act [see Short Title of 1996 Amendments note set out under section 301 of this title], and in taking an action to review an application for approval of a new animal drug under section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b), or a request for an investigational exemption for a new animal drug under subsection (j) of such section, that is pending or has been submitted prior to the effective date of the regulations, the Secretary shall—

"(A) further define the term 'adequate and well controlled', as used in subsection (d)(3) of section 512 of such Act, to require that field investigations be designed and conducted in a scientifically sound manner, taking into account practical conditions in the field and differences between field conditions and laboratory conditions;

"(B) further define the term 'substantial evidence', as defined in subsection (d)(3) of such section, in a manner that encourages the submission of applications and supplemental applications; and

"(C) take into account the proposals contained in the citizen petition (FDA Docket No. 91P–0434/CP) jointly submitted by the American Veterinary Medical Association and the Animal Health Institute, dated October 21, 1991.

Until the regulations required by subparagraph (A) are issued, nothing in the regulations published at 21 C.F.R. 514.111(a)(5) (April 1, 1996) shall be construed to compel the Secretary of Health and Human Services to require a field investigation under section 512(d)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)(E)) or to apply any of its provisions in a manner inconsistent with the considerations for scientifically sound field investigations set forth in subparagraph (A)."

Pub. L. 103–396, §2(c), Oct. 22, 1994, 108 Stat. 4154, provided that: "Not later than 2 years after the date of the enactment of this Act [Oct. 22, 1994], the Secretary of Health and Human Services shall promulgate regulations to implement paragraphs (4)(A) and (5) of section 512(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b(a)(4)(A), (5)] (as amended by subsection (a))."

Pub. L. 100–670, title I, §103, Nov. 16, 1988, 102 Stat. 3982, provided that:

"(a) General Rule.—The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 512 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b], as amended by sections 101 through 103 of this title, within one year of the date of enactment of this Act [Nov. 16, 1988].

"(b) Transition.—During the period beginning 60 days after the date of enactment of this Act [Nov. 16, 1988] and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new animal drug applications may be submitted in accordance with the provisions of section 314.55 and part 320 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 512(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b(c)] before the date of enactment of this Act. If any such provision of section 314.55 or part 320 is inconsistent with the requirements of section 512 of the Federal Food, Drug, and Cosmetic Act (as amended by this title), the Secretary shall consider the application under the applicable requirements of section 512 (as so amended)."

Guidance Addressing Investigation Designs

Pub. L. 115–234, title III, §305, Aug. 14, 2018, 132 Stat. 2440, provided that:

"(a) In General.—For purposes of assisting sponsors in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints (referred to in this section as 'elements of investigations') into proposed clinical investigation protocols and applications for new animal drugs under sections 512 and 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b; 360ccc), the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall issue guidance addressing the use of such elements of investigations in the development and regulatory review of such new animal drugs.

"(b) Contents.—The guidance under subsection (a) shall address how the Secretary will evaluate the elements of investigations proposed or submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act or to meet the commitment under section 571(a)(2)(F) of such Act, and how sponsors of such applications may obtain feedback from the Secretary on technical issues related to such investigations prior to the submission of an application to the Secretary.

"(c) Meeting.—Prior to issuing the guidance under subsection (a), the Secretary shall consult with stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers, through a public meeting to be held not later than 1 year after the date of enactment of this Act [Aug. 14, 2018].

"(d) Timing.—The Secretary shall issue a draft guidance under subsection (a) not later than 1 year after the date of the public meeting under subsection (c), and shall finalize such guidance not later than 1 year after the date on which the public comment period on such draft guidance ends."

Antimicrobial Animal Drug Distribution Reports

Pub. L. 110–316, title I, §105(b), (c), Aug. 14, 2008, 122 Stat. 3514, provided that:

"(b) First Report.—For each new animal drug that is subject to the reporting requirement under section 512(l)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b(l)(3)], as added by subsection (a), and for which an approval of an application filed pursuant to section 512(b) or 571 of such Act [21 U.S.C. 360b(b), 360ccc] is in effect on the date of the enactment of this title [Aug. 14, 2008], the Secretary of Health and Human Services shall require the sponsor of the drug to submit the first report under such section 512(l)(3) for the drug not later than March 31, 2010.

"(c) Separate Report.—The reports required under section 512(l)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall be separate from periodic drug experience reports that are required under section 514.80(b)(4) of title 21, Code of Federal Regulations (as in effect on the date of the enactment of this title)."

Drugs Intended for Minor Species and Minor Uses

Pub. L. 104–250, §2(f), Oct. 9, 1996, 110 Stat. 3154, provided that: "The Secretary of Health and Human Services shall consider legislative and regulatory options for facilitating the approval under section 512 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b] of animal drugs intended for minor species and for minor uses and, within 18 months after the date of enactment of this Act [Oct. 9, 1996], announce proposals for legislative or regulatory change to the approval process under such section for animal drugs intended for use in minor species or for minor uses."

Transitional Provision Regarding Implementation of Pub. L. 104–250; Approved Medicated Feed Application Deemed License

Pub. L. 104–250, §6(c), Oct. 9, 1996, 110 Stat. 3160, provided that: "A person engaged in the manufacture of animal feeds bearing or containing new animal drugs who holds at least one approved medicated feed application for an animal feed bearing or containing new animal drugs, the manufacture of which was not otherwise exempt from the requirement for an approved medicated feed application on the date of the enactment of this Act [Oct. 9, 1996], shall be deemed to hold a license for the manufacturing site identified in the approved medicated feed application. The revocation of license provisions of section 512(m)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b(m)(4)], as amended by this Act, shall apply to such licenses. Such license shall expire within 18 months from the date of enactment of this Act unless the person submits to the Secretary a completed license application for the manufacturing site accompanied by a copy of an approved medicated feed application for such site, which license application shall be deemed to be approved upon receipt by the Secretary."

Drugs Primarily Manufactured Using Biotechnology

Pub. L. 100–670, title I, §106, Nov. 16, 1988, 102 Stat. 3984, provided that: "Notwithstanding section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b(b)(2)], the Secretary of Health and Human Services may not approve an abbreviated application submitted under such section for a new animal drug which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques."

¹ See References in Text note below.

² So in original. Probably should be "Alimentarius".

³ So in original. Probably should be "clause (iii)(III)".

§360b–1. Priority zoonotic animal drugs

(a) In general

The Secretary shall, at the request of the sponsor intending to submit an application for approval of a new animal drug under section 360b(b)(1) of this title or an application for conditional approval of a new animal drug under section 360ccc of this title, expedite the development and review of such new animal drug if preliminary clinical evidence indicates that the new animal drug, alone or in combination with 1 or more other animal drugs, has the potential to prevent or treat a zoonotic disease in animals, including a vector borne-disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.

(b) Request for designation

The sponsor of a new animal drug may request the Secretary to designate a new animal drug described in subsection (a) as a priority zoonotic animal drug. A request for the designation may be made concurrently with, or at any time after, the opening of an investigational new animal drug file under section 360b(j) of this title or the filing of an application under section 360b(b)(1) or 360ccc of this title.

(c) Designation

(1) In general

Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether the new animal drug that is the subject of the request meets the criteria described in subsection (a). If the Secretary determines that the new animal drug meets the criteria, the Secretary shall designate the new animal drug as a priority zoonotic animal drug and shall take such actions as are appropriate to expedite the development and review of the application for approval or conditional approval of such new animal drug.

(2) Actions

The actions to expedite the development and review of an application under paragraph (1) may include, as appropriate—

(A) taking steps to ensure that the design of clinical trials is as efficient as practicable, when scientifically appropriate, such as by utilizing novel trial designs or drug development tools (including biomarkers) that may reduce the number of animals needed for studies;

(B) providing timely advice to, and interactive communication with, the sponsor (which may include meetings with the sponsor and review team) regarding the development of the new animal drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable;

(C) involving senior managers and review staff with experience in zoonotic or vector-borne disease to facilitate collaborative, cross-disciplinary review, including, as appropriate, across agency centers; and

(D) implementing additional administrative or process enhancements, as necessary, to facilitate an efficient review and development program.

(June 25, 1938, ch. 675, §512A, as added Pub. L. 116–136, div. A, title III, §3302, Mar. 27, 2020, 134 Stat. 384.)

§360c. Classification of devices intended for human use

(a) Classes of devices

(1) There are established the following classes of devices intended for human use:

(A) Class I, General Controls.—

(i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.

(ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it—

(I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and

(II) does not present a potential unreasonable risk of illness or injury,

is to be regulated by the controls referred to in clause (i).

(B) Class II, Special Controls.—A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 360(k) of this title), recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.

(C) Class III, Premarket Approval.—A device which because—

(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness, and

(ii)(I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or

(II) presents a potential unreasonable risk of illness or injury,

is to be subject, in accordance with section 360e of this title, to premarket approval to provide reasonable assurance of its safety and effectiveness.

If there is not sufficient information to establish a performance standard for a device to provide reasonable assurance of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain such information.

(2) For purposes of this section and sections 360d and 360e of this title, the safety and effectiveness of a device are to be determined—

(A) with respect to the persons for whose use the device is represented or intended,

(B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and

(C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.

(3)(A) Except as authorized by subparagraph (B), the effectiveness of a device is, for purposes of this section and sections 360d and 360e of this title, to be determined, in accordance with regulations promulgated by the Secretary, on the basis of well-controlled investigations, including 1 or more clinical investigations where appropriate, by experts qualified by training and experience to evaluate the effectiveness of the device, from which investigations it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device.

(B) If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A))—

(i) which is sufficient to determine the effectiveness of a device, and

(ii) from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device,

then, for purposes of this section and sections 360d and 360e of this title, the Secretary may authorize the effectiveness of the device to be determined on the basis of such evidence.

(C) In making a determination of a reasonable assurance of the effectiveness of a device for which an application under section 360e of this title has been submitted, the Secretary shall consider whether the extent of data that otherwise would be required for approval of the application with respect to effectiveness can be reduced through reliance on postmarket controls.

(D)(i) The Secretary, upon the written request of any person intending to submit an application under section 360e of this title, shall meet with such person to determine the type of valid scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be necessary to demonstrate for purposes of approval of an application the effectiveness of a device for the conditions of use proposed by such person. The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance from the device. Within 30 days after such meeting, the Secretary shall specify in writing the type of valid scientific evidence that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person.

(ii) Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as result of a determination by the Secretary that such data are necessary to establish device effectiveness. The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.

(iii) For purposes of clause (ii), the term "necessary" means the minimum required information that would support a determination by the Secretary that an application provides reasonable assurance of the effectiveness of the device.

(iv) Nothing in this subparagraph shall alter the criteria for evaluating an application for premarket approval of a device.

(v) The determination of the Secretary with respect to the specification of valid scientific evidence under clauses (i) and (ii) shall be binding upon the Secretary, unless such determination by the Secretary could be contrary to the public health.

(b) Classification panels

(1) For purposes of—

(A) determining which devices intended for human use should be subject to the requirements of general controls, performance standards, or premarket approval, and

(B) providing notice to the manufacturers and importers of such devices to enable them to prepare for the application of such requirements to devices manufactured or imported by them,

the Secretary shall classify all such devices (other than devices classified by subsection (f)) into the classes established by subsection (a). For the purpose of securing recommendations with respect to the classification of devices, the Secretary shall establish panels of experts or use panels of experts established before May 28, 1976, or both. Section 1013 of title 5 shall not apply to the duration of a panel established under this paragraph.

(2) The Secretary shall appoint to each panel established under paragraph (1) persons who are qualified by training and experience to evaluate the safety and effectiveness of the devices to be referred to the panel and who, to the extent feasible, possess skill in the use of, or experience in the development, manufacture, or utilization of, such devices. The Secretary shall make appointments to each panel so that each panel shall consist of members with adequately diversified expertise in such fields as clinical and administrative medicine, engineering, biological and physical sciences, and other related professions. In addition, each panel shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in the administration of this chapter may be a member of any panel. The Secretary shall designate one of the members of each panel to serve as chairman thereof.

(3) Panel members (other than officers or employees of the United States), while attending meetings or conferences of a panel or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, but not at rates exceeding the daily equivalent of the rate in effect for grade GS–18 of the General Schedule, for each day so engaged, including traveltime; and while so serving away from their homes or regular places of business each member may be allowed travel expenses (including per diem in lieu of subsistence) as authorized by section 5703 of title 5, for persons in the Government service employed intermittently.

(4) The Secretary shall furnish each panel with adequate clerical and other necessary assistance.

(5)(A) Classification panels covering each type of device shall be scheduled to meet at such times as may be appropriate for the Secretary to meet applicable statutory deadlines.

(B) When a device is specifically the subject of review by a classification panel, the Secretary shall—

(i) ensure that adequate expertise is represented on the classification panel to assess—

(I) the disease or condition which the device is intended to cure, treat, mitigate, prevent, or diagnose; and

(II) the technology of the device; and

(ii) provide an opportunity for the person whose device is specifically the subject of panel review to provide recommendations on the expertise needed among the voting members of the panel.

(C) For purposes of subparagraph (B)(i), the term "adequate expertise" means that the membership of the classification panel includes—

(i) two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and

(ii) at least one voting member who is knowledgeable about the technology of the device.

(D) The Secretary shall provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels.

(6)(A) Any person whose device is specifically the subject of review by a classification panel shall have—

(i) the same access to data and information submitted to a classification panel (except for data and information that are not available for public disclosure under section 552 of title 5) as the Secretary;

(ii) the opportunity to submit, for review by a classification panel, information that is based on the data or information provided in the application submitted under section 360e of this title by the person, which information shall be submitted to the Secretary for prompt transmittal to the classification panel; and

(iii) the same opportunity as the Secretary to participate in meetings of the panel, including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information, and permitting the person or representative to call on experts within the person's organization to address such specific issues in the time provided.

(B)(i) Any meeting of a classification panel with respect to the review of a device shall—

(I) provide adequate time for initial presentations by the person whose device is specifically the subject of such review and by the Secretary; and

(II) encourage free and open participation by all interested persons.

(ii) Following the initial presentations described in clause (i), the panel may—

(I) pose questions to a designated representative described in subparagraph (A)(iii); and

(II) consider the responses to such questions in the panel's review of the device.

(7) After receiving from a classification panel the conclusions and recommendations of the panel on a matter that the panel has reviewed, the Secretary shall review the conclusions and recommendations, shall make a final decision on the matter in accordance with section 360e(d)(2) of this title, and shall notify the affected persons of the decision in writing and, if the decision differs from the conclusions and recommendations of the panel, shall include the reasons for the difference.

(8) A classification panel under this subsection shall not be subject to the annual chartering and annual report requirements of the ¹ chapter 10 of title 5.

(c) Classification panel organization and operation

(1) The Secretary shall organize the panels according to the various fields of clinical medicine and fundamental sciences in which devices intended for human use are used. The Secretary shall refer a device to be classified under this section to an appropriate panel established or authorized to be used under subsection (b) for its review and for its recommendation respecting the classification of the device. The Secretary shall by regulation prescribe the procedure to be followed by the panels in making their reviews and recommendations. In making their reviews of devices, the panels, to the maximum extent practicable, shall provide an opportunity for interested persons to submit data and views on the classification of the devices.

(2)(A) Upon completion of a panel's review of a device referred to it under paragraph (1), the panel shall, subject to subparagraphs (B) and (C), submit to the Secretary its recommendation for the classification of the device. Any such recommendation shall (i) contain (I) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and (III) an identification of the risks to health (if any) presented by the device with respect to which the recommendation is made, and (ii) to the extent practicable, include a recommendation for the assignment of a priority for the application of the requirements of section 360d or 360e of this title to a device recommended to be classified in class II or class III.

(B) A recommendation of a panel for the classification of a device in class I shall include a recommendation as to whether the device should be exempted from the requirements of section 360, 360i, or 360j(f) of this title.

(C) In the case of a device which has been referred under paragraph (1) to a panel, and which—

(i) is intended to be implanted in the human body or is purported or represented to be for a use in supporting or sustaining human life, and

(ii)(I) has been introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or

(II) is within a type of device which was so introduced or delivered before such date and is substantially equivalent to another device within that type,

such panel shall recommend to the Secretary that the device be classified in class III unless the panel determines that classification of the device in such class is not necessary to provide reasonable assurance of its safety and effectiveness. If a panel does not recommend that such a device be classified in class III, it shall in its recommendation to the Secretary for the classification of the device set forth the reasons for not recommending classification of the device in such class.

(3) The panels shall submit to the Secretary within one year of the date funds are first appropriated for the implementation of this section their recommendations respecting all devices of a type introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976.

(d) Panel recommendation; publication; priorities

(1) Upon receipt of a recommendation from a panel respecting a device, the Secretary shall publish in the Federal Register the panel's recommendation and a proposed regulation classifying such device and shall provide interested persons an opportunity to submit comments on such recommendation and the proposed regulation. After reviewing such comments, the Secretary shall, subject to paragraph (2), by regulation classify such device.

(2)(A) A regulation under paragraph (1) classifying a device in class I shall prescribe which, if any, of the requirements of section 360, 360i, or 360j(f) of this title shall not apply to the device. A regulation which makes a requirement of section 360, 360i, or 360j(f) of this title inapplicable to a device shall be accompanied by a statement of the reasons of the Secretary for making such requirement inapplicable.

(B) A device described in subsection (c)(2)(C) shall be classified in class III unless the Secretary determines that classification of the device in such class is not necessary to provide reasonable assurance of its safety and effectiveness. A proposed regulation under paragraph (1) classifying such a device in a class other than class III shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for not classifying such device in such class and an identification of the risks to health (if any) presented by such device.

(3) In the case of devices classified in class II and devices classified under this subsection in class III and described in section 360e(b)(1) of this title the Secretary may establish priorities which, in his discretion, shall be used in applying sections 360d and 360e of this title, as appropriate, to such devices.

(e) Classification changes

(1)(A)(i) Based on new information respecting a device, the Secretary may, upon the initiative of the Secretary or upon petition of an interested person, change the classification of such device, and revoke, on account of the change in classification, any regulation or requirement in effect under section 360d or 360e of this title with respect to such device, by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in subsection (b), and consideration of comments to a public docket, notwithstanding subchapter II of chapter 5 of title 5. The proposed reclassification order published in the Federal Register shall set forth the proposed reclassification, and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including—

(I) the public health benefit of the use of the device, and the nature and, if known, incidence of the risk of the device;

(II) in the case of a reclassification from class II to class III, why general controls pursuant to subsection (a)(1)(A) and special controls pursuant to subsection (a)(1)(B) together are not sufficient to provide a reasonable assurance of safety and effectiveness for such device; and

(III) in the case of reclassification from class III to class II, why general controls pursuant to subsection (a)(1)(A) and special controls pursuant to subsection (a)(1)(B) together are sufficient to provide a reasonable assurance of safety and effectiveness for such device.

(ii) An order under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 360d of this title for such device.

(B) Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.

(2) By an order issued under paragraph (1), the Secretary may change the classification of a device from class III—

(A) to class II if the Secretary determines that special controls would provide reasonable assurance of the safety and effectiveness of the device and that general controls would not provide reasonable assurance of the safety and effectiveness of the device, or

(B) to class I if the Secretary determines that general controls would provide reasonable assurance of the safety and effectiveness of the device.

(f) Initial classification and reclassification of certain devices

(1) Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, is classified in class III unless—

(A) the device—

(i) is within a type of device (I) which was introduced or delivered for introduction into interstate commerce for commercial distribution before such date and which is to be classified pursuant to subsection (b), or (II) which was not so introduced or delivered before such date and has been classified in class I or II, and

(ii) is substantially equivalent to another device within such type;

(B) the Secretary in response to a petition submitted under paragraph (3) has classified such device in class I or II; or

(C) the device is classified pursuant to a request submitted under paragraph (2).

A device classified in class III under this paragraph shall be classified in that class until the effective date of an order of the Secretary under paragraph (2) or (3) classifying the device in class I or II.

(2)(A)(i) Any person who submits a report under section 360(k) of this title for a type of device that has not been previously classified under this chapter, and that is classified into class III under paragraph (1), may request, after receiving written notice of such a classification, the Secretary to classify the device.

(ii) In lieu of submitting a report under section 360(k) of this title and submitting a request for classification under clause (i) for a device, if a person determines there is no legally marketed device upon which to base a determination of substantial equivalence (as defined in subsection (i)), a person may submit a request under this clause for the Secretary to classify the device.

(iii) Upon receipt of a request under clause (i) or (ii), the Secretary shall classify the device subject to the request under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) within 120 days.

(iv) Notwithstanding clause (iii), the Secretary may decline to undertake a classification request submitted under clause (ii) if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence under paragraph (1), or when the Secretary determines that the device submitted is not of low to moderate risk or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

(v) The person submitting the request for classification under this subparagraph may recommend to the Secretary a classification for the device and shall, if recommending classification in class II, include in the request an initial draft proposal for applicable special controls, as described in subsection (a)(1)(B), that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.

(B)(i) The Secretary shall by written order classify the device involved. Such classification shall be the initial classification of the device for purposes of paragraph (1) and any device classified under this paragraph shall be a predicate device for determining substantial equivalence under paragraph (1).

(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the meaning of section 351(f)(1)(B) of this title until approved under section 360e of this title or exempted from such approval under section 360j(g) of this title.

(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.

(3)(A) The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer or importer of a device classified under paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the device in class I or class II. Within thirty days of the filing of such a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision on the petition.

(B)(i) Upon determining that a petition does not contain any deficiency which prevents the Secretary from making a decision on the petition, the Secretary may for good cause shown refer the petition to an appropriate panel established or authorized to be used under subsection (b). A panel to which such a petition has been referred shall not later than ninety days after the referral of the petition make a recommendation to the Secretary respecting approval or denial of the petition. Any such recommendation shall contain (I) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and (III) an identification of the risks to health (if any) presented by the device with respect to which the petition was filed. In the case of a petition for a device which is intended to be implanted in the human body or which is purported or represented to be for a use in supporting or sustaining human life, the panel shall recommend that the petition be denied unless the panel determines that the classification in class III of the device is not necessary to provide reasonable assurance of its safety and effectiveness. If the panel recommends that such petition be approved, it shall in its recommendation to the Secretary set forth its reasons for such recommendation.

(ii) The requirements of paragraphs (1) and (2) of subsection (c) (relating to opportunities for submission of data and views and recommendations respecting priorities and exemptions from sections 360, 360i, and 360j(f) of this title) shall apply with respect to consideration by panels of petitions submitted under subparagraph (A).

(C)(i) Within ninety days from the date the Secretary receives the recommendation of a panel respecting a petition (but not later than 210 days after the filing of such petition) the Secretary shall by order deny or approve the petition. If the Secretary approves the petition, the Secretary shall order the classification of the device into class I or class II in accordance with the criteria prescribed by subsection (a)(1)(A) or (a)(1)(B). In the case of a petition for a device which is intended to be implanted in the human body or which is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall deny the petition unless the Secretary determines that the classification in class III of the device is not necessary to provide reasonable assurance of its safety and effectiveness. An order approving such petition shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for approving the petition and an identification of the risks to health (if any) presented by the device to which such order applies.

(ii) The requirements of paragraphs (1) and (2)(A) of subsection (d) (relating to publication of recommendations, opportunity for submission of comments, and exemption from sections 360, 360i, and 360j(f) of this title) shall apply with respect to action by the Secretary on petitions submitted under subparagraph (A).

(4) If a manufacturer reports to the Secretary under section 360(k) of this title that a device is substantially equivalent to another device—

(A) which the Secretary has classified as a class III device under subsection (b),

(B) which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990, and

(C) for which no final regulation requiring premarket approval has been promulgated under section 360e(b) of this title,

the manufacturer shall certify to the Secretary that the manufacturer has conducted a reasonable search of all information known or otherwise available to the manufacturer respecting such other device and has included in the report under section 360(k) of this title a summary of and a citation to all adverse safety and effectiveness data respecting such other device and respecting the device for which the section 360(k) report is being made and which has not been submitted to the Secretary under section 360i of this title. The Secretary may require the manufacturer to submit the adverse safety and effectiveness data described in the report.

(5) The Secretary may not withhold a determination of the initial classification of a device under paragraph (1) because of a failure to comply with any provision of this chapter unrelated to a substantial equivalence decision, including a finding that the facility in which the device is manufactured is not in compliance with good manufacturing requirements as set forth in regulations of the Secretary under section 360j(f) of this title (other than a finding that there is a substantial likelihood that the failure to comply with such regulations will potentially present a serious risk to human health).

(6)(A) Subject to the succeeding subparagraphs of this paragraph, the Secretary shall, by written order, classify an accessory under this section based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.

(B) The classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, shall continue to apply unless and until the accessory is reclassified by the Secretary, notwithstanding the classification of any other device with which such accessory is intended to be used. Nothing in this paragraph shall preclude the Secretary's authority to initiate the classification of an accessory through regulation or written order, as appropriate.

(C)(i) In the case of a device intended to be used with an accessory, where the accessory has been included in an application for premarket approval of such device under section 360e of this title or a report under section 360(k) of this title for clearance of such device and the Secretary has not classified such accessory distinctly from another device in accordance with subparagraph (A), the person filing the application or report (as applicable) at the time such application or report is filed—

(I) may include a written request for the proper classification of the accessory pursuant to subparagraph (A);

(II) shall include in any such request such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a); and

(III) shall, if the request under subclause (I) is requesting classification of the accessory in class II, include in the application an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B).

(ii) The Secretary's response under section 360e(d) or section 360(n) of this title (as applicable) to an application or report described in clause (i) shall also contain the Secretary's granting or denial of the request for classification of the accessory involved.

(iii) The Secretary's evaluation of an accessory under clause (i) shall constitute an order establishing a new classification for such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses as such accessory.

(D) For accessories that have been granted marketing authorization as part of a submission for another device with which the accessory involved is intended to be used, through an application for such other device under section 360e(c) of this title, a report under section 360(k) of this title, or a request for classification under paragraph (2) of this subsection, the following shall apply:

(i) Not later than the date that is one year after August 18, 2017, and at least once every 5 years thereafter, and as the Secretary otherwise determines appropriate, pursuant to this paragraph, the Secretary shall publish in the Federal Register a notice proposing a list of such accessories that the Secretary determines may be suitable for a distinct classification in class I and the proposed regulations for such classifications. In developing such list, the Secretary shall consider recommendations from sponsors of device submissions and other stakeholders for accessories to be included on such list. The notices shall provide for a period of not less than 60 calendar days for public comment. Within 180 days after the end of the comment period, the Secretary shall publish in the Federal Register a final action classifying such suitable accessories into class I.

(ii) A manufacturer or importer of an accessory that has been granted such marketing authorization may submit to the Secretary a written request for the appropriate classification of the accessory based on the risks and appropriate level of regulatory controls as described in subparagraph (A), and shall, if the request is requesting classification of the accessory in class II, include in the submission an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B). Such request shall include such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a). The Secretary shall provide an opportunity for a manufacturer or importer to meet with appropriate personnel of the Food and Drug Administration to discuss the appropriate classification of such accessory prior to submitting a written request under this clause for classification of the accessory.

(iii) The Secretary shall respond to a request made under clause (ii) not later than 85 calendar days after receiving such request by issuing a written order classifying the accessory or denying the request. If the Secretary does not agree with the recommendation for classification submitted by the manufacturer or importer, the response shall include a detailed description and justification for such determination. Within 30 calendar days after granting such a request, the Secretary shall publish a notice in the Federal Register announcing such response.

(E) Nothing in this paragraph may be construed as precluding a manufacturer of an accessory of a new type from using the classification process described in subsection (f)(2) to obtain classification of such accessory in accordance with the criteria and requirements set forth in that subsection.

(g) Information

Within sixty days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this chapter, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this chapter applicable to the device.

(h) Definitions

For purposes of this section and sections 351, 360, 360d, 360e, 360f, 360i, and 360j of this title

(1) a reference to "general controls" is a reference to the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title,

(2) a reference to "class I", "class II", or "class III" is a reference to a class of medical devices described in subparagraph (A), (B), or (C) of subsection (a)(1), and

(3) a reference to a "panel under section 360c of this title" is a reference to a panel established or authorized to be used under this section.

(i) Substantial equivalence

(1)(A) For purposes of determinations of substantial equivalence under subsection (f) and section 360j(l) of this title, the term "substantially equivalent" or "substantial equivalence" means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device—

(i) has the same technological characteristics as the predicate device, or

(ii)(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 360m of this title, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.

(B) For purposes of subparagraph (A), the term "different technological characteristics" means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device.

(C) To facilitate reviews of reports submitted to the Secretary under section 360(k) of this title, the Secretary shall consider the extent to which reliance on postmarket controls may expedite the classification of devices under subsection (f)(1) of this section.

(D)(i) Whenever the Secretary requests information to demonstrate that devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to making substantial equivalence determinations. In making such request, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and request information accordingly.

(ii) For purposes of clause (i), the term "necessary" means the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device.

(iii) Nothing in this subparagraph shall alter the standard for determining substantial equivalence between a new device and a predicate device.

(E)(i) Any determination by the Secretary of the intended use of a device shall be based upon the proposed labeling submitted in a report for the device under section 360(k) of this title. However, when determining that a device can be found substantially equivalent to a legally marketed device, the director of the organizational unit responsible for regulating devices (in this subparagraph referred to as the "Director") may require a statement in labeling that provides appropriate information regarding a use of the device not identified in the proposed labeling if, after providing an opportunity for consultation with the person who submitted such report, the Director determines and states in writing—

(I) that there is a reasonable likelihood that the device will be used for an intended use not identified in the proposed labeling for the device; and

(II) that such use could cause harm.

(ii) Such determination shall—

(I) be provided to the person who submitted the report within 10 days from the date of the notification of the Director's concerns regarding the proposed labeling;

(II) specify the limitations on the use of the device not included in the proposed labeling; and

(III) find the device substantially equivalent if the requirements of subparagraph (A) are met and if the labeling for such device conforms to the limitations specified in subclause (II).

(iii) The responsibilities of the Director under this subparagraph may not be delegated.

(F) Not later than 270 days after November 21, 1997, the Secretary shall issue guidance specifying the general principles that the Secretary will consider in determining when a specific intended use of a device is not reasonably included within a general use of such device for purposes of a determination of substantial equivalence under subsection (f) or section 360j(l) of this title.

(2) A device may not be found to be substantially equivalent to a predicate device that has been removed from the market at the initiative of the Secretary or that has been determined to be misbranded or adulterated by a judicial order.

(3)(A) As part of a submission under section 360(k) of this title respecting a device, the person required to file a premarket notification under such section shall provide an adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request by any person.

(B) Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such device is substantially equivalent to another device.

(j) Training and oversight of least burdensome requirements

(1) The Secretary shall—

(A) ensure that each employee of the Food and Drug Administration who is involved in the review of premarket submissions, including supervisors, receives training regarding the meaning and implementation of the least burdensome requirements under subsections (a)(3)(D) and (i)(1)(D) of this section and section 360e(c)(5) of this title; and

(B) periodically assess the implementation of the least burdensome requirements, including the employee training under subparagraph (A), to ensure that the least burdensome requirements are fully and consistently applied.

(2) Not later than 18 months after December 13, 2016, the ombudsman for any organizational unit of the Food and Drug Administration responsible for the premarket review of devices shall—

(A) conduct an audit of the training described in paragraph (1)(A), including the effectiveness of such training in implementing the least burdensome requirements;

(B) include in such audit interviews of persons who are representatives of the device industry regarding their experiences in the device premarket review process, including with respect to the application of least burdensome concepts to premarket review and decisionmaking;

(C) include in such audit a list of the measurement tools the Secretary uses to assess the implementation of the least burdensome requirements, including under paragraph (1)(B) and section 360g–1(a)(3) of this title, and may also provide feedback on the effectiveness of such tools in the implementation of the least burdensome requirements;

(D) summarize the findings of such audit in a final audit report; and

(E) within 30 calendar days of completion of such final audit report, make such final audit report available—

(i) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives; and

(ii) on the Internet website of the Food and Drug Administration.

(k) Dual submission for certain devices

For a device authorized for emergency use under section 360bbb–3 of this title for which, in accordance with section 360bbb–3(m) of this title, the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 263a(d)(3) of title 42, the sponsor of such device may, when submitting a request for classification under subsection (f)(2), submit a single submission containing—

(1) the information needed for such a request; and

(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 263a(d)(3) of title 42.

(June 25, 1938, ch. 675, §513, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 540; amended Pub. L. 101–629, §§4(a), 5(a)–(c)(1), (3), 12(a), 18(a), Nov. 28, 1990, 104 Stat. 4515, 4517, 4518, 4523, 4528; Pub. L. 102–300, §6(e), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(s), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title II, §§205(a), (b), 206(b), (c), 207, 208, 217, Nov. 21, 1997, 111 Stat. 2336, 2337, 2339, 2340, 2350; Pub. L. 107–250, title II, §208, Oct. 26, 2002, 116 Stat. 1613; Pub. L. 112–144, title VI, §§602, 607–608(a)(2)(A), July 9, 2012, 126 Stat. 1051, 1054-1056; Pub. L. 114–255, div. A, title III, §§3055, 3058(a), 3060(c), 3101(a)(2)(I), Dec. 13, 2016, 130 Stat. 1127, 1128, 1133, 1154; Pub. L. 115–52, title VII, §707(a), (b), title IX, §901(h), Aug. 18, 2017, 131 Stat. 1060, 1062, 1077; Pub. L. 117–286, §4(a)(155), Dec. 27, 2022, 136 Stat. 4323; Pub. L. 117–328, div. FF, title III, §3301, Dec. 29, 2022, 136 Stat. 5831.)

Editorial Notes

Amendments

2022—Subsec. (b)(1). Pub. L. 117–286, §4(a)(155)(A), substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in concluding provisions.

Subsec. (b)(8). Pub. L. 117–286, §4(a)(155)(B), substituted "chapter 10 of title 5." for "Federal Advisory Committee Act."

Subsec. (k). Pub. L. 117–328 added subsec. (k).

2017—Subsec. (b)(5)(D). Pub. L. 115–52, §901(h), substituted "medical devices that may be specifically the subject of a review by a classification panel" for "medical device submissions".

Subsec. (b)(9). Pub. L. 115–52, §707(b), struck out par. (9) which read as follows: "The Secretary shall classify an accessory under this section based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used."

Subsec. (f)(6). Pub. L. 115–52, §707(a), added par. (6).

2016—Subsec. (b)(5). Pub. L. 114–255, §3055(a), designated existing provisions as subpar. (A) and added subpars. (B) to (D).

Subsec. (b)(6)(A)(iii). Pub. L. 114–255, §3055(b)(1), inserted before period at end ", including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information, and permitting the person or representative to call on experts within the person's organization to address such specific issues in the time provided".

Subsec. (b)(6)(B). Pub. L. 114–255, §3055(b)(2), added subpar. (B) and struck out former subpar. (B) which read as follows: "Any meetings of a classification panel shall provide adequate time for initial presentations and for response to any differing views by persons whose devices are specifically the subject of a classification panel review, and shall encourage free and open participation by all interested persons."

Subsec. (b)(9). Pub. L. 114–255, §3060(c), added par. (9).

Subsec. (f)(2)(A)(i). Pub. L. 114–255, §3101(a)(2)(I)(i), struck out "within 30 days" after "may request,".

Subsec. (f)(2)(A)(iv). Pub. L. 114–255, §3101(a)(2)(I)(ii), substituted "low to moderate" for "low-moderate".

Subsec. (j). Pub. L. 114–255, §3058(a), added subsec. (j).

2012—Subsec. (a)(3)(D)(iii) to (v). Pub. L. 112–144, §602(a), added cls. (iii) and (iv) and redesignated former cl. (iii) as (v).

Subsec. (e)(1). Pub. L. 112–144, §608(a)(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Based on new information respecting a device, the Secretary may, upon his own initiative or upon petition of an interested person, by regulation (A) change such device's classification, and (B) revoke, because of the change in classification, any regulation or requirement in effect under section 360d or 360e of this title with respect to such device. In the promulgation of such a regulation respecting a device's classification, the Secretary may secure from the panel to which the device was last referred pursuant to subsection (c) of this section a recommendation respecting the proposed change in the device's classification and shall publish in the Federal Register any recommendation submitted to the Secretary by the panel respecting such change. A regulation under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 360d of this title for such device."

Subsec. (e)(2). Pub. L. 112–144, §608(a)(2)(A), substituted "an order issued" for "regulation promulgated" in introductory provisions.

Subsec. (f)(1)(C). Pub. L. 112–144, §607(b), added subpar. (C).

Subsec. (f)(2)(A). Pub. L. 112–144, §607(a)(1)–(3), designated existing provisions as cl. (i), struck out "under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) of this section. The person may, in the request, recommend to the Secretary a classification for the device. Any such request shall describe the device and provide detailed information and reasons for the recommended classification" before period at end, and added cls. (ii) to (v).

Subsec. (f)(2)(B)(i). Pub. L. 112–144, §607(a)(4), substituted "The Secretary" for "Not later than 60 days after the date of the submission of the request under subparagraph (A), the Secretary".

Subsec. (i)(1)(D). Pub. L. 112–144, §602(b), designated existing provisions as cl. (i) and added cls. (ii) and (iii).

2002—Subsec. (i)(1)(E)(iv). Pub. L. 107–250 struck out cl. (iv) which read as follows: "This subparagraph has no legal effect after the expiration of the five-year period beginning on November 21, 1997."

1997—Subsec. (a)(3)(A). Pub. L. 105–115, §217, substituted "1 or more clinical investigations" for "clinical investigations".

Subsec. (a)(3)(C), (D). Pub. L. 105–115, §205(a), added subpars. (C) and (D).

Subsec. (b)(5) to (8). Pub. L. 105–115, §208, added pars. (5) to (8).

Subsec. (f)(1). Pub. L. 105–115, §207(1)(B), substituted "paragraph (2) or (3)" for "paragraph (2)" in closing provisions.

Subsec. (f)(1)(B). Pub. L. 105–115, §207(1)(A), substituted "paragraph (3)" for "paragraph (2)".

Subsec. (f)(2) to (4). Pub. L. 105–115, §207(2), (3), added par. (2) and redesignated former pars. (2) and (3) as (3) and (4), respectively.

Subsec. (f)(5). Pub. L. 105–115, §206(b), added par. (5).

Subsec. (i)(1)(A)(ii). Pub. L. 105–115, §206(c)(1), substituted "appropriate clinical or scientific data" for "clinical data", inserted "or a person accredited under section 360m of this title" after "Secretary", and substituted "effectiveness" for "efficacy".

Subsec. (i)(1)(C) to (E). Pub. L. 105–115, §205(b), added subpars. (C) to (E).

Subsec. (i)(1)(F). Pub. L. 105–115, §206(c)(2), added subpar. (F).

1993—Subsec. (b)(3). Pub. L. 103–80 substituted "5703" for "5703(b)".

1992—Subsec. (f)(3). Pub. L. 102–300 redesignated clauses (i) to (iii) as subpars. (A) to (C), respectively, and substituted "the section 360(k) report" for "the 360(k) report" in closing provisions.

1990—Subsec. (a)(1)(A)(ii). Pub. L. 101–629, §5(a)(1), substituted "or to establish special controls" for "or to establish a performance standard".

Subsec. (a)(1)(B). Pub. L. 101–629, §5(a)(2), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "Class II, Performance Standards.—A device which cannot be classified as a class I device because the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, for which there is sufficient information to establish a performance standard to provide such assurance, and for which it is therefore necessary to establish for the device a performance standard under section 360d of this title to provide reasonable assurance of its safety and effectiveness."

Subsec. (a)(1)(C)(i). Pub. L. 101–629, §5(a)(3), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "it (I) cannot be classified as a class I device because insufficient information exists to determine that the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title are sufficient to provide reasonable assurance of the safety and effectiveness of the device and (II) cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness, and".

Subsec. (e). Pub. L. 101–629, §5(b), designated existing provisions as par. (1), redesignated cls. (1) and (2) as (A) and (B), respectively, and added par. (2).

Subsec. (f). Pub. L. 101–629, §5(c)(3), inserted "and reclassification" before "of" in heading.

Subsec. (f)(2)(A). Pub. L. 101–629, §5(c)(1), substituted "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer" for "The manufacturer".

Subsec. (f)(2)(B)(i). Pub. L. 101–629, §18(a), substituted "the Secretary may for good cause shown" for "the Secretary shall".

Subsec. (f)(3). Pub. L. 101–629, §4(a), added par. (3).

Subsec. (i). Pub. L. 101–629, §12(a), added subsec. (i).

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Pub. L. 115–52, title VII, §707(c), Aug. 18, 2017, 131 Stat. 1062, provided that: "The amendments made by subsections (a) and (b) [amending this section] shall take effect on the date that is 60 days after the date of enactment of this Act [Aug. 18, 2017]."

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Short Title of 1976 Amendment

Pub. L. 94–295, §1(a), May 28, 1976, 90 Stat. 539, provided that: "This Act [enacting sections 360c to 360k, 379, and 379a of this title and section 3512 of Title 42, The Public Health and Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360, 374, 379e, and 381 of this title and section 55 of Title 15, Commerce and Trade] may be cited as the 'Medical Device Amendments of 1976'."

Regulations

Pub. L. 101–629, §12(b), Nov. 28, 1990, 104 Stat. 4524, provided that: "Within 12 months of the date of the enactment of this Act [Nov. 28, 1990], the Secretary of Health and Human Services shall issue regulations establishing the requirements of the summaries under section 513(i)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(i)(3)], as added by the amendment made by subsection (a)."

Devices Reclassified Prior to July 9, 2012

Pub. L. 112–144, title VI, §608(a)(3), July 9, 2012, 126 Stat. 1056, provided that:

"(A) In general.—The amendments made by this subsection [amending this section and sections 360d and 360g of this title] shall have no effect on a regulation promulgated with respect to the classification of a device under section 513(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(e)] prior to the date of enactment of this Act [July 9, 2012].

"(B) Applicability of other provisions.—In the case of a device reclassified under section 513(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(e)] by regulation prior to the date of enactment of this Act [July 9, 2012], section 517(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to such regulation promulgated under section 513(e) of such Act with respect to such device in the same manner such section 517(a)(1) applies to an administrative order issued with respect to a device reclassified after the date of enactment of this Act."

Daily Wear Soft or Daily Wear Nonhydrophilic Plastic Contact Lenses

Pub. L. 101–629, §4(b)(3), Nov. 28, 1990, 104 Stat. 4517, provided that:

"(A) Notwithstanding section 520(l)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360j(l)(5)], the Secretary of Health and Human Services shall not retain any daily wear soft or daily wear nonhydrophilic plastic contact lens in class III under such Act [this chapter] unless the Secretary finds that it meets the criteria set forth in section 513(a)(1)(C) of such Act [21 U.S.C. 360c(a)(1)(C)]. The finding and the grounds for the finding shall be published in the Federal Register. For any such lens, the Secretary shall make the determination respecting reclassification required in section 520(l)(5)(B) of such Act within 24 months of the date of the enactment of this paragraph [Nov. 28, 1990].

"(B) The Secretary of Health and Human Services may by notice published in the Federal Register extend the two-year period prescribed by subparagraph (A) for a lens for an additional period not to exceed one year.

"(C)(i) Before classifying a lens in class II pursuant to subparagraph (A), the Secretary of Health and Human Services shall pursuant to section 513(a)(1)(B) of such Act assure that appropriate regulatory safeguards are in effect which provide reasonable assurance of the safety and effectiveness of such lens, including clinical and preclinical data if deemed necessary by the Secretary.

"(ii) Prior to classifying a lens in class I pursuant to subparagraph (A), the Secretary shall assure that appropriate regulatory safeguards are in effect which provide reasonable assurance of the safety and effectiveness of such lens, including clinical and preclinical data if deemed necessary by the Secretary.

"(D) Notwithstanding section 520(l)(5) of such Act, if the Secretary of Health and Human Services has not made the finding and published the finding required by subparagraph (A) within 36 months of the date of the enactment of this subparagraph [Nov. 28, 1990], the Secretary shall issue an order placing the lens in class II.

"(E) Any person adversely affected by a final regulation under this paragraph revising the classification of a lens may challenge the revision of the classification of such lens only by filing a petition under section 513(e) for a classification change."

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

¹ So in original. The word "the" probably should not appear.

§360c–1. Reporting

The Secretary of Health and Human Services shall annually post on the Internet Web site of the Food and Drug Administration—

(1) the number and type of class I and class II devices reclassified as class II or class III in the previous calendar year under section 360c(e)(1) of this title;

(2) the number and type of class II and class III devices reclassified as class I or class II in the previous calendar year under such section 360c(e)(1) of this title; and

(3) the number and type of devices reclassified in the previous calendar year under section 360e of this title.

(Pub. L. 112–144, title VI, §608(c), July 9, 2012, 126 Stat. 1059.)

Editorial Notes

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§360d. Performance standards

(a) Reasonable assurance of safe and effective performance; periodic evaluation

(1) The special controls required by section 360c(a)(1)(B) of this title shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device. A class III device may also be considered a class II device for purposes of establishing a standard for the device under subsection (b) if the device has been reclassified as a class II device under an administrative order under section 360c(e) of this title (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation) provides that the reclassification is not to take effect until the effective date of such a standard for the device.

(2) A performance standard established under subsection (b) for a device—

(A) shall include provisions to provide reasonable assurance of its safe and effective performance;

(B) shall, where necessary to provide reasonable assurance of its safe and effective performance, include—

(i) provisions respecting the construction, components, ingredients, and properties of the device and its compatibility with power systems and connections to such systems,

(ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the device or, if it is determined that no other more practicable means are available to the Secretary to assure the conformity of the device to the standard, provisions for the testing (on a sample basis or, if necessary, on an individual basis) by the Secretary or by another person at the direction of the Secretary,

(iii) provisions for the measurement of the performance characteristics of the device,

(iv) provisions requiring that the results of each or of certain of the tests of the device required to be made under clause (ii) show that the device is in conformity with the portions of the standard for which the test or tests were required, and

(v) a provision requiring that the sale and distribution of the device be restricted but only to the extent that the sale and distribution of a device may be restricted under a regulation under section 360j(e) of this title; and

(C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper installation, maintenance, operation, and use of the device.

(3) The Secretary shall provide for periodic evaluation of performance standards established under subsection (b) to determine if such standards should be changed to reflect new medical, scientific, or other technological data.

(4) In carrying out his duties under this subsection and subsection (b), the Secretary shall, to the maximum extent practicable—

(A) use personnel, facilities, and other technical support available in other Federal agencies,

(B) consult with other Federal agencies concerned with standard-setting and other nationally or internationally recognized standard-setting entities, and

(C) invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, or consumer organizations who in his judgment can make a significant contribution.

(b) Establishment of a standard

(1)(A) The Secretary shall publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any performance standard for a device.

(B) A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device shall—

(i) set forth a finding with supporting justification that the performance standard is appropriate and necessary to provide reasonable assurance of the safety and effectiveness of the device,

(ii) set forth proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate,

(iii) invite interested persons to submit to the Secretary, within 30 days of the publication of the notice, requests for changes in the classification of the device pursuant to section 360c(e) of this title based on new information relevant to the classification, and

(iv) invite interested persons to submit an existing performance standard for the device, including a draft or proposed performance standard, for consideration by the Secretary.

(C) A notice of proposed rulemaking for the revocation of a performance standard shall set forth a finding with supporting justification that the performance standard is no longer necessary to provide reasonable assurance of the safety and effectiveness of a device.

(D) The Secretary shall provide for a comment period of not less than 60 days.

(2) If, after publication of a notice in accordance with paragraph (1), the Secretary receives a request for a change in the classification of the device, the Secretary shall, within 60 days of the publication of the notice, after consultation with the appropriate panel under section 360c of this title, either deny the request or give notice of an intent to initiate such change under section 360c(e) of this title.

(3)(A) After the expiration of the period for comment on a notice of proposed rulemaking published under paragraph (1) respecting a performance standard and after consideration of such comments and any report from an advisory committee under paragraph (5), the Secretary shall (i) promulgate a regulation establishing a performance standard and publish in the Federal Register findings on the matters referred to in paragraph (1), or (ii) publish a notice terminating the proceeding for the development of the standard together with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless such notice is issued because the device is a banned device under section 360f of this title) initiate a proceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice.

(B) A regulation establishing a performance standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before one year after the date of its publication unless (i) the Secretary determines that an earlier effective date is necessary for the protection of the public health and safety, or (ii) such standard has been established for a device which, effective upon the effective date of the standard, has been reclassified from class III to class II. Such date or dates shall be established so as to minimize, consistent with the public health and safety, economic loss to, and disruption or dislocation of, domestic and international trade.

(4)(A) The Secretary, upon his own initiative or upon petition of an interested person may by regulation, promulgated in accordance with the requirements of paragraphs (1), (2), and (3)(B) of this subsection, amend or revoke a performance standard.

(B) The Secretary may declare a proposed amendment of a performance standard to be effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if he determines that making it so effective is in the public interest. A proposed amendment of a performance standard made so effective under the preceding sentence may not prohibit, during the period in which it is so effective, the introduction or delivery for introduction into interstate commerce of a device which conforms to such standard without the change or changes provided by such proposed amendment.

(5)(A) The Secretary—

(i) may on his own initiative refer a proposed regulation for the establishment, amendment, or revocation of a performance standard, or

(ii) shall, upon the request of an interested person which demonstrates good cause for referral and which is made before the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation,

to an advisory committee of experts, established pursuant to subparagraph (B), for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment. If a proposed regulation is referred under this subparagraph to an advisory committee, the Secretary shall provide the advisory committee with the data and information on which such proposed regulation is based. The advisory committee shall, within sixty days of the referral of a proposed regulation and after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation respecting such regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. A copy of such report and recommendation shall be made public by the Secretary.

(B) The Secretary shall establish advisory committees (which may not be panels under section 360c of this title) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee persons qualified in the subject matter to be referred to the committee and of appropriately diversified professional background, except that the Secretary may not appoint to such a committee any individual who is in the regular full-time employ of the United States and engaged in the administration of this chapter. Each such committee shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Members of an advisory committee who are not officers or employees of the United States, while attending conferences or meetings of their committee or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent of the rate in effect for grade GS–18 of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The Secretary shall designate one of the members of each advisory committee to serve as chairman thereof. The Secretary shall furnish each advisory committee with clerical and other assistance, and shall by regulation prescribe the procedures to be followed by each such committee in acting on referrals made under subparagraph (A).

(c) Recognition of standard

(1)(A) In addition to establishing a performance standard under this section, the Secretary shall, by publication in the Federal Register (or, with respect to a susceptibility test interpretive criteria standard under section 360a–2 of this title, by posting on the Interpretive Criteria Website in accordance with such section), recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this chapter to which such standard is applicable.

(B) If a person elects to use a standard recognized by the Secretary under subparagraph (A) to meet the requirements described in such subparagraph, the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to meet any requirement regarding devices under this chapter.

(C)(i) Any person may submit a request for recognition under subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized standard organization.¹

(ii) Not later than 60 calendar days after the Secretary receives such a request, the Secretary shall—

(I) make a determination to recognize all, part, or none of the standard that is the subject of the request; and

(II) issue to the person who submitted such request a response in writing that states the Secretary's rationale for that determination, including the scientific, technical, regulatory, or other basis for such determination.

(iii) The Secretary shall make a response issued under clause (ii)(II) publicly available, in such a manner as the Secretary determines appropriate.

(iv) The Secretary shall take such actions as may be necessary to implement all or part of a standard recognized under clause (ii)(I), in accordance with subparagraph (A).

(D) The Secretary shall make publicly available, in such manner as the Secretary determines appropriate, the rationale for recognition under subparagraph (A) of all, part, or none of a standard, including the scientific, technical, regulatory, or other basis for the decision regarding such recognition.

(2) The Secretary may withdraw such recognition of a standard through publication of a notice in the Federal Register if the Secretary determines that the standard is no longer appropriate for meeting a requirement regarding devices under this chapter.

(3)(A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds—

(i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of conformity; or

(ii) that the standard identified in the declaration of conformity is not applicable to the particular device under review.

(B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1).

(C) A person making a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of two years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer.

(4) The Secretary shall provide to all employees of the Food and Drug Administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this chapter, including standards relevant to an employee's area of device review.

(d) Accreditation scheme for conformity assessment

(1) In general

The Secretary shall establish a program under which—

(A) testing laboratories meeting criteria specified in guidance by the Secretary may be accredited, by accreditation bodies meeting criteria specified in guidance by the Secretary, to conduct testing to support the assessment of the conformity of a device to certain standards recognized under this section; and

(B) subject to paragraph (2), results from tests conducted to support the assessment of conformity of devices as described in subparagraph (A) conducted by testing laboratories accredited pursuant to this subsection shall be accepted by the Secretary for purposes of demonstrating such conformity unless the Secretary finds that certain results of such tests should not be so accepted.

(2) Secretarial review of accredited laboratory results

The Secretary may—

(A) review the results of tests conducted by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the processes of accredited bodies or testing laboratories;

(B) following such review, take additional measures under this chapter, as the Secretary determines appropriate, such as—

(i) suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or

(ii) requesting additional information with respect to a device; and

(C) if the Secretary becomes aware of information materially bearing on the safety or effectiveness of a device for which an assessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection, take such additional measures under this chapter, as the Secretary determines appropriate, such as—

(i) suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or

(ii) requesting additional information with regard to such device.

(3) Report

The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the program under this subsection.

(June 25, 1938, ch. 675, §514, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 546; amended Pub. L. 94–460, title III, §304, Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101–629, §§6(a), (b)(1), 18(b), Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102–300, §6(g), June 16, 1992, 106 Stat. 241; Pub. L. 103–80, §4(a)(1), Aug. 13, 1993, 107 Stat. 779; Pub. L. 105–115, title II, §204(a), (d), Nov. 21, 1997, 111 Stat. 2335, 2336; Pub. L. 112–144, title VI, §608(a)(2)(B), July 9, 2012, 126 Stat. 1056; Pub. L. 114–255, div. A, title III, §§3044(b)(3), 3053(a), Dec. 13, 2016, 130 Stat. 1121, 1125; Pub. L. 115–52, title II, §205(a), Aug. 18, 2017, 131 Stat. 1016; Pub. L. 117–180, div. F, title II, §2005, Sept. 30, 2022, 136 Stat. 2153.)

Editorial Notes

Amendments

2022—Subsec. (d). Pub. L. 117–180 amended subsec. (d) generally. Prior to amendment, subsec. (d) related to a pilot program for accrediting laboratories to assess device conformance.

2017—Subsec. (d). Pub. L. 115–52 added subsec. (d).

2016—Subsec. (c)(1)(A). Pub. L. 114–255, §3044(b)(3), inserted "(or, with respect to a susceptibility test interpretive criteria standard under section 360a–2 of this title, by posting on the Interpretive Criteria Website in accordance with such section)" after "the Secretary shall, by publication in the Federal Register".

Subsec. (c)(1)(C), (D). Pub. L. 114–255, §3053(a)(1), added subpars. (C) and (D).

Subsec. (c)(4). Pub. L. 114–255, §3053(a)(2), added par. (4).

2012—Subsec. (a)(1). Pub. L. 112–144 substituted "under an administrative order under section 360c(e) of this title (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation)" for "under a regulation under section 360c(e) of this title but such regulation".

1997—Subsec. (a)(1). Pub. L. 105–115, §204(d)(1), substituted "under subsection (b)" for "under this section".

Subsec. (a)(2). Pub. L. 105–115, §204(d)(2), substituted "under subsection (b)" for "under this section" in introductory provisions.

Subsec. (a)(3). Pub. L. 105–115, §204(d)(3), substituted "under subsection (b)" for "under this section".

Subsec. (a)(4). Pub. L. 105–115, §204(d)(4), substituted "this subsection and subsection (b)" for "this section" in introductory provisions.

Subsec. (c). Pub. L. 105–115, §204(a), added subsec. (c).

1993—Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 103–80 amended directory language of Pub. L. 101–619, §18(b), identical to amendment by Pub. L. 102–300, §6(g)(1). See 1992 and 1990 Amendment notes below.

1992—Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 102–300 made technical corrections to directory language of Pub. L. 101–629, §18(b)(1), (2). See 1990 Amendment note below.

1990—Subsec. (a)(1). Pub. L. 101–629, §6(a)(1), substituted "The special controls required by section 360c(a)(1)(B) of this title shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device." for "The Secretary may by regulation, promulgated in accordance with this section, establish a performance standard for a class II device."

Subsec. (b). Pub. L. 101–629, §6(a)(2), (3), redesignated subsec. (g) as (b) and struck out former subsec. (b) which read as follows:

"(1) A proceeding for the development of a performance standard for a device shall be initiated by the Secretary by the publication in the Federal Register of notice of the opportunity to submit to the Secretary a request (within fifteen days of the date of the publication of the notice) for a change in the classification of the device based on new information relevant to its classification.

"(2) If, after publication of a notice pursuant to paragraph (1) the Secretary receives a request for a change in the device's classification, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 360c of this title, by order published in the Federal Register, either deny the request for change in classification or give notice of his intent to initiate such a change under section 360c(e) of this title."

Subsec. (b)(1), (2). Pub. L. 101–629, §6(a)(4), amended pars. (1) and (2) generally. Prior to amendment, pars. (1) and (2) read as follows:

"(1)(A) After publication pursuant to subsection (c) of this section of a notice respecting a performance standard for a device, the Secretary shall either—

"(i) publish, in the Federal Register in a notice of proposed rulemaking, a proposed performance standard for the device (I) developed by an offeror under such notice and accepted by the Secretary, (II) developed under subsection (c)(4) of this section, (III) accepted by the Secretary under subsection (d) of this section, or (IV) developed by him under subsection (f) of this section, or

"(ii) issue a notice in the Federal Register that the proceeding is terminated together with the reasons for such termination.

"(B) If the Secretary issues under subparagraph (A)(ii) a notice of termination of a proceeding to establish a performance standard for a device, he shall (unless such notice is issued because the device is a banned device under section 360f of this title) initiate a proceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice.

"(2) A notice of proposed rulemaking for the establishment of a performance standard for a device published under paragraph (1)(A)(i) shall set forth proposed findings with respect to the degree of the risk of illness or injury designed to be eliminated or reduced by the proposed standard and the benefit to the public from the device."

Subsec. (b)(3)(A)(i). Pub. L. 101–629, §6(b)(1)(A), substituted "paragraph (1)" for "paragraph (2)".

Subsec. (b)(4)(A). Pub. L. 101–629, §6(b)(1)(B), substituted "paragraphs (1), (2), and (3)(B)" for "paragraphs (2) and (3)(B)".

Subsec. (b)(4)(B). Pub. L. 101–629, §18(b)(1), as amended by Pub. L. 102–300, §6(g)(1), (2), and Pub. L. 103–80, §4(a)(1), struck out ", after affording all interested persons an opportunity for an informal hearing," after "if he determines".

Subsec. (b)(5)(A)(ii). Pub. L. 101–629, §18(b)(2), as amended by Pub. L. 102–300, §6(g)(1), (3), and Pub. L. 103–80, §4(a)(1), substituted "which demonstrates good cause for referral and which is made before the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation," for "unless the Secretary finds the request to be without good cause or the request is made after the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation,".

Subsecs. (c) to (f). Pub. L. 101–629, §6(a)(2), struck out subsec. (c) relating to invitations for standards, subsec. (d) relating to acceptance of certain existing standards, subsec. (e) relating to acceptance of offers to develop standards, and subsec. (f) relating to development of standards by the Secretary after publication of notice inviting submissions or offers of standards.

Subsec. (g). Pub. L. 101–629, §6(a)(3), redesignated subsec. (g) as (b).

1976—Subsec. (a). Pub. L. 94–460 redesignated pars. (4) and (5) as (3) and (4), respectively. Section as originally enacted contained no par. (3).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–180, div. F, title II, §2008, Sept. 30, 2022, 136 Stat. 2154, provided that: "The amendments made by this title [amending this section and sections 360m and 379i to 379j–1 of this title and repealing provisions set out as notes under sections 379i and 379j–1 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.) shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2022, regardless of the date of the enactment of this Act."

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Construction of 2016 Amendment

Nothing in amendment by section 3044(b)(3) of Pub. L. 114–255 to be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under section 356(h) of this title, by health care professionals, or to limit the practice of health care, see section 3043 of Pub. L. 114–255, set out as a note under section 356 of this title.

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

Guidance

Pub. L. 114–255, div. A, title III, §3053(b), Dec. 13, 2016, 130 Stat. 1125, provided that: "The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall review and update, if necessary, previously published guidance and standard operating procedures identifying the principles for recognizing standards, and for withdrawing the recognition of standards, under section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking into account the experience with and reliance on a standard by foreign regulatory authorities and the device industry, and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices."

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

¹ So in original. Probably should be "standard development organization."

§360e. Premarket approval

(a) General requirement

A class III device—

(1) which is subject to an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012); or

(2) which is a class III device because of section 360c(f) of this title,

is required to have, unless exempt under section 360j(g) of this title, an approval under this section of an application for premarket approval or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval.

(b) Order to require premarket approval

(1) In the case of a class III device which—

(A) was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976; or

(B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type,

the Secretary shall by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, require that such device have an approval under this section of an application for premarket approval. Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.

(2) A proposed order required under paragraph (1) shall contain—

(A) the proposed order;

(B) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved application for premarket approval and the benefit to the public from use of the device;

(C) opportunity for the submission of comments on the proposed order and the proposed findings; and

(D) opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.

(3) After the expiration of the period for comment on a proposed order and proposed findings published under paragraph (2), consideration of comments submitted on such proposed order and findings, and a meeting of a device classification panel described in section 360c(b) of this title, the Secretary shall (A) issue an administrative order under paragraph (1) and publish in the Federal Register findings on the matters referred to in paragraph (2)(B), or (B) publish a notice terminating the proceeding for the issuance of the administrative order together with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless such notice is issued because the device is a banned device under section 360f of this title) initiate a proceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice.

(c) Application for premarket approval

(1) Any person may file with the Secretary an application for premarket approval for a class III device. Such an application for a device shall contain—

(A) full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective;

(B) a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device;

(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device;

(D) an identifying reference to any performance standard under section 360d of this title which would be applicable to any aspect of such device if it were a class II device, and either adequate information to show that such aspect of such device fully meets such performance standard or adequate information to justify any deviation from such standard;

(E) such samples of such device and of components thereof as the Secretary may reasonably require, except that where the submission of such samples is impracticable or unduly burdensome, the requirement of this subparagraph may be met by the submission of complete information concerning the location of one or more such devices readily available for examination and testing;

(F) specimens of the labeling proposed to be used for such device;

(G) the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application); and

(H) such other information relevant to the subject matter of the application as the Secretary, with the concurrence of the appropriate panel under section 360c of this title, may require.

(2)(A) Any person may file with the Secretary a report seeking premarket approval for a class III device referred to in subsection (a) that is a reprocessed single-use device. Such a report shall contain the following:

(i) The device name, including both the trade or proprietary name and the common or usual name.

(ii) The establishment registration number of the owner or operator submitting the report.

(iii) Actions taken to comply with performance standards under section 360d of this title.

(iv) Proposed labels, labeling, and advertising sufficient to describe the device, its intended use, and directions for use.

(v) Full reports of all information, published or known to or which should be reasonably known to the applicant, concerning investigations which have been made to show whether or not the device is safe or effective.

(vi) A description of the device's components, ingredients, and properties.

(vii) A full description of the methods used in, and the facilities and controls used for, the reprocessing and packing of the device.

(viii) Such samples of the device that the Secretary may reasonably require.

(ix) A financial certification or disclosure statement or both, as required by part 54 of title 21, Code of Federal Regulations.

(x) A statement that the applicant believes to the best of the applicant's knowledge that all data and information submitted to the Secretary are truthful and accurate and that no material fact has been omitted in the report.

(xi) Any additional data and information, including information of the type required in paragraph (1) for an application under such paragraph, that the Secretary determines is necessary to determine whether there is reasonable assurance of safety and effectiveness for the reprocessed device.

(xii) Validation data described in section 360(o)(1)(A) of this title that demonstrates that the reasonable assurance of the safety or effectiveness of the device will remain after the maximum number of times the device is reprocessed as intended by the person submitting such report.

(B) In the case of a class III device referred to in subsection (a) that is a reprocessed single-use device:

(i) Subparagraph (A) of this paragraph applies in lieu of paragraph (1).

(ii) Subject to clause (i), the provisions of this section apply to a report under subparagraph (A) to the same extent and in the same manner as such provisions apply to an application under paragraph (1).

(iii) Each reference in other sections of this chapter to an application under this section, other than such a reference in section 379i or 379j of this title, shall be considered to be a reference to a report under subparagraph (A).

(iv) Each reference in other sections of this chapter to a device for which an application under this section has been approved, or has been denied, suspended, or withdrawn, other than such a reference in section 379i or 379j of this title, shall be considered to be a reference to a device for which a report under subparagraph (A) has been approved, or has been denied, suspended, or withdrawn, respectively.

(3) Upon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary—

(A) may on the Secretary's own initiative, or

(B) shall, upon the request of an applicant unless the Secretary finds that the information in the application which would be reviewed by a panel substantially duplicates information which has previously been reviewed by a panel appointed under section 360c of this title,

refer such application to the appropriate panel under section 360c of this title for study and for submission (within such period as he may establish) of a report and recommendation respecting approval of the application, together with all underlying data and the reasons or basis for the recommendation. Where appropriate, the Secretary shall ensure that such panel includes, or consults with, one or more pediatric experts.

(4)(A) Prior to the submission of an application under this subsection, the Secretary shall accept and review any portion of the application that the applicant and the Secretary agree is complete, ready, and appropriate for review, except that such requirement does not apply, and the Secretary has discretion whether to accept and review such portion, during any period in which, under section 379j(g) of this title, the Secretary does not have the authority to collect fees under section 379j(a) of this title.

(B) Each portion of a submission reviewed under subparagraph (A) and found acceptable by the Secretary shall not be further reviewed after receipt of an application that satisfies the requirements of paragraph (1), unless a significant issue of safety or effectiveness provides the Secretary reason to review such accepted portion.

(C) Whenever the Secretary determines that a portion of a submission under subparagraph (A) is unacceptable, the Secretary shall, in writing, provide to the applicant a description of any deficiencies in such portion and identify the information that is required to correct these deficiencies, unless the applicant is no longer pursuing the application.

(5)(A) In requesting additional information with respect to an application under this section, the Secretary shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness.

(B) For purposes of subparagraph (A), the term "necessary" means the minimum required information that would support a determination by the Secretary that an application provides a reasonable assurance of the safety and effectiveness of the device.

(C) For purposes of this paragraph, the Secretary shall consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness.

(D) Nothing in this paragraph alters the standards for premarket approval of a device.

(d) Action on application for premarket approval

(1)(A) As promptly as possible, but in no event later than one hundred and eighty days after the receipt of an application under subsection (c) (except as provided in section 360j(l)(3)(D)(ii) of this title or unless, in accordance with subparagraph (B)(i), an additional period as agreed upon by the Secretary and the applicant), the Secretary, after considering the report and recommendation submitted under paragraph (2) of such subsection, shall—

(i) issue an order approving the application if he finds that none of the grounds for denying approval specified in paragraph (2) of this subsection applies; or

(ii) deny approval of the application if he finds (and sets forth the basis for such finding as part of or accompanying such denial) that one or more grounds for denial specified in paragraph (2) of this subsection apply.

In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.

(B)(i) The Secretary may not enter into an agreement to extend the period in which to take action with respect to an application submitted for a device subject to a regulation promulgated under subsection (b) unless he finds that the continued availability of the device is necessary for the public health.

(ii) An order approving an application for a device may require as a condition to such approval that the sale and distribution of the device be restricted but only to the extent that the sale and distribution of a device may be restricted under a regulation under section 360j(e) of this title.

(iii) The Secretary shall accept and review statistically valid and reliable data and any other information from investigations conducted under the authority of regulations required by section 360j(g) of this title to make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject to a pending application under this section if—

(I) the data or information is derived from investigations of an earlier version of the device, the device has been modified during or after the investigations (but prior to submission of an application under subsection (c)) and such a modification of the device does not constitute a significant change in the design or in the basic principles of operation of the device that would invalidate the data or information; or

(II) the data or information relates to a device approved under this section, is available for use under this chapter, and is relevant to the design and intended use of the device for which the application is pending.

(2) The Secretary shall deny approval of an application for a device if, upon the basis of the information submitted to the Secretary as part of the application and any other information before him with respect to such device, the Secretary finds that—

(A) there is a lack of a showing of reasonable assurance that such device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof;

(B) there is a lack of a showing of reasonable assurance that the device is effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof;

(C) the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or installation of such device do not conform to the requirements of section 360j(f) of this title;

(D) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or

(E) such device is not shown to conform in all respects to a performance standard in effect under section 360d of this title compliance with which is a condition to approval of the application and there is a lack of adequate information to justify the deviation from such standard.

Any denial of an application shall, insofar as the Secretary determines to be practicable, be accompanied by a statement informing the applicant of the measures required to place such application in approvable form (which measures may include further research by the applicant in accordance with one or more protocols prescribed by the Secretary).

(3)(A)(i) The Secretary shall, upon the written request of an applicant, meet with the applicant, not later than 100 days after the receipt of an application that has been filed as complete under subsection (c), to discuss the review status of the application.

(ii) The Secretary shall, in writing and prior to the meeting, provide to the applicant a description of any deficiencies in the application that, at that point, have been identified by the Secretary based on an interim review of the entire application and identify the information that is required to correct those deficiencies.

(iii) The Secretary shall notify the applicant promptly of—

(I) any additional deficiency identified in the application, or

(II) any additional information required to achieve completion of the review and final action on the application,

that was not described as a deficiency in the written description provided by the Secretary under clause (ii).

(B) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting required under this paragraph.

(4) An applicant whose application has been denied approval may, by petition filed on or before the thirtieth day after the date upon which he receives notice of such denial, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g), and any interested person may obtain review, in accordance with paragraph (1) or (2) of subsection (g), of an order of the Secretary approving an application.

(5)(A)(i) Unless the change is consistent with a predetermined change control plan approved under section 360e–4 of this title, a supplemental application shall be required for any change to a device subject to an approved application under this subsection that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing and the holder of the approved application submits a written notice to the Secretary that describes in detail the change, summarizes the data or information supporting the change, and informs the Secretary that the change has been made under the requirements of section 360j(f) of this title.

(ii) The holder of an approved application who submits a notice under clause (i) with respect to a manufacturing change of a device may distribute the device 30 days after the date on which the Secretary receives the notice, unless the Secretary within such 30-day period notifies the holder that the notice is not adequate and describes such further information or action that is required for acceptance of such change. If the Secretary notifies the holder that a supplemental application is required, the Secretary shall review the supplement within 135 days after the receipt of the supplement. The time used by the Secretary to review the notice of the manufacturing change shall be deducted from the 135-day review period if the notice meets appropriate content requirements for premarket approval supplements.

(B)(i) Subject to clause (ii), in reviewing a supplement to an approved application, for an incremental change to the design of a device that affects safety or effectiveness, the Secretary shall approve such supplement if—

(I) nonclinical data demonstrate that the design modification creates the intended additional capacity, function, or performance of the device; and

(II) clinical data from the approved application and any supplement to the approved application provide a reasonable assurance of safety and effectiveness for the changed device.

(ii) The Secretary may require, when necessary, additional clinical data to evaluate the design modification of the device to provide a reasonable assurance of safety and effectiveness.

(e) Withdrawal and temporary suspension of approval of application

(1) The Secretary shall, upon obtaining, where appropriate, advice on scientific matters from a panel or panels under section 360c of this title, and after due notice and opportunity for informal hearing to the holder of an approved application for a device, issue an order withdrawing approval of the application if the Secretary finds—

(A) that such device is unsafe or ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

(B) on the basis of new information before him with respect to such device, evaluated together with the evidence available to him when the application was approved, that there is a lack of a showing of reasonable assurance that the device is safe or effective under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

(C) that the application contained or was accompanied by an untrue statement of a material fact;

(D) that the applicant (i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 360i(a) of this title, (ii) has refused to permit access to, or copying or verification of, such records as required by section 374 of this title, or (iii) has not complied with the requirements of section 360 of this title;

(E) on the basis of new information before him with respect to such device, evaluated together with the evidence before him when the application was approved, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such device do not conform with the requirements of section 360j(f) of this title and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity;

(F) on the basis of new information before him, evaluated together with the evidence before him when the application was approved, that the labeling of such device, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or

(G) on the basis of new information before him, evaluated together with the evidence before him when the application was approved, that such device is not shown to conform in all respects to a performance standard which is in effect under section 360d of this title compliance with which was a condition to approval of the application and that there is a lack of adequate information to justify the deviation from such standard.

(2) The holder of an application subject to an order issued under paragraph (1) withdrawing approval of the application may, by petition filed on or before the thirtieth day after the date upon which he receives notice of such withdrawal, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g).

(3) If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a device under an approved application would cause serious, adverse health consequences or death, the Secretary shall by order temporarily suspend the approval of the application approved under this section. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application.

(f) Product development protocol

(1) In the case of a class III device which is required to have an approval of an application submitted under subsection (c), such device shall be considered as having such an approval if a notice of completion of testing conducted in accordance with a product development protocol approved under paragraph (4) has been declared completed under paragraph (6).

(2) Any person may submit to the Secretary a proposed product development protocol with respect to a device. Such a protocol shall be accompanied by data supporting it. If, within thirty days of the receipt of such a protocol, the Secretary determines that it appears to be appropriate to apply the requirements of this subsection to the device with respect to which the protocol is submitted, the Secretary—

(A) may, at the initiative of the Secretary, refer the proposed protocol to the appropriate panel under section 360c of this title for its recommendation respecting approval of the protocol; or

(B) shall so refer such protocol upon the request of the submitter, unless the Secretary finds that the proposed protocol and accompanying data which would be reviewed by such panel substantially duplicate a product development protocol and accompanying data which have previously been reviewed by such a panel.

(3) A proposed product development protocol for a device may be approved only if—

(A) the Secretary determines that it is appropriate to apply the requirements of this subsection to the device in lieu of the requirement of approval of an application submitted under subsection (c); and

(B) the Secretary determines that the proposed protocol provides—

(i) a description of the device and the changes which may be made in the device,

(ii) a description of the preclinical trials (if any) of the device and a specification of (I) the results from such trials to be required before the commencement of clinical trials of the device, and (II) any permissible variations in preclinical trials and the results therefrom,

(iii) a description of the clinical trials (if any) of the device and a specification of (I) the results from such trials to be required before the filing of a notice of completion of the requirements of the protocol, and (II) any permissible variations in such trials and the results therefrom,

(iv) a description of the methods to be used in, and the facilities and controls to be used for, the manufacture, processing, and, when relevant, packing and installation of the device,

(v) an identifying reference to any performance standard under section 360d of this title to be applicable to any aspect of such device,

(vi) if appropriate, specimens of the labeling proposed to be used for such device,

(vii) such other information relevant to the subject matter of the protocol as the Secretary, with the concurrence of the appropriate panel or panels under section 360c of this title, may require, and

(viii) a requirement for submission of progress reports and, when completed, records of the trials conducted under the protocol which records are adequate to show compliance with the protocol.

(4) The Secretary shall approve or disapprove a proposed product development protocol submitted under paragraph (2) within one hundred and twenty days of its receipt unless an additional period is agreed upon by the Secretary and the person who submitted the protocol. Approval of a protocol or denial of approval of a protocol is final agency action subject to judicial review under chapter 7 of title 5.

(5) At any time after a product development protocol for a device has been approved pursuant to paragraph (4), the person for whom the protocol was approved may submit a notice of completion—

(A) stating (i) his determination that the requirements of the protocol have been fulfilled and that, to the best of his knowledge, there is no reason bearing on safety or effectiveness why the notice of completion should not become effective, and (ii) the data and other information upon which such determination was made, and

(B) setting forth the results of the trials required by the protocol and all the information required by subsection (c)(1).

(6)(A) The Secretary may, after providing the person who has an approved protocol an opportunity for an informal hearing and at any time prior to receipt of notice of completion of such protocol, issue a final order to revoke such protocol if he finds that—

(i) such person has failed substantially to comply with the requirements of the protocol,

(ii) the results of the trials obtained under the protocol differ so substantially from the results required by the protocol that further trials cannot be justified, or

(iii) the results of the trials conducted under the protocol or available new information do not demonstrate that the device tested under the protocol does not present an unreasonable risk to health and safety.

(B) After the receipt of a notice of completion of an approved protocol the Secretary shall, within the ninety-day period beginning on the date such notice is received, by order either declare the protocol completed or declare it not completed. An order declaring a protocol not completed may take effect only after the Secretary has provided the person who has the protocol opportunity for an informal hearing on the order. Such an order may be issued only if the Secretary finds—

(i) such person has failed substantially to comply with the requirements of the protocol,

(ii) the results of the trials obtained under the protocol differ substantially from the results required by the protocol, or

(iii) there is a lack of a showing of reasonable assurance of the safety and effectiveness of the device under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.

(C) A final order issued under subparagraph (A) or (B) shall be in writing and shall contain the reasons to support the conclusions thereof.

(7) At any time after a notice of completion has become effective, the Secretary may issue an order (after due notice and opportunity for an informal hearing to the person for whom the notice is effective) revoking the approval of a device provided by a notice of completion which has become effective as provided in subparagraph (B) if he finds that any of the grounds listed in subparagraphs (A) through (G) of subsection (e)(1) of this section apply. Each reference in such subparagraphs to an application shall be considered for purposes of this paragraph as a reference to a protocol and the notice of completion of such protocol, and each reference to the time when an application was approved shall be considered for purposes of this paragraph as a reference to the time when a notice of completion took effect.

(8) A person who has an approved protocol subject to an order issued under paragraph (6)(A) revoking such protocol, a person who has an approved protocol with respect to which an order under paragraph (6)(B) was issued declaring that the protocol had not been completed, or a person subject to an order issued under paragraph (7) revoking the approval of a device may, by petition filed on or before the thirtieth day after the date upon which he receives notice of such order, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g).

(g) Review

(1) Upon petition for review of—

(A) an order under subsection (d) approving or denying approval of an application or an order under subsection (e) withdrawing approval of an application, or

(B) an order under subsection (f)(6)(A) revoking an approved protocol, under subsection (f)(6)(B) declaring that an approved protocol has not been completed, or under subsection (f)(7) revoking the approval of a device,

the Secretary shall, unless he finds the petition to be without good cause or unless a petition for review of such order has been submitted under paragraph (2), hold a hearing, in accordance with section 554 of title 5, on the order. The panel or panels which considered the application, protocol, or device subject to such order shall designate a member to appear and testify at any such hearing upon request of the Secretary, the petitioner, or the officer conducting the hearing, but this requirement does not preclude any other member of the panel or panels from appearing and testifying at any such hearing. Upon completion of such hearing and after considering the record established in such hearing, the Secretary shall issue an order either affirming the order subject to the hearing or reversing such order and, as appropriate, approving or denying approval of the application, reinstating the application's approval, approving the protocol, or placing in effect a notice of completion.

(2)(A) Upon petition for review of—

(i) an order under subsection (d) approving or denying approval of an application or an order under subsection (e) withdrawing approval of an application, or

(ii) an order under subsection (f)(6)(A) revoking an approved protocol, under subsection (f)(6)(B) declaring that an approved protocol has not been completed, or under subsection (f)(7) revoking the approval of a device,

the Secretary shall refer the application or protocol subject to the order and the basis for the order to an advisory committee of experts established pursuant to subparagraph (B) for a report and recommendation with respect to the order. The advisory committee shall, after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation, together with all underlying data and information and a statement of the reasons or basis for the recommendation. A copy of such report shall be promptly supplied by the Secretary to any person who petitioned for such referral to the advisory committee.

(B) The Secretary shall establish advisory committees (which may not be panels under section 360c of this title) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee persons qualified in the subject matter to be referred to the committee and of appropriately diversified professional backgrounds, except that the Secretary may not appoint to such a committee any individual who is in the regular full-time employ of the United States and engaged in the administration of this chapter. Members of an advisory committee (other than officers or employees of the United States), while attending conferences or meetings of their committee or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent for grade GS–18 of the General Schedule for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The Secretary shall designate the chairman of an advisory committee from its members. The Secretary shall furnish each advisory committee with clerical and other assistance, and shall by regulation prescribe the procedures to be followed by each such committee in acting on referrals made under subparagraph (A).

(C) The Secretary shall make public the report and recommendation made by an advisory committee with respect to an application and shall by order, stating the reasons therefor, either affirm the order referred to the advisory committee or reverse such order and, if appropriate, approve or deny approval of the application, reinstate the application's approval, approve the protocol, or place in effect a notice of completion.

(h) Service of orders

Orders of the Secretary under this section shall be served (1) in person by any officer or employee of the department designated by the Secretary, or (2) by mailing the order by registered mail or certified mail addressed to the applicant at his last known address in the records of the Secretary.

(i) Revision

(1) Before December 1, 1995, the Secretary shall by order require manufacturers of devices, which were introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and which are subject to revision of classification under paragraph (2), to submit to the Secretary a summary of and citation to any information known or otherwise available to the manufacturer respecting such devices, including adverse safety or effectiveness information which has not been submitted under section 360i of this title. The Secretary may require the manufacturer to submit the adverse safety or effectiveness data for which a summary and citation were submitted, if such data are available to the manufacturer.

(2) After the issuance of an order under paragraph (1) but before the date that is 2 years after July 9, 2012, the Secretary shall issue an administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, for each device—

(A) which the Secretary has classified as a class III device, and

(B) for which no administrative order has been issued under subsection (b) (or no regulation has been promulgated under such subsection prior to July 9, 2012),

revising the classification of the device so that the device is classified into class I or class II, unless the administrative order issued under this paragraph requires the device to remain in class III. In determining whether to revise the classification of a device or to require a device to remain in class III, the Secretary shall apply the criteria set forth in section 360c(a) of this title.

(3) The Secretary shall, as promptly as is reasonably achievable, but not later than 12 months after the effective date of the order requiring a device to remain in class III, establish a schedule for the issuance of an administrative order under subsection (b) for each device which is subject to the order requiring the device to remain in class III.

(June 25, 1938, ch. 675, §515, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 552; amended Pub. L. 101–629, §§4(b)(1), 9(a), 18(c), Nov. 28, 1990, 104 Stat. 4515, 4521, 4528; Pub. L. 103–80, §3(t), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title II, §§201(b), 202, 205(c), 209(b), 216(b), Nov. 21, 1997, 111 Stat. 2334, 2338, 2341, 2349; Pub. L. 107–250, title II, §§209, 210, title III, §302(c), Oct. 26, 2002, 116 Stat. 1613, 1614, 1618; Pub. L. 108–214, §2(d)(1), Apr. 1, 2004, 118 Stat. 576; Pub. L. 110–85, title VIII, §801(b)(3)(D), Sept. 27, 2007, 121 Stat. 921; Pub. L. 112–144, title II, §203(g), title VI, §608(b)(1), July 9, 2012, 126 Stat. 1006, 1056; Pub. L. 114–255, div. A, title III, §§3051(c)(1), 3058(b), 3101(a)(2)(J), Dec. 13, 2016, 130 Stat. 1124, 1129, 1154; Pub. L. 115–52, title II, §203(f)(2)(A), Aug. 18, 2017, 131 Stat. 1015; Pub. L. 117–328, div. FF, title III, §3308(b)(2), Dec. 29, 2022, 136 Stat. 5836.)

Editorial Notes

Amendments

2022—Subsec. (d)(5)(A)(i). Pub. L. 117–328 substituted "Unless the change is consistent with a predetermined change control plan approved under section 360e–4 of this title, a supplemental" for "A supplemental".

2017—Subsec. (c)(4)(A). Pub. L. 115–52 substituted "section 379j(g)" for "section 379j(h)".

2016—Subsec. (a)(1). Pub. L. 114–255, §3101(a)(2)(J), substituted "subject to an order" for "subject to a an order".

Subsec. (c)(5). Pub. L. 114–255, §3058(b), added par. (5).

Subsec. (d)(5), (6). Pub. L. 114–255, §3051(c)(1), redesignated par. (6) as (5) and struck out former par. (5) which read as follows: "In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, the Secretary shall provide review priority for devices—

"(A) representing breakthrough technologies,

"(B) for which no approved alternatives exist,

"(C) which offer significant advantages over existing approved alternatives, or

"(D) the availability of which is in the best interest of the patients."

2012—Subsec. (a)(1). Pub. L. 112–144, §608(b)(1)(A), substituted "an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012)" for "regulation promulgated under subsection (b)".

Subsec. (b). Pub. L. 112–144, §608(b)(1)(B)(i)(I), which directed substitution of "Order" for "Regulation" in the heading of par. (1) of subsec. (b), was executed by making the substitution in the heading of subsec. (b), to reflect the probable intent of Congress.

Subsec. (b)(1). Pub. L. 112–144, §608(b)(1)(B)(i)(II), in concluding provisions, substituted "by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5" for "by regulation, promulgated in accordance with this subsection" and inserted at end "Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner."

Subsec. (b)(2). Pub. L. 112–144, §608(b)(1)(B)(ii), struck out subpar. (A) designation after "(2)" and substituted "A proposed order required under paragraph (1) shall contain—" for "A proceeding for the promulgation of a regulation under paragraph (1) respecting a device shall be initiated by the publication in the Federal Register of a notice of proposed rulemaking. Such notice shall contain—" in introductory provisions, redesignated cls. (i) to (iv) as subpars. (A) to (D), respectively, substituted "order" for "regulation" in subpars. (A) and (C), and struck out former subpar. (B) which read as follows: "If, within fifteen days after publication of a notice under subparagraph (A), the Secretary receives a request for a change in the classification of a device, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 360c of this title, by order published in the Federal Register, either deny the request for change in classification or give notice of his intent to initiate such a change under section 360c(e) of this title."

Subsec. (b)(3). Pub. L. 112–144, §608(b)(1)(B)(iii)(I), (II), (IV), (V), substituted "proposed order" for "proposed regulation" in two places, "paragraph (2)," for "paragraph (2) and after", "(A) issue an administrative order under paragraph (1)" for "(A) promulgate such regulation", "paragraph (2)(B)" for "paragraph (2)(A)(ii)", and "issuance of the administrative order" for "promulgation of the regulation".

Pub. L. 112–144, §608(b)(1)(B)(iii)(III), which directed insertion of "and a meeting of a device classification panel described in section 360c(b) of this title," after "such proposed regulation and findings," was inserted after "such proposed order and findings," to reflect the probable intent of Congress and amendment by Pub. L. 112–144, §608(b)(1)(B)(iii)(I). See above.

Subsec. (b)(4). Pub. L. 112–144, §608(b)(1)(B)(iv), struck out par. (4) which read as follows: "The Secretary, upon his own initiative or upon petition of an interested person, may by regulation amend or revoke any regulation promulgated under this subsection. A regulation to amend or revoke a regulation under this subsection shall be promulgated in accordance with the requirements prescribed by this subsection for the promulgation of the regulation to be amended or revoked."

Subsec. (c)(4)(A). Pub. L. 112–144, §203(g), substituted "379j(h)" for "379j(g)".

Subsec. (i)(2). Pub. L. 112–144, §608(b)(1)(C)(i)(III), (IV), in concluding provisions, substituted "administrative order issued under this paragraph requires" for "regulation requires" and struck out at end "Before the publication of a regulation requiring a device to remain in class III or revising its classification, the Secretary shall publish a proposed regulation respecting the classification of a device under this paragraph and provide reasonable opportunity for the submission of comments on any such regulation. No regulation requiring a device to remain in class III or revising its classification may take effect before the expiration of 90 days from the date of its publication in the Federal Register as a proposed regulation."

Pub. L. 112–144, §608(b)(1)(C)(i)(I), in introductory provisions, substituted "the date that is 2 years after July 9, 2012" for "December 1, 1995" and "issue an administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5," for "publish a regulation in the Federal Register".

Subsec. (i)(2)(B). Pub. L. 112–144, §608(b)(1)(C)(i)(II), substituted "administrative order has been issued under subsection (b) (or no regulation has been promulgated under such subsection prior to July 9, 2012)" for "final regulation has been promulgated under subsection (b) of this section".

Subsec. (i)(3). Pub. L. 112–144, §608(b)(1)(C)(ii), substituted "order requiring" for "regulation requiring" in two places and "issuance of an administrative order under subsection (b)" for "promulgation of a subsection (b) of this section regulation".

2007—Subsec. (c)(1)(G), (H). Pub. L. 110–85 added subpar. (G) and redesignated former subpar. (G) as (H).

2004—Subsec. (c)(3). Pub. L. 108–214, §2(d)(1)(B), amended directory language of Pub. L. 107–250, §210. See 2002 Amendment note below.

Pub. L. 108–214, §2(d)(1)(A)(i), redesignated par. (3) relating to acceptance and review of any portion of the application prior to submission as (4).

Subsec. (c)(4). Pub. L. 108–214, §2(d)(1)(A), redesignated par. (3) relating to acceptance and review of any portion of the application prior to submission as (4) and substituted "unless a significant issue of safety" for "unless an issue of safety" in subpar. (B).

2002—Subsec. (a). Pub. L. 107–250, §302(c)(1), inserted "or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval" before period in concluding provisions.

Subsec. (c)(2). Pub. L. 107–250, §302(c)(2)(B), added par. (2). Former par. (2) redesignated (3).

Subsec. (c)(3). Pub. L. 107–250, §302(c)(2)(A), redesignated par. (2) relating to Secretary's referral of application to appropriate panel as (3).

Pub. L. 107–250, §210, as amended by Pub. L. 108–214, §2(d)(1)(B), inserted "Where appropriate, the Secretary shall ensure that such panel includes, or consults with, one or more pediatric experts." at the end of the concluding provisions of par. (3) as redesignated by Pub. L. 107–250, §302(c)(2)(A).

Pub. L. 107–250, §209, added par. (3) relating to acceptance and review of any portion of the application prior to submission.

1997—Subsec. (d)(1)(A). Pub. L. 105–115, §205(c)(1), inserted at end "In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling."

Subsec. (d)(1)(B)(iii). Pub. L. 105–115, §201(b), added cl. (iii).

Subsec. (d)(3), (4). Pub. L. 105–115, §202(1), 209(b), added par. (3) and redesignated former par. (3) as (4).

Subsec. (d)(5). Pub. L. 105–115, §202(2), added par. (5).

Subsec. (d)(6). Pub. L. 105–115, §205(c)(2), added par. (6).

Subsec. (f)(2). Pub. L. 105–115, §216(b), substituted "the Secretary—" and subpars. (A) and (B) for "he shall refer the proposed protocol to the appropriate panel under section 360c of this title for its recommendation respecting approval of the protocol."

1993—Subsec. (c)(2)(A). Pub. L. 103–80 struck out "refer such application" after "own initiative".

1990—Subsec. (c)(2). Pub. L. 101–629, §18(c), substituted "the Secretary—" for "the Secretary shall" and added subpars. (A) and (B).

Subsec. (e). Pub. L. 101–629, §9(a)(2), inserted "and temporary suspension" after "Withdrawal" in heading.

Subsec. (e)(3). Pub. L. 101–629, §9(a)(1), added par. (3).

Subsec. (i). Pub. L. 101–629, §4(b)(1), added subsec. (i).

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by section 203(g) of Pub. L. 112–144 effective Oct. 1, 2012, with additional provision for assessment of certain fees, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

Report on Certain Devices

Pub. L. 107–250, title II, §205, Oct. 26, 2002, 116 Stat. 1612, directed the Secretary of Health and Human Services, not later than one year after Oct. 26, 2002, to report to the appropriate committees of Congress on the timeliness and effectiveness of device premarket reviews by centers other than the Center for Devices and Radiological Health, including information on the times required to log in and review original submissions and supplements, times required to review manufacturers' replies to submissions, times to approve or clear such devices, and recommendations on improvement of performance and reassignment of responsibility for regulating such devices.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

§360e–1. Pediatric uses of devices

(a) New devices

(1) In general

A person that submits to the Secretary an application under section 360j(m) of this title, or an application (or supplement to an application) or a product development protocol under section 360e of this title, shall include in the application or protocol the information described in paragraph (2).

(2) Required information

The application or protocol described in paragraph (1) shall include, with respect to the device for which approval is sought and if readily available—

(A) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and

(B) the number of affected pediatric patients.

(3) Annual report

Not later than 18 months after September 27, 2007, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes—

(A) the number of devices approved in the year preceding the year in which the report is submitted, for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure;

(B) any information, based on a review of data available to the Secretary, regarding devices used in pediatric patients but not labeled for such use for which the Secretary determines that approved pediatric labeling could confer a benefit to pediatric patients;

(C) the number of pediatric devices that receive a humanitarian use exemption under section 360j(m) of this title;

(D) the number of devices approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients;

(E) the number of pediatric devices approved in the year preceding the year in which the report is submitted, exempted from a fee pursuant to section 379j(a)(2)(B)(v) of this title;

(F) the review time for each device described in subparagraphs (A), (C), (D), and (E);

(G) the number of devices for which the Secretary relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients; and

(H) the number of devices for which the Secretary relied on data from one pediatric subpopulation to support a determination of a reasonable assurance of safety and effectiveness in another pediatric subpopulation.

For the items described in this paragraph, such report shall disaggregate the number of devices by pediatric subpopulation.

(b) Determination of pediatric effectiveness based on similar course of disease or condition or similar effect of device on adults

(1) In general

If the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients, the Secretary may conclude that adult data may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations, as appropriate.

(2) Extrapolation between subpopulations

A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another subpopulation.

(c) Pediatric subpopulation

For purposes of this section, the term "pediatric subpopulation" has the meaning given the term in section 360j(m)(6)(E)(ii) of this title.

(June 25, 1938, ch. 675, §515A, as added Pub. L. 110–85, title III, §302, Sept. 27, 2007, 121 Stat. 859; amended Pub. L. 115–52, title V, §502(a), Aug. 18, 2017, 131 Stat. 1037.)

Editorial Notes

Amendments

2017—Subsec. (a)(3). Pub. L. 115–52 added subpars. (B), (C), (G), and (H), redesignated former subpars. (B) to (D) as (D) to (F), respectively, substituted "(C), (D), and (E);" for "(B), and (C)." in subpar. (F), and inserted concluding provisions.

Statutory Notes and Related Subsidiaries

Final Rule Relating to Tracking of Pediatric Uses of Devices

Pub. L. 112–144, title VI, §620(b), July 9, 2012, 126 Stat. 1064, provided that: "The Secretary of Health and Human Services shall issue—

"(1) a proposed rule implementing section 515A(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(2)) not later than December 31, 2012; and

"(2) a final rule implementing such section not later than December 31, 2013."

§360e–3. Breakthrough devices

(a) Purpose

The purpose of this section is to encourage the Secretary, and provide the Secretary with sufficient authority, to apply efficient and flexible approaches to expedite the development of, and prioritize the Food and Drug Administration's review of, devices that represent breakthrough technologies.

(b) Establishment of program

The Secretary shall establish a program to expedite the development of, and provide for the priority review for, devices, as determined by the Secretary—

(1) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and

(2)(A) that represent breakthrough technologies;

(B) for which no approved or cleared alternatives exist;

(C) that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients' ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or

(D) the availability of which is in the best interest of patients.

(c) Request for designation

A sponsor of a device may request that the Secretary designate such device for expedited development and priority review under this section. Any such request for designation may be made at any time prior to the submission of an application under section 360e(c) of this title, a notification under section 360(k) of this title, or a petition for classification under section 360c(f)(2) of this title.

(d) Designation process

(1) In general

Not later than 60 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the device that is the subject of the request meets the criteria described in subsection (b). If the Secretary determines that the device meets the criteria, the Secretary shall designate the device for expedited development and priority review.

(2) Review

Review of a request under subsection (c) shall be undertaken by a team that is composed of experienced staff and senior managers of the Food and Drug Administration.

(3) Withdrawal

The Secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection (b) no longer applying because of the subsequent clearance or approval of another device that—

(A) was designated under this section; or

(B) was given priority review under section 360e(d)(5) of this title, as in effect prior to December 13, 2016.

(e) Expedited development and priority review

(1) Actions

For purposes of expediting the development and review of devices designated under subsection (d) the Secretary shall—

(A) assign a team of staff, including a team leader with appropriate subject matter expertise and experience, for each device for which a request is submitted under subsection (c);

(B) provide for oversight of the team by senior agency personnel to facilitate the efficient development of the device and the efficient review of any submission described in subsection (c) for the device;

(C) adopt an efficient process for timely dispute resolution;

(D) provide for interactive and timely communication with the sponsor of the device during the development program and review process;

(E) expedite the Secretary's review of manufacturing and quality systems compliance, as applicable;

(F) disclose to the sponsor, not less than 5 business days in advance, the topics of any consultation the Secretary intends to undertake with external experts or an advisory committee concerning the sponsor's device and provide the sponsor the opportunity to recommend such external experts;

(G) provide for advisory committee input, as the Secretary determines appropriate (including in response to the request of the sponsor) for applications submitted under section 360e(c) of this title; and

(H) assign staff to be available within a reasonable time to address questions by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section 360j(g) of this title.

(2) Additional actions

In addition to the actions described in paragraph (1), for purposes of expediting the development and review of devices designated under subsection (d), the Secretary, in collaboration with the device sponsor, may, as appropriate—

(A) coordinate with the sponsor regarding early agreement on a data development plan;

(B) take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate;

(C) facilitate, when scientifically appropriate, expedited and efficient development and review of the device through utilization of timely postmarket data collection with regard to application for approval under section 360e(c) of this title; and

(D) agree in writing to clinical protocols that the Secretary will consider binding on the Secretary and the sponsor, subject to—

(i) changes to such protocols agreed to in writing by the sponsor and the Secretary; or

(ii) a decision, made by the director of the office responsible for reviewing the device submission, that a substantial scientific issue essential to determining the safety or effectiveness of such device exists, provided that such decision is in writing, and is made only after the Secretary provides to the device sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the substantial scientific issue.

(f) Priority review guidance

(1) Content

Not later than 1 year after December 13, 2016, the Secretary shall issue guidance on the implementation of this section. Such guidance shall—

(A) set forth the process by which a person may seek a designation under subsection (d);

(B) provide a template for requests under subsection (c);

(C) identify the criteria the Secretary will use in evaluating a request for designation under this section; and

(D) identify the criteria and processes the Secretary will use to assign a team of staff, including team leaders, to review devices designated for expedited development and priority review, including any training required for such personnel to ensure effective and efficient review.

(2) Process

Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a draft version of that guidance.

(g) Rule of construction

Nothing in this section shall be construed to affect—

(1) the criteria and standards for evaluating an application pursuant to section 360e(c) of this title, a report and request for classification under section 360c(f)(2) of this title, or a report under section 360(k) of this title, including the recognition of valid scientific evidence as described in section 360c(a)(3)(B) of this title and consideration and application of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics, as applicable;

(2) the authority of the Secretary with respect to clinical holds under section 360j(g)(8)(A) of this title;

(3) the authority of the Secretary to act on an application pursuant to section 360e(d) of this title before completion of an establishment inspection, as the Secretary determines appropriate; or

(4) the authority of the Secretary with respect to postmarket surveillance under sections 360i(h) and 360l of this title.

(June 25, 1938, ch. 675, §515B, formerly §515C, as added Pub. L. 114–255, div. A, title III, §3051(a), Dec. 13, 2016, 130 Stat. 1121; renumbered §515B and amended Pub. L. 115–52, title IX, §901(f), (g), Aug. 18, 2017, 131 Stat. 1076, 1077.)

Editorial Notes

Amendments

2017—Pub. L. 115–52, §901(f)(1), made technical amendment to directory language of Pub. L. 114–255, §3051(a), which added this section.

Subsec. (f)(2). Pub. L. 115–52, §901(g), substituted "a draft version of that guidance" for "a proposed guidance".

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Pub. L. 115–52, title IX, §901(f), Aug. 18, 2017, 131 Stat. 1076, provided that the renumbering and amendment made by section 901(f) is effective as of the enactment of Pub. L. 114–255.

§360e–4. Predetermined change control plans for devices

(a) Approved devices

(1) In general

Notwithstanding section 360e(d)(5)(A) of this title, a supplemental application shall not be required for a change to a device approved under section 360e of this title, if such change is consistent with a predetermined change control plan that is approved pursuant to paragraph (2).

(2) Predetermined change control plan

The Secretary may approve a predetermined change control plan submitted in an application, including a supplemental application, under section 360e of this title that describes planned changes that may be made to the device (and that would otherwise require a supplemental application under section 360e of this title), if the device remains safe and effective without any change.

(3) Scope

The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.

(b) Cleared devices

(1) In general

Notwithstanding section 360(k) of this title, a premarket notification shall not be required for a change to a device cleared under section 360(k) of this title, if such change is consistent with an established predetermined change control plan granted pursuant to paragraph (2).

(2) Predetermined change control plan

The Secretary may clear a predetermined change control plan submitted in a notification submitted under section 360(k) of this title that describes planned changes that may be made to the device (and that would otherwise require a new notification), if—

(A) the device remains safe and effective without any such change; and

(B) the device would remain substantially equivalent to the predicate.

(3) Scope

The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.

(c) Predicate devices

In making a determination of substantial equivalence pursuant to section 360c(i) of this title, the Secretary shall not compare a device to changed versions of a device implemented in accordance with an established predetermined change control plan as a predicate device. Only the version of the device cleared or approved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predicate device.

(June 25, 1938, ch. 675, §515C, as added Pub. L. 117–328, div. FF, title III, §3308(a), Dec. 29, 2022, 136 Stat. 5835.)

Editorial Notes

Prior Provisions

A prior section 515C of act June 25, 1938, was renumbered section 515B and is classified to section 360e–3 of this title.

§360f. Banned devices

(a) General rule

Whenever the Secretary finds, on the basis of all available data and information, that—

(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury for one or more intended uses; and

(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period;

he may initiate a proceeding to promulgate a regulation to make such device a banned device or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under section 396 of this title when intended for such use or uses.

(b) Special effective date

The Secretary may declare a proposed regulation under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting such regulation if (1) he determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with the use of the device which is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and (2) before the date of the publication of such regulation, the Secretary notifies the manufacturer of such device that such regulation is to be made so effective. If the Secretary makes a proposed regulation so effective, he shall, as expeditiously as possible, give interested persons prompt notice of his action under this subsection, provide reasonable opportunity for an informal hearing on the proposed regulation, and either affirm, modify, or revoke such proposed regulation.

(June 25, 1938, ch. 675, §516, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 560; amended Pub. L. 101–629, §18(d), Nov. 28, 1990, 104 Stat. 4529; Pub. L. 117–328, div. FF, title III, §3306(a), Dec. 29, 2022, 136 Stat. 5834.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328, §3306(a)(2), inserted "or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under section 396 of this title when intended for such use or uses" after "banned device" in concluding provisions.

Subsec. (a)(1). Pub. L. 117–328, §3306(a)(1), inserted "for one or more intended uses" before semicolon at end.

1990—Subsec. (a). Pub. L. 101–629 struck out "and after consultation with the appropriate panel or panels under section 360c of this title" after "data and information" in introductory provisions and struck out at end "The Secretary shall afford all interested persons opportunity for an informal hearing on a regulation proposed under this subsection."

Statutory Notes and Related Subsidiaries

Construction of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3306(b), Dec. 29, 2022, 136 Stat. 5834, provided that: "Nothing in this section [amending this section] shall be construed to limit the authority of the Secretary [of Health and Human Services] to amend, in accordance with section 516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360f), as amended by this section, and chapter 5 of title 5, United States Code, regulations promulgated pursuant to such section 516, as amended by this section."

§360g. Judicial review

(a) Petition; record

Not later than thirty days after—

(1) the promulgation of a regulation under section 360c of this title classifying a device in class I, an administrative order changing the classification of a device to class I, or an order under subsection (f)(2) of such section reclassifying a device or denying a petition for reclassification of a device,

(2) the promulgation of a regulation under section 360d of this title establishing, amending, or revoking a performance standard for a device,

(3) the issuance of an order under section 360d(b)(2) or 360e(b)(2)(B) of this title denying a request for reclassification of a device,

(4) the promulgation of a regulation under paragraph (3) of section 360e(b) of this title requiring a device to have an approval of a premarket application, a regulation under paragraph (4) of that section amending or revoking a regulation under paragraph (3), or an order pursuant to section 360e(g)(1) or 360e(g)(2)(C) of this title,

(5) the promulgation of a regulation under section 360f of this title (other than a proposed regulation made effective under subsection (b) of such section upon the regulation's publication) making a device a banned device,

(6) the issuance of an order under section 360j(f)(2) of this title,

(7) an order under section 360j(g)(4) of this title disapproving an application for an exemption of a device for investigational use or an order under section 360j(g)(5) of this title withdrawing such an exemption for a device,

(8) an order pursuant to section 360c(i) of this title, or

(9) a regulation under section 360e(i)(2) or 360j(l)(5)(B) of this title,

any person adversely affected by such regulation or order may file a petition with the United States Court of Appeals for the District of Columbia or for the circuit wherein such person resides or has his principal place of business for judicial review of such regulation or order. A copy of the petition shall be transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary shall file in the court the record of the proceedings on which the Secretary based his regulation or order as provided in section 2112 of title 28. For purposes of this section, the term "record" means all notices and other matter published in the Federal Register with respect to the regulation or order reviewed, all information submitted to the Secretary with respect to such regulation or order, proceedings of any panel or advisory committee with respect to such regulation or order, any hearing held with respect to such regulation or order, and any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.

(b) Additional data, views, and arguments

If the petitioner applies to the court for leave to adduce additional data, views, or arguments respecting the regulation or order being reviewed and shows to the satisfaction of the court that such additional data, views, or arguments are material and that there were reasonable grounds for the petitioner's failure to adduce such data, views, or arguments in the proceedings before the Secretary, the court may order the Secretary to provide additional opportunity for the oral presentation of data, views, or arguments and for written submissions. The Secretary may modify his findings, or make new findings by reason of the additional data, views, or arguments so taken and shall file with the court such modified or new findings, and his recommendation, if any, for the modification or setting aside of the regulation or order being reviewed, with the return of such additional data, views, or arguments.

(c) Standard for review

Upon the filing of the petition under subsection (a) of this section for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5 and to grant appropriate relief, including interim relief, as provided in such chapter. A regulation described in paragraph (2) or (5) of subsection (a) and an order issued after the review provided by section 360e(g) of this title shall not be affirmed if it is found to be unsupported by substantial evidence on the record taken as a whole.

(d) Finality of judgments

The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28.

(e) Remedies

The remedies provided for in this section shall be in addition to and not in lieu of any other remedies provided by law.

(f) Statement of reasons

To facilitate judicial review under this section or under any other provision of law of a regulation or order issued under section 360c, 360d, 360e, 360f, 360h, 360i, 360j, or 360k of this title each such regulation or order shall contain a statement of the reasons for its issuance and the basis, in the record of the proceedings held in connection with its issuance, for its issuance.

(June 25, 1938, ch. 675, §517, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 560; amended Pub. L. 101–629, §13, Nov. 28, 1990, 104 Stat. 4524; Pub. L. 102–300, §6(f), June 16, 1992, 106 Stat. 240; Pub. L. 105–115, title II, §216(a)(2), Nov. 21, 1997, 111 Stat. 2349; Pub. L. 112–144, title VI, §608(a)(2)(C), July 9, 2012, 126 Stat. 1056.)

Editorial Notes

Amendments

2012—Subsec. (a)(1). Pub. L. 112–144 substituted ", an administrative order changing the classification of a device to class I," for "or changing the classification of a device to class I".

1997—Subsec. (a)(8). Pub. L. 105–115, §216(a)(2)(A), inserted "or" at end.

Subsec. (a)(9). Pub. L. 105–115, §216(a)(2)(B), substituted comma for ", or" at end.

Subsec. (a)(10). Pub. L. 105–115, §216(a)(2)(C), struck out par. (10) which read as follows: "an order under section 360j(h)(4)(B) of this title,".

1992—Subsec. (a)(10). Pub. L. 102–300 substituted "360j(h)(4)(B)" for "360j(c)(4)(B)".

1990—Subsec. (a)(8) to (10). Pub. L. 101–629 added pars. (8) to (10).

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

§360g–1. Agency documentation and review of significant decisions regarding devices

(a) Documentation of rationale for significant decisions

(1) In general

The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 360(k) of this title, a petition for classification under section 360c(f) of this title, an application under section 360e of this title, or an application for an exemption under section 360j(g) of this title, including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.

(2) Provision of documentation

Upon request, the Secretary shall furnish such substantive summary to the person who is seeking to submit, or who has submitted, such report or application.

(3) Application of least burdensome requirements

The substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section 360c(i)(1)(D) of this title, section 360c(a)(3)(D) of this title, and section 360e(c)(5) of this title, as applicable.

(b) Review of significant decisions

(1) Request for supervisory review of significant decision

Any person may request a supervisory review of the significant decision described in subsection (a)(1). Such review may be conducted at the next supervisory level or higher above the individual who made the significant decision.

(2) Submission of request

A person requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after such decision and shall indicate in the request whether such person seeks an in-person meeting or a teleconference review.

(3) Timeframe

(A) In general

Except as provided in subparagraph (B), the Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after such request is made. The Secretary shall issue a decision to the person requesting a review under this subsection not later than 45 days after the request is made under paragraph (1), or, in the case of a person who requests an in-person meeting or teleconference, 30 days after such meeting or teleconference.

(B) Exception

Subparagraph (A) shall not apply in cases that are referred to experts outside of the Food and Drug Administration.

(June 25, 1938, ch. 675, §517A, as added Pub. L. 112–144, title VI, §603, July 9, 2012, 126 Stat. 1051; amended Pub. L. 114–255, div. A, title III, §§3051(b), 3058(c), Dec. 13, 2016, 130 Stat. 1124, 1129; Pub. L. 117–328, div. FF, title III, §3308(b)(3), Dec. 29, 2022, 136 Stat. 5836.)

Editorial Notes

Amendments

2022—Subsec. (a)(1). Pub. L. 117–328 amended par. (1) generally. Prior to amendment, text read as follows: "The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 360(k) of this title, an application under section 360e of this title, a request for designation under section 360e–3 of this title, or an application for an exemption under section 360j(g) of this title, including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion."

2016—Subsec. (a)(1). Pub. L. 114–255, §3051(b), inserted "a request for designation under section 360e–3 of this title," after "application under section 360e of this title,".

Subsec. (a)(3). Pub. L. 114–255, §3058(c), added par. (3).

§360g–2. Third party data transparency

(a) In general

To the extent the Secretary relies on any data, analysis, or other information or findings provided by entities that has been funded in whole or in part by, or otherwise performed under contract with, the Food and Drug Administration, in regulatory decision-making with respect to devices, the Secretary shall—

(1) request access to the datasets, inputs, clinical or other assumptions, methods, analytical code, results, and other components underlying or comprising the analysis, conclusions, or other findings upon which the Secretary seeks to rely; and

(2) in the event that information described in paragraph (1) is used to support regulatory decision-making, and as otherwise appropriate, to the extent practicable, provide the manufacturer or manufacturers subject to such decision a summary of such information, subject to protection of confidential commercial information or trade secret information or personally identifiable information.

(b) Report

Not later than September 30, 2023, and biennially thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and publish on the website of the Food and Drug Administration, a report on the number of postmarket device signals communications issued by the Secretary, the sources of data for such signals, and how such signals were revised or resolved.

(c) Rule of construction

Nothing in this section shall be construed to require the delay of any regulatory decision-making or other action of the Food and Drug Administration.

(Pub. L. 117–328, div. FF, title III, §3307, Dec. 29, 2022, 136 Stat. 5834.)

Editorial Notes

Codification

Section was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Definition of "Secretary"

Secretary as used in this section means the Secretary of Health and Human Services, see section 3002 of div. FF of Pub. L. 117–328, set out as a note under section 350a–1 of this title.

§360h. Notification and other remedies

(a) Notification

If the Secretary determines that—

(1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health, and

(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this chapter (other than this section) to eliminate such risk,

the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all health professionals who prescribe or use the device and to any other person (including manufacturers, importers, distributors, retailers, and device users) who should properly receive such notification in order to eliminate such risk. An order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the Secretary determines that notice to such individuals would present a greater danger to the health of such individuals than no such notification. If the Secretary makes such a determination with respect to such individuals, the order shall require that the health professionals who prescribe or use the device provide for the notification of the individuals whom the health professionals treated with the device of the risk presented by the device and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order.

(b) Repair, replacement, or refund

(1)(A) If, after affording opportunity for an informal hearing, the Secretary determines that—

(i) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health,

(ii) there are reasonable grounds to believe that the device was not properly designed or manufactured with reference to the state of the art as it existed at the time of its design or manufacture,

(iii) there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a manufacturer, importer, distributor, or retailer of the device to exercise due care in the installation, maintenance, repair, or use of the device, and

(iv) the notification authorized by subsection (a) would not by itself be sufficient to eliminate the unreasonable risk and action described in paragraph (2) of this subsection is necessary to eliminate such risk,

the Secretary may order the manufacturer, importer, or any distributor of such device, or any combination of such persons, to submit to him within a reasonable time a plan for taking one or more of the actions described in paragraph (2). An order issued under the preceding sentence which is directed to more than one person shall specify which person may decide which action shall be taken under such plan and the person specified shall be the person who the Secretary determines bears the principal, ultimate financial responsibility for action taken under the plan unless the Secretary cannot determine who bears such responsibility or the Secretary determines that the protection of the public health requires that such decision be made by a person (including a device user or health professional) other than the person he determines bears such responsibility.

(B) The Secretary shall approve a plan submitted pursuant to an order issued under subparagraph (A) unless he determines (after affording opportunity for an informal hearing) that the action or actions to be taken under the plan or the manner in which such action or actions are to be taken under the plan will not assure that the unreasonable risk with respect to which such order was issued will be eliminated. If the Secretary disapproves a plan, he shall order a revised plan to be submitted to him within a reasonable time. If the Secretary determines (after affording opportunity for an informal hearing) that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the Secretary within the prescribed time, the Secretary shall (i) prescribe a plan to be carried out by the person or persons to whom the order issued under subparagraph (A) was directed, or (ii) after affording an opportunity for an informal hearing, by order prescribe a plan to be carried out by a person who is a manufacturer, importer, distributor, or retailer of the device with respect to which the order was issued but to whom the order under subparagraph (A) was not directed.

(2) The actions which may be taken under a plan submitted under an order issued under paragraph (1) are as follows:

(A) To repair the device so that it does not present the unreasonable risk of substantial harm with respect to which the order under paragraph (1) was issued.

(B) To replace the device with a like or equivalent device which is in conformity with all applicable requirements of this chapter.

(C) To refund the purchase price of the device (less a reasonable allowance for use if such device has been in the possession of the device user for one year or more—

(i) at the time of notification ordered under subsection (a), or

(ii) at the time the device user receives actual notice of the unreasonable risk with respect to which the order was issued under paragraph (1),

whichever first occurs).

(3) No charge shall be made to any person (other than a manufacturer, importer, distributor or retailer) for availing himself of any remedy, described in paragraph (2) and provided under an order issued under paragraph (1), and the person subject to the order shall reimburse each person (other than a manufacturer, importer, distributor, or retailer) who is entitled to such a remedy for any reasonable and foreseeable expenses actually incurred by such person in availing himself of such remedy.

(c) Reimbursement

An order issued under subsection (b) with respect to a device may require any person who is a manufacturer, importer, distributor, or retailer of the device to reimburse any other person who is a manufacturer, importer, distributor, or retailer of such device for such other person's expenses actually incurred in connection with carrying out the order if the Secretary determines such reimbursement is required for the protection of the public health. Any such requirement shall not affect any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party.

(d) Effect on other liability

Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account.

(e) Recall authority

(1) If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device)—

(A) to immediately cease distribution of such device, and

(B) to immediately notify health professionals and device user facilities of the order and to instruct such professionals and facilities to cease use of such device.

The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such device. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

(2)(A) If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the device with respect to which the order was issued, the Secretary shall, except as provided in subparagraphs (B) and (C), amend the order to require a recall. The Secretary shall specify a timetable in which the device recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.

(B) An amended order under subparagraph (A)—

(i) shall—

(I) not include recall of a device from individuals, and

(II) not include recall of a device from device user facilities if the Secretary determines that the risk of recalling such device from the facilities presents a greater health risk than the health risk of not recalling the device from use, and

(ii) shall provide for notice to individuals subject to the risks associated with the use of such device.

In providing the notice required by clause (ii), the Secretary may use the assistance of health professionals who prescribed or used such a device for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 375(b) of this title.

(3) The remedy provided by this subsection shall be in addition to remedies provided by subsections (a), (b), and (c).

(June 25, 1938, ch. 675, §518, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 562; amended Pub. L. 101–629, §8, Nov. 28, 1990, 104 Stat. 4520; Pub. L. 102–300, §4, June 16, 1992, 106 Stat. 239.)

Editorial Notes

Amendments

1992—Subsec. (b)(1)(A)(ii). Pub. L. 102–300 substituted "or" for "and" after "properly designed" and "time of its design".

1990—Subsec. (e). Pub. L. 101–629 added subsec. (e).

§360h–1. Program to improve the device recall system

(a) In general

The Secretary shall—

(1) establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices;

(2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;

(3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall; and

(4) document the basis for each termination by the Food and Drug Administration of a device recall.

(b) Assessment content

The program established under subsection (a)(1) shall, at a minimum, identify—

(1) trends in the number and types of device recalls;

(2) devices that are most frequently the subject of a recall; and

(3) underlying causes of device recalls.

(c) Definition

In this section, the term "recall" means—

(1) the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of section 360h of this title; or

(2) the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under section 360i(g) of this title.

(June 25, 1938, ch. 675, §518A, as added Pub. L. 112–144, title VI, §605, July 9, 2012, 126 Stat. 1053; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(K), Dec. 13, 2016, 130 Stat. 1154.)

Editorial Notes

Amendments

2016—Subsecs. (c), (d). Pub. L. 114–255 redesignated subsec. (d) as (c) and struck out former subsec. (c). Prior to amendment, text read as follows: "The Secretary shall document the basis for the termination by the Food and Drug Administration of a device recall."

§360i. Records and reports on devices

(a) General rule

Every person who is a manufacturer or importer of a device intended for human use shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to otherwise assure its safety and effectiveness. Regulations prescribed under the preceding sentence—

(1) shall require a device manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices—

(A) may have caused or contributed to a death or serious injury, or

(B) has malfunctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, which report under this subparagraph—

(i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is—

(I) a class III device;

(II) a class II device that is permanently implantable, is life supporting, or is life sustaining; or

(III) a type of device which the Secretary has, by notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device, indicated should be subject to such part 803 in order to protect the public health;

(ii) shall, if the device is not subject to clause (i), be submitted in accordance with criteria established by the Secretary for reports made pursuant to this clause, which criteria shall require the reports to be in summary form and made on a quarterly basis; or

(iii) shall, if the device is imported into the United States and for which part 803 of title 21, Code of Federal Regulations (or successor regulations) requires an importer to submit a report to the manufacturer, be submitted by the importer to the manufacturer in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations) ¹

(2) shall define the term "serious injury" to mean an injury that—

(A) is life threatening,

(B) results in permanent impairment of a body function or permanent damage to a body structure, or

(C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure;

(3) shall require reporting of other significant adverse device experiences as determined by the Secretary to be necessary to be reported;

(4) shall not impose requirements unduly burdensome to a device manufacturer or importer taking into account his cost of complying with such requirements and the need for the protection of the public health and the implementation of this chapter;

(5) which prescribe the procedure for making requests for reports or information shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information;

(6) which require submission of a report or information to the Secretary shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information;

(7) may not require that the identity of any patient be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine the safety or effectiveness of a device, or to verify a record, report, or information submitted under this chapter; and

(8) may not require a manufacturer or importer of a class I device to—

(A) maintain for such a device records respecting information not in the possession of the manufacturer or importer, or

(B) to submit for such a device to the Secretary any report or information—

(i) not in the possession of the manufacturer or importer, or

(ii) on a periodic basis,

unless such report or information is necessary to determine if the device should be reclassified or if the device is adulterated or misbranded. and ²

In prescribing such regulations, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (7) of this subsection continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient. The Secretary shall by regulation require distributors to keep records and make such records available to the Secretary upon request. Paragraphs (4) and (8) apply to distributors to the same extent and in the same manner as such paragraphs apply to manufacturers and importers.

(b) User reports

(1)(A) Whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that a device has or may have caused or contributed to the death of a patient of the facility, the facility shall, as soon as practicable but not later than 10 working days after becoming aware of the information, report the information to the Secretary and, if the identity of the manufacturer is known, to the manufacturer of the device. In the case of deaths, the Secretary may by regulation prescribe a shorter period for the reporting of such information.

(B) Whenever a device user facility receives or otherwise becomes aware of—

(i) information that reasonably suggests that a device has or may have caused or contributed to the serious illness of, or serious injury to, a patient of the facility, or

(ii) other significant adverse device experiences as determined by the Secretary by regulation to be necessary to be reported,

the facility shall, as soon as practicable but not later than 10 working days after becoming aware of the information, report the information to the manufacturer of the device or to the Secretary if the identity of the manufacturer is not known.

(C) Each device user facility shall submit to the Secretary on an annual basis a summary of the reports made under subparagraphs (A) and (B). Such summary shall be submitted on January 1 of each year. The summary shall be in such form and contain such information from such reports as the Secretary may require and shall include—

(i) sufficient information to identify the facility which made the reports for which the summary is submitted,

(ii) in the case of any product which was the subject of a report, the product name, serial number, and model number,

(iii) the name and the address of the manufacturer of such device, and

(iv) a brief description of the event reported to the manufacturer.

(D) For purposes of subparagraphs (A), (B), and (C), a device user facility shall be treated as having received or otherwise become aware of information with respect to a device of that facility when medical personnel who are employed by or otherwise formally affiliated with the facility receive or otherwise become aware of information with respect to that device in the course of their duties.

(2) The Secretary may not disclose the identity of a device user facility which makes a report under paragraph (1) except in connection with—

(A) an action brought to enforce section 331(q) of this title, or

(B) a communication to a manufacturer of a device which is the subject of a report under paragraph (1).

This paragraph does not prohibit the Secretary from disclosing the identity of a device user facility making a report under paragraph (1) or any information in such a report to employees of the Department of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress.

(3) No report made under paragraph (1) by—

(A) a device user facility,

(B) an individual who is employed by or otherwise formally affiliated with such a facility, or

(C) a physician who is not required to make such a report,

shall be admissible into evidence or otherwise used in any civil action involving private parties unless the facility, individual, or physician who made the report had knowledge of the falsity of the information contained in the report.

(4) A report made under paragraph (1) does not affect any obligation of a manufacturer who receives the report to file a report as required under subsection (a).

(5) With respect to device user facilities:

(A) The Secretary shall by regulation plan and implement a program under which the Secretary limits user reporting under paragraphs (1) through (4) to a subset of user facilities that constitutes a representative profile of user reports for device deaths and serious illnesses or serious injuries.

(B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to apply.

(C) During the period in which the Secretary is providing for a transition to the full implementation of the program, paragraphs (1) through (4) apply except to the extent that the Secretary determines otherwise.

(D) On and after the date on which the program is fully implemented, paragraphs (1) through (4) do not apply to a user facility unless the facility is included in the subset referred to in subparagraph (A).

(E) Not later than 2 years after November 21, 1997, the Secretary shall submit to the Committee on Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the plan developed by the Secretary under subparagraph (A) and the progress that has been made toward the implementation of the plan.

(6) For purposes of this subsection:

(A) The term "device user facility" means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a physician's office. The Secretary may by regulation include an outpatient diagnostic facility which is not a physician's office in such term.

(B) The terms "serious illness" and "serious injury" mean illness or injury, respectively, that—

(i) is life threatening,

(ii) results in permanent impairment of a body function or permanent damage to a body structure, or

(iii) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

(c) Persons exempt

Subsection (a) shall not apply to—

(1) any practitioner who is licensed by law to prescribe or administer devices intended for use in humans and who manufactures or imports devices solely for use in the course of his professional practice;

(2) any person who manufactures or imports devices intended for use in humans solely for such person's use in research or teaching and not for sale (including any person who uses a device under an exemption granted under section 360j(g) of this title); and

(3) any other class of persons as the Secretary may by regulation exempt from subsection (a) upon a finding that compliance with the requirements of such subsection by such class with respect to a device is not necessary to (A) assure that a device is not adulterated or misbranded or (B) otherwise to assure its safety and effectiveness.

(d) Repealed. Pub. L. 105–115, title II, §213(a)(2), Nov. 21, 1997, 111 Stat. 2347

(e) Device tracking

(1) The Secretary may by order require a manufacturer to adopt a method of tracking a class II or class III device—

(A) the failure of which would be reasonably likely to have serious adverse health consequences; or

(B) which is—

(i) intended to be implanted in the human body for more than one year, or

(ii) a life sustaining or life supporting device used outside a device user facility.

(2) Any patient receiving a device subject to tracking under paragraph (1) may refuse to release, or refuse permission to release, the patient's name, address, social security number, or other identifying information for the purpose of tracking.

(f) Unique device identification system

Not later than December 31, 2012, the Secretary shall issue proposed regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number. The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, or life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies.

(g) Reports of removals and corrections

(1) Except as provided in paragraph (2), the Secretary shall by regulation require a manufacturer or importer of a device to report promptly to the Secretary any correction or removal of a device undertaken by such manufacturer or importer if the removal or correction was undertaken—

(A) to reduce a risk to health posed by the device, or

(B) to remedy a violation of this chapter caused by the device which may present a risk to health.

A manufacturer or importer of a device who undertakes a correction or removal of a device which is not required to be reported under this paragraph shall keep a record of such correction or removal.

(2) No report of the corrective action or removal of a device may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a).

(3) For purposes of paragraphs (1) and (2), the terms "correction" and "removal" do not include routine servicing.

(h) Inclusion of devices in the postmarket risk identification and analysis system

(1) In general

(A) Application to devices

The Secretary shall amend the procedures established and maintained under clauses (i), (ii), (iii), and (v) of section 355(k)(3)(C) of this title in order to expand the postmarket risk identification and analysis system established under such section to include and apply to devices.

(B) Exception

Subclause (II) of clause (i) of section 355(k)(3)(C) of this title shall not apply to devices.

(C) Clarification

With respect to devices, the private sector health-related electronic data provided under section 355(k)(3)(C)(i)(III)(bb) of this title may include medical device utilization data, health insurance claims data, and procedure and device registries.

(2) Data

In expanding the system as described in paragraph (1)(A), the Secretary shall use relevant data with respect to devices cleared under section 360(k) of this title or approved under section 360e of this title, including claims data, patient survey data, and any other data deemed appropriate by the Secretary.

(3) Stakeholder input

To help ensure effective implementation of the system as described in paragraph (1) with respect to devices, the Secretary shall engage outside stakeholders in development of the system, and gather information from outside stakeholders regarding the content of an effective sentinel program, through a public hearing, advisory committee meeting, maintenance of a public docket, or other similar public measures.

(4) Voluntary surveys

Chapter 35 of title 44 shall not apply to the collection of voluntary information from health care providers, such as voluntary surveys or questionnaires, initiated by the Secretary for purposes of postmarket risk identification, mitigation, and analysis for devices.

(i) Postmarket pilot

(1) In general

In order to provide timely and reliable information on the safety and effectiveness of devices approved under section 360e of this title, cleared under section 360(k) of this title, or classified under section 360c(f)(2) of this title, including responses to adverse events and malfunctions, and to advance the objectives of part 803 of title 21, Code of Federal Regulations (or successor regulations), and advance the objectives of, and evaluate innovative new methods of compliance with, this section and section 360l of this title, the Secretary shall, within one year of August 18, 2017, initiate one or more pilot projects for voluntary participation by a manufacturer or manufacturers of a device or device type, or continue existing projects, in accordance with paragraph (3), that—

(A) are designed to efficiently generate reliable and timely safety and active surveillance data for use by the Secretary or manufacturers of the devices that are involved in the pilot project;

(B) inform the development of methods, systems, data criteria, and programs that could be used to support safety and active surveillance activities for devices included or not included in such project;

(C) may be designed and conducted in coordination with a comprehensive system for evaluating medical device technology that operates under a governing board with appropriate representation of stakeholders, including patient groups and device manufacturers;

(D) use electronic health data including claims data, patient survey data, or any other data, as the Secretary determines appropriate; and

(E) prioritize devices and device types that meet one or more of the following criteria:

(i) Devices and device types for which the collection and analysis of real world evidence regarding a device's safety and effectiveness is likely to advance public health.

(ii) Devices and device types that are widely used.

(iii) Devices and device types, the failure of which has significant health consequences.

(iv) Devices and device types for which the Secretary—

(I) has received public recommendations in accordance with paragraph (2)(B); and

(II) has determined to meet one or more of the criteria under clause (i), (ii), or (iii) and is appropriate for such a pilot project.

(2) Participation

The Secretary shall establish the conditions and processes—

(A) under which a manufacturer of a device may voluntarily participate in a pilot project described in paragraph (1); and

(B) for facilitating public recommendations for devices to be prioritized under such a pilot project, including requirements for the data necessary to support such a recommendation.

(3) Continuation of ongoing projects

The Secretary may continue or expand projects, with respect to providing timely and reliable information on the safety and effectiveness of devices approved under section 360e of this title, cleared under section 360(k) of this title, or classified under section 360c(f)(2) of this title, that are being carried out as of August 18, 2017. The Secretary shall, beginning on such date, take such steps as may be necessary—

(A) to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and

(B) to increase the voluntary participation in such projects of manufacturers of devices and facilitate public recommendations for any devices prioritized under such a project.

(4) Implementation

(A) Contracting authority

The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions:

(i) If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures.

(ii) In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following:

(I) The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) with respect to all data disclosed to the entity under such an agreement.

(II) The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data.

(iii) The entity or entities shall have one or more qualifications with respect to—

(I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection;

(II) an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate;

(III) experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or

(IV) such other expertise which the Secretary determines necessary to carry out such a project.

(B) Review of contract in the event of a merger or acquisition

The Secretary shall review any contract, cooperative agreement, grant, or other appropriate agreement entered into under this paragraph with an entity meeting the conditions specified in subparagraph (A) in the event of a merger or acquisition of the entity in order to ensure that the requirements specified in this subsection will continue to be met.

(5) Compliance with requirements for records or reports on devices

The participation of a manufacturer in pilot projects under this subsection or a project continued or expanded under paragraph (3) shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program with respect to devices carried out under this section 360i ³ or section 360l of this title. The Secretary may determine that, for a specified time period to be determined by the Secretary, a manufacturer's participation in a pilot project under this subsection or a project continued or expanded under paragraph (3) may meet the applicable requirements of this section or section 360l of this title, if—

(A) the project has demonstrated success in capturing relevant adverse event information; and

(B) the Secretary has established procedures for making adverse event and safety information collected from such project public, to the extent possible.

(6) Privacy requirements

With respect to the disclosure of any health information collected through a project conducted under this subsection—

(A) individually identifiable health information so collected shall not be disclosed when presenting any information from such project; and

(B) any such disclosure shall be made in compliance with regulations issued pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note) and sections 552 and 552a of title 5.

(7) Limitations

No pilot project under this subsection, or in coordination with the comprehensive system described in paragraph (1)(C), may allow for an entity participating in such project, other than the Secretary, to make determinations of safety or effectiveness, or substantial equivalence, for purposes of this chapter.

(8) Other projects required to comply

Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply with respect to any pilot project undertaken in coordination with the comprehensive system described in paragraph (1)(C) that relates to the use of real world evidence for devices in the same manner and to the same extent as such paragraphs apply with respect to pilot projects conducted under this subsection.

(9) Report to Congress

Not later than 18 months after August 18, 2017, and annually thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report containing a description of the pilot projects being conducted under this subsection and projects continued or expanded pursuant to paragraph (3), including for each such project—

(A) how the project is being implemented in accordance with paragraph (4), including how such project is being implemented through a contract, cooperative agreement, grant, or other appropriate agreement, if applicable;

(B) the number of manufacturers that have agreed to participate in such project;

(C) the data sources used to conduct such project;

(D) the devices or device categories involved in such project;

(E) the number of patients involved in such project; and

(F) the findings of the project in relation to device safety, including adverse events, malfunctions, and other safety information.

(10) Sunset

The Secretary may not carry out a pilot project initiated by the Secretary under this subsection after October 1, 2022.

(June 25, 1938, ch. 675, §519, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 564; amended Pub. L. 101–629, §§2(a), 3(a)(1), (b)(1), 7, Nov. 28, 1990, 104 Stat. 4511, 4513, 4514, 4520; Pub. L. 102–300, §5(a), June 16, 1992, 106 Stat. 239; Pub. L. 103–80, §3(u), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title II, §§211, 213(a), (c), Nov. 21, 1997, 111 Stat. 2345–2347; Pub. L. 110–85, title II, §§226(a), 227, Sept. 27, 2007, 121 Stat. 854; Pub. L. 112–144, title VI, §§614, 615, July 9, 2012, 126 Stat. 1061; Pub. L. 114–255, div. A, title III, §3101(a)(2)(L), Dec. 13, 2016, 130 Stat. 1154; Pub. L. 115–52, title VII, §708(a), Aug. 18, 2017, 131 Stat. 1062.)

Editorial Notes

References in Text

Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (i)(6)(B), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of Title 42, The Public Health and Welfare.

Amendments

2017—Subsec. (i). Pub. L. 115–52 added subsec. (i).

2016—Subsec. (f). Pub. L. 114–255 substituted "or life sustaining" for "and life sustaining".

2012—Subsec. (f). Pub. L. 112–144, §614, substituted "Not later than December 31, 2012, the Secretary shall issue proposed" for "The Secretary shall promulgate" and inserted at end "The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies."

Subsec. (h). Pub. L. 112–144, §615, added subsec. (h).

2007—Subsec. (a)(1)(B). Pub. L. 110–85, §227, substituted "were to recur, which report under this subparagraph—" for "were to recur;" and added cls. (i) to (iii).

Subsecs. (f), (g). Pub. L. 110–85, §226(a), added subsec. (f) and redesignated former subsec. (f) as (g).

1997—Subsec. (a). Pub. L. 105–115, §213(a)(1)(A), (F), in introductory provisions, substituted "manufacturer or importer" for "manufacturer, importer, or distributor" and, in closing provisions, inserted at end "The Secretary shall by regulation require distributors to keep records and make such records available to the Secretary upon request. Paragraphs (4) and (8) apply to distributors to the same extent and in the same manner as such paragraphs apply to manufacturers and importers."

Subsec. (a)(4). Pub. L. 105–115, §213(a)(1)(B), substituted "manufacturer or importer" for "manufacturer, importer, or distributor".

Subsec. (a)(7). Pub. L. 105–115, §213(a)(1)(C), inserted "and" after semicolon at end.

Subsec. (a)(8). Pub. L. 105–115, §213(a)(1)(D), substituted "manufacturer or importer" for "manufacturer, importer, or distributor" wherever appearing and substituted period for semicolon after "misbranded".

Subsec. (a)(9). Pub. L. 105–115, §213(a)(1)(E), struck out par. (9) which read as follows: "shall require distributors who submit such reports to submit copies of the reports to the manufacturer of the device for which the report was made."

Subsec. (b)(1)(C). Pub. L. 105–115, §213(c)(1)(A), in introductory provisions, substituted "on an annual basis" for "on a semi-annual basis" and struck out "and July 1" after "January 1" and struck out closing provisions which read as follows: "The Secretary may by regulation alter the frequency and timing of reports required by this subparagraph."

Subsec. (b)(2)(A). Pub. L. 105–115, §213(c)(1)(B)(i), inserted "or" after comma at end.

Subsec. (b)(2)(B). Pub. L. 105–115, §213(c)(1)(B)(ii), substituted period for ", or" at end.

Subsec. (b)(2)(C). Pub. L. 105–115, §213(c)(1)(B)(iii), struck out subpar. (C) which read as follows: "a disclosure required under subsection (a) of this section."

Subsec. (b)(5), (6). Pub. L. 105–115, §213(c)(2), added par. (5) and redesignated former par. (5) as (6).

Subsec. (d). Pub. L. 105–115, §213(a)(2), struck out heading and text of subsec. (d). Text read as follows: "Each manufacturer, importer, and distributor required to make reports under subsection (a) of this section shall submit to the Secretary annually a statement certifying that—

"(1) the manufacturer, importer, or distributor did file a certain number of such reports, or

"(2) the manufacturer, importer, or distributor did not file any report under subsection (a) of this section."

Subsec. (e). Pub. L. 105–115, §211, amended heading and text of subsec. (e) generally. Prior to amendment, text read as follows: "Every person who registers under section 360 of this title and is engaged in the manufacture of—

"(1) a device the failure of which would be reasonably likely to have serious adverse health consequences and which is (A) a permanently implantable device, or (B) a life sustaining or life supporting device used outside a device user facility, or

"(2) any other device which the Secretary may designate,

shall adopt a method of device tracking."

Subsec. (f)(1). Pub. L. 105–115, §213(a)(3), substituted "or importer" for ", importer, or distributor" wherever appearing.

1993—Subsec. (a). Pub. L. 103–80 substituted "paragraph (7)" for "paragraph (4)" in last sentence.

1992—Subsec. (a). Pub. L. 102–300, §5(a)(1), added pars. (1) to (3) and redesignated former pars. (1) to (6) as (4) to (9), respectively.

Subsec. (b)(1)(A). Pub. L. 102–300, §5(a)(2)(A), substituted "a device has or may have" for "there is a probability that a device has".

Subsec. (b)(1)(B). Pub. L. 102–300, §5(a)(2)(A), (B), substituted "a device has or may have" for "there is a probability that a device has", designated existing provisions as cl. (i), and added cl. (ii).

Subsec. (b)(5)(B)(iii). Pub. L. 102–300, §5(a)(2)(C), struck out "immediate" before "medical".

1990—Subsec. (a)(6). Pub. L. 101–629, §3(a)(1), added par. (6).

Subsecs. (b), (c). Pub. L. 101–629, §2(a), added subsec. (b) and redesignated former subsec. (b) as (c).

Subsecs. (d), (e). Pub. L. 101–629, §3(b)(1), added subsecs. (d) and (e).

Subsec. (f). Pub. L. 101–629, §7, added subsec. (f).

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Effective Date of 1997 Amendment

Pub. L. 105–115, title II, §211, Nov. 21, 1997, 111 Stat. 2345, provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997.

Amendment by section 213(a), (c) of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1992 Amendment

Pub. L. 102–300, §2(b), June 16, 1992, 106 Stat. 238, provided that: "The amendments made by subsection (a) [amending sections 3(b)(3) and 3(c) of Pub. L. 101–629, set out as notes below] shall take effect as of May 27, 1992 and any rule to implement section 519(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(e)] proposed under section 3(c)(2) of the Safe Medical Devices Act of 1990 [Pub. L. 101–629, set out as a note below] shall revert to its proposed status as of such date."

Pub. L. 102–300, §5(b), June 16, 1992, 106 Stat. 240, provided that: "The amendments made by subsection (a) [amending this section] shall take effect—

"(1) 1 year after the date of the enactment of this Act [June 16, 1992]; or

"(2) on the effective date of regulations of the Secretary to implement such amendments,

whichever occurs first."

Effective Date of 1990 Amendment

Pub. L. 101–629, §2(c), Nov. 28, 1990, 104 Stat. 4513, provided that: "Section 519(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as added by the amendment made by subsection (a), shall take effect—

"(1) upon the effective date of regulations promulgated under subsection (b) [set out below], or

"(2) upon the expiration of 12 months from the date of the enactment of this Act [Nov. 28, 1990],

whichever occurs first."

Pub. L. 101–629, §3(a)(2), Nov. 28, 1990, 104 Stat. 4514, provided that: "Section 519(a)(6) [21 U.S.C. 360i(a)(6)], as added by the amendment made by paragraph (1), shall take effect upon the effective date of final regulations under subsection (c) [set out below]."

Pub. L. 101–629, §3(b)(3), Nov. 28, 1990, 104 Stat. 4514, as amended by Pub. L. 102–300, §2(a)(1), June 16, 1992, 106 Stat. 238, provided that: "Section 519(e) [21 U.S.C. 360i(e)], as added by the amendment made by paragraph (1), shall take effect upon the expiration of 9 months after the issuance of final regulations under subsection (c) [set out below]."

[For effective date of amendment by Pub. L. 102–300, see section 2(b) of Pub. L. 102–300, set out above as an Effective Date of 1992 Amendment note.]

Regulations

Pub. L. 101–629, §2(b), Nov. 28, 1990, 104 Stat. 4512, provided that: "The Secretary of Health and Human Services shall promulgate regulations to implement section 519(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as added by the amendment made by subsection (a) (including a definition of the summary required by paragraph (1)(C) of such section) not later than 12 months after the date of enactment of this Act [Nov. 28, 1990]. In promulgating the regulations, the Secretary shall minimize the administrative burdens on device user facilities consistent with the need to assure adequate information."

Pub. L. 101–629, §3(c), Nov. 28, 1990, 104 Stat. 4514, as amended by Pub. L. 102–300, §2(a)(2), (3), June 16, 1992, 106 Stat. 238, provided that:

"(1)(A) Not later than 9 months after the date of the enactment of this Act [Nov. 28, 1990], the Secretary of Health and Human Services shall issue proposed regulations—

"(i) to require distributors of devices to establish and maintain records and to make reports (including reports required by part 803 of title 21 of the Code of Federal Regulations) under section 519(a)(6) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(a)(6)], and

"(ii) to implement section 519(e) of such Act.

The Secretary may exempt from regulations described in clause (i) classes of distributors of class I and class II devices from whom reports are not necessary for the protection of the public health.

"(B) Regulations under subparagraph (A) shall—

"(i) require appropriate methods for maintenance of records to ensure that patients who receive devices can be provided the notification required by such Act [this chapter],

"(ii) require that manufacturers adopt effective methods of tracking devices,

"(iii) take into account the position of distributors in the device distribution process, and

"(iv) include such other requirements as the Secretary deems necessary for the adoption of an effective user tracking program under section 519(e) of such Act.

"(2) Not later than 18 months after the date of the enactment of this Act, the Secretary shall issue final regulations to implement sections [sic] 519(a)(6) of the Federal Food, Drug, and Cosmetic Act. If the Secretary does not promulgate such final regulations upon the expiration of such 18 months, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to comment because the implementation of sections [sic] 519(a)(6) of such Act is essential to protect the health of patients who use such devices. Consequently, in such event, the proposed regulations issued under paragraph (1) shall become final regulations as of the expiration of such 18 months. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations.

"(3) Not later than November 28, 1992, the Secretary shall issue final regulations to implement section 519(e) of the Federal Food, Drug, and Cosmetic Act. If the Secretary does not promulgate such final regulations by November 28, 1992, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to comment because the implementation of section 519(e) of such Act is essential to protect the health of patients who use devices. In such event, the proposed regulations issued under paragraph (1) shall become the issued final regulations on November 29, 1992. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations."

[For effective date of amendment by Pub. L. 102–300, see section 2(b) of Pub. L. 102–300, set out above as an Effective Date of 1992 Amendment note.]

Information Concerning Reporting Requirements for Device User Facilities

Pub. L. 101–629, §2(d), Nov. 28, 1990, 104 Stat. 4513, directed Secretary of Health and Human Services, during the 18-month period beginning on Nov. 28, 1990, to inform device user facilities (as defined in 21 U.S.C. 360i(b)(5)(A)) and manufacturers and distributors of devices respecting the requirements of 21 U.S.C. 360i(b), and, to the extent practicable, provide persons subject to such requirements assistance in the form of publications regarding such requirements.

Study of Reporting Requirements; Compliance by Device User Facilities; Actions by Manufacturers; Cost Effectiveness; Recommendations

Pub. L. 101–629, §2(e), Nov. 28, 1990, 104 Stat. 4513, directed Comptroller General of the United States, not more than 36 months after Nov. 28, 1990, to conduct a study of compliance by device user facilities with the requirements of 21 U.S.C. 360i(b), actions taken by manufacturers of devices in response to reports made to them, cost effectiveness of such requirements and their implementation, and any recommendations for improvements to such requirements, with Comptroller General to complete the study and submit a report on the study not later than 45 months from Nov. 28, 1990, to appropriate committees of Congress.

Report to Congress on Reporting Requirements for Device User Facilities

Pub. L. 101–629, §2(f), Nov. 28, 1990, 104 Stat. 4513, directed Secretary of Health and Human Services, not later than 36 months after Nov. 28, 1990, to prepare and submit to appropriate committees of Congress a report containing an evaluation of the requirements of 21 U.S.C. 360i(b), consisting of an evaluation of the safety benefits of the requirements, the burdens placed on the Food and Drug Administration and on device user facilities by the requirements, and the cost-effectiveness of the requirements and recommendations for legislative reform.

¹ So in original. Probably should be followed by a semicolon.

² So in original. The word "and" probably should not appear.

³ So in original. The section number probably should not appear.

§360j. General provisions respecting control of devices intended for human use

(a) General rule

Any requirement authorized by or under section 351, 352, 360, or 360i of this title applicable to a device intended for human use shall apply to such device until the applicability of the requirement to the device has been changed by action taken under section 360c, 360d, or 360e of this title or under subsection (g) of this section, and any requirement established by or under section 351, 352, 360, or 360i of this title which is inconsistent with a requirement imposed on such device under section 360d or 360e of this title or under subsection (g) of this section shall not apply to such device.

(b) Custom devices

(1) In general

The requirements of sections 360d and 360e of this title shall not apply to a device that—

(A) is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing);

(B) in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 360d of this title or requirement under section 360e of this title;

(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;

(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;

(E)(i) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or

(ii) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated);

(F) is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause (i) or (ii) of subparagraph (E); and

(G) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices.

(2) Limitations

Paragraph (1) shall apply to a device only if—

(A) such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;

(B) production of such device under paragraph (1) is limited to no more than 5 units per year of a particular device type, provided that such replication otherwise complies with this section; and

(C) the manufacturer of such device notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device.

(3) Guidance

Not later than 2 years after July 9, 2012, the Secretary shall issue final guidance on replication of multiple devices described in paragraph (2)(B).

(c) Trade secrets

Any information reported to or otherwise obtained by the Secretary or his representative under section 360c, 360d, 360e, 360f, 360h, 360i, or 374 of this title or under subsection (f) or (g) of this section which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section shall be considered confidential and shall not be disclosed and may not be used by the Secretary as the basis for the reclassification of a device from class III to class II or class I or as the basis for the establishment or amendment of a performance standard under section 360d of this title for a device reclassified from class III to class II, except (1) in accordance with subsection (h), and (2) that such information may be disclosed to other officers or employees concerned with carrying out this chapter or when relevant in any proceeding under this chapter (other than section 360c or 360d of this title).

(d) Notices and findings

Each notice of proposed rulemaking under section 360c, 360d, 360e, 360f, 360h, or 360i of this title, or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—

(1) the manner in which interested persons may examine data and other information on which the notice or findings is based, and

(2) the period within which interested persons may present their comments on the notice or findings (including the need therefor) orally or in writing, which period shall be at least sixty days but may not exceed ninety days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefor.

(e) Restricted devices

(1) The Secretary may by regulation require that a device be restricted to sale, distribution, or use—

(A) only upon the written or oral authorization of a practitioner licensed by law to administer or use such device, or

(B) upon such other conditions as the Secretary may prescribe in such regulation,

if, because of its potentiality for harmful effect or the collateral measures necessary to its use, the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness. No condition prescribed under subparagraph (B) may restrict the use of a device to persons with specific training or experience in its use or to persons for use in certain facilities unless the Secretary determines that such a restriction is required for the safe and effective use of the device. No such condition may exclude a person from using a device solely because the person does not have the training or experience to make him eligible for certification by a certifying board recognized by the American Board of Medical Specialties or has not been certified by such a Board. A device subject to a regulation under this subsection is a restricted device.

(2) The label of a restricted device shall bear such appropriate statements of the restrictions required by a regulation under paragraph (1) as the Secretary may in such regulation prescribe.

(f) Good manufacturing practice requirements

(1)(A) The Secretary may, in accordance with subparagraph (B), prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device), packing, storage, and installation of a device conform to current good manufacturing practice, as prescribed in such regulations, to assure that the device will be safe and effective and otherwise in compliance with this chapter.

(B) Before the Secretary may promulgate any regulation under subparagraph (A) he shall—

(i) afford the advisory committee established under paragraph (3) an opportunity to submit recommendations to him with respect to the regulation proposed to be promulgated;

(ii) afford opportunity for an oral hearing; and

(iii) ensure that such regulation conforms, to the extent practicable, with internationally recognized standards defining quality systems, or parts of the standards, for medical devices.

The Secretary shall provide the advisory committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A).

(2)(A) Any person subject to any requirement prescribed by regulations under paragraph (1) may petition the Secretary for an exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as he shall prescribe and shall—

(i) in the case of a petition for an exemption from a requirement, set forth the basis for the petitioner's determination that compliance with the requirement is not required to assure that the device will be safe and effective and otherwise in compliance with this chapter,

(ii) in the case of a petition for a variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed to be used for, the manufacture, packing, storage, and installation of the device in lieu of the methods, facilities, and controls prescribed by the requirement, and

(iii) contain such other information as the Secretary shall prescribe.

(B) The Secretary may refer to the advisory committee established under paragraph (3) any petition submitted under subparagraph (A). The advisory committee shall report its recommendations to the Secretary with respect to a petition referred to it within sixty days of the date of the petition's referral. Within sixty days after—

(i) the date the petition was submitted to the Secretary under subparagraph (A), or

(ii) if the petition was referred to an advisory committee, the expiration of the sixty-day period beginning on the date the petition was referred to the advisory committee,

whichever occurs later, the Secretary shall by order either deny the petition or approve it.

(C) The Secretary may approve—

(i) a petition for an exemption for a device from a requirement if he determines that compliance with such requirement is not required to assure that the device will be safe and effective and otherwise in compliance with this chapter, and

(ii) a petition for a variance for a device from a requirement if he determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, storage, and installation of the device in lieu of the methods, controls, and facilities prescribed by the requirement are sufficient to assure that the device will be safe and effective and otherwise in compliance with this chapter.

An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of the device to be granted the variance under the petition as may be necessary to assure that the device will be safe and effective and otherwise in compliance with this chapter.

(D) After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order.

(3) The Secretary shall establish an advisory committee for the purpose of advising and making recommendations to him with respect to regulations proposed to be promulgated under paragraph (1)(A) and the approval or disapproval of petitions submitted under paragraph (2). The advisory committee shall be composed of nine members as follows:

(A) Three of the members shall be appointed from persons who are officers or employees of any State or local government or of the Federal Government.

(B) Two of the members shall be appointed from persons who are representative of interests of the device manufacturing industry; two of the members shall be appointed from persons who are representative of the interests of physicians and other health professionals; and two of the members shall be representative of the interests of the general public.

Members of the advisory committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent of the rate in effect for grade GS–18 of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The Secretary shall designate one of the members of the advisory committee to serve as its chairman. The Secretary shall furnish the advisory committee with clerical and other assistance. Section 1013 of title 5 shall not apply with respect to the duration of the advisory committee established under this paragraph.

(g) Exemption for devices for investigational use

(1) It is the purpose of this subsection to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

(2)(A) The Secretary shall, within the one hundred and twenty-day period beginning on May 28, 1976, by regulation prescribe procedures and conditions under which devices intended for human use may upon application be granted an exemption from the requirements of section 352, 360, 360d, 360e, 360f, 360i, or 379e of this title or subsection (e) or (f) of this section or from any combination of such requirements to permit the investigational use of such devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of such devices.

(B) The conditions prescribed pursuant to subparagraph (A) shall include the following:

(i) A requirement that an application be submitted to the Secretary before an exemption may be granted and that the application be submitted in such form and manner as the Secretary shall specify.

(ii) A requirement that the person applying for an exemption for a device assure the establishment and maintenance of such records, and the making of such reports to the Secretary of safety or effectiveness data obtained as a result of the investigational use of the device during the exemption, as the Secretary determines will enable him to assure compliance with such conditions, review the progress of the investigation, and evaluate the safety and effectiveness of the device.

(iii) Such other requirements as the Secretary may determine to be necessary for the protection of the public health and safety.

(C) Procedures and conditions prescribed pursuant to subparagraph (A) for an exemption may appropriately vary depending on (i) the scope and duration of clinical testing to be conducted under such exemption, (ii) the number of human subjects that are to be involved in such testing, (iii) the need to permit changes to be made in the device subject to the exemption during testing conducted in accordance with a clinical testing plan required under paragraph (3)(A), and (iv) whether the clinical testing of such device is for the purpose of developing data to obtain approval for the commercial distribution of such device.

(3) Procedures and conditions prescribed pursuant to paragraph (2)(A) shall require, as a condition to the exemption of any device to be the subject of testing involving human subjects, that the person applying for the exemption—

(A) submit a plan for any proposed clinical testing of the device and a report of prior investigations of the device (including, where appropriate, tests on animals) adequate to justify the proposed clinical testing—

(i) to the institutional review committee established in accordance with regulations of the Secretary to supervise clinical testing of devices in the facilities where the proposed clinical testing is to be conducted, or

(ii) to the Secretary, if—

(I) no such committee exists, or

(II) the Secretary finds that the process of review by such committee is inadequate (whether or not the plan for such testing has been approved by such committee),

for review for adequacy to justify the commencement of such testing; and, unless the plan and report are submitted to the Secretary, submit to the Secretary a summary of the plan and a report of prior investigations of the device (including, where appropriate, tests on animals);

(B) promptly notify the Secretary (under such circumstances and in such manner as the Secretary prescribes) of approval by an institutional review committee of any clinical testing plan submitted to it in accordance with subparagraph (A);

(C) in the case of a device to be distributed to investigators for testing, obtain signed agreements from each of such investigators that any testing of the device involving human subjects will be under such investigator's supervision and in accordance with subparagraph (D) and submit such agreements to the Secretary; and

(D) assure that informed consent will be obtained from each human subject (or his representative) of proposed clinical testing involving such device, except where, subject to such conditions as the Secretary may prescribe—

(i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or

(ii) the investigator conducting or supervising the proposed clinical testing of the device determines in writing that there exists a life threatening situation involving the human subject of such testing which necessitates the use of such device and it is not feasible to obtain informed consent from the subject and there is not sufficient time to obtain such consent from his representative.

The determination required by subparagraph (D)(ii) shall be concurred in by a licensed physician who is not involved in the testing of the human subject with respect to which such determination is made unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence.

(4)(A) An application, submitted in accordance with the procedures prescribed by regulations under paragraph (2), for an exemption for a device (other than an exemption from section 360f of this title) shall be deemed approved on the thirtieth day after the submission of the application to the Secretary unless on or before such day the Secretary by order disapproves the application and notifies the applicant of the disapproval of the application.

(B) The Secretary may disapprove an application only if he finds that the investigation with respect to which the application is submitted does not conform to procedures and conditions prescribed under regulations under paragraph (2). Such a notification shall contain the order of disapproval and a complete statement of the reasons for the Secretary's disapproval of the application and afford the applicant opportunity for an informal hearing on the disapproval order.

(C) Consistent with paragraph (1), the Secretary shall not disapprove an application under this subsection because the Secretary determines that—

(i) the investigation may not support a substantial equivalence or de novo classification determination or approval of the device;

(ii) the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or

(iii) an additional or different investigation may be necessary to support clearance or approval of the device.

(5) The Secretary may by order withdraw an exemption granted under this subsection for a device if the Secretary determines that the conditions applicable to the device under this subsection for such exemption are not met. Such an order may be issued only after opportunity for an informal hearing, except that such an order may be issued before the provision of an opportunity for an informal hearing if the Secretary determines that the continuation of testing under the exemption with respect to which the order is to be issued will result in an unreasonable risk to the public health.

(6)(A) Not later than 1 year after November 21, 1997, the Secretary shall by regulation establish, with respect to a device for which an exemption under this subsection is in effect, procedures and conditions that, without requiring an additional approval of an application for an exemption or the approval of a supplement to such an application, permit—

(i) developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or in basic principles of operation and that are made in response to information gathered during the course of an investigation; and

(ii) changes or modifications to clinical protocols that do not affect—

(I) the validity of data or information resulting from the completion of an approved protocol, or the relationship of likely patient risk to benefit relied upon to approve a protocol;

(II) the scientific soundness of an investigational plan submitted under paragraph (3)(A); or

(III) the rights, safety, or welfare of the human subjects involved in the investigation.

(B) Regulations under subparagraph (A) shall provide that a change or modification described in such subparagraph may be made if—

(i) the sponsor of the investigation determines, on the basis of credible information (as defined by the Secretary) that the applicable conditions under subparagraph (A) are met; and

(ii) the sponsor submits to the Secretary, not later than 5 days after making the change or modification, a notice of the change or modification.

(7)(A) In the case of a person intending to investigate the safety or effectiveness of a class III device or any implantable device, the Secretary shall ensure that the person has an opportunity, prior to submitting an application to the Secretary or to an institutional review committee, to submit to the Secretary, for review, an investigational plan (including a clinical protocol). If the applicant submits a written request for a meeting with the Secretary regarding such review, the Secretary shall, not later than 30 days after receiving the request, meet with the applicant for the purpose of reaching agreement regarding the investigational plan (including a clinical protocol). The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan (including a clinical protocol) for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance from the device.

(B) Any agreement regarding the parameters of an investigational plan (including a clinical protocol) that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Any such agreement shall not be changed, except—

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with subparagraph (C) by the director of the office in which the device involved is reviewed, that a substantial scientific issue essential to determining the safety or effectiveness of the device involved has been identified.

(C) A decision under subparagraph (B)(ii) by the director shall be in writing, and may be made only after the Secretary has provided to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the scientific issue involved.

(8)(A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a "clinical hold") if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing.

(B) For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is a determination that—

(i) the device involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the subjects involved; or

(ii) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish.

(C) Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold.

(9)(A)(i) ¹ The sponsor of a device for which submission of an application for an investigational device exemption is required shall submit to the Secretary in such application a diversity action plan for clinical studies of the device, in the form and manner specified in guidance issued by the Secretary.

(ii) The sponsor of a device for which submission of an application for an investigational device exemption is not required, except for a device being studied as described in section 812.2(c) of title 21, Code of Federal Regulations (or successor regulations), shall develop a diversity action plan for any clinical study with respect to the device. Such diversity action plan shall be submitted to the Secretary in any premarket notification under section 360(k) of this title, request for classification under section 360c(f)(2) of this title, or application for premarket approval under section 360e of this title for such device.

(B) A diversity action plan under clause (i) or (ii) of subparagraph (A) shall include—

(i) the sponsor's goals for enrollment in the clinical study;

(ii) the sponsor's rationale for such goals; and

(iii) an explanation of how the sponsor intends to meet such goals.

(C)(i) On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any requirement in subparagraph (A) or (B) if the Secretary determines that a waiver is necessary based on what is known or can be determined about the prevalence or incidence of the disease or condition for which the device is under investigation (including in terms of the patient population that may use the device), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency.

(ii) The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request.

(D) No diversity action plan shall be required for a submission described in section 360bbb of this title.

(h) Release of information respecting safety and effectiveness

(1) The Secretary shall promulgate regulations under which a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the Secretary and which was the basis for—

(A) an order under section 360e(d)(1)(A) of this title approving an application for premarket approval for the device or denying approval of such an application or an order under section 360e(e) of this title withdrawing approval of such an application for the device,

(B) an order under section 360e(f)(6)(A) of this title revoking an approved protocol for the device, an order under section 360e(f)(6)(B) of this title declaring a protocol for the device completed or not completed, or an order under section 360e(f)(7) of this title revoking the approval of the device, or

(C) an order approving an application under subsection (g) for an exemption for the device from section 360f of this title or an order disapproving, or withdrawing approval of, an application for an exemption under such subsection for the device,

shall be made available to the public upon issuance of the order. Summaries of information made available pursuant to this paragraph respecting a device shall include information respecting any adverse effects on health of the device.

(2) The Secretary shall promulgate regulations under which each advisory committee established under section 360e(g)(2)(B) of this title shall make available to the public a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the advisory committee and which was the basis for its recommendation to the Secretary made pursuant to section 360e(g)(2)(A) of this title. A summary of information upon which such a recommendation is based shall be made available pursuant to this paragraph only after the issuance of the order with respect to which the recommendation was made and each summary shall include information respecting any adverse effect on health of the device subject to such order.

(3) Except as provided in paragraph (4), any information respecting a device which is made available pursuant to paragraph (1) or (2) of this subsection (A) may not be used to establish the safety or effectiveness of another device for purposes of this chapter by any person other than the person who submitted the information so made available, and (B) shall be made available subject to subsection (c) of this section.

(4)(A) Subject to subparagraph (C), any information contained in an application for premarket approval filed with the Secretary pursuant to section 360e(c) of this title (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition and other trade secrets) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in—

(i) approving another device;

(ii) determining whether a product development protocol has been completed, under section 360e of this title for another device;

(iii) establishing a performance standard or special control under this chapter; or

(iv) classifying or reclassifying another device under section 360c of this title and subsection (l)(2).

(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency actions described in subparagraph (A).

(C) No information contained in an application for premarket approval filed with the Secretary pursuant to section 360e(c) of this title may be used to approve or clear any application submitted under section 360e or 360(k) of this title or to classify a product under section 360c(f)(2) of this title for a combination product containing as a constituent part an approved drug (as defined in section 353(g)(5)(B) of this title) unless—

(i) the application includes the certification or statement referenced in section 353(g)(5)(A) of this title;

(ii) the applicant provides notice as described in section 353(g)(5)(A) of this title; and

(iii) the Secretary's approval of such application is subject to the provisions in section 353(g)(5)(C) of this title.

(i) Proceedings of advisory panels and committees

Each panel under section 360c of this title and each advisory committee established under section 360d(b)(5)(B) or 360e(g) of this title or under subsection (f) of this section shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made pursuant to this subsection information which under subsection (c) of this section is to be considered confidential.

(j) Traceability

Except as provided in section 360i(e) of this title, no regulation under this chapter may impose on a type or class of device requirements for the traceability of such type or class of device unless such requirements are necessary to assure the protection of the public health.

(k) Research and development

The Secretary may enter into contracts for research, testing, and demonstrations respecting devices and may obtain devices for research, testing, and demonstration purposes without regard to section 3324(a) and (b) of title 31 and section 6101 of title 41.

(l) Transitional provisions for devices considered as new drugs

(1) Any device intended for human use—

(A) for which on May 28, 1976 (hereinafter in this subsection referred to as the "enactment date") an approval of an application submitted under section 355(b) of this title was in effect;

(B) for which such an application was filed on or before the enactment date and with respect to which application no order of approval or refusing to approve had been issued on such date under subsection (c) or (d) of such section;

(C) for which on the enactment date an exemption under subsection (i) of such section was in effect;

(D) which is within a type of device described in subparagraph (A), (B), or (C) and is substantially equivalent to another device within that type;

(E) which the Secretary in a notice published in the Federal Register before the enactment date has declared to be a new drug subject to section 355 of this title; or

(F) with respect to which on the enactment date an action is pending in a United States court under section 332, 333, or 334 of this title for an alleged violation of a provision of section 331 of this title which enforces a requirement of section 355 of this title or for an alleged violation of section 355(a) of this title,

is classified in class III unless the Secretary in response to a petition submitted under paragraph (2) has classified such device in class I or II.

(2) The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer or importer of a device classified under paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the device in class I or class II. Within thirty days of the filing of such a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision on the petition. Except as provided in paragraph (3)(D)(ii), within one hundred and eighty days after the filing of a petition under this paragraph, the Secretary shall, after consultation with the appropriate panel under section 360c of this title, by order either deny the petition or order the classification, in accordance with the criteria prescribed by section 360c(a)(1)(A) of this title or 360c(a)(1)(B) of this title, of the device in class I or class II.

(3)(A) In the case of a device which is described in paragraph (1)(A) and which is in class III—

(i) such device shall on the enactment date be considered a device with an approved application under section 360e of this title, and

(ii) the requirements applicable to such device before the enactment date under section 355 of this title shall continue to apply to such device until changed by the Secretary as authorized by this chapter.

(B) In the case of a device which is described in paragraph (1)(B) and which is in class III, an application for such device shall be considered as having been filed under section 360e of this title on the enactment date. The period in which the Secretary shall act on such application in accordance with section 360e(d)(1) of this title shall be one hundred and eighty days from the enactment date (or such greater period as the Secretary and the applicant may agree upon after the Secretary has made the finding required by section 360e(d)(1)(B)(i) of this title) less the number of days in the period beginning on the date an application for such device was filed under section 355 of this title and ending on the enactment date. After the expiration of such period such device is required, unless exempt under subsection (g), to have in effect an approved application under section 360e of this title.

(C) A device which is described in paragraph (1)(C) and which is in class III shall be considered a new drug until the expiration of the ninety-day period beginning on the date of the promulgation of regulations under subsection (g) of this section. After the expiration of such period such device is required, unless exempt under subsection (g), to have in effect an approved application under section 360e of this title.

(D)(i) Except as provided in clauses (ii) and (iii), a device which is described in subparagraph (D), (E), or (F) of paragraph (1) and which is in class III is required, unless exempt under subsection (g) of this section, to have on and after sixty days after the enactment date in effect an approved application under section 360e of this title.

(ii) If—

(I) a petition is filed under paragraph (2) for a device described in subparagraph (D), (E), or (F) of paragraph (1), or

(II) an application for premarket approval is filed under section 360e of this title for such a device,

within the sixty-day period beginning on the enactment date (or within such greater period as the Secretary, after making the finding required under section 360e(d)(1)(B) of this title, and the petitioner or applicant may agree upon), the Secretary shall act on such petition or application in accordance with paragraph (2) or section 360e of this title except that the period within which the Secretary must act on the petition or application shall be within the one hundred and twenty-day period beginning on the date the petition or application is filed. If such a petition or application is filed within such sixty-day (or greater) period, clause (i) of this subparagraph shall not apply to such device before the expiration of such one hundred and twenty-day period, or if such petition is denied or such application is denied approval, before the date of such denial, whichever occurs first.

(iii) In the case of a device which is described in subparagraph (E) of paragraph (1), which the Secretary in a notice published in the Federal Register after March 31, 1976, declared to be a new drug subject to section 355 of this title, and which is in class III—

(I) the device shall, after eighteen months after the enactment date, have in effect an approved application under section 360e of this title unless exempt under subsection (g) of this section, and

(II) the Secretary may, during the period beginning one hundred and eighty days after the enactment date and ending eighteen months after such date, restrict the use of the device to investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of such device, and to investigational use in accordance with the requirements applicable under regulations under subsection (g) of this section to investigational use of devices granted an exemption under such subsection.

If the requirements under subsection (g) of this section are made applicable to the investigational use of such a device, they shall be made applicable in such a manner that the device shall be made reasonably available to physicians meeting appropriate qualifications prescribed by the Secretary.

(4) Repealed. Pub. L. 105–115, title I, §125(b)(2)(E), Nov. 21, 1997, 111 Stat. 2325.

(5)(A) Before December 1, 1991, the Secretary shall by order require manufacturers of devices described in paragraph (1), which are subject to revision of classification under subparagraph (B), to submit to the Secretary a summary of and citation to any information known or otherwise available to the manufacturers respecting the devices, including adverse safety or effectiveness information which has not been submitted under section 360i of this title. The Secretary may require a manufacturer to submit the adverse safety or effectiveness data for which a summary and citation were submitted, if such data are available to the manufacturer.

(B) Except as provided in subparagraph (C), after the issuance of an order under subparagraph (A) but before December 1, 1992, the Secretary shall publish a regulation in the Federal Register for each device which is classified in class III under paragraph (1) revising the classification of the device so that the device is classified into class I or class II, unless the regulation requires the device to remain in class III. In determining whether to revise the classification of a device or to require a device to remain in class III, the Secretary shall apply the criteria set forth in section 360c(a) of this title. Before the publication of a regulation requiring a device to remain in class III or revising its classification, the Secretary shall publish a proposed regulation respecting the classification of a device under this subparagraph and provide an opportunity for the submission of comments on any such regulation. No regulation under this subparagraph requiring a device to remain in class III or revising its classification may take effect before the expiration of 90 days from the date of the publication in the Federal Register of the proposed regulation.

(C) The Secretary may by notice published in the Federal Register extend the period prescribed by subparagraph (B) for a device for an additional period not to exceed 1 year.

(m) Humanitarian device exemption

(1) To the extent consistent with the protection of the public health and safety and with ethical standards, it is the purpose of this subsection to encourage the discovery and use of devices intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect not more than 8,000 individuals in the United States.

(2) The Secretary may grant a request for an exemption from the effectiveness requirements of sections 360d and 360e of this title for a device for which the Secretary finds that—

(A) the device is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States,

(B) the device would not be available to a person with a disease or condition referred to in subparagraph (A) unless the Secretary grants such an exemption and there is no comparable device, other than under this exemption, available to treat or diagnose such disease or condition, and

(C) the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.

The request shall be in the form of an application submitted to the Secretary and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application). Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.

(3) Except as provided in paragraph (6), no person granted an exemption under paragraph (2) with respect to a device may sell the device for an amount that exceeds the costs of research and development, fabrication, and distribution of the device.

(4) Devices granted an exemption under paragraph (2) may only be used—

(A) in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the Secretary; and

(B) if, before the use of a device, an institutional review committee or an appropriate local committee approves the use in the treatment or diagnosis of a disease or condition referred to in paragraph (2)(A), unless a physician determines in an emergency situation that approval from an institutional review committee or an appropriate local committee can not be obtained in time to prevent serious harm or death to a patient.

In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee or an appropriate local committee, the physician shall, after the use of the device, notify the chairperson of the institutional review committee or an appropriate local committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.

(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met, or if the Secretary has reason to believe that the criteria for the exemption are no longer met. If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.

(6)(A) Except as provided in subparagraph (D), the prohibition in paragraph (3) shall not apply with respect to a person granted an exemption under paragraph (2) if each of the following conditions apply:

(i) The device with respect to which the exemption is granted—

(I) is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or

(II) is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe.

(ii) During any calendar year, the number of such devices distributed during that year under each exemption granted under this subsection does not exceed the annual distribution number for such device. In this paragraph, the term "annual distribution number" means the number of such devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the United States. The Secretary shall determine the annual distribution number when the Secretary grants such exemption.

(iii) Such person immediately notifies the Secretary if the number of such devices distributed during any calendar year exceeds the annual distribution number referred to in clause (ii).

(iv) The request for such exemption is submitted on or before October 1, 2027.

(B) The Secretary may inspect the records relating to the number of devices distributed during any calendar year of a person granted an exemption under paragraph (2) for which the prohibition in paragraph (3) does not apply.

(C) A person may petition the Secretary to modify the annual distribution number determined by the Secretary under subparagraph (A)(ii) with respect to a device if additional information arises, and the Secretary may modify such annual distribution number.

(D) If a person notifies the Secretary, or the Secretary determines through an inspection under subparagraph (B), that the number of devices distributed during any calendar year exceeds the annual distribution number, as required under subparagraph (A)(iii), and modified under subparagraph (C), if applicable, then the prohibition in paragraph (3) shall apply with respect to such person for such device for any sales of such device after such notification.

(E)(i) In this subsection, the term "pediatric patients" means patients who are 21 years of age or younger at the time of the diagnosis or treatment.

(ii) In this subsection, the term "pediatric subpopulation" means 1 of the following populations:

(I) Neonates.

(II) Infants.

(III) Children.

(IV) Adolescents.

(7) The Secretary shall refer any report of an adverse event regarding a device described in paragraph (6)(A)(i)(I) for which the prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to the Office of Pediatric Therapeutics, established under section 393a of this title. In considering the report, the Director of the Office of Pediatric Therapeutics, in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action under this chapter in response to the report.

(8) The Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee of all devices described in paragraph (6)(A)(i)(I) to ensure that the exemption under paragraph (2) remains appropriate for the pediatric populations for which it is granted.

(n) Regulation of contact lenses as devices

(1) All contact lenses shall be deemed to be devices under section 321(h) of this title.

(2) Paragraph (1) shall not be construed as bearing on or being relevant to the question of whether any product other than a contact lens is a device as defined by section 321(h) of this title or a drug as defined by section 321(g) of this title.

(o) Regulation of medical and certain decisions support software

(1) The term device,² as defined in section 321(h) of this title, shall not include a software function that is intended—

(A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow;

(B) for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

(C) to serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as—

(i) such records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals;

(ii) such records are part of health information technology that is certified under section 300jj–11(c)(5) of title 42; and

(iii) such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

(D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings; or

(E) unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, for the purpose of—

(i) displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);

(ii) supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and

(iii) enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.

(2) In the case of a product with multiple functions that contains—

(A) at least one software function that meets the criteria under paragraph (1) or that otherwise does not meet the definition of device under section 321(h) of this title; and

(B) at least one function that does not meet the criteria under paragraph (1) and that otherwise meets the definition of a device under section 321(h) of this title,

the Secretary shall not regulate the software function of such product described in subparagraph (A) as a device. Notwithstanding the preceding sentence, when assessing the safety and effectiveness of the device function or functions of such product described in subparagraph (B), the Secretary may assess the impact that the software function or functions described in subparagraph (A) have on such device function or functions.

(3)(A) Notwithstanding paragraph (1), a software function described in subparagraph (C), (D), or (E) of paragraph (1) shall not be excluded from the definition of device under section 321(h) of this title if—

(i) the Secretary makes a finding that use of such software function would be reasonably likely to have serious adverse health consequences; and

(ii) the software function has been identified in a final order issued by the Secretary under subparagraph (B).

(B) Subparagraph (A) shall apply only if the Secretary—

(i) publishes a notification and proposed order in the Federal Register;

(ii) includes in such notification the Secretary's finding, including the rationale and identification of the evidence on which such finding was based, as described in subparagraph (A)(i); and

(iii) provides for a period of not less than 30 calendar days for public comment before issuing a final order or withdrawing such proposed order.

(C) In making a finding under subparagraph (A)(i) with respect to a software function, the Secretary shall consider—

(i) the likelihood and severity of patient harm if the software function were to not perform as intended;

(ii) the extent to which the software function is intended to support the clinical judgment of a health care professional;

(iii) whether there is a reasonable opportunity for a health care professional to review the basis of the information or treatment recommendation provided by the software function; and

(iv) the intended user and user environment, such as whether a health care professional will use a software function of a type described in subparagraph (E) of paragraph (1).

(4) Nothing in this subsection shall be construed as limiting the authority of the Secretary to—

(A) exercise enforcement discretion as to any device subject to regulation under this chapter;

(B) regulate software used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans; or

(C) regulate software as a device under this chapter if such software meets the criteria under section 360c(a)(1)(C) of this title.

(p) Diagnostic imaging devices intended for use with contrast agents

(1) In general

The Secretary may, subject to the succeeding provisions of this subsection, approve an application (or a supplement to such an application) submitted under section 360e of this title with respect to an applicable medical imaging device, or, in the case of an applicable medical imaging device for which a notification is submitted under section 360(k) of this title, may make a substantial equivalence determination with respect to an applicable medical imaging device, or may grant a request submitted under section 360c(f)(2) of this title for an applicable medical imaging device, if such application, notification, or request involves the use of a contrast agent that is not—

(A) in a concentration, rate of administration, or route of administration that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in concentration, rate of administration, or route of administration exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device;

(B) in a region, organ, or system of the body that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in region, organ, or system of the body exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device;

(C) in a patient population that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines such differences in patient population exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; or

(D) in an imaging modality that is different from those described in the approved labeling of the contrast agent.

(2) Premarket review

The agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application, notification, or request described in paragraph (1). In conducting such review, such agency center may—

(A) consult with the agency center charged with the premarket review of drugs or biological products; and

(B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application submitted under section 355 of this title or section 262 of title 42, so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference and the application is submitted in accordance with this subsection.

(3) Applicable requirements

An application submitted under section 360e of this title, a notification submitted under section 360(k) of this title, or a request submitted under section 360c(f)(2) of this title, as described in paragraph (1), with respect to an applicable medical imaging device shall be subject to the requirements of such respective section. Such application, notification, or request shall only be subject to the requirements of this chapter applicable to devices.

(4) Definitions

For purposes of this subsection—

(A) the term "applicable medical imaging device" means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent); and

(B) the term "contrast agent" means a drug that is approved under section 355 of this title or licensed under section 262 of title 42, is intended for use in conjunction with an applicable medical imaging device, and—

(i) is a diagnostic radiopharmaceutical, as defined in section ³ 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.

(q) Regulation of over-the-counter hearing aids

(1) Definition

(A) In general

In this subsection, the term "over-the-counter hearing aid" means a device that—

(i) uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation);

(ii) is intended to be used by adults age 18 and older to compensate for perceived mild to moderate hearing impairment;

(iii) through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user's hearing needs;

(iv) may—

(I) use wireless technology; or

(II) include tests for self-assessment of hearing loss; and

(v) is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

(B) Exception

Such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching.

(2) Regulation

An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 709(b) of the FDA Reauthorization Act of 2017 and shall be exempt from sections 801.420 and 801.421 of title 21, Code of Federal Regulations (or any successor regulations).

(June 25, 1938, ch. 675, §520, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 565; amended Pub. L. 101–629, §§3(b)(2), 4(b)(2), 5(c)(2), 6(b)(2), 11, 14(a), 18(e), (f), Nov. 28, 1990, 104 Stat. 4514, 4516, 4518, 4519, 4522, 4524, 4529; Pub. L. 102–571, title I, §107(10), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105–115, title I, §125(b)(2)(E), title II, §§201(a), 203, 216(a)(1), title IV, §410(a), Nov. 21, 1997, 111 Stat. 2325, 2332, 2334, 2349, 2372; Pub. L. 109–96, §1, Nov. 9, 2005, 119 Stat. 2119; Pub. L. 110–85, title III, §303(a), title VIII, §801(b)(3)(E), Sept. 27, 2007, 121 Stat. 860, 921; Pub. L. 112–144, title V, §507(c), title VI, §§601, 606, 613(a), 617, July 9, 2012, 126 Stat. 1045, 1051, 1054, 1060, 1062; Pub. L. 114–255, div. A, title III, §§3024(a), 3038(b), 3052(a), 3056, 3060(a), Dec. 13, 2016, 130 Stat. 1099, 1110, 1124, 1128, 1130; Pub. L. 115–52, title V, §502(b), title VII, §§706(a), 709(a), Aug. 18, 2017, 131 Stat. 1037, 1058, 1065; Pub. L. 117–180, div. F, title V, §5002, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, §303, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–286, §4(a)(156), Dec. 27, 2022, 136 Stat. 4323; Pub. L. 117–328, div. FF, title III, §§3103, 3601(b), Dec. 29, 2022, 136 Stat. 5807, 5861.)

Delayed Applicability of Amendment

For provisions related to delayed applicability of subsection (g)(9) of this section as added by section 3601(b) of Pub. L. 117–328, see Effective Date of 2022 Amendment note set out under section 355 of this title.

Editorial Notes

References in Text

July 9, 2012, referred to in subsec. (b)(3), was in the original "the date of enactment of this section", which was translated as meaning the date of enactment of Pub. L. 112–144, which amended subsec. (b) generally, to reflect the probable intent of Congress.

Section 709(b) of the FDA Reauthorization Act of 2017, referred to in subsec. (q)(2), is section 709(b) of Pub. L. 115–52, which is set out as a note below.

Codification

In subsec. (k), "section 3324(a) and (b) of title 31 and section 6101 of title 41" substituted for "sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5)" on authority of Pub. L. 97–258, §4(b), Sept. 13, 1982, 96 Stat. 1067, which Act enacted Title 31, Money and Finance, and Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

2022—Subsec. (f)(3). Pub. L. 117–286 substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in concluding provisions.

Subsec. (g)(9). Pub. L. 117–328, §3601(b), added par. (9).

Subsec. (m)(6)(A)(iv). Pub. L. 117–328, §3103, substituted "October 1, 2027" for "December 24, 2022".

Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022".

Pub. L. 117–180 substituted "December 17" for "October 1".

2017—Subsec. (m)(4). Pub. L. 115–52, §502(b)(1)(B), inserted "or an appropriate local committee" after "review committee" in two places in concluding provisions.

Subsec. (m)(4)(B). Pub. L. 115–52, §502(b)(1)(A), inserted "or an appropriate local committee" after "review committee" in two places.

Subsec. (m)(6)(A)(iv). Pub. L. 115–52, §502(b)(2), substituted "2022" for "2017".

Subsec. (p). Pub. L. 115–52, §706(a), added subsec. (p).

Subsec. (q). Pub. L. 115–52, §709(a), added subsec. (q). Amendment was executed to this section as amended by section 706(a) of Pub. L. 115–52, notwithstanding directory language referring to section as amended by section 708 of Pub. L. 115–52, which did not amend this section.

2016—Subsec. (g)(3). Pub. L. 114–255, §3024(a)(2), substituted "subparagraph (D)(ii)" for "subparagraph (D)" in concluding provisions.

Subsec. (g)(3)(A)(i). Pub. L. 114–255, §3056(1)(A), struck out "local" before "institutional review committee" and "which has been" before "established in accordance with".

Subsec. (g)(3)(B). Pub. L. 114–255, §3056(1)(B), substituted "an institutional" for "a local institutional".

Subsec. (g)(3)(D). Pub. L. 114–255, §3024(a)(1), substituted "except where, subject to such conditions as the Secretary may prescribe—" for "except where subject to such conditions as the Secretary may prescribe,", added cl. (i), and inserted cl. (ii) designation before "the investigator".

Subsec. (h)(4)(A). Pub. L. 114–255, §3038(b)(1), substituted "Subject to subparagraph (C), any information" for "Any information" in introductory provisions.

Subsec. (h)(4)(C). Pub. L. 114–255, §3038(b)(2), added subpar. (C).

Subsec. (m)(1). Pub. L. 114–255, §3052(a)(1), substituted "not more than 8,000" for "fewer than 4,000".

Subsec. (m)(2)(A). Pub. L. 114–255, §3052(a)(2), substituted "not more than 8,000" for "fewer than 4,000".

Subsec. (m)(4). Pub. L. 114–255, §3056(2)(C), struck out "local" after "chairperson of the" in concluding provisions.

Subsec. (m)(4)(A). Pub. L. 114–255, §3056(2)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: "in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and".

Subsec. (m)(4)(B). Pub. L. 114–255, §3056(2)(B), substituted "an institutional" for "a local institutional".

Subsec. (m)(6)(A)(ii). Pub. L. 114–255, §3052(a)(3), substituted "8,000" for "4,000".

Subsec. (o). Pub. L. 114–255, §3060(a), added subsec. (o).

2012—Subsec. (b). Pub. L. 112–144, §617, amended subsec. (b) generally. Prior to amendment, subsec. (b) related to custom devices.

Subsec. (g)(2)(B)(ii). Pub. L. 112–144, §601(1), inserted "safety or effectiveness" before "data obtained".

Subsec. (g)(4)(C). Pub. L. 112–144, §601(2), added subpar. (C).

Subsec. (g)(8). Pub. L. 112–144, §606, added par. (8).

Subsec. (m)(6)(A)(i). Pub. L. 112–144, §613(a)(1)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows:

"(i)(I) The device with respect to which the exemption is granted is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs.

"(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to September 27, 2007."

Subsec. (m)(6)(A)(ii). Pub. L. 112–144, §613(a)(1)(A)(ii), added cl. (ii) and struck out former cl. (ii) which read as follows: "During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A)."

Subsec. (m)(6)(A)(iv). Pub. L. 112–144, §507(c), substituted "2017" for "2012".

Subsec. (m)(6)(C). Pub. L. 112–144, §613(a)(1)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: "A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A)."

Subsec. (m)(7). Pub. L. 112–144, §613(a)(2), substituted "regarding a device described in paragraph (6)(A)(i)(I)" for "regarding a device".

Subsec. (m)(8). Pub. L. 112–144, §613(a)(3), substituted "of all devices described in paragraph (6)(A)(i)(I)" for "of all devices described in paragraph (6)".

2007—Subsec. (m)(2). Pub. L. 110–85, §801(b)(3)(E), inserted before period at end of first sentence of concluding provisions "and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application)".

Subsec. (m)(3). Pub. L. 110–85, §303(a)(1), substituted "Except as provided in paragraph (6), no" for "No".

Subsec. (m)(5). Pub. L. 110–85, §303(a)(2), inserted ", if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met," after "public health" and inserted at end "If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing."

Subsec. (m)(6) to (8). Pub. L. 110–85, §303(a)(3), added pars. (6) to (8) and struck out former par. (6) which read as follows: "The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing."

2005—Subsec. (n). Pub. L. 109–96 added subsec. (n).

1997—Subsec. (f)(1)(B)(iii). Pub. L. 105–115, §410(a), added cl. (iii).

Subsec. (g)(6), (7). Pub. L. 105–115, §201(a), added pars. (6) and (7).

Subsec. (h)(4). Pub. L. 105–115, §216(a)(1), amended par. (4) generally. Prior to amendment, par. (4) related to premarket approval of devices.

Subsec. (l). Pub. L. 105–115, §125(b)(2)(E), struck out "or antibiotic drugs" after "new drugs" in heading.

Subsec. (l)(4). Pub. L. 105–115, §125(b)(2)(E), struck out par. (4) which read as follows: "Any device intended for human use which on the enactment date was subject to the requirements of section 357 of this title shall be subject to such requirements as follows:

"(A) In the case of such a device which is classified into class I, such requirements shall apply to such device until the effective date of the regulation classifying the device into such class.

"(B) In the case of such a device which is classified into class II, such requirements shall apply to such device until the effective date of a performance standard applicable to the device under section 360d of this title.

"(C) In the case of such a device which is classified into class III, such requirements shall apply to such device until the date on which the device is required to have in effect an approved application under section 360e of this title."

Subsec. (m)(2). Pub. L. 105–115, §203(1), inserted at end "The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application."

Subsec. (m)(4). Pub. L. 105–115, §203(2)(B), inserted at end "In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use."

Subsec. (m)(4)(B). Pub. L. 105–115, §203(2)(A), inserted before period at end ", unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient".

Subsec. (m)(5). Pub. L. 105–115, §203(3), amended par. (5) generally. Prior to amendment, par. (5) read as follows: "An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5-year period."

Subsec. (m)(6). Pub. L. 105–115, §203(4), amended par. (6) generally. Prior to amendment, par. (6) read as follows: "Within one year of November 28, 1990, the Secretary shall issue regulations to implement this subsection."

1992—Subsec. (g)(2)(A). Pub. L. 102–571 substituted "379e" for "376".

1990—Subsec. (c). Pub. L. 101–629, §11(1), substituted "from class III to class II or class I" for "under section 360c of this title from class III to class II" and inserted "(1) in accordance with subsection (h), and (2)" after "except".

Subsec. (f)(1)(A). Pub. L. 101–629, §18(e), inserted "pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device)," after "manufacture,".

Subsec. (h)(3). Pub. L. 101–629, §11(2)(A), substituted "Except as provided in paragraph (4), any" for "Any".

Subsec. (h)(4). Pub. L. 101–629, §11(2)(B), added par. (4).

Subsec. (i). Pub. L. 101–629, §6(b)(2), substituted "section 360d(b)(5)(B)" for "section 360d(g)(5)(B)".

Subsec. (j). Pub. L. 101–629, §3(b)(2), substituted "Except as provided in section 360i(e) of this title, no" for "No".

Subsec. (l)(2). Pub. L. 101–629, §18(f), struck out "and after affording the petitioner an opportunity for an informal hearing" after "under this paragraph".

Pub. L. 101–629, §5(c)(2), substituted "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer" for "The manufacturer".

Subsec. (l)(5). Pub. L. 101–629, §4(b)(2), added par. (5).

Subsec. (m). Pub. L. 101–629, §14(a), added subsec. (m).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Subsec. (g)(9) of this section, as added by section 3601(b) of Pub. L. 117–328, applicable only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under section 3602 of Pub. L. 117–328, see section 3602(c) of Pub. L. 117–328, set out as a note under section 355 of this title.

Effective Date of 1997 Amendment

Amendment by sections 201(a), 203, 216(a)(1), and 410(a) of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1990 Amendment

Pub. L. 101–629, §14(b), Nov. 28, 1990, 104 Stat. 4525, provided that: "Subsection (m) of section 520 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360j(m)], as added by the amendment made by subsection (a), shall take effect on the effective date of the regulations issued by the Secretary under paragraph (6) of such subsection."

Regulations and Guidance Concerning Over-the-Counter Hearing Aids

Pub. L. 115–52, title VII, §709(b), (c), Aug. 18, 2017, 131 Stat. 1066, 1067, provided that:

"(b) Regulations To Establish Category.—

"(1) In general.—The Secretary of Health and Human Services (referred to in this section [amending this section and enacting this note] as the 'Secretary'), not later than 3 years after the date of enactment of this Act [Aug. 18, 2017], shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.

"(2) Requirements.—In promulgating the regulations under paragraph (1), the Secretary shall—

"(A) include requirements that provide reasonable assurances of the safety and effectiveness of over-the-counter hearing aids;

"(B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids;

"(C) include requirements for appropriate labeling of over-the-counter hearing aids, including requirements that such labeling include a conspicuous statement that the device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed health care practitioner; and

"(D) describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

"(3) Premarket notification.—The Secretary shall make findings under section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(q)]), as amended by subsection (a)) require a report under section 510(k) [21 U.S.C. 360(k)] to provide reasonable assurance of safety and effectiveness.

"(4) Effect on state law.—No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(q)]), as amended by subsection (a)) through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.

"(5) No effect on private remedies.—Nothing in this section shall be construed to modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law.

"(c) New Guidance Issued.—Not later than the date on which final regulations are issued under subsection (b), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled 'Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products', issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet the definition of a personal sound amplification product, as set forth in such guidance."

Guidance Document on Probable Benefit

Pub. L. 114–255, div. A, title III, §3052(b), Dec. 13, 2016, 130 Stat. 1125, provided that: "Not later than 18 months after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that defines the criteria for establishing 'probable benefit' as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C))."

Reports

Pub. L. 114–255, div. A, title III, §3060(b), Dec. 13, 2016, 130 Stat. 1132, provided that: "The Secretary of Health and Human Services (referred to in this subsection as the 'Secretary'), after consultation with agencies and offices of the Department of Health and Human Services involved in health information technology, shall publish a report, not later than 2 years after the date of enactment of this Act [Dec. 13, 2016] and every 2 years thereafter, that—

"(1) includes input from outside experts, such as representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary;

"(2) examines information available to the Secretary on any risks and benefits to health associated with software functions described in section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(o)(1)]) (as amended by subsection (a)); and

"(3) summarizes findings regarding the impact of such software functions on patient safety, including best practices to promote safety, education, and competency related to such functions."

Applicability to Existing Devices

Pub. L. 112–144, title VI, §613(b), July 9, 2012, 126 Stat. 1061, provided that: "A sponsor of a device for which an exemption was approved under paragraph (2) of section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the date of enactment of this Act [July 9, 2012] may seek a determination under subclause (I) or (II) of section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary of Health and Human Services determines that such subclause (I) or (II) applies with respect to a device, clauses (ii), (iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section 520(m) shall apply to such device, and the Secretary shall determine the annual distribution number for purposes of clause (ii) of such subparagraph (A) when making the determination under this subsection."

Guidance

Pub. L. 110–85, title III, §303(c), Sept. 27, 2007, 121 Stat. 862, provided that: "Not later than 180 days after the date of the enactment of this Act [Sept. 27, 2007], the Commissioner of Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests for approval for devices for which a humanitarian device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted."

Pub. L. 107–250, title II, §213, Oct. 26, 2002, 116 Stat. 1614, provided that: "Not later than 270 days after the date of the enactment of this Act [Oct. 26, 2002], the Secretary of Health and Human Services shall issue guidance on the following:

"(1) The type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in pediatric populations.

"(2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness of such devices."

Report on Humanitarian Device Exemptions

Pub. L. 101–629, §14(c), Nov. 28, 1990, 104 Stat. 4525, directed Secretary of Health and Human Services, within 4 years after issuance of regulations under 21 U.S.C. 360j(m)(6), to report to Congress on types of devices exempted, an evaluation of effects of such section, and a recommendation on extension of the section.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

¹ See Delayed Applicability of Amendment note below.

² So in original. Probably should be "The term 'device',".

³ So in original. Probably should be "sections".

§360k. State and local requirements respecting devices

(a) General rule

Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

(b) Exempt requirements

Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—

(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or

(2) the requirement—

(A) is required by compelling local conditions, and

(B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.

(June 25, 1938, ch. 675, §521, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 574.)

§360l. Postmarket surveillance

(a) Postmarket surveillance

(1) In general

(A) Conduct

The Secretary may by order, at the time of approval or clearance of a device or at any time thereafter, require a manufacturer to conduct postmarket surveillance for any device of the manufacturer that is a class II or class III device—

(i) the failure of which would be reasonably likely to have serious adverse health consequences;

(ii) that is expected to have significant use in pediatric populations; or

(iii) that is intended to be—

(I) implanted in the human body for more than 1 year; or

(II) a life-sustaining or life-supporting device used outside a device user facility.

(B) Condition

The Secretary may order a postmarket surveillance under subparagraph (A) as a condition to approval or clearance of a device described in subparagraph (A)(ii).

(2) Rule of construction

The provisions of paragraph (1) shall have no effect on authorities otherwise provided under the ¹ chapter or regulations issued under this chapter.

(b) Surveillance approval

(1) In general

Each manufacturer required to conduct a surveillance of a device shall, within 30 days of receiving an order from the Secretary prescribing that the manufacturer is required under this section to conduct such surveillance, submit, for the approval of the Secretary, a plan for the required surveillance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person designated to conduct the surveillance has appropriate qualifications and experience to undertake such surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health. The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section. Except as provided in paragraph (2), the Secretary, in consultation with the manufacturer, may by order require a prospective surveillance period of up to 36 months. Except as provided in paragraph (2), any determination by the Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the manufacturer or, if no agreement can be reached, after the completion of a dispute resolution process as described in section 360bbb–1 of this title.

(2) Longer surveillance for pediatric devices

The Secretary may by order require a prospective surveillance period of more than 36 months with respect to a device that is expected to have significant use in pediatric populations if such period of more than 36 months is necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device.

(c) Dispute resolution

A manufacturer may request review under section 360bbb–1 of this title of any order or condition requiring postmarket surveillance under this section. During the pendency of such review, the device subject to such a postmarket surveillance order or condition shall not, because of noncompliance with such order or condition, be deemed in violation of section 331(q)(1)(C) of this title, adulterated under section 351(f)(1) of this title, misbranded under section 352(t)(3) of this title, or in violation of, as applicable, section 360(k) of this title or section 360e of this title, unless deemed necessary to protect the public health.

(June 25, 1938, ch. 675, §522, as added Pub. L. 101–629, §10, Nov. 28, 1990, 104 Stat. 4521; amended Pub. L. 102–300, §3(b), June 16, 1992, 106 Stat. 239; Pub. L. 105–115, title II, §212, Nov. 21, 1997, 111 Stat. 2346; Pub. L. 110–85, title III, §307, Sept. 27, 2007, 121 Stat. 865; Pub. L. 112–144, title VI, §616, July 9, 2012, 126 Stat. 1062.)

Editorial Notes

Amendments

2012—Subsec. (a)(1)(A). Pub. L. 112–144, §616(1), inserted ", at the time of approval or clearance of a device or at any time thereafter," after "by order" in introductory provisions.

Subsec. (b)(1). Pub. L. 112–144, §616(2), inserted "The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section." after "the public health."

2007—Pub. L. 110–85, §307(1), made technical amendment to section catchline.

Subsec. (a). Pub. L. 110–85, §307(2), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows: "The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be—

"(1) implanted in the human body for more than one year, or

"(2) a life sustaining or life supporting device used outside a device user facility."

Subsec. (b). Pub. L. 110–85, §307(3), designated existing provisions as par. (1), inserted par. heading, substituted "Except as provided in paragraph (2), the Secretary, in consultation" for "The Secretary, in consultation" and "Except as provided in paragraph (2), any determination" for "Any determination", and added par. (2).

Subsec. (c). Pub. L. 110–85, §307(3)(D), added subsec. (c).

1997—Pub. L. 105–115 amended section generally, substituting present provisions for former provisions which related to required surveillance, discretionary surveillance, and surveillance approval.

1992—Subsec. (b). Pub. L. 102–300 substituted "(a)(1)" for "(a)", inserted comma after "commerce", and inserted after first sentence "Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) of this section shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance."

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Pub. L. 105–115, title II, §212, Nov. 21, 1997, 111 Stat. 2346, provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997.

Study by Institute of Medicine of Postmarket Surveillance Regarding Pediatric Populations

Pub. L. 107–250, title II, §212, Oct. 26, 2002, 116 Stat. 1614, as amended by Pub. L. 108–214, §2(d)(3)(C), Apr. 1, 2004, 118 Stat. 577, provided that the Secretary of Health and Human Services would request the Institute of Medicine to study whether the system under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for the postmarket surveillance of medical devices provides adequate safeguards regarding the use of devices in pediatric populations, and provided that the Secretary, not later than four years after Oct. 26, 2002, would submit to Congress a report on the study and legislative and administrative recommendations.

¹ So in original. Probably should be "this".

§360m. Accredited persons

(a) In general

(1) Review and classification of devices

Not later than 1 year after November 21, 1997, the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports submitted under section 360(k) of this title and making recommendations to the Secretary regarding the initial classification of devices under section 360c(f)(1) of this title.

(2) Requirements regarding review

(A) In general

In making a recommendation to the Secretary under paragraph (1), an accredited person shall notify the Secretary in writing of the reasons for the recommendation.

(B) Time period for review

Not later than 30 days after the date on which the Secretary is notified under subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification.

(C) Special rule

The Secretary may change the initial classification under section 360c(f)(1) of this title that is recommended under paragraph (1) by an accredited person, and in such case shall provide to such person, and the person who submitted the report under section 360(k) of this title for the device, a statement explaining in detail the reasons for the change.

(3) Certain devices

(A) In general

An accredited person may not be used to perform a review of—

(i) a class III device;

(ii) a device classified under section 360c(f)(2) of this title or designated under section 360e–3(d) ¹ of this title;

(iii) a device that is intended to be permanently implantable, life sustaining, or life supporting, unless otherwise determined by the Secretary in accordance with subparagraph (B)(i)(II) and listed as eligible for review under subparagraph (B)(iii); or

(iv) a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).

(B) Designation for review

The Secretary shall—

(i) issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person, including—

(I) the risk of the device type, or subset of such device type; and

(II) whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting, and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset;

(ii) not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and

(iii) beginning on the date such guidance is finalized, designate and post on the internet website of the Food and Drug Administration, an updated list of class I and class II device types, or subsets of such device types, and the Secretary's determination with respect to whether each such device type, or subset of a device type, is eligible or not eligible for review by an accredited person under this section based on the factors described in clause (i).

(C) Interim rule

Until the date on which the updated list is designated and posted in accordance with subparagraph (B)(iii), the list in effect on August 18, 2017, shall be in effect.

(b) Accreditation

(1) Programs

The Secretary shall provide for such accreditation through programs administered by the Food and Drug Administration, other government agencies, or by other qualified nongovernment organizations.

(2) Accreditation

(A) In general

Not later than 180 days after November 21, 1997, the Secretary shall establish and publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in subsection (a). The Secretary shall respond to a request for accreditation within 60 days of the receipt of the request. The accreditation of such person shall specify the particular activities under subsection (a) for which such person is accredited.

(B) Withdrawal of accreditation

The Secretary may suspend or withdraw accreditation of any person accredited under this paragraph, after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the requirements of this section or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this section.

(C) Performance auditing

To ensure that persons accredited under this section will continue to meet the standards of accreditation, the Secretary shall—

(i) make onsite visits on a periodic basis to each accredited person to audit the performance of such person; and

(ii) take such additional measures as the Secretary determines to be appropriate.

(D) Periodic reaccreditation

(i) Period

Subject to suspension or withdrawal under subparagraph (B), any accreditation under this section shall be valid for a period of 3 years after its issuance.

(ii) Response to reaccreditation request

Upon the submission of a request by an accredited person for reaccreditation under this section, the Secretary shall approve or deny such request not later than 60 days after receipt of the request.

(iii) Criteria

Not later than 120 days after July 9, 2012, the Secretary shall establish and publish in the Federal Register criteria to reaccredit or deny reaccreditation to persons under this section. The reaccreditation of persons under this section shall specify the particular activities under subsection (a), and the devices, for which such persons are reaccredited.

(3) Qualifications

An accredited person shall, at a minimum, meet the following requirements:

(A) Such person may not be an employee of the Federal Government.

(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of devices and which has no organizational, material, or financial affiliation with such a manufacturer, supplier, or vendor.

(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation.

(D) Such person shall not engage in the design, manufacture, promotion, or sale of devices.

(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices.

(F) Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section—

(i) certify that reported information accurately reflects data reviewed;

(ii) limit work to that for which competence and capacity are available;

(iii) treat information received, records, reports, and recommendations as proprietary information;

(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and

(v) protect against the use, in carrying out subsection (a) with respect to a device, of any officer or employee of the person who has a financial conflict of interest regarding the device, and annually make available to the public disclosures of the extent to which the person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest.

(4) Selection of accredited persons

The Secretary shall provide each person who chooses to use an accredited person to receive a section 360(k) of this title report a panel of at least two or more accredited persons from which the regulated person may select one for a specific regulatory function.

(5) Compensation of accredited persons

Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services.

(c) Duration

The authority provided by this section terminates on October 1, 2027.

(June 25, 1938, ch. 675, §523, as added Pub. L. 105–115, title II, §210(a), Nov. 21, 1997, 111 Stat. 2342; amended Pub. L. 107–250, title II, §202, Oct. 26, 2002, 116 Stat. 1609; Pub. L. 110–85, title II, §221, Sept. 27, 2007, 121 Stat. 852; Pub. L. 111–31, div. A, title I, §103(f), June 22, 2009, 123 Stat. 1837; Pub. L. 112–144, title VI, §611, July 9, 2012, 126 Stat. 1059; Pub. L. 114–255, div. A, title III, §3102(4), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title II, §206, Aug. 18, 2017, 131 Stat. 1018; Pub. L. 117–180, div. F, title II, §2006, Sept. 30, 2022, 136 Stat. 2154; Pub. L. 117–229, div. C, title III, §309, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, §3109, Dec. 29, 2022, 136 Stat. 5808.)

Editorial Notes

References in Text

Section 360e–3 of this title, referred to in subsec. (a)(3)(A)(ii), was in the original a reference to section 515C of act June 25, 1938, which was renumbered section 515B by Pub. L. 115–52, title IX, §901(f)(2), Aug. 18, 2017, 131 Stat. 1077.

Amendments

2022—Subsec. (c). Pub. L. 117–328 substituted "on October 1, 2027" for "December 24, 2022".

Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022".

Pub. L. 117–180 substituted "December 17" for "October 1".

2017—Subsec. (a)(3)(A)(ii) to (iv). Pub. L. 115–52, §206(1)(A), added cls. (ii) to (iv) and struck out former cls. (ii) and (iii) which read as follows:

"(ii) a class II device which is intended to be permanently implantable or life sustaining or life supporting; or

"(iii) a class II device which requires clinical data in the report submitted under section 360(k) of this title for the device, except that the number of class II devices to which the Secretary applies this clause for a year, less the number of such reports to which clauses (i) and (ii) apply, may not exceed 6 percent of the number that is equal to the total number of reports submitted to the Secretary under such section for such year less the number of such reports to which such clauses apply for such year."

Subsec. (a)(3)(B). Pub. L. 115–52, §206(1)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: "In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall not include in the numerator class III devices that the Secretary reclassified into class II, and the Secretary shall include in the denominator class II devices for which reports under section 360(k) of this title were not required to be submitted by reason of the operation of section 360(m) of this title."

Subsec. (a)(3)(C). Pub. L. 115–52, §206(1)(C), added subpar. (C).

Subsec. (b)(2)(D), (E). Pub. L. 115–52, §206(2)(A), redesignated subpar. (E) as (D) and struck out former subpar. (D). Prior to amendment, text of subpar. (D) read as follows: "The Secretary shall include in the annual report required under section 393(g) of this title the names of all accredited persons and the particular activities under subsection (a) for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year."

Subsec. (b)(3)(E). Pub. L. 115–52, §206(2)(B)(iii), added subpar. (E). Former subpar. (E) redesignated (F).

Subsec. (b)(3)(F). Pub. L. 115–52, §206(2)(B)(i), (ii), redesignated subpar. (E) as (F) and substituted "Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section" for "The operations of such person shall be in accordance with generally accepted professional and ethical business practices and shall agree in writing that as a minimum it will" in introductory provisions.

Subsec. (c). Pub. L. 115–52, §206(3), substituted "2022' for "2017".

2016—Subsec. (d). Pub. L. 114–255 struck out subsec. (d) which related to report to Congress.

2012—Subsec. (b)(2)(E). Pub. L. 112–144, §611(a), added subpar. (E).

Subsec. (c). Pub. L. 112–144, §611(b), substituted "October 1, 2017" for "October 1, 2012".

2009—Subsec. (b)(2)(D). Pub. L. 111–31 made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title.

2007—Subsec. (c). Pub. L. 110–85 substituted "2012" for "2007".

2002—Subsec. (c). Pub. L. 107–250, §202(1), substituted "The authority provided by this section terminates October 1, 2007." for "The authority provided by this section terminates—

"(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) of this section are available to review at least 60 percent of the submissions under section 360(k) of this title, or

"(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a determination described in paragraph (2)(B) of subsection (a) of this section for at least 35 percent of the devices that are subject to review under paragraph (1) of such subsection,

whichever occurs first."

Subsec. (d). Pub. L. 107–250, §202(2), added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Reports on Program of Accreditation

Pub. L. 105–115, title II, §210(d), Nov. 21, 1997, 111 Stat. 2345, provided that:

"(1) Comptroller general.—

"(A) Implementation of program.—Not later than 5 years after the date of the enactment of this Act [Nov. 21, 1997], the Comptroller General of the United States shall submit to the Committee on Commerce [now Committee on Energy and Commerce] of the House of Representatives and the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate a report describing the extent to which the program of accreditation required by the amendment made by subsection (a) [enacting this section] has been implemented.

"(B) Evaluation of program.—Not later than 6 months prior to the date on which, pursuant to subsection (c) of section 523 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360m(c)] (as added by subsection (a)), the authority provided under subsection (a) of such section will terminate, the Comptroller General shall submit to the Committee on Commerce [now Committee on Energy and Commerce] of the House of Representatives and the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate a report describing the use of accredited persons under such section 523, including an evaluation of the extent to which such use assisted the Secretary in carrying out the duties of the Secretary under such Act [21 U.S.C. 301 et seq.] with respect to devices, and the extent to which such use promoted actions which are contrary to the purposes of such Act.

"(2) Inclusion of certain devices within program.—Not later than 3 years after the date of the enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate a report providing a determination by the Secretary of whether, in the program of accreditation established pursuant to the amendment made by subsection (a), the limitation established in clause (iii) of section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360m(a)(3)(A)] (relating to class II devices for which clinical data are required in reports under section 510(k) [21 U.S.C. 360(k)]) should be removed."

¹ See References in Text note below.

§360n. Priority review to encourage treatments for tropical diseases

(a) Definitions

In this section:

(1) Priority review

The term "priority review", with respect to a human drug application as defined in section 379g(1) of this title, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.

(2) Priority review voucher

The term "priority review voucher" means a voucher issued by the Secretary to the sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 262 of title 42 after the date of approval of the tropical disease product application.

(3) Tropical disease

The term "tropical disease" means any of the following:

(A) Tuberculosis.

(B) Malaria.

(C) Blinding trachoma.

(D) Buruli Ulcer.

(E) Cholera.

(F) Dengue/dengue haemorrhagic fever.

(G) Dracunculiasis (guinea-worm disease).

(H) Fascioliasis.

(I) Human African trypanosomiasis.

(J) Leishmaniasis.

(K) Leprosy.

(L) Lymphatic filariasis.

(M) Onchocerciasis.

(N) Schistosomiasis.

(O) Soil transmitted helmithiasis.

(P) Yaws.

(Q) Filovirus Diseases.

(R) Zika Virus Disease.

(S) Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by order of the Secretary.

(4) Tropical disease product application

The term "tropical disease product application" means an application that—

(A) is a human drug application as defined in section 379g(1) of this title—

(i) for prevention or treatment of a tropical disease;

(ii) the Secretary deems eligible for priority review;

(iii) that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and

(iv) that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.¹

(B) is approved after September 27, 2007, by the Secretary for use in the prevention, detection, or treatment of a tropical disease; and

(C) is for—

(i) a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 355(b)(1) of this title; or

(ii) a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42.

(b) Priority review voucher

(1) In general

The Secretary shall award a priority review voucher to the sponsor of a tropical disease product application upon approval by the Secretary of such tropical disease product application.

(2) Transferability

The sponsor of a tropical disease product that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 355(b)(1) of this title or section 262 of title 42 will be submitted after the date of the approval of the tropical disease product application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.

(3) Limitation

(A) No award for prior approved application

A sponsor of a tropical disease product may not receive a priority review voucher under this section if the tropical disease product application was submitted to the Secretary prior to September 27, 2007.

(B) One-year waiting period

The Secretary shall issue a priority review voucher to the sponsor of a tropical disease product no earlier than the date that is 1 year after September 27, 2007.

(4) Notification

The sponsor of a human drug application shall notify the Secretary not later than 90 days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section.

(c) Priority review user fee

(1) In general

The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under subchapter VII.

(2) Fee amount

The amount of the priority review user fee shall be determined each fiscal year by the Secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year.

(3) Annual fee setting

The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2007, for that fiscal year, the amount of the priority review user fee.

(4) Payment

(A) In general

The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 355(b)(1) of this title or section 262 of title 42 for which the priority review voucher is used.

(B) Complete application

An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary's procedures for paying such fees.

(C) No waivers, exemptions, reductions, or refunds

The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section.

(5) Offsetting collections

Fees collected pursuant to this subsection for any fiscal year—

(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and

(B) shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.

(June 25, 1938, ch. 675, §524, as added Pub. L. 110–85, title XI, §1102, Sept. 27, 2007, 121 Stat. 972; amended Pub. L. 113–233, §2, Dec. 16, 2014, 128 Stat. 2127; Pub. L. 114–146, §2, Apr. 19, 2016, 130 Stat. 357; Pub. L. 114–255, div. A, title III, §3101(a)(2)(M), Dec. 13, 2016, 130 Stat. 1154; Pub. L. 115–52, title VI, §611(a), Aug. 18, 2017, 131 Stat. 1054; Pub. L. 117–9, §1(a)(3), Apr. 23, 2021, 135 Stat. 257.)

Editorial Notes

References in Text

Section 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. (a)(1), is section 101(c) of Pub. L. 110–85, which is set out as a note under section 379g of this title.

Amendments

2021—Subsec. (a)(4)(C). Pub. L. 117–9 amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: "is for a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under section 355(b)(1) of this title or section 262 of title 42."

2017—Subsec. (a)(4)(A)(iii), (iv). Pub. L. 115–52 added cls. (iii) and (iv).

2016—Subsec. (a)(3)(Q). Pub. L. 114–146, §2(2), substituted "Filovirus Diseases" for "Filoviruses".

Subsec. (a)(3)(R), (S). Pub. L. 114–146, §2(1), (3), added subpar. (R) and redesignated former subpar. (R) as (S).

Subsec. (c)(4)(A). Pub. L. 114–255 made technical amendment to reference in original act which appears in text as reference to section 262 of title 42.

2014—Subsec. (a)(3)(Q), (R). Pub. L. 113–233, §2(1), added subpar. (Q), redesignated former subpar. (Q) as (R), and in subpar. (R) substituted "order of" for "regulation by".

Subsec. (b)(2). Pub. L. 113–233, §2(2)(A), inserted at end "There is no limit on the number of times a priority review voucher may be transferred before such voucher is used."

Subsec. (b)(4). Pub. L. 113–233, §2(2)(B), substituted "90 days" for "365 days".

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Pub. L. 115–52, title VI, §611(b), Aug. 18, 2017, 131 Stat. 1054, provided that: "The amendments made by subsection (a) [amending this section] shall apply to human drug applications submitted after September 30, 2017."

¹ So in original. The period probably should be a semicolon.

§360n–1. Priority review for qualified infectious disease products

(a) In general

If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under section 355(b) of this title, or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness.

(b) Construction

Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 355(b) of this title that otherwise meets the criteria for the Secretary to grant priority review.

(June 25, 1938, ch. 675, §524A, as added Pub. L. 112–144, title VIII, §802(a), July 9, 2012, 126 Stat. 1079; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(N), Dec. 13, 2016, 130 Stat. 1154; Pub. L. 117–328, div. FF, title III, §3212(b), Dec. 29, 2022, 136 Stat. 5826.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328 inserted ", or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness" before period at end.

2016—Pub. L. 114–255 designated existing provisions as subsec. (a), inserted heading, substituted "the first application" for "any application", and added subsec. (b).

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 112–144, title VIII, §802(b), July 9, 2012, 126 Stat. 1079, provided that: "Section 524A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360n–1], as added by subsection (a), applies only with respect to an application that is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) on or after the date of the enactment of this Act [July 9, 2012]."

§360n–2. Ensuring cybersecurity of devices

(a) In general

A person who submits an application or submission under section 360(k), 360c, 360e(c), 360e(f), or 360j(m) of this title for a device that meets the definition of a cyber device under this section shall include such information as the Secretary may require to ensure that such cyber device meets the cybersecurity requirements under subsection (b).

(b) Cybersecurity requirements

The sponsor of an application or submission described in subsection (a) shall—

(1) submit to the Secretary a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures;

(2) design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure, and make available postmarket updates and patches to the device and related systems to address—

(A) on a reasonably justified regular cycle, known unacceptable vulnerabilities; and

(B) as soon as possible out of cycle, critical vulnerabilities that could cause uncontrolled risks;

(3) provide to the Secretary a software bill of materials, including commercial, open-source, and off-the-shelf software components; and

(4) comply with such other requirements as the Secretary may require through regulation to demonstrate reasonable assurance that the device and related systems are cybersecure.

(c) Definition

In this section, the term "cyber device" means a device that—

(1) includes software validated, installed, or authorized by the sponsor as a device or in a device;

(2) has the ability to connect to the internet; and

(3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats.

(d) Exemption

The Secretary may identify devices, or categories or types of devices, that are exempt from meeting the cybersecurity requirements established by this section and regulations promulgated pursuant to this section. The Secretary shall publish in the Federal Register, and update, as appropriate, a list of the devices, or categories or types of devices, so identified by the Secretary.

(June 25, 1938, ch. 675, §524B, as added Pub. L. 117–328, div. FF, title III, §3305(a), Dec. 29, 2022, 136 Stat. 5832.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Dec. 29, 2022, see section 3305(d) of Pub. L. 117–328, set out as an Effective Date of 2022 Amendment note under section 331 of this title.

Construction

Nothing in section 3305(a) of Pub. L. 117–328, which enacted this section, to be construed to affect the Secretary's of Health and Human Services authority related to ensuring that there is a reasonable assurance of the safety and effectiveness of devices, which may include ensuring that there is a reasonable assurance of the cybersecurity of certain cyber devices, including for devices approved or cleared prior to Dec. 29, 2022, see section 3305(c) of Pub. L. 117–328, set out as a Construction of 2022 Amendment note under section 331 of this title.

Guidance for Industry and FDA Staff on Device Cybersecurity

Pub. L. 117–328, div. FF, title III, §3305(e), Dec. 29, 2022, 136 Stat. 5833, provided that: "Not later than 2 years after the date of enactment of this Act [Dec. 29, 2022], and periodically thereafter as appropriate, the Secretary [of Health and Human Services], in consultation with the Director of the Cybersecurity and Infrastructure Security Agency, shall review and, as appropriate and after soliciting and receiving feedback from device manufacturers, health care providers, third-party-device servicers, patient advocates, and other appropriate stakeholders, update the guidance entitled 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices' (or a successor document)."

[For definition of "device" as used in section 3305(e) of Pub. L. 117–328, set out above, see section 321(h) of this title, as made applicable by section 3305(h) of Pub. L. 117–328, which is set out below.]

Resources Regarding Cybersecurity of Devices

Pub. L. 117–328, div. FF, title III, §3305(f), Dec. 29, 2022, 136 Stat. 5834, provided that: "Not later than 180 days after the date of enactment of this Act [Dec. 29, 2022], and not less than annually thereafter, the Secretary [of Health and Human Services] shall update public information provided by the Food and Drug Administration, including on the website of the Food and Drug Administration, with information regarding improving cybersecurity of devices. Such information shall include information on identifying and addressing cyber vulnerabilities for health care providers, health systems, and device manufacturers, and how such entities may access support through the Cybersecurity and Infrastructure Security Agency and other Federal entities, including the Department of Health and Human Services, to improve the cybersecurity of devices."

[For definition of "device" as used in section 3305(f) of Pub. L. 117–328, set out above, see section 321(h) of this title, as made applicable by section 3305(h) of Pub. L. 117–328, which is set out below.]

Definition

Pub. L. 117–328, div. FF, title III, §3305(h), Dec. 29, 2022, 136 Stat. 5834, provided that: "In this section [enacting this section, amending section 331 of this title, and enacting provisions set out as notes under this section and section 331 of this title], the term 'device' has the meaning given such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))."

Part B—Drugs for Rare Diseases or Conditions

§360aa. Recommendations for investigations of drugs for rare diseases or conditions

(a) Request by sponsor; response by Secretary

The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before—

(1) it may be approved for such disease or condition under section 355 of this title, or

(2) if the drug is a biological product, it may be licensed for such disease or condition under section 262 of title 42.

If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under section 355 of this title or licensing of such drug for such disease or condition under section 262 of title 42.

(b) Regulations

The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

(June 25, 1938, ch. 675, §525, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2049; amended Pub. L. 99–91, §3(a)(1), Aug. 15, 1985, 99 Stat. 387; Pub. L. 105–115, title I, §125(b)(2)(F), (G), Nov. 21, 1997, 111 Stat. 2325, 2326.)

Editorial Notes

Amendments

1997—Subsec. (a). Pub. L. 105–115, §125(b)(2)(G), struck out ", certification of such drug for such disease or condition under section 357 of this title," before "or licensing of such drug" in closing provisions.

Subsec. (a)(1) to (3). Pub. L. 105–115, §125(b)(2)(F), inserted "or" at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2), which read as follows: "if the drug is an antibiotic, it may be certified for such disease or condition under section 357 of this title, or".

1985—Subsec. (a). Pub. L. 99–91 struck out "or" at end of par. (1), inserted par. (2), redesignated former par. (2) as (3) and struck out "before" after "product,", and in last sentence inserted provisions relating to certification of such drug for disease or condition under section 357 of this title and substituted "licensing of such drug for such disease or condition under section 262 of title 42" for "licensing under section 262 of title 42 for such disease or condition".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Pub. L. 99–91, §8, Aug. 15, 1985, 99 Stat. 392, provided that:

"(a) General Rule.—Except as provided in subsection (b), this Act and the amendments made by this Act [amending this section, sections 360bb, 360cc, and 360ee of this title, and sections 295g–1 and 6022 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under section 301 of this title and section 236 of Title 42] shall take effect October 1, 1985.

"(b) Exception.—The amendments made by sections 2, 3, and 6(a) [amending this section and sections 360bb and 360cc of this title] shall take effect on the date of the enactment of this Act [Aug. 15, 1985]. The amendment made by section 6(b) [amending section 6022 of Title 42] shall take effect October 19, 1984. The amendments made by section 7 [amending section 295g–1 of Title 42] shall take effect October 1, 1984 and shall cease to be in effect after September 30, 1985."

Rare Disease Endpoint Advancement Pilot Program

Pub. L. 117–328, div. FF, title III, §3208, Dec. 29, 2022, 136 Stat. 5821, provided that:

"(a) In General.—The Secretary [of Health and Human Services] shall establish a pilot program under which the Secretary establishes procedures to provide increased interaction with sponsors of rare disease drug development programs for purposes of advancing the development of efficacy endpoints, including surrogate and intermediate endpoints, for drugs intended to treat rare diseases, including through—

"(1) determining eligibility of participants for such program; and

"(2) developing and implementing a process for applying to, and participating in, such a program.

"(b) Public Workshops.—The Secretary shall conduct up to 3 public workshops, which shall be completed not later than September 30, 2026, to discuss topics relevant to the development of endpoints for rare diseases, which may include discussions about—

"(1) novel endpoints developed through the pilot program established under this section; and

"(2) as appropriate, the use of real world evidence and real world data to support the validation of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.

"(c) Reports.—

"(1) Interim report.—Not later than September 30, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the completed and ongoing activities in the pilot program established under this section and public workshops described in subsection (b).

"(2) Final report.—Not later than September 30, 2027, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the outcomes of the pilot program established under this section.

"(d) Guidance.—Not later than September 30, 2027, the Secretary shall issue guidance describing best practices and strategies for development of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.

"(e) Sunset.—The Secretary may not accept any new application or request to participate in the program established by this section on or after October 1, 2027."

ALS and Other Rare Neurodegenerative Disease Action Plan

Pub. L. 117–79, §4, Dec. 23, 2021, 135 Stat. 1536, provided that:

"(a) In General.—Not later than 6 months after the date of enactment of this Act [Dec. 23, 2021], the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration an action plan describing actions the Food and Drug Administration intends to take during the 5-year period following publication of the plan with respect to program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives to—

"(1) foster the development of safe and effective drugs that improve or extend, or both, the lives of people living with amyotrophic lateral sclerosis and other rare neurodegenerative diseases; and

"(2) facilitate access to investigational drugs for amyotrophic lateral sclerosis and other rare neurodegenerative diseases.

"(b) Contents.—The initial action plan published under subsection (a) shall—

"(1) identify appropriate representation from within the Food and Drug Administration to be responsible for implementation of such action plan;

"(2) include elements to facilitate—

"(A) interactions and collaboration between the Food and Drug Administration, including the review centers thereof, and stakeholders including patients, sponsors, and the external biomedical research community;

"(B) consideration of cross-cutting clinical and regulatory policy issues, including consistency of regulatory advice and decisionmaking;

"(C) identification of key regulatory science and policy issues critical to advancing development of safe and effective drugs; and

"(D) enhancement of collaboration and engagement of the relevant centers and offices of the Food and Drug Administration with other operating divisions within the Department of Health and Human Services, the Partnership, and the broader neurodegenerative disease community; and

"(3) be subject to revision, as determined appropriate by the Secretary of Health and Human Services."

Review Groups on Rare Diseases and Neglected Diseases of the Developing World; Report; Guidance; Standards

Pub. L. 111–80, title VII, §740, Oct. 21, 2009, 123 Stat. 2127, provided that:

"(a) The Commissioner of Food and Drugs shall establish within the Food and Drug Administration a review group which shall recommend to the Commissioner of Food and Drugs appropriate preclinical, trial design, and regulatory paradigms and optimal solutions for the prevention, diagnosis, and treatment of rare diseases: Provided, That the Commissioner of Food and Drugs shall appoint individuals employed by the Food and Drug Administration to serve on the review group: Provided further, That members of the review group shall have specific expertise relating to the development of articles for use in the prevention, diagnosis, or treatment of rare diseases, including specific expertise in developing or carrying out clinical trials.

"(b) The Commissioner of Food and Drugs shall establish within the Food and Drug Administration a review group which shall recommend to the Commissioner of Food and Drugs appropriate preclinical, trial design, and regulatory paradigms and optimal solutions for the prevention, diagnosis, and treatment of neglected diseases of the developing world: Provided, That the Commissioner of Food and Drugs shall appoint individuals employed by the Food and Drug Administration to serve on the review group: Provided further, That members of the review group shall have specific expertise relating to the development of articles for use in the prevention, diagnosis, or treatment of neglected diseases of the developing world, including specific expertise in developing or carrying out clinical trials: Provided further, That for the purposes of this section the term 'neglected disease of the developing world' means a tropical disease, as defined in section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(3)).

"(c) The Commissioner of Food and Drugs shall—

"(1) submit, not later than 1 year after the date of the establishment of review groups under subsections (a) and (b), a report to Congress that describes both the findings and recommendations made by the review groups under subsections (a) and (b);

"(2) issue, not later than 180 days after submission of the report to Congress under paragraph (1), guidance based on such recommendations for articles for use in the prevention, diagnosis, and treatment of rare diseases and for such uses in neglected diseases of the developing world; and

"(3) develop, not later than 180 days after submission of the report to Congress under paragraph (1), internal review standards based on such recommendations for articles for use in the prevention, diagnosis, and treatment of rare diseases and for such uses in neglected diseases of the developing world."

Study

Pub. L. 100–290, §3(d), Apr. 18, 1988, 102 Stat. 91, directed Secretary of Health and Human Services to conduct a study to determine whether the application of subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360aa et seq. (relating to drugs for rare diseases and conditions), and 26 U.S.C. 28 (relating to tax credit) to medical devices or medical foods for rare diseases or conditions or to both was needed to encourage development of such devices and foods and report results of the study to Congress not later than one year after Apr. 18, 1988.

Congressional Findings

Pub. L. 97–414, §1(b), Jan. 4, 1983, 96 Stat. 2049, provided that: "The Congress finds that—

"(1) there are many diseases and conditions, such as Huntington's disease, myoclonus, ALS (Lou Gehrig's disease), Tourette syndrome, and muscular dystrophy which affect such small numbers of individuals residing in the United States that the diseases and conditions are considered rare in the United States;

"(2) adequate drugs for many of such diseases and conditions have not been developed;

"(3) drugs for these diseases and conditions are commonly referred to as 'orphan drugs';

"(4) because so few individuals are affected by any one rare disease or condition, a pharmaceutical company which develops an orphan drug may reasonably expect the drug to generate relatively small sales in comparison to the cost of developing the drug and consequently to incur a financial loss;

"(5) there is reason to believe that some promising orphan drugs will not be developed unless changes are made in the applicable Federal laws to reduce the costs of developing such drugs and to provide financial incentives to develop such drugs; and

"(6) it is in the public interest to provide such changes and incentives for the development of orphan drugs."

§360bb. Designation of drugs for rare diseases or conditions

(a) Request by sponsor; preconditions; "rare disease or condition" defined

(1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, or the submission of an application for licensing of the drug under section 262 of title 42. If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—

(A) if an application for such drug is approved under section 355 of this title, or

(B) if a license for such drug is issued under section 262 of title 42,

the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) ¹ respecting the designation of the drug.

(2) For purposes of paragraph (1), the term "rare disease or condition" means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made.

(b) Notification of discontinuance of drug or application as condition

A designation of a drug under subsection (a) shall be subject to the condition that—

(1) if an application was approved for the drug under section 355(b) of this title or a license was issued for the drug under section 262 of title 42, the manufacturer of the drug will notify the Secretary of any discontinuance of the production of the drug at least one year before discontinuance, and

(2) if an application has not been approved for the drug under section 355(b) of this title or a license has not been issued for the drug under section 262 of title 42 and if preclinical investigations or investigations under section 355(i) of this title are being conducted with the drug, the manufacturer or sponsor of the drug will notify the Secretary of any decision to discontinue active pursuit of approval of an application under section 355(b) of this title or approval of a license under section 262 of title 42.

(c) Notice to public

Notice respecting the designation of a drug under subsection (a) shall be made available to the public.

(d) Regulations

The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

(June 25, 1938, ch. 675, §526, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98–551, §4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99–91, §3(a)(2), Aug. 15, 1985, 99 Stat. 387; Pub. L. 100–290, §2, Apr. 18, 1988, 102 Stat. 90; Pub. L. 105–115, title I, §125(b)(2)(H), (I), Nov. 21, 1997, 111 Stat. 2326.)

Editorial Notes

References in Text

Subsection (b), referred to in subsec. (a)(1), was redesignated as subsec. (c) of this section by Pub. L. 100–290, §2(b), Apr. 18, 1988, 102 Stat. 90.

Amendments

1997—Subsec. (a)(1). Pub. L. 105–115, §125(b)(2)(H), struck out "the submission of an application for certification of the drug under section 357 of this title," before "or the submission of an application for licensing of the drug" in introductory provisions, inserted "or" at end of subpar. (A), redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: "if a certification for such drug is issued under section 357 of this title, or".

Subsec. (b)(1). Pub. L. 105–115, §125(b)(2)(I)(i), struck out ", a certificate was issued for the drug under section 357 of this title," before "or a license was issued".

Subsec. (b)(2). Pub. L. 105–115, §125(b)(2)(I)(ii), struck out ", a certificate has not been issued for the drug under section 357 of this title," before "or a license has not been issued" and ", approval of an application for certification under section 357 of this title," before "or approval of a license".

1988—Subsec. (a)(1). Pub. L. 100–290, §2(a), inserted after first sentence "A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, the submission of an application for certification of the drug under section 357 of this title, or the submission of an application for licensing of the drug under section 262 of title 42."

Subsecs. (b) to (d). Pub. L. 100–290, §2(b), added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively.

1985—Subsec. (a)(1). Pub. L. 99–91 struck out "or" at end of subpar. (A), struck out subpar. (B) and substituted subpars. (B) and (C), and inserted ", certification," after "approval".

1984—Subsec. (a)(2). Pub. L. 98–551 substituted "which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which" for "which occurs so infrequently in the United States that".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.

¹ See References in Text note below.

§360cc. Protection for drugs for rare diseases or conditions

(a) Exclusive approval, certification, or license

Except as provided in subsection (b), if the Secretary—

(1) approves an application filed pursuant to section 355 of this title, or

(2) issues a license under section 262 of title 42

for a drug designated under section 360bb of this title for a rare disease or condition, the Secretary may not approve another application under section 355 of this title or issue another license under section 262 of title 42 for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 355(c)(2) ¹ of this title does not apply to the refusal to approve an application under the preceding sentence.

(b) Exceptions

During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if—

(1) the Secretary finds, after providing the holder of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or

(2) the holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period.

(c) Condition of clinical superiority

(1) In general

If a sponsor of a drug that is designated under section 360bb of this title and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug.

(2) Definition

For purposes of paragraph (1), the term "clinically superior" with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care.

(3) Applicability

This subsection applies to any drug designated under section 360bb of this title for which an application was approved under section 355 of this title or licensed under section 262 of title 42 after August 18, 2017, regardless of the date on which such drug was designated under section 360bb of this title.

(d) Regulations

The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on August 18, 2017, until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act.

(e) Demonstration of clinical superiority standard

To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary—

(1) upon the designation of any drug under section 360bb of this title, shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and

(2) upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.

(June 25, 1938, ch. 675, §527, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98–417, title I, §102(b)(6), Sept. 24, 1984, 98 Stat. 1593; Pub. L. 99–91, §§2, 3(a)(3), Aug. 15, 1985, 99 Stat. 387, 388; Pub. L. 103–80, §3(v), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title I, §125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107–281, §4, Nov. 6, 2002, 116 Stat. 1993; Pub. L. 115–52, title VI, §607(a), Aug. 18, 2017, 131 Stat. 1049; Pub. L. 116–260, div. BB, title III, §323, Dec. 27, 2020, 134 Stat. 2933.)

Editorial Notes

References in Text

Section 355(c)(2) of this title, referred to in subsec. (a), was redesignated as section 355(c)(1)(B) of this title by Pub. L. 98–417, title I, §102(a)(2), Sept. 24, 1984, 98 Stat. 1592.

This section, as amended by such Act, referred to in subsec. (d), means this section as amended by the FDA Reauthorization Act of 2017, Pub. L. 115–52.

Amendments

2020—Subsec. (c)(3). Pub. L. 116–260 added par. (3).

2017—Subsec. (a). Pub. L. 115–52, §607(a)(1), substituted "the same drug for the same disease or condition" for "such drug for such disease or condition" in concluding provisions.

Subsec. (b). Pub. L. 115–52, §607(a)(2)(A), in introductory provisions, substituted "During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if" for "If an application filed pursuant to section 355 of this title is approved for a drug designated under section 360bb of this title for a rare disease or condition or if a license is issued under section 262 of title 42 for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 355 of this title or issue a license under section 262 of title 42, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if".

Subsec. (b)(1). Pub. L. 115–52, §607(a)(2)(B), substituted "of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure" for "notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure".

Subsec. (b)(2). Pub. L. 115–52, §607(a)(2)(C), substituted "the holder provides" for "such holder provides".

Subsecs. (c) to (e). Pub. L. 115–52, §607(a)(3), added subsecs. (c) to (e).

2002—Subsec. (a). Pub. L. 107–281, in concluding provisions, struck out ", of such certification," after "such approved application" and ", the issuance of the certification," after "approval of the approved application".

1997—Subsec. (a). Pub. L. 105–115, §125(b)(2)(J), struck out ", issue another certification under section 357 of this title," before "or issue another license" in closing provisions, inserted "or" at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: "issues a certification under section 357 of this title, or".

Subsec. (b). Pub. L. 105–115, §125(b)(2)(K), in introductory provisions, struck out ", if a certification is issued under section 357 of this title for such a drug," after "rare disease or condition", ", of the issuance of the certification under section 357 of this title," after "application approval", ", issue another certification under section 357 of this title," after "application under section 355 of this title", and ", of such certification," after "approved application".

Subsec. (b)(1). Pub. L. 105–115, §125(b)(2)(K), struck out ", of the certification," after "holder of the approved application".

Subsec. (b)(2). Pub. L. 105–115, §125(b)(2)(K), struck out ", issuance of other certifications," after "approval of other applications".

1993—Subsec. (b). Pub. L. 103–80 struck out extraneous comma before "or issue a license under section 262" in introductory provisions and substituted "the" for "The" at beginning of par. (1).

1985—Pub. L. 99–91, §2(3), struck out "unpatented" before "drugs" in section catchline.

Subsec. (a). Pub. L. 99–91, §§2(1), 3(a)(3)(A)–(D), struck out "or" at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out "and for which a United States Letter of Patent may not be issued" after "rare disease or condition", inserted in first sentence ", issue another certification under section 357 of this title," after "section 355 of this title" the second time it appeared, inserted ", of such certification," after "holder of such approved application", and inserted ", the issuance of the certification," after "approval of the approved application".

Subsec. (b). Pub. L. 99–91, §§2(2), 3(a)(3)(E)–(K), struck out "and if a United States Letter of Patent may not be issued for the drug" after "such a drug", substituted ", if a certification is issued under section 357 of this title for such a drug, or if a license" for "or a license", inserted ", of the issuance of the certification under section 357 of this title," after "application approval", struck out ", if the drug is a biological product," before "issue a license", inserted ", issue another certification under section 357 of this title," after "section 355 of this title", inserted ", of such certification," after "holder of such approved application", inserted ", of such certification," after "application" in par. (1), and inserted ", issuance of other certifications," after "other applications" in par. (2).

1984—Subsecs. (a), (b). Pub. L. 98–417 substituted "section 355" for "section 355(b)" wherever appearing.

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.

Construction

Pub. L. 115–52, title VI, §607(b), Aug. 18, 2017, 131 Stat. 1050, provided that: "Nothing in the amendments made by subsection (a) [amending this section] shall affect any determination under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017 [Aug. 18, 2017]."

¹ See References in Text note below.

§360dd. Open protocols for investigations of drugs for rare diseases or conditions

If a drug is designated under section 360bb of this title as a drug for a rare disease or condition and if notice of a claimed exemption under section 355(i) of this title or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.

(June 25, 1938, ch. 675, §528, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2051.)

§360ee. Grants and contracts for development of drugs for rare diseases and conditions

(a) Authority of Secretary

The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in (1) defraying the costs of developing drugs for rare diseases or conditions, including qualified testing expenses, (2) defraying the costs of developing medical devices for rare diseases or conditions, (3) defraying the costs of developing medical foods for rare diseases or conditions, and (4) developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions.

(b) Definitions

For purposes of subsection (a):

(1) The term "qualified testing" means—

(A) human clinical testing—

(i) which is carried out under an exemption for a drug for a rare disease or condition under section 355(i) of this title (or regulations issued under such section); and

(ii) which occurs before the date on which an application with respect to such drug is submitted under section 355(b) of this title or under section 262 of title 42;

(B) preclinical testing involving a drug for a rare disease or condition which occurs after the date such drug is designated under section 360bb of this title and before the date on which an application with respect to such drug is submitted under section 355(b) of this title or under section 262 of title 42; and

(C) prospectively planned and designed observational studies and other analyses conducted to assist in the understanding of the natural history of a rare disease or condition and in the development of a therapy, including studies and analyses to—

(i) develop or validate a drug development tool related to a rare disease or condition; or

(ii) understand the full spectrum of the disease manifestations, including describing genotypic and phenotypic variability and identifying and defining distinct subpopulations affected by a rare disease or condition.

(2) The term "rare disease or condition" means (1) in the case of a drug, any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug, (2) in the case of a medical device, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical device for such disease or condition will be developed without assistance under subsection (a), and (3) in the case of a medical food, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical food for such disease or condition will be developed without assistance under subsection (a). Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under section 360bb of this title is made.

(3) The term "medical food" means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

(c) Authorization of appropriations

For grants and contracts under subsection (a), there is authorized to be appropriated $6,904,110 for the period beginning on October 1, 2022 and ending on December 23, 2022.¹

(Pub. L. 97–414, §5, Jan. 4, 1983, 96 Stat. 2056; Pub. L. 98–551, §4(b), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99–91, §5, Aug. 15, 1985, 99 Stat. 391; Pub. L. 100–290, §3(a)–(c), Apr. 18, 1988, 102 Stat. 90, 91; Pub. L. 105–115, title I, §125(b)(2)(N), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107–281, §3, Nov. 6, 2002, 116 Stat. 1993; Pub. L. 110–85, title XI, §1112(b), Sept. 27, 2007, 121 Stat. 976; Pub. L. 112–144, title IX, §906, July 9, 2012, 126 Stat. 1092; Pub. L. 114–255, div. A, title III, §3015, Dec. 13, 2016, 130 Stat. 1094; Pub. L. 115–52, title VI, §603, Aug. 18, 2017, 131 Stat. 1048; Pub. L. 117–180, div. F, title V, §5006, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, §307, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, §3107, Dec. 29, 2022, 136 Stat. 5808.)

Editorial Notes

Codification

Section was enacted as part of the Orphan Drug Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

2022—Subsec. (a)(4). Pub. L. 117–328, §3107(1), added par. (4).

Subsec. (c). Pub. L. 117–328, §3107(2), which directed the substitution of "$30,000,000 for each of fiscal years 2023 through 2027" for "$6,328,767 for the period beginning on October 1, 2022, and ending on December 23, 2022", could not be executed because "$6,328,767" did not appear after the intervening amendment by Pub. L. 117–229. See below.

Pub. L. 117–229 substituted "$6,904,110 for the period beginning on October 1, 2022 and ending on December 23, 2022" for "$6,328,767 for the period beginning on October 1, 2022, and ending on December 16, 2022".

Pub. L. 117–180 substituted "$6,328,767 for the period beginning on October 1, 2022, and ending on December 16, 2022" for "$30,000,000 for each of fiscal years 2018 through 2022".

2017—Subsec. (c). Pub. L. 115–52 substituted "2018 through 2022" for "2013 through 2017".

2016—Subsec. (a)(1). Pub. L. 114–255, §3015(1), added par. (1) and struck out former par. (1) which read as follows: "defraying the costs of qualified testing expenses incurred in connection with the development of drugs for rare diseases and conditions,".

Subsec. (b)(1)(C). Pub. L. 114–255, §3015(2), added subpar. (C).

2012—Subsec. (b)(1)(A)(ii). Pub. L. 112–144, §906(a), struck out "after the date such drug is designated under section 360bb of this title and" after "which occurs".

Subsec. (c). Pub. L. 112–144, §906(b), amended subsec. (c) generally. Prior to amendment, text read as follows: "For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000 for each of fiscal years 2008 through 2012."

2007—Subsec. (c). Pub. L. 110–85 amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: "For grants and contracts under subsection (a) of this section, there are authorized to be appropriated such sums as already have been appropriated for fiscal year 2002, and $25,000,000 for each of the fiscal years 2003 through 2006."

2002—Subsec. (c). Pub. L. 107–281 amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: "For grants and contracts under subsection (a) of this section there are authorized to be appropriated $10,000,000 for fiscal year 1988, $12,000,000 for fiscal year 1989, $14,000,000 for fiscal year 1990."

1997—Subsec. (b)(1)(A)(ii), (B). Pub. L. 105–115 struck out "or 357" after "355(b)".

1988—Subsec. (a). Pub. L. 100–290, §3(a)(1), (b)(1), inserted "(1)" after "assist in" and added pars. (2) and (3).

Subsec. (b)(2). Pub. L. 100–290, §3(a)(2), (b)(2), inserted "(1) in the case of a drug," after "means", added cls. (2) and (3), and substituted "under section 360bb of this title" for "under this subsection" in last sentence.

Subsec. (b)(3). Pub. L. 100–290, §3(b)(3), added par. (3).

Subsec. (c). Pub. L. 100–290, §3(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: "For grants and contracts under subsection (a) of this section there are authorized to be appropriated $4,000,000 for fiscal year 1986, $4,000,000 for fiscal year 1987, and $4,000,000 for fiscal year 1988."

1985—Subsec. (a). Pub. L. 99–91, §5(a)(1), struck out "clinical" before "testing".

Subsec. (b)(1). Pub. L. 99–91, §5(a)(2), substituted provisions defining "qualified testing" for provisions defining "qualified clinical testing".

Subsec. (c). Pub. L. 99–91, §5(b), substituted provisions authorizing appropriations for fiscal years 1986 to 1988, for provisions authorizing appropriations for fiscal years 1983 and the two succeeding fiscal years.

1984—Subsec. (b)(2). Pub. L. 98–551 substituted "which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which" for "which occurs so infrequently in the United States that".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–91 effective Oct. 1, 1985, see section 8(a) of Pub. L. 99–91, set out as a note under section 360aa of this title.

Grants for Research on Therapies for ALS

Pub. L. 117–79, §2, Dec. 23, 2021, 135 Stat. 1533, provided that:

"(a) In General.—The Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall award grants to participating entities for purposes of scientific research utilizing data from expanded access to investigational drugs for individuals who are not otherwise eligible for clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis. In the case of a participating entity seeking such a grant, an expanded access request must be submitted, and allowed to proceed by the Secretary, under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) and part 312 of title 21, Code of Federal Regulations (or any successor regulations), before the application for such grant is submitted.

"(b) Application.—

"(1) In general.—A participating entity seeking a grant under this section shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary shall specify.

"(2) Use of data.—An application submitted under paragraph (1) shall include a description of how data generated through an expanded access request under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) with respect to the investigational drug involved will be used to support research or development related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.

"(3) Noninterference with clinical trials.—An application submitted under paragraph (1) shall include a description of how the proposed expanded access program will be designed so as not to interfere with patient enrollment in ongoing clinical trials for investigational therapies for the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.

"(c) Selection.—Consistent with sections 406 and 492 of the Public Health Service Act (42 U.S.C. 284a, 289a), the Secretary shall, in determining whether to award a grant under this section, confirm that—

"(1) such grant will be used to support a scientific research objective relating to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis (as described in subsection (a));

"(2) such grant shall not have the effect of diminishing eligibility for, or impeding enrollment of, ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis by determining that individuals who receive expanded access to investigational drugs through such a grant are not eligible for enrollment in—

"(A) ongoing clinical trials that are registered on ClinicalTrials.gov (or successor website), with respect to a drug for the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis; or

"(B) clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis for which an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) has been granted by the Food and Drug Administration and which are expected to begin enrollment within one year; and

"(3) the resulting project funded by such grant will allow for equitable access to investigational drugs by minority and underserved populations.

"(d) Use of Funds.—A participating entity shall use funds received through the grant—

"(1) to pay the manufacturer or sponsor for the direct costs of the investigational drug, as authorized under section 312.8(d) of title 21, Code of Federal Regulations (or successor regulations), to prevent, diagnose, mitigate, treat, or cure amyotrophic lateral sclerosis that is the subject of an expanded access request described in subsection (a), if such costs are justified as part of peer review of the grant;

"(2) for the entity's direct costs incurred in providing such drug consistent with the research mission of the grant; or

"(3) for the direct and indirect costs of the entity in conducting research with respect to such drug.

"(e) Definitions.—In this section:

"(1) The term 'participating entity' means a participating clinical trial site or sites sponsored by a small business concern (as defined in section 3(a) of the Small Business Act (15 U.S.C. 632(a))) that is the sponsor of a drug that is the subject of an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) to prevent, diagnose, mitigate, treat, or cure amyotrophic lateral sclerosis.

"(2) The term 'participating clinical trial' means a phase 3 clinical trial conducted pursuant to an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) to investigate a drug intended to prevent, diagnose, mitigate, treat, or cure amyotrophic lateral sclerosis.

"(3) The term 'participating clinical trial site' means a health care facility, or network of facilities, at which patients participating in a participating clinical trial receive an investigational drug through such trial.

"(f) Sunset.—The Secretary may not award grants under this section on or after September 30, 2026."

Findings and Purposes

Pub. L. 107–281, §2, Nov. 6, 2002, 116 Stat. 1992, provided that:

"(a) Findings.—Congress makes the following findings:

"(1) Rare diseases and disorders are those which affect small patient populations, typically populations smaller than 200,000 individuals in the United States. Such diseases and conditions include Huntington's disease, amyotrophic lateral sclerosis (Lou Gehrig's disease), Tourette syndrome, Crohn's disease, cystic fibrosis, cystinosis, and Duchenne muscular dystrophy.

"(2) For many years, the 25,000,000 Americans suffering from the over 6,000 rare diseases and disorders were denied access to effective medicines because prescription drug manufacturers could rarely make a profit from marketing drugs for such small groups of patients. The prescription drug industry did not adequately fund research into such treatments. Despite the urgent health need for these medicines, they came to be known as 'orphan drugs' because no companies would commercialize them.

"(3) During the 1970s, an organization called the National Organization for Rare Disorders (NORD) was founded to provide services and to lobby on behalf of patients with rare diseases and disorders. NORD was instrumental in pressing Congress for legislation to encourage the development of orphan drugs.

"(4) The Orphan Drug Act [see Short Title of 1983 Amendments note set out under section 301 of this title] created financial incentives for the research and production of such orphan drugs. New Federal programs at the National Institutes of Health and the Food and Drug Administration encouraged clinical research and commercial product development for products that target rare diseases. An Orphan Products Board was established to promote the development of drugs and devices for rare diseases or disorders.

"(5) Before 1983, some 38 orphan drugs had been developed. Since the enactment of the Orphan Drug Act [Jan. 4, 1983], more than 220 new orphan drugs have been approved and marketed in the United States and more than 800 additional drugs are in the research pipeline.

"(6) Despite the tremendous success of the Orphan Drug Act, rare diseases and disorders deserve greater emphasis in the national biomedical research enterprise.

"(7) The Food and Drug Administration supports small clinical trials through Orphan Products Research Grants. Such grants embody successful partnerships of government and industry, and have led to the development of at least 23 drugs and four medical devices for rare diseases and disorders. Yet the appropriations in fiscal year 2001 for such grants were less than in fiscal year 1995.

"(b) Purposes.—The purpose of this Act [see Short Title of 2002 Amendments note set out under section 301 of this title] is to increase the national investment in the development of diagnostics and treatments for patients with rare diseases and disorders."

¹ See 2022 Amendment notes below.

§360ee–1. FDA rare neurodegenerative disease grant program

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall award grants and contracts to public and private entities to cover the costs of research on, and development of interventions intended to prevent, diagnose, mitigate, treat, or cure, amyotrophic lateral sclerosis and other rare neurodegenerative diseases in adults and children, including costs incurred with respect to the development and critical evaluation of tools, methods, and processes—

(1) to characterize such neurodegenerative diseases and their natural history;

(2) to identify molecular targets for such neurodegenerative diseases; and

(3) to increase efficiency and productivity of clinical development of therapies, including through—

(A) the use of master protocols and adaptive and add-on clinical trial designs; and

(B) efforts to establish new or leverage existing clinical trial networks.

(Pub. L. 117–79, §5, Dec. 23, 2021, 135 Stat. 1537.)

Editorial Notes

Codification

Section was enacted as part of the Accelerating Access to Critical Therapies for ALS Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§360ff. Priority review to encourage treatments for rare pediatric diseases

(a) Definitions

In this section:

(1) Priority review

The term "priority review", with respect to a human drug application as defined in section 379g(1) of this title, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.

(2) Priority review voucher

The term "priority review voucher" means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the rare pediatric disease product application.

(3) Rare pediatric disease

The term "rare pediatric disease" means a disease that meets each of the following criteria:

(A) The disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.

(B) The disease is a rare disease or condition, within the meaning of section 360bb of this title.

(4) Rare pediatric disease product application

The term "rare pediatric disease product application" means a human drug application, as defined in section 379g(1) of this title, that—

(A) is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease;

(B)(i) is for such a drug—

(I) that contains no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 355 of this title; and

(II) that is the subject of an application submitted under section 355(b)(1) of this title; or

(ii) is for such a biological product—

(I) that contains no active ingredient that has been previously approved in any other application under section 351(a) or 351(k) of the Public Health Service Act [42 U.S.C. 262(a), 262(k)]; and

(II) that is the subject of an application submitted under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)];

(C) the Secretary deems eligible for priority review;

(D) that ¹ relies on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population;

(E) that ¹ does not seek approval for an adult indication in the original rare pediatric disease product application; and

(F) is approved after September 30, 2016.

(b) Priority review voucher

(1) In general

The Secretary shall award a priority review voucher to the sponsor of a rare pediatric disease product application upon approval by the Secretary of such rare pediatric disease product application.

(2) Transferability

(A) In general

The sponsor of a rare pediatric disease product application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.

(B) Notification of transfer

Each person to whom a voucher is transferred shall notify the Secretary of such change in ownership of the voucher not later than 30 days after such transfer.

(3) Limitation

A sponsor of a rare pediatric disease product application may not receive a priority review voucher under this section if the rare pediatric disease product application was submitted to the Secretary prior to the date that is 90 days after July 9, 2012.

(4) Notification

(A) Sponsor of a rare pediatric disease product

(i) In general

Beginning on the date that is 90 days after September 30, 2016, the sponsor of a rare pediatric disease product application that intends to request a priority review voucher under this section shall notify the Secretary of such intent upon submission of the rare pediatric disease product application that is the basis of the request for a priority review voucher.

(ii) Applications submitted but not yet approved

The sponsor of a rare pediatric disease product application that was submitted and that has not been approved as of September 30, 2016, shall be considered eligible for a priority review voucher, if—

(I) such sponsor has submitted such rare pediatric disease product application—

(aa) on or after the date that is 90 days after July 9, 2012; and

(bb) on or before September 30, 2016; and

(II) such application otherwise meets the criteria for a priority review voucher under this section.

(B) Sponsor of a drug application using a priority review voucher

(i) In general

The sponsor of a human drug application shall notify the Secretary not later than 90 days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay the user fee to be assessed in accordance with this section.

(ii) Transfer after notice

The sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under clause (i) may transfer the voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification.

(5) Termination of authority

The Secretary may not award any priority review vouchers under paragraph (1) after September 30, 2024, unless the rare pediatric disease product application—

(A) is for a drug that, not later than September 30, 2024, is designated under subsection (d) as a drug for a rare pediatric disease; and

(B) is, not later than September 30, 2026, approved under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)].

(c) Priority review user fee

(1) In general

The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under subchapter VII.

(2) Fee amount

The amount of the priority review user fee shall be determined each fiscal year by the Secretary, based on the difference between—

(A) the average cost incurred by the Food and Drug Administration in the review of a human drug application subject to priority review in the previous fiscal year; and

(B) the average cost incurred by the Food and Drug Administration in the review of a human drug application that is not subject to priority review in the previous fiscal year.

(3) Annual fee setting

The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2012, the amount of the priority review user fee for that fiscal year.

(4) Payment

(A) In general

The priority review user fee required by this subsection shall be due upon the notification by a sponsor of the intent of such sponsor to use the voucher, as specified in subsection (b)(4)(A).² All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.

(B) Complete application

An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary's procedures for paying such fees.

(C) No waivers, exemptions, reductions, or refunds

The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section.

(5) Offsetting collections

Fees collected pursuant to this subsection for any fiscal year—

(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and

(B) shall not be collected for any fiscal year except to the extent provided in advance in appropriations Acts.

(d) Designation process

(1) In general

Upon the request of the manufacturer or the sponsor of a new drug, the Secretary may designate—

(A) the new drug as a drug for a rare pediatric disease; and

(B) the application for the new drug as a rare pediatric disease product application.

(2) Request for designation

The request for a designation under paragraph (1) shall be made at the same time a request for designation of orphan disease status under section 360bb of this title or fast-track designation under section 356 of this title is made. Requesting designation under this subsection is not a prerequisite to receiving a priority review voucher under this section.

(3) Determination by Secretary

Not later than 60 days after a request is submitted under paragraph (1), the Secretary shall determine whether—

(A) the disease or condition that is the subject of such request is a rare pediatric disease; and

(B) the application for the new drug is a rare pediatric disease product application.

(e) Marketing of rare pediatric disease products

(1) Revocation

The Secretary may revoke any priority review voucher awarded under subsection (b) if the rare pediatric disease product for which such voucher was awarded is not marketed in the United States within the 365-day period beginning on the date of the approval of such drug under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(2) Postapproval production report

The sponsor of an approved rare pediatric disease product shall submit a report to the Secretary not later than 5 years after the approval of the applicable rare pediatric disease product application. Such report shall provide the following information, with respect to each of the first 4 years after approval of such product:

(A) The estimated population in the United States suffering from the rare pediatric disease.

(B) The estimated demand in the United States for such rare pediatric disease product.

(C) The actual amount of such rare pediatric disease product distributed in the United States.

(f) Notice and report

(1) Notice of issuance of voucher and approval of products under voucher

The Secretary shall publish a notice in the Federal Register and on the Internet Web site of the Food and Drug Administration not later than 30 days after the occurrence of each of the following:

(A) The Secretary issues a priority review voucher under this section.

(B) The Secretary approves a drug pursuant to an application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the sponsor of the application used a priority review voucher under this section.

(2) Notification

If, after the last day of the 1-year period that begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section, a sponsor of an application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for a drug uses a priority review voucher under this section for such application, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a document—

(A) notifying such Committees of the use of such voucher; and

(B) identifying the drug for which such priority review voucher is used.

(g) Eligibility for other programs

Nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program, including under this chapter, except that no sponsor of a rare pediatric disease product application may receive more than one priority review voucher issued under any section of this chapter with respect to the drug for which the application is made..³

(h) Relation to other provisions

The provisions of this section shall supplement, not supplant, any other provisions of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] that encourage the development of drugs for tropical diseases and rare pediatric diseases.

(i) GAO study and report

(1) Study

(A) In general

Beginning on the date that the Secretary awards the third rare pediatric disease priority voucher under this section, the Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under this section in the development of human drug products that treat or prevent such diseases.

(B) Contents of study

In conducting the study under subparagraph (A), the Comptroller General shall examine the following:

(i) The indications for which each rare disease product for which a priority review voucher was awarded was approved under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(ii) Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval of such a rare disease product.

(iii) The value of the priority review voucher if transferred.

(iv) Identification of each drug for which a priority review voucher was used.

(v) The length of the period of time between the date on which a priority review voucher was awarded and the date on which it was used.

(2) Report

Not later than 1 year after the date under paragraph (1)(A), the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report containing the results of the study under paragraph (1).

(June 25, 1938, ch. 675, §529, as added Pub. L. 112–144, title IX, §908, July 9, 2012, 126 Stat. 1094; amended Pub. L. 114–113, div. A, title VII, §765, Dec. 18, 2015, 129 Stat. 2286; Pub. L. 114–229, §2(a), Sept. 30, 2016, 130 Stat. 943; Pub. L. 114–255, div. A, title III, §3013(a), Dec. 13, 2016, 130 Stat. 1093; Pub. L. 116–159, div. C, title I, §2105, Oct. 1, 2020, 134 Stat. 729; Pub. L. 116–215, div. B, title II, §1211, Dec. 11, 2020, 134 Stat. 1045; Pub. L. 116–260, div. BB, title III, §321, Dec. 27, 2020, 134 Stat. 2932; Pub. L. 117–9, §1(a)(4), Apr. 23, 2021, 135 Stat. 257.)

Editorial Notes

References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsec. (a)(1), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

Subsection (b)(4)(A), referred to in subsec. (c)(4)(A), was part of subsec. (b)(4) of this section that was struck out by Pub. L. 114–229, §2(a)(2)(A), Sept. 30, 2016, 130 Stat. 943, which provision also added a new subsec. (b)(4) in which former subsec. (b)(4)(A) was restated as subsec. (b)(4)(B)(i).

The Public Health Service Act, referred to in subsec. (h), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2021—Subsec. (a)(4)(A), (B). Pub. L. 117–9 added subpars. (A) and (B) and struck out former subpars. (A) and (B) which read as follows:

"(A) is for a drug or biological product—

"(i) that is for the prevention or treatment of a rare pediatric disease; and

"(ii) that contains no active ingredient (including any ester or salt of the active ingredient) that has been previously approved in any other application under section 355(b)(1), 355(b)(2), or 355(j) of this title or section 351(a) or 351(k) of the Public Health Service Act;

"(B) is submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act;".

2020—Subsec. (b)(5). Pub. L. 116–260 substituted "September 30, 2024" for "December 18, 2020" in introductory provisions and in subpar. (A) and substituted "September 30, 2026" for "December 18, 2022" in subpar. (B).

Pub. L. 116–215 substituted "December 18, 2020" for "December 11, 2020" in introductory provisions and in subpar. (A) and substituted "December 18, 2022" for "December 11, 2022" in subpar. (B).

Pub. L. 116–159 substituted "December 11, 2020" for "September 30, 2020" in introductory provisions and in subpar. (A) and substituted "December 11, 2022" for "September 30, 2022" in subpar. (B).

2016—Subsec. (a)(3)(A). Pub. L. 114–229, §2(a)(1)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "The disease primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents."

Subsec. (a)(4)(F). Pub. L. 114–229, §2(a)(1)(B), substituted "September 30, 2016" for "July 9, 2012".

Subsec. (b)(4). Pub. L. 114–229, §2(a)(2)(A), added par. (4) and struck out former par. (4). Prior to amendment, text read as follows:

"(A) In general.—The sponsor of a human drug application shall notify the Secretary not later than 90 days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section.

"(B) Transfer after notice.—The sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification."

Subsec. (b)(5). Pub. L. 114–255 added par. (5) and struck out former par. (5). Prior to amendment, text read as follows: "The Secretary may not award any priority review vouchers under paragraph (1) after December 31, 2016."

Pub. L. 114–229, §2(a)(2)(B), added par. (5) and struck out former par. (5). Prior to amendment, text read as follows: "The Secretary may not award any priority review vouchers under paragraph (1) after September 30, 2016."

Subsec. (g). Pub. L. 114–229, §2(a)(3), inserted before period at end ", except that no sponsor of a rare pediatric disease product application may receive more than one priority review voucher issued under any section of this chapter with respect to the drug for which the application is made."

2015—Subsec. (b)(5). Pub. L. 114–113 substituted "September 30, 2016." for "the last day of the 1-year period that begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section."

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 114–229, §2(b), Sept. 30, 2016, 130 Stat. 944, provided that: "Nothing in this Act [amending this section and enacting provisions set out as a note under section 301 of this title], or the amendments made by this Act, shall be construed to affect the validity of a priority review voucher that was issued under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) before the date of enactment of this Act [Sept. 30, 2016]."

¹ So in original. The word "that" probably should not appear.

² See References in Text note below.

³ So in original.

§360ff–1. Targeted drugs for rare diseases

(a) Purpose

The purpose of this section, through the approach provided for in subsection (b), is to—

(1) facilitate the development, review, and approval of genetically targeted drugs and variant protein targeted drugs to address an unmet medical need in one or more patient subgroups, including subgroups of patients with different mutations of a gene, with respect to rare diseases or conditions that are serious or life-threatening; and

(2) maximize the use of scientific tools or methods, including surrogate endpoints and other biomarkers, for such purposes.

(b) Leveraging of data from previously approved drug application or applications

The Secretary may, consistent with applicable standards for approval under this chapter or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act for a genetically targeted drug or a variant protein targeted drug to rely upon data and information—

(1) previously developed by the same sponsor (or another sponsor that has provided the sponsor with a contractual right of reference to such data and information); and

(2) submitted by a sponsor described in paragraph (1) in support of one or more previously approved applications that were submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act,

for a drug that incorporates or utilizes the same or similar genetically targeted technology as the drug or drugs that are the subject of an application or applications described in paragraph (2) or for a variant protein targeted drug that is the same or incorporates or utilizes the same variant protein targeted drug, as the drug or drugs that are the subject of an application or applications described in paragraph (2).

(c) Definitions

For purposes of this section—

(1) the term "genetically targeted drug" means a drug that—

(A) is the subject of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for the treatment of a rare disease or condition (as such term is defined in section 360bb of this title) that is serious or life-threatening;

(B) may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product; and

(C) incorporates or utilizes a genetically targeted technology;

(2) the term "genetically targeted technology" means a technology comprising non-replicating nucleic acid or analogous compounds with a common or similar chemistry that is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition, including a disease or condition due to other variants in the same gene; and

(3) the term "variant protein targeted drug" means a drug that—

(A) is the subject of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for the treatment of a rare disease or condition (as such term is defined in section 360bb of this title) that is serious or life-threatening;

(B) modulates the function of a product of a mutated gene where such mutation is responsible in whole or in part for a given disease or condition; and

(C) is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition.

(d) Rule of construction

Nothing in this section shall be construed to—

(1) alter the authority of the Secretary to approve drugs pursuant to this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262] (as authorized prior to December 13, 2016), including the standards of evidence, and applicable conditions, for approval under such applicable chapter or Act; or

(2) confer any new rights, beyond those authorized under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] prior to December 13, 2016, with respect to the permissibility of a sponsor referencing information contained in another application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)].

(June 25, 1938, ch. 675, §529A, as added Pub. L. 114–255, div. A, title III, §3012, Dec. 13, 2016, 130 Stat. 1091.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (d)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Part C—Electronic Product Radiation Control

Editorial Notes

Codification

This part was classified to subpart 3 (§263c et seq.) of part F of subchapter II of chapter 6A of Title 42, The Public Health and Welfare, prior to its renumbering by Pub. L. 101–629, §19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as amended by Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.

§360hh. Definitions

As used in this part—

(1) the term "electronic product radiation" means—

(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or

(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product;

(2) the term "electronic product" means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation;

(3) the term "manufacturer" means any person engaged in the business of manufacturing, assembling, or importing of electronic products;

(4) the term "commerce" means (A) commerce between any place in any State and any place outside thereof; and (B) commerce wholly within the District of Columbia; and

(5) the term "State" includes the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, and American Samoa.

(June 25, 1938, ch. 675, §531, formerly act July 1, 1944, ch. 373, title III, §531, formerly §355, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1174; amended Pub. L. 94–484, title IX, §905(b)(1), Oct. 12, 1976, 90 Stat. 2325; renumbered §531 and amended Pub. L. 101–629, §19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263c of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263c of Title 42, The Public Health and Welfare, as this section.

1990—Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" in introductory provisions.

1976—Par. (5). Pub. L. 94–484 defined "State" to include Northern Mariana Islands.

Statutory Notes and Related Subsidiaries

Short Title

For short title of Pub. L. 90–602, which enacted provisions now comprising this part (§§360hh to 360ss), as the "Radiation Control for Health and Safety Act of 1968", see section 1 of Pub. L. 90–602, set out as a Short Title of 1968 Amendments note under section 301 of this title.

Transfer of Subpart; Construction

Pub. L. 101–629, §19(c), Nov. 28, 1990, 104 Stat. 4530, provided that: "The transfer of subpart 3 of part F of title III of the Public Health Service Act [42 U.S.C. 263b et seq.] to the Federal Food, Drug, and Cosmetic Act [this chapter] does not change the application of the requirements of such subpart and such Act to electronic products which were in effect on the date of the enactment of this Act [Nov. 28, 1990]."

Definition of "Secretary" and "Department"

Pub. L. 90–602, §3, Oct. 18, 1968, 82 Stat. 1186, as amended by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, provided that: "As used in the amendments made by section 2 of this Act [enacting provisions now comprising sections 360hh to 360ss of this title], except when otherwise specified, the term 'Secretary' means the Secretary of Health and Human Services, and the term 'Department' means the Department of Health and Human Services."

Noninterference With Other Federal Agencies

Pub. L. 90–602, §4, Oct. 18, 1968, 82 Stat. 1187, provided that: "The amendments made by section 2 of this Act [enacting provisions now comprising sections 360hh to 360ss of this title] shall not be construed as superseding or limiting the functions, under any other provision of law, of any officer or agency of the United States."

§360ii. Program of control

(a) Establishment

The Secretary shall establish and carry out an electronic product radiation control program designed to protect the public health and safety from electronic product radiation. As a part of such program, he shall—

(1) pursuant to section 360kk of this title, develop and administer performance standards for electronic products;

(2) plan, conduct, coordinate, and support research, development, training, and operational activities to minimize the emissions of and the exposure of people to, unnecessary electronic product radiation;

(3) maintain liaison with and receive information from other Federal and State departments and agencies with related interests, professional organizations, industry, industry and labor associations, and other organizations on present and future potential electronic product radiation;

(4) study and evaluate emissions of, and conditions of exposure to, electronic product radiation and intense magnetic fields;

(5) develop, test, and evaluate the effectiveness of procedures and techniques for minimizing exposure to electronic product radiation; and

(6) consult and maintain liaison with the Secretary of Commerce, the Secretary of Defense, the Secretary of Labor, the Atomic Energy Commission, and other appropriate Federal departments and agencies on (A) techniques, equipment, and programs for testing and evaluating electronic product radiation, and (B) the development of performance standards pursuant to section 360kk of this title to control such radiation emissions.

(b) Powers of Secretary

In carrying out the purposes of subsection (a), the Secretary is authorized to—

(1)(A) collect and make available, through publications and other appropriate means, the results of, and other information concerning, research and studies relating to the nature and extent of the hazards and control of electronic product radiation; and (B) make such recommendations relating to such hazards and control as he considers appropriate;

(2) make grants to public and private agencies, organizations, and institutions, and to individuals for the purposes stated in paragraphs (2), (4), and (5) of subsection (a) of this section;

(3) contract with public or private agencies, institutions, and organizations, and with individuals, without regard to section 3324 of title 31 and section 6101 of title 41; and

(4) procure (by negotiation or otherwise) electronic products for research and testing purposes, and sell or otherwise dispose of such products.

(c) Record keeping

(1) Each recipient of assistance under this part pursuant to grants or contracts entered into under other than competitive bidding procedures shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such assistance, the total cost of the project or undertaking in connection with which such assistance is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.

(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipients that are pertinent to the grants or contracts entered into under this part under other than competitive bidding procedures.

(June 25, 1938, ch. 675, §532, formerly act July 1, 1944, ch. 373, title III, §532, formerly §356, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1174; renumbered §532 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(A), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

In subsec. (b)(3), "section 6101 of title 41" substituted for "section 3709 of the Revised Statutes of the United States (41 U.S.C. 5)" on authority of Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Section was classified to section 263d of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263d of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(1), (6). Pub. L. 101–629, §19(a)(2)(A)(i), substituted "section 360kk" for "section 263f".

Subsec. (b)(3). Pub. L. 101–629, §19(a)(2)(A)(ii), substituted reference to section 3324 of title 31 for reference to section 3648 of the Revised Statutes (31 U.S.C. 529).

Subsec. (c)(1), (2). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

Statutory Notes and Related Subsidiaries

Transfer of Functions

Atomic Energy Commission abolished and functions transferred by sections 5814 and 5841 of Title 42, The Public Health and Welfare. See also Transfer of Functions notes set out under those sections.

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law or any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360jj. Studies by Secretary

(a) Report to Congress

The Secretary shall conduct the following studies, and shall make a report or reports of the results of such studies to the Congress on or before January 1, 1970, and from time to time thereafter as he may find necessary, together with such recommendations for legislation as he may deem appropriate:

(1) A study of present State and Federal control of health hazards from electronic product radiation and other types of ionizing radiation, which study shall include, but not be limited to—

(A) control of health hazards from radioactive materials other than materials regulated under the Atomic Energy Act of 1954 [42 U.S.C. 2011 et seq.];

(B) any gaps and inconsistencies in present controls;

(C) the need for controlling the sale of certain used electronic products, particularly antiquated X-ray equipment, without upgrading such products to meet the standards for new products or separate standards for used products;

(D) measures to assure consistent and effective control of the aforementioned health hazards;

(E) measures to strengthen radiological health programs of State governments; and

(F) the feasibility of authorizing the Secretary to enter into arrangements with individual States or groups of States to define their respective functions and responsibilities for the control of electronic product radiation and other ionizing radiation;

(2) A study to determine the necessity for the development of standards for the use of nonmedical electronic products for commercial and industrial purposes; and

(3) A study of the development of practicable procedures for the detection and measurement of electronic product radiation which may be emitted from electronic products manufactured or imported prior to the effective date of any applicable standard established pursuant to this part.

(b) Participation of other Federal agencies

In carrying out these studies, the Secretary shall invite the participation of other Federal departments and agencies having related responsibilities and interests, State governments—particularly those of States which regulate radioactive materials under section 274 of the Atomic Energy Act of 1954, as amended [42 U.S.C. 2021], and interested professional, labor, and industrial organizations. Upon request from congressional committees interested in these studies, the Secretary shall keep these committees currently informed as to the progress of the studies and shall permit the committees to send observers to meetings of the study groups.

(c) Organization of studies and participation

The Secretary or his designee shall organize the studies and the participation of the invited participants as he deems best. Any dissent from the findings and recommendations of the Secretary shall be included in the report if so requested by the dissenter.

(June 25, 1938, ch. 675, §533, formerly act July 1, 1944, ch. 373, title III, §533, formerly §357, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1176; renumbered §533 and amended Pub. L. 101–629, §19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

References in Text

The Atomic Energy Act of 1954, referred to in subsec. (a)(1)(A), is act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch. 1073, §1, 68 Stat. 919, which is classified principally to chapter 23 (§2011 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 2011 of Title 42 and Tables.

Codification

Section was classified to section 263e of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263e of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(3). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360kk. Performance standards for electronic products

(a) Promulgation of regulations

(1) The Secretary shall by regulation prescribe performance standards for electronic products to control the emission of electronic product radiation from such products if he determines that such standards are necessary for the protection of the public health and safety. Such standards may include provisions for the testing of such products and the measurement of their electronic product radiation emissions, may require the attachment of warning signs and labels, and may require the provision of instructions for the installation, operation, and use of such products. Such standards may be prescribed from time to time whenever such determinations are made, but the first of such standards shall be prescribed prior to January 1, 1970. In the development of such standards, the Secretary shall consult with Federal and State departments and agencies having related responsibilities or interests and with appropriate professional organizations and interested persons, including representatives of industries and labor organizations which would be affected by such standards, and shall give consideration to—

(A) the latest available scientific and medical data in the field of electronic product radiation;

(B) the standards currently recommended by (i) other Federal agencies having responsibilities relating to the control and measurement of electronic product radiation, and (ii) public or private groups having an expertise in the field of electronic product radiation;

(C) the reasonableness and technical feasibility of such standards as applied to a particular electronic product;

(D) the adaptability of such standards to the need for uniformity and reliability of testing and measuring procedures and equipment; and

(E) in the case of a component, or accessory described in paragraph (2)(B) of section 360hh of this title, the performance of such article in the manufactured or assembled product for which it is designed.

(2) The Secretary may prescribe different and individual performance standards, to the extent appropriate and feasible, for different electronic products so as to recognize their different operating characteristics and uses.

(3) The performance standards prescribed under this section shall not apply to any electronic product which is intended solely for export if (A) such product and the outside of any shipping container used in the export of such product are labeled or tagged to show that such product is intended for export, and (B) such product meets all the applicable requirements of the country to which such product is intended for export.

(4) The Secretary may by regulation amend or revoke any performance standard prescribed under this section.

(5) The Secretary may exempt from the provisions of this section any electronic product intended for use by departments or agencies of the United States provided such department or agency has prescribed procurement specifications governing emissions of electronic product radiation and provided further that such product is of a type used solely or predominantly by departments or agencies of the United States.

(b) Administrative procedure

The provisions of subchapter II of chapter 5 of title 5 (relating to the administrative procedure for rulemaking), and of chapter 7 of title 5 (relating to judicial review), shall apply with respect to any regulation prescribing, amending, or revoking any standard prescribed under this section.

(c) Publication in Federal Register

Each regulation prescribing, amending, or revoking a standard shall specify the date on which it shall take effect which, in the case of any regulation prescribing, or amending any standard, may not be sooner than one year or not later than two years after the date on which such regulation is issued, unless the Secretary finds, for good cause shown, that an earlier or later effective date is in the public interest and publishes in the Federal Register his reason for such finding, in which case such earlier or later date shall apply.

(d) Judicial review

(1) In a case of actual controversy as to the validity of any regulation issued under this section prescribing, amending, or revoking a performance standard, any person who will be adversely affected by such regulation when it is effective may at any time prior to the sixtieth day after such regulation is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such regulation. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based the regulation, as provided in section 2112 of title 28.

(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendations, if any, for the modification or setting aside of his original regulation, with the return of such additional evidence.

(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to review the regulation in accordance with chapter 7 of title 5 and to grant appropriate relief as provided in such chapter.

(4) The judgment of the court affirming or setting aside, in whole or in part, any such regulation of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28.

(5) Any action instituted under this subsection shall survive, notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.

(e) Availability of record

A certified copy of the transcript of the record and administrative proceedings under this section shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, exclusion of imports, or other proceeding arising under or in respect of this part irrespective of whether proceedings with respect to the regulation have previously been initiated or become final under this section.

(f) Technical Electronic Product Radiation Safety Standards Committee

(1)(A) The Secretary shall establish a Technical Electronic Product Radiation Safety Standards Committee (hereafter in this part referred to as the "Committee") which he shall consult before prescribing any standard under this section. The Committee shall be appointed by the Secretary, after consultation with public and private agencies concerned with the technical aspect of electronic product radiation safety, and shall be composed of fifteen members each of whom shall be technically qualified by training and experience in one or more fields of science or engineering applicable to electronic product radiation safety, as follows:

(i) Five members shall be selected from governmental agencies, including State and Federal Governments;

(ii) Five members shall be selected from the affected industries after consultation with industry representatives; and

(iii) Five members shall be selected from the general public, of which at least one shall be a representative of organized labor.

(B) The Committee may propose electronic product radiation safety standards to the Secretary for his consideration. All proceedings of the Committee shall be recorded and the record of each such proceeding shall be available for public inspection.

(2) Payments to members of the Committee who are not officers or employees of the United States pursuant to subsection (c) of section 210 of title 42 shall not render members of the Committee officers or employees of the United States for any purpose.

(g) Review and evaluation

The Secretary shall review and evaluate on a continuing basis testing programs carried out by industry to assure the adequacy of safeguards against hazardous electronic product radiation and to assure that electronic products comply with standards prescribed under this section.

(h) Product certification

Every manufacturer of an electronic product to which is applicable a standard in effect under this section shall furnish to the distributor or dealer at the time of delivery of such product, in the form of a label or tag permanently affixed to such product or in such manner as approved by the Secretary, the certification that such product conforms to all applicable standards under this section. Such certification shall be based upon a test, in accordance with such standard, of the individual article to which it is attached or upon a testing program which is in accord with good manufacturing practice and which has not been disapproved by the Secretary (in such manner as he shall prescribe by regulation) on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this section.

(June 25, 1938, ch. 675, §534, formerly act July 1, 1944, ch. 373, title III, §534, formerly §358, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1177; amended Pub. L. 91–515, title VI, §601(b)(2), (3), Oct. 30, 1970, 84 Stat. 1311; renumbered §534 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §§3(w), 4(a)(2), Aug. 13, 1993, 107 Stat. 778, 779.)

Editorial Notes

Codification

Section was classified to section 263f of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80, §4(a)(2), amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263f of Title 42, The Public Health and Welfare, as this section.

Subsec. (f)(2). Pub. L. 103–80, §3(w), made technical amendment to reference to section 210 of title 42 to reflect correction of corresponding provision of original act.

1990—Subsec. (a)(1)(E). Pub. L. 101–629, §19(a)(2)(B), substituted "section 360hh" for "section 263c".

Subsecs. (e), (f)(1)(A). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

1970—Subsec. (f)(2). Pub. L. 91–515 struck out provisions related to payment of compensation and travel expenses of members of the Committee who are not officers or employees of the United States, and substituted "to members of the Committee who are not officers or employees of the United States pursuant to subsection (c) of section 210 of title 42" for "under this subsection".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360ll. Notification of defects in and repair or replacement of electronic products

(a) Notification; exemption

(1) Every manufacturer of electronic products who discovers that an electronic product produced, assembled, or imported by him has a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, or that an electronic product produced, assembled, or imported by him on or after the effective date of an applicable standard prescribed pursuant to section 360kk of this title fails to comply with such standard, shall immediately notify the Secretary of such defect or failure to comply if such product has left the place of manufacture and shall (except as authorized by paragraph (2)) with reasonable promptness furnish notification of such defect or failure to the persons (where known to the manufacturer) specified in subsection (b) of this section.

(2) If, in the opinion of such manufacturer, the defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he may, at the time of giving notice to the Secretary of such defect or failure to comply, apply to the Secretary for an exemption from the requirement of notice to the persons specified in subsection (b). If such application states reasonable grounds for such exemption, the Secretary shall afford such manufacturer an opportunity to present his views and evidence in support of the application, the burden of proof being on the manufacturer. If, after such presentation, the Secretary is satisfied that such defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he shall exempt such manufacturer from the requirement of notice to the persons specified in subsection (b) of this section and from the requirements of repair or replacement imposed by subsection (f) of this section.

(b) Method of notification

The notification (other than to the Secretary) required by paragraph (1) of subsection (a) of this section shall be accomplished—

(1) by certified mail to the first purchaser of such product for purposes other than resale, and to any subsequent transferee of such product; and

(2) by certified mail or other more expeditious means to the dealers or distributors of such manufacturer to whom such product was delivered.

(c) Requisite elements of notification

The notifications required by paragraph (1) of subsection (a) of this section shall contain a clear description of such defect or failure to comply with an applicable standard, an evaluation of the hazard reasonably related to such defect or failure to comply, and a statement of the measures to be taken to repair such defect. In the case of a notification to a person referred to in subsection (b) of this section, the notification shall also advise the person of his rights under subsection (f) of this section.

(d) Copies to Secretary of communications by manufacturers to dealers or distributors regarding defects

Every manufacturer of electronic products shall furnish to the Secretary a true or representative copy of all notices, bulletins, and other communications to the dealers or distributors of such manufacturer or to purchasers (or subsequent transferees) of electronic products of such manufacturer regarding any such defect in such product or any such failure to comply with a standard applicable to such product. The Secretary shall disclose to the public so much of the information contained in such notice or other information obtained under section 360nn of this title as he deems will assist in carrying out the purposes of this part, but he shall not disclose any information which contains or relates to a trade secret or other matter referred to in section 1905 of title 18 unless he determines that it is necessary to carry out the purposes of this part.

(e) Notice from Secretary to manufacturer of defects or failure to comply with standards

If through testing, inspection, investigation, or research carried out pursuant to this part, or examination of reports submitted pursuant to section 360nn of this title, or otherwise, the Secretary determines that any electronic product—

(1) does not comply with an applicable standard prescribed pursuant to section 360kk of this title; or

(2) contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation;

he shall immediately notify the manufacturer of such product of such defect or failure to comply. The notice shall contain the findings of the Secretary and shall include all information upon which the findings are based. The Secretary shall afford such manufacturer an opportunity to present his views and evidence in support thereof, to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the product by reason of the emission of such radiation hazard. If after such presentation by the manufacturer the Secretary determines that such product does not comply with an applicable standard prescribed pursuant to section 360kk of this title, or that it contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, the Secretary shall direct the manufacturer to furnish the notification specified in subsection (c) of this section to the persons specified in paragraphs (1) and (2) of subsection (b) of this section (where known to the manufacturer), unless the manufacturer has applied for an exemption from the requirement of such notification on the ground specified in paragraph (2) of subsection (a) and the Secretary is satisfied that such noncompliance or defect is not such as to create a significant risk of injury, including genetic injury, to any person.

(f) Correction of defects

If any electronic product is found under subsection (a) or (e) to fail to comply with an applicable standard prescribed under this part or to have a defect which relates to the safety of use of such product, and the notification specified in subsection (c) is required to be furnished on account of such failure or defect, the manufacturer of such product shall (1) without charge, bring such product into conformity with such standard or remedy such defect and provide reimbursement for any expenses for transportation of such product incurred in connection with having such product brought into conformity or having such defect remedied, (2) replace such product with a like or equivalent product which complies with each applicable standard prescribed under this part and which has no defect relating to the safety of its use, or (3) make a refund of the cost of such product. The manufacturer shall take the action required by this subsection in such manner, and with respect to such persons, as the Secretary by regulations shall prescribe.

(g) Effective date

This section shall not apply to any electronic product that was manufactured before October 18, 1968.

(June 25, 1938, ch. 675, §535, formerly act July 1, 1944, ch. 373, title III, §535, formerly §359, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered §535 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(C), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263g of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263g of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(1). Pub. L. 101–629, §19(a)(2)(C)(i), substituted "section 360kk" for "section 263f".

Subsec. (d). Pub. L. 101–629, §19(a)(1)(B), (2)(C)(ii), substituted "section 360nn" for "section 263i" and "this part" for "this subpart" in two places.

Subsec. (e). Pub. L. 101–629, §19(a)(1)(B), (2)(C), substituted "this part" for "this subpart" and "section 360nn" for "section 263i" in introductory provisions and "section 360kk" for "section 263f" in par. (1) and concluding provisions.

Subsec. (f). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" in two places.

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360mm. Imports

(a) Refusal of admission to noncomplying electronic products

Any electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed under this part, or to which is not affixed a certification in the form of a label or tag in conformity with section 360kk(h) of this title shall be refused admission into the United States. The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon the latter's request, samples of electronic products which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may have a hearing before the Secretary of Health and Human Services. If it appears from an examination of such samples or otherwise that any electronic product fails to comply with applicable standards prescribed pursuant to section 360kk of this title, then, unless subsection (b) of this section applies and is complied with, (1) such electronic product shall be refused admission, and (2) the Secretary of the Treasury shall cause the destruction of such electronic product unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days after the date of notice of refusal of admission or within such additional time as may be permitted by such regulations.

(b) Bond

If it appears to the Secretary of Health and Human Services that any electronic product refused admission pursuant to subsection (a) of this section can be brought into compliance with applicable standards prescribed pursuant to section 360kk of this title, final determination as to admission of such electronic product may be deferred upon filing of timely written application by the owner or consignee and the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as the Secretary of Health and Human Services may by regulation prescribe. If such application is filed and such bond is executed the Secretary of Health and Human Services may, in accordance with rules prescribed by him, permit the applicant to perform such operations with respect to such electronic product as may be specified in the notice of permission.

(c) Liability of owner or consignee for expenses connected with refusal of admission

All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of operations provided for in subsection (b) of this section, and all expenses in connection with the storage, cartage, or labor with respect to any electronic product refused admission pursuant to subsection (a) of this section, shall be paid by the owner or consignee, and, in event of default, shall constitute a lien against any future importations made by such owner or consignee.

(d) Designation of agent for purposes of service

It shall be the duty of every manufacturer offering an electronic product for importation into the United States to designate in writing an agent upon whom service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made for and on behalf of said manufacturer, and to file such designation with the Secretary, which designation may from time to time be changed by like writing, similarly filed. Service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made upon said manufacturer by service upon such designated agent at his office or usual place of residence with like effect as if made personally upon said manufacturer, and in default of such designation of such agent, service of process, notice, order, requirement, or decision in any proceeding before the Secretary or in any judicial proceeding for enforcement of this part or any standards prescribed pursuant to this part may be made by posting such process, notice, order, requirement, or decision in the Office of the Secretary or in a place designated by him by regulation.

(June 25, 1938, ch. 675, §536, formerly act July 1, 1944, ch. 373, title III, §536, formerly §360, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1181; renumbered §536 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(D), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263h of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263h of Title 42, The Public Health and Welfare, as this section.

1992—Subsecs. (a), (b). Pub. L. 102–300 substituted "Health and Human Services" for "Health, Education, and Welfare" wherever appearing.

1990—Subsec. (a). Pub. L. 101–629, §19(a)(1)(B), (2)(D), substituted "this part" for "this subpart", "section 360kk(h)" for "section 263f(h)", and "section 360kk" for "section 263f".

Subsec. (b). Pub. L. 101–629, §19(a)(2)(D), substituted "section 360kk" for "section 263f".

Subsec. (d). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" in two places.

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360nn. Inspection, records, and reports

(a) Inspection of premises

If the Secretary finds for good cause that the methods, tests, or programs related to electronic product radiation safety in a particular factory, warehouse, or establishment in which electronic products are manufactured or held, may not be adequate or reliable, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are thereafter authorized (1) to enter, at reasonable times, any area in such factory, warehouse, or establishment in which the manufacturer's tests (or testing programs) required by section 360kk(h) of this title are carried out, and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, the facilities and procedures within such area which are related to electronic product radiation safety. Each such inspection shall be commenced and completed with reasonable promptness. In addition to other grounds upon which good cause may be found for purposes of this subsection, good cause will be considered to exist in any case where the manufacturer has introduced into commerce any electronic product which does not comply with an applicable standard prescribed under this part and with respect to which no exemption from the notification requirements has been granted by the Secretary under section 360ll(a)(2) or 360ll(e) of this title.

(b) Record keeping

Every manufacturer of electronic products shall establish and maintain such records (including testing records), make such reports, and provide such information, as the Secretary may reasonably require to enable him to determine whether such manufacturer has acted or is acting in compliance with this part and standards prescribed pursuant to this part and shall, upon request of an officer or employee duly designated by the Secretary, permit such officer or employee to inspect appropriate books, papers, records, and documents relevant to determining whether such manufacturer has acted or is acting in compliance with standards prescribed pursuant to this part.

(c) Disclosure of technical data

Every manufacturer of electronic products shall provide to the Secretary such performance data and other technical data related to safety as may be required to carry out the purposes of this part. The Secretary is authorized to require the manufacturer to give such notification of such performance and technical data at the time of original purchase to the ultimate purchaser of the electronic product, as he determines necessary to carry out the purposes of this part after consulting with the affected industry.

(d) Public nature of reports

Accident and investigation reports made under this part by any officer, employee, or agent of the Secretary shall be available for use in any civil, criminal, or other judicial proceeding arising out of such accident. Any such officer, employee, or agent may be required to testify in such proceedings as to the facts developed in such investigations. Any such report shall be made available to the public in a manner which need not identify individuals. All reports on research projects, demonstration projects, and other related activities shall be public information.

(e) Trade secrets

The Secretary or his representative shall not disclose any information reported to or otherwise obtained by him, pursuant to subsection (a) or (b) of this section, which concerns any information which contains or relates to a trade secret or other matter referred to in section 1905 of title 18, except that such information may be disclosed to other officers or employees of the Department and of other agencies concerned with carrying out this part or when relevant in any proceeding under this part. Nothing in this section shall authorize the withholding of information by the Secretary, or by any officers or employees under his control, from the duly authorized committees of the Congress.

(f) Information required to identify and locate first purchasers of electronic products

The Secretary may by regulation (1) require dealers and distributors of electronic products, to which there are applicable standards prescribed under this part and the retail prices of which is not less than $50, to furnish manufacturers of such products such information as may be necessary to identify and locate, for purposes of section 360ll of this title, the first purchasers of such products for purposes other than resale, and (2) require manufacturers to preserve such information. Any regulation establishing a requirement pursuant to clause (1) of the preceding sentence shall (A) authorize such dealers and distributors to elect, in lieu of immediately furnishing such information to the manufacturer, to hold and preserve such information until advised by the manufacturer or Secretary that such information is needed by the manufacturer for purposes of section 360ll of this title, and (B) provide that the dealer or distributor shall, upon making such election, give prompt notice of such election (together with information identifying the notifier and the product) to the manufacturer and shall, when advised by the manufacturer or Secretary, of the need therefor for the purposes of section 360ll of this title, immediately furnish the manufacturer with the required information. If a dealer or distributor discontinues the dealing in or distribution of electronic products, he shall turn the information over to the manufacturer. Any manufacturer receiving information pursuant to this subsection concerning first purchasers of products for purposes other than resale shall treat it as confidential and may use it only if necessary for the purpose of notifying persons pursuant to section 360ll(a) of this title.

(June 25, 1938, ch. 675, §537, formerly act July 1, 1944, ch. 373, title III, §537, formerly §360A, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered §537 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(E), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263i of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263i of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a). Pub. L. 101–629, §19(a)(1)(B), (2)(E), substituted "section 360kk(h)" for "section 263f(h)", "this part" for "this subpart", and "section 360ll(a)(2) or 360ll(e)" for "section 263g(a)(2) or 263g(e)".

Subsecs. (b) to (e). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" wherever appearing.

Subsec. (f). Pub. L. 101–629, §19(a)(1)(B), (2)(E)(ii), substituted "this part" for "this subpart", "section 360ll" for "section 263g" in three places, and "section 360ll(a)" for "section 263g(a)".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360oo. Prohibited acts

(a) It shall be unlawful—

(1) for any manufacturer to introduce, or to deliver for introduction, into commerce, or to import into the United States, any electronic product which does not comply with an applicable standard prescribed pursuant to section 360kk of this title;

(2) for any person to fail to furnish any notification or other material or information required by section 360ll or 360nn of this title; or to fail to comply with the requirements of section 360ll(f) of this title;

(3) for any person to fail or to refuse to establish or maintain records required by this part or to permit access by the Secretary or any of his duly authorized representatives to, or the copying of, such records, or to permit entry or inspection, as required by or pursuant to section 360nn of this title;

(4) for any person to fail or to refuse to make any report required pursuant to section 360nn(b) of this title or to furnish or preserve any information required pursuant to section 360nn(f) of this title; or

(5) for any person (A) to fail to issue a certification as required by section 360kk(h) of this title, or (B) to issue such a certification when such certification is not based upon a test or testing program meeting the requirements of section 360kk(h) of this title or when the issuer, in the exercise of due care, would have reason to know that such certification is false or misleading in a material respect.

(b) The Secretary may exempt any electronic product, or class thereof, from all or part of subsection (a), upon such conditions as he may find necessary to protect the public health or welfare, for the purpose of research, investigations, studies, demonstrations, or training, or for reasons of national security.

(June 25, 1938, ch. 675, §538, formerly act July 1, 1944, ch. 373, title III, §538, formerly §360B, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered §538 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(F), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263j of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263j of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(1). Pub. L. 101–629, §19(a)(2)(F)(i), substituted "section 360kk" for "section 263f".

Subsec. (a)(2). Pub. L. 101–629, §19(a)(2)(F)(ii), (iii), substituted "section 360ll or 360nn" for "section 263g or 263i" and "section 360ll(f)" for "section 263g(f)".

Subsec. (a)(3). Pub. L. 101–629, §19(a)(1)(B), (2)(F)(iii), substituted "this part" for "this subpart" and "section 360nn" for "section 263i".

Subsec. (a)(4). Pub. L. 101–629, §19(a)(2)(F)(iii), substituted "section 360nn(b)" for "section 263i(b)" and "section 360nn(f)" for "section 263i(f)".

Subsec. (a)(5). Pub. L. 101–629, §19(a)(2)(F)(i), substituted "section 360kk(h)" for "section 263f(h)" in two places.

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360pp. Enforcement

(a) Jurisdiction of courts

The district courts of the United States shall have jurisdiction, for cause shown, to restrain violations of section 360oo of this title and to restrain dealers and distributors of electronic products from selling or otherwise disposing of electronic products which do not conform to an applicable standard prescribed pursuant to section 360kk of this title except when such products are disposed of by returning them to the distributor or manufacturer from whom they were obtained. The district courts of the United States shall also have jurisdiction in accordance with section 1355 of title 28 to enforce the provisions of subsection (b) of this section.

(b) Penalties

(1) Any person who violates section 360oo of this title shall be subject to a civil penalty of not more than $1,000. For purposes of this subsection, any such violation shall with respect to each electronic product involved, or with respect to each act or omission made unlawful by section 360oo of this title, constitute a separate violation, except that the maximum civil penalty imposed on any person under this subsection for any related series of violations shall not exceed $300,000.

(2) Any such civil penalty may on application be remitted or mitigated by the Secretary. In determining the amount of such penalty, or whether it should be remitted or mitigated and in what amount, the appropriateness of such penalty to the size of the business of the person charged and the gravity of the violation shall be considered. The amount of such penalty, when finally determined, may be deducted from any sums owing by the United States to the person charged.

(c) Venue; process

Actions under subsections (a) and (b) of this section may be brought in the district court of the United States for the district wherein any act or omission or transaction constituting the violation occurred, or in such court for the district where the defendant is found or transacts business, and process in such cases may be served in any other district of which the defendant is an inhabitant or wherever the defendant may be found.

(d) Warnings

Nothing in this part shall be construed as requiring the Secretary to report for the institution of proceedings minor violations of this part whenever he believes that the public interest will be adequately served by a suitable written notice or warning.

(e) Compliance with regulations

Except as provided in the first sentence of section 360ss of this title, compliance with this part or any regulations issued thereunder shall not relieve any person from liability at common law or under statutory law.

(f) Additional remedies

The remedies provided for in this part shall be in addition to and not in substitution for any other remedies provided by law.

(June 25, 1938, ch. 675, §539, formerly act July 1, 1944, ch. 373, title III, §539, formerly §360C, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered §539 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(G), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263k of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263k of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a). Pub. L. 101–629, §19(a)(2)(G)(i), (ii), substituted "section 360oo" for "section 263j" and "section 360kk" for "section 263f".

Subsec. (b)(1). Pub. L. 101–629, §19(a)(2)(G)(ii), substituted "section 360oo" for "section 263j" in two places.

Subsec. (d). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" in two places.

Subsec. (e). Pub. L. 101–629, §19(a)(1)(B), (2)(G)(iii), substituted "section 360ss" for "section 263n" and "this part" for "this subpart".

Subsec. (f). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360qq. Repealed. Pub. L. 105–362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285

Section, act June 25, 1938, ch. 675, §540, formerly act July 1, 1944, ch. 373, title III, §540, formerly §360D, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1185; renumbered §540 and amended Pub. L. 101–629, §19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779, related to annual report on administration of electronic product radiation control program.

§360rr. Federal-State cooperation

The Secretary is authorized (1) to accept from State and local authorities engaged in activities related to health or safety or consumer protection, on a reimbursable basis or otherwise, any assistance in the administration and enforcement of this part which he may request and which they may be able and willing to provide and, if so agreed, may pay in advance or otherwise for the reasonable cost of such assistance, and (2) he may, for the purpose of conducting examinations, investigations, and inspections, commission any officer or employee of any such authority as an officer of the Department.

(June 25, 1938, ch. 675, §541, formerly act July 1, 1944, ch. 373, title III, §541, formerly §360E, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered §541 and amended Pub. L. 101–629, §19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263m of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263m of Title 42, The Public Health and Welfare, as this section.

1990—Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360ss. State standards

Whenever any standard prescribed pursuant to section 360kk of this title with respect to an aspect of performance of an electronic product is in effect, no State or political subdivision of a State shall have any authority either to establish, or to continue in effect, any standard which is applicable to the same aspect of performance of such product and which is not identical to the Federal standard. Nothing in this part shall be construed to prevent the Federal Government or the government of any State or political subdivision thereof from establishing a requirement with respect to emission of radiation from electronic products procured for its own use if such requirement imposes a more restrictive standard than that required to comply with the otherwise applicable Federal standard.

(June 25, 1938, ch. 675, §542, formerly act July 1, 1944, ch. 373, title III, §542, formerly §360F, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered §542 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(H), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263n of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263n of Title 42, The Public Health and Welfare, as this section.

1990—Pub. L. 101–629, §19(a)(1)(B), (2)(H), substituted "section 360kk" for "section 263f" and "this part" for "this subpart".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

Part D—Dissemination of Treatment Information

§§360aaa to 360aaa–6. Omitted

Editorial Notes

Codification

Sections 360aaa to 360aaa–6 ceased to be effective pursuant to section 401(e) of Pub. L. 105–115, set out as an Effective and Termination Dates note below.

Section 360aaa, act June 25, 1938, ch. 675, §551, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2356, related to requirements for dissemination of treatment information on drugs or devices.

Section 360aaa–1, act June 25, 1938, ch. 675, §552, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2358, related to information authorized to be disseminated under section 360aaa.

Section 360aaa–2, act June 25, 1938, ch. 675, §553, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2359, related to establishment of list of articles and publications disseminated and list of providers that received articles and reference publications.

Section 360aaa–3, act June 25, 1938, ch. 675, §554, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2359, related to requirement regarding submission of supplemental application for new use and an exemption from that requirement.

Section 360aaa–4, act June 25, 1938, ch. 675, §555, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2361, related to corrective actions and cessation of dissemination.

Section 360aaa–5, act June 25, 1938, ch. 675, §556, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2362, related to definitions.

Section 360aaa–6, act June 25, 1938, ch. 675, §557, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2363, related to rules of construction.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates

Pub. L. 105–115, title IV, §401(d), Nov. 21, 1997, 111 Stat. 2364, provided that: "The amendments made by this section [enacting this part and amending section 331 of this title] shall take effect 1 year after the date of enactment of this Act [Nov. 21, 1997], or upon the Secretary's issuance of final regulations pursuant to subsection (c) [section 401(c) of Pub. L. 105–115 set out below] [Such regulations were issued effective Nov. 20, 1998. See 63 F.R. 64556.], whichever is sooner."

Pub. L. 105–115, title IV, §401(e), Nov. 21, 1997, 111 Stat. 2364, provided that: "The amendments made by this section [enacting this part and amending section 331 of this title] cease to be effective September 30, 2006, or 7 years after the date on which the Secretary promulgates the regulations described in subsection (c) [section 401(c) of Pub. L. 105–115 set out below] [Such regulations were issued effective Nov. 20, 1998. See 63 F.R. 64556.], whichever is later."

Regulations

Pub. L. 105–115, title IV, §401(c), Nov. 21, 1997, 111 Stat. 2364, provided that: "Not later than 1 year after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall promulgate regulations to implement the amendments made by this section [enacting this part and amending section 331 of this title]."

Part E—General Provisions Relating to Drugs and Devices

§360bbb. Expanded access to unapproved therapies and diagnostics

(a) Emergency situations

The Secretary may, under appropriate conditions determined by the Secretary, authorize the shipment of investigational drugs or investigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations.

(b) Individual patient access to investigational products intended for serious diseases

Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may, after complying with the provisions of this subsection, provide to such physician an investigational drug or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition if—

(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the person from the investigational drug or investigational device is not greater than the probable risk from the disease or condition;

(2) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the use of the investigational drug or investigational device in the case described in paragraph (1);

(3) the Secretary determines that provision of the investigational drug or investigational device will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval; and

(4) the sponsor, or clinical investigator, of the investigational drug or investigational device submits to the Secretary a clinical protocol consistent with the provisions of section 355(i) or 360j(g) of this title, including any regulations promulgated under section 355(i) or 360j(g) of this title, describing the use of the investigational drug or investigational device in a single patient or a small group of patients.

(c) Treatment investigational new drug applications and treatment investigational device exemptions

Upon submission by a sponsor or a physician of a protocol intended to provide widespread access to an investigational drug or investigational device for eligible patients (referred to in this subsection as an "expanded access protocol"), the Secretary shall permit such investigational drug or investigational device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if the Secretary determines that—

(1) under the treatment investigational new drug application or treatment investigational device exemption, the investigational drug or investigational device is intended for use in the diagnosis, monitoring, or treatment of a serious or immediately life-threatening disease or condition;

(2) there is no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat that stage of disease or condition in the population of patients to which the investigational drug or investigational device is intended to be administered;

(3)(A) the investigational drug or investigational device is under investigation in a controlled clinical trial for the use described in paragraph (1) under an investigational drug application in effect under section 355(i) of this title or investigational device exemption in effect under section 360j(g) of this title; or

(B) all clinical trials necessary for approval of that use of the investigational drug or investigational device have been completed;

(4) the sponsor of the controlled clinical trials is actively pursuing marketing approval of the investigational drug or investigational device for the use described in paragraph (1) with due diligence;

(5) in the case of an investigational drug or investigational device described in paragraph (3)(A), the provision of the investigational drug or investigational device will not interfere with the enrollment of patients in ongoing clinical investigations under section 355(i) or 360j(g) of this title;

(6) in the case of serious diseases, there is sufficient evidence of safety and effectiveness to support the use described in paragraph (1); and

(7) in the case of immediately life-threatening diseases, the available scientific evidence, taken as a whole, provides a reasonable basis to conclude that the investigational drug or investigational device may be effective for its intended use and would not expose patients to an unreasonable and significant risk of illness or injury.

A protocol submitted under this subsection shall be subject to the provisions of section 355(i) or 360j(g) of this title, including regulations promulgated under section 355(i) or 360j(g) of this title. The Secretary may inform national, State, and local medical associations and societies, voluntary health associations, and other appropriate persons about the availability of an investigational drug or investigational device under expanded access protocols submitted under this subsection. The information provided by the Secretary, in accordance with the preceding sentence, shall be the same type of information that is required by section 282(i)(3) of title 42.

(d) Termination

The Secretary may, at any time, with respect to a sponsor, physician, manufacturer, or distributor described in this section, terminate expanded access provided under this section for an investigational drug or investigational device if the requirements under this section are no longer met.

(e) Definitions

In this section, the terms "investigational drug", "investigational device", "treatment investigational new drug application", and "treatment investigational device exemption" shall have the meanings given the terms in regulations prescribed by the Secretary.

(June 25, 1938, ch. 675, §561, as added Pub. L. 105–115, title IV, §402, Nov. 21, 1997, 111 Stat. 2365; amended Pub. L. 109–482, title I, §102(f)(2), Jan. 15, 2007, 120 Stat. 3685.)

Editorial Notes

Amendments

2007—Subsec. (c). Pub. L. 109–482 substituted "section 282(i)(3)" for "section 282(j)(3)" in concluding provisions.

Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of Title 42, The Public Health and Welfare.

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Investigational Drugs

Pub. L. 115–52, title VI, §610(a), (b), Aug. 18, 2017, 131 Stat. 1051, 1053, provided that:

"(a) Patient Access to Investigational Drugs.—

"(1) Public meeting.—

"(A) In general.—The Secretary of Health and Human Services (referred to in this section as the 'Secretary'), acting through the Commissioner of Food and Drugs, in coordination with the Director of the National Institutes of Health, and in consultation with patients, health care providers, drug sponsors, bioethicists, and other stakeholders, shall, not later than 270 days after the date of enactment of this Act [Aug. 18, 2007], convene a public meeting to discuss clinical trial inclusion and exclusion criteria to inform the guidance under paragraph (3). The Secretary shall inform the Comptroller General of the United States of the date when the public meeting will take place.

"(B) Topics.—The Secretary shall make available on the internet website of the Food and Drug Administration a report on the topics discussed at the meeting described in subparagraph (A) within 90 days of such meeting. Such topics shall include discussion of—

"(i) the rationale for, and potential barriers for patients created by, research clinical trial inclusion and exclusion criteria;

"(ii) how appropriate patient populations can benefit from the results of trials that employ alternative designs;

"(iii) barriers to participation in clinical trials, including—

     "(I) information regarding any potential risks and benefits of participation;

     "(II) regulatory, geographical, and socioeconomic barriers; and

     "(III) the impact of exclusion criteria on the enrollment in clinical trials of particular populations, including infants and children, pregnant and lactating women, seniors, individuals with advanced disease, and individuals with co-morbid conditions;

"(iv) clinical trial designs and methods, including expanded access trials, that increase enrollment of more diverse patient populations, when appropriate, while facilitating the collection of data to establish safe use and support substantial evidence of effectiveness, including data obtained from expanded access trials; and

"(v) how changes to clinical trial inclusion and exclusion criteria may impact the complexity and length of clinical trials, the data necessary to demonstrate safety and effectiveness, and potential approaches to mitigating those impacts.

"(2) Report.—Not later than 1 year after the Secretary issues the report under paragraph (1)(B), the Comptroller General of the United States shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on individual access to investigational drugs through the expanded access program under section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). The report shall include—

"(A) a description of actions taken by manufacturers and distributors under section 561A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0);

"(B) consideration of whether Form FDA 3926 and the guidance documents titled 'Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers' and 'Individual Patient Expanded Access Applications: Form FDA 3926', issued by the Food and Drug Administration in June 2016, have reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) and improved clarity for patients, physicians, and drug manufacturers about such process;

"(C) consideration of whether the guidance or regulations issued to implement section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) have improved access for individual patients to investigational drugs who do not qualify for clinical trials of such investigational drugs, and what barriers to such access remain;

"(D) an assessment of methods patients and health care providers use to engage with the Food and Drug Administration or drug sponsors on expanded access; and

"(E) an analysis of the Secretary's report under paragraph (1)(B).

"(3) Guidance.—

"(A) In general.—Not later than 1 year after the publication of the report under paragraph (1)(B), the Secretary, acting through the Commissioner of Food and Drugs, shall issue one or more draft guidances regarding eligibility criteria for clinical trials. Not later than 1 year after the public comment period on each such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

"(B) Contents.—The guidance documents described in subparagraph (A) shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to—

"(i) broaden eligibility criteria for clinical trials and expanded access trials, especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need;

"(ii) develop eligibility criteria for, and increase trial recruitment to, clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug, as applicable and as appropriate, while establishing safe use and supporting findings of substantial evidence of effectiveness; and

"(iii) use the criteria described in clauses (i) and (ii) in a manner that is appropriate for drugs intended for the treatment of rare diseases or conditions.

"(b) Improving Institutional Review Board Review of Single Patient Expanded Access Protocol.—Not later than 1 year after the date of enactment of this Act [Aug. 18, 2017], the Secretary, acting through the Commissioner of Food and Drugs, shall issue guidance or regulations, or revise existing guidance or regulations, to streamline the institutional review board review of individual patient expanded access protocols submitted under [section] 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). To facilitate the use of expanded access protocols, any guidance or regulations so issued or revised may include a description of the process for any person acting through a physician licensed in accordance with State law to request that an institutional review board chair (or designated member of the institutional review board) review a single patient expanded access protocol submitted under such section 561(b) for a drug. The Secretary shall update any relevant forms associated with individual patient expanded access requests under such section 561(b) as necessary."

§360bbb–0. Expanded access policy required for investigational drugs

(a) In general

The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 360bbb(b) of this title for provision of such a drug.

(b) Public availability of expanded access policy

The policies under subsection (a) shall be made public and readily available, such as by posting such policies on a publicly available Internet website. Such policies may be generally applicable to all investigational drugs of such manufacturer or distributor.

(c) Content of policy

A policy described in subsection (a) shall include—

(1) contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);

(2) procedures for making such requests;

(3) the general criteria the manufacturer or distributor will use to evaluate such requests for individual patients, and for responses to such requests;

(4) the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests; and

(5) a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug that is required under section 282(j)(2)(A)(ii)(II)(gg) of title 42.

(d) No guarantee of access

The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

(e) Revised policy

Nothing in this section shall prevent a manufacturer or distributor from revising a policy required under this section at any time.

(f) Application

This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the earlier of—

(1) the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational drug; or

(2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 356 of this title.

(June 25, 1938, ch. 675, §561A, as added Pub. L. 114–255, div. A, title III, §3032, Dec. 13, 2016, 130 Stat. 1100; amended Pub. L. 115–52, title VI, §610(c), Aug. 18, 2017, 131 Stat. 1053.)

Editorial Notes

Amendments

2017—Subsec. (f). Pub. L. 115–52 substituted "earlier" for "later" in introductory provisions, added par. (2), redesignated former par. (2) as (1), and struck out former par. (1) which read as follows: "the date that is 60 calendar days after December 13, 2016; or".

§360bbb–0a. Investigational drugs for use by eligible patients

(a) Definitions

For purposes of this section—

(1) the term "eligible patient" means a patient—

(A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations));

(B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who—

(i) is in good standing with the physician's licensing organization or board; and

(ii) will not be compensated directly by the manufacturer for so certifying; and

(C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent;

(2) the term "eligible investigational drug" means an investigational drug (as such term is used in section 360bbb of this title)—

(A) for which a Phase 1 clinical trial has been completed;

(B) that has not been approved or licensed for any use under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262];

(C)(i) for which an application has been filed under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; or

(ii) that is under investigation in a clinical trial that—

(I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; and

(II) is the subject of an active investigational new drug application under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)], as applicable; and

(D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 355(i) of this title; and

(3) the term "phase 1 trial" means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).

(b) Exemptions

Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 352(f), 353(b)(4), 355(a), and 355(i) of this title, section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], and parts 50, 56, and 312 of title 21, Code of Federal Regulations (or any successor regulations), provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the applicable requirements set forth in sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of Federal Regulations (or any successor regulations) that apply to investigational drugs.

(c) Use of clinical outcomes

(1) In general

Notwithstanding any other provision of this chapter, the Public Health Service Act [42 U.S.C. 201 et seq.], or any other provision of Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] unless—

(A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or

(B) the sponsor requests use of such outcomes.

(2) Limitation

If the Secretary makes a determination under paragraph (1)(A), the Secretary shall provide written notice of such determination to the sponsor, including a public health justification for such determination, and such notice shall be made part of the administrative record. Such determination shall not be delegated below the director of the agency center that is charged with the premarket review of the eligible investigational drug.

(d) Reporting

(1) In general

The manufacturer or sponsor of an eligible investigational drug shall submit to the Secretary an annual summary of any use of such drug under this section. The summary shall include the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. The Secretary shall specify by regulation the deadline of submission of such annual summary and may amend section 312.33 of title 21, Code of Federal Regulations (or any successor regulations) to require the submission of such annual summary in conjunction with the annual report for an applicable investigational new drug application for such drug.

(2) Posting of information

The Secretary shall post an annual summary report of the use of this section on the internet website of the Food and Drug Administration, including the number of drugs for which clinical outcomes associated with the use of an eligible investigational drug pursuant to this section was—

(A) used in accordance with subsection (c)(1)(A);

(B) used in accordance with subsection (c)(1)(B); and

(C) not used in the review of an application under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(June 25, 1938, ch. 675, §561B, as added Pub. L. 115–176, §2(a), May 30, 2018, 132 Stat. 1372.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (c)(1), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Statutory Notes and Related Subsidiaries

Limitation of Liability

Pub. L. 115–176, §2(b), May 30, 2018, 132 Stat. 1374, provided that:

"(1) Alleged acts or omissions.—With respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–0a] and in compliance with such section, no liability in a cause of action shall lie against—

"(A) a sponsor or manufacturer; or

"(B) a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer), unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law.

"(2) Determination not to provide drug.—No liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug under section 561B of the Federal Food, Drug, and Cosmetic Act.

"(3) Limitation.—Except as set forth in paragraphs (1) and (2), nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action under any State or Federal product liability, tort, consumer protection, or warranty law."

§360bbb–1. Dispute resolution

If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [42 U.S.C. 262], there is a scientific controversy between the Secretary and a person who is a sponsor, applicant, or manufacturer and no specific provision of the Act involved, including a regulation promulgated under such Act, provides a right of review of the matter in controversy, the Secretary shall, by regulation, establish a procedure under which such sponsor, applicant, or manufacturer may request a review of such controversy, including a review by an appropriate scientific advisory panel described in section 355(n) of this title or an advisory committee described in section 360e(g)(2)(B) of this title. Any such review shall take place in a timely manner. The Secretary shall promulgate such regulations within 1 year after November 21, 1997.

(June 25, 1938, ch. 675, §562, as added Pub. L. 105–115, title IV, §404, Nov. 21, 1997, 111 Stat. 2368.)

Editorial Notes

References in Text

This Act, referred to in text, is the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§360bbb–2. Classification of products

(a) Request

A person who submits an application or submission (including a petition, notification, and any other similar form of request) under this chapter for a product, may submit a request to the Secretary respecting the classification of the product as a drug, biological product, device, or a combination product subject to section 353(g) of this title or respecting the component of the Food and Drug Administration that will regulate the product. In submitting the request, the person shall recommend a classification for the product, or a component to regulate the product, as appropriate.

(b) Statement

Not later than 60 days after the receipt of the request described in subsection (a), the Secretary shall determine the classification of the product under subsection (a), or the component of the Food and Drug Administration that will regulate the product, and shall provide to the person a written statement that identifies such classification or such component, and the reasons for such determination. The Secretary may not modify such statement except with the written consent of the person, or for public health reasons based on scientific evidence.

(c) Inaction of Secretary

If the Secretary does not provide the statement within the 60-day period described in subsection (b), the recommendation made by the person under subsection (a) shall be considered to be a final determination by the Secretary of such classification of the product, or the component of the Food and Drug Administration that will regulate the product, as applicable, and may not be modified by the Secretary except with the written consent of the person, or for public health reasons based on scientific evidence.

(June 25, 1938, ch. 675, §563, as added Pub. L. 105–115, title IV, §416, Nov. 21, 1997, 111 Stat. 2378.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§360bbb–3. Authorization for medical products for use in emergencies

(a) In general

(1) Emergency uses

Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 262], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an "emergency use").

(2) Approval status of product

An authorization under paragraph (1) may authorize an emergency use of a product that—

(A) is not approved, licensed, or cleared for commercial distribution under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title (referred to in this section as an "unapproved product"); or

(B) is approved, conditionally approved under section 360ccc of this title, licensed, or cleared under such a provision, but which use is not under such provision an approved, conditionally approved under section 360ccc of this title, licensed, or cleared use of the product (referred to in this section as an "unapproved use of an approved product").

(3) Relation to other uses

An emergency use authorized under paragraph (1) for a product is in addition to any other use that is authorized for the product under a section of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] referred to in paragraph (2)(A).

(4) Definitions

For purposes of this section:

(A) The term "biological product" has the meaning given such term in section 351 of the Public Health Service Act [42 U.S.C. 262].

(B) The term "emergency use" has the meaning indicated for such term in paragraph (1).

(C) The term "product" means a drug, device, or biological product.

(D) The term "unapproved product" has the meaning indicated for such term in paragraph (2)(A).

(E) The term "unapproved use of an approved product" has the meaning indicated for such term in paragraph (2)(B).

(b) Declaration of emergency or threat justifying emergency authorized use

(1) In general

The Secretary may make a declaration that the circumstances exist justifying the authorization under this subsection for a product on the basis of—

(A) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents;

(B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with—

(i) a biological, chemical, radiological, or nuclear agent or agents; or

(ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces;

(C) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or

(D) the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b] sufficient to affect national security or the health and security of United States citizens living abroad.

(2) Termination of declaration

(A) In general

A declaration under this subsection shall terminate upon the earlier of—

(i) a determination by the Secretary, in consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances described in paragraph (1) have ceased to exist; or

(ii) a change in the approval status of the product such that the circumstances described in subsection (a)(2) have ceased to exist.

(B) Disposition of product

If an authorization under this section with respect to an unapproved product ceases to be effective as a result of a termination under subparagraph (A) of this paragraph, the Secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product.

(3) Advance notice of termination

The Secretary shall provide advance notice that a declaration under this subsection will be terminated. The period of advance notice shall be a period reasonably determined to provide—

(A) in the case of an unapproved product, a sufficient period for disposition of the product, including the return of such product (except such quantities of product as are necessary to provide for continued use consistent with subsection (f)(2)) to the manufacturer (in the case of a manufacturer that chooses to have such product returned); and

(B) in the case of an unapproved use of an approved product, a sufficient period for the disposition of any labeling, or any information under subsection (e)(2)(B)(ii), as the case may be, that was provided with respect to the emergency use involved.

(4) Publication

The Secretary shall promptly publish in the Federal Register each declaration, determination, and advance notice of termination under this subsection.

(5) Explanation by Secretary

If an authorization under this section with respect to an unapproved product or an unapproved use of an approved product has been in effect for more than 1 year, the Secretary shall provide in writing to the sponsor of such product an explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be taken by the Secretary and the sponsor to overcome such obstacles.

(6) Military emergencies

In the case of a determination described in paragraph (1)(B), the Secretary shall determine, within 45 calendar days of such determination, whether to make a declaration under paragraph (1), and, if appropriate, shall promptly make such a declaration.

(c) Criteria for issuance of authorization

The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances described in subsection (b)(1)), the Secretary concludes—

(1) that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or condition;

(2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that—

(A) the product may be effective in diagnosing, treating, or preventing—

(i) such disease or condition; or

(ii) a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this chapter, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262], for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and

(B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable;

(3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;

(4) in the case of a determination described in subsection (b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and

(5) that such other criteria as the Secretary may by regulation prescribe are satisfied.

(d) Scope of authorization

An authorization of a product under this section shall state—

(1) each disease or condition that the product may be used to diagnose, prevent, or treat within the scope of the authorization;

(2) the Secretary's conclusions, made under subsection (c)(2)(B), that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product; and

(3) the Secretary's conclusions, made under subsection (c), concerning the safety and potential effectiveness of the product in diagnosing, preventing, or treating such diseases or conditions, including, to the extent practicable given the circumstances of the emergency, an assessment of the available scientific evidence.

(e) Conditions of authorization

(1) Unapproved product

(A) Required conditions

With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed—

(I) that the Secretary has authorized the emergency use of the product;

(II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and

(III) of the alternatives to the product that are available, and of their benefits and risks.

(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

(I) that the Secretary has authorized the emergency use of the product;

(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

(iii) Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the product.

(iv) For manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.

(B) Authority for additional conditions

With respect to the emergency use of an unapproved product, the Secretary may, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

(i) Appropriate conditions on which entities may distribute the product with respect to the emergency use of the product (including limitation to distribution by government entities), and on how distribution is to be performed.

(ii) Appropriate conditions on who may administer the product with respect to the emergency use of the product, and on the categories of individuals to whom, and the circumstances under which, the product may be administered with respect to such use.

(iii) Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period.

(iv) For persons other than manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.

(2) Unapproved use

With respect to the emergency use of a product that is an unapproved use of an approved product:

(A) For a person who carries out any activity for which the authorization is issued, the Secretary shall, to the extent practicable given the applicable circumstances described in subsection (b)(1), establish conditions described in clauses (i) and (ii) of paragraph (1)(A), and may establish conditions described in clauses (iii) and (iv) of such paragraph or in paragraph (1)(B).

(B)(i) If the authorization under this section regarding the emergency use authorizes a change in the labeling of the product, but the manufacturer of the product chooses not to make such change, such authorization may not authorize distributors of the product or any other person to alter or obscure the labeling provided by the manufacturer, except as provided in section 360bbb–3a of this title with respect to authorized changes to the product expiration date.

(ii) In the circumstances described in clause (i), for a person who does not manufacture the product and who chooses to act under this clause, an authorization under this section regarding the emergency use shall, to the extent practicable given the circumstances of the emergency, authorize such person to provide appropriate information with respect to such product in addition to the labeling provided by the manufacturer, subject to compliance with clause (i). While the authorization under this section is effective, such additional information shall not be considered labeling for purposes of section 352 of this title.

(C) In establishing conditions under this paragraph with respect to the distribution and administration of the product for the unapproved use, the Secretary shall not impose conditions that would restrict distribution or administration of the product when distributed or administered for the approved use.

(3) Good manufacturing practice; prescription

With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the applicable circumstances described in subsection (b)(1)—

(A) requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including such requirements established under section 351 or 360j(f)(1) of this title, and including relevant conditions prescribed with respect to the product by an order under section 360j(f)(2) of this title;

(B) requirements established under subsection (b) or (f) of section 353 of this title or under section 354 of this title; and

(C) requirements established under section 360j(e) of this title.

(4) Advertising

The Secretary may establish conditions on advertisements and other promotional descriptive printed matter that relate to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), including, as appropriate—

(A) with respect to drugs and biological products, requirements applicable to prescription drugs pursuant to section 352(n) of this title; or

(B) with respect to devices, requirements applicable to restricted devices pursuant to section 352(r) of this title.

(f) Duration of authorization

(1) In general

Except as provided in paragraph (2), an authorization under this section shall be effective until the earlier of the termination of the declaration under subsection (b) or a revocation under subsection (g).

(2) Continued use after end of effective period

Notwithstanding the termination of the declaration under subsection (b) or a revocation under subsection (g), an authorization shall continue to be effective to provide for continued use of an unapproved product with respect to a patient to whom, or an animal to which, it was administered during the period described by paragraph (1), to the extent found necessary by such patient's attending physician or by the veterinarian caring for such animal, as applicable.

(g) Review and revocation of authorization

(1) Review

The Secretary shall periodically review the circumstances and the appropriateness of an authorization under this section. As part of such review, the Secretary shall regularly review the progress made with respect to the approval, conditional approval under section 360ccc of this title, licensure, or clearance of—

(A) an unapproved product for which an authorization was issued under this section; or

(B) an unapproved use of an approved product for which an authorization was issued under this section.

(2) Revision and revocation

The Secretary may revise or revoke an authorization under this section if—

(A) the circumstances described under subsection (b)(1) no longer exist;

(B) the criteria under subsection (c) for issuance of such authorization are no longer met; or

(C) other circumstances make such revision or revocation appropriate to protect the public health or safety.

(h) Publication; confidential information

(1) Publication

The Secretary shall promptly publish on the internet website of the Food and Drug Administration and in the Federal Register a notice of each authorization, and each termination or revocation of an authorization under this section, and an explanation of the reasons therefor (which may include a summary of data or information that has been submitted to the Secretary in an application, request, or submission under this section or section 355(b), 355(i), 355(j), 360b(b), 360b(j), 360b(n), 360e, 360(k), 360c(f)(2), 360j(g), 360j(m), 360ccc, or 360ccc–1 of this title, or section 351(a) or 351(k) of the Public Health Service Act [42 U.S.C. 262(a), (k)], even if such summary may reveal the existence of such an application, request, or submission, or data contained in such application, request, or submission). The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration, which may include a summary of the data and information supporting such revisions.

(2) Confidential information

Nothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5. Information made publicly available by the Secretary in accordance with paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18 ¹

(i) Actions committed to agency discretion

Actions under the authority of this section by the Secretary, by the Secretary of Defense, or by the Secretary of Homeland Security are committed to agency discretion.

(j) Rules of construction

The following applies with respect to this section:

(1) Nothing in this section impairs the authority of the President as Commander in Chief of the Armed Forces of the United States under article II, section 2 of the United States Constitution.

(2) Nothing in this section impairs the authority of the Secretary of Defense with respect to the Department of Defense, including the armed forces, under other provisions of Federal law.

(3) Nothing in this section (including any exercise of authority by a manufacturer under subsection (e)(2)) impairs the authority of the United States to use or manage quantities of a product that are owned or controlled by the United States (including quantities in the stockpile maintained under section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b]).

(4) Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the Secretary of any application or submission pending before the Food and Drug Administration for a product for which an authorization under this section is issued.

(k) Relation to other provisions

If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].

(l) Option to carry out authorized activities

Nothing in this section provides the Secretary any authority to require any person to carry out any activity that becomes lawful pursuant to an authorization under this section, and no person is required to inform the Secretary that the person will not be carrying out such activity, except that a manufacturer of a sole-source unapproved product authorized for emergency use shall report to the Secretary within a reasonable period of time after the issuance by the Secretary of such authorization if such manufacturer does not intend to carry out any activity under the authorization. This section only has legal effect on a person who carries out an activity for which an authorization under this section is issued. This section does not modify or affect activities carried out pursuant to other provisions of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262]. Nothing in this subsection may be construed as restricting the Secretary from imposing conditions on persons who carry out any activity pursuant to an authorization under this section.

(m) Categorization of laboratory tests associated with devices subject to authorization

(1) In general

In issuing an authorization under this section with respect to a device, the Secretary may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such device shall be deemed, for purposes of section 353 of the Public Health Service Act [42 U.S.C. 263a], to be in a particular category of examinations and procedures (including the category described by subsection (d)(3) of such section) if, based on the totality of scientific evidence available to the Secretary—

(A) such categorization would be beneficial to protecting the public health; and

(B) the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.

(2) Conditions of determination

The Secretary may establish appropriate conditions on the performance of the examination or procedure pursuant to such determination.

(3) Effective period

A determination under this subsection shall be effective for purposes of section 353 of the Public Health Service Act [42 U.S.C. 263a] notwithstanding any other provision of that section during the effective period of the relevant declaration under subsection (b).

(June 25, 1938, ch. 675, §564, as added Pub. L. 108–136, div. A, title XVI, §1603(a), Nov. 24, 2003, 117 Stat. 1684; amended Pub. L. 108–276, §4(a), July 21, 2004, 118 Stat. 853; Pub. L. 113–5, title III, §302(a), Mar. 13, 2013, 127 Stat. 179; Pub. L. 114–255, div. A, title III, §3088(a), Dec. 13, 2016, 130 Stat. 1148; Pub. L. 115–92, §1(a), Dec. 12, 2017, 131 Stat. 2023; Pub. L. 117–328, div. FF, title II, §2504, Dec. 29, 2022, 136 Stat. 5802.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (a)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2022—Subsec. (h)(1). Pub. L. 117–328, §2504(1)(A), (C), inserted "on the internet website of the Food and Drug Administration and" after "promptly publish" and ", which may include a summary of the data and information supporting such revisions" before period at end of second sentence.

Pub. L. 117–328, §2504(1)(B), which directed substitution of "application, request, or submission under this section or section 355(b), 355(i), 355(j), 360b(b), 360b(j), 360b(n), 360e, 360(k), 360c(f)(2), 360j(g), 360j(m), 360ccc, or 360ccc–1 of this title, or section 351(a) or 351(k) of the Public Health Service Act, even if such summary may reveal the existence of such an application, request, or submission, or data contained in such application, request, or submission" for "application under section 355(i), 360b(j), or 360j(g) of this title, even if such summary may indirectly reveal the existence of such application", was executed by making the substitution for "application under section 355(i) 360b(j), or 360j(g) of this title, even if such summary may indirectly reveal the existence of such application", to reflect the probable intent of Congress.

Subsec. (h)(2). Pub. L. 117–328, §2504(2), inserted at end "Information made publicly available by the Secretary in accordance with paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18".

2017—Subsec. (b)(1)(B). Pub. L. 115–92, §1(a)(1)(A), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a biological, chemical, radiological, or nuclear agent or agents;".

Subsec. (b)(6). Pub. L. 115–92, §1(a)(1)(B), added par. (6).

Subsec. (c)(4), (5). Pub. L. 115–92, §1(a)(2), added par. (4) and redesignated former par. (4) as (5).

2016—Subsec. (a)(2)(A). Pub. L. 114–255, §3088(a)(1)(A), substituted "360b, or 360e" for "or 360e" and inserted "or conditionally approved under section 360ccc of this title" after "Public Health Service Act".

Subsec. (a)(2)(B). Pub. L. 114–255, §3088(a)(1)(B), inserted "conditionally approved under section 360ccc of this title," after "approved," in two places.

Subsec. (b)(4). Pub. L. 114–255, §3088(a)(2), struck out second comma after "determination".

Subsec. (e)(3)(B). Pub. L. 114–255, §3088(a)(3), substituted "subsection (b) or (f) of section 353 of this title or under section 354 of this title" for "section 353(b) of this title".

Subsec. (f)(2). Pub. L. 114–255, §3088(a)(4), inserted ", or an animal to which," after "to a patient to whom" and "or by the veterinarian caring for such animal, as applicable" after "attending physician".

Subsec. (g)(1). Pub. L. 114–255, §3088(a)(5), inserted "conditional approval under section 360ccc of this title," after "approval,".

Subsec. (h)(1). Pub. L. 114–255, §3088(a)(6), substituted "360b(j), or 360j(g) of this title" for "or section 360j(g) of this title".

Subsec. (k). Pub. L. 114–255, §3088(a)(7), substituted "360b(j), or 360j(g) of this title" for "section 360j(g) of this title,".

2013—Subsec. (a)(1). Pub. L. 113–5, §302(a)(1)(A), substituted "any provision of this chapter" for "sections 355, 360(k), and 360e of this title".

Subsec. (a)(2)(A). Pub. L. 113–5, §302(a)(1)(B), substituted "under section 355, 360(k), or 360e of this title or section 351 of the Public Health Service Act" for "under a provision of law referred to in such paragraph".

Subsec. (a)(3). Pub. L. 113–5, §302(a)(1)(C), substituted "a section of this chapter or the Public Health Service Act referred to in paragraph (2)(A)" for "a provision of law referred to in such paragraph".

Subsec. (b). Pub. L. 113–5, §302(a)(2)(A), inserted "or threat justifying emergency authorized use" after "emergency" in heading.

Subsec. (b)(1). Pub. L. 113–5, §302(a)(2)(B), substituted "may make a declaration that the circumstances exist" for "may declare an emergency" in introductory provisions, struck out "specified" before "biological" in subpars. (A) and (B), added subpar. (D), and amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: "a determination by the Secretary of a public health emergency under section 319 of the Public Health Service Act that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents."

Subsec. (b)(2)(A)(ii). Pub. L. 113–5, §302(a)(2)(C)(i), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: "the expiration of the one-year period beginning on the date on which the declaration is made."

Subsec. (b)(2)(B), (C). Pub. L. 113–5, §302(a)(2)(C)(ii), (iii), redesignated subpar. (C) as (B) and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: "Notwithstanding subparagraph (A), the Secretary may renew a declaration under this subsection, and this paragraph shall apply to any such renewal."

Subsec. (b)(4). Pub. L. 113–5, §302(a)(2)(D), substituted ", and advance notice of termination under this subsection" for "advance notice of termination, and renewal under this subsection".

Subsec. (b)(5). Pub. L. 113–5, §302(a)(2)(E), added par. (5).

Subsec. (c). Pub. L. 113–5, §302(a)(3)(A), in introductory provisions, inserted "the Assistant Secretary for Preparedness and Response," after "consultation with" and substituted "Director of the National Institutes of Health, and" for "Director of the National Institutes of Health and" and "applicable circumstances described in subsection (b)(1)" for "circumstances of the emergency involved".

Subsec. (c)(1). Pub. L. 113–5, §302(a)(3)(B), substituted "referred to" for "specified".

Subsec. (c)(2)(B). Pub. L. 113–5, §302(a)(3)(C), inserted ", taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable" after "risks of the product".

Subsec. (d)(3). Pub. L. 113–5, §302(a)(4), inserted ", to the extent practicable given the circumstances of the emergency," after "including".

Subsec. (e)(1)(A). Pub. L. 113–5, §302(a)(5)(A), substituted "applicable circumstances described in subsection (b)(1)" for "circumstances of the emergency" in introductory provisions.

Subsec. (e)(1)(B)(iii). Pub. L. 113–5, §302(a)(5)(B), amended cl. (iii) generally. Prior to amendment, cl. (iii) read as follows: "Appropriate conditions with respect to the collection and analysis of information, during the period when the authorization is in effect, concerning the safety and effectiveness of the product with respect to the emergency use of such product."

Subsec. (e)(2)(A). Pub. L. 113–5, §302(a)(5)(C)(i), substituted "person" for "manufacturer of the product" and "applicable circumstances described in subsection (b)(1)" for "circumstances of the emergency" and inserted "or in paragraph (1)(B)" before period at end.

Subsec. (e)(2)(B)(i). Pub. L. 113–5, §302(a)(5)(C)(ii), inserted ", except as provided in section 360bbb–3a of this title with respect to authorized changes to the product expiration date" before period at end.

Subsec. (e)(2)(C). Pub. L. 113–5, §302(a)(5)(C)(iii), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: "The Secretary may establish with respect to the distribution and administration of the product for the unapproved use conditions no more restrictive than those established by the Secretary with respect to the distribution and administration of the product for the approved use."

Subsec. (e)(3). Pub. L. 113–5, §302(a)(5)(D), amended par. (3) generally. Prior to amendment, text read as follows: "With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the circumstances of the emergency, requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including such requirements established under section 351 of this title."

Subsec. (g). Pub. L. 113–5, §302(a)(6)(A), substituted "Review and revocation" for "Revocation" in heading.

Subsec. (g)(1). Pub. L. 113–5, §302(a)(6)(B), inserted at end "As part of such review, the Secretary shall regularly review the progress made with respect to the approval, licensure, or clearance of—

"(A) an unapproved product for which an authorization was issued under this section; or

"(B) an unapproved use of an approved product for which an authorization was issued under this section."

Subsec. (g)(2). Pub. L. 113–5, §302(a)(6)(C), amended par. (2) generally. Prior to amendment, text read as follows: "The Secretary may revoke an authorization under this section if the criteria under subsection (c) of this section for issuance of such authorization are no longer met or other circumstances make such revocation appropriate to protect the public health or safety."

Subsec. (h)(1). Pub. L. 113–5, §302(a)(7), inserted at end "The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration."

Subsec. (j)(4). Pub. L. 113–5, §302(a)(8), added par. (4).

Subsec. (m). Pub. L. 113–5, §302(a)(9), added subsec. (m).

2004—Pub. L. 108–276 amended section generally, substituting provisions of subsecs. (a) to (l) for similar former provisions, except for additional provisions in subsec. (b)(1) allowing Secretary to authorize use of medical products in actual or potential domestic and public health emergencies in addition to actual or potential military emergencies.

Executive Documents

Making General Use Respirators Available

Memorandum of President of the United States, Mar. 11, 2020, 85 F.R. 15049, provided:

Memorandum for the Secretary of Health and Human Services [and] the Secretary of Labor

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

It is the policy of the United States to take proactive measures to prepare for and respond to public health threats, including the public health emergency involving Coronavirus Disease 2019 (COVID–19), which was declared by the Secretary of Health and Human Services on February 4, 2020, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3). We must ensure that our healthcare providers have full access to the products they need. On March 10, 2020, the Secretary of Health and Human Services took action by issuing a declaration pursuant to section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d), which will help bring products necessary for addressing the epidemic to healthcare providers across the Nation. Unfortunately, at present, public health experts anticipate shortages in the supply of personal respiratory devices (respirators) available for use by healthcare workers in mitigating further transmission of COVID–19.

To help prevent the spread of COVID–19, the Secretary of Health and Human Services shall take all appropriate and necessary steps with respect to general use respirators to facilitate their emergency use by healthcare personnel in healthcare facilities and elsewhere, including under the authorities granted by section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d) and section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3). Additionally, the Secretary of Labor shall consider all appropriate and necessary steps to increase the availability of respirators.

The Secretary of Health and Human Services is authorized and directed to publish this memorandum in the Federal Register.

Donald J. Trump.      

¹ So in original. Probably should be followed by a period.

§360bbb–3a. Emergency use of medical products

(a) Definitions

In this section:

(1) Eligible product

The term "eligible product" means a product that—

(A) is approved or cleared under this subchapter, conditionally approved under section 360ccc of this title, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262];

(B)(i) is intended for use to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents; or

(ii) is intended for use to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by a product described in clause (i); and

(C) is intended for use during the circumstances under which—

(i) a determination described in subparagraph (A), (B), or (C) of section 360bbb–3(b)(1) of this title has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or

(ii) the identification of a material threat described in subparagraph (D) of section 360bbb–3(b)(1) of this title has been made pursuant to section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b].

(2) Product

The term "product" means a drug, device, or biological product.

(b) Expiration dating

(1) In general

The Secretary may extend the expiration date and authorize the introduction or delivery for introduction into interstate commerce of an eligible product after the expiration date provided by the manufacturer if—

(A) the expiration date extension is intended to support the United States ability to protect—

(i) the public health; or

(ii) military preparedness and effectiveness; and

(B) the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the Secretary.

(2) Requirements and conditions

Any extension of an expiration date under paragraph (1) shall, as part of the extension, identify—

(A) each specific lot, batch, or other unit of the product for which extended expiration is authorized;

(B) the duration of the extension; and

(C) any other requirements or conditions as the Secretary may deem appropriate for the protection of the public health, which may include requirements for, or conditions on, product sampling, storage, packaging or repackaging, transport, labeling, notice to product recipients, recordkeeping, periodic testing or retesting, or product disposition.

(3) Effect

Notwithstanding any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], an eligible product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has, under paragraph (1), extended the expiration date and authorized the introduction or delivery for introduction into interstate commerce of such product after the expiration date provided by the manufacturer.

(4) Expiration date

For purposes of this subsection, the term "expiration date" means the date established through appropriate stability testing required by the regulations issued by the Secretary to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use.

(c) Current good manufacturing practice

(1) In general

The Secretary may, when the circumstances of a domestic, military, or public health emergency or material threat described in subsection (a)(1)(C) so warrant, authorize, with respect to an eligible product, deviations from current good manufacturing practice requirements otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including requirements under section 351 or 360j(f)(1) of this title or applicable conditions prescribed with respect to the eligible product by an order under section 360j(f)(2) of this title.

(2) Effect

Notwithstanding any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], an eligible product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1).

(d) Emergency dispensing

The requirements of subsections (b) and (f) of section 353, section 354, and section 360j(e) of this title shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title) and shall not be deemed adulterated or misbranded under this chapter because it is dispensed without an individual prescription, if—

(1) the product is dispensed during the circumstances described in subsection (a)(1)(C); and

(2) such dispensing without an individual prescription occurs—

(A) as permitted under the law of the State in which the product is dispensed; or

(B) in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances described in subsection (a)(1)(C).

(e) Emergency use instructions

(1) In general

The Secretary, acting through an appropriate official within the Department of Health and Human Services, may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning such product's approved, licensed, or cleared conditions of use.

(2) Effect

Notwithstanding any other provisions of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], a product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this chapter because of the issuance of emergency use instructions under paragraph (1) with respect to such product or the introduction or delivery for introduction of such product into interstate commerce accompanied by such instructions—

(A) during an emergency response to an actual emergency that is the basis for a determination described in subsection (a)(1)(C); or

(B) by a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, in preparation for an emergency response.

(June 25, 1938, ch. 675, §564A, as added Pub. L. 113–5, title III, §302(b), Mar. 13, 2013, 127 Stat. 183; amended Pub. L. 114–255, div. A, title III, §3088(c), Dec. 13, 2016, 130 Stat. 1149; Pub. L. 116–22, title VII, §705(c), June 24, 2019, 133 Stat. 964.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsecs. (b)(3), (c)(2), and (e)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2019—Subsec. (e)(2)(A). Pub. L. 116–22 substituted "subsection (a)(1)(C)" for "subsection (a)(1)(C)(i)".

2016—Subsec. (a)(1)(A). Pub. L. 114–255, §3088(c)(1), inserted ", conditionally approved under section 360ccc of this title," after "subchapter".

Subsec. (d). Pub. L. 114–255, §3088(c)(2), substituted "subsections (b) and (f) of section 353, section 354, and section 360j(e) of this title" for "sections 353(b) and 360j(e) of this title" in introductory provisions.

§360bbb–3b. Products held for emergency use

It is not a violation of any section of this chapter or of the Public Health Service Act [42 U.S.C. 201 et seq.] for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 360bbb–3(a)(4) of this title) intended for emergency use, if that product—

(1) is intended to be held and not used; and

(2) is held and not used, unless and until that product—

(A) is approved, cleared, or licensed under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title;

(B) is authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or

(C) is authorized for use under section 360bbb–3 of this title or section 360bbb–3a of this title.

(June 25, 1938, ch. 675, §564B, as added Pub. L. 113–5, title III, §302(d), Mar. 13, 2013, 127 Stat. 185; amended Pub. L. 114–255, div. A, title III, §3088(d), Dec. 13, 2016, 130 Stat. 1149; Pub. L. 116–22, title VII, §705(d), June 24, 2019, 133 Stat. 964.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in text, is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2019—Par. (2)(B). Pub. L. 116–22, §705(d)(1), inserted comma after "355".

Par. (2)(C). Pub. L. 116–22, §705(d)(2), inserted "or section 360bbb–3a of this title" before period at end.

2016—Par. (2)(A). Pub. L. 114–255, §3088(d)(1), substituted "360b, or 360e of this title" for "or 360e of this title" and inserted "or conditionally approved under section 360ccc of this title" after "Public Health Service Act".

Par. (2)(B). Pub. L. 114–255, §3088(d)(2), substituted "360b, or 360j of this title" for "or 360j of this title".

§360bbb–3c. Expedited development and review of medical products for emergency uses

(1) In general

The Secretary of Defense may request that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, take actions to expedite the development of a medical product, review of investigational new drug applications under section 355(i) of this title, review of investigational device exemptions under section 360j(g) of this title, and review of applications for approval and clearance of medical products under sections 355, 360(k), and 360e of this title and section 262 of title 42, including applications for licensing of vaccines or blood as biological products under such section 262 of title 42, or applications for review of regenerative medicine advanced therapy products under section 356(g) of this title, if there is a military emergency, or significant potential for a military emergency, involving a specific and imminently life-threatening risk to United States military forces of attack with an agent or agents, and the medical product that is the subject of such application, submission, or notification would be reasonably likely to diagnose, prevent, treat, or mitigate such life-threatening risk.

(2) Actions

Upon a request by the Secretary of Defense under paragraph (1), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall take action to expedite the development and review of an applicable application or notification with respect to a medical product described in paragraph (1), which may include, as appropriate—

(A) holding meetings with the sponsor and the review team throughout the development of the medical product;

(B) providing timely advice to, and interactive communication with, the sponsor regarding the development of the medical product to ensure that the development program to gather the nonclinical and clinical data necessary for approval or clearance is as efficient as practicable;

(C) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

(D) assigning a cross-disciplinary project lead for the review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor;

(E) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment;

(F) applying any applicable Food and Drug Administration program intended to expedite the development and review of a medical product; and

(G) in appropriate circumstances, permitting expanded access to the medical product during the investigational phase, in accordance with applicable requirements of the Food and Drug Administration.

(3) Enhanced collaboration and communication

In order to facilitate enhanced collaboration and communication with respect to the most current priorities of the Department of Defense—

(A) the Food and Drug Administration shall meet with the Department of Defense and any other appropriate development partners, such as the Biomedical Advanced Research and Development Authority, on a semi-annual basis for the purposes of conducting a full review of the relevant products in the Department of Defense portfolio; and

(B) the Director of the Center for Biologics Evaluation and Research shall meet quarterly with the Department of Defense to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that are the highest priorities to the Department of Defense (which may include freeze dried plasma products and platelet alternatives),

unless the Secretary of Defense determines that any such meetings are not necessary.

(4) Medical product

In this subsection, the term "medical product" means a drug (as defined in section 321 of this title), a device (as defined in such section 321 of this title), or a biological product (as defined in section 262 of title 42).

(Pub. L. 115–92, §1(b), Dec. 12, 2017, 131 Stat. 2023.)

Editorial Notes

Codification

Section was enacted as part of Pub. L. 115–92, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§360bbb–4. Countermeasure development, review, and technical assistance

(a) Definitions

In this section—

(1) the term "countermeasure" means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic product;

(2) the term "qualified countermeasure" has the meaning given such term in section 247d–6a of title 42;

(3) the term "security countermeasure" has the meaning given such term in section 247d–6b of title 42; and

(4) the term "qualified pandemic or epidemic product" means a product that meets the definition given such term in section 247d–6d of title 42 and—

(A) that has been identified by the Department of Health and Human Services or the Department of Defense as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including pandemic influenza; or

(B) is included under this paragraph pursuant to a determination by the Secretary.

(b) General duties

In order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, shall—

(1) ensure the appropriate involvement of Food and Drug Administration personnel in interagency activities related to countermeasure advanced research and development, consistent with sections 247d–6, 247d–6a, 247d–6b, 247d–6d, 247d–7e, and 300hh–10 of title 42;

(2) ensure the appropriate involvement and consultation of Food and Drug Administration personnel in any flexible manufacturing activities carried out under section 247d–7e of title 42, including with respect to meeting regulatory requirements set forth in this chapter;

(3) promote countermeasure expertise within the Food and Drug Administration by—

(A) ensuring that Food and Drug Administration personnel involved in reviewing countermeasures for approval, licensure, or clearance are informed by the Assistant Secretary for Preparedness and Response on the material threat assessment conducted under section 247d–6b of title 42 for the agent or agents for which the countermeasure under review is intended;

(B) training Food and Drug Administration personnel regarding review of countermeasures for approval, licensure, or clearance;

(C) holding public meetings at least twice annually to encourage the exchange of scientific ideas; and

(D) establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures;

(4) maintain teams, composed of Food and Drug Administration personnel with expertise on countermeasures, including specific countermeasures, populations with special clinical needs (including children and pregnant women that may use countermeasures, as applicable and appropriate), classes or groups of countermeasures, or other countermeasure-related technologies and capabilities, that shall—

(A) consult with countermeasure experts, including countermeasure sponsors and applicants, to identify and help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops or public meetings; and

(B) improve and advance the science relating to the development of new tools, standards, and approaches to assessing and evaluating countermeasures—

(i) in order to inform the process for countermeasure approval, clearance, and licensure; and

(ii) with respect to the development of countermeasures for populations with special clinical needs, including children and pregnant women, in order to meet the needs of such populations, as necessary and appropriate; and

(5) establish within the Food and Drug Administration a team of experts on manufacturing and regulatory activities (including compliance with current Good Manufacturing Practice) to provide both off-site and on-site technical assistance to the manufacturers of qualified countermeasures (as defined in section 247d–6a of title 42), security countermeasures (as defined in section 247d–6b of title 42), or vaccines, at the request of such a manufacturer and at the discretion of the Secretary, if the Secretary determines that a shortage or potential shortage may occur in the United States in the supply of such vaccines or countermeasures and that the provision of such assistance would be beneficial in helping alleviate or avert such shortage.

(c) Final guidance on development of animal models

(1) In general

Not later than 1 year after March 13, 2013, the Secretary shall provide final guidance to industry regarding the development of animal models to support approval, clearance, or licensure of countermeasures referred to in subsection (a) when human efficacy studies are not ethical or feasible.

(2) Authority to extend deadline

The Secretary may extend the deadline for providing final guidance under paragraph (1) by not more than 6 months upon submission by the Secretary of a report on the status of such guidance to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.

(d) Development and animal modeling procedures

(1) Availability of animal model meetings

To facilitate the timely development of animal models and support the development, stockpiling, licensure, approval, and clearance of countermeasures, the Secretary shall, not later than 180 days after March 13, 2013, establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive—

(A) a meeting to discuss proposed animal model development activities; and

(B) a meeting prior to initiating pivotal animal studies.

(2) Pediatric models

To facilitate the development and selection of animal models that could translate to pediatric studies, any meeting conducted under paragraph (1) shall include discussion of animal models for pediatric populations, as appropriate.

(e) Review and approval of countermeasures

(1) Material threat

When evaluating an application or submission for approval, licensure, or clearance of a countermeasure, the Secretary shall take into account the material threat posed by the chemical, biological, radiological, or nuclear agent or agents identified under section 247d–6b of title 42 for which the countermeasure under review is intended.

(2) Review expertise

When practicable and appropriate, teams of Food and Drug Administration personnel reviewing applications or submissions described under paragraph (1) shall include a reviewer with sufficient training or experience with countermeasures pursuant to the protocols established under subsection (b)(3)(D).

(f) Regulatory management plan

(1) Definition

In this subsection, the term "eligible countermeasure" means—

(A) a security countermeasure with respect to which the Secretary has entered into a procurement contract under section 247d–6b(c) of title 42; or

(B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under section 247d–7e of title 42 for advanced research and development.

(2) Regulatory management plan process

The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority, shall establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans in accordance with this subsection.

(3) Publication

The Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including—

(A) the process by which an applicant may submit a request for a regulatory management plan;

(B) the timeframe by which the Secretary is required to respond to such request;

(C) the information required for the submission of such request;

(D) a description of the types of development milestones and performance targets that could be discussed and included in such plans; and

(E) contact information for beginning the regulatory management plan process.

(4) Submission of request and proposed plan by sponsor or applicant

(A) In general

A sponsor or applicant of an eligible countermeasure may initiate the process described under paragraph (2) upon submission of a written request to the Secretary. Such request shall include a proposed regulatory management plan.

(B) Timing of submission

A sponsor or applicant may submit a written request under subparagraph (A) after the eligible countermeasure has an investigational new drug or investigational device exemption in effect.

(C) Response by Secretary

The Secretary shall direct the Food and Drug Administration, upon submission of a written request by a sponsor or applicant under subparagraph (A), to work with the sponsor or applicant to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the Secretary determines that no plan can be agreed upon, the Secretary shall provide to the sponsor or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached.

(5) Plan

The content of a regulatory management plan agreed to by the Secretary and a sponsor or applicant shall include—

(A) an agreement between the Secretary and the sponsor or applicant regarding developmental milestones that will trigger responses by the Secretary as described in subparagraph (B);

(B) performance targets and goals for timely and appropriate responses by the Secretary to the triggers described under subparagraph (A), including meetings between the Secretary and the sponsor or applicant, written feedback, decisions by the Secretary, and other activities carried out as part of the development and review process; and

(C) an agreement on how the plan shall be modified, if needed.

(6) Milestones and performance targets

The developmental milestones described in paragraph (5)(A) and the performance targets and goals described in paragraph (5)(B) shall include—

(A) feedback from the Secretary regarding the data required to support the approval, clearance, or licensure of the eligible countermeasure involved;

(B) feedback from the Secretary regarding the data necessary to inform any authorization under section 360bbb–3 of this title;

(C) feedback from the Secretary regarding the data necessary to support the positioning and delivery of the eligible countermeasure, including to the Strategic National Stockpile;

(D) feedback from the Secretary regarding the data necessary to support the submission of protocols for review under section 355(b)(5)(B) of this title;

(E) feedback from the Secretary regarding any gaps in scientific knowledge that will need resolution prior to approval, licensure, or clearance of the eligible countermeasure and plans for conducting the necessary scientific research;

(F) identification of the population for which the countermeasure sponsor or applicant seeks approval, licensure, or clearance and the population for which desired labeling would not be appropriate, if known; and

(G) as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible countermeasure, provided that such plan would not delay authorization under section 360bbb–3 of this title, approval, licensure, or clearance for adults.

(7) Prioritization

(A) Plans for security countermeasures

The Secretary shall establish regulatory management plans for all security countermeasures for which a request is submitted under paragraph (4)(A).

(B) Plans for other eligible countermeasures

The Secretary shall determine whether resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures. If resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures, and if resources are not available to establish regulatory management plans for all eligible countermeasures for which requests have been submitted, the Director of the Biomedical Advanced Research and Development Authority, in consultation with the Commissioner, shall prioritize which eligible countermeasures may receive regulatory management plans.

(g) Annual report

Not later than 180 days after March 13, 2013, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food and Drug Administration a report that details the countermeasure development and review activities of the Food and Drug Administration, including—

(1) with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures—

(A) the identification of the priorities of the Food and Drug Administration and the progress made on such priorities; and

(B) the identification of scientific gaps that impede the development, approval, licensure, or clearance of countermeasures for populations with special clinical needs, including children and pregnant women, and the progress made on resolving these challenges;

(2) with respect to countermeasures for which a regulatory management plan has been agreed upon under subsection (f), the extent to which the performance targets and goals set forth in subsection (f)(4)(B) and the regulatory management plan have been met, including, for each such countermeasure—

(A) whether the regulatory management plan was completed within the required timeframe, and the length of time taken to complete such plan;

(B) whether the Secretary adhered to the timely and appropriate response times set forth in such plan; and

(C) explanations for any failure to meet such performance targets and goals;

(3) the number of regulatory teams established pursuant to subsection (b)(4), the number of products, classes of products, or technologies assigned to each such team, and the number of, type of, and any progress made as a result of consultations carried out under subsection (b)(4)(A);

(4) an estimate of resources obligated to countermeasure development and regulatory assessment, including—

(A) Center-specific objectives and accomplishments; and

(B) the number of full-time equivalent employees of the Food and Drug Administration who directly support the review of countermeasures;

(5) the number of countermeasure applications and submissions submitted, the number of countermeasures approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to section 360bbb–3 of this title;

(6) the number of written requests for a regulatory management plan submitted under subsection (f)(3)(A), the number of regulatory management plans developed, and the number of such plans developed for security countermeasures; and

(7) the number, type, and frequency of meetings between the Food and Drug Administration and—

(A) sponsors of a countermeasure as defined in subsection (a); or

(B) another agency engaged in development or management of portfolios for such countermeasures, including the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the National Institutes of Health, and the appropriate agencies of the Department of Defense.

(h) Accelerating countermeasure development and review during an emergency

(1) Acceleration of countermeasure development and review

The Secretary may, at the request of the sponsor of a countermeasure, during a domestic, military, or public health emergency or material threat described in section 360bbb–3a(a)(1)(C) of this title, expedite the development and review of countermeasures that are intended to address such domestic, military, or public health emergency or material threat for approval, licensure, clearance, or authorization under this title or section 262 of title 42.

(2) Actions

The actions to expedite the development and review of a countermeasure under paragraph (1) may include the following:

(A) Expedited review of submissions made by sponsors of countermeasures to the Food and Drug Administration, including rolling submissions of countermeasure applications and other submissions.

(B) Expedited and increased engagement with sponsors regarding countermeasure development and manufacturing, including—

(i) holding meetings with the sponsor and the review team and providing timely advice to, and interactive communication with, the sponsor regarding the development of the countermeasure to ensure that the development program to gather the nonclinical and clinical data necessary for approval, licensure, clearance, or authorization is as efficient as practicable;

(ii) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

(iii) assigning a cross-disciplinary project lead for the review team to facilitate;

(iv) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; and

(v) streamlining the review of approved, licensed, cleared, or authorized countermeasures to treat or prevent new or emerging threats, including the review of any changes to such countermeasures.

(C) Expedited issuance of guidance documents and publication of other regulatory information regarding countermeasure development and manufacturing.

(D) Other steps to expedite the development and review of a countermeasure application submitted for approval, licensure, clearance, or authorization, as the Secretary determines appropriate.

(3) Limitation of effect

Nothing in this subsection shall be construed to require the Secretary to grant, or take any other action related to, a request of a sponsor to expedite the development and review of a countermeasure for approval, licensure, clearance, or authorization under paragraph (1).

(i) Third party evaluation of tests used during an emergency

(1) In general

For purposes of conducting evaluations regarding whether an in vitro diagnostic product (as defined in section 809.3 of title 21, Code of Federal Regulations (or any successor regulations)) for which a request for emergency use authorization is submitted under section 360bbb–3 of this title meets the criteria for issuance of such authorization, the Secretary may, as appropriate, consult with persons with appropriate expertise with respect to such evaluations or enter into cooperative agreements or contracts with such persons under which such persons conduct such evaluations and make such recommendations, including, as appropriate, evaluations and recommendations regarding the scope of authorization and conditions of authorization.

(2) Requirements regarding evaluations and recommendations

(A) In general

In evaluating and making recommendations to the Secretary regarding the validity, accuracy, and reliability of in vitro diagnostic products, as described in paragraph (1), a person shall consider and document whether the relevant criteria under subsection (c)(2) of section 360bbb–3 of this title for issuance of authorization under such section are met with respect to the in vitro diagnostic product.

(B) Written recommendations

Recommendations made by a person under this subsection shall be submitted to the Secretary in writing, and shall include the reasons for such recommendation and other information that may be requested by the Secretary.

(3) Rule of construction

Nothing in this subsection shall be construed to require the Secretary to consult with, or enter into cooperative agreements or contracts with, persons as described in paragraph (1) for purposes of authorizing an in vitro diagnostic product or otherwise affecting the emergency use authorization authorities under this section or section 360bbb–3 of this title.

(June 25, 1938, ch. 675, §565, as added Pub. L. 109–417, title IV, §404, Dec. 19, 2006, 120 Stat. 2875; amended Pub. L. 113–5, title III, §§303–306, Mar. 13, 2013, 127 Stat. 185–190; Pub. L. 116–22, title V, §503, June 24, 2019, 133 Stat. 951; Pub. L. 117–328, div. FF, title II, §§2501, 2502(a), Dec. 29, 2022, 136 Stat. 5796, 5797.)

Editorial Notes

Amendments

2022—Subsec. (h). Pub. L. 117–328, §2501, added subsec. (h).

Subsec. (i). Pub. L. 117–328, §2502(a), added subsec. (i).

2019—Subsec. (f)(3) to (5). Pub. L. 116–22, §503(1), (2), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively. Former par. (5) redesignated (6).

Subsec. (f)(6). Pub. L. 116–22, §503(1), (3), redesignated par. (5) as (6) and, in introductory provisions, substituted "paragraph (5)(A)" for "paragraph (4)(A)" and "paragraph (5)(B)" for "paragraph (4)(B)". Former par. (6) redesignated (7).

Subsec. (f)(7). Pub. L. 116–22, §503(1), redesignated par. (6) as (7).

Subsec. (f)(7)(A). Pub. L. 116–22, §503(4), substituted "paragraph (4)(A)" for "paragraph (3)(A)".

2013—Pub. L. 113–5, §304(1), substituted "Countermeasure development, review, and technical assistance" for "Technical assistance" in section catchline.

Pub. L. 113–5, §303, designated existing provisions as subsec. (b) and inserted heading.

Subsec. (a). Pub. L. 113–5, §303, added subsec. (a).

Subsec. (b). Pub. L. 113–5, §304(2), reenacted heading without change, substituted "In order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, shall—" for "The Secretary, in consultation with the Commissioner of Food and Drugs, shall", added pars. (1) to (4), and designated remainder of existing provisions as par. (5).

Subsecs. (c) to (e). Pub. L. 113–5, §304(3), added subsecs. (c) to (e).

Subsec. (f). Pub. L. 113–5, §305, added subsec. (f).

Subsec. (g). Pub. L. 113–5, §306, added subsec. (g).

Statutory Notes and Related Subsidiaries

Guidance

Pub. L. 117–328, div. FF, title II, §2502(b), Dec. 29, 2022, 136 Stat. 5798, provided that: "Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall issue draft guidance on consultations with persons under subsection (i) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as added by subsection (a), including considerations concerning conflicts of interest, compensation arrangements, and information sharing. Not later than 1 year after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance."

Predictable Review Timelines of Vaccines by the Advisory Committee on Immunization Practices

Pub. L. 114–255, div. A, title III, §3091, Dec. 13, 2016, 130 Stat. 1149, provided that:

"(a) Consideration of New Vaccines.—Upon the licensure of any vaccine or any new indication for a vaccine, the Advisory Committee on Immunization Practices (in this section referred to as the 'Advisory Committee') shall, as appropriate, consider the use of the vaccine at its next regularly scheduled meeting.

"(b) Additional Information.—If the Advisory Committee does not make a recommendation with respect to the use of a vaccine at the Advisory Committee's first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine, the Advisory Committee shall provide an update on the status of such committee's review.

"(c) Consideration for Breakthrough Therapies and for Potential Use During Public Health Emergency.—The Advisory Committee shall make recommendations with respect to the use of certain vaccines in a timely manner, as appropriate, including vaccines that—

"(1) are designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) and licensed under section 351 of the Public Health Service Act (42 U.S.C. 262); or

"(2) could be used in a public health emergency.

"(d) Definition.—In this section, the terms 'Advisory Committee on Immunization Practices' and 'Advisory Committee' mean the Advisory Committee on Immunization Practices established by the Secretary pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Disease Control and Prevention."

§360bbb–4a. Priority review to encourage treatments for agents that present national security threats

(a) Definitions

In this section:

(1) Human drug application

The term "human drug application" has the meaning given such term in section 379g(1) of this title.

(2) Priority review

The term "priority review", with respect to a human drug application, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures in the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act.

(3) Priority review voucher

The term "priority review voucher" means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the material threat medical countermeasure application.

(4) Material threat medical countermeasure application

The term "material threat medical countermeasure application" means an application that—

(A) is a human drug application for a drug intended for use—

(i) to prevent, or treat harm from a biological, chemical, radiological, or nuclear agent identified as a material threat under section 319F–2(c)(2)(A)(ii) of the Public Health Service Act [42 U.S.C. 247d–6b(c)(2)(A)(ii)]; or

(ii) to mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, or biological product against such agent; and

(B) the Secretary determines eligible for priority review;

(C) is approved after December 13, 2016; and

(D) is for—

(i) a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 355(b)(1) of this title; or

(ii) a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act [42 U.S.C. 262].

(b) Priority review voucher

(1) In general

The Secretary shall award a priority review voucher to the sponsor of a material threat medical countermeasure application upon approval by the Secretary of such material threat medical countermeasure application.

(2) Transferability

The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] will be submitted after the date of the approval of the material threat medical countermeasure application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.

(3) Notification

(A) In general

The sponsor of a human drug application shall notify the Secretary not later than 90 calendar days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section.

(B) Transfer after notice

The sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification.

(c) Priority review user fee

(1) In general

The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under subchapter VII.

(2) Fee amount

The amount of the priority review user fee shall be determined each fiscal year by the Secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year.

(3) Annual fee setting

The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2016, for that fiscal year, the amount of the priority review user fee.

(4) Payment

(A) In general

The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the priority review voucher is used.

(B) Complete application

An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary's procedures for paying such fees.

(C) No waivers, exemptions, reductions, or refunds

The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section.

(5) Offsetting collections

Fees collected pursuant to this subsection for any fiscal year—

(A) ¹ shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and

(6) ² shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.

(d) Notice of issuance of voucher and approval of products under voucher

The Secretary shall publish a notice in the Federal Register and on the Internet website of the Food and Drug Administration not later than 30 calendar days after the occurrence of each of the following:

(1) The Secretary issues a priority review voucher under this section.

(2) The Secretary approves a drug pursuant to an application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the sponsor of the application used a priority review voucher issued under this section.

(e) Eligibility for other programs

Nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program, including under this chapter, except that no sponsor of a material threat medical countermeasure application may receive more than one priority review voucher issued under any section of this chapter with respect to such drug.

(f) Relation to other provisions

The provisions of this section shall supplement, not supplant, any other provisions of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] that encourage the development of medical countermeasures.

(g) Sunset

The Secretary may not award any priority review vouchers under subsection (b) after October 1, 2023.

(June 25, 1938, ch. 675, §565A, as added Pub. L. 114–255, div. A, title III, §3086, Dec. 13, 2016, 130 Stat. 1144; Pub. L. 117–9, §1(a)(5), Apr. 23, 2021, 135 Stat. 258.)

Editorial Notes

References in Text

Section 101(b) of the Food and Drug Administration Safety and Innovation Act, referred to in subsec. (a)(2), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

The Public Health Service Act, referred to in subsec. (f), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2021—Subsec. (a)(4)(D). Pub. L. 117–9 amended subpar. (D) generally. Prior to amendment, subpar. (D) read as follows: "is for a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act."

¹ So in original. No subpar. (B) has been enacted.

² So in original. Probably should be designated as subpar. (B).

§360bbb–4b. Medical countermeasure master files

(a) Applicability of reference

(1) In general

A person may submit data and information in a master file to the Secretary with the intent to reference, or to authorize, in writing, another person to reference, such data or information to support a medical countermeasure submission (including a supplement or amendment to any such submission), without requiring the master file holder to disclose the data and information to any such persons authorized to reference the master file. Such data and information shall be available for reference by the master file holder or by a person authorized by the master file holder, in accordance with applicable privacy and confidentiality protocols and regulations.

(2) Reference of certain master files

In the case that data or information within a medical countermeasure master file is used only to support the conditional approval of an application filed under section 360ccc of this title, such master file may be relied upon to support the effectiveness of a product that is the subject of a subsequent medical countermeasure submission only if such application is supplemented by additional data or information to support review and approval in a manner consistent with the standards applicable to such review and approval for such countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.

(b) Medical countermeasure master file content

(1) In general

A master file under this section may include data or information to support—

(A) the development of medical countermeasure submissions to support the approval, licensure, classification, clearance, conditional approval, or authorization of one or more security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products; and

(B) the manufacture of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products.

(2) Required updates

The Secretary may require, as appropriate, that the master file holder ensure that the contents of such master file are updated during the time such master file is referenced for a medical countermeasure submission.

(c) Sponsor reference

(1) In general

Each incorporation of data or information within a medical countermeasure master file shall describe the incorporated material in a manner in which the Secretary determines appropriate and that permits the review of such information within such master file without necessitating resubmission of such data or information. Master files shall be submitted in an electronic format in accordance with sections 360b(b)(4), 360ccc(a)(4), and 379k–1 of this title, as applicable, and as specified in applicable guidance.

(2) Reference by a master file holder

A master file holder that is the sponsor of a medical countermeasure submission shall notify the Secretary in writing of the intent to reference the medical countermeasure master file as a part of the submission.

(3) Reference by an authorized person

A person submitting an application for review may, where the Secretary determines appropriate, incorporate by reference all or part of the contents of a medical countermeasure master file, if the master file holder authorizes the incorporation in writing.

(d) Acknowledgment of and reliance upon a master file by the Secretary

(1) In general

The Secretary shall provide the master file holder with a written notification indicating that the Secretary has reviewed and relied upon specified data or information within a master file and the purposes for which such data or information was incorporated by reference if the Secretary has reviewed and relied upon such specified data or information to support the approval, classification, conditional approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product. The Secretary may rely upon the data and information within the medical countermeasure master file for which such written notification was provided in additional applications, as applicable and appropriate and upon the request of the master file holder so notified in writing or by an authorized person of such holder.

(2) Certain applications

If the Secretary has reviewed and relied upon specified data or information within a medical countermeasure master file to support the conditional approval of an application under section 360ccc of this title to subsequently support the approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product, the Secretary shall provide a brief written description to the master file holder regarding the elements of the application fulfilled by the data or information within the master file and how such data or information contained in such application meets the standards of evidence under subsection (c) or (d) of section 355 of this title, subsection (d) of section 360b of this title, or section 351 of the Public Health Service Act [42 U.S.C. 262] (as applicable), which shall not include any trade secret or confidential commercial information.

(e) Rules of construction

Nothing in this section shall be construed to—

(1) limit the authority of the Secretary to approve, license, clear, conditionally approve, or authorize drugs, biological products, or devices pursuant to, as applicable, this Act [this chapter] or section 351 of the Public Health Service Act [42 U.S.C. 262] (as such applicable Act is in effect on the day before June 24, 2019), including the standards of evidence, and applicable conditions, for approval under the applicable Act;

(2) alter the standards of evidence with respect to approval, licensure, or clearance, as applicable, of drugs, biological products, or devices under this Act [this chapter] or section 351 of the Public Health Service Act [42 U.S.C. 262], including, as applicable, the substantial evidence standards under sections 355(d) and 360b(d) of this title and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; or

(3) alter the authority of the Secretary under this Act [this chapter] or the Public Health Service Act [42 U.S.C. 201 et seq.] to determine the types of data or information previously submitted by a sponsor or any other person that may be incorporated by reference in an application, request, or notification for a drug, biological product, or device submitted under sections 355(i), 355(b), 355(j), 360b(b)(1), 360b(b)(2), 360b(j), 360bbb–3, 360ccc, 360j(g), 360e(c), 360c(f)(2), or 360(k) of this title, or subsection (a) or (k) of section 351 of the Public Health Service Act [42 U.S.C. 262], including a supplement or amendment to any such submission, and the requirements associated with such reference.

(f) Definitions

In this section:

(1) The term "master file holder" means a person who submits data and information to the Secretary with the intent to reference or authorize another person to reference such data or information to support a medical countermeasure submission, as described in subsection (a).

(2) The term "medical countermeasure submission" means an investigational new drug application under section 355(i) of this title, a new drug application under section 355(b) of this title, or an abbreviated new drug application under section 355(j) of this title, a biological product license application under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] or a biosimilar biological product license application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)], a new animal drug application under section 360b(b)(1) of this title or abbreviated new animal drug application under section 360b(b)(2) of this title, an application for conditional approval of a new animal drug under section 360ccc of this title, an investigational device application under section 360j(g) of this title, an application with respect to a device under section 360e(c) of this title, a request for classification of a device under section 360c(f)(2) of this title, a notification with respect to a device under section 360(k) of this title, or a request for an emergency use authorization under section 360bbb–3 of this title to support—

(A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product; or

(B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.

(3) The terms "qualified countermeasure", "security countermeasure", and "qualified pandemic or epidemic product" have the meanings given such terms in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [42 U.S.C. 247d–6a, 247d–6b, 247d–6d].

(June 25, 1938, ch. 675, §565B, as added Pub. L. 116–22, title VI, §603(b), June 24, 2019, 133 Stat. 953.)

Editorial Notes

References in Text

This Act, referred to in subsec. (e), is the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter (§301 et seq.). For complete classification of this Act to the Code, see section 301 of this title and Tables.

The Public Health Service Act, referred to in subsec. (e)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Statutory Notes and Related Subsidiaries

Medical Countermeasure Master Files

Pub. L. 116–22, title VI, §603, June 24, 2019, 133 Stat. 953, provided that:

"(a) In General.—The purpose of this section (including section 565B of the Federal Food, Drug, and Cosmetic Act [this section], as added by subsection (b)) is to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support the development of such products, and through clarifying the authority to cross-reference to data and information previously submitted to the Secretary of Health and Human Services (referred to in this section as the 'Secretary'), including data and information submitted to medical countermeasure master files or other master files.

"(b) Medical Countermeasure Master Files.—[Enacted this section.]

"(c) Stakeholder Input.—Not later than 18 months after the date of enactment of this Act [June 24, 2019], the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Assistant Secretary for Preparedness and Response, shall solicit input from stakeholders, including stakeholders developing security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products, and stakeholders developing technologies to assist in the development of such countermeasures with respect to how the Food and Drug Administration can advance the use of tools and technologies to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, including through reliance on cross-referenced data and information contained within master files and submissions previously submitted to the Secretary as set forth in section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).

"(d) Guidance.—Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b) or submissions otherwise submitted to the Secretary may be used for specific tools or technologies (including platform technologies) that have the potential to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products. The Secretary, acting through the Commissioner of Food and Drugs, shall publish the final guidance not later than 3 years after the enactment of this Act."

§360bbb–5. Critical Path Public-Private Partnerships

(a) Establishment

The Secretary, acting through the Commissioner of Food and Drugs, may enter into collaborative agreements, to be known as Critical Path Public-Private Partnerships, with one or more eligible entities to implement the Critical Path Initiative of the Food and Drug Administration by developing innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety.

(b) Eligible entity

In this section, the term "eligible entity" means an entity that meets each of the following:

(1) The entity is—

(A) an institution of higher education (as such term is defined in section 1001 of title 20) or a consortium of such institutions; or

(B) an organization described in section 501(c)(3) of title 26 and exempt from tax under section 501(a) of such title.

(2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which may include graduate training programs in areas relevant to priorities of the Critical Path Initiative.

(3) The entity demonstrates to the Secretary's satisfaction that the entity is capable of—

(A) developing and critically evaluating tools, methods, and processes—

(i) to increase efficiency, predictability, and productivity of medical product development; and

(ii) to more accurately identify the benefits and risks of new and existing medical products;

(B) establishing partnerships, consortia, and collaborations with health care practitioners and other providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers; health maintenance organizations and other managed health care organizations; health care insurers; government agencies; patients and consumers; manufacturers of prescription drugs, biological products, diagnostic technologies, and devices; and academic scientists; and

(C) securing funding for the projects of a Critical Path Public-Private Partnership from Federal and nonfederal governmental sources, foundations, and private individuals.

(c) Funding

The Secretary may not enter into a collaborative agreement under subsection (a) unless the eligible entity involved provides an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not be influenced by any source of funding.

(d) Annual report

Not later than 18 months after September 27, 2007, and annually thereafter, the Secretary, in collaboration with the parties to each Critical Path Public-Private Partnership, shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives—

(1) reviewing the operations and activities of the Partnerships in the previous year; and

(2) addressing such other issues relating to this section as the Secretary determines to be appropriate.

(e) Definition

In this section, the term "medical product" includes a drug, a biological product as defined in section 262 of title 42, a device, and any combination of such products.

(f) Authorization of appropriations

To carry out this section, there is authorized to be appropriated $1,380,822 for the period beginning on October 1, 2022 and ending on December 23, 2022.¹

(June 25, 1938, ch. 675, §566, as added Pub. L. 110–85, title VI, §603, Sept. 27, 2007, 121 Stat. 898; amended Pub. L. 112–144, title XI, §1102, July 9, 2012, 126 Stat. 1108; Pub. L. 115–52, title VI, §602, Aug. 18, 2017, 131 Stat. 1048; Pub. L. 117–180, div. F, title V, §5005, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, §301, Dec. 16, 2022, 136 Stat. 2311; Pub. L. 117–328, div. FF, title III, §3101, Dec. 29, 2022, 136 Stat. 5807.)

Editorial Notes

Amendments

2022—Subsec. (f). Pub. L. 117–328, which directed the substitution of "$6,000,000 for each of fiscal years 2023 through 2027" for "$1,265,753 for the period beginning on October 1, 2022 and ending on December 23, 2022", could not be executed because "$1,265,753" did not appear after the intervening amendment by section 301 of Pub. L. 117–229. See below.

Pub. L. 117–229 substituted "$1,380,822 for the period beginning on October 1, 2022 and ending on December 23, 2022" for "$1,265,753 for the period beginning on October 1, 2022 and ending on December 16, 2022".

Pub. L. 117–180 substituted "$1,265,753 for the period beginning on October 1, 2022 and ending on December 16, 2022" for "$6,000,000 for each of fiscal years 2018 through 2022".

2017—Subsec. (f). Pub. L. 115–52 substituted "2018 through 2022" for "2013 through 2017".

2012—Subsec. (f). Pub. L. 112–144 amended subsec. (f) generally. Prior to amendment, text read as follows: "To carry out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2008 and such sums as may be necessary for each of fiscal years 2009 through 2012."

¹ See 2022 Amendment notes below.

§360bbb–5a. Emerging technology program

(a) Program establishment

(1) In general

The Secretary shall establish a program to support the adoption of, and improve the development of, innovative approaches to drug design and manufacturing.

(2) Actions

In carrying out the program under paragraph (1), the Secretary may—

(A) facilitate and increase communication between public and private entities, consortia, and individuals with respect to innovative drug product design and manufacturing;

(B) solicit information regarding, and conduct or support research on, innovative approaches to drug product design and manufacturing;

(C) convene meetings with representatives of industry, academia, other Federal agencies, international agencies, and other interested persons, as appropriate;

(D) convene working groups to support drug product design and manufacturing research and development;

(E) support education and training for regulatory staff and scientists related to innovative approaches to drug product design and manufacturing;

(F) advance regulatory science related to the development and review of innovative approaches to drug product design and manufacturing;

(G) convene or participate in working groups to support the harmonization of international regulatory requirements related to innovative approaches to drug product design and manufacturing; and

(H) award grants or contracts to carry out or support the program under paragraph (1).

(3) Grants and contracts

To seek a grant or contract under this section, an entity shall submit an application—

(A) in such form and manner as the Secretary may require; and

(B) containing such information as the Secretary may require, including a description of—

(i) how the entity will conduct the activities to be supported through the grant or contract; and

(ii) how such activities will further research and development related to, or adoption of, innovative approaches to drug product design and manufacturing.

(b) Guidance

The Secretary shall—

(1) issue or update guidance to help facilitate the adoption of, and advance the development of, innovative approaches to drug product design and manufacturing; and

(2) include in such guidance descriptions of—

(A) any regulatory requirements related to the development or review of technologies related to innovative approaches to drug product design and manufacturing, including updates and improvements to such technologies after product approval; and

(B) data that can be used to demonstrate the identity, safety, purity, and potency of drugs manufactured using such technologies.

(c) Report to Congress

Not later than 4 years after December 29, 2022, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing—

(1) an annual accounting of the allocation of funds made available to carry out this section;

(2) a description of how Food and Drug Administration staff were utilized to carry out this section and, as applicable, any challenges or limitations related to staffing;

(3) the number of public meetings held or participated in by the Food and Drug Administration pursuant to this section, including meetings convened as part of a working group described in subparagraph (D) or (G) of subsection (a)(2), and the topics of each such meeting; and

(4) the number of drug products approved or licensed, after December 29, 2022, using an innovative approach to drug product design and manufacturing.

(June 25, 1938, ch. 675, §566A, as added Pub. L. 117–328, div. FF, title III, §3203, Dec. 29, 2022, 136 Stat. 5814.)

§360bbb–6. Risk communication

(a) Advisory Committee on Risk Communication

(1) In general

The Secretary shall establish an advisory committee to be known as the "Advisory Committee on Risk Communication" (referred to in this section as the "Committee").

(2) Duties of Committee

The Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration.

(3) Members

The Secretary shall ensure that the Committee is composed of experts on risk communication, experts on the risks described in subsection (b), and representatives of patient, consumer, and health professional organizations.

(4) Permanence of Committee

Section 1013 of title 5 shall not apply to the Committee established under this subsection.

(b) Partnerships for risk communication

(1) In general

The Secretary shall partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks.

(2) Partnerships

The systems developed under paragraph (1) shall—

(A) account for the diversity among physicians in terms of practice, willingness to adopt technology, and medical specialty; and

(B) include the use of existing communication channels, including electronic communications, in place at the Food and Drug Administration.

(June 25, 1938, ch. 675, §567, as added Pub. L. 110–85, title IX, §917, Sept. 27, 2007, 121 Stat. 960; amended Pub. L. 117–286, §4(a)(157), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

Amendments

2022—Subsec. (a)(4). Pub. L. 117–286 substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act".

§360bbb–7. Notification

(a) Notification to Secretary

With respect to a drug, the Secretary may require notification to the Secretary by a regulated person if the regulated person knows—

(1) that the use of such drug in the United States may result in serious injury or death;

(2) of a significant loss or known theft of such drug intended for use in the United States; or

(3) that—

(A) such drug has been or is being counterfeited; and

(B)(i) the counterfeit product is in commerce in the United States or could be reasonably expected to be introduced into commerce in the United States; or

(ii) such drug has been or is being imported into the United States or may reasonably be expected to be offered for import into the United States.

(b) Manner of notification

Notification under this section shall be made in such manner and by such means as the Secretary may specify by regulation or guidance.

(c) Savings clause

Nothing in this section shall be construed as limiting any other authority of the Secretary to require notifications related to a drug under any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.].

(d) Definition

In this section, the term "regulated person" means—

(1) a person who is required to register under section 360 or 381(s) of this title;

(2) a wholesale distributor of a drug product; or

(3) any other person that distributes drugs except a person that distributes drugs exclusively for retail sale.

(June 25, 1938, ch. 675, §568, as added Pub. L. 112–144, title VII, §715(b), July 9, 2012, 126 Stat. 1075.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (c), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

§360bbb–8. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments

(a) In general

For the purpose of promoting the efficiency of and informing the review by the Food and Drug Administration of new drugs and biological products for rare diseases and drugs and biological products that are genetically targeted, the following shall apply:

(1) Consultation with stakeholders

Consistent with sections X.C and IX.E.4 of the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017, as referenced in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012, the Secretary shall ensure that opportunities exist, at a time the Secretary determines appropriate, for consultations with stakeholders on the topics described in subsection (b).

(2) Consultation with external experts

(A) In general

The Secretary shall develop and maintain a list of external experts who, because of their special expertise, are qualified to provide advice on rare disease issues, including topics described in subsection (b). The Secretary may, when appropriate to address a specific regulatory question, consult such external experts on issues related to the review of new drugs and biological products for rare diseases and drugs and biological products that are genetically targeted, including the topics described in subsection (b), when such consultation is necessary because the Secretary lacks the specific scientific, medical, or technical expertise necessary for the performance of the Secretary's regulatory responsibilities and the necessary expertise can be provided by the external experts.

(B) External experts

For purposes of subparagraph (A), external experts are individuals who possess scientific or medical training that the Secretary lacks with respect to one or more rare diseases.

(b) Topics for consultation

Topics for consultation pursuant to this section may include—

(1) rare diseases;

(2) the severity of rare diseases;

(3) the unmet medical need associated with rare diseases;

(4) the willingness and ability of individuals with a rare disease to participate in clinical trials;

(5) an assessment of the benefits and risks of therapies to treat rare diseases;

(6) the general design of clinical trials for rare disease populations and subpopulations;

(7) the demographics and the clinical description of patient populations; and

(8) the science of small population studies.

(c) Classification as special government employees

The external experts who are consulted under this section may be considered special government employees, as defined under section 202 of title 18.

(d) Protection of confidential information and trade secrets

(1) Rule of construction

Nothing in this section shall be construed to alter the protections offered by laws, regulations, and policies governing disclosure of confidential commercial or trade secret information, and any other information exempt from disclosure pursuant to section 552(b) of title 5 as such provisions would be applied to consultation with individuals and organizations prior to July 9, 2012.

(2) Consent required for disclosure

The Secretary shall not disclose confidential commercial or trade secret information to an expert consulted under this section without the written consent of the sponsor unless the expert is a special government employee (as defined under section 202 of title 18) or the disclosure is otherwise authorized by law.

(e) Other consultation

Nothing in this section shall be construed to limit the ability of the Secretary to consult with individuals and organizations as authorized prior to July 9, 2012.

(f) No right or obligation

(1) No right to consultation

Nothing in this section shall be construed to create a legal right for a consultation on any matter or require the Secretary to meet with any particular expert or stakeholder.

(2) No altering of goals

Nothing in this section shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.

(3) No change to number of review cycles

Nothing in this section is intended to increase the number of review cycles as in effect before July 9, 2012.

(g) No delay in product review

(1) In general

Prior to a consultation with an external expert, as described in this section, relating to an investigational new drug application under section 355(i) of this title, a new drug application under section 355(b) of this title, or a biologics license application under section 262 of title 42, the Director of the Center for Drug Evaluation and Research or the Director of the Center for Biologics Evaluation and Research (or appropriate Division Director), as appropriate, shall determine that—

(A) such consultation will—

(i) facilitate the Secretary's ability to complete the Secretary's review; and

(ii) address outstanding deficiencies in the application; or

(B) the sponsor authorized such consultation.

(2) Limitation

The requirements of this subsection shall apply only in instances where the consultation is undertaken solely under the authority of this section. The requirements of this subsection shall not apply to any consultation initiated under any other authority.

(June 25, 1938, ch. 675, §569, as added Pub. L. 112–144, title IX, §903, July 9, 2012, 126 Stat. 1088; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(O), Dec. 13, 2016, 130 Stat. 1154; Pub. L. 117–328, div. FF, title III, §3202(e), Dec. 29, 2022, 136 Stat. 5812.)

Editorial Notes

References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsecs. (a)(1) and (f)(2), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

Amendments

2022—Subsec. (b)(8). Pub. L. 117–328 added par. (8).

2016—Subsec. (a)(2)(A). Pub. L. 114–255 substituted "subsection (b)" for "subsection (c)" before period in first sentence.

§360bbb–8a. Optimizing global clinical trials

(a) In general

The Secretary shall—

(1) work with other regulatory authorities of similar standing, medical research companies, and international organizations to foster and encourage uniform, scientifically driven clinical trial standards with respect to medical products around the world; and

(2) enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to—

(A) enhance medical product development;

(B) facilitate the use of foreign data; and

(C) minimize the need to conduct duplicative clinical studies, preclinical studies, or nonclinical studies.

(b) Medical product

In this section, the term "medical product" means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].

(c) Savings clause

Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter or under the Public Health Service Act [42 U.S.C. 201 et seq.].

(June 25, 1938, ch. 675, §569A, as added Pub. L. 112–144, title XI, §1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(P), Dec. 13, 2016, 130 Stat. 1154.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (c), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2016—Subsec. (c). Pub. L. 114–255 inserted "or under the Public Health Service Act" before period at end.

§360bbb–8b. Use of clinical investigation data from outside the United States

(a) In general

In determining whether to approve, license, or clear a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug, biological product, or device in the United States.

(b) Notice to sponsor

If the Secretary finds under subsection (a) that the data from clinical investigations conducted outside the United States, including in the European Union, are inadequate for the purpose of making a determination on approval, clearance, or licensure of a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall provide written notice to the sponsor of the application of such finding and include the rationale for such finding.

(June 25, 1938, ch. 675, §569B, as added Pub. L. 112–144, title XI, §1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(Q), Dec. 13, 2016, 130 Stat. 1155.)

Editorial Notes

Amendments

2016—Pub. L. 114–255 substituted "drug, biological product, or device" for "drug or device" wherever appearing.

§360bbb–8c. Patient participation in medical product discussion

(a) Patient engagement in drugs and devices

(1) In general

The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions, including by—

(A) fostering participation of a patient representative who may serve as a special government employee in appropriate agency meetings with medical product sponsors and investigators; and

(B) exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry.

(2) Protection of proprietary information

Nothing in this section shall be construed to alter the protections offered by laws, regulations, or policies governing disclosure of confidential commercial or trade secret information and any other information exempt from disclosure pursuant to section 552(b) of title 5 as such laws, regulations, or policies would apply to consultation with individuals and organizations prior to July 9, 2012.

(3) Other consultation

Nothing in this section shall be construed to limit the ability of the Secretary to consult with individuals and organizations as authorized prior to July 9, 2012.

(4) No right or obligation

Nothing in this section shall be construed to create a legal right for a consultation on any matter or require the Secretary to meet with any particular expert or stakeholder. Nothing in this section shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012. Nothing in this section is intended to increase the number of review cycles as in effect before July 9, 2012.

(5) Financial interest

In this section, the term "financial interest" means a financial interest under section 208(a) of title 18.

(b) Statement of patient experience

(1) In general

Following the approval of an application that was submitted under section 355(b) of this title or section 262(a) of title 42 at least 180 days after December 13, 2016, the Secretary shall make public a brief statement regarding the patient experience data and related information, if any, submitted and reviewed as part of such application.

(2) Data and information

The data and information referred to in paragraph (1) are—

(A) patient experience data;

(B) information on patient-focused drug development tools; and

(C) other relevant information, as determined by the Secretary.

(c) Patient experience data

For purposes of this section, the term "patient experience data" includes data that—

(1) are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and

(2) are intended to provide information about patients' experiences with a disease or condition, including—

(A) the impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation on patients' lives; and

(B) patient preferences with respect to treatment of such disease or condition.

(June 25, 1938, ch. 675, §569C, as added Pub. L. 112–144, title XI, §1137, July 9, 2012, 126 Stat. 1124; amended Pub. L. 114–255, div. A, title III, §3001, Dec. 13, 2016, 130 Stat. 1083; Pub. L. 115–52, title VI, §605, Aug. 18, 2017, 131 Stat. 1048.)

Editorial Notes

References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsec. (a)(4), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

Amendments

2017—Subsec. (c)(2)(A). Pub. L. 115–52 substituted "impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation" for "impact of such disease or condition, or a related therapy,".

2016—Subsec. (a). Pub. L. 114–255, §3001(1), (2), substituted "Patient engagement in drugs and devices" for "In general" in subsec. heading, designated existing provisions as par. (1) and inserted par. heading, redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), redesignated subsecs. (b) to (e) as as pars. (2) to (5), respectively, and realigned margins.

Subsecs. (b), (c). Pub. L. 114–255, §3001(3), added subsecs. (b) and (c). Former subsecs. (b) and (c) redesignated pars. (2) and (3), respectively, of subsec. (a).

Subsecs. (d), (e). Pub. L. 114–255, §3001(2), redesignated subsecs. (d) and (e) as pars. (4) and (5), respectively, of subsec. (a).

Statutory Notes and Related Subsidiaries

Patient-Focused Drug Development Guidance

Pub. L. 114–255, div. A, title III, §3002, Dec. 13, 2016, 130 Stat. 1084, provided that:

"(a) Publication of Guidance Documents.—Not later than 180 days after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services (referred to in this section as the 'Secretary'), acting through the Commissioner of Food and Drugs, shall develop a plan to issue draft and final versions of one or more guidance documents, over a period of 5 years, regarding the collection of patient experience data, and the use of such data and related information in drug development. Not later than 18 months after the date of enactment of this Act, the Secretary shall issue a draft version of at least one such guidance document. Not later than 18 months after the public comment period on the draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

"(b) Patient Experience Data.—For purposes of this section, the term 'patient experience data' has the meaning given such term in section 569C of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–8c] (as added by section 3001).

"(c) Contents.—The guidance documents described in subsection (a) shall address—

"(1) methodological approaches that a person seeking to collect patient experience data for submission to, and proposed use by, the Secretary in regulatory decisionmaking may use, that are relevant and objective and ensure that such data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis;

"(2) methodological approaches that may be used to develop and identify what is most important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease;

"(3) approaches to identifying and developing methods to measure impacts to patients that will help facilitate collection of patient experience data in clinical trials;

"(4) methodologies, standards, and technologies to collect and analyze clinical outcome assessments for purposes of regulatory decisionmaking;

"(5) how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the Secretary may submit such proposed draft guidance to the Secretary;

"(6) the format and content required for submissions under this section to the Secretary, including with respect to the information described in paragraph (1);

"(7) how the Secretary intends to respond to submissions of information described in paragraph (1), if applicable, including any timeframe for response when such submission is not part of a regulatory application or other submission that has an associated timeframe for response; and

"(8) how the Secretary, if appropriate, anticipates using relevant patient experience data and related information, including with respect to the structured risk-benefit assessment framework described in section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory decisionmaking."

Streamlining Patient Input

Pub. L. 114–255, div. A, title III, §3003, Dec. 13, 2016, 130 Stat. 1085, provided that: "Chapter 35 of title 44, United States Code, shall not apply to the collection of information to which a response is voluntary, that is initiated by the Secretary under section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended by section 3001) or section 3002 [set out as a note above]."

§360bbb–8d. Notification, nondistribution, and recall of controlled substances

(a) Order to cease distribution and recall

(1) In general

If the Secretary determines there is a reasonable probability that a controlled substance would cause serious adverse health consequences or death, the Secretary may, after providing the appropriate person with an opportunity to consult with the agency, issue an order requiring manufacturers, importers, distributors, or pharmacists, who distribute such controlled substance to immediately cease distribution of such controlled substance.

(2) Hearing

An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify an amendment to the order, and what actions are required by such amended order pursuant to subparagraph (3).

(3) Order resolution

After an order is issued according to the process under paragraphs (1) and (2), the Secretary shall, except as provided in paragraph (4)—

(A) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;

(B) continue the order ceasing distribution of the controlled substance until a date specified in such order; or

(C) amend the order to require a recall of the controlled substance, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.

(4) Risk assessment

If the Secretary determines that the risk of recalling a controlled substance presents a greater health risk than the health risk of not recalling such controlled substance from use, an amended order under subparagraph (B) or (C) of paragraph (3) shall not include either a recall order for, or an order to cease distribution of, such controlled substance, as applicable.

(5) Action following order

Any person who is subject to an order pursuant to subparagraph (B) or (C) of paragraph (3) shall immediately cease distribution of or recall, as applicable, the controlled substance and provide notification as required by such order.

(b) Notice to persons affected

If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substance, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substances.

(c) Nondelegation

An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research or an official senior to such Director.

(d) Savings clause

Nothing contained in this section shall be construed as limiting—

(1) the authority of the Secretary to issue an order to cease distribution of, or to recall, any drug under any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.]; or

(2) the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this chapter or the Public Health Service Act.

(June 25, 1938, ch. 675, §569D, as added Pub. L. 115–271, title III, §3012(b), Oct. 24, 2018, 132 Stat. 3935.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (d), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Part F—New Animal Drugs for Minor Use and Minor Species

§360ccc. Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs

(a) Application requirements

(1)(A) Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of—

(i) a new animal drug intended for a minor use or a minor species; or

(ii) a new animal drug not intended for a minor use or minor species—

(I) that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need; and

(II) for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies.

(B) The Secretary shall, not later than September 30, 2019, issue guidance or regulations further clarifying the criteria specified in subparagraph (A)(ii).

(C) An application under this paragraph shall comply in all respects with the provisions of section 360b of this title except for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of such section unless otherwise stated in this section, and any additional provisions of this section.

(D) New animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under section 360b(d) of this title (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance).

(2) The applicant shall submit to the Secretary as part of an application for the conditional approval of a new animal drug—

(A) all information necessary to meet the requirements of section 360b(b)(1) of this title except section 360b(b)(1)(A) of this title;

(B) full reports of investigations which have been made to show whether or not such drug is safe under section 360b(d) of this title (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance) and there is a reasonable expectation of effectiveness for use;

(C) data for establishing a conditional dose;

(D) projections of expected need and the justification for that expectation based on the best information available;

(E) information regarding the quantity of drug expected to be distributed on an annual basis to meet the expected need; and

(F) a commitment that the applicant will conduct additional investigations to meet the requirements for the full demonstration of effectiveness under section 360b(d)(1)(E) of this title within 5 years.

(3)(A) A person may not file an application under paragraph (1) if—

(i) the application seeks conditional approval of a new animal drug that is contained in, or is a product of, a transgenic animal.¹

(ii) the person has previously filed an application for conditional approval under paragraph (1) for the same drug in the same dosage form for the same intended use whether or not subsequently conditionally approved by the Secretary under subsection (b); or

(iii) the person obtained the application, or data or other information contained therein, directly or indirectly from the person who filed for conditional approval under paragraph (1) for the same drug in the same dosage form for the same intended use whether or not subsequently conditionally approved by the Secretary under subsection (b).

(B) A person may not file an application under paragraph (1)(A)(ii) if the application seeks conditional approval of a new animal drug that contains an antimicrobial active ingredient.

(4) Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require.

(b) Order of approval or hearing

Within 180 days after the filing of an application pursuant to subsection (a), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either—

(1) issue an order, effective for one year, conditionally approving the application if the Secretary finds that none of the grounds for denying conditional approval, specified in subsection (c) of this section applies and publish a Federal Register notice of the conditional approval, or

(2) give the applicant notice of an opportunity for an informal hearing on the question whether such application can be conditionally approved.

(c) Order of approval or refusal after hearing

If the Secretary finds, after giving the applicant notice and an opportunity for an informal hearing, that—

(1) any of the provisions of section 360b(d)(1)(A) through (D) or (F) through (I) of this title are applicable;

(2) the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such drug, is insufficient to show that there is a reasonable expectation that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or

(3) another person has received approval under section 360b of this title for the same drug in the same dosage form for the same intended use, and that person is able to assure the availability of sufficient quantities of the drug to meet the needs for which the drug is intended;

the Secretary shall issue an order refusing to conditionally approve the application. If, after such notice and opportunity for an informal hearing, the Secretary finds that paragraphs (1) through (3) do not apply, the Secretary shall issue an order conditionally approving the application effective for one year and publish a Federal Register notice of the conditional approval. Any order issued under this subsection refusing to conditionally approve an application shall state the findings upon which it is based.

(d) Effective period; renewal; refusal of renewal

A conditional approval under this section is effective for a 1-year period and is thereafter renewable by the Secretary annually for up to 4 additional 1-year terms. A conditional approval shall be in effect for no more than 5 years from the date of approval under subsection (b)(1) or (c) of this section unless extended as provided for in subsection (h) of this section. The following shall also apply:

(1) No later than 90 days from the end of the 1-year period for which the original or renewed conditional approval is effective, the applicant may submit a request to renew a conditional approval for an additional 1-year term.

(2) A conditional approval shall be deemed renewed at the end of the 1-year period, or at the end of a 90-day extension that the Secretary may, at the Secretary's discretion, grant by letter in order to complete review of the renewal request, unless the Secretary determines before the expiration of the 1-year period or the 90-day extension that—

(A) the applicant failed to submit a timely renewal request;

(B) the request fails to contain sufficient information to show that—

(i) the applicant is making sufficient progress toward meeting approval requirements under section 360b(d)(1)(E) of this title, and is likely to be able to fulfill those requirements and obtain an approval under section 360b of this title before the expiration of the 5-year maximum term of the conditional approval;

(ii) the quantity of the drug that has been distributed is consistent with the conditionally approved intended use and conditions of use, unless there is adequate explanation that ensures that the drug is only used for its intended purpose; or

(iii) the same drug in the same dosage form for the same intended use has not received approval under section 360b of this title, or if such a drug has been approved, that the holder of the approved application is unable to assure the availability of sufficient quantities of the drug to meet the needs for which the drug is intended; or

(C) any of the provisions of section 360b(e)(1)(A) through (B) or (D) through (F) of this title are applicable.

(3) If the Secretary determines before the end of the 1-year period or the 90-day extension, if granted, that a conditional approval should not be renewed, the Secretary shall issue an order refusing to renew the conditional approval, and such conditional approval shall be deemed withdrawn and no longer in effect. The Secretary shall thereafter provide an opportunity for an informal hearing to the applicant on the issue whether the conditional approval shall be reinstated.

(4)(A) In the case of an application under subsection (a) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], conditional approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].

(B) For purposes of this section, with respect to an application described in subparagraph (A), the term "date of approval" shall mean the later of—

(i) the date an application under subsection (a) is conditionally approved under subsection (b); or

(ii) the date of issuance of the interim final rule controlling the drug.

(e) Withdrawal of conditional approval

(1) The Secretary shall issue an order withdrawing conditional approval of an application filed pursuant to subsection (a) if the Secretary finds that another person has received approval under section 360b of this title for the same drug in the same dosage form for the same intended use and that person is able to assure the availability of sufficient quantities of the drug to meet the needs for which the drug is intended.

(2) The Secretary shall, after due notice and opportunity for an informal hearing to the applicant, issue an order withdrawing conditional approval of an application filed pursuant to subsection (a) if the Secretary finds that—

(A) any of the provisions of section 360b(e)(1)(A) through (B) or (D) through (F) of this title are applicable; or

(B) on the basis of new information before the Secretary with respect to such drug, evaluated together with the evidence available to the Secretary when the application was conditionally approved, that there is not a reasonable expectation that such drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof.

(3) The Secretary may also, after due notice and opportunity for an informal hearing to the applicant, issue an order withdrawing conditional approval of an application filed pursuant to subsection (a) if the Secretary finds that any of the provisions of section 360b(e)(2) of this title are applicable.

(f) Labeling

(1) The label and labeling of a new animal drug with a conditional approval under this section shall for the conditionally approved use—

(A) bear the statement, "conditionally approved by FDA pending a full demonstration of effectiveness under application number"; and

(B) contain such other information as prescribed by the Secretary.

(2) The Secretary shall, through regulation or guidance, determine under what conditions an intended use that is the subject of a conditional approval under this section may be included in the same product label with any intended use approved under section 360b of this title.

(g) Amendment of application

A conditionally approved new animal drug application may not be amended or supplemented to add indications for use.

(h) Order of approval after conditional approval period termination

180 days prior to the termination date established under subsection (d) of this section, an applicant shall have submitted all the information necessary to support a complete new animal drug application in accordance with section 360b(b)(1) of this title or the conditional approval issued under this section is no longer in effect. Following review of this information, the Secretary shall either—

(1) issue an order approving the application under section 360b(c) of this title if the Secretary finds that none of the grounds for denying approval specified in section 360b(d)(1) of this title applies, or

(2) give the applicant an opportunity for a hearing before the Secretary under section 360b(d) of this title on the question whether such application can be approved.

Upon issuance of an order approving the application, product labeling and administrative records of approval shall be modified accordingly. If the Secretary has not issued an order under section 360b(c) of this title approving such application prior to the termination date established under subsection (d) of this section, the conditional approval issued under this section is no longer in effect unless the Secretary grants an extension of an additional 180-day period so that the Secretary can complete review of the application. The decision to grant an extension is committed to the discretion of the Secretary and not subject to judicial review.

(i) Judicial review

The decision of the Secretary under subsection (c), (d), or (e) of this section refusing or withdrawing conditional approval of an application shall constitute final agency action subject to judicial review.

(j) Definition

In this section and section 360ccc–1 of this title, the term "transgenic animal" means an animal whose genome contains a nucleotide sequence that has been intentionally modified in vitro, and the progeny of such an animal; Provided that the term "transgenic animal" does not include an animal of which the nucleotide sequence of the genome has been modified solely by selective breeding.

(k) Sunset

(1) The Secretary's authority to grant conditional approval of new animal drugs not intended for a minor use or minor species pursuant to subsection (a)(1)(A)(ii) terminates on October 1, 2028.

(2) The Secretary—

(A) may not accept any new applications for such conditional approval pursuant to subsection (a)(1)(A)(ii) on or after such date; and

(B) may continue all activities under this section with respect to drugs that were conditionally approved pursuant to ² (a)(1)(A)(ii) prior to such date.

(3) The Secretary may, until October 1, 2032, accept applications for approval under ³ 360b of this title of drugs conditionally approved pursuant to ² (a)(1)(A)(ii).

(June 25, 1938, ch. 675, §571, as added Pub. L. 108–282, title I, §102(b)(4), Aug. 2, 2004, 118 Stat. 892; amended Pub. L. 114–89, §2(a)(3)(B), Nov. 25, 2015, 129 Stat. 699; Pub. L. 115–234, title III, §§301(b), 304(a), Aug. 14, 2018, 132 Stat. 2436.)

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (d)(4)(A), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Amendments

2018—Pub. L. 115–234, §304(a)(1), substituted "species and certain new animal drugs" for "species" in section catchline.

Subsec. (a)(1). Pub. L. 115–234, §304(a)(2)(A), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Except as provided in paragraph (3) of this section, any person may file with the Secretary an application for conditional approval of a new animal drug intended for a minor use or a minor species. Such an application may not be a supplement to an application approved under section 360b of this title. Such application must comply in all respects with the provisions of section 360b of this title except sections 360b(a)(4), 360b(b)(2), 360b(c)(1), 360b(c)(2), 360b(c)(3), 360b(d)(1), 360b(e), 360b(h), and 360b(n) of this title unless otherwise stated in this section, and any additional provisions of this section. New animal drugs are subject to application of the same safety standards that would be applied to such drugs under section 360b(d) of this title (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance)."

Subsec. (a)(3). Pub. L. 115–234, §304(a)(2)(B), designated existing provisions as subpar. (A), redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), and added subpar. (B).

Subsec. (a)(4). Pub. L. 115–234, §301(b), added par. (4).

Subsec. (f)(1). Pub. L. 115–234, §304(a)(3)(A), inserted "for the conditionally approved use" after "shall" in introductory provisions.

Subsec. (f)(2). Pub. L. 115–234, §304(a)(3)(B), substituted "The Secretary shall, through regulation or guidance, determine under what conditions an intended use" for "An intended use" and "may be included" for "shall not be included".

Subsec. (k). Pub. L. 115–234, §304(a)(4), added subsec. (k).

2015—Subsec. (d)(4). Pub. L. 114–89 added par. (4).

Statutory Notes and Related Subsidiaries

Findings

Pub. L. 108–282, title I, §102(a), Aug. 2, 2004, 118 Stat. 891, provided that: "Congress makes the following findings:

"(1) There is a severe shortage of approved new animal drugs for use in minor species.

"(2) There is a severe shortage of approved new animal drugs for treating animal diseases and conditions that occur infrequently or in limited geographic areas.

"(3) Because of the small market shares, low-profit margins involved, and capital investment required, it is generally not economically feasible for new animal drug applicants to pursue approvals for these species, diseases, and conditions.

"(4) Because the populations for which such new animal drugs are intended may be small and conditions of animal management may vary widely, it is often difficult to design and conduct studies to establish drug safety and effectiveness under traditional new animal drug approval processes.

"(5) It is in the public interest and in the interest of animal welfare to provide for special procedures to allow the lawful use and marketing of certain new animal drugs for minor species and minor uses that take into account these special circumstances and that ensure that such drugs do not endanger animal or public health.

"(6) Exclusive marketing rights for clinical testing expenses have helped encourage the development of 'orphan' drugs for human use, and comparable incentives should encourage the development of new animal drugs for minor species and minor uses."

Regulations

Pub. L. 108–282, title I, §102(b)(6), Aug. 2, 2004, 118 Stat. 905, provided that: "On the date of enactment of this Act [Aug. 2, 2004], the Secretary of Health and Human Services shall implement sections 571 and 573 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ccc, 360ccc–2] and subsequently publish implementing regulations. Not later than 12 months after the date of enactment of this Act, the Secretary shall issue proposed regulations to implement section 573 of the Federal Food, Drug, and Cosmetic Act (as added by this Act), and not later than 24 months after the date of enactment of this Act, the Secretary shall issue final regulations implementing section 573 of the Federal Food, Drug, and Cosmetic Act. Not later than 18 months after the date of enactment of this Act, the Secretary shall issue proposed regulations to implement section 572 of the Federal Food, Drug, and Cosmetic Act (as added by this Act) [21 U.S.C. 360ccc–1], and not later than 36 months after the date of enactment of this Act, the Secretary shall issue final regulations implementing section 572 of the Federal Food, Drug, and Cosmetic Act. Not later than 30 months after the date of enactment of this Act, the Secretary shall issue proposed regulations to implement section 571 of the Federal Food, Drug, and Cosmetic Act (as added by this Act), and not later than 42 months after the date of enactment of this Act, the Secretary shall issue final regulations implementing section 571 of the Federal Food, Drug, and Cosmetic Act. These timeframes shall be extended by 12 months for each fiscal year, in which the funds authorized to be appropriated under subsection (i) [no subsection (i) of section 102 has been enacted] are not in fact appropriated."

¹ So in original. The period probably should be a semicolon.

² So in original. The word "subsection" probably should appear.

³ So in original. The word "section" probably should appear.

§360ccc–1. Index of legally marketed unapproved new animal drugs for minor species

(a) Establishment and content

(1) The Secretary shall establish an index limited to—

(A) new animal drugs intended for use in a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food-producing animals; and

(B) new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained man-made structure in an early, non-food life stage of a food-producing minor species, where safety for humans is demonstrated in accordance with the standard of section 360b(d) of this title (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance).

(2) The index shall not include a new animal drug that is contained in or a product of a transgenic animal.

(b) Conferences

Any person intending to file a request under this section shall be entitled to one or more conferences to discuss the requirements for indexing a new animal drug.

(c) Request for determination of eligibility for inclusion in index

(1) Any person may submit a request to the Secretary for a determination whether a new animal drug may be eligible for inclusion in the index. Such a request shall include—

(A) information regarding the need for the new animal drug, the species for which the new animal drug is intended, the proposed intended use and conditions of use, and anticipated annual distribution;

(B) information to support the conclusion that the proposed use meets the conditions of subparagraph (A) or (B) of subsection (a)(1) of this section;

(C) information regarding the components and composition of the new animal drug;

(D) a description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such new animal drug;

(E) an environmental assessment that meets the requirements of the National Environmental Policy Act of 1969 [42 U.S.C. 4321 et seq.], as amended, and as defined in 21 CFR Part 25, as it appears on August 2, 2004, and amended thereafter or information to support a categorical exclusion from the requirement to prepare an environmental assessment;

(F) information sufficient to support the conclusion that the proposed use of the new animal drug is safe under section 360b(d) of this title with respect to individuals exposed to the new animal drug through its manufacture or use; and

(G) such other information as the Secretary may deem necessary to make this eligibility determination.

(2) Within 90 days after the submission of a request for a determination of eligibility for indexing based on subsection (a)(1)(A) of this section, or 180 days for a request submitted based on subsection (a)(1)(B) of this section, the Secretary shall grant or deny the request, and notify the person who requested such determination of the Secretary's decision. The Secretary shall grant the request if the Secretary finds that—

(A) the same drug in the same dosage form for the same intended use is not approved or conditionally approved;

(B) the proposed use of the drug meets the conditions of subparagraph (A) or (B) of subsection (a)(1), as appropriate;

(C) the person requesting the determination has established appropriate specifications for the manufacture and control of the new animal drug and has demonstrated an understanding of the requirements of current good manufacturing practices;

(D) the new animal drug will not significantly affect the human environment; and

(E) the new animal drug is safe with respect to individuals exposed to the new animal drug through its manufacture or use.

If the Secretary denies the request, the Secretary shall thereafter provide due notice and an opportunity for an informal conference. A decision of the Secretary to deny an eligibility request following an informal conference shall constitute final agency action subject to judicial review.

(d) Request for addition to index

(1) With respect to a new animal drug for which the Secretary has made a determination of eligibility under subsection (c), the person who made such a request may ask that the Secretary add the new animal drug to the index established under subsection (a). The request for addition to the index shall include—

(A) a copy of the Secretary's determination of eligibility issued under subsection (c);

(B) a written report that meets the requirements in subsection (d)(2) of this section;

(C) a proposed index entry;

(D) facsimile labeling;

(E) anticipated annual distribution of the new animal drug;

(F) a written commitment to manufacture the new animal drug and animal feeds bearing or containing such new animal drug according to current good manufacturing practices;

(G) a written commitment to label, distribute, and promote the new animal drug only in accordance with the index entry;

(H) upon specific request of the Secretary, information submitted to the expert panel described in paragraph (3); and

(I) any additional requirements that the Secretary may prescribe by general regulation or specific order.

(2) The report required in paragraph (1) shall—

(A) be authored by a qualified expert panel;

(B) include an evaluation of all available target animal safety and effectiveness information, including anecdotal information;

(C) state the expert panel's opinion regarding whether the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm being caused by the absence of an approved or conditionally approved new animal drug for the minor species in question;

(D) include information from which labeling can be written; and

(E) include a recommendation regarding whether the new animal drug should be limited to use under the professional supervision of a licensed veterinarian.

(3) A qualified expert panel, as used in this section, is a panel that—

(A) is composed of experts qualified by scientific training and experience to evaluate the target animal safety and effectiveness of the new animal drug under consideration;

(B) operates external to FDA; and

(C) is not subject to chapter 10 of title 5.

The Secretary shall define the criteria for selection of a qualified expert panel and the procedures for the operation of the panel by regulation.

(4) Within 180 days after the receipt of a request for listing a new animal drug in the index, the Secretary shall grant or deny the request. The Secretary shall grant the request if the request for indexing continues to meet the eligibility criteria in subsection (a) and the Secretary finds, on the basis of the report of the qualified expert panel and other information available to the Secretary, that the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm caused by the absence of an approved or conditionally-approved new animal drug for the minor species in question. If the Secretary denies the request, the Secretary shall thereafter provide due notice and the opportunity for an informal conference. The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review.

(e) Index contents; publication

(1) The index established under subsection (a) shall include the following information for each listed drug—

(A) the name and address of the person who holds the index listing;

(B) the name of the drug and the intended use and conditions of use for which it is being indexed;

(C) product labeling; and

(D) conditions and any limitations that the Secretary deems necessary regarding use of the drug.

(2) The Secretary shall publish the index, and revise it periodically.

(3) The Secretary may establish by regulation a process for reporting changes in the conditions of manufacturing or labeling of indexed products.

(f) Removal from index; suspended listing

(1) If the Secretary finds, after due notice to the person who requested the index listing and an opportunity for an informal conference, that—

(A) the expert panel failed to meet the requirements as set forth by the Secretary by regulation;

(B) on the basis of new information before the Secretary, evaluated together with the evidence available to the Secretary when the new animal drug was listed in the index, the benefits of using the new animal drug for the indexed use do not outweigh its risks to the target animal;

(C) the conditions of subsection (c)(2) of this section are no longer satisfied;

(D) the manufacture of the new animal drug is not in accordance with current good manufacturing practices;

(E) the labeling, distribution, or promotion of the new animal drug is not in accordance with the index entry;

(F) the conditions and limitations of use associated with the index listing have not been followed; or

(G) the request for indexing contains any untrue statement of material fact,

the Secretary shall remove the new animal drug from the index. The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review.

(2) If the Secretary finds that there is a reasonable probability that the use of the drug would present a risk to the health of humans or other animals, the Secretary may—

(A) suspend the listing of such drug immediately;

(B) give the person listed in the index prompt notice of the Secretary's action; and

(C) afford that person the opportunity for an informal conference.

The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review.

(g) Regulations concerning exemptions for investigational use

For purposes of indexing new animal drugs under this section, to the extent consistent with the public health, the Secretary shall promulgate regulations for exempting from the operation of section 360b of this title minor species new animal drugs and animal feeds bearing or containing new animal drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of minor species animal drugs. Such regulations may, at the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such article, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of such article, as the Secretary finds will enable the Secretary to evaluate the safety and effectiveness of such article in the event of the filing of a request for an index listing pursuant to this section.

(h) Labeling contents

The labeling of a new animal drug that is the subject of an index listing shall state, prominently and conspicuously—

(1) "LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF #" (followed by the applicable minor species index file number and a period) "Extra-label use is prohibited.";

(2) except in the case of new animal drugs indexed for use in an early life stage of a food-producing animal, "This product is not to be used in animals intended for use as food for humans or food-producing animals."; and

(3) such other information as may be prescribed by the Secretary in the index listing.

(i) Records and reports

(1) In the case of any new animal drug for which an index listing pursuant to subsection (a) is in effect, the person who has an index listing shall establish and maintain such records, and make such reports to the Secretary, of data relating to experience, and other data or information, received or otherwise obtained by such person with respect to such drug, or with respect to animal feeds bearing or containing such drug, as the Secretary may by general regulation, or by order with respect to such listing, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (f). Such regulation or order shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulation or order is applicable, of similar information received or otherwise obtained by the Secretary.

(2) Every person required under this subsection to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(j) Public disclosure of safety and effectiveness data

(1) Safety and effectiveness data and information which has been submitted in support of a request for a new animal drug to be indexed under this section and which has not been previously disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown—

(A) if no work is being or will be undertaken to have the drug indexed in accordance with the request,

(B) if the Secretary has determined that such drug cannot be indexed and all legal appeals have been exhausted,

(C) if the indexing of such drug is terminated and all legal appeals have been exhausted, or

(D) if the Secretary has determined that such drug is not a new animal drug.

(2) Any request for data and information pursuant to paragraph (1) shall include a verified statement by the person making the request that any data or information received under such paragraph shall not be disclosed by such person to any other person—

(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the request for indexing; and

(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Secretary, which meets the requirements of this paragraph.

(k) Date of determination in the case of recommended controls under the CSA

In the case of a request under subsection (d) to add a drug to the index under subsection (a) with respect to a drug for which the Secretary provides notice to the person filing the request that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], a determination to grant the request to add such drug to the index shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].

(June 25, 1938, ch. 675, §572, as added Pub. L. 108–282, title I, §102(b)(4), Aug. 2, 2004, 118 Stat. 896; amended Pub. L. 114–89, §2(a)(3)(C), Nov. 25, 2015, 129 Stat. 699; Pub. L. 115–234, title III, §302, Aug. 14, 2018, 132 Stat. 2436; Pub. L. 117–286, §4(a)(158), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

References in Text

The National Environmental Policy Act of 1969, referred to in subsec. (c)(1)(E), is Pub. L. 91–190, Jan. 1, 1970, 83 Stat. 852, which is classified generally to chapter 55 (§4321 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 4321 of Title 42 and Tables.

The Controlled Substances Act, referred to in subsec. (k), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Amendments

2022—Subsec. (d)(3)(C). Pub. L. 117–286 substituted "chapter 10 of title 5." for "the Federal Advisory Committee Act."

2018—Subsec. (h)(1). Pub. L. 115–234, §302(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: " 'Not approved by fda.—Legally marketed as an FDA indexed product. Extra-label use is prohibited.';".

Subsec. (h)(2). Pub. L. 115–234, §302(2), substituted "or food-producing animals" for "or other animals".

2015—Subsec. (k). Pub. L. 114–89 added subsec. (k).

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Pub. L. 115–234, title III, §302, Aug. 14, 2018, 132 Stat. 2436, provided that the amendment made by section 302 is effective Oct. 1, 2018.

§360ccc–2. Designated new animal drugs for minor use or minor species

(a) Designation

(1) The manufacturer or the sponsor of a new animal drug for a minor use or use in a minor species may request that the Secretary declare that drug a "designated new animal drug". A request for designation of a new animal drug shall be made before the submission of an application under section 360b(b) of this title or section 360ccc of this title for the new animal drug.

(2) The Secretary may declare a new animal drug a "designated new animal drug" if—

(A) it is intended for a minor use or use in a minor species; and

(B) the same drug in the same dosage form for the same intended use is not approved under section 360b or 360ccc of this title or designated under this section at the time the request is made.

(3) Regarding the termination of a designation—

(A) the sponsor of a new animal drug shall notify the Secretary of any decision to discontinue active pursuit of approval under section 360b or 360ccc of this title of an application for a designated new animal drug. The Secretary shall terminate the designation upon such notification;

(B) the Secretary may also terminate designation if the Secretary independently determines that the sponsor is not actively pursuing approval under section 360b or 360ccc of this title with due diligence;

(C) the sponsor of an approved designated new animal drug shall notify the Secretary of any discontinuance of the manufacture of such new animal drug at least one year before discontinuance. The Secretary shall terminate the designation upon such notification; and

(D) the designation shall terminate upon the expiration of any applicable exclusivity period under subsection (c).

(4) Notice respecting the designation or termination of designation of a new animal drug shall be made available to the public.

(b) Grants and contracts for development of designated new animal drugs

(1) The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in defraying the costs of qualified safety and effectiveness testing expenses and manufacturing expenses incurred in connection with the development of designated new animal drugs.

(2) For purposes of paragraph (1) of this section—

(A) The term "qualified safety and effectiveness testing" means testing—

(i) which occurs after the date such new animal drug is designated under this section and before the date on which an application with respect to such drug is submitted under section 360b of this title; and

(ii) which is carried out under an investigational exemption under section 360b(j) of this title.

(B) The term "manufacturing expenses" means expenses incurred in developing processes and procedures associated with manufacture of the designated new animal drug which occur after the new animal drug is designated under this section and before the date on which an application with respect to such new animal drug is submitted under section 360b or 360ccc of this title.

(c) Exclusivity for designated new animal drugs

(1) Except as provided in subsection (c)(2), if the Secretary approves or conditionally approves an application for a designated new animal drug, the Secretary may not approve or conditionally approve another application submitted for such new animal drug with the same intended use as the designated new animal drug for another applicant before the expiration of seven years from the date of approval or conditional approval of the application.

(2) If an application filed pursuant to section 360b of this title or section 360ccc of this title is approved for a designated new animal drug, the Secretary may, during the 7-year exclusivity period beginning on the date of the application approval or conditional approval, approve or conditionally approve another application under section 360b of this title or section 360ccc of this title for such drug for such minor use or minor species for another applicant if—

(A) the Secretary finds, after providing the holder of such an approved application notice and opportunity for the submission of views, that in the granted exclusivity period the holder of the approved application cannot assure the availability of sufficient quantities of the drug to meet the needs for which the drug was designated; or

(B) such holder provides written consent to the Secretary for the approval or conditional approval of other applications before the expiration of such exclusivity period.

(3) For purposes of determining the 7-year period of exclusivity under paragraph (1) for a drug for which the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], the drug shall not be considered approved or conditionally approved until the date that the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].

(June 25, 1938, ch. 675, §573, as added Pub. L. 108–282, title I, §102(b)(4), Aug. 2, 2004, 118 Stat. 900; amended Pub. L. 114–89, §2(a)(4), Nov. 25, 2015, 129 Stat. 700.)

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (c)(3), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Amendments

2015—Subsec. (c)(3). Pub. L. 114–89 added par. (3).

Part G—Medical Gases

§360ddd. Definitions

In this part:

(1) The term "designated medical gas" means any of the following:

(A) Oxygen that meets the standards set forth in an official compendium.

(B) Nitrogen that meets the standards set forth in an official compendium.

(C) Nitrous oxide that meets the standards set forth in an official compendium.

(D) Carbon dioxide that meets the standards set forth in an official compendium.

(E) Helium that meets the standards set forth in an official compendium.

(F) Carbon monoxide that meets the standards set forth in an official compendium.

(G) Medical air that meets the standards set forth in an official compendium.

(H) Any other medical gas deemed appropriate by the Secretary, after taking into account any investigational new drug application or investigational new animal drug application for the same medical gas submitted in accordance with regulations applicable to such applications in title 21 of the Code of Federal Regulations, unless any period of exclusivity for a new drug under section 355(c)(3)(E)(ii) of this title or section 355(j)(5)(F)(ii) of this title, or the extension of any such period under section 355a of this title, or any period of exclusivity for a new animal drug under section 360b(c)(2)(F) of this title, applicable to such medical gas has not expired.

(2) The term "medical gas" means a drug that—

(A) is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and

(B) is administered as a gas.

(June 25, 1938, ch. 675, §575, as added Pub. L. 112–144, title XI, §1111, July 9, 2012, 126 Stat. 1108; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(R), Dec. 13, 2016, 130 Stat. 1155.)

Editorial Notes

Amendments

2016—Par. (1)(H). Pub. L. 114–255 inserted "for a new drug" after "any period of exclusivity" and "or any period of exclusivity for a new animal drug under section 360b(c)(2)(F) of this title," after "section 355a of this title,".

Statutory Notes and Related Subsidiaries

Changes to Regulations

Pub. L. 112–144, title XI, §1112, July 9, 2012, 126 Stat. 1111, provided that:

"(a) Report.—Not later than 18 months after the date of the enactment of this Act [July 9, 2012], the Secretary, after obtaining input from medical gas manufacturers and any other interested members of the public, shall—

"(1) determine whether any changes to the Federal drug regulations are necessary for medical gases; and

"(2) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report regarding any such changes.

"(b) Regulations.—If the Secretary determines under subsection (a) that changes to the Federal drug regulations are necessary for medical gases, the Secretary shall issue final regulations revising the Federal drug regulations with respect to medical gases not later than 48 months after the date of the enactment of this Act [July 9, 2012].

"(c) Definitions.—In this section:

"(1) The term 'Federal drug regulations' means regulations in title 21 of the Code of Federal Regulations pertaining to drugs.

"(2) The term 'medical gas' has the meaning given to such term in section 575 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ddd], as added by section 1111 of this Act.

"(3) The term 'Secretary' means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs."

Rules of Construction

Pub. L. 112–144, title XI, §1113, July 9, 2012, 126 Stat. 1112, provided that: "Nothing in this subtitle [subtitle B (§§1111–1113) of title XI of Pub. L. 112–144, enacting this section and sections 360ddd–1 and 360ddd–2 of this title and provisions set out as notes under this section] and the amendments made by this subtitle applies with respect to—

"(1) a drug that is approved prior to May 1, 2012, pursuant to an application submitted under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);

"(2) any gas listed in subparagraphs (A) through (G) of section 575(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ddd(1)], as added by section 1111 of this Act, or any combination of any such gases, for an indication that—

"(A) is not included in, or is different from, those specified in subclauses (I) through (VII) of section 576(a)(3)(A)(i) of such Act [21 U.S.C. 360ddd–1(a)(3)(A)(i)]; and

"(B) is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512 [21 U.S.C. 355, 360b]; or

"(3) any designated medical gas added pursuant to subparagraph (H) of section 575(1) of such Act [21 U.S.C. 360ddd(1)] for an indication that—

"(A) is not included in, or is different from, those originally added pursuant to subparagraph (H) of section 575(1) [21 U.S.C. 360ddd(1)(H)] and section 576(a)(3)(A)(i)(VIII) [21 U.S.C. 360ddd–1(a)(3)(A)(i)(VIII)]; and

"(B) is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512 of such Act [21 U.S.C. 355, 360b]."

§360ddd–1. Regulation of medical gases

(a) Certification of designated medical gases

(1) Submission

Beginning 180 days after July 9, 2012, any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce may file with the Secretary a request for certification of a medical gas as a designated medical gas. Any such request shall contain the following information:

(A) A description of the medical gas.

(B) The name and address of the sponsor.

(C) The name and address of the facility or facilities where the medical gas is or will be manufactured.

(D) Any other information deemed appropriate by the Secretary to determine whether the medical gas is a designated medical gas.

(2) Grant of certification

The certification requested under paragraph (1) is deemed to be granted unless, within 60 days of the filing of such request, the Secretary finds that—

(A) the medical gas subject to the certification is not a designated medical gas;

(B) the request does not contain the information required under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the medical gas is a designated medical gas; or

(C) denying the request is necessary to protect the public health.

(3) Effect of certification

(A) In general

(i) Approved uses

A designated medical gas for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section 355 or 360b of this title, subject to all applicable postapproval requirements, for the following indications for use:

(I) In the case of oxygen, the treatment or prevention of hypoxemia or hypoxia.

(II) In the case of nitrogen, use in hypoxic challenge testing.

(III) In the case of nitrous oxide, analgesia.

(IV) In the case of carbon dioxide, use in extracorporeal membrane oxygenation therapy or respiratory stimulation.

(V) In the case of helium, the treatment of upper airway obstruction or increased airway resistance.

(VI) In the case of medical air, to reduce the risk of hyperoxia.

(VII) In the case of carbon monoxide, use in lung diffusion testing.

(VIII) Any other indication for use for a designated medical gas or combination of designated medical gases deemed appropriate by the Secretary, unless any period of exclusivity for a new drug under clause (iii) or (iv) of section 355(c)(3)(E) of this title, clause (iii) or (iv) of section 355(j)(5)(F) of this title, or section 360cc of this title, or the extension of any such period under section 355a of this title, applicable to such indication for use for such gas or combination of gases has not expired.

(ii) Labeling

The requirements of sections 353(b)(4) and 352(f) of this title are deemed to have been met for a designated medical gas if the labeling on the final use container for such medical gas bears—

(I) the information required by section 353(b)(4) of this title;

(II) a warning statement concerning the use of the medical gas as determined by the Secretary by regulation; and

(III) appropriate directions and warnings concerning storage and handling.

(B) Inapplicability of exclusivity provisions

(i) No exclusivity for a certified medical gas

No designated medical gas deemed under subparagraph (A)(i) to have in effect an approved application is eligible for any period of exclusivity for a new drug under section 355(c), 355(j), or 360cc of this title, or the extension of any such period under section 355a of this title, on the basis of such deemed approval.

(ii) Effect on certification

No period of exclusivity under section 355(c), 355(j), or section 360cc of this title, or the extension of any such period under section 355a of this title, with respect to an application for a drug product, shall prohibit, limit, or otherwise affect the submission, grant, or effect of a certification under this section, except as provided in subsection (a)(3)(A)(i)(VIII) and section 360ddd(1)(H) of this title.

(4) Withdrawal, suspension, or revocation of approval

(A) Withdrawal, suspension of approval

Nothing in this part limits the Secretary's authority to withdraw or suspend approval of a drug product, including a designated medical gas deemed under this section to have in effect an approved application under section 355 of this title or section 360b of this title.

(B) Revocation of certification

The Secretary may revoke the grant of a certification under paragraph (2) if the Secretary determines that the request for certification contains any material omission or falsification.

(b) Prescription requirement

(1) In general

A designated medical gas shall be subject to the requirements of section 353(b)(1) of this title unless the Secretary exercises the authority provided in section 353(b)(3) of this title to remove such medical gas from the requirements of section 353(b)(1) of this title, the gas is approved for use without a prescription pursuant to an application under section 355 or 360b of this title, or the use in question is authorized pursuant to another provision of this chapter relating to use of medical products in emergencies.

(2) Oxygen

(A) No prescription required for certain uses

Notwithstanding paragraph (1), oxygen may be provided without a prescription for the following uses:

(i) For use in the event of depressurization or other environmental oxygen deficiency.

(ii) For oxygen deficiency or for use in emergency resuscitation, when administered by properly trained personnel.

(B) Labeling

For oxygen provided pursuant to subparagraph (A), the requirements of section 353(b)(4) of this title shall be deemed to have been met if its labeling bears a warning that the oxygen can be used for emergency use only and for all other medical applications a prescription is required.

(June 25, 1938, ch. 675, §576, as added Pub. L. 112–144, title XI, §1111, July 9, 2012, 126 Stat. 1109; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(S), Dec. 13, 2016, 130 Stat. 1155.)

Editorial Notes

Amendments

2016—Subsec. (a)(1). Pub. L. 114–255, §3101(a)(2)(S)(i), inserted "who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce" after "any person" in introductory provisions.

Subsec. (a)(3)(A)(i)(VIII). Pub. L. 114–255, §3101(a)(2)(S)(ii)(I)(aa), inserted "for a new drug" after "any period of exclusivity".

Subsec. (a)(3)(A)(ii). Pub. L. 114–255, §3101(a)(2)(S)(ii)(I)(bb), inserted "the" before "final use" in introductory provisions.

Subsec. (a)(3)(B)(i). Pub. L. 114–255, §3101(a)(2)(S)(ii)(II)(aa), inserted "for a new drug" after "any period of exclusivity".

Subsec. (a)(3)(B)(ii). Pub. L. 114–255, §3101(a)(2)(S)(ii)(II)(bb), inserted comma after "drug product".

§360ddd–2. Inapplicability of drug fees to designated medical gases

A designated medical gas, alone or in combination with another designated gas or gases (as medically appropriate) deemed under section 360ddd–1 of this title to have in effect an approved application shall not be assessed fees under section 379h(a) or 379j–12(a) of this title on the basis of such deemed approval.

(June 25, 1938, ch. 675, §577, as added Pub. L. 112–144, title XI, §1111, July 9, 2012, 126 Stat. 1111; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(T), Dec. 13, 2016, 130 Stat. 1155.)

Editorial Notes

Amendments

2016—Pub. L. 114–255 inserted "or 379j–12(a)" after "section 379h(a)".

Part H—Pharmaceutical Distribution Supply Chain

§360eee. Definitions

In this part:

(1) Affiliate

The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has the power to control, both of the business entities.

(2) Authorized

The term "authorized" means—

(A) in the case of a manufacturer or repackager, having a valid registration in accordance with section 360 of this title;

(B) in the case of a wholesale distributor, having a valid license under State law or section 360eee–2 of this title, in accordance with section 360eee–1(a)(6) of this title, and complying with the licensure reporting requirements under section 353(e) of this title;

(C) in the case of a third-party logistics provider, having a valid license under State law or section 360eee–3(a)(1) of this title, in accordance with section 360eee–1(a)(7) of this title, and complying with the licensure reporting requirements under section 360eee–3(b) of this title; and

(D) in the case of a dispenser, having a valid license under State law.

(3) Dispenser

The term "dispenser"—

(A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and

(B) does not include a person who dispenses only products to be used in animals in accordance with section 360b(a)(5) of this title.

(4) Disposition

The term "disposition", with respect to a product within the possession or control of an entity, means the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal or other appropriate handling and other actions, such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency.

(5) Distribute or distribution

The term "distribute" or "distribution" means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title or the dispensing of a product approved under section 360b(b) of this title.

(6) Exclusive distributor

The term "exclusive distributor" means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer's product to a subsequent repackager, wholesale distributor, or dispenser.

(7) Homogeneous case

The term "homogeneous case" means a sealed case containing only product that has a single National Drug Code number belonging to a single lot.

(8) Illegitimate product

The term "illegitimate product" means a product for which credible evidence shows that the product—

(A) is counterfeit, diverted, or stolen;

(B) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(C) is the subject of a fraudulent transaction; or

(D) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

(9) Licensed

The term "licensed" means—

(A) in the case of a wholesale distributor, having a valid license in accordance with section 353(e) of this title or section 360eee–1(a)(6) of this title, as applicable;

(B) in the case of a third-party logistics provider, having a valid license in accordance with section 360eee–3(a) of this title or section 360eee–1(a)(7) of this title, as applicable; and

(C) in the case of a dispenser, having a valid license under State law.

(10) Manufacturer

The term "manufacturer" means, with respect to a product—

(A) a person that holds an application approved under section 355 of this title or a license issued under section 262 of title 42 for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product;

(B) a co-licensed partner of the person described in subparagraph (A) that obtains the product directly from a person described in this subparagraph or subparagraph (A) or (C); or

(C) an affiliate of a person described in subparagraph (A) or (B) that receives the product directly from a person described in this subparagraph or subparagraph (A) or (B).

(11) Package

(A) In general

The term "package" means the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product.

(B) Individual saleable unit

For purposes of this paragraph, an "individual saleable unit" is the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser.

(12) Prescription drug

The term "prescription drug" means a drug for human use subject to section 353(b)(1) of this title.

(13) Product

The term "product" means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 360eee–1 of this title, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42, imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 360ddd of this title), homeopathic drugs marketed in accordance with applicable guidance under this chapter, or a drug compounded in compliance with section 353a or 353b of this title.

(14) Product identifier

The term "product identifier" means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.

(15) Quarantine

The term "quarantine" means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.

(16) Repackager

The term "repackager" means a person who owns or operates an establishment that repacks and relabels a product or package for—

(A) further sale; or

(B) distribution without a further transaction.

(17) Return

The term "return" means providing product to the authorized immediate trading partner from which such product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product.

(18) Returns processor or reverse logistics provider

The term "returns processor" or "reverse logistics provider" means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution.

(19) Specific patient need

The term "specific patient need" refers to the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.

(20) Standardized numerical identifier

The term "standardized numerical identifier" means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.

(21) Suspect product

The term "suspect product" means a product for which there is reason to believe that such product—

(A) is potentially counterfeit, diverted, or stolen;

(B) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(C) is potentially the subject of a fraudulent transaction; or

(D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

(22) Third-party logistics provider

The term "third-party logistics provider" means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.

(23) Trading partner

The term "trading partner" means—

(A) a manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or

(B) a third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product.

(24) Transaction

(A) In general

The term "transaction" means the transfer of product between persons in which a change of ownership occurs.

(B) Exemptions

The term "transaction" does not include—

(i) intracompany distribution of any product between members of an affiliate or within a manufacturer;

(ii) the distribution of a product among hospitals or other health care entities that are under common control;

(iii) the distribution of a product for emergency medical reasons including a public health emergency declaration pursuant to section 247d of title 42, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(iv) the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title;

(v) the distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with section 353(d) of this title;

(vi) the distribution of blood or blood components intended for transfusion;

(vii) the distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;

(viii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in section 501(c)(3) of title 26 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

(ix) the distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors, except that any records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors;

(x) the dispensing of a product approved under section 360b(c) of this title;

(xi) products transferred to or from any facility that is licensed by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42;

(xii) a combination product that is not subject to approval under section 355 of this title or licensure under section 262 of title 42, and that is—

(I) a product comprised of a device and 1 or more other regulated components (such as a drug/device, biologic/device, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(II) 2 or more separate products packaged together in a single package or as a unit and comprised of a drug and device or device and biological product; or

(III) 2 or more finished medical devices plus one or more drug or biological products that are packaged together in what is referred to as a "medical convenience kit" as described in clause (xiii);

(xiii) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this clause as a "medical convenience kit") if—

(I) the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance with section 360(b)(2) of this title;

(II) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.];

(III) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit—

(aa) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and

(bb) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and

(IV) in the case of a medical convenience kit that includes a product, the product is—

(aa) an intravenous solution intended for the replenishment of fluids and electrolytes;

(bb) a product intended to maintain the equilibrium of water and minerals in the body;

(cc) a product intended for irrigation or reconstitution;

(dd) an anesthetic;

(ee) an anticoagulant;

(ff) a vasopressor; or

(gg) a sympathomimetic;

(xiv) the distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);

(xv) the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;

(xvi) the distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;

(xvii) the distribution of a medical gas (as defined in section 360ddd of this title); or

(xviii) the distribution or sale of any licensed product under section 262 of title 42 that meets the definition of a device under section 321(h) of this title.

(25) Transaction history

The term "transaction history" means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

(26) Transaction information

The term "transaction information" means—

(A) the proprietary or established name or names of the product;

(B) the strength and dosage form of the product;

(C) the National Drug Code number of the product;

(D) the container size;

(E) the number of containers;

(F) the lot number of the product;

(G) the date of the transaction;

(H) the date of the shipment, if more than 24 hours after the date of the transaction;

(I) the business name and address of the person from whom ownership is being transferred; and

(J) the business name and address of the person to whom ownership is being transferred.

(27) Transaction statement

The "transaction statement" is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—

(A) is authorized as required under the Drug Supply Chain Security Act;

(B) received the product from a person that is authorized as required under the Drug Supply Chain Security Act;

(C) received transaction information and a transaction statement from the prior owner of the product, as required under section 360eee–1 of this title;

(D) did not knowingly ship a suspect or illegitimate product;

(E) had systems and processes in place to comply with verification requirements under section 360eee–1 of this title;

(F) did not knowingly provide false transaction information; and

(G) did not knowingly alter the transaction history.

(28) Verification or verify

The term "verification" or "verify" means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 360eee–1 of this title.

(29) Wholesale distributor

The term "wholesale distributor" means a person (other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or repackager) engaged in wholesale distribution (as defined in section 353(e)(4) of this title).

(June 25, 1938, ch. 675, §581, as added Pub. L. 113–54, title II, §202, Nov. 27, 2013, 127 Stat. 599.)

Editorial Notes

References in Text

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in par. (24)(B)(xiii)(II), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to chapter 13 (§801 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Drug Supply Chain Security Act, referred to in par. (27)(A), (B), is Pub. L. 113–54, title II, Nov. 27, 2013, 127 Stat. 599. For complete classification of this Act to the Code, see Short Title note set out under section 301 of this title and Tables.

§360eee–1. Requirements

(a) In general

(1) Other activities

Each manufacturer, repackager, wholesale distributor, and dispenser shall comply with the requirements set forth in this section with respect to the role of such manufacturer, repackager, wholesale distributor, or dispenser in a transaction involving product. If an entity meets the definition of more than one of the entities listed in the preceding sentence, such entity shall comply with all applicable requirements in this section, but shall not be required to duplicate requirements.

(2) Initial standards

(A) In general

The Secretary shall, in consultation with other appropriate Federal officials, manufacturers, repackagers, wholesale distributors, dispensers, and other pharmaceutical distribution supply chain stakeholders, issue a draft guidance document that establishes standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for compliance with this subsection and subsections (b), (c), (d), and (e). In establishing such standards, the Secretary shall consider the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data. The standards established under this paragraph shall take into consideration the standards established under section 355e of this title and shall comply with a form and format developed by a widely recognized international standards development organization.

(B) Public input

Prior to issuing the draft guidance under subparagraph (A), the Secretary shall gather comments and information from stakeholders and maintain such comments and information in a public docket for at least 60 days prior to issuing such guidance.

(C) Publication

The Secretary shall publish the standards established under subparagraph (A) not later than 1 year after November 27, 2013.

(3) Waivers, exceptions, and exemptions

(A) In general

Not later than 2 years after November 27, 2013, the Secretary shall, by guidance—

(i) establish a process by which an authorized manufacturer, repackager, wholesale distributor, or dispenser may request a waiver from any of the requirements set forth in this section, which the Secretary may grant if the Secretary determines that such requirements would result in an undue economic hardship or for emergency medical reasons, including a public health emergency declaration pursuant to section 247d of title 42;

(ii) establish a process by which the Secretary determines exceptions, and a process through which a manufacturer or repackager may request such an exception, to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with this section; and

(iii) establish a process by which the Secretary may determine other products or transactions that shall be exempt from the requirements of this section.

(B) Content

The guidance issued under subparagraph (A) shall include a process for the biennial review and renewal of such waivers, exceptions, and exemptions, as applicable.

(C) Process

In issuing the guidance under this paragraph, the Secretary shall provide an effective date that is not later than 180 days prior to the date on which manufacturers are required to affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction into commerce consistent with this section.

(4) Self-executing requirements

Except where otherwise specified, the requirements of this section may be enforced without further regulations or guidance from the Secretary.

(5) Grandfathering product

(A) Product identifier

Not later than 2 years after November 27, 2013, the Secretary shall finalize guidance specifying whether and under what circumstances product that is not labeled with a product identifier and that is in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of this section shall be exempted from the requirements of this section.

(B) Tracing

For a product that entered the pharmaceutical distribution supply chain prior to January 1, 2015—

(i) authorized trading partners shall be exempt from providing transaction information as required under subsections (b)(1)(A)(i), (c)(1)(A)(ii), (d)(1)(A)(ii), and (e)(1)(A)(ii);

(ii) transaction history required under this section shall begin with the owner of such product on such date; and

(iii) the owners of such product on such date shall be exempt from asserting receipt of transaction information and transaction statement from the prior owner as required under this section.

(6) Wholesale distributor licenses

Notwithstanding section 360eee(9)(A) of this title, until the effective date of the wholesale distributor licensing regulations under section 360eee–2 of this title, the term "licensed" or "authorized", as it relates to a wholesale distributor with respect to prescription drugs, shall mean a wholesale distributor with a valid license under State law.

(7) Third-party logistics provider licenses

Until the effective date of the third-party logistics provider licensing regulations under section 360eee–3 of this title, a third-party logistics provider shall be considered "licensed" under section 360eee(9)(B) of this title unless the Secretary has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and publishes notice thereof.

(8) Label changes

Changes made to package labels solely to incorporate the product identifier may be submitted to the Secretary in the annual report of an establishment, in accordance with section 314.70(d) of chapter ¹ 21, Code of Federal Regulations (or any successor regulation).

(9) Product identifiers

With respect to any requirement relating to product identifiers under this part—

(A) unless the Secretary allows, through guidance, the use of other technologies for data instead of or in addition to the technologies described in clauses (i) and (ii), the applicable data—

(i) shall be included in a 2-dimensional data matrix barcode when affixed to, or imprinted upon, a package; and

(ii) shall be included in a linear or 2-dimensional data matrix barcode when affixed to, or imprinted upon, a homogeneous case; and

(B) verification of the product identifier may occur by using human-readable or machine-readable methods.

(b) Manufacturer requirements

(1) Product tracing

(A) In general

Beginning not later than January 1, 2015, a manufacturer shall—

(i) prior to, or at the time of, each transaction in which such manufacturer transfers ownership of a product, provide the subsequent owner with transaction history, transaction information, and a transaction statement, in a single document in an ² paper or electronic format; and

(ii) capture the transaction information (including lot level information), transaction history, and transaction statement for each transaction and maintain such information, history, and statement for not less than 6 years after the date of the transaction.

(B) Requests for information

Upon a request by the Secretary or other appropriate Federal or State official, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, a manufacturer shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request, or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, provide the applicable transaction information, transaction history, and transaction statement for the product.

(C) Electronic format

(i) In general

Beginning not later than 4 years after November 27, 2013, except as provided under clause (ii), a manufacturer shall provide the transaction information, transaction history, and transaction statement required under subparagraph (A)(i) in electronic format.

(ii) Exception

A manufacturer may continue to provide the transaction information, transaction history, and transaction statement required under subparagraph (A)(i) in a paper format to a licensed health care practitioner authorized to prescribe medication under State law or other licensed individual under the supervision or direction of such a practitioner who dispenses product in the usual course of professional practice.

(2) Product identifier

(A) In general

Beginning not later than 4 years after November 27, 2013, a manufacturer shall affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce. Such manufacturer shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction.

(B) Exception

A package that is required to have a standardized numerical identifier is not required to have a unique device identifier.

(3) Authorized trading partners

Beginning not later than January 1, 2015, the trading partners of a manufacturer may be only authorized trading partners.

(4) Verification

Beginning not later than January 1, 2015, a manufacturer shall have systems in place to enable the manufacturer to comply with the following requirements:

(A) Suspect product

(i) In general

Upon making a determination that a product in the possession or control of the manufacturer is a suspect product, or upon receiving a request for verification from the Secretary that has made a determination that a product within the possession or control of a manufacturer is a suspect product, a manufacturer shall—

(I) quarantine such product within the possession or control of the manufacturer from product intended for distribution until such product is cleared or dispositioned; and

(II) promptly conduct an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product, which shall include validating any applicable transaction history and transaction information in the possession of the manufacturer and otherwise investigating to determine whether the product is an illegitimate product, and, beginning 4 years after November 27, 2013, verifying the product at the package level, including the standardized numerical identifier.

(ii) Cleared product

If the manufacturer makes the determination that a suspect product is not an illegitimate product, the manufacturer shall promptly notify the Secretary, if applicable, of such determination and such product may be further distributed.

(iii) Records

A manufacturer shall keep records of the investigation of a suspect product for not less than 6 years after the conclusion of the investigation.

(B) Illegitimate product

(i) In general

Upon determining that a product in the possession or control of a manufacturer is an illegitimate product, the manufacturer shall, in a manner consistent with the systems and processes of such manufacturer—

(I) quarantine such product within the possession or control of the manufacturer from product intended for distribution until such product is dispositioned;

(II) disposition the illegitimate product within the possession or control of the manufacturer;

(III) take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the manufacturer; and

(IV) retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the Secretary (or other appropriate Federal or State official), as necessary and appropriate.

(ii) Making a notification

(I) Illegitimate product

Upon determining that a product in the possession or control of the manufacturer is an illegitimate product, the manufacturer shall notify the Secretary and all immediate trading partners that the manufacturer has reason to believe may have received such illegitimate product of such determination not later than 24 hours after making such determination.

(II) High risk of illegitimacy

A manufacturer shall notify the Secretary and immediate trading partners that the manufacturer has reason to believe may have in the trading partner's possession a product manufactured by, or purported to be a product manufactured by, the manufacturer not later than 24 hours after determining or being notified by the Secretary or a trading partner that there is a high risk that such product is an illegitimate product. For purposes of this subclause, a "high risk" may include a specific high risk that could increase the likelihood that illegitimate product will enter the pharmaceutical distribution supply chain and other high risks as determined by the Secretary in guidance pursuant to subsection (h).

(iii) Responding to a notification

Upon the receipt of a notification from the Secretary or a trading partner that a determination has been made that a product is an illegitimate product, a manufacturer shall identify all illegitimate product subject to such notification that is in the possession or control of the manufacturer, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).

(iv) Terminating a notification

Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a manufacturer shall promptly notify immediate trading partners that the manufacturer notified pursuant to clause (ii) that such notification has been terminated.

(v) Records

A manufacturer shall keep records of the disposition of an illegitimate product for not less than 6 years after the conclusion of the disposition.

(C) Requests for verification

Beginning 4 years after November 27, 2013, upon receiving a request for verification from an authorized repackager, wholesale distributor, or dispenser that is in possession or control of a product such person believes to be manufactured by such manufacturer, a manufacturer shall, not later than 24 hours after receiving the request for verification or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, notify the person making the request whether the product identifier, including the standardized numerical identifier, that is the subject of the request corresponds to the product identifier affixed or imprinted by the manufacturer. If a manufacturer responding to a request for verification identifies a product identifier that does not correspond to that affixed or imprinted by the manufacturer, the manufacturer shall treat such product as suspect product and conduct an investigation as described in subparagraph (A). If the manufacturer has reason to believe the product is an illegitimate product, the manufacturer shall advise the person making the request of such belief at the time such manufacturer responds to the request for verification.

(D) Electronic database

A manufacturer may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity. The owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical distribution supply chain, as appropriate. The development and operation of such a database shall not relieve a manufacturer of the requirement under this paragraph to respond to a request for verification submitted by means other than a secure electronic database.

(E) Saleable returned product

Beginning 4 years after November 27, 2013 (except as provided pursuant to subsection (a)(5)), upon receipt of a returned product that the manufacturer intends to further distribute, before further distributing such product, the manufacturer shall verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier, including the standardized numerical identifier, on each package.

(F) Nonsaleable returned product

A manufacturer may return a nonsaleable product to the manufacturer or repackager, to the wholesale distributor from whom such product was purchased, or to a person acting on behalf of such a person, including a returns processor, without providing the information described in paragraph (1)(A)(i).

(c) Wholesale distributor requirements

(1) Product tracing

(A) In general

Beginning not later than January 1, 2015, the following requirements shall apply to wholesale distributors:

(i) A wholesale distributor shall not accept ownership of a product unless the previous owner prior to, or at the time of, the transaction provides the transaction history, transaction information, and a transaction statement for the product, as applicable under this subparagraph.

(ii)(I)(aa) If the wholesale distributor purchased a product directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager that purchased directly from the manufacturer, then prior to, or at the time of, each transaction in which the wholesale distributor transfers ownership of a product, the wholesale distributor shall provide to the subsequent purchaser—

(AA) a transaction statement, which shall state that such wholesale distributor, or a member of the affiliate of such wholesale distributor, purchased the product directly from the manufacturer, exclusive distributor of the manufacturer, or repackager that purchased the product directly from the manufacturer; and

(BB) subject to subclause (II), the transaction history and transaction information.

(bb) The wholesale distributor shall provide the transaction history, transaction information, and transaction statement under item (aa)—

(AA) if provided to a dispenser, on a single document in a paper or electronic format; and

(BB) if provided to a wholesale distributor, through any combination of self-generated paper, electronic data, or manufacturer-provided information on the product package.

(II) For purposes of transactions described in subclause (I), transaction history and transaction information shall not be required to include the lot number of the product, the initial transaction date, or the initial shipment date from the manufacturer (as defined in subparagraphs (F), (G), and (H) of section 360eee(26) of this title).

(iii) If the wholesale distributor did not purchase a product directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager that purchased directly from the manufacturer, as described in clause (ii), then prior to, or at the time of, each transaction or subsequent transaction, the wholesale distributor shall provide to the subsequent purchaser a transaction statement, transaction history, and transaction information, in a paper or electronic format that complies with the guidance document issued under subsection (a)(2).

(iv) For the purposes of clause (iii), the transaction history supplied shall begin only with the wholesale distributor described in clause (ii)(I), but the wholesale distributor described in clause (iii) shall inform the subsequent purchaser that such wholesale distributor received a direct purchase statement from a wholesale distributor described in clause (ii)(I).

(v) A wholesale distributor shall—

(I) capture the transaction information (including lot level information) consistent with the requirements of this section, transaction history, and transaction statement for each transaction described in clauses (i), (ii), and (iii) and maintain such information, history, and statement for not less than 6 years after the date of the transaction; and

(II) maintain the confidentiality of the transaction information (including any lot level information consistent with the requirements of this section), transaction history, and transaction statement for a product in a manner that prohibits disclosure to any person other than the Secretary or other appropriate Federal or State official, except to comply with clauses (ii) and (iii), and, as applicable, pursuant to an agreement under subparagraph (D).

(B) Returns

(i) Saleable returns

Notwithstanding subparagraph (A)(i), the following shall apply:

(I) Requirements

Until the date that is 6 years after November 27, 2013 (except as provided pursuant to subsection (a)(5)), a wholesale distributor may accept returned product from a dispenser or repackager pursuant to the terms and conditions of any agreement between the parties, and, notwithstanding subparagraph (A)(ii), may distribute such returned product without providing the transaction history. For transactions subsequent to the return, the transaction history of such product shall begin with the wholesale distributor that accepted the returned product, consistent with the requirements of this subsection.

(II) Enhanced requirements

Beginning 6 years after November 27, 2013 (except as provided pursuant to subsection (a)(5)), a wholesale distributor may accept returned product from a dispenser or repackager only if the wholesale distributor can associate returned product with the transaction information and transaction statement associated with that product. For all transactions after such date, the transaction history, as applicable, of such product shall begin with the wholesale distributor that accepted and verified the returned product. For purposes of this subparagraph, the transaction information and transaction history, as applicable, need not include transaction dates if it is not reasonably practicable to obtain such dates.

(ii) Nonsaleable returns

A wholesale distributor may return a nonsaleable product to the manufacturer or repackager, to the wholesale distributor from whom such product was purchased, or to a person acting on behalf of such a person, including a returns processor, without providing the information required under subparagraph (A)(i).

(C) Requests for information

Upon a request by the Secretary or other appropriate Federal or State official, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, a wholesale distributor shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, provide the applicable transaction information, transaction history, and transaction statement for the product.

(D) Trading partner agreements

Beginning 6 years after November 27, 2013, a wholesale distributor may disclose the transaction information, including lot level information, transaction history, or transaction statement of a product to the subsequent purchaser of the product, pursuant to a written agreement between such wholesale distributor and such subsequent purchaser. Nothing in this subparagraph shall be construed to limit the applicability of subparagraphs (A) through (C).

(2) Product identifier

Beginning 6 years after November 27, 2013, a wholesale distributor may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to subsection (a)(5)).

(3) Authorized trading partners

Beginning not later than January 1, 2015, the trading partners of a wholesale distributor may be only authorized trading partners.

(4) Verification

Beginning not later than January 1, 2015, a wholesale distributor shall have systems in place to enable the wholesale distributor to comply with the following requirements:

(A) Suspect product

(i) In general

Upon making a determination that a product in the possession or control of a wholesale distributor is a suspect product, or upon receiving a request for verification from the Secretary that has made a determination that a product within the possession or control of a wholesale distributor is a suspect product, a wholesale distributor shall—

(I) quarantine such product within the possession or control of the wholesale distributor from product intended for distribution until such product is cleared or dispositioned; and

(II) promptly conduct an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product, which shall include validating any applicable transaction history and transaction information in the possession of the wholesale distributor and otherwise investigating to determine whether the product is an illegitimate product, and, beginning 6 years after November 27, 2013 (except as provided pursuant to subsection (a)(5)), verifying the product at the package level, including the standardized numerical identifier.

(ii) Cleared product

If the wholesale distributor determines that a suspect product is not an illegitimate product, the wholesale distributor shall promptly notify the Secretary, if applicable, of such determination and such product may be further distributed.

(iii) Records

A wholesale distributor shall keep records of the investigation of a suspect product for not less than 6 years after the conclusion of the investigation.

(B) Illegitimate product

(i) In general

Upon determining, in coordination with the manufacturer, that a product in the possession or control of a wholesale distributor is an illegitimate product, the wholesale distributor shall, in a manner that is consistent with the systems and processes of such wholesale distributor—

(I) quarantine such product within the possession or control of the wholesale distributor from product intended for distribution until such product is dispositioned;

(II) disposition the illegitimate product within the possession or control of the wholesale distributor;

(III) take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the wholesale distributor; and

(IV) retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the manufacturer or Secretary (or other appropriate Federal or State official), as necessary and appropriate.

(ii) Making a notification

Upon determining that a product in the possession or control of the wholesale distributor is an illegitimate product, the wholesale distributor shall notify the Secretary and all immediate trading partners that the wholesale distributor has reason to believe may have received such illegitimate product of such determination not later than 24 hours after making such determination.

(iii) Responding to a notification

Upon the receipt of a notification from the Secretary or a trading partner that a determination has been made that a product is an illegitimate product, a wholesale distributor shall identify all illegitimate product subject to such notification that is in the possession or control of the wholesale distributor, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).

(iv) Terminating a notification

Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a wholesale distributor shall promptly notify immediate trading partners that the wholesale distributor notified pursuant to clause (ii) that such notification has been terminated.

(v) Records

A wholesale distributor shall keep records of the disposition of an illegitimate product for not less than 6 years after the conclusion of the disposition.

(C) Electronic database

A wholesale distributor may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity. The owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical distribution supply chain, as appropriate. The development and operation of such a database shall not relieve a wholesale distributor of the requirement under this paragraph to respond to a verification request submitted by means other than a secure electronic database.

(D) Verification of saleable returned product

Beginning 6 years after November 27, 2013, upon receipt of a returned product that the wholesale distributor intends to further distribute, before further distributing such product, the wholesale distributor shall verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier, including the standardized numerical identifier, on each package.

(d) Dispenser requirements

(1) Product tracing

(A) In general

Beginning July 1, 2015, a dispenser—

(i) shall not accept ownership of a product, unless the previous owner prior to, or at the time of, the transaction, provides transaction history, transaction information, and a transaction statement;

(ii) prior to, or at the time of, each transaction in which the dispenser transfers ownership of a product (but not including dispensing to a patient or returns) shall provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product, except that the requirements of this clause shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need; and

(iii) shall capture transaction information (including lot level information, if provided), transaction history, and transaction statements, as necessary to investigate a suspect product, and maintain such information, history, and statements for not less than 6 years after the transaction.

(B) Agreements with third parties

A dispenser may enter into a written agreement with a third party, including an authorized wholesale distributor, under which the third party confidentially maintains the transaction information, transaction history, and transaction statements required to be maintained under this subsection on behalf of the dispenser. If a dispenser enters into such an agreement, the dispenser shall maintain a copy of the written agreement and shall not be relieved of the obligations of the dispenser under this subsection.

(C) Returns

(i) Saleable returns

A dispenser may return product to the trading partner from which the dispenser obtained the product without providing the information required under subparagraph (A).

(ii) Nonsaleable returns

A dispenser may return a nonsaleable product to the manufacturer or repackager, to the wholesale distributor from whom such product was purchased, to a returns processor, or to a person acting on behalf of such a person without providing the information required under subparagraph (A).

(D) Requests for information

Upon a request by the Secretary or other appropriate Federal or State official, in the event of a recall or for the purpose of investigating a suspect or an illegitimate product, a dispenser shall, not later than 2 business days after receiving the request or in another such reasonable time as determined by the Secretary, based on the circumstances of the request, provide the applicable transaction information, transaction statement, and transaction history which the dispenser received from the previous owner, which shall not include the lot number of the product, the initial transaction date, or the initial shipment date from the manufacturer unless such information was included in the transaction information, transaction statement, and transaction history provided by the manufacturer or wholesale distributor to the dispenser. The dispenser may respond to the request by providing the applicable information in either paper or electronic format. Until the date that is 4 years after November 27, 2013, the Secretary or other appropriate Federal or State official shall grant a dispenser additional time, as necessary, only with respect to a request to provide lot level information described in subparagraph (F) of section 360eee(26) of this title that was provided to the dispenser in paper format, limit the request time period to the 6 months preceding the request or other relevant date, and, in the event of a recall, the Secretary, or other appropriate Federal or State official may request information only if such recall involves a serious adverse health consequence or death to humans.

(2) Product identifier

Beginning not later than 7 years after November 27, 2013, a dispenser may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to subsection (a)(5)).

(3) Authorized trading partners

Beginning not later than January 1, 2015, the trading partners of a dispenser may be only authorized trading partners.

(4) Verification

Beginning not later than January 1, 2015, a dispenser shall have systems in place to enable the dispenser to comply with the following requirements:

(A) Suspect product

(i) In general

Upon making a determination that a product in the possession or control of the dispenser is a suspect product, or upon receiving a request for verification from the Secretary that has made a determination that a product within the possession or control of a dispenser is a suspect product, a dispenser shall—

(I) quarantine such product within the possession or control of the dispenser from product intended for distribution until such product is cleared or dispositioned; and

(II) promptly conduct an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product.

(ii) Investigation

An investigation conducted under clause (i)(II) shall include—

(I) beginning 7 years after November 27, 2013, verifying whether the lot number of a suspect product corresponds with the lot number for such product;

(II) beginning 7 years after November 27, 2013, verifying that the product identifier, including the standardized numerical identifier, of at least 3 packages or 10 percent of such suspect product, whichever is greater, or all packages, if there are fewer than 3, corresponds with the product identifier for such product;

(III) validating any applicable transaction history and transaction information in the possession of the dispenser; and

(IV) otherwise investigating to determine whether the product is an illegitimate product.

(iii) Cleared product

If the dispenser makes the determination that a suspect product is not an illegitimate product, the dispenser shall promptly notify the Secretary, if applicable, of such determination and such product may be further distributed or dispensed.

(iv) Records

A dispenser shall keep records of the investigation of a suspect product for not less than 6 years after the conclusion of the investigation.

(B) Illegitimate product

(i) In general

Upon determining, in coordination with the manufacturer, that a product in the possession or control of a dispenser is an illegitimate product, the dispenser shall—

(I) disposition the illegitimate product within the possession or control of the dispenser;

(II) take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the dispenser; and

(III) retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the manufacturer or Secretary (or other appropriate Federal or State official), as necessary and appropriate.

(ii) Making a notification

Upon determining that a product in the possession or control of the dispenser is an illegitimate product, the dispenser shall notify the Secretary and all immediate trading partners that the dispenser has reason to believe may have received such illegitimate product of such determination not later than 24 hours after making such determination.

(iii) Responding to a notification

Upon the receipt of a notification from the Secretary or a trading partner that a determination has been made that a product is an illegitimate product, a dispenser shall identify all illegitimate product subject to such notification that is in the possession or control of the dispenser, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).

(iv) Terminating a notification

Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a dispenser shall promptly notify immediate trading partners that the dispenser notified pursuant to clause (ii) that such notification has been terminated.

(v) Records

A dispenser shall keep records of the disposition of an illegitimate product for not less than 6 years after the conclusion of the disposition.

(C) Electronic database

A dispenser may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity.

(5) Exception

Notwithstanding any other provision of law, the requirements under paragraphs (1) and (4) shall not apply to licensed health care practitioners authorized to prescribe or administer medication under State law or other licensed individuals under the supervision or direction of such practitioners who dispense or administer product in the usual course of professional practice.

(e) Repackager requirements

(1) Product tracing

(A) In general

Beginning not later than January 1, 2015, a repackager described in section 360eee(16)(A) of this title shall—

(i) not accept ownership of a product unless the previous owner, prior to, or at the time of, the transaction, provides transaction history, transaction information, and a transaction statement for the product;

(ii) prior to, or at the time of, each transaction in which the repackager transfers ownership of a product, provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product; and

(iii) capture the transaction information (including lot level information), transaction history, and transaction statement for each transaction described in clauses (i) and (ii) and maintain such information, history, and statement for not less than 6 years after the transaction.

(B) Returns

(i) Nonsaleable product

A repackager described in section 360eee(16)(A) of this title may return a nonsaleable product to the manufacturer or repackager, or to the wholesale distributor from whom such product was purchased, or to a person acting on behalf of such a person, including a returns processor, without providing the information required under subparagraph (A)(ii).

(ii) Saleable or nonsaleable product

A repackager described in section 360eee(16)(B) of this title may return a saleable or nonsaleable product to the manufacturer, repackager, or to the wholesale distributor from whom such product was received without providing the information required under subparagraph (A)(ii) on behalf of the hospital or other health care entity that took ownership of such product pursuant to the terms and conditions of any agreement between such repackager and the entity that owns the product.

(C) Requests for information

Upon a request by the Secretary or other appropriate Federal or State official, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, a repackager described in section 360eee(16)(A) of this title shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request or in other such reasonable time as determined by the Secretary, provide the applicable transaction information, transaction history, and transaction statement for the product.

(2) Product identifier

(A) In general

Beginning not later than 5 years after November 27, 2013, a repackager described in section 360eee(16)(A) of this title—

(i) shall affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction in commerce;

(ii) shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction;

(iii) may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to subsection (a)(5)); and

(iv) shall maintain records for not less than 6 years to allow the repackager to associate the product identifier the repackager affixes or imprints with the product identifier assigned by the original manufacturer of the product.

(B) Exception

A package that is required to have a standardized numerical identifier is not required to have a unique device identifier.

(3) Authorized trading partners

Beginning January 1, 2015, the trading partners of a repackager described in section 360eee(16) of this title may be only authorized trading partners.

(4) Verification

Beginning not later than January 1, 2015, a repackager described in section 360eee(16)(A) of this title shall have systems in place to enable the repackager to comply with the following requirements:

(A) Suspect product

(i) In general

Upon making a determination that a product in the possession or control of the repackager is a suspect product, or upon receiving a request for verification from the Secretary that has made a determination that a product within the possession or control of a repackager is a suspect product, a repackager shall—

(I) quarantine such product within the possession or control of the repackager from product intended for distribution until such product is cleared or dispositioned; and

(II) promptly conduct an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product, which shall include validating any applicable transaction history and transaction information in the possession of the repackager and otherwise investigating to determine whether the product is an illegitimate product, and, beginning 5 years after November 27, 2013 (except as provided pursuant to subsection (a)(5)), verifying the product at the package level, including the standardized numerical identifier.

(ii) Cleared product

If the repackager makes the determination that a suspect product is not an illegitimate product, the repackager shall promptly notify the Secretary, if applicable, of such determination and such product may be further distributed.

(iii) Records

A repackager shall keep records of the investigation of a suspect product for not less than 6 years after the conclusion of the investigation.

(B) Illegitimate product

(i) In general

Upon determining, in coordination with the manufacturer, that a product in the possession or control of a repackager is an illegitimate product, the repackager shall, in a manner that is consistent with the systems and processes of such repackager—

(I) quarantine such product within the possession or control of the repackager from product intended for distribution until such product is dispositioned;

(II) disposition the illegitimate product within the possession or control of the repackager;

(III) take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the repackager; and

(IV) retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the manufacturer or Secretary (or other appropriate Federal or State official), as necessary and appropriate.

(ii) Making a notification

Upon determining that a product in the possession or control of the repackager is an illegitimate product, the repackager shall notify the Secretary and all immediate trading partners that the repackager has reason to believe may have received the illegitimate product of such determination not later than 24 hours after making such determination.

(iii) Responding to a notification

Upon the receipt of a notification from the Secretary or a trading partner, a repackager shall identify all illegitimate product subject to such notification that is in the possession or control of the repackager, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).

(iv) Terminating a notification

Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a repackager shall promptly notify immediate trading partners that the repackager notified pursuant to clause (ii) that such notification has been terminated.

(v) Records

A repackager shall keep records of the disposition of an illegitimate product for not less than 6 years after the conclusion of the disposition.

(C) Requests for verification

Beginning 5 years after November 27, 2013, upon receiving a request for verification from an authorized manufacturer, wholesale distributor, or dispenser that is in possession or control of a product they believe to be repackaged by such repackager, a repackager shall, not later than 24 hours after receiving the verification request or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, notify the person making the request whether the product identifier, including the standardized numerical identifier, that is the subject of the request corresponds to the product identifier affixed or imprinted by the repackager. If a repackager responding to a verification request identifies a product identifier that does not correspond to that affixed or imprinted by the repackager, the repackager shall treat such product as suspect product and conduct an investigation as described in subparagraph (A). If the repackager has reason to believe the product is an illegitimate product, the repackager shall advise the person making the request of such belief at the time such repackager responds to the verification request.

(D) Electronic database

A repackager may satisfy the requirements of paragraph (4) by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity. The owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical distribution supply chain, as appropriate. The development and operation of such a database shall not relieve a repackager of the requirement under subparagraph (C) to respond to a verification request submitted by means other than a secure electronic database.

(E) Verification of saleable returned product

Beginning 5 years after November 27, 2013, upon receipt of a returned product that the repackager intends to further distribute, before further distributing such product, the repackager shall verify the product identifier for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier on each package.

(f) Drop shipments

(1) In general

A wholesale distributor that does not physically handle or store product shall be exempt from the provisions of this section, except the notification requirements under clauses (ii), (iii), and (iv) of subsection (c)(4)(B), provided that the manufacturer, repackager, or other wholesale distributor that distributes the product to the dispenser by means of a drop shipment for such wholesale distributor includes on the transaction information and transaction history to the dispenser the contact information of such wholesale distributor and provides the transaction information, transaction history, and transaction statement directly to the dispenser.

(2) Clarification

For purposes of this subsection, providing administrative services, including processing of orders and payments, shall not by itself, be construed as being involved in the handling, distribution, or storage of a product.

(g) Enhanced drug distribution security

(1) In general

On the date that is 10 years after November 27, 2013, the following interoperable, electronic tracing of product at the package level requirements shall go into effect:

(A) The transaction information and the transaction statements as required under this section shall be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs (3) and (4) of subsection (h), including any revision of such guidance issued in accordance with paragraph (5) of such subsection.

(B) The transaction information required under this section shall include the product identifier at the package level for each package included in the transaction.

(C) Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required in accordance with the standards established under the guidance issued pursuant to subsection (a)(2) and the guidances issued pursuant to paragraphs (2), (3), and (4) of subsection (h), including any revision of such guidances issued in accordance with paragraph (5) of such subsection, which may include the use of aggregation and inference as necessary.

(D) The systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon a request by the Secretary (or other appropriate Federal or State official) in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product shall be required.

(E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable, shall be required—

(i) in the event of a request by the Secretary (or other appropriate Federal or State official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product; or

(ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate Federal or State official) with a request described in clause (i).

(F) Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the transaction information and transaction statement associated with that product.

(2) Compliance

(A) Information maintenance agreement

A dispenser may enter into a written agreement with a third party, including an authorized wholesale distributor, under which the third party shall confidentially maintain any information and statements required to be maintained under this section. If a dispenser enters into such an agreement, the dispenser shall maintain a copy of the written agreement and shall not be relieved of the obligations of the dispenser under this subsection.

(B) Alternative methods

The Secretary, taking into consideration the assessment conducted under paragraph (3), shall provide for alternative methods of compliance with any of the requirements set forth in paragraph (1), including—

(i) establishing timelines for compliance by small businesses (including small business dispensers with 25 or fewer full-time employees) with such requirements, in order to ensure that such requirements do not impose undue economic hardship for small businesses, including small business dispensers for whom the criteria set forth in the assessment under paragraph (3) is not met, if the Secretary determines that such requirements under paragraph (1) would result in undue economic hardship; and

(ii) establishing a process by which a dispenser may request a waiver from any of the requirements set forth in paragraph (1) if the Secretary determines that such requirements would result in an undue economic hardship, which shall include a process for the biennial review and renewal of any such waiver.

(3) Assessment

(A) In general

Not later than the date that is 18 months after the Secretary issues the final guidance required under subsection (h), the Secretary shall enter into a contract with a private, independent consulting firm with expertise to conduct a technology and software assessment that looks at the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level. Such assessment shall be completed not later than 8½ years after November 27, 2013.

(B) Condition

As a condition of the award of the contract under subparagraph (A), the private, independent consulting firm shall agree to consult with dispensers with 25 or fewer full-time employees when conducting the assessment under such subparagraph.

(C) Content

The assessment under subparagraph (A) shall assess whether—

(i) the necessary software and hardware is readily accessible to such dispensers;

(ii) the necessary software and hardware is prohibitively expensive to obtain, install, and maintain for such dispensers; and

(iii) the necessary hardware and software can be integrated into business practices, such as interoperability with wholesale distributors, for such dispensers.

(D) Publication

The Secretary shall—

(i) publish the statement of work for the assessment under subparagraph (A) for public comment prior to beginning the assessment;

(ii) publish the final assessment for public comment not later than 30 calendar days after receiving such assessment; and

(iii) hold a public meeting not later than 180 calendar days after receiving the final assessment at which public stakeholders may present their views on the assessment.

(4) Procedure

Notwithstanding section 553 of title 5, the Secretary, in promulgating any regulation pursuant to this section, shall—

(A) provide appropriate flexibility by—

(i) not requiring the adoption of specific business systems for the maintenance and transmission of data;

(ii) prescribing alternative methods of compliance for any of the requirements set forth in paragraph (1) or set forth in regulations implementing such requirements, including—

(I) timelines for small businesses to comply with the requirements set forth in the regulations in order to ensure that such requirements do not impose undue economic hardship for small businesses (including small business dispensers for whom the criteria set forth in the assessment under paragraph (3) is not met), if the Secretary determines that such requirements would result in undue economic hardship; and

(II) the establishment of a process by which a dispenser may request a waiver from any of the requirements set forth in such regulations if the Secretary determines that such requirements would result in an undue economic hardship; and

(iii) taking into consideration—

(I) the results of pilot projects, including pilot projects pursuant to this section and private sector pilot projects, including those involving the use of aggregation and inference;

(II) the public meetings held and related guidance documents issued under this section;

(III) the public health benefits of any additional regulations in comparison to the cost of compliance with such requirements, including on entities of varying sizes and capabilities;

(IV) the diversity of the pharmaceutical distribution supply chain by providing appropriate flexibility for each sector, including both large and small businesses; and

(V) the assessment pursuant to paragraph (3) with respect to small business dispensers, including related public comment and the public meeting, and requirements under this section;

(B) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;

(C) provide a period of not less than 60 days for comments on the proposed regulation; and

(D) publish in the Federal Register the final regulation not less than 2 years prior to the effective date of the regulation.

(h) Guidance documents

(1) In general

For the purposes of facilitating the successful and efficient adoption of secure, interoperable product tracing at the package level in order to enhance drug distribution security and further protect the public health, the Secretary shall issue the guidance documents as provided for in this subsection.

(2) Suspect and illegitimate product

(A) In general

Not later than 180 days after November 27, 2013, the Secretary shall issue a guidance document to aid trading partners in the identification of a suspect product and notification termination. Such guidance document shall—

(i) identify specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain;

(ii) provide recommendation on how trading partners may identify such product and make a determination on whether the product is a suspect product as soon as practicable; and

(iii) set forth the process by which manufacturers, repackagers, wholesale distributors, and dispensers shall terminate notifications in consultation with the Secretary regarding illegitimate product pursuant to subsections (b)(4)(B), (c)(4)(B), (d)(4)(B), and (e)(4)(B).

(B) Revised guidance

If the Secretary revises the guidance issued under subparagraph (A), the Secretary shall follow the procedure set forth in paragraph (5).

(3) Unit level tracing

(A) In general

In order to enhance drug distribution security at the package level, not later than 18 months after conducting a public meeting on the system attributes necessary to enable secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary, the Secretary shall issue a final guidance document that outlines and makes recommendations with respect to the system attributes necessary to enable secure tracing at the package level as required under the requirements established under subsection (g). Such guidance document shall—

(i) define the circumstances under which the sectors within the pharmaceutical distribution supply chain may, in the most efficient manner practicable, infer the contents of a case, pallet, tote, or other aggregate of individual packages or containers of product, from a product identifier associated with the case, pallet, tote, or other aggregate, without opening each case, pallet, tote, or other aggregate or otherwise individually scanning each package;

(ii) identify methods and processes to enhance secure tracing of product at the package level, such as secure processes to facilitate the use of inference, enhanced verification activities, the use of aggregation and inference, processes that utilize the product identifiers to enhance tracing of product at the package level, including the standardized numerical identifier, or package security features; and

(iii) ensure the protection of confidential commercial information and trade secrets.

(B) Procedure

In issuing the guidance under subparagraph (A), and in revising such guidance, if applicable, the Secretary shall follow the procedure set forth in paragraph (5).

(4) Standards for interoperable data exchange

(A) In general

In order to enhance secure tracing of a product at the package level, the Secretary, not later than 18 months after conducting a public meeting on the interoperable standards necessary to enhance the security of the pharmaceutical distribution supply chain, shall update the guidance issued pursuant to subsection (a)(2), as necessary and appropriate, and finalize such guidance document so that the guidance document—

(i) identifies and makes recommendations with respect to the standards necessary for adoption in order to support the secure, interoperable electronic data exchange among the pharmaceutical distribution supply chain that comply with a form and format developed by a widely recognized international standards development organization;

(ii) takes into consideration standards established pursuant to subsection (a)(2) and section 355e of this title;

(iii) facilitates the creation of a uniform process or methodology for product tracing; and

(iv) ensures the protection of confidential commercial information and trade secrets.

(B) Procedure

In issuing the guidance under subparagraph (A), and in revising such guidance, if applicable, the Secretary shall follow the procedure set forth in paragraph (5).

(5) Procedure

In issuing or revising any guidance issued pursuant to this subsection or subsection (g), except the initial guidance issued under paragraph (2)(A), the Secretary shall—

(A) publish a notice in the Federal Register for a period not less than 30 days announcing that the draft or revised draft guidance is available;

(B) post the draft guidance document on the Internet Web site of the Food and Drug Administration and make such draft guidance document available in hard copy;

(C) provide an opportunity for comment and review and take into consideration any comments received;

(D) revise the draft guidance, as appropriate;

(E) publish a notice in the Federal Register for a period not less than 30 days announcing that the final guidance or final revised guidance is available;

(F) post the final guidance document on the Internet Web site of the Food and Drug Administration and make such final guidance document available in hard copy; and

(G) provide for an effective date of not earlier than 1 year after such guidance becomes final.

(i) Public meetings

(1) In general

The Secretary shall hold not less than 5 public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment. The Secretary may hold the first such public meeting not earlier than 1 year after November 27, 2013. In carrying out the public meetings described in this paragraph, the Secretary shall—

(A) prioritize topics necessary to inform the issuance of the guidance described in paragraphs (3) and (4) of subsection (h); and

(B) take all measures reasonable and practicable to ensure the protection of confidential commercial information and trade secrets.

(2) Content

Each of the following topics shall be addressed in at least one of the public meetings described in paragraph (1):

(A) An assessment of the steps taken under subsections (b) through (e) to build capacity for a unit-level system, including the impact of the requirements of such subsections on—

(i) the ability of the health care system collectively to maintain patient access to medicines;

(ii) the scalability of such requirements, including as it relates to product lines; and

(iii) the capability of different sectors and subsectors, including both large and small businesses, to affix and utilize the product identifier.

(B) The system attributes necessary to support the requirements set forth under subsection (g), including the standards necessary for adoption in order to support the secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain.

(C) Best practices in each of the different sectors within the pharmaceutical distribution supply chain to implement the requirements of this section.

(D) The costs and benefits of the implementation of this section, including the impact on each pharmaceutical distribution supply chain sector and on public health.

(E) Whether electronic tracing requirements, including tracing of product at the package level, are feasible, cost effective, and needed to protect the public health.

(F) The systems and processes needed to utilize the product identifiers to enhance tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary.

(G) The technical capabilities and legal authorities, if any, needed to establish an interoperable, electronic system that provides for tracing of product at the package level.

(H) The impact that such additional requirements would have on patient safety, the drug supply, cost and regulatory burden, and timely patient access to prescription drugs.

(I) Other topics, as determined appropriate by the Secretary.

(j) Pilot projects

(1) In general

The Secretary shall establish 1 or more pilot projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Such projects shall build upon efforts, in existence as of November 27, 2013, to enhance the safety and security of the pharmaceutical distribution supply chain, take into consideration any pilot projects conducted prior to November 27, 2013, including any pilot projects that use aggregation and inference, and inform the draft and final guidance under paragraphs (3) and (4) of subsection (h).

(2) Content

(A) In general

The Secretary shall ensure that the pilot projects under paragraph (1) reflect the diversity of the pharmaceutical distribution supply chain and that the pilot projects, when taken as a whole, include participants representative of every sector, including both large and small businesses.

(B) Project design

The pilot projects under paragraph (1) shall be designed to—

(i) utilize the product identifier for tracing of a product, which may include verification of the product identifier of a product, including the use of aggregation and inference;

(ii) improve the technical capabilities of each sector and subsector to comply with systems and processes needed to utilize the product identifiers to enhance tracing of a product;

(iii) identify system attributes that are necessary to implement the requirements established under this section; and

(iv) complete other activities as determined by the Secretary.

(k) Sunset

The following requirements shall have no force or effect beginning on the date that is 10 years after November 27, 2013:

(1) The provision and receipt of transaction history under this section.

(2) The requirements set forth for returns under subsections (b)(4)(E), (c)(1)(B)(i), (d)(1)(C)(i), and (e)(4)(E).

(3) The requirements set forth under subparagraphs (A)(v)(II) and (D) of subsection (c)(1), as applied to lot level information only.

(l) Rule of construction

The requirements set forth in subsections (g)(4), (i), and (j) shall not be construed as a condition, prohibition, or precedent for precluding or delaying the provisions becoming effective pursuant to subsection (g).

(m) Requests for information

On the date that is 10 years after November 27, 2013, the timeline for responses to requests for information from the Secretary, or other appropriate Federal or State official, as applicable, under subsections (b)(1)(B), (c)(1)(C), and (e)(1)(C) shall be not later than 24 hours after receiving the request from the Secretary or other appropriate Federal or State official, as applicable, or in such other reasonable time as determined by the Secretary based on the circumstances of the request.

(June 25, 1938, ch. 675, §582, as added and amended Pub. L. 113–54, title II, §§202, 203, Nov. 27, 2013, 127 Stat. 605, 623.)

Editorial Notes

Amendments

2013—Subsecs. (g) to (m). Pub. L. 113–54, §203, added subsecs. (g) to (m).

¹ So in original. Probably should be "title".

² So in original. Probably should be "a".

§360eee–2. National standards for prescription drug wholesale distributors

(a) In general

The Secretary shall, not later than 2 years after November 27, 2013, establish by regulation standards for the licensing of persons under section 353(e)(1) of this title, including the revocation, reissuance, and renewal of such license.

(b) Content

For the purpose of ensuring uniformity with respect to standards set forth in this section, the standards established under subsection (a) shall apply to all State and Federal licenses described under section 353(e)(1) of this title and shall include standards for the following:

(1) The storage and handling of prescription drugs, including facility requirements.

(2) The establishment and maintenance of records of the distributions of such drugs.

(3) The furnishing of a bond or other equivalent means of security, as follows:

(A)(i) For the issuance or renewal of a wholesale distributor license, an applicant that is not a government owned and operated wholesale distributor shall submit a surety bond of $100,000 or other equivalent means of security acceptable to the State.

(ii) For purposes of clause (i), the State or other applicable authority may accept a surety bond in the amount of $25,000 if the annual gross receipts of the previous tax year for the wholesaler is $10,000,000 or less.

(B) If a wholesale distributor can provide evidence that it possesses the required bond in a State, the requirement for a bond in another State shall be waived.

(4) Mandatory background checks and fingerprinting of facility managers or designated representatives.

(5) The establishment and implementation of qualifications for key personnel.

(6) The mandatory physical inspection of any facility to be used in wholesale distribution within a reasonable time frame from the initial application of the facility and to be conducted by the licensing authority or by the State, consistent with subsection (c).

(7) In accordance with subsection (d), the prohibition of certain persons from receiving or maintaining licensure for wholesale distribution.

(c) Inspections

To satisfy the inspection requirement under subsection (b)(6), the Federal or State licensing authority may conduct the inspection or may accept an inspection by the State in which the facility is located, or by a third-party accreditation or inspection service approved by the Secretary or the State licensing such wholesale distributor.

(d) Prohibited persons

The standards established under subsection (a) shall include requirements to prohibit a person from receiving or maintaining licensure for wholesale distribution if the person—

(1) has been convicted of any felony for conduct relating to wholesale distribution, any felony violation of subsection (i) or (k) of section 331 of this title, or any felony violation of section 1365 of title 18 relating to product tampering; or

(2) has engaged in a pattern of violating the requirements of this section, or State requirements for licensure, that presents a threat of serious adverse health consequences or death to humans.

(e) Requirements

The Secretary, in promulgating any regulation pursuant to this section, shall, notwithstanding section 553 of title 5—

(1) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;

(2) provide a period of not less than 60 days for comments on the proposed regulation; and

(3) provide that the final regulation take effect on the date that is 2 years after the date such final regulation is published.

(June 25, 1938, ch. 675, §583, as added Pub. L. 113–54, title II, §204(a)(5), Nov. 27, 2013, 127 Stat. 634.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Jan. 1, 2015, see section 204(c) of Pub. L. 113–54, set out as an Effective Date of 2013 Amendment note under section 353 of this title.

§360eee–3. National standards for third-party logistics providers

(a) Requirements

No third-party logistics provider in any State may conduct activities in any State unless each facility of such third-party logistics provider—

(1)(A) is licensed by the State from which the drug is distributed by the third-party logistics provider, in accordance with the regulations promulgated under subsection (d); or

(B) if the State from which the drug distributed by the third-party logistics provider has not established a licensure requirement, is licensed by the Secretary, in accordance with the regulations promulgated under subsection (d); and

(2) if the drug is distributed interstate, is licensed by the State into which the drug is distributed by the third-party logistics provider if such State licenses third-party logistics providers that distribute drugs into the State and the third-party logistics provider is not licensed by the Secretary as described in paragraph (1)(B).

(b) Reporting

Beginning 1 year after November 27, 2013, a facility of a third-party logistics provider shall report to the Secretary, on an annual basis pursuant to a schedule determined by the Secretary—

(1) the State by which the facility is licensed and the appropriate identification number of such license; and

(2) the name and address of the facility and all trade names under which such facility conducts business.

(c) Costs

(1) Authorized fees of Secretary

If a State does not establish a licensing program for a third-party logistics provider, the Secretary shall license the third-party logistics provider located in such State and may collect a reasonable fee in such amount necessary to reimburse the Secretary for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section. The Secretary shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.

(2) State licensing fees

(A) State established program

Nothing in this chapter shall prohibit a State that has established a program to license a third-party logistics provider from collecting fees from a third-party logistics provider for such a license.

(B) No State established program

A State that does not establish a program to license a third-party logistics provider in accordance with this section shall be prohibited from collecting a State licensing fee from a third-party logistics provider.

(d) Regulations

(1) In general

Not later than 2 years after November 27, 2013, the Secretary shall issue regulations regarding the standards for licensing under subsection (a), including the revocation and reissuance of such license, to third-party logistics providers under this section.

(2) Content

Such regulations shall—

(A) establish a process by which a third-party accreditation program approved by the Secretary shall, upon request by a third-party logistics provider, issue a license to each third-party logistics provider that meets the requirements set forth in this section;

(B) establish a process by which the Secretary shall issue a license to each third-party logistics provider that meets the requirements set forth in this section if the Secretary is not able to approve a third-party accreditation program because no such program meets the Secretary's requirements necessary for approval of such a third-party accreditation program;

(C) require that the entity complies with storage practices, as determined by the Secretary for such facility, including—

(i) maintaining access to warehouse space of suitable size to facilitate safe operations, including a suitable area to quarantine suspect product;

(ii) maintaining adequate security; and

(iii) having written policies and procedures to—

(I) address receipt, security, storage, inventory, shipment, and distribution of a product;

(II) identify, record, and report confirmed losses or thefts in the United States;

(III) correct errors and inaccuracies in inventories;

(IV) provide support for manufacturer recalls;

(V) prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the facility, such as a strike, fire, or flood;

(VI) ensure that any expired product is segregated from other products and returned to the manufacturer or repackager or destroyed;

(VII) maintain the capability to trace the receipt and outbound distribution of a product, and supplies and records of inventory; and

(VIII) quarantine or destroy a suspect product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency;

(D) provide for periodic inspection by the licensing authority, as determined by the Secretary, of such facility warehouse space to ensure compliance with this section;

(E) prohibit a facility from having as a manager or designated representative anyone convicted of any felony violation of subsection (i) or (k) of section 331 of this title or any violation of section 1365 of title 18, relating to product tampering;

(F) provide for mandatory background checks of a facility manager or a designated representative of such manager;

(G) require a third-party logistics provider to provide the applicable licensing authority, upon a request by such authority, a list of all product manufacturers, wholesale distributors, and dispensers for whom the third-party logistics provider provides services at such facility; and

(H) include procedures under which any third-party logistics provider license—

(i) expires on the date that is 3 years after issuance of the license; and

(ii) may be renewed for additional 3-year periods.

(3) Procedure

In promulgating the regulations under this subsection, the Secretary shall, notwithstanding section 553 of title 5—

(A) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;

(B) provide a period of not less than 60 days for comments on the proposed regulation; and

(C) provide that the final regulation takes effect upon the expiration of 1 year after the date that such final regulation is issued.

(e) Validity

A license issued under this section shall remain valid as long as such third-party logistics provider remains licensed consistent with this section. If the Secretary finds that the third-party accreditation program demonstrates that all applicable requirements for licensure under this section are met, the Secretary shall issue a license under this section to a third-party logistics provider receiving accreditation, pursuant to subsection (d)(2)(A).

(June 25, 1938, ch. 675, §584, as added Pub. L. 113–54, title II, §205, Nov. 27, 2013, 127 Stat. 636.)

§360eee–4. Uniform national policy

(a) Product tracing and other requirements

Beginning on November 27, 2013, no State or political subdivision of a State may establish or continue in effect any requirements for tracing products through the distribution system (including any requirements with respect to statements of distribution history, transaction history, transaction information, or transaction statement of a product as such product changes ownership in the supply chain, or verification, investigation, disposition, notification, or recordkeeping relating to such systems, including paper or electronic pedigree systems or for tracking and tracing drugs throughout the distribution system) which are inconsistent with, more stringent than, or in addition to, any requirements applicable under section 353(e) of this title or this part (or regulations issued thereunder), or which are inconsistent with—

(1) any waiver, exception, or exemption pursuant to section 360eee or 360eee–1 of this title; or

(2) any restrictions specified in section 360eee–1 of this title.

(b) Wholesale distributor and third-party logistics provider standards

(1) In general

Beginning on November 27, 2013, no State or political subdivision of a State may establish or continue any standards, requirements, or regulations with respect to wholesale prescription drug distributor or third-party logistics provider licensure that are inconsistent with, less stringent than, directly related to, or covered by the standards and requirements applicable under section 353(e) of this title, in the case of a wholesale distributor, or section 360eee–3 of this title, in the case of a third-party logistics provider.

(2) State regulation of third-party logistics providers

No State shall regulate third-party logistics providers as wholesale distributors.

(3) Administration fees

Notwithstanding paragraph (1), a State may administer fee collections for effectuating the wholesale drug distributor and third-party logistics provider licensure requirements under sections 353(e), 360eee–2, and 360eee–3 of this title.

(4) Enforcement, suspension, and revocation

Notwithstanding paragraph (1), a State—

(A) may take administrative action, including fines, to enforce a requirement promulgated by the State in accordance with section 353(e) of this title or this part;

(B) may provide for the suspension or revocation of licenses issued by the State for violations of the laws of such State;

(C) upon conviction of violations of Federal, State, or local drug laws or regulations, may provide for fines, imprisonment, or civil penalties; and

(D) may regulate activities of licensed entities in a manner that is consistent with product tracing requirements under section 360eee–1 of this title.

(c) Exception

Nothing in this section shall be construed to preempt State requirements related to the distribution of prescription drugs if such requirements are not related to product tracing as described in subsection (a) or wholesale distributor and third-party logistics provider licensure as described in subsection (b) applicable under section 353(e) of this title or this part (or regulations issued thereunder).

(June 25, 1938, ch. 675, §585, as added Pub. L. 113–54, title II, §205, Nov. 27, 2013, 127 Stat. 638.)

Part I—Nonprescription Sunscreen and Other Active Ingredients

Termination of Part

This part ceased to be effective at the end of fiscal year 2022, see section 360fff–8 of this title.

§360fff. Definitions

In this part—

(1) the term "Advisory Committee" means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee;

(2) the term "final sunscreen order" means an order published by the Secretary in the Federal Register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A) is GRASE and is not misbranded if marketed in accordance with such order; or

(B) is not GRASE and is misbranded;

(3) the term "GRASE" means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in section 321(p) of this title;

(4) the term "GRASE determination" means, with respect to a nonprescription active ingredient or a combination of nonprescription active ingredients, a determination of whether such ingredient or combination of ingredients is GRASE;

(5) the term "nonprescription" means not subject to section 353(b)(1) of this title;

(6) the term "pending request" means each request with respect to a nonprescription sunscreen active ingredient submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014) for consideration for inclusion in the over-the-counter drug monograph system—

(A) that was determined to be eligible for such review by publication of a notice of eligibility in the Federal Register prior to November 26, 2014; and

(B) for which safety and effectiveness data have been submitted to the Secretary prior to November 26, 2014;

(7) the term "proposed sunscreen order" means an order containing a tentative determination published by the Secretary in the Federal Register containing information proposing that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A) is GRASE and is not misbranded if marketed in accordance with such order;

(B) is not GRASE and is misbranded; or

(C) is not GRASE and is misbranded because the data are insufficient to classify such ingredient or combination of ingredients as GRASE and not misbranded and additional information is necessary to allow the Secretary to determine otherwise;

(8) the term "sponsor" means the person that submitted—

(A) a request under section 360fff–1 of this title;

(B) a pending request; or

(C) any other application subject to this part;

(9) the term "sunscreen" means a drug containing one or more sunscreen active ingredients; and

(10) the term "sunscreen active ingredient" means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation.

(June 25, 1938, ch. 675, §586, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2035.)

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 113–195, §2(b), Nov. 26, 2014, 128 Stat. 2045, provided that: "Nothing in the amendment made by this section [enacting this section and sections 360fff–1 to [former] 360fff–5 of this title] shall be construed to—

"(1) limit the right of a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360fff(8)], as added by subsection (a)) to request that the Secretary of Health and Human Services convene an advisory committee; or

"(2) limit the authority of the Secretary of Health and Human Services to meet with a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a))."

§360fff–1. Submission of requests

Any person may submit a request to the Secretary for a determination of whether a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dosage strength, and route of administration) is GRASE and should be included in part 352 of title 21, Code of Federal Regulations (or any successor regulations) concerning nonprescription sunscreen.

(June 25, 1938, ch. 675, §586A, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2036.)

§360fff–2. Eligibility determinations; data submission; filing

(a) Eligibility determinations

(1) In general

Not later than 60 calendar days after the date of receipt of a request under section 360fff–1 of this title, the Secretary shall—

(A) determine, in accordance with paragraph (2), whether the request is eligible for further review under subsection (b) and section 360fff–3 of this title;

(B) notify the sponsor of the determination of the Secretary; and

(C) make such determination publicly available in accordance with paragraph (3) and subsection (b)(1).

(2) Criteria for eligibility

(A) In general

To be eligible for review under subsection (b) and section 360fff–3 of this title, a request shall be for a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof, that—

(i) is not included in part 352 of title 21, Code of Federal Regulations (or any successor regulations) concerning nonprescription sunscreen; and

(ii) has been used to a material extent and for a material time under such conditions, as described in section 321(p)(2) of this title.

(B) Establishment of time and extent

A sponsor shall include in a request under section 360fff–1 of this title the information required under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations) to meet the standard described in subparagraph (A)(ii).

(3) Public availability

(A) Redactions for confidential information

If a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is determined under paragraph (1)(A) to be eligible for further review, the Secretary shall make the request publicly available, with redactions for information that is treated as confidential under section 552(b) of title 5, section 1905 of title 18, or section 331(j) of this title.

(B) Identification of confidential information by sponsor

At the time that a request is made under section 360fff–1 of this title, the sponsor of such request shall identify any information that such sponsor considers to be confidential information described in subparagraph (A).

(C) Confidentiality during eligibility review

The information contained in a request under section 360fff–1 of this title shall remain confidential during the Secretary's consideration under this section of whether the request is eligible for further review consistent with section 330.14 of title 21, Code of Federal Regulations (or any successor regulations).

(b) Data submission and filing of requests

(1) In general

In the case of a request under section 360fff–1 of this title that is determined to be eligible under subsection (a) for further review under this section and section 360fff–3 of this title, the Secretary shall, in notifying the public under subsection (a)(1)(C) of such eligibility determination, post the eligibility determination on the Internet website of the Food and Drug Administration, invite the sponsor of such request and any other interested party to submit comments, and provide a period of not less than 45 calendar days for comments in support of or otherwise relating to a GRASE determination, including published and unpublished data and other information related to the safety and efficacy of such request.

(2) Filing determination

Not later than 60 calendar days after the submission of data and other information described in paragraph (1) by the sponsor, the Secretary shall determine whether the data and other information submitted by the sponsor under this section are sufficiently complete, including being formatted in a manner that enables the Secretary to determine the completeness of such data and information, to enable the Secretary to conduct a substantive review under section 360fff–3 of this title with respect to such request. Not later than 60 calendar days after the submission of data and other information described in paragraph (1) by the sponsor, if the Secretary determines—

(A) that such data and other information are sufficiently complete, the Secretary shall—

(i) issue a written notification to the sponsor of the determination to file such request, and make such notification publicly available; and

(ii) file such request made under section 360fff–1 of this title; or

(B) that such data and other information are not sufficiently complete, the Secretary shall issue a written notification to the sponsor of the determination to refuse to file the request, which shall include the reasons for the refusal, including why such data and other information are not sufficiently complete, and make such notification publicly available.

(3) Refusal to file a request

(A) Request for meetings; submission of additional data or other information

If the Secretary refuses to file a request made under section 360fff–1 of this title, the sponsor may—

(i) within 30 calendar days of receipt of written notification of such refusal, request, in writing, a meeting with the Secretary regarding the filing determination; and

(ii) submit additional data or other information.

(B) Meetings

(i) In general

If a sponsor seeks a meeting under subparagraph (A)(i), the Secretary shall convene the meeting within 30 calendar days of the request for such meeting.

(ii) Actions after meeting

Following any meeting held under clause (i)—

(I) the Secretary may file the request within 60 calendar days;

(II) the sponsor may submit additional data or other information; or

(III) if the sponsor elects, within 120 calendar days, to have the Secretary file the request (with or without amendments to correct any purported deficiencies to the request)—

(aa) the Secretary shall file the request over protest, not later than 30 calendar days after the sponsor makes such election;

(bb) at the time of filing, the Secretary shall provide written notification of such filing to the sponsor; and

(cc) the Secretary shall make such notification publicly available.

(iii) Requests filed over protest

The Secretary shall not require the sponsor to resubmit a copy of the request for purposes of filing a request filed over protest, as described in clause (ii)(III).

(C) Submissions of additional data or other information

Within 60 calendar days of any submission of additional data or other information under subparagraph (A)(ii) or (B)(ii)(II), the Secretary shall reconsider the previous determination made under paragraph (2) with respect to the applicable request and make a new determination in accordance with paragraph (2).

(4) Public availability

(A) Redactions for confidential information

After the period of confidentiality described in subsection (a)(3)(C), the Secretary shall make data and other information submitted in connection with a request under section 360fff–1 of this title publicly available, with redactions for information that is treated as confidential under section 552(b) of title 5, section 1905 of title 18, or section 331(j) of this title.

(B) Identification of confidential information by sponsor

A person submitting information under this section shall identify at the time of such submission the portions of such information that the person considers to be confidential information described in subparagraph (A).

(June 25, 1938, ch. 675, §586B, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2036.)

§360fff–3. GRASE determination

(a) Review of new request

(1) Proposed sunscreen order

In the case of a request under section 360fff–1 of this title, not later than 300 calendar days after the date on which such request is filed under subsection (b)(2)(A) or (b)(3)(B)(ii)(III) of section 360fff–2 of this title, the Secretary—

(A) may convene a meeting of the Advisory Committee to review such request; and

(B) shall complete the review of such request and issue a proposed sunscreen order with respect to such request.

(2) Proposed sunscreen order by Commissioner

If the Secretary does not issue a proposed sunscreen order under paragraph (1)(B) within such 300-day period, the sponsor of such request may notify the Office of the Commissioner of such request and request review by the Office of the Commissioner. If such sponsor so notifies the Office of the Commissioner, the Commissioner shall, not later than 60 calendar days after the date of notification under this paragraph, issue a proposed sunscreen order with respect to such request.

(3) Public comment period

A proposed sunscreen order issued under paragraph (1)(B) or (2) with respect to a request shall provide for a period of 45 calendar days for public comment.

(4) Meeting

A sponsor may request, in writing, a meeting with respect to a proposed sunscreen order issued under this subsection and described in subparagraph (B) or (C) of section 360fff(7) of this title, not later than 30 calendar days after the Secretary issues such order. The Secretary shall convene a meeting with such sponsor not later than 45 calendar days after such request for a meeting.

(5) Final sunscreen order

With respect to a proposed sunscreen order under paragraph (1)(B) or (2)—

(A) the Secretary shall issue a final sunscreen order—

(i) in the case of a proposed sunscreen order described in subparagraph (A) or (B) of section 360fff(7) of this title, not later than 90 calendar days after the end of the public comment period under paragraph (3); or

(ii) in the case of a proposed sunscreen order described in subparagraph (C) of section 360fff(7) of this title, not later than 210 calendar days after the date on which the sponsor submits the additional information requested pursuant to such proposed sunscreen order; or

(B) if the Secretary does not issue such final sunscreen order within such 90- or 210-calendar-day period, as applicable, the sponsor of such request may notify the Office of the Commissioner of such request and request review by the Office of the Commissioner.

(6) Final sunscreen order by Commissioner

The Commissioner shall issue a final sunscreen order with respect to a proposed sunscreen order subject to paragraph (5)(B) not later than 60 calendar days after the date of notification under such paragraph.

(b) Review of pending requests

(1) In general

The review of a pending request shall be carried out by the Secretary in accordance with this subsection.

(2) Inapplicability of sections 360fff–1 and 360fff–2 of this title

Sections 360fff–1 and 360fff–2 of this title shall not apply with respect to any pending request.

(3) Feedback letters as proposed sunscreen order

Notwithstanding the requirements of section 360fff(7) of this title, a letter issued pursuant to section 330.14(g) of title 21, Code of Federal Regulations before November 26, 2014, with respect to a pending request, shall be deemed to be a proposed sunscreen order and displayed on the Internet website of the Food and Drug Administration. Notification of the availability of such letter shall be published in the Federal Register not later than 45 calendar days after November 26, 2014.

(4) Proposed sunscreen order

In the case of a pending request for which the Secretary has not issued a letter pursuant to section 330.14(g) of title 21, Code of Federal Regulations before November 26, 2014, the Secretary shall complete review of such request and, not later than 90 calendar days after November 26, 2014, issue a proposed sunscreen order with respect to such request.

(5) Proposed sunscreen order by Commissioner

If the Secretary does not issue a proposed sunscreen order under paragraph (4), or the Secretary does not publish a notification of the availability of a letter under paragraph (3), as applicable, the sponsor of such request may notify the Office of the Commissioner of such request and request review by the Office of the Commissioner. The Commissioner shall, not later than 60 calendar days after the date of notification under this paragraph, issue a proposed order with respect to such request.

(6) Public comment period

A proposed sunscreen order issued under paragraph (4) or (5), or a notification of the availability of a letter under paragraph (3), with respect to a pending request shall provide for a period of 45 calendar days for public comment.

(7) Meeting

(A) In general

A sponsor may request, in writing, a meeting with respect to a proposed sunscreen order issued under this subsection, including a letter deemed to be a proposed sunscreen order under paragraph (3), not later than 30 calendar days after the Secretary issues such order or the date upon which such feedback letter is deemed to be a proposed sunscreen order, as applicable. The Secretary shall convene a meeting with such sponsor not later than 45 calendar days after the date of such request for a meeting.

(B) Confidential meetings

A sponsor may request one or more confidential meetings with respect to a proposed sunscreen order, including a letter deemed to be a proposed sunscreen order under paragraph (3), to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such proposed sunscreen order, as appropriate. The Secretary shall convene a confidential meeting with such sponsor in a reasonable time period. If a sponsor requests more than one confidential meeting for the same proposed sunscreen order, the Secretary may refuse to grant an additional confidential meeting request if the Secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order, or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion. The Secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets. This subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to 552(b)(4) ¹ of title 5 or section 1905 of title 18.

(8) Advisory Committee

In the case of a proposed sunscreen order under paragraph (3), (4), or (5), an Advisory Committee meeting may be convened for the purpose of reviewing and providing recommendations regarding the pending request.

(9) Final sunscreen order

In the case of a proposed sunscreen order under paragraph (3), (4), or (5)—

(A) the Secretary shall issue a final sunscreen order with respect to the request—

(i) in the case of a proposed sunscreen order described in subparagraph (A) or (B) of section 360fff(7) of this title, not later than 90 calendar days after the end of the public comment period under paragraph (6); or

(ii) in the case of a proposed sunscreen order described in subparagraph (C) of section 360fff(7) of this title—

(I) if the Advisory Committee is not convened under paragraph (8), not later than 210 calendar days after the date on which the sponsor submits the additional information requested pursuant to such proposed sunscreen order, which shall include a rationale for not convening such Advisory Committee; or

(II) if the Advisory Committee is convened under paragraph (8), not later than 270 calendar days after the date on which the sponsor submits such additional information; or

(B) if the Secretary does not issue such final sunscreen order within such 90-, 210-, or 270-calendar-day period, as applicable, the sponsor of such request may notify the Office of the Commissioner about such request and request review by the Office of the Commissioner.

(10) Final sunscreen order by Commissioner

The Commissioner shall issue a final sunscreen order with respect to a proposed sunscreen order subject to paragraph (9)(B) not later than 60 calendar days after the date of notification under such paragraph.

(c) Advisory Committee

The Secretary shall not be required to—

(1) convene the Advisory Committee—

(A) more than once with respect to any request under section 360fff–1 of this title or any pending request; or

(B) more than twice in any calendar year with respect to the review under this section; or

(2) submit more than a total of 3 requests under section 360fff–1 of this title or pending requests to the Advisory Committee per meeting.

(d) No delegation

Any responsibility vested in the Commissioner by subsection (a)(2), (a)(6), (b)(5), or (b)(10) shall not be delegated.

(e) Effect of final sunscreen order

(1) In general

(A) Sunscreen active ingredients determined to be GRASE

Upon issuance of a final sunscreen order determining that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded, a sunscreen containing such ingredient or combination of ingredients shall be permitted to be introduced or delivered into interstate commerce for use under the conditions described in such final sunscreen order, in accordance with all requirements applicable to drugs not subject to section 353(b)(1) of this title, for so long as such final sunscreen order remains in effect.

(B) Sunscreen active ingredients determined not to be GRASE

Upon issuance of a final sunscreen order determining that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not GRASE and is misbranded, a sunscreen containing such ingredient or combination of ingredients shall not be introduced or delivered into interstate commerce, for use under the conditions described in such final sunscreen order, unless an application is approved pursuant to section 355 of this title with respect to a sunscreen containing such ingredient or combination of ingredients, or unless conditions are later established under which such ingredient or combination of ingredients is later determined to be GRASE and not misbranded under the over-the-counter drug monograph system.

(2) Amendments to final sunscreen orders

(A) Amendments at initiative of Secretary

In the event that information relevant to a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients becomes available to the Secretary after issuance of a final sunscreen order, the Secretary may amend such final sunscreen order by issuing a new proposed sunscreen order under subsection (a)(1) and following the procedures set forth in this section.

(B) Petition to amend final order

Any interested person may petition the Secretary to amend a final sunscreen order under section 10.30, title 21 Code of Federal Regulations (or any successor regulations). If the Secretary grants any petition under such section, the Secretary shall initiate the process for amending a final sunscreen order by issuing a new proposed sunscreen order under subsection (a)(1) and following the procedures set forth in this section.

(C) Applicability of final orders

Once the Secretary issues a new proposed sunscreen order to amend a final sunscreen order under subparagraph (A) or (B), such final sunscreen order shall remain in effect and paragraph (3) shall not apply to such final sunscreen order until the Secretary has issued a new final sunscreen order or has determined not to amend the final sunscreen order.

(3) Relationship to orders under section 355h of this title

A final sunscreen order shall be deemed to be a final order under section 355h of this title.

(f) Exclusivity

(1) In general

A final sunscreen order shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) for a period of 18 months, to market a sunscreen ingredient under this section incorporating changes described in paragraph (2) subject to the limitations under paragraph (4), beginning on the date the requestor (or any licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) may lawfully market such sunscreen ingredient pursuant to the order.

(2) Changes described

A change described in this paragraph is a change subject to an order specified in paragraph (1) that permits a sunscreen to contain an active sunscreen ingredient not previously incorporated in a marketed sunscreen listed in paragraph (3).

(3) Marketed sunscreen

The marketed sunscreen ingredients described in this paragraph are sunscreen ingredients—

(A) marketed in accordance with a final monograph for sunscreen drug products set forth at part 352 of title 21, Code of Federal Regulations (as published at 64 Fed. Reg. 27687); or

(B) marketed in accordance with a final order issued under this section.

(4) Limitations on exclusivity

Only one 18-month period may be granted per ingredient under paragraph (1).

(5) Listing of licensees, assignees, or successors in interest

Requestors shall submit to the Secretary at the time when a drug subject to such request is introduced or delivered for introduction into interstate commerce, a list of licensees, assignees, or successors in interest under paragraph (1).

(June 25, 1938, ch. 675, §586C, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2039; amended Pub. L. 116–136, div. A, title III, §3854(b)(1)–(3), Mar. 27, 2020, 134 Stat. 455, 456.)

Editorial Notes

Amendments

2020—Subsec. (b)(7). Pub. L. 116–136, §3854(b)(2), designated existing provisions as subpar. (A), inserted heading, and added subpar. (B).

Subsec. (e)(3). Pub. L. 116–136, §3854(b)(1), amended par. (3) generally. Prior to amendment, par. (3) related to inclusion of ingredients that are subjects of final orders in the sunscreen monograph.

Subsec. (f). Pub. L. 116–136, §3854(b)(3), added subsec. (f).

Statutory Notes and Related Subsidiaries

Review of Nonprescription Sunscreen Active Ingredients

Pub. L. 116–136, div. A, title III, §3854(a), Mar. 27, 2020, 134 Stat. 454, provided that:

"(1) Applicability of section 505g for pending submissions.—

"(A) In general.—A sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that, as of the date of enactment of this Act [Mar. 27, 2020], is subject to a proposed sunscreen order under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3) may elect, by means of giving written notification to the Secretary of Health and Human Services within 180 calendar days of the enactment of this Act, to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section 505G of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h], as added by section 3851 of this subtitle.

"(B) Election exercised.—Upon receipt by the Secretary of Health and Human Services of a timely notification under subparagraph (A)—

"(i) the proposed sunscreen order involved is deemed to be a request for an order under subsection (b) of section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle; and

"(ii) such order is deemed to have been accepted for filing under subsection (b)(6)(A)(i) of such section 505G.

"(C) Election not exercised.—If a notification under subparagraph (A) is not received by the Secretary of Health and Human Services within 180 calendar days of the date of enactment of this Act, the review of the proposed sunscreen order described in subparagraph (A)—

"(i) shall continue under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3); and

"(ii) shall not be eligible for review under section 505G, added by section 3851 of this subtitle.

"(2) Definitions.—In this subsection, the terms 'sponsor', 'nonprescription', 'sunscreen active ingredient', and 'proposed sunscreen order' have the meanings given to those terms in section 586 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff)."

¹ So in original. Probably should be preceded by "section".

§360fff–4. Guidance; other provisions

(a) Guidance

(1) In general

(A) Draft guidance

Not later than 1 year after November 26, 2014, the Secretary shall issue draft guidance on the implementation of, and compliance with, the requirements with respect to sunscreen under this part, including guidance on—

(i) the format and content of information submitted by a sponsor in support of a request under section 360fff–1 of this title or a pending request;

(ii) the data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded;

(iii) the process by which a request under section 360fff–1 of this title or a pending request is withdrawn; and

(iv) the process by which the Secretary will carry out section 360fff–3(c) of this title, including with respect to how the Secretary will address the total number of requests received under section 360fff–1 of this title and pending requests.

(B) Final guidance

The Secretary shall finalize the guidance described in subparagraph (A) not later than 2 years after November 26, 2014.

(C) Inapplicability of Paperwork Reduction Act

Chapter 35 of title 44 shall not apply to collections of information made for purposes of guidance under this subsection.

(2) Submissions pending issuance of final guidance

Irrespective of whether final guidance under paragraph (1) has been issued—

(A) persons may, beginning on November 26, 2014, make submissions under this part; and

(B) the Secretary shall review and act upon such submissions in accordance with this part.

(b) Rules of construction

(1) Currently marketed sunscreens

Nothing in this part shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before November 26, 2014, except as otherwise provided in this part.

(2) Ensuring safety and effectiveness

Nothing in this part shall be construed to alter the authority of the Secretary with respect to prohibiting the marketing of a sunscreen that is not safe and effective or is misbranded, or with respect to imposing restrictions on the marketing of a sunscreen to ensure safety and effectiveness, except as otherwise provided in this part, including section 360fff–3(e) of this title.

(3) Other drugs

Except as otherwise provided in section 360fff–6 of this title, nothing in this part shall be construed to affect the authority of the Secretary under this chapter or the Public Health Service Act (42 U.S.C. 201 et seq.) with respect to a drug other than a nonprescription sunscreen.

(4) Effect on drugs otherwise approved

Nothing in this part shall affect the marketing of a drug approved under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(c) Timelines

The timelines for the processes and procedures under paragraphs (1), (2), (5), and (6) of section 360fff–3(a) of this title shall not apply to any requests submitted to the Secretary under section 360fff–1 of this title after the date that is 6 years after November 26, 2014.

(June 25, 1938, ch. 675, §586D, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2044.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

§360fff–5. Repealed. Pub. L. 116–136, div. A, title III, §3854(b)(5), Mar. 27, 2020, 134 Stat. 456

Section, June 25, 1938, ch. 675, §586E, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2045, related to sunscreen monograph.

§360fff–6. Non-sunscreen time and extent applications

(a) Pending time and extent applications

(1) In general

(A) Request for framework for review

If, prior to November 26, 2014, an application was submitted pursuant to section 330.14 of title 21, Code of Federal Regulations for a GRASE determination for a drug other than a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients and such drug was found to be eligible to be considered for inclusion in the over-the-counter drug monograph system pursuant to section 330.14 of title 21, Code of Federal Regulations, the sponsor of such application may request that the Secretary provide a framework under paragraph (2) for the review of such application.

(B) Request requirements

A request for a framework for review of an application made under subparagraph (A) shall be made within 180 calendar days of November 26, 2014, and shall include the preference of such sponsor as to whether such application is reviewed by the Secretary in accordance with—

(i) the processes and procedures set forth for pending requests under section 360fff–3(b) of this title, except that specific timelines shall be determined in accordance with other applicable requirements under this section;

(ii) the processes and procedures set forth under part 330 of title 21, Code of Federal Regulations (or any successor regulations);

(iii) an initial filing determination under the processes and procedures described in section 360fff–2(b) of this title and the processes and procedures set forth for pending requests under section 360fff–3(b) of this title, except that specific timelines shall be determined in accordance with other applicable requirements under this section; or

(iv) an initial filing determination under the processes and procedures described in section 360fff–2(b) of this title and the processes and procedures set forth under part 330 of title 21, Code of Federal Regulations (or any successor regulations).

(C) No request

If a sponsor described in subparagraph (A) does not make such request within 180 calendar days of November 26, 2014, such application shall be reviewed by the Secretary in accordance with the timelines of the applicable regulations when such regulations are finalized under subsection (b).

(2) Framework

Not later than 1 year after November 26, 2014, the Secretary shall provide, in writing, a framework to each sponsor that submitted a request under paragraph (1). Such framework shall set forth the various timelines, in calendar days, with respect to the processes and procedures for review under clauses (i), (ii), (iii), and (iv) of paragraph (1)(B) and—

(A) such timelines shall account for the considerations under paragraph (5); and

(B) the timelines for the various processes and procedures shall not be shorter than the timelines set forth for pending requests under sections 360fff–2(b) and 360fff–3(b) of this title, as applicable.

(3) Governing processes and procedures for review

(A) Election

Not later than 60 calendar days after the Secretary provides a framework to a sponsor under paragraph (2), such sponsor may provide an election to the Secretary regarding the processes and procedures for review under clause (i), (ii), (iii), or (iv) of paragraph (1)(B). If such sponsor makes such election, the Secretary shall review the application that is the subject of such election pursuant to the processes and procedures elected by such sponsor and the applicable timelines in calendar days set forth under such framework, which the Secretary shall confirm in writing to the sponsor not later than the date upon which the Secretary provides a report under paragraph (4). If such sponsor does not make such election, such application shall be reviewed by the Secretary in accordance with the timelines of the applicable regulations when such regulations are finalized under subsection (b).

(B) Different processes and procedures

At any time during review of an application, the Secretary may review such application under different processes and procedures under clause (i), (ii), (iii), or (iv) of paragraph (1)(B) than the processes and procedures the sponsor elected in accordance with subparagraph (A), so long as the Secretary proposes, in writing, the change and the sponsor agrees, in writing, to such change.

(C) Inclusion of ingredients in monographs

If the sponsor elects to use the processes and procedures for review in accordance with clause (i) or (iii) of paragraph (1)(B), the Secretary may incorporate any resulting final order into a regulation addressing the conditions under which other drugs in the same therapeutic category are GRASE and not misbranded, including through direct final rulemaking, and the final order so incorporated shall cease to be effective on the effective date of the final regulation that addresses such drug.

(4) Letter regarding pending applications

Not later than 18 months after November 26, 2014, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, in writing, regarding all pending applications subject to paragraph (1). In such letter, the Secretary shall provide a report on the review of such applications, including the timelines, in calendar days, for the review and GRASE determination for each application. Such timelines shall account for the considerations under paragraph (5).

(5) Timelines

The timelines in calendar days established by the Secretary pursuant to this subsection—

(A) may vary based on the content, complexity, and format of the application submitted to the Secretary; and

(B) shall—

(i) reflect the public health priorities of the Food and Drug Administration, including the potential public health benefits posed by the inclusion of additional drugs in the over-the-counter drug monograph system;

(ii) take into consideration the resources available to the Secretary for carrying out such priorities and the processes and procedures described in paragraphs (1)(B) and (2); and

(iii) be reasonable, taking into consideration the requirements described in clauses (i) and (ii).

(b) New time and extent applications

(1) In general

Not later than 18 months after November 26, 2014, the Secretary shall issue proposed regulations establishing timelines for the review of applications for GRASE determinations for drugs other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients that are submitted to the Secretary after November 26, 2014, under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations), and that are found to be eligible to be considered for inclusion in the over-the-counter drug monograph system pursuant to section 330.14 of title 21, Code of Federal Regulations (or any successor regulations), or that are subject to this subsection pursuant to paragraph (1) or (3) of subsection (a), as applicable, providing—

(A) timely and efficient completion of evaluations of applications under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations) for drugs other than sunscreens; and

(B) timely and efficient completion of the review of the safety and effectiveness submissions pursuant to such applications, including establishing—

(i) reasonable timelines, in calendar days, for the applicable proposed and final regulations for applications of various content, complexity, and format, and timelines for internal procedures related to such processes; and

(ii) measurable metrics for tracking the extent to which the timelines set forth in the regulations are met.

(2) Timelines

The timelines in calendar days established in the regulations under paragraph (1)—

(A) may vary based on the content, complexity, and format of the application submitted to the Secretary; and

(B) shall—

(i) reflect the public health priorities of the Food and Drug Administration, including the potential public health benefits posed by the inclusion of additional drugs in the over-the-counter drug monograph system;

(ii) take into consideration the resources available to the Secretary for carrying out such priorities and the processes and procedures described in paragraph (1); and

(iii) be reasonable, taking into consideration the requirements described in clauses (i) and (ii).

(3) Procedure

In promulgating regulations under this subsection, the Secretary shall issue a notice of proposed rulemaking that includes a copy of the proposed regulation, provide a period of not less than 60 calendar days for comments on the proposed regulation, and publish the final regulation not less than 30 calendar days before the effective date of the regulation.

(4) Restrictions

Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraphs (1), (2), and (3).

(5) Final regulations

The Secretary shall finalize the regulations under this section not later than 27 months after November 26, 2014.

(June 25, 1938, ch. 675, §586F, as added Pub. L. 113–195, §3, Nov. 26, 2014, 128 Stat. 2046.)

Statutory Notes and Related Subsidiaries

Treatment of Non-Sunscreen Time and Extent Applications

Pub. L. 116–136, div. A, title III, §3854(d), Mar. 27, 2020, 134 Stat. 457, provided that:

"(1) In general.—Any application described in section 586F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–6) that was submitted to the Secretary pursuant to section 330.14 of title 21, Code of Federal Regulations, as such provisions were in effect immediately prior to the date of enactment date of this Act [Mar. 27, 2020], shall be extinguished as of such date of enactment, subject to paragraph (2).

"(2) Order request.—Nothing in paragraph (1) precludes the submission of an order request under section 505G(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)], as added by section 3851 of this subtitle, with respect to a drug that was the subject of an application extinguished under paragraph (1)."

§360fff–7. Report

(a) In general

(1) In general

Not later than 18 months after November 26, 2014, and on the dates that are 2 and 4 years thereafter, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives describing actions taken under this part.

(2) Contents

The reports under this subsection shall include—

(A) a review of the progress made in issuing GRASE determinations for pending requests, including the number of pending requests—

(i) reviewed and the decision times for each request, measured from the date of the original request for an eligibility determination submitted by the sponsor;

(ii) resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded;

(iii) resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not GRASE and is misbranded and the reasons for such determinations; and

(iv) for which a determination has not been made, and an explanation for the delay, a description of the current status of each such request, and the length of time each such request has been pending, measured from the date of original request for an eligibility determination by the sponsor;

(B) a review of the progress made in issuing GRASE determinations for requests not included in the reporting under subparagraph (A), including the number of such requests—

(i) reviewed and the decision times for each request;

(ii) resulting in a determination that the nonprescription sunscreen active ingredient, combination of nonprescription sunscreen active ingredients, or other ingredient is GRASE and is not misbranded;

(iii) resulting in a determination that the nonprescription sunscreen active ingredient, combination of nonprescription sunscreen active ingredients, or other ingredient is not GRASE and is misbranded and the reasons for such determinations; and

(iv) for which a determination has not been made, and an explanation for the delay, a description of the current status of each such request, and the length of time each such request has been pending, measured from the date of original request for an eligibility determination by the sponsor;

(C) an annual accounting (including information from years prior to November 26, 2014, where such information is available) of the total number of requests submitted, pending, or completed under this part, including whether such requests were the subject of an advisory committee convened by the Secretary;

(D) a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to requests under this part;

(E) a review of the progress made in meeting the deadlines with respect to processing requests under this part; and

(F) to the extent the Secretary determines appropriate, recommendations for process improvements in the handling of requests under this part, including the advisory committee review process.

(b) Method

The Secretary shall publish the reports under subsection (a) in the manner the Secretary determines to be the most effective for efficiently disseminating the report, including publication of the report on the Internet website of the Food and Drug Administration.

(June 25, 1938, ch. 675, §586G, as added Pub. L. 113–195, §4(c), Nov. 26, 2014, 128 Stat. 2050.)

§360fff–8. Sunset

This part shall cease to be effective at the end of fiscal year 2022.

(June 25, 1938, ch. 675, §586H, as added Pub. L. 116–136, div. A, title III, §3854(b)(4), Mar. 27, 2020, 134 Stat. 456.)

SUBCHAPTER VI—COSMETICS

§361. Adulterated cosmetics

A cosmetic shall be deemed to be adulterated—

(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.", and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes.

(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.

(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.

(f) If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 364b of this title.

(g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for ¹ safety, as defined in section 364d(c) of this title.

(June 25, 1938, ch. 675, §601, 52 Stat. 1054; Pub. L. 86–618, title I, §102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L. 102–571, title I, §107(11), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §3(x), Aug. 13, 1993, 107 Stat. 778; Pub. L. 117–328, div. FF, title III, §3503(a)(2), Dec. 29, 2022, 136 Stat. 5858.)

Editorial Notes

Amendments

2022—Subsecs. (f), (g). Pub. L. 117–328 added subsecs. (f) and (g).

1993—Subsec. (a). Pub. L. 103–80 substituted "usual, except that this" for "usual: Provided, That this".

1992—Par. (e). Pub. L. 102–571 substituted "379e(a)" for "376(a)".

1960—Par. (e). Pub. L. 86–618 substituted "and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376(a) of this title" for "and it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 364 of this title".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date; Postponement

Par. (e) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Effective Date

Section effective twelve months after June 25, 1938, except par. (a), which, with certain exceptions, became effective on June 25, 1938, see section 1002(a) of act June 25, 1938, set out as a note under section 301 of this title.

Construction; Confidentiality

Nothing in amendment made by Pub. L. 117–328, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

¹ So in original. Probably should be "of".

§362. Misbranded cosmetics

A cosmetic shall be deemed to be misbranded—

(a) If its labeling is false or misleading in any particular.

(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and (3) the information required under section 364e of this title: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

(c) If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(d) If its container is so made, formed, or filled as to be misleading.

(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 379e of this title. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 361(a) of this title).

(f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15.

(June 25, 1938, ch. 675, §602, 52 Stat. 1054; Pub. L. 86–618, title I, §102(c)(2), July 12, 1960, 74 Stat. 398; Pub. L. 91–601, §6(f), formerly §7(f), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, §1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 102–571, title I, §107(12), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 117–328, div. FF, title III, §3503(a)(3), Dec. 29, 2022, 136 Stat. 5858.)

Editorial Notes

Amendments

2022—Subsec. (b)(3). Pub. L. 117–328 added par. (3) before proviso.

1992—Par. (e). Pub. L. 102–571 substituted "379e" for "376".

1970—Par. (f). Pub. L. 91–601 added par. (f).

1960—Par. (e). Pub. L. 86–618 added par. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date; Postponement

Par. (b) effective Jan. 1, 1940, and such subsection effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers bearing certain labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Construction; Confidentiality

Nothing in amendment made by Pub. L. 117–328, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§363. Regulations making exemptions

The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.

(June 25, 1938, ch. 675, §603, 52 Stat. 1054.)

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§364. Definitions

In this subchapter:

(1) Adverse event

The term "adverse event" means any health-related event associated with the use of a cosmetic product that is adverse.

(2) Cosmetic product

The term "cosmetic product" means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.

(3) Facility

(A) In general.—The term "facility" includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

(B) Such term does not include any of the following:

(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.

(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of title 26), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.

(iii) Hospitals, physicians' offices, and health care clinics.

(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.

(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.

(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.

(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.

(viii) An establishment that solely performs one or more of the following with respect to cosmetic products:

(I) Labeling.

(II) Relabeling.

(III) Packaging.

(IV) Repackaging.

(V) Holding.

(VI) Distributing.

(C) Clarification.—For the purposes of subparagraph (B)(viii), the terms "packaging" and "repackaging" do not include filling a product container with a cosmetic product.

(4) Responsible person

The term "responsible person" means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 364e(a) of this title or section 1453(a) of title 15.

(5) Serious adverse event

The term "serious adverse event" means an adverse event that—

(A) results in—

(i) death;

(ii) a life-threatening experience;

(iii) inpatient hospitalization;

(iv) a persistent or significant disability or incapacity;

(v) a congenital anomaly or birth defect;

(vi) an infection; or

(vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or

(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).

(June 25, 1938, ch. 675, §604, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5847.)

Editorial Notes

Prior Provisions

A prior section 364, act June 25, 1938, ch. 675, §604, 52 Stat. 1055, directed Secretary to promulgate regulations for listing of coal-tar colors for cosmetics, prior to repeal by Pub. L. 86–618, title I, §103(a)(3), July 12, 1960, 74 Stat. 398, effective July 12, 1960. See section 379e of this title.

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Pub. L. 117–328, div. FF, title III, §3503(c), Dec. 29, 2022, 136 Stat. 5859, provided that:

"(1) In general.—The Secretary [of Health and Human Services] shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential commercial information that is obtained by the Secretary of Health and Human Services pursuant to this subtitle [subtitle E (§§3501–3508) of title III of div. FF of Pub. L. 117–328, see Short Title of 2022 Amendment set out under section 301 of this title], including the amendments made by this subtitle.

"(2) Clarification.—Nothing in this subtitle, including the amendments made by this subtitle, shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code."

§364a. Adverse events

(a) Serious adverse event reporting requirements

The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person.

(b) Submission of reports

(1) Serious adverse event report

The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.

(2) New medical information

The responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person.

(3) Consolidation of reports

The Secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event.

(c) Exemptions

The Secretary may establish by regulation an exemption to any of the requirements of this section if the Secretary determines that such exemption would have no significant adverse effect on public health.

(d) Contact information

The responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information included on the label in accordance with section 364e(a) of this title.

(e) Maintenance and inspection of adverse event records

(1) Maintenance

The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years, except that a responsible person that is considered a small business for the purposes of section 364h of this title, who does not engage in the manufacturing or processing of the cosmetic products described in subsection 364h(b) of this title, shall maintain such records for a period of 3 years.

(2) Inspection

(A) In general

The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 374 of this title.

(B) Authorized person

For purposes of this paragraph, the term "authorized person" means an officer or employee of the Department of Health and Human Services who has—

(i) appropriate credentials, as determined by the Secretary; and

(ii) been duly designated by the Secretary to have access to the records required under this section.

(f) Fragrance and flavor ingredients

If the Secretary has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported under this section, the Secretary may request in writing a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person. The responsible person shall ensure that the requested information is submitted to the Secretary within 30 days of such request. In response to a request under section 552 of title 5, information submitted to the Secretary under this subsection shall be withheld under section 552(b)(3) of title 5.

(g) Protected information

A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (b)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered to be—

(1) a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and

(2) a record about an individual under section 552a of title 5 (commonly referred to as the "Privacy Act of 1974") and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the "Freedom of Information Act"), and shall not be publicly disclosed unless all personally identifiable information is redacted.

(h) Effect of section

(1) In general

Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.

(2) Personally identifiable information

Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—

(A) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

(B) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

(3) Use of reports

Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with this section.

(4) Rule of construction

The submission of any report in compliance with this section shall not be construed as an admission that the cosmetic product involved caused or contributed to the relevant adverse event.

(June 25, 1938, ch. 675, §605, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5848.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

§364b. Good manufacturing practice

(a) In general

The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with section 361 of this title. Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph ¹ during an inspection conducted under section 374 of this title.

(b) Considerations

In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.

(c) Timeframe

The Secretary shall publish a notice of proposed rulemaking not later than 2 years after December 29, 2022, and shall publish a final such rule not later than 3 years after December 29, 2022.

(June 25, 1938, ch. 675, §606, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5850.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

¹ So in original. Probably should be "this subsection".

§364c. Registration and product listing

(a) Submission of registration

(1) Initial registration

(A) Existing facilities

Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after December 29, 2022.

(B) New facilities

Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.

(2) Biennial renewal of registration

A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.

(3) Contract manufacturers

If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.

(4) Updates to content

A person that is required to register under subsection (a)(1) shall notify the Secretary within 60 days of any changes to information required under subsection (b)(2).

(5) Abbreviated renewal registrations

The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates under paragraph (4) for a registered facility since submission of the most recent registration of such facility under paragraph (1) or (2).

(b) Format; contents of registration

(1) In general

Registration information under this section may be submitted at such time and in such manner as the Secretary may prescribe.

(2) Contents

The registration under subsection (a) shall contain—

(A) the facility's name, physical address, email address, and telephone number;

(B) with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information;

(C) the facility registration number, if any, previously assigned by the Secretary under subsection (d);

(D) all brand names under which cosmetic products manufactured or processed in the facility are sold; and

(E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.

(c) Cosmetic product listing

(1) In general

For each cosmetic product, the responsible person shall submit to the Secretary a cosmetic product listing, or ensure that such submission is made, at such time and in such manner as the Secretary may prescribe.

(2) Cosmetic product listing

The responsible person of a cosmetic product that is marketed on December 29, 2022, shall submit to the Secretary a cosmetic product listing not later than 1 year after December 29, 2022, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce. Thereafter, any updates to such listing shall be made annually, consistent with paragraphs (4) and (5).

(3) Abbreviated renewal

The Secretary shall provide for an abbreviated process for the renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person submitted the previous listing.

(4) Contents of listing

(A) In general

Each such cosmetic product listing shall include—

(i) the facility registration number of each facility where the cosmetic product is manufactured or processed;

(ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;

(iii) the applicable cosmetic category or categories for the cosmetic product;

(iv) a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and

(v) the product listing number, if any previously assigned by the Secretary under subsection (d).

(B) Flexible listings

A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.

(5) Updates to content

A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually.

(6) Submission

A responsible person may submit product listing information as part of a facility registration or separately.

(d) Facility registration and product listing numbers

At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1),¹ the Secretary shall assign a facility registration number to the facility and a product listing number to each cosmetic product. The Secretary shall not make such product listing number publicly available.

(e) Confidentiality

In response to a request under section 552 of title 5, information described in subsection (b)(2)(D) or (c)(4)(A)(i) that is derived from a registration or listing under this section shall be withheld under section 552(b)(3) of title 5.

(f) Suspensions

(1) Suspension of registration of a facility

The Secretary may suspend the registration of a facility if the Secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.

(2) Notice of suspension

Before suspending a facility registration under this section, the Secretary shall provide—

(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and

(B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration.

(3) Hearing on suspension

The Secretary shall provide the registrant subject to an order under paragraph (1) or (2) with an opportunity for an informal hearing, to be held as soon as possible but not later than 5 business days after the issuance of the order, or such other time period agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.

(4) Post-hearing corrective action plan

If, after providing opportunity for an informal hearing under paragraph (3), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 business days after the submission of the corrective action plan or such other time period as determined by the Secretary, in consultation with the registrant.

(5) Vacating of order; reinstatement

Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions, the Secretary shall promptly vacate the suspension and reinstate the registration of the facility.

(6) Effect of suspension

If the registration of the facility is suspended under this section, no person shall introduce or deliver for introduction into commerce in the United States cosmetic products from such facility.

(7) No delegation

The authority conferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.

(June 25, 1938, ch. 675, §607, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5851.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

¹ So in original. Probably should be preceded by "subsection".

§364d. Safety substantiation

(a) Substantiation of safety

A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.

(b) Coal-tar hair dye

Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 361(a) of this title. A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.

(c) Definitions

For purposes of this section:

(1) Adequate substantiation of safety

The term "adequate substantiation of safety" means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.

(2) Safe

The term "safe" means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.

(June 25, 1938, ch. 675, §608, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5854.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

Talc-Containing Cosmetics

Pub. L. 117–328, div. FF, title III, §3505, Dec. 29, 2022, 136 Stat. 5859, provided that:

"The Secretary of Health and Human Services—

"(1) not later than one year after the date of enactment of this Act [Dec. 29, 2022], shall promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products; and

"(2) not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations."

§364e. Labeling

(a) General requirement

Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.

(b) Fragrance allergens

The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.

(c) Cosmetic products for professional use

(1) Definition of professional

For purposes of this subsection, the term "professional" means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.

(2) Professional use labeling

A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—

(A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and

(B) is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and section 1453(a) of title 15.

(June 25, 1938, ch. 675, §609, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5854.)

Delayed Effective Date of Subsection (a)

For delayed effective date of subsection (a) of this section, see Effective Date of 2022 Amendment note below.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3503(b)(2), Dec. 29, 2022, 136 Stat. 5859, provided that: "Section 609(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 364e(a)], as added by section 802 [probably should be "section 3502"], shall take effect on the date that is 2 years after the date of enactment of this Act [Dec. 29, 2022]."

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

§364f. Records

(a) In general

If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).

(b) Rule of construction

Nothing in this section shall be construed to limit the authority of the Secretary to inspect records or require establishment and maintenance of records under any other provision of this chapter, including section 364a or 364b of this title.

(June 25, 1938, ch. 675, §610, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5855.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

§364g. Mandatory recall authority

(a) In general

If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under section 361 of this title or misbranded under section 362 of this title and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary determines necessary, such person to immediately cease distribution of such article.

(b) Hearing

The Secretary shall provide the responsible person who is subject to an order under subsection (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order.

(c) Order resolution

After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)—

(1) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;

(2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or

(3) amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.

(d) Action following order

Any person who is subject to an order pursuant to paragraph (2) or (3) of subsection (c) shall immediately cease distribution of or recall, as applicable, the cosmetic and provide notification as required by such order.

(e) Notice to persons affected

If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to subsection (a) or an amended order pursuant to paragraph (2) or (3) of subsection (c) to provide either a notice of a recall order for, or an order to cease distribution of, such cosmetic, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public.

(f) Public notification

In conducting a recall under this section, the Secretary shall—

(1) ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification—

(A) of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and

(B) that includes, at a minimum—

(i) the name of the cosmetic subject to the recall;

(ii) a description of the risk associated with such article; and

(iii) to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and

(2) ensure publication, as appropriate, on the website of the Food and Drug Administration of an image of the cosmetic that is the subject of the press release described in paragraph (1), if available.

(g) No delegation

The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.

(h) Effect

Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this subchapter.

(June 25, 1938, ch. 675, §611, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5855.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

§364h. Small businesses

(a) In general

Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.

(b) Requirements applicable to all manufacturers and processors of cosmetics

The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:

(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.

(2) Cosmetic products that are injected.

(3) Cosmetic products that are intended for internal use.

(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

(June 25, 1938, ch. 675, §612, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5857.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

§364i. Exemption for certain products and facilities

(a) In general

Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.

(b) Exception

A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of subchapter V shall not be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title, with respect to such cosmetic products.

(June 25, 1938, ch. 675, §613, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5857.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

§364j. Preemption

(a) In general

No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement applicable under this subchapter with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation.

(b) Limitation

Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a). Notwithstanding subsection (a), nothing in this section shall be construed to prevent any State from prohibiting the use or limiting the amount of an ingredient in a cosmetic product, or from continuing in effect a requirement of any State that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient in a cosmetic product.

(c) Savings

Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, nor any standard, rule, requirement, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any State, whether statutory or based in common law.

(d) Rule of construction

Nothing in this section shall be construed to amend, expand, or limit the provisions under section 379s of this title.

(June 25, 1938, ch. 675, §614, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5857.)

Editorial Notes

References in Text

The amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, referred to in subsecs. (b) and (c), means the amendments made by subtitle E (§§3501–3508) of title III of div. FF of Pub. L. 117–328, which enacted this section and sections 364 to 364i of this title and amended sections 331, 361, 362, 374, and 381 of this title.

The time of enactment of the Modernization of Cosmetics Regulation Act of 2022, referred to in subsec. (b), probably means the date of enactment of subtitle E (§§3501–3508) of title III of div. FF of Pub. L. 117–328, which was approved Dec. 29, 2022.

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

SUBCHAPTER VII—GENERAL AUTHORITY

Part A—General Administrative Provisions

§371. Regulations and hearings

(a) Authority to promulgate regulations

The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary.

(b) Regulations for imports and exports

The Secretary of the Treasury and the Secretary of Health and Human Services shall jointly prescribe regulations for the efficient enforcement of the provisions of section 381 of this title, except as otherwise provided therein. Such regulations shall be promulgated in such manner and take effect at such time, after due notice, as the Secretary of Health and Human Services shall determine.

(c) Conduct of hearings

Hearings authorized or required by this chapter shall be conducted by the Secretary or such officer or employee as he may designate for the purpose.

(d) Effectiveness of definitions and standards of identity

The definitions and standards of identity promulgated in accordance with the provisions of this chapter shall be effective for the purposes of the enforcement of this chapter, notwithstanding such definitions and standards as may be contained in other laws of the United States and regulations promulgated thereunder.

(e) Procedure for establishment

(1) Any action for the issuance, amendment, or repeal of any regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under section 341 of this title for any dairy product (including products regulated under parts 131, 133 and 135 of title 21, Code of Federal Regulations) shall be begun by a proposal made (A) by the Secretary on his own initiative, or (B) by petition of any interested person, showing reasonable grounds therefor, filed with the Secretary. The Secretary shall publish such proposal and shall afford all interested persons an opportunity to present their views thereon, orally or in writing. As soon as practicable thereafter, the Secretary shall by order act upon such proposal and shall make such order public. Except as provided in paragraph (2), the order shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under such paragraph.

(2) On or before the thirtieth day after the date on which an order entered under paragraph (1) is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. Until final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As soon as practicable after the time for filing objections has expired the Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact.

(3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions.

(f) Review of order

(1) In a case of actual controversy as to the validity of any order under subsection (e), any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based his order, as provided in section 2112 of title 28.

(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence.

(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently. If the order of the Secretary refuses to issue, amend, or repeal a regulation and such order is not in accordance with law the court shall by its judgment order the Secretary to take action, with respect to such regulation, in accordance with law. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.

(4) The judgment of the court affirming or setting aside, in whole or in part, any such order of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28.

(5) Any action instituted under this subsection shall survive notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.

(g) Copies of records of hearings

A certified copy of the transcript of the record and proceedings under subsection (e) shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, libel for condemnation, exclusion of imports, or other proceeding arising under or in respect to this chapter, irrespective of whether proceedings with respect to the order have previously been instituted or become final under subsection (f).

(h) Guidance documents

(1)(A) The Secretary shall develop guidance documents with public participation and ensure that information identifying the existence of such documents and the documents themselves are made available to the public both in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for or on any person, although they present the views of the Secretary on matters under the jurisdiction of the Food and Drug Administration.

(B) Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use guidance documents and shall monitor the development and issuance of such documents.

(C)(i) For guidance documents that set forth initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues, the Secretary shall ensure public participation prior to implementation of guidance documents, unless the Secretary determines that such prior public participation is not feasible or appropriate. In such cases, the Secretary shall provide for public comment upon implementation and take such comment into account.

(ii) With respect to devices, if a notice to industry guidance letter, a notice to industry advisory letter, or any similar notice sets forth initial interpretations of a regulation or policy or sets forth changes in interpretation or policy, such notice shall be treated as a guidance document for purposes of this subparagraph.

(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary shall provide for public comment upon implementation.

(2) In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents and revisions of such documents are properly dated and indicate the nonbinding nature of the documents. The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents.

(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public.

(4) The Secretary shall ensure that an effective appeals mechanism is in place to address complaints that the Food and Drug Administration is not developing and using guidance documents in accordance with this subsection.

(5) Not later than July 1, 2000, the Secretary after evaluating the effectiveness of the Good Guidance Practices document, published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation consistent with this subsection specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.

(June 25, 1938, ch. 675, §701, 52 Stat. 1055; June 25, 1948, ch. 646, §32, 62 Stat. 991; Apr. 15, 1954, ch. 143, §2, 68 Stat. 55; Aug. 1, 1956, ch. 861, §2, 70 Stat. 919; Pub. L. 85–791, §21, Aug. 28, 1958, 72 Stat. 948; Pub. L. 86–618, title I, §103(a)(4), July 12, 1960, 74 Stat. 398; Pub. L. 101–535, §8, Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §§3(y), (dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103–396, §3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105–115, title IV, §405, Nov. 21, 1997, 111 Stat. 2368; Pub. L. 112–144, title VI, §619, July 9, 2012, 126 Stat. 1063.)

Editorial Notes

Amendments

2012—Subsec. (h)(1)(C). Pub. L. 112–144 designated existing provisions as cl. (i) and added cl. (ii).

1997—Subsec. (h). Pub. L. 105–115 added subsec. (h).

1994—Subsec. (e)(1). Pub. L. 103–396 which directed the amendment of par. (1) by striking out "or maple syrup (regulated under section 168.140 of title 21, Code of Federal Regulations).", was executed by striking out "or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)" before "shall be begun by a proposal", to reflect the probable intent of Congress.

1993—Subsec. (b). Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture" in two places.

Subsec. (e)(1). Pub. L. 103–80, §4(c), made technical correction to directory language of Pub. L. 101–535, §8. See 1990 Amendment note below.

Pub. L. 103–80, §3(y)(1), struck out period after second reference to "Regulations)".

Subsec. (f)(4). Pub. L. 103–80, §3(y)(2), substituted reference to section 1254 of title 28 for "sections 239 and 240 of the Judicial Code, as amended".

1992—Subsec. (b). Pub. L. 102–300, which directed the substitution of "Health and Human Services" for "Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

1990—Subsec. (e)(1). Pub. L. 101–535, §8, as amended by Pub. L. 103–80, §4(c), substituted "Any action for the issuance, amendment, or repeal of any regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under section 341 of this title for any dairy product (including products regulated under parts 131, 133 and 135 of title 21, Code of Federal Regulations) or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)" for "Any action for the issuance, amendment, or repeal of any regulation under section 341, 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title".

1960—Subsec. (e). Pub. L. 86–618 substituted "section 341, 343(j), 344(a), 346, 351(b), or 352(d) or (h), of this title" for "section 341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or (h), 354 or 364 of this title".

1958—Subsec. (f)(1). Pub. L. 85–791, §21(a), substituted provisions requiring transmission of a copy of the petition by clerk to Secretary, and filing of the record by Secretary, for provisions which permitted service of summons and petition any place in United States and required Secretary to certify and file transcript of the proceedings and record upon service.

Subsec. (f)(3). Pub. L. 85–791, §21(b), inserted "Upon the filing of the petition referred to in paragraph (1) of this subsection".

1956—Subsec. (e). Act Aug. 1, 1956, simplified procedures governing prescribing of regulations under certain provisions of this chapter.

1954—Subsec. (e). Act Apr. 15, 1954, struck out reference to section 341 of this title, before "343(j)", such section 341 now containing its own provisions with respect to hearings regarding the establishment of food standards.

Statutory Notes and Related Subsidiaries

Change of Name

Circuit Court of Appeals of the United States changed to United States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.

Savings Provision

Savings clause of act Aug. 1, 1956, see note set out under section 341 of this title.

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

Notification of FDA Intent To Regulate Laboratory-Developed Tests

Pub. L. 112–144, title XI, §1143, July 9, 2012, 126 Stat. 1130, provided that the Food and Drug Administration could not issue any draft or final guidance on the regulation of laboratory-developed tests under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) without, at least 60 days prior to such issuance, notifying the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the Administration's intent to take such action and including in such notification the anticipated details of such action, and that such provision ceased to have force or effect on the date that was 5 years after the date of enactment of Pub. L. 112–144, which was approved July 9, 2012.

Approval of Supplemental Applications for Approved Products

Pub. L. 105–115, title IV, §403, Nov. 21, 1997, 111 Stat. 2367, provided that:

"(a) Standards.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall publish in the Federal Register standards for the prompt review of supplemental applications submitted for approved articles under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262).

"(b) Guidance to Industry.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary shall issue final guidances to clarify the requirements for, and facilitate the submission of data to support, the approval of supplemental applications for the approved articles described in subsection (a). The guidances shall—

"(1) clarify circumstances in which published matter may be the basis for approval of a supplemental application;

"(2) specify data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application; and

"(3) define supplemental applications that are eligible for priority review.

"(c) Responsibilities of Centers.—The Secretary shall designate an individual in each center within the Food and Drug Administration (except the Center for Food Safety and Applied Nutrition) to be responsible for—

"(1) encouraging the prompt review of supplemental applications for approved articles; and

"(2) working with sponsors to facilitate the development and submission of data to support supplemental applications.

"(d) Collaboration.—The Secretary shall implement programs and policies that will foster collaboration between the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies, and other persons, to identify published and unpublished studies that may support a supplemental application, and to encourage sponsors to make supplemental applications or conduct further research in support of a supplemental application based, in whole or in part, on such studies."

Hearings Pending on April 15, 1954, With Respect to Food Standards

Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings begun prior to such date under subsection (e) of this section, regarding food standards, see Savings Provisions note set out under section 341 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§372. Examinations and investigations

(a) Authority to conduct

(1)(A) The Secretary is authorized to conduct examinations and investigations for the purposes of this chapter through officers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department.

(B)(i) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this chapter.

(ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this chapter on Indian country without the express written consent of the Indian tribe involved.

(2)(A) In addition to the authority established in paragraph (1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or agency, is authorized to conduct examinations and investigations for the purposes of this chapter through the officers and employees of such other department or agency, subject to subparagraph (B). Such a memorandum shall include provisions to ensure adequate training of such officers and employees to conduct the examinations and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency.

(B) A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency.

(C) For any fiscal year in which the Secretary and the head of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or agencies submit to the committees of jurisdiction (authorizing and appropriating) in the House of Representatives and the Senate a report that provides, for such year—

(i) the number of officers or employees that carried out one or more programs, projects, or activities under such memorandum;

(ii) the number of additional articles that were inspected or examined as a result of such memorandum; and

(iii) the number of additional examinations or investigations that were carried out pursuant to such memorandum.

(3) In the case of food packed in the Commonwealth of Puerto Rico or a Territory the Secretary shall attempt to make inspection of such food at the first point of entry within the United States when, in his opinion and with due regard to the enforcement of all the provisions of this chapter, the facilities at his disposal will permit of such inspection.

(4) For the purposes of this subsection, the term "United States" means the States and the District of Columbia.

(b) Availability to owner of part of analysis samples

Where a sample of a food, drug, or cosmetic is collected for analysis under this chapter the Secretary shall, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent; except that the Secretary is authorized, by regulations, to make such reasonable exceptions from, and impose such reasonable terms and conditions relating to, the operation of this subsection as he finds necessary for the proper administration of the provisions of this chapter.

(c) Records of other departments and agencies

For purposes of enforcement of this chapter, records of any department or independent establishment in the executive branch of the Government shall be open to inspection by any official of the Department duly authorized by the Secretary to make such inspection.

(d) Information on patents for drugs

The Secretary is authorized and directed, upon request from the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, to furnish full and complete information with respect to such questions relating to drugs as the Director may submit concerning any patent application. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required.

(e) Powers of enforcement personnel

Any officer or employee of the Department designated by the Secretary to conduct examinations, investigations, or inspections under this chapter relating to counterfeit drugs may, when so authorized by the Secretary—

(1) carry firearms;

(2) execute and serve search warrants and arrest warrants;

(3) execute seizure by process issued pursuant to libel under section 334 of this title;

(4) make arrests without warrant for offenses under this chapter with respect to such drugs if the offense is committed in his presence or, in the case of a felony, if he has probable cause to believe that the person so arrested has committed, or is committing, such offense; and

(5) make, prior to the institution of libel proceedings under section 334(a)(2) of this title, seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling, or other things, if they are, or he has reasonable grounds to believe that they are, subject to seizure and condemnation under such section 334(a)(2). In the event of seizure pursuant to this paragraph (5), libel proceedings under section 334(a)(2) of this title shall be instituted promptly and the property seized be placed under the jurisdiction of the court.

(June 25, 1938, ch. 675, §702, 52 Stat. 1056; Pub. L. 87–781, title III, §§307(b), 308, Oct. 10, 1962, 76 Stat. 796; Pub. L. 89–74, §8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91–513, title II, §701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L. 106–113, div. B, §1000(a)(9) [title IV, §4732(b)(12)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584; Pub. L. 107–188, title III, §314, June 12, 2002, 116 Stat. 674; Pub. L. 111–31, div. A, title I, §103(g), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Subsec. (a)(1). Pub. L. 111–31 designated existing provisions as subpar. (A) and added subpar. (B).

2002—Subsec. (a). Pub. L. 107–188 inserted "(1)" before "The Secretary is authorized to conduct", added par. (2), inserted "(3)" before "In the case of food packed", and substituted "(4) For the purposes of this subsection," for "For the purposes of this subsection".

1999—Subsec. (d). Pub. L. 106–113, in first sentence, substituted "Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office" for "Commissioner of Patents" and "Director" for "Commissioner".

1993—Subsec. (c). Pub. L. 103–80 struck out "of Agriculture" after "Department".

1992—Subsec. (c). Pub. L. 102–300, which directed the amendment of subsec. (c) by striking out "of Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

1970—Subsec. (e). Pub. L. 91–513 struck out reference to depressant or stimulant drugs.

1965—Subsec. (e). Pub. L. 89–74 added subsec. (e).

1962—Subsec. (a). Pub. L. 87–781, §307(b), inserted "the Commonwealth of Puerto Rico or" before "a Territory the Secretary".

Subsec. (d). Pub. L. 87–781, §308, added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 1999 Amendment

Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, §4731] of Pub. L. 106–113, set out as a note under section 1 of Title 35, Patents.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1965 Amendment

Amendment by Pub. L. 89–74 effective July 15, 1965, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see note set out under section 321 of this title.

§372a. Transferred

Editorial Notes

Codification

Section, act June 25, 1938, ch. 675, §702A, formerly June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712, 48 Stat. 1204, and amended, which related to examination of sea food, was renumbered section 706 of act June 25, 1938, by Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498, and transferred to section 376 of this title.

§373. Records

(a) In general

For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in interstate commerce or holding such articles so received, shall, upon the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times, to have access to and to copy all records showing the movement in interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper, and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a statement in writing specifying the nature or kind of food, drug, device, tobacco product, or cosmetic to which such request relates, except that evidence obtained under this section, or any evidence which is directly or indirectly derived from such evidence, shall not be used in a criminal prosecution of the person from whom obtained, and except that carriers shall not be subject to the other provisions of this chapter by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual course of business as carriers, except as provided in subsection (b).

(b) Food transportation records

A shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to section 350e of this title shall, on request of an officer or employee designated by the Secretary, permit the officer or employee, at reasonable times, to have access to and to copy all records that the Secretary requires to be kept under section 350e(c)(1)(E) of this title.

(June 25, 1938, ch. 675, §703, 52 Stat. 1057; Pub. L. 91–452, title II, §230, Oct. 15, 1970, 84 Stat. 930; Pub. L. 103–80, §3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109–59, title VII, §7202(c), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 111–31, div. A, title I, §103(h), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Subsec. (a). Pub. L. 111–31 inserted "tobacco product," after "device," in two places and "tobacco products," after "devices," in two places.

2005—Pub. L. 109–59 struck out "of interstate shipment" after "Records" in section catchline, designated existing provisions as subsec. (a), inserted subsec. heading, substituted "carriers, except as provided in subsection (b)" for "carriers" before period at end, and added subsec. (b).

1993—Pub. L. 103–80 substituted ", except that" for ": Provided, That" and ", and except that" for ": Provided further, That".

1970—Pub. L. 91–452 inserted ", or any evidence which is directly or indirectly derived from such evidence," after "under this section".

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–59 effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as a note under section 331 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–452 effective on sixtieth day following Oct. 15, 1970, and not to affect any immunity to which any individual is entitled under this section by reason of any testimony given before sixtieth day following Oct. 15, 1970, see section 260 of Pub. L. 91–452, set out as an Effective Date; Savings Provision note under section 6001 of Title 18, Crimes and Criminal Procedure.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§374. Inspection

(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions

(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to the limitations established in section 350c(d) of this title. In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.

(2) The provisions of the third sentence of paragraph (1) shall not apply to—

(A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail;

(B) practitioners licensed by law to prescribe or administer drugs, or prescribe or use devices, as the case may be, and who manufacture, prepare, propagate, compound, or process drugs, or manufacture or process devices, solely for use in the course of their professional practice;

(C) persons who manufacture, prepare, propagate, compound, or process drugs or manufacture or process devices, solely for use in research, teaching, or chemical analysis and not for sale;

(D) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that inspection as applied to such classes of persons in accordance with this section is not necessary for the protection of the public health.

(3) An officer or employee making an inspection under paragraph (1) for purposes of enforcing the requirements of section 350a of this title applicable to infant formulas shall be permitted, at all reasonable times, to have access to and to copy and verify any records—

(A) bearing on whether the infant formula manufactured or held in the facility inspected meets the requirements of section 350a of this title, or

(B) required to be maintained under section 350a of this title.

(4)(A) Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C), shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. The Secretary's request shall include a sufficient description of the records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.

(B) Upon receipt of the records requested under subparagraph (A), the Secretary shall provide to the person confirmation of receipt.

(C) The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspections, if applicable and appropriate.

(D) Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter.

(5)(A) The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.

(B) An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.

(C)(i) The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—

(I) developing an application or other submission to the Secretary under this chapter or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);

(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or

(III) holding any records or other information described in subparagraph (B).

(ii) A person described in this clause is—

(I) the sponsor of an application or submission specified in subparagraph (E);

(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor;

(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or

(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).

(D)(i) Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—

(I) permitting the Secretary to record or copy such information for purposes of this paragraph;

(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and

(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.

(ii) Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.

(iii) An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner.

(E) The studies and submissions described in this subparagraph are each of the following:

(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this chapter or the Public Health Service Act for marketing authorization of a product described in paragraph (1).

(ii) Postmarket safety activities conducted under this chapter or the Public Health Service Act.

(iii) Any other clinical investigation of—

(I) a drug subject to section 355 or 360b of this title or section 262 of title 42; or

(II) a device subject to section 360j(g) of this title.

(iv) Any other submissions made under this chapter or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.

(F) This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to December 29, 2022, the Secretary lacked the authority to conduct such inspections, including under this chapter or the Public Health Service Act.

(b) Written report to owner; copy to Secretary

(1) Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, tobacco product, or cosmetic in such establishment (A) consists in whole or in part of any filthy, putrid, or decomposed substance, or (B) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.

(2) In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection (c) or (j) of section 355 of this title for which a notification has been submitted in accordance with section 356c of this title is, or has been in the last 5 years, listed on the drug shortage list under section 356e of this title, or that is described in section 355(j)(11)(A) of this title, a copy of the report shall be sent promptly to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages.

(c) Receipt for samples taken

If the officer or employee making any such inspection of a factory, warehouse, or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained.

(d) Analysis of samples furnished owner

Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.

(e) Accessibility of records

Every person required under section 360i or 360j(g) of this title to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records.

(f) Recordkeeping

(1) An accredited person described in paragraph (3) shall maintain records documenting the training qualifications of the person and the employees of the person, the procedures used by the person for handling confidential information, the compensation arrangements made by the person, and the procedures used by the person to identify and avoid conflicts of interest. Upon the request of an officer or employee designated by the Secretary, the person shall permit the officer or employee, at all reasonable times, to have access to, to copy, and to verify, the records.

(2) Within 15 days after the receipt of a written request from the Secretary to an accredited person described in paragraph (3) for copies of records described in paragraph (1), the person shall produce the copies of the records at the place designated by the Secretary.

(3) For purposes of paragraphs (1) and (2), an accredited person described in this paragraph is a person who—

(A) is accredited under subsection (g); or

(B) is accredited under section 360m of this title.

(g) Inspections by accredited persons

(1) The Secretary shall, subject to the provisions of this subsection, accredit persons for the purpose of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title. The owner or operator of such an establishment that is eligible under paragraph (6) may, from the list published under paragraph (4), select an accredited person to conduct such inspections.

(2) The Secretary shall publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1). Thereafter, the Secretary shall inform those requesting accreditation, within 60 days after the receipt of such request, whether the request for accreditation is adequate for review, and the Secretary shall promptly act on the request for accreditation. Any resulting accreditation shall state that such person is accredited to conduct inspections at device establishments identified in paragraph (1). The accreditation of such person shall specify the particular activities under this subsection for which such person is accredited.

(3) An accredited person shall, at a minimum, meet the following requirements:

(A) Such person may not be an employee of the Federal Government.

(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of articles regulated under this chapter and which has no organizational, material, or financial affiliation (including a consultative affiliation) with such a manufacturer, supplier, or vendor.

(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation.

(D) Such person shall not engage in the design, manufacture, promotion, or sale of articles regulated under this chapter.

(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices, and such person shall agree in writing that at a minimum the person will—

(i) certify that reported information accurately reflects data reviewed, inspection observations made, other matters that relate to or may influence compliance with this chapter, and recommendations made during an inspection or at an inspection's closing meeting;

(ii) limit work to that for which competence and capacity are available;

(iii) treat information received, records, reports, and recommendations as confidential commercial or financial information or trade secret information, except such information may be made available to the Secretary;

(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and

(v) protect against the use, in carrying out paragraph (1), of any officer or employee of the accredited person who has a financial conflict of interest regarding any product regulated under this chapter, and annually make available to the public disclosures of the extent to which the accredited person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest.

(F) Such person shall notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems standard referred to in paragraph (7) for any device establishment that such person inspects under this subsection not later than 30 days after such withdrawal, suspension, restriction, or expiration.

(G) Such person may conduct audits to establish conformance with the quality systems standard referred to in paragraph (7).

(4) The Secretary shall publish on the Internet site of the Food and Drug Administration a list of persons who are accredited under paragraph (2). Such list shall be updated to ensure that the identity of each accredited person, and the particular activities for which the person is accredited, is known to the public. The updating of such list shall be no later than one month after the accreditation of a person under this subsection or the suspension or withdrawal of accreditation, or the modification of the particular activities for which the person is accredited.

(5)(A) To ensure that persons accredited under this subsection continue to meet the standards of accreditation, the Secretary shall (i) audit the performance of such persons on a periodic basis through the review of inspection reports and inspections by persons designated by the Secretary to evaluate the compliance status of a device establishment and the performance of accredited persons, and (ii) take such additional measures as the Secretary determines to be appropriate.

(B) The Secretary may withdraw accreditation of any person accredited under paragraph (2), after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the standards of accreditation, poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection. The Secretary may suspend the accreditation of such person during the pendency of the process under the preceding sentence.

(6)(A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspection by persons accredited under paragraph (2) if the following conditions are met:

(i) The Secretary classified the results of the most recent inspection of the establishment as "no action indicated" or "voluntary action indicated".

(ii) With respect to inspections of the establishment to be conducted by an accredited person, the owner or operator of the establishment submits to the Secretary a notice that—

(I) provides the date of the last inspection of the establishment by the Secretary and the classification of that inspection;

(II) states the intention of the owner or operator to use an accredited person to conduct inspections of the establishment;

(III) identifies the particular accredited person the owner or operator intends to select to conduct such inspections; and

(IV) includes a certification that, with respect to the devices that are manufactured, prepared, propagated, compounded, or processed in the establishment—

(aa) at least 1 of such devices is marketed in the United States; and

(bb) at least 1 of such devices is marketed, or is intended to be marketed, in 1 or more foreign countries, 1 of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph (2) and identified under subclause (III) as a person authorized to conduct inspections of device establishments.

(B)(i) Except with respect to the requirement of subparagraph (A)(i), a device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 30 days after receiving such notice, issues a response that—

(I) denies clearance to participate as provided under subparagraph (C); or

(II) makes a request under clause (ii).

(ii) The Secretary may request from the owner or operator of a device establishment in response to the notice under subparagraph (A)(ii) with respect to the establishment, or from the particular accredited person identified in such notice—

(I) compliance data for the establishment in accordance with clause (iii)(I); or

(II) information concerning the relationship between the owner or operator of the establishment and the accredited person identified in such notice in accordance with clause (iii)(II).

The owner or operator of the establishment, or such accredited person, as the case may be, shall respond to such a request not later than 60 days after receiving such request.

(iii)(I) The compliance data to be submitted by the owner or operator of a device establishment in response to a request under clause (ii)(I) are data describing whether the quality controls of the establishment have been sufficient for ensuring consistent compliance with current good manufacturing practice within the meaning of section 351(h) of this title and with other applicable provisions of this chapter. Such data shall include complete reports of inspectional findings regarding good manufacturing practice or other quality control audits that, during the preceding 2-year period, were conducted at the establishment by persons other than the owner or operator of the establishment, together with all other compliance data the Secretary deems necessary. Data under the preceding sentence shall demonstrate to the Secretary whether the establishment has facilitated consistent compliance by promptly correcting any compliance problems identified in such inspections.

(II) A request to an accredited person under clause (ii)(II) may not seek any information that is not required to be maintained by such person in records under subsection (f)(1).

(iv) A device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 60 days after receiving the information requested under clause (ii), issues a response that denies clearance to participate as provided under subparagraph (C).

(C)(i) The Secretary may deny clearance to a device establishment if the Secretary has evidence that the certification under subparagraph (A)(ii)(IV) is untrue and the Secretary provides to the owner or operator of the establishment a statement summarizing such evidence.

(ii) The Secretary may deny clearance to a device establishment if the Secretary determines that the establishment has failed to demonstrate consistent compliance for purposes of subparagraph (B)(iii)(I) and the Secretary provides to the owner or operator of the establishment a statement of the reasons for such determination.

(iii)(I) The Secretary may reject the selection of the accredited person identified in the notice under subparagraph (A)(ii) if the Secretary provides to the owner or operator of the establishment a statement of the reasons for such rejection. Reasons for the rejection may include that the establishment or the accredited person, as the case may be, has failed to fully respond to the request, or that the Secretary has concerns regarding the relationship between the establishment and such accredited person.

(II) If the Secretary rejects the selection of an accredited person by the owner or operator of a device establishment, the owner or operator may make an additional selection of an accredited person by submitting to the Secretary a notice that identifies the additional selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I) of this clause, apply to the selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as such provisions apply to a selection of an accredited person through a notice under subparagraph (A)(ii).

(iv) In the case of a device establishment that is denied clearance under clause (i) or (ii) or with respect to which the selection of the accredited person is rejected under clause (iii), the Secretary shall designate a person to review the statement of reasons, or statement summarizing such evidence, as the case may be, of the Secretary under such clause if, during the 30-day period beginning on the date on which the owner or operator of the establishment receives such statement, the owner or operator requests the review. The review shall commence not later than 30 days after the owner or operator requests the review, unless the Secretary and the owner or operator otherwise agree.

(7)(A) Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment's designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report in a form and manner designated by the Secretary to conduct inspections, taking into consideration the goals of international harmonization of quality systems standards. Any official classification of the inspection shall be determined by the Secretary.

(B) At a minimum, an inspection report under subparagraph (A) shall identify the persons responsible for good manufacturing practice compliance at the inspected device establishment, the dates of the inspection, the scope of the inspection, and shall describe in detail each observation identified by the accredited person, identify other matters that relate to or may influence compliance with this chapter, and describe any recommendations during the inspection or at the inspection's closing meeting.

(C) An inspection report under subparagraph (A) shall be sent to the Secretary and to the designated representative of the inspected device establishment at the same time, but under no circumstances later than three weeks after the last day of the inspection. The report to the Secretary shall be accompanied by all written inspection observations previously provided to the designated representative of the establishment.

(D) Any statement or representation made by an employee or agent of a device establishment to a person accredited under paragraph (2) to conduct inspections shall be subject to section 1001 of title 18.

(E) If at any time during an inspection by an accredited person the accredited person discovers a condition that could cause or contribute to an unreasonable risk to the public health, the accredited person shall immediately notify the Secretary of the identification of the device establishment subject to inspection and such condition.

(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality systems standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.

(8) Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services.

(9) Nothing in this subsection affects the authority of the Secretary to inspect any device establishment pursuant to this chapter.

(10)(A) For fiscal year 2005 and each subsequent fiscal year, no device establishment may be inspected during the fiscal year involved by a person accredited under paragraph (2) if—

(i) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the preceding fiscal year (referred to in this subparagraph as the "first prior fiscal year"), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such first prior fiscal year; and

(ii) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the fiscal year preceding the first prior fiscal year (referred to in this subparagraph as the "second prior fiscal year"), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such second prior fiscal year.

(B)(i) Subject to clause (ii), the Comptroller General of the United States shall determine the amount that was obligated by the Secretary for fiscal year 2002 for compliance activities of the Food and Drug Administration with respect to devices (referred to in this subparagraph as the "compliance budget"), and of such amount, the amount that was obligated for inspections by the Secretary of device establishments (referred to in this subparagraph as the "inspection budget").

(ii) For purposes of determinations under clause (i), the Comptroller General shall not include in the compliance budget or the inspection budget any amounts obligated for inspections of device establishments conducted as part of the process of reviewing applications under section 360e of this title.

(iii) Not later than March 31, 2003, the Comptroller General shall complete the determinations required in this subparagraph and submit to the Secretary and the Congress a report describing the findings made through such determinations.

(C) For purposes of this paragraph:

(i) The term "base amount" means the inspection budget determined under subparagraph (B) for fiscal year 2002.

(ii) The term "adjusted base amount", in the case of applicability to fiscal year 2003, means an amount equal to the base amount increased by 5 percent.

(iii) The term "adjusted base amount", with respect to applicability to fiscal year 2004 or any subsequent fiscal year, means the adjusted base amount applicable to the preceding year increased by 5 percent.

(11) The authority provided by this subsection terminates on October 1, 2027.

(12) No later than four years after October 26, 2002, the Comptroller General shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate—

(A) the number of inspections conducted by accredited persons pursuant to this subsection and the number of inspections conducted by Federal employees pursuant to section 360(h) of this title and of device establishments required to register under section 360(i) of this title;

(B) the number of persons who sought accreditation under this subsection, as well as the number of persons who were accredited under this subsection;

(C) the reasons why persons who sought accreditation, but were denied accreditation, were denied;

(D) the number of audits conducted by the Secretary of accredited persons, the quality of inspections conducted by accredited persons, whether accredited persons are meeting their obligations under this chapter, and whether the number of audits conducted is sufficient to permit these assessments;

(E) whether this subsection is achieving the goal of ensuring more information about device establishment compliance is being presented to the Secretary, and whether that information is of a quality consistent with information obtained by the Secretary pursuant to inspections conducted by Federal employees;

(F) whether this subsection is advancing efforts to allow device establishments to rely upon third-party inspections for purposes of compliance with the laws of foreign governments; and

(G) whether the Congress should continue, modify, or terminate the program under this subsection.

(13) The Secretary shall include in the annual report required under section 393(g) of this title the names of all accredited persons and the particular activities under this subsection for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year.

(14) Notwithstanding any provision of this subsection, this subsection does not have any legal effect on any agreement described in section 383(b) of this title between the Secretary and a foreign country.

(15)(A) Notwithstanding any other provision of this subsection, the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of—

(i) establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under section 262 of title 42), as required under section 360(h) of this title; or

(ii) establishments required to register pursuant to section 360(i) of this title.

(B) Nothing in this paragraph affects—

(i) the authority of the Secretary to inspect any device establishment pursuant to this chapter; or

(ii) the authority of the Secretary to determine the official classification of an inspection.

(h) Improvements to inspections process for device establishments

(1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of August 18, 2017, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such uniform processes and standards shall provide for—

(A) exceptions to such processes and standards, as appropriate;

(B) announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection;

(C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested; and

(D) regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent.

(2)(A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request.

(B) A request described in this subparagraph is a request for feedback—

(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and

(ii) with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary).

(3) Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter.

(June 25, 1938, ch. 675, §704, 52 Stat. 1057; Aug. 7, 1953, ch. 350, §1, 67 Stat. 476; Pub. L. 87–781, title II, §201(a), (b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94–295, §6, May 28, 1976, 90 Stat. 581; Pub. L. 96–359, §4, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 103–80, §3(aa), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title I, §125(b)(2)(L), title II, §210(b), title IV, §412(b), Nov. 21, 1997, 111 Stat. 2326, 2344, 2375; Pub. L. 107–188, title III, §306(b), June 12, 2002, 116 Stat. 670; Pub. L. 107–250, title II, §201(a), (b), Oct. 26, 2002, 116 Stat. 1602, 1609; Pub. L. 108–214, §2(b)(1), Apr. 1, 2004, 118 Stat. 573; Pub. L. 110–85, title II, §228, Sept. 27, 2007, 121 Stat. 855; Pub. L. 111–31, div. A, title I, §103(i), June 22, 2009, 123 Stat. 1837; Pub. L. 111–353, title I, §101(b), Jan. 4, 2011, 124 Stat. 3887; Pub. L. 112–144, title VI, §612, title VII, §706, July 9, 2012, 126 Stat. 1060, 1067; Pub. L. 115–52, title VII, §§702(a), 703, 705, Aug. 18, 2017, 131 Stat. 1055–1057; Pub. L. 116–136, div. A, title III, §3112(d), Mar. 27, 2020, 134 Stat. 362; Pub. L. 117–180, div. F, title V, §5007, Sept. 30, 2022, 136 Stat. 2168; Pub. L. 117–229, div. C, title III, §306, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title II, §2515(a)(2), title III, §§3106, 3504, 3611(a), (b)(1), 3612(a), 3613(b), Dec. 29, 2022, 136 Stat. 5806, 5807, 5859, 5869, 5872.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (a)(5), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2022—Subsec. (a)(1). Pub. L. 117–328, §3611(a), substituted "devices" for "restricted devices" in two places.

Pub. L. 117–328, §3504, inserted "In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies." after "limitations established in section 350c(d) of this title."

Subsec. (a)(4)(A). Pub. L. 117–328, §3611(b)(1), substituted "an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C)," for "an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug" and "records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection." for "records requested."

Subsec. (a)(4)(C), (D). Pub. L. 117–328, §3613(b), added subpar. (C) and redesignated former subpar. (C) as (D).

Subsec. (a)(5). Pub. L. 117–328, §3612(a), added par. (5).

Subsec. (b). Pub. L. 117–328, §2515(a)(2), made technical amendment to directory language of Pub. L. 116–136, §3112(d)(1). See 2020 Amendment note below.

Subsec. (g)(11). Pub. L. 117–328, §3106, substituted "October 1, 2027" for "December 24, 2022".

Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022".

Pub. L. 117–180 substituted "December 17" for "October 1".

2020—Subsec. (b). Pub. L. 116–136, §3112(d)(1), as amended by Pub. L. 117–328, §2515(a)(2), designated existing provisions as par. (1), redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added par. (2).

2017—Subsec. (g)(11). Pub. L. 115–52, §703, substituted "October 1, 2022" for "October 1, 2017".

Subsec. (g)(15). Pub. L. 115–52, §705, added par. (15).

Subsec. (h). Pub. L. 115–52, §702(a), added subsec. (h).

2012—Subsec. (a)(4). Pub. L. 112–144, §706, added par. (4).

Subsec. (g)(11). Pub. L. 112–144, §612, substituted "October 1, 2017" for "October 1, 2012".

2011—Subsec. (a)(1). Pub. L. 111–353, which directed the amendment of subsec. (a)(1)(B) by substituting "section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to" for "section 350c of this title when" and all that follows through "subject to", was executed by making the substitution for "section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to" in the sentence following subpar. (B) of subsec. (a)(1), to reflect the probable intent of Congress.

2009—Subsec. (a)(1). Pub. L. 111–31, §103(i)(1)(C), substituted "devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products" for "and devices and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) section 360i, or 360j(g) of this title, and data relating to other drugs or devices".

Pub. L. 111–31, §103(i)(1)(B), substituted "restricted devices, or tobacco products" for "or restricted devices" in two places.

Subsec. (a)(1)(A). Pub. L. 111–31, §103(i)(1)(A), substituted "devices, tobacco products, or cosmetics" for "devices, or cosmetics" in two places.

Subsec. (b). Pub. L. 111–31, §103(i)(2), inserted "tobacco product," after "device,".

Subsec. (g)(13). Pub. L. 111–31, §103(i)(3), made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title.

2007—Subsec. (g)(1). Pub. L. 110–85, §228(1), substituted "The Secretary" for "Not later than one year after October 26, 2002, the Secretary".

Subsec. (g)(2). Pub. L. 110–85, §228(2), substituted "The Secretary" for "Not later than 180 days after October 26, 2002, the Secretary" and struck out at end "In the first year following the publication in the Federal Register of criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1), the Secretary shall accredit no more than 15 persons who request to perform duties specified in paragraph (1)."

Subsec. (g)(3)(F), (G). Pub. L. 110–85, §228(3), added subpars. (F) and (G).

Subsec. (g)(6). Pub. L. 110–85, §228(4), amended par. (6) generally, revising and restating provisions of former subpars. (A) to (C).

Subsec. (g)(7)(A). Pub. L. 110–85, §228(5)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: "Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment's designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report (including for inspections classified as 'no action indicated') in a form and manner consistent with such reports prepared by employees and officials designated by the Secretary to conduct inspections."

Subsec. (g)(7)(F). Pub. L. 110–85, §228(5)(B), added subpar. (F).

Subsec. (g)(10)(C)(iii). Pub. L. 110–85, §228(6), substituted "base amount applicable" for "based amount applicable".

2004—Subsec. (g)(1). Pub. L. 108–214, §2(b)(1)(A), in first sentence, substituted "conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title." for "conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices that are required in section 360(h) of this title, or inspections of such establishments required to register pursuant to section 360(i) of this title."

Subsec. (g)(5)(B). Pub. L. 108–214, §2(b)(1)(B), in first sentence, substituted "poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection." for "or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this subsection."

Subsec. (g)(6)(A)(i). Pub. L. 108–214, §2(b)(1)(C)(i), substituted "described in paragraph (1)" for "of the establishment pursuant to subsection (h) or (i) of section 360 of this title".

Subsec. (g)(6)(A)(ii). Pub. L. 108–214, §2(b)(1)(C)(ii)(I), substituted "inspections" for "each inspection" and inserted "during a 2-year period" after "person" in introductory provisions.

Subsec. (g)(6)(A)(ii)(I). Pub. L. 108–214, §2(b)(1)(C)(ii)(II), substituted "an accredited person" for "such a person".

Subsec. (g)(6)(A)(iii). Pub. L. 108–214, §2(b)(1)(C)(iii)(I), substituted "and 1 or both of the following additional conditions are met:" for "and the following additional conditions are met:" in introductory provisions.

Subsec. (g)(6)(A)(iii)(I). Pub. L. 108–214, §2(b)(1)(C)(iii)(II), substituted "(accredited under paragraph (2) and identified under clause (ii)(II)) as a person authorized to conduct such inspections of device establishments." for "accredited under paragraph (2) and identified under subclause (II) of this clause."

Subsec. (g)(6)(A)(iii)(II). Pub. L. 108–214, §2(b)(1)(C)(iii)(III), inserted "or by a person accredited under paragraph (2)" after "by the Secretary".

Subsec. (g)(6)(A)(iv)(I). Pub. L. 108–214, §2(b)(1)(C)(iv), in first sentence, inserted "section" after "pursuant to" and substituted "inspections of the establishment during the previous 4 years" for "the two immediately preceding inspections of the establishment", in third sentence, struck out "the petition states a commercial reason for the waiver;" after "granted only if" and inserted "not" after "the Secretary has not determined that the public health would", and, in last sentence, substituted "granted or deemed to be granted until" for "granted until".

Subsec. (g)(6)(A)(iv)(II). Pub. L. 108–214, §2(b)(1)(C)(v), inserted "of a device establishment required to register" after "to be conducted" and "section" after "pursuant to".

Subsec. (g)(6)(B)(iii). Pub. L. 108–214, §2(b)(1)(D), in first sentence, substituted "and with other" for ", and data otherwise describing whether the establishment has consistently been in compliance with sections 351 and 352 of this title and other" and, in second sentence, substituted "inspectional findings" for "inspections" and inserted "relevant" after "together with all other".

Subsec. (g)(6)(B)(iv). Pub. L. 108–214, §2(b)(1)(E), designated existing provisions as subcl. (I) and added subcl. (II).

Subsec. (g)(6)(C)(ii). Pub. L. 108–214, §2(b)(1)(F), struck out "in accordance with section 360(h) of this title, or has not during such period been inspected pursuant to section 360(i) of this title, as applicable" after "inspected by the Secretary".

Subsec. (g)(10)(B)(iii). Pub. L. 108–214, §2(b)(1)(G), substituted "a report" for "a reporting".

Subsec. (g)(12)(A). Pub. L. 108–214, §2(b)(1)(H)(i), added subpar. (A) and struck out former subpar. (A) which read as follows: "the number of inspections pursuant to subsections (h) and (i) of section 360 of this title conducted by accredited persons and the number of inspections pursuant to such subsections conducted by Federal employees;".

Subsec. (g)(12)(E). Pub. L. 108–214, §2(b)(1)(H)(ii), substituted "obtained by the Secretary pursuant to inspections conducted by Federal employees;" for "obtained by the Secretary pursuant to subsection (h) or (i) of section 360 of this title;".

2002—Subsec. (a)(1). Pub. L. 107–188, §306(b)(1), inserted after first sentence "In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 350c(d) of this title."

Subsec. (a)(2). Pub. L. 107–188, §306(b)(2), substituted "third sentence" for "second sentence" in introductory provisions.

Subsec. (f)(1). Pub. L. 107–250, §201(b)(1), in first sentence, substituted "An accredited person described in paragraph (3) shall maintain records" for "A person accredited under section 360m of this title to review reports made under section 360(k) of this title and make recommendations of initial classifications of devices to the Secretary shall maintain records".

Subsec. (f)(2). Pub. L. 107–250, §201(b)(2), substituted "an accredited person described in paragraph (3)" for "a person accredited under section 360m of this title".

Subsec. (f)(3). Pub. L. 107–250, §201(b)(3), added par. (3).

Subsec. (g). Pub. L. 107–250, §201(a), added subsec. (g).

1997—Subsec. (a)(1). Pub. L. 105–115, §412(b), substituted "prescription drugs, nonprescription drugs intended for human use," for "prescription drugs" in two places.

Pub. L. 105–115, §125(b)(2)(L), struck out ", section 357(d) or (g)," before "section 360i".

Subsec. (f). Pub. L. 105–115, §210(b), added subsec. (f).

1993—Subsec. (a)(1). Pub. L. 103–80 substituted a comma for semicolon after "finished and unfinished materials" and "section 355(i) or (k)" for "section 355(i) or (j)".

1980—Subsec. (a)(1). Pub. L. 96–359, §4(1), (2), restructured first five sentences of former subsec. (a) as par. (1) and, as so restructured, inserted reference to paragraph (3) and substituted "(A)" and "(B)" for "(1)" and "(2)", respectively.

Subsec. (a)(2). Pub. L. 96–359, §4(3), redesignated sixth sentence of former subsec. (a) as par. (2) and, as so redesignated, substituted reference to second sentence of paragraph (1) for reference to former second sentence of this subsection, and "(A)", "(B)", "(C)", and "(D)", for "(1)", "(2)", "(3)", and "(4)", respectively.

Subsec. (a)(3). Pub. L. 96–359, §4(4), added par. (3).

1976—Subsec. (a). Pub. L. 94–295, §6(a)–(c), expanded existing provisions to encompass medical devices by inserting references to factories, warehouses, establishments, and consulting laboratories in which restricted devices are manufactured, processed, packed, or held, inspections relating to devices, reporting and inspection regulations issued pursuant to sections 360i and 360j(g) of this title, and the manufacture and processing of devices.

Subsec. (e). Pub. L. 94–295, §6(d), added subsec. (e).

1962—Subsec. (a). Pub. L. 87–781, §201(a), extended the inspection, where prescription drugs are manufactured, processed, packed, or held, to all things bearing on whether adulterated or misbranded drugs, or any which may not be manufactured, introduced in interstate commerce, or sold or offered for sale under any provision of this chapter, have been or are being manufactured, processed, packed, transported or held in any such place, or otherwise bearing on violation of this chapter, but excluded from such inspection, data concerning finance, sales other than shipment, pricing, personnel other than qualifications of technical and professional personnel, research other than relating to new drugs subject to reporting, provided that provisions of second sentence of this subsection shall be inapplicable to pharmacies, practitioners and other persons enumerated in pars. (1) to (4), and struck out "are held" before "after such introduction".

Subsec. (b). Pub. L. 87–781, §201(b), inserted "consulting laboratory" after "warehouse".

1953—Act Aug. 7, 1953, designated existing provisions as subsec. (a) and amended them by substituting provisions permitting entry and inspection upon presentation of appropriate credentials and a written notice to the owner, operator, or agent in charge for provisions which authorized entry and inspection only after making a request and obtaining permission from the owner, operator, or custodian, and inserting provisions requiring a separate written notice for each inspection but not for each entry made during the period covered by the inspection, and directing that the inspection shall be conducted within reasonable limits, in a reasonable manner and completed with reasonable promptness, and added subsecs. (b) to (d).

Statutory Notes and Related Subsidiaries

Effective Date of 2020 Amendment

Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.

Effective Date of 1997 Amendment

Amendment by sections 210(b) and 412(b) of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 203 of Pub. L. 87–781, set out as a note under section 332 of this title.

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Review of Processes and Practices; Guidance for Industry

Pub. L. 117–328, div. FF, title III, §3612(b), Dec. 29, 2022, 136 Stat. 5871, provided that:

"(1) In general.—The Secretary [of Health and Human Services] shall—

"(A) review processes and practices in effect as of the date of enactment of this Act [Dec. 29, 2022] applicable to inspections of foreign and domestic sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374(a)(5)], as added by subsection (a); and

"(B) evaluate whether any updates are needed to facilitate the consistency of such processes and practices.

"(2) Guidance.—

"(A) In general.—The Secretary shall issue guidance describing the processes and practices applicable to inspections of sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), including with respect to the types of records and information required to be provided, best practices for communication between the Food and Drug Administration and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct, to the extent not specified in existing publicly available Food and Drug Administration guides and manuals for such inspections.

"(B) Timing.—The Secretary shall—

"(i) not later than 18 months after the date of enactment of this Act, issue draft guidance under subparagraph (A); and

"(ii) not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under subparagraph (A)."

Unannounced Foreign Facility Inspections Pilot Program

Pub. L. 117–328, div. FF, title III, §3615, Dec. 29, 2022, 136 Stat. 5873, provided that:

"(a) In General.—The Secretary [of Health and Human Services] shall conduct a pilot program under which the Secretary increases the conduct of unannounced surveillance inspections of foreign human drug establishments and evaluates the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection. Such pilot program shall evaluate—

"(1) differences in the number and type of violations of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) identified as a result of unannounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection;

"(2) costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments;

"(3) barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections; and

"(4) approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments.

"(b) Pilot Program Scope.—The inspections evaluated under the pilot program under this section shall be routine surveillance inspections and shall not include inspections conducted as part of the Secretary's evaluation of a request for approval to market a drug submitted under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.).

"(c) Pilot Program Initiation.—The Secretary shall initiate the pilot program under this section not later than 180 days after the date of enactment of this Act [Dec. 29, 2022].

"(d) Report.—The Secretary shall, not later than 180 days following the completion of the pilot program under this section, make available on the website of the Food and Drug Administration a final report on the pilot program under this section, including—

"(1) findings and any associated recommendations with respect to the evaluation under subsection (a), including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments;

"(2) findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and

"(3) the number of unannounced inspections during the pilot program that would not be unannounced under practices in use as of the date of the enactment of this Act."

Guidance

Pub. L. 117–328, div. FF, title III, §3611(b)(2), Dec. 29, 2022, 136 Stat. 5869, provided that:

"(A) In general.—The Secretary [of Health and Human Services] shall issue or update guidance describing—

"(i) circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374(a)(4)], as amended by paragraph (1);

"(ii) processes for responding to such requests electronically or in physical form; and

"(iii) factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.

"(B) Timing.—The Secretary shall—

"(i) not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], issue draft guidance under subparagraph (A); and

"(ii) not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under subparagraph (A)."

Pub. L. 115–52, title VII, §702(b), Aug. 18, 2017, 131 Stat. 1055, provided that:

"(1) Draft guidance.—Not later than 18 months after the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance that—

"(A) specifies how the Food and Drug Administration will implement the processes and standards described in paragraph (1) of subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a), and the requirements described in paragraph (2) of such subsection (h);

"(B) provides for standardized methods for communications described in such paragraphs;

"(C) establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360(h)(2)], as amended by subsection (a) [of section 701 of Pub. L. 115–52]), a standard timeframe for such inspections—

"(i) that occurs over consecutive days; and

"(ii) to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and

"(D) identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

"(2) Final guidance.—Not later than 1 year after providing notice and opportunity for public comment on the draft guidance issued under paragraph (1), the Secretary of Health and Human Services shall issue final guidance to implement subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a)."

Inspections

Pub. L. 115–52, title VIII, §806, Aug. 18, 2017, 131 Stat. 1073, provided that:

"Within 6 months of the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall—

"(1) apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)—

"(A) for which the approval is dependent upon remediation of conditions identified in the report;

"(B) for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and

"(C) where the drug that is the subject of the application is a drug—

"(i) for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that reference the same listed drug and for which there are less than 6 abbreviated new drug applications tentatively approved; or

"(ii) that is included on the list under section 506E of such Act (21 U.S.C. 356e);

"(2) address expedited re-inspection of facilities, as appropriate; and

"(3) establish a 6-month timeline for completion of review of such responses to such reports."

Authority of Secretary Prior to October 10, 1962

Pub. L. 87–781, title II, §201(d), Oct. 10, 1962, 76 Stat. 793, provided that: "Nothing in the amendments made by subsections (a) and (b) of this section [amending this section] shall be construed to negate or derogate from any authority of the Secretary existing prior to the enactment of this Act [Oct. 10, 1962]."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§374a. Inspections relating to food allergens

The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 374 of this title of facilities in which foods are manufactured, processed, packed, or held—

(1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and

(2) to ensure that major food allergens are properly labeled on foods.

(Pub. L. 108–282, title II, §205, Aug. 2, 2004, 118 Stat. 909.)

Editorial Notes

Codification

Section was enacted as a part of the Food Allergen Labeling and Consumer Protection Act of 2004, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§375. Publicity

(a) Reports

The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this chapter, including the nature of the charge and the disposition thereof.

(b) Information regarding certain goods

The Secretary may also cause to be disseminated information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.

(June 25, 1938, ch. 675, §705, 52 Stat. 1057; Pub. L. 111–31, div. A, title I, §103(j), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Subsec. (b). Pub. L. 111–31 inserted "tobacco products," after "devices,".

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§376. Examination of sea food on request of packer; marking food with results; fees; penalties

The Secretary, upon application of any packer of any sea food for shipment or sale within the jurisdiction of this chapter, may, at his discretion, designate inspectors to examine and inspect such food and the production, packing, and labeling thereof. If on such examination and inspection compliance is found with the provisions of this chapter and regulations promulgated thereunder, the applicant shall be authorized or required to mark the food as provided by regulation to show such compliance. Services under this section shall be rendered only upon payment by the applicant of fees fixed by regulation in such amounts as may be necessary to provide, equip, and maintain an adequate and efficient inspection service. Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary for expenditures incurred in carrying out the purposes of this section, including expenditures for salaries of additional inspectors when necessary to supplement the number of inspectors for whose salaries Congress has appropriated. The Secretary is authorized to promulgate regulations governing the sanitary and other conditions under which the service herein provided shall be granted and maintained, and for otherwise carrying out the purposes of this section. Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other identification devices authorized or required by the provisions of this section or regulations thereunder, shall be guilty of a misdemeanor, and shall on conviction thereof be subject to imprisonment for not more than one year or a fine of not less than $1,000 nor more than $5,000, or both such imprisonment and fine.

(June 25, 1938, ch. 675, §706, formerly §702A, formerly June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712, 48 Stat. 1204; amended Aug. 27, 1935, ch. 739, 49 Stat. 871; June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059, renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784; renumbered §702A of act June 25, 1938, July 12, 1943, ch. 221, title II, 57 Stat. 500; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; renumbered §706, Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498; Pub. L. 103–80, §3(dd)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was formerly classified to section 372a of this title prior to renumbering by Pub. L. 102–571.

Section, which formerly was not a part of the Federal Food, Drug, and Cosmetic Act, originally was classified to section 14a of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that the section should remain in force and effect and be applicable to the provisions of this chapter. Act July 12, 1943, renumbered this section as 702A of the Federal Food, Drug, and Cosmetic Act.

Prior Provisions

A prior section 376, act June 25, 1938, ch. 675, §706, 52 Stat. 1058, as amended, which related to listing and certification of color additives for foods, drugs, devices, and cosmetics, was renumbered section 721 of act June 25, 1938, by Pub. L. 102–571, title I, §106(4), Oct. 29, 1992, 106 Stat. 4498, and transferred to section 379e of this title.

Amendments

1993—Pub. L. 103–80 struck out "of Agriculture" after "Secretary" in two places.

1992—Pub. L. 102–300, which directed the amendment of the section by striking out "of Health, Education, and Welfare" wherever appearing, could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

Statutory Notes and Related Subsidiaries

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§377. Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests

The Secretary, in carrying into effect the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], is authorized on and after July 12, 1943, to cooperate with associations and scientific societies in the revision of the United States Pharmacopoeia and in the development of methods of analysis and mechanical and physical tests necessary to carry out the work of the Food and Drug Administration.

(July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section was enacted as part of the Labor-Federal Security Appropriation Act, 1944, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§378. Advertising of foods

(a) Determination of misbranding; notification of Federal Trade Commission by Secretary; contents

(1) Except as provided in subsection (c), before the Secretary may initiate any action under subchapter III—

(A) with respect to any food which the Secretary determines is misbranded under section 343(a)(2) of this title because of its advertising, or

(B) with respect to a food's advertising which the Secretary determines causes the food to be so misbranded,

the Secretary shall, in accordance with paragraph (2), notify in writing the Federal Trade Commission of the action the Secretary proposes to take respecting such food or advertising.

(2) The notice required by paragraph (1) shall—

(A) contain (i) a description of the action the Secretary proposes to take and of the advertising which the Secretary has determined causes a food to be misbranded, (ii) a statement of the reasons for the Secretary's determination that such advertising has caused such food to be misbranded, and

(B) be accompanied by the records, documents, and other written materials which the Secretary determines supports his determination that such food is misbranded because of such advertising.

(b) Action by Federal Trade Commission precluding action by Secretary; exception

(1) If the Secretary notifies the Federal Trade Commission under subsection (a) of action proposed to be taken under subchapter III with respect to a food or food advertising and the Commission notifies the Secretary in writing, within the 30-day period beginning on the date of the receipt of such notice, that—

(A) it has initiated under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] an investigation of such advertising to determine if it is prohibited by such Act or any order or rule under such Act,

(B) it has commenced (or intends to commence) a civil action under section 5, 13, or 19 [15 U.S.C. 45, 53, or 57b] with respect to such advertising or the Attorney General has commenced (or intends to commence) a civil action under section 5 [15 U.S.C. 45] with respect to such advertising,

(C) it has issued and served (or intends to issue and serve) a complaint under section 5(b) of such Act [15 U.S.C. 45(b)] respecting such advertising, or

(D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it has made a certification to the Attorney General respecting such advertising,

the Secretary may not, except as provided by paragraph (2), initiate the action described in the Secretary's notice to the Federal Trade Commission.

(2) If, before the expiration of the 60-day period beginning on the date the Secretary receives a notice described in paragraph (1) from the Federal Trade Commission in response to a notice of the Secretary under subsection (a)—

(A) the Commission or the Attorney General does not commence a civil action described in subparagraph (B) of paragraph (1) of this subsection respecting the advertising described in the Secretary's notice,

(B) the Commission does not issue and serve a complaint described in subparagraph (C) of such paragraph respecting such advertising, or

(C) the Commission does not (as described in subparagraph (D) of such paragraph) make a certification to the Attorney General respecting such advertising, or, if the Commission does make such a certification to the Attorney General respecting such advertising, the Attorney General, before the expiration of such period, does not cause appropriate criminal proceedings to be brought against such advertising,

the Secretary may, after the expiration of such period, initiate the action described in the notice to the Commission pursuant to subsection (a). The Commission shall promptly notify the Secretary of the commencement by the Commission of such a civil action, the issuance and service by it of such a complaint, or the causing by the Attorney General of criminal proceedings to be brought against such advertising.

(c) Secretary's determination of imminent hazard to health as suspending applicability of provisions

The requirements of subsections (a) and (b) do not apply with respect to action under subchapter III with respect to any food or food advertising if the Secretary determines that such action is required to eliminate an imminent hazard to health.

(d) Coordination of action by Secretary with Federal Trade Commission

For the purpose of avoiding unnecessary duplication, the Secretary shall coordinate any action taken under subchapter III because of advertising which the Secretary determines causes a food to be misbranded with any action of the Federal Trade Commission under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] with respect to such advertising.

(June 25, 1938, ch. 675, §707, as added Pub. L. 94–278, title V, §502(b), Apr. 22, 1976, 90 Stat. 412.)

Editorial Notes

References in Text

The Federal Trade Commission Act, referred to in subsecs. (b) and (d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, which is classified generally to subchapter I (§41 et seq.) of chapter 2 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see section 58 of Title 15 and Tables.

§379. Confidential information

(a) Contractors

The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section to a person other than an officer or employee of the Department if the Secretary determines such other person requires the information in connection with an activity which is undertaken under contract with the Secretary, which relates to the administration of this chapter, and with respect to which the Secretary (or an officer or employee of the Department) is not prohibited from using such information. The Secretary shall require as a condition to the provision of information under this section that the person receiving it take such security precautions respecting the information as the Secretary may by regulation prescribe.

(b) Ability to receive and protect confidential information obtained from foreign governments

(1) In general

The Secretary shall not be required to disclose under section 552 of title 5 (commonly referred to as the "Freedom of Information Act"), or any other provision of law, any information relating to drugs obtained from a foreign government agency, if—

(A) the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals;

(B) the information is provided or made available to the United States Government voluntarily on the condition that it not be released to the public; and

(C) the information is covered by, and subject to, a written agreement between the Secretary and the foreign government.

(2) Time limitations

The written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of section 552 of title 5 and section 247d–7e(e)(1) of title 42, as applicable, shall continue to apply to such information. If no date is specified in the written agreement, paragraph (1) shall not apply with respect to such information for a period of more than 36 months.

(3) Disclosures not affected

Nothing in this section authorizes any official to withhold, or to authorize the withholding of, information from Congress or information required to be disclosed pursuant to an order of a court of the United States.

(4) Relation to other law

For purposes of section 552 of title 5, this subsection shall be considered a statute described in subsection (b)(3)(B) of such section 552.

(c) Authority to enter into memoranda of understanding for purposes of information exchange

The Secretary may enter into written agreements to provide information referenced in section 331(j) of this title to foreign governments subject to the following criteria:

(1) Certification

The Secretary may enter into a written agreement to provide information under this subsection to a foreign government only if the Secretary has certified such government as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs.

(2) Written agreement

The written agreement to provide information to the foreign government under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to section 247d of title 42 that is relevant to the information.

(3) Information exchange

The Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in section 331(j) of this title in only the following circumstances:

(A) Information concerning the inspection of a facility may be provided to a foreign government if—

(i) the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and

(ii) the written agreement executed under paragraph (2) limits the recipient's use of the information to the recipient's civil regulatory purposes.

(B) Information not described in subparagraph (A) may be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, if the Secretary has reasonable grounds to believe that a drug has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

(4) Effect of subsection

Nothing in this subsection affects the ability of the Secretary to enter into any written agreement authorized by other provisions of law to share confidential information.

(June 25, 1938, ch. 675, §708, as added Pub. L. 94–295, §8, May 28, 1976, 90 Stat. 582; amended Pub. L. 112–144, title VII, §710, July 9, 2012, 126 Stat. 1070.)

Editorial Notes

Amendments

2012—Pub. L. 112–144 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).

§379a. Presumption of existence of jurisdiction

In any action to enforce the requirements of this chapter respecting a device, tobacco product, food, drug, or cosmetic the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.

(June 25, 1938, ch. 675, §709, as added Pub. L. 94–295, §8, May 28, 1976, 90 Stat. 583; amended Pub. L. 105–115, title IV, §419, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 111–31, div. A, title I, §103(k), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Pub. L. 111–31 inserted "tobacco product," after "device,".

1997—Pub. L. 105–115 substituted "a device, food, drug, or cosmetic" for "a device".

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

§379b. Consolidated administrative and laboratory facility

(a) Authority

The Secretary, in consultation with the Administrator of the General Services Administration, shall enter into contracts for the design, construction, and operation of a consolidated Food and Drug Administration administrative and laboratory facility.

(b) Awarding of contract

The Secretary shall solicit contract proposals under subsection (a) from interested parties. In awarding contracts under such subsection, the Secretary shall review such proposals and give priority to those alternatives that are the most cost effective for the Federal Government and that allow for the use of donated land, federally owned property, or lease-purchase arrangements. A contract under this subsection shall not be entered into unless such contract results in a net cost savings to the Federal Government over the duration of the contract, as compared to the Government purchase price including borrowing by the Secretary of the Treasury.

(c) Donations

In carrying out this section, the Secretary shall have the power, in connection with real property, buildings, and facilities, to accept on behalf of the Food and Drug Administration gifts or donations of services or property, real or personal, as the Secretary determines to be necessary.

(d) Authorization of appropriations

There are authorized to be appropriated to carry out this section $100,000,000 for fiscal year 1991, and such sums as may be necessary for each of the subsequent fiscal years, to remain available until expended.

(June 25, 1938, ch. 675, §710, as added Pub. L. 101–635, title I, §101, Nov. 28, 1990, 104 Stat. 4583.)

§379c. Transferred

Editorial Notes

Codification

Section, act June 25, 1938, ch. 675, §711, as added Nov. 28, 1990, Pub. L. 101–635, title II, §201, 104 Stat. 4584, which related to recovery and retention of fees for freedom of information requests, was renumbered section 731 of act June 25, 1938, by Pub. L. 102–571, title I, §106(6), Oct. 29, 1992, 106 Stat. 4499, and transferred to section 379f of this title.

§379d. Automation of Food and Drug Administration

(a) In general

The Secretary, acting through the Commissioner of Food and Drugs, shall automate appropriate activities of the Food and Drug Administration to ensure timely review of activities regulated under this chapter.

(b) Authorization of appropriations

There are authorized to be appropriated each fiscal year such sums as are necessary to carry out this section.

(June 25, 1938, ch. 675, §711, formerly §712, as added Pub. L. 101–635, title IV, §401, Nov. 28, 1990, 104 Stat. 4585; renumbered §711, Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498.)

Editorial Notes

Prior Provisions

A prior section 711 of act June 25, 1938, was renumbered section 731 by Pub. L. 102–571 and is classified to section 379f of this title.

§379d–1. Conflicts of interest

(a) Definitions

For purposes of this section:

(1) Advisory committee

The term "advisory committee" means an advisory committee under chapter 10 of title 5 that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.

(2) Financial interest

The term "financial interest" means a financial interest under section 208(a) of title 18.

(b) Recruitment for advisory committees

(1) In general

The Secretary shall—

(A) develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups;

(B) seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities;

(C) at least every 180 days, request referrals for potential members of advisory committees from a variety of stakeholders, including—

(i) product developers, patient groups, and disease advocacy organizations; and

(ii) relevant—

(I) professional societies;

(II) medical societies;

(III) academic organizations; and

(IV) governmental organizations; and

(D) in carrying out subparagraphs (A) and (B), take into account the levels of activity (including the numbers of annual meetings) and the numbers of vacancies of the advisory committees.

(2) Recruitment activities

The recruitment activities under paragraph (1) may include—

(A) advertising the process for becoming an advisory committee member at medical and scientific society conferences;

(B) making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and

(C) developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person whom the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.

(3) Expertise

In carrying out this subsection, the Secretary shall seek to ensure that the Secretary has access to the most current expert advice.

(c) Disclosure of determinations and certifications

Notwithstanding section 13109(a)(2) of title 5, the following shall apply:

(1) 15 or more days in advance

As soon as practicable, but (except as provided in paragraph (2)) not later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18 or a written certification as referred to in section 208(b)(3) of such title, applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 or section 552a of title 5 (popularly known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet Web site of the Food and Drug Administration—

(A) the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination or certification applies; and

(B) the reasons of the Secretary for such determination or certification, including, as appropriate, the public health interest in having the expertise of the member with respect to the particular matter before the advisory committee.

(2) Less than 30 days in advance

In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18 or a written certification as referred to in section 208(b)(3) of such title applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 or 552a of title 5) on the Internet Web site of the Food and Drug Administration, the information described in subparagraphs (A) and (B) of paragraph (1) as soon as practicable after the Secretary makes such determination or certification, but in no case later than the date of such meeting.

(d) Public record

The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c) (other than information exempted from disclosure under section 552 of title 5 and section 552a of title 5).

(e) Annual report

(1) In general

Not later than February 1 of each year, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives, a report that describes—

(A) with respect to the fiscal year that ended on September 30 of the previous year, the number of persons nominated for participation at meetings for each advisory committee, the number of persons so nominated, and willing to serve, the number of vacancies on each advisory committee, and the number of persons contacted for service as members on each advisory committee meeting for each advisory committee who did not participate because of the potential for such participation to constitute a disqualifying financial interest under section 208 of title 18;

(B) with respect to such year, the number of persons contacted for service as members for each advisory committee meeting for each advisory committee who did not participate because of reasons other than the potential for such participation to constitute a disqualifying financial interest under section 208 of title 18;

(C) with respect to such year, the number of members attending meetings for each advisory committee; and

(D) with respect to such year, the aggregate number of disclosures required under subsection (d) and the percentage of individuals to whom such disclosures did not apply who served on such committee.

(2) Public availability

Not later than 30 days after submitting any report under paragraph (1) to the committees specified in such paragraph, the Secretary shall make each such report available to the public.

(f) Periodic review of guidance

Not less than once every 5 years, the Secretary shall—

(1) review guidance of the Food and Drug Administration with respect to advisory committees regarding disclosure of conflicts of interest and the application of section 208 of title 18; and

(2) update such guidance as necessary to ensure that the Food and Drug Administration receives appropriate access to needed scientific expertise, with due consideration of the requirements of such section 208.

(g) Guidance on reported disclosed financial interest or involvement

The Secretary shall issue guidance that describes how the Secretary reviews the financial interests and involvement of advisory committee members that are disclosed under subsection (c) but that the Secretary determines not to meet the definition of a disqualifying interest under section 208 of title 18 for the purposes of participating in a particular matter.

(June 25, 1938, ch. 675, §712, as added Pub. L. 110–85, title VII, §701(a), Sept. 27, 2007, 121 Stat. 900; amended Pub. L. 112–144, title XI, §1142(a), July 9, 2012, 126 Stat. 1127; Pub. L. 114–255, div. A, title III, §3101(a)(2)(U), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 117–286, §4(a)(159), (c)(29), Dec. 27, 2022, 136 Stat. 4323, 4357.)

Editorial Notes

References in Text

The Privacy Act of 1974, referred to in subsec. (c)(3)(A), is Pub. L. 93–579, Dec. 31, 1974, 88 Stat. 1896, which enacted section 552a of Title 5, Government Organization and Employees, and provisions set out as notes under section 552a of Title 5. For complete classification of this Act to the Code, see Short Title of 1974 Amendment note set out under section 552a of Title 5 and Tables.

Prior Provisions

A prior section 712 of act June 25, 1938, was renumbered section 711 by Pub. L. 102–571 and is classified to section 379d of this title.

Amendments

2022—Subsec. (a)(1). Pub. L. 117–286, §4(a)(159), substituted "chapter 10 of title 5" for "the Federal Advisory Committee Act".

Subsec. (c). Pub. L. 117–286, §4(c)(29), substituted "section 13109(a)(2) of title 5," for "section 107(a)(2) of the Ethics in Government Act of 1978,".

2016—Subsec. (e)(1)(B). Pub. L. 114–255 substituted "service as members" for "services as members".

2012—Subsecs. (b), (c). Pub. L. 112–144, §1142(a)(1), added subsecs. (b) and (c) and struck out former subsecs. (b) and (c) which related to appointments to advisory committees and disclosures, prohibitions on participation, and waivers.

Subsec. (d). Pub. L. 112–144, §1142(a)(2), substituted "subsection (c)" for "subsection (c)(3)".

Subsec. (e). Pub. L. 112–144, §1142(a)(3), amended subsec. (e) generally. Prior to amendment, subsec. (e) related to annual report.

Subsec. (f). Pub. L. 112–144, §1142(a)(4), substituted "shall—" for "shall review guidance of the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory committees and update such guidance as necessary." and added pars. (1) and (2).

Subsec. (g). Pub. L. 112–144, §1142(a)(5), added subsec. (g).

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Pub. L. 112–144, title XI, §1142(b), July 9, 2012, 126 Stat. 1130, provided that: "The amendments made by subsection (a) [amending this section] apply beginning on October 1, 2012."

Effective Date

Section effective Oct. 1, 2007, see section 701(c) of Pub. L. 110–85, set out as an Effective Date of 2007 Amendment note under section 355 of this title.

§379d–2. Policy on the review and clearance of scientific articles published by FDA employees

(a) Definition

In this section, the term "article" means a paper, poster, abstract, book, book chapter, or other published writing.

(b) Policies

The Secretary, through the Commissioner of Food and Drugs, shall establish and make publicly available clear written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles.

(c) Timing of submission for review

If an officer or employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug Administration is directed by the policies established under subsection (b) to submit an article to the supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for review and clearance before such officer or employee may seek to publish or present such an article at a conference, such officer or employee shall submit such article for such review and clearance not less than 30 days before submitting the article for publication or presentation.

(d) Timing for review and clearance

The supervisor or other reviewing official shall review such article and provide written clearance, or written clearance on the condition of specified changes being made, to such officer or employee not later than 30 days after such officer or employee submitted such article for review.

(e) Non-timely review

If, 31 days after such submission under subsection (c), the supervisor or other reviewing official has not cleared or has not reviewed such article and provided written clearance, such officer or employee may consider such article not to have been cleared and may submit the article for publication or presentation with an appropriate disclaimer as specified in the policies established under subsection (b).

(f) Effect

Nothing in this section shall be construed as affecting any restrictions on such publication or presentation provided by other provisions of law.

(June 25, 1938, ch. 675, §713, as added Pub. L. 110–85, title XI, §1101, Sept. 27, 2007, 121 Stat. 971.)

§379d–3. Streamlined hiring authority

(a) In general

In addition to any other personnel authorities under other provisions of law, the Secretary may, without regard to the provisions of title 5 governing appointments in the competitive service, appoint employees to positions in the Food and Drug Administration to perform, administer, or support activities described in subsection (b), if the Secretary determines that such appointments are needed to achieve the objectives specified in subsection (c).

(b) Activities described

The activities described in this subsection are—

(1) activities under this chapter related to the process for the review of device applications (as defined in section 379i(9) of this title); and

(2) activities under this chapter related to human generic drug activities (as defined in section 379j–41 of this title).

(c) Objectives specified

The objectives specified in this subsection are—

(1) with respect to the activities under subsection (b)(1), the goals referred to in section 379j–1(a)(1) of this title; and

(2) with respect to the activities under subsection (b)(2), the goals referred to in section 379j–43(a) of this title.

(d) Internal controls

The Secretary shall institute appropriate internal controls for appointments under this section.

(e) Sunset

The authority to appoint employees under this section shall terminate on the date that is 3 years after July 9, 2012.

(June 25, 1938, ch. 675, §714, as added and amended Pub. L. 112–144, title II, §208, title III, §307, July 9, 2012, 126 Stat. 1007, 1025; Pub. L. 115–52, title II, §202(b), Aug. 18, 2017, 131 Stat. 1013.)

Editorial Notes

Amendments

2017—Subsec. (b)(1). Pub. L. 115–52 substituted "379i(9)" for "379i(8)".

2012—Subsec. (b). Pub. L. 112–144, §307(1), amended subsec. (b) generally. Prior to amendment, text read as follows: "The activities described in this subsection are activities under this chapter related to the process for the review of device applications (as defined in section 379i(8) of this title)."

Subsec. (c). Pub. L. 112–144, §307(2), amended subsec. (c) generally. Prior to amendment, text read as follows: "The objectives specified in this subsection are with respect to the activities under subsection (b), the goals referred to in section 379j–1(a)(1) of this title."

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of this subchapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by section 307 of Pub. L. 112–144 effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–41 of this title.

Effective Date

Section effective Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as an Effective Date of 2012 Amendment note under section 379i of this title.

§379d–3a. Hiring authority for scientific, technical, and professional personnel

(a) In general

The Secretary may, notwithstanding title 5, governing appointments in the competitive service, appoint outstanding and qualified candidates to scientific, technical, or professional positions, including cross-cutting operational positions, that support the development, review, and regulation of medical products and the regulation of food and cosmetics. Such positions shall be within the competitive service.

(b) Compensation

(1) In general

Notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, and consistent with the requirements of paragraph (2), the Commissioner of Food and Drugs may determine and set—

(A) the annual rate of pay of any individual appointed under subsection (a); and

(B) for purposes of retaining qualified employees, the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position described in subsection (a) before December 13, 2016.

(2) Limitation

The annual rate of pay established pursuant to paragraph (1) may not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3.

(3) Public availability

The annual rate of pay provided to an individual in accordance with this section shall be publicly available information.

(c) Rule of construction

The authorities under this section shall not be construed to affect the authority provided under section 379d–3 of this title.

(d) Report on workforce planning

(1) In general

Not later than 18 months after December 29, 2022, the Secretary shall submit a report on workforce planning to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—

(A) an updated analysis of the workforce needs at the Food and Drug Administration and the Secretary's strategic plan for addressing such needs, including through use of the authority under this section;

(B) an analysis of how the Secretary has used the authorities provided under this section, and a plan for how the Secretary will use the authority under this section, and other applicable hiring authorities, for employees of the Food and Drug Administration; and

(C) an updated recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which may include the use of—

(i) recruitment through nongovernmental recruitment or placement agencies;

(ii) recruitment through academic institutions;

(iii) recruitment or hiring bonuses, if applicable;

(iv) recruitment using targeted direct hiring authorities; and

(v) retention of qualified scientific, technical, and professional employees using the authority under this section, or other applicable authorities of the Secretary.

(2) Recommendations

The report under paragraph (1) may include the recommendations of the Commissioner of Food and Drugs that would help the Food and Drug Administration to better recruit and retain qualified individuals for scientific, technical, or professional positions at the agency.

(June 25, 1938, ch. 675, §714A, as added Pub. L. 114–255, div. A, title III, §3072(a), Dec. 13, 2016, 130 Stat. 1134; amended Pub. L. 117–328, div. FF, title III, §3624, Dec. 29, 2022, 136 Stat. 5879.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328, §3624(1), inserted ", including cross-cutting operational positions," after "professional positions" and "and the regulation of food and cosmetics" after "medical products".

Subsec. (d)(1). Pub. L. 117–328, §3624(2)(A), in introductory provisions, substituted "December 29, 2022" for "December 13, 2016" and "that includes" for "that examines the extent to which the Food and Drug Administration has a critical need for qualified individuals for scientific, technical, or professional positions, including".

Subsec. (d)(1)(A). Pub. L. 117–328, §3624(2)(B), inserted "updated" before "analysis" and substituted semicolon for "; and".

Subsec. (d)(1)(B). Pub. L. 117–328, §3624(2)(D), added subpar. (B). Former subpar. (B) redesignated (C).

Subsec. (d)(1)(C). Pub. L. 117–328, §3624(2)(C), (E), redesignated subpar. (B) as (C) and substituted "an updated recruitment" for "a recruitment" in introductory provisions.

§379d–3b. Strategic Workforce Plan and report

(a) In general

Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop, begin implementation of, and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated strategy and report to provide direction for the activities and programs of the Secretary to recruit, hire, train, develop, and retain the workforce needed to fulfill the public health mission of the Food and Drug Administration, including to facilitate collaboration across centers, to keep pace with new biomedical, technological, and scientific advancements, and support the development, review, and regulation of medical products. Each such report shall be known as the "Food and Drug Administration Strategic Workforce Plan".

(b) Use of the Food and Drug Administration Strategic Workforce Plan

Each center within the Food and Drug Administration shall develop and update, as appropriate, a strategic plan that will be informed by the Food and Drug Administration Strategic Workforce Plans developed under subsection (a).

(c) Contents of the Food and Drug Administration Strategic Workforce Plan

Each Food and Drug Administration Strategic Workforce Plan under subsection (a) shall—

(1) include agency-wide human capital strategic goals and priorities for recruiting, hiring, training, developing, and retaining a qualified workforce for the Food and Drug Administration;

(2) establish specific actions the Secretary will take to achieve such strategic goals and priorities and address the workforce needs of the Food and Drug Administration in the forthcoming fiscal years;

(3) identify challenges and risks the Secretary will face in meeting its strategic goals and priorities, and the actions the Secretary will take to overcome those challenges and mitigate those risks;

(4) establish performance measures, benchmarks, or other elements that the Secretary will use to measure and evaluate progress in achieving such strategic goals and priorities and the effectiveness of such strategic goals and priorities; and

(5) define functions, capabilities, and gaps in such workforce and identify strategies to recruit, hire, train, develop, and retain such workforce.

(d) Considerations

In developing each Food and Drug Administration Strategic Workforce Plan under subsection (a), the Secretary shall consider—

(1) the number of employees (including senior leadership and non-senior leadership employees) eligible for retirement, the expertise of such employees, and the employing center of such employees;

(2) the vacancy and turnover rates for employees with different types of expertise and from different centers, including any changes or trends related to such rates;

(3) the results of the Federal Employee Viewpoint Survey for employees of the Food and Drug Administration, including any changes or trends related to such results;

(4) rates of pay for different types of positions, including rates for different types of expertise within the same field (such as differences in pay between different medical specialists), and how such rates of pay impact the ability of the Secretary to achieve the strategic goals and priorities described in subsection (c);

(5) the statutory hiring authorities used to hire Food and Drug Administration employees, and the time to hire across different hiring authorities; and

(6) any other timely and relevant information, as the Secretary determines appropriate.

(e) Evaluation of progress

Each Food and Drug Administration Strategic Workforce Plan issued pursuant to subsection (a), with the exception of the first such Food and Drug Administration Strategic Workforce Plan, shall include an evaluation of—

(1) the progress the Secretary has made, based on the performance measures, benchmarks, and other elements that measure successful recruitment, hiring, training, development, and retention activities; and

(2) whether actions taken in response to the Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities described in subsection (c)(1).

(f) Additional considerations

The Food and Drug Administration Strategic Workforce Plan issued in fiscal year 2023 shall address the effect of the COVID–19 pandemic on hiring, retention, and other workforce challenges for the Food and Drug Administration, including protecting such workforce during public health emergencies.

(June 25, 1938, ch. 675, §714B, as added Pub. L. 117–328, div. FF, title III, §3623, Dec. 29, 2022, 136 Stat. 5878.)

§379d–4. Reporting requirements

(a) Generic drugs

Beginning with fiscal year 2013 and ending after fiscal year 2017, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 7 of part C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning, for all applications for approval of a generic drug under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year—

(1) the number of such applications that met the goals identified for purposes of subpart 7 of part C, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record;

(2) the average total time to decision by the Secretary for applications for approval of a generic drug under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year, including the number of calendar days spent during the review by the Food and Drug Administration and the number of calendar days spent by the sponsor responding to a complete response letter;

(3) the total number of applications under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications that were pending with the Secretary for more than 10 months on July 9, 2012; and

(4) the number of applications described in paragraph (3) on which the Food and Drug Administration took final regulatory action in the previous fiscal year.

(b) Biosimilar biological products

(1) In general

Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 8 of part C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning—

(A) the number of applications for approval filed under section 262(k) of title 42; and

(B) the percentage of applications described in subparagraph (A) that were approved by the Secretary.

(2) Additional information

As part of the performance report described in paragraph (1), the Secretary shall include an explanation of how the Food and Drug Administration is managing the biological product review program to ensure that the user fees collected under subpart 2 ¹ are not used to review an application under section 262(k) of title 42.

(June 25, 1938, ch. 675, §715, as added and amended Pub. L. 112–144, title III, §308, title IV, §408, July 9, 2012, 126 Stat. 1025, 1039.)

Editorial Notes

Amendments

2012—Subsec. (b). Pub. L. 112–144, §408, added subsec. (b).

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Amendment by section 408 of Pub. L. 112–144 effective Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–51 of this title.

Effective Date

Section effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–41 of this title.

¹ So in original. Probably means subpart 2 of part C.

§379d–5. Guidance document regarding product promotion using the Internet

Not later than 2 years after July 9, 2012, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

(Pub. L. 112–144, title XI, §1121, July 9, 2012, 126 Stat. 1112.)

Editorial Notes

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Part B—Colors

§379e. Listing and certification of color additives for foods, drugs, devices, and cosmetics

(a) Unsafe color additives

A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless—

(1)(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or

(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.

While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of section 342(a) of this title if such article is a food, or within the meaning of section 361(a) of this title if such article is a cosmetic other than a hair dye (as defined in the last sentence of section 361(a) of this title). A color additive for use in or on a device shall be subject to this section only if the color additive comes in direct contact with the body of man or other animals for a significant period of time. The Secretary may by regulation designate the uses of color additives in or on devices which are subject to this section.

(b) Listing of colors; regulations; issuance, amendment or repeal; referral to advisory committee; report and recommendations; appointment and compensation of advisory committee

(1) The Secretary shall, by regulation, provide for separately listing color additives for use in or on food, color additives for use in or on drugs, or devices, and color additives for use in or on cosmetics, if and to the extent that such additives are suitable and safe for any such use when employed in accordance with such regulations.

(2)(A) Such regulations may list any color additive for use generally in or on food, or in or on drugs or devices, or in or on cosmetics, if the Secretary finds that such additive is suitable and may safely be employed for such general use.

(B) If the data before the Secretary do not establish that the additive satisfies the requirements for listing such additive on the applicable list pursuant to subparagraph (A) of this paragraph, or if the proposal is for listing such additive for a more limited use or uses, such regulations may list such additive only for any more limited use or uses for which it is suitable and may safely be employed.

(3) Such regulations shall, to the extent deemed necessary by the Secretary to assure the safety of the use or uses for which a particular color additive is listed, prescribe the conditions under which such additive may be safely employed for such use or uses (including, but not limited to, specifications, hereafter in this section referred to as tolerance limitations, as to the maximum quantity or quantities which may be used or permitted to remain in or on the article or articles in or on which it is used; specifications as to the manner in which such additive may be added to or used in or on such article or articles; and directions or other labeling or packaging requirements for such additive).

(4) The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe: Provided, however, That a color additive shall be deemed to be suitable and safe for the purpose of listing under this subsection for use generally in or on food, while there is in effect a published finding of the Secretary declaring such substance exempt from the term "food additive" because of its being generally recognized by qualified experts as safe for its intended use, as provided in section 321(s) of this title.

(5)(A) In determining, for the purposes of this section, whether a proposed use of a color additive is safe, the Secretary shall consider, among other relevant factors—

(i) the probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs or devices, or cosmetics because of the use of the additive;

(ii) the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet;

(iii) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of color additives for the use or uses for which the additive is proposed to be listed, are generally recognized as appropriate for the use of animal experimentation data; and

(iv) the availability of any needed practicable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, (II) such additive in or on any article of food, drug or device, or cosmetic, and (III) any substance formed in or on such article because of the use of such additive.

(B) A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal: Provided, That clause (i) of this subparagraph (B) shall not apply with respect to the use of a color additive as an ingredient of feed for animals which are raised for food production, if the Secretary finds that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsection (d)) in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animal.

(C)(i) In any proceeding for the issuance, amendment, or repeal of a regulation listing a color additive, whether commenced by a proposal of the Secretary on his own initiative or by a proposal contained in a petition, the petitioner, or any other person who will be adversely affected by such proposal or by the Secretary's order issued in accordance with paragraph (1) of section 371(e) of this title if placed in effect, may request, within the time specified in this subparagraph, that the petition or order thereon, or the Secretary's proposal, be referred to an advisory committee for a report and recommendations with respect to any matter arising under subparagraph (B) of this paragraph, which is involved in such proposal or order and which requires the exercise of scientific judgment. Upon such request, or if the Secretary within such time deems such a referral necessary, the Secretary shall forthwith appoint an advisory committee under subparagraph (D) of this paragraph and shall refer to it, together with all the data before him, such matter arising under subparagraph (B) for study thereof and for a report and recommendations on such matter. A person who has filed a petition or who has requested the referral of a matter to an advisory committee pursuant to this subparagraph (C), as well as representatives of the Department, shall have the right to consult with such advisory committee in connection with the matter referred to it. The request for referral under this subparagraph, or the Secretary's referral on his own initiative, may be made at any time before, or within thirty days after, publication of an order of the Secretary acting upon the petition or proposal.

(ii) Within sixty days after the date of such referral, or within an additional thirty days if the committee deems such additional time necessary, the committee shall, after independent study of the data furnished to it by the Secretary and other data before it, certify to the Secretary a report and recommendations, together with all underlying data and a statement of the reasons or basis for the recommendations. A copy of the foregoing shall be promptly supplied by the Secretary to any person who has filed a petition, or who has requested such referral to the advisory committee. Within thirty days after such certification, and after giving due consideration to all data then before him, including such report, recommendations, underlying data, and statement, and to any prior order issued by him in connection with such matter, the Secretary shall by order confirm or modify any order theretofore issued or, if no such prior order has been issued, shall by order act upon the petition or other proposal.

(iii) Where—

(I) by reason of subparagraph (B) of this paragraph, the Secretary has initiated a proposal to remove from listing a color additive previously listed pursuant to this section; and

(II) a request has been made for referral of such proposal to an advisory committee;

the Secretary may not act by order on such proposal until the advisory committee has made a report and recommendations to him under clause (ii) of this subparagraph and he has considered such recommendations, unless the Secretary finds that emergency conditions exist necessitating the issuance of an order notwithstanding this clause.

(D) The advisory committee referred to in subparagraph (C) of this paragraph shall be composed of experts selected by the National Academy of Sciences, qualified in the subject matter referred to the committee and of adequately diversified professional background, except that in the event of the inability or refusal of the National Academy of Sciences to act, the Secretary shall select the members of the committee. The size of the committee shall be determined by the Secretary. Members of any advisory committee established under this chapter, while attending conferences or meetings of their committees or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary but at rates not exceeding the daily equivalent of the rate specified at the time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The members shall not be subject to any other provisions of law regarding the appointment and compensation of employees of the United States. The Secretary shall furnish the committee with adequate clerical and other assistance, and shall by rules and regulations prescribe the procedure to be followed by the committee.

(6) The Secretary shall not list a color additive under this subsection for a proposed use if the data before him show that such proposed use would promote deception of the consumer in violation of this chapter or would otherwise result in misbranding or adulteration within the meaning of this chapter.

(7) If, in the judgment of the Secretary, a tolerance limitation is required in order to assure that a proposed use of a color additive will be safe, the Secretary—

(A) shall not list the additive for such use if he finds that the data before him do not establish that such additive, if used within a safe tolerance limitation, would achieve the intended physical or other technical effect; and

(B) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the intended physical or other technical effect.

(8) If, having regard to the aggregate quantity of color additive likely to be consumed in the diet or to be applied to the human body, the Secretary finds that the data before him fail to show that it would be safe and otherwise permissible to list a color additive (or pharmacologically related color additives) for all the uses proposed therefor and at the levels of concentration proposed, the Secretary shall, in determining for which use or uses such additive (or such related additives) shall be or remain listed, or how the aggregate allowable safe tolerance for such additive or additives shall be allocated by him among the uses under consideration, take into account, among other relevant factors (and subject to the paramount criterion of safety), (A) the relative marketability of the articles involved as affected by the proposed uses of the color additive (or of such related additives) in or on such articles, and the relative dependence of the industries concerned on such uses; (B) the relative aggregate amounts of such color additive which he estimates would be consumed in the diet or applied to the human body by reason of the various uses and levels of concentration proposed; and (C) the availability, if any, of other color additives suitable and safe for one or more of the uses proposed.

(c) Certification of colors

The Secretary shall further, by regulation, provide (1) for the certification, with safe diluents or without diluents, of batches of color additives listed pursuant to subsection (b) and conforming to the requirements for such additives established by regulations under such subsection and this subsection, and (2) for exemption from the requirement of certification in the case of any such additive, or any listing or use thereof, for which he finds such requirement not to be necessary in the interest of the protection of the public health: Provided, That, with respect to any use in or on food for which a listed color additive is deemed to be safe by reason of the proviso to paragraph (4) of subsection (b), the requirement of certification shall be deemed not to be necessary in the interest of public health protection.

(d) Procedure for issuance, amendment, or repeal of regulations

The provisions of section 371(e), (f), and (g) of this title shall, subject to the provisions of subparagraph (C) of subsection (b)(5) of this section, apply to and in all respects govern proceedings for the issuance, amendment, or repeal of regulations under subsection (b) or (c) of this section (including judicial review of the Secretary's action in such proceedings) and the admissibility of transcripts of the record of such proceedings in other proceedings, except that—

(1) if the proceeding is commenced by the filing of a petition, notice of the proposal made by the petition shall be published in general terms by the Secretary within thirty days after such filing, and the Secretary's order (required by paragraph (1) of section 371(e) of this title) acting upon such proposal shall, in the absence of prior referral (or request for referral) to an advisory committee, be issued within ninety days after the date of such filing, except that the Secretary may (prior to such ninetieth day), by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition;

(2) any report, recommendations, underlying data, and reasons certified to the Secretary by an advisory committee appointed pursuant to subparagraph (D) of subsection (b)(5) of this section, shall be made a part of the record of any hearing if relevant and material, subject to the provisions of section 556(d) of title 5. The advisory committee shall designate a member to appear and testify at any such hearing with respect to the report and recommendations of such committee upon request of the Secretary, the petitioner, or the officer conducting the hearing, but this shall not preclude any other member of the advisory committee from appearing and testifying at such hearing;

(3) the Secretary's order after public hearing (acting upon objections filed to an order made prior to hearing) shall be subject to the requirements of section 348(f)(2) of this title; and

(4) the scope of judicial review of such order shall be in accordance with the fourth sentence of paragraph (2), and with the provisions of paragraph (3), of section 348(g) of this title.

(e) Fees

The admitting to listing and certification of color additives, in accordance with regulations prescribed under this chapter, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes.

(f) Exemptions

The Secretary shall by regulations (issued without regard to subsection (d)) provide for exempting from the requirements of this section any color additive or any specific type of use thereof, and any article of food, drug, or device, or cosmetic bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

(June 25, 1938, ch. 675, §721, formerly §706, 52 Stat. 1058; Pub. L. 86–618, title I, §103(b), July 12, 1960, 74 Stat. 399; Pub. L. 87–781, title I, §104(f)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91–515, title VI, §601(d)(2), Oct. 30, 1970, 84 Stat. 1311; Pub. L. 94–295, §9(a), May 28, 1976, 90 Stat. 583; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; renumbered §721, Pub. L. 102–571, title I, §106(4), Oct. 29, 1992, 106 Stat. 4498; Pub. L. 103–80, §3(bb), Aug. 13, 1993, 107 Stat. 778.)

Editorial Notes

Codification

Section was formerly classified to section 376 of this title prior to renumbering by Pub. L. 102–571.

In subsec. (d)(2), "section 556(d) of title 5" substituted for "section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))" on authority of Pub. L. 89–554, §7(b), Sept. 6, 1966, 80 Stat. 631, the first section of which enacted Title 5, Government Organization and Employees.

Amendments

1993—Subsec. (b)(5)(D). Pub. L. 103–80 substituted "section 5703" for "section 5703(b)".

1992—Subsec. (b)(5)(C)(i). Pub. L. 102–300 struck out "of Health, Education, and Welfare" after "representatives of the Department".

1976—Subsec. (a). Pub. L. 94–295, §9(a)(2), (3), inserted reference to devices and inserted provisions directing that color additives for use in or on devices be subject to this section only if the color additives come in direct contact with the body of man or other animals for a significant period of time and authorizing the Secretary to designate by regulation the uses of color additives in or on devices which are subject to this section.

Subsec. (b). Pub. L. 94–295, §9(a)(1), (2), substituted "drug or device" for "drug" and "drugs or devices" for "drugs" wherever appearing.

Subsec. (f). Pub. L. 94–295, §9(a)(1), substituted "drug or device" for "drug".

1970—Subsec. (b)(5)(D). Pub. L. 91–515 substituted provisions authorizing members of an advisory committee to receive compensation at rates fixed by the Secretary, with a specific maximum amount, and travel expenses, including per diem in lieu of subsistence, as authorized by section 5703(b) of Title 5, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent on committee work, and necessary traveling and subsistence expenses while serving away from their places of residence.

1962—Subsec. (b)(5)(B). Pub. L. 87–781 provided that clause (i) of this subparagraph shall not apply to a color additive in feed of animals raised for food production, if under the conditions of use specified in proposed labeling, and which conditions are reasonably certain to be followed in practice, such additive will not adversely affect the animals and no residue will be found in any edible portion of such animal after slaughter or in any food from the living animal.

1960—Pub. L. 86–618 amended section generally. Prior to amendment, section read as follows: "The admitting to listing and certification of coal-tar colors, in accordance with regulations prescribed under this chapter, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes."

Statutory Notes and Related Subsidiaries

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment, Transitional Provisions, and Effect on Other Laws

Pub. L. 86–618, title II, July 12, 1960, 74 Stat. 404, provided that:

"Sec. 201. [Definitions.] As used in this title, the term 'basic Act' means the Federal Food, Drug, and Cosmetic Act [this chapter]; the term 'enactment date' means the date of enactment of this Act [July 12, 1960]; and other terms, insofar as also used in the basic Act (whether before or after enactment of this Act) shall have the same meaning as they have, or had when in effect, under the basic Act.

"Sec. 202. [Effective Date.] This Act [amending this section and sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of this title and repealing sections 354 and 364 of this title] shall, subject to the provisions of section 203, take effect on the enactment date [July 12, 1960].

"Sec. 203. [Provisional Listings of Commercially Established Colors.] (a)(1) The purpose of this section is to make possible, on an interim basis for a reasonable period, through provisional listings, the use of commercially established color additives to the extent consistent with the public health, pending the completion of the scientific investigations needed as a basis for making determinations as to listing of such additives under the basic Act as amended by this Act. A provisional listing (including a deemed provisional listing) of a color additive under this section for any use shall, unless sooner terminated or expiring under the provisions of this section, expire (A) on the closing date (as defined in paragraph (2) of this subsection) or (B) on the effective date of a listing of such additive for such use under section 706 [now 721] of the basic Act, [this section], whichever date first occurs.

"(2) For the purposes of this section, the term 'closing date' means (A) the last day of the two and one-half year period beginning on the enactment date [July 12, 1960] or (B), with respect to a particular provisional listing (or deemed provisional listing) of a color additive or use thereof, such later closing date as the Secretary may from time to time establish pursuant to the authority of this paragraph. The Secretary may by regulation, upon application of an interested person or on his own initiative, from time to time postpone the original closing date with respect to a provisional listing (or deemed provisional listing) under this section of a specified color additive, or of a specified use or uses of such additive, for such period or periods as he finds necessary to carry out the purpose of this section, if in the Secretary's judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination as to listing such additive, or such specified use or uses thereof, under section 706 [now 721] of the basic Act [this section]. The Secretary may terminate a postponement of the closing date at any time if he finds that such postponement should not have been granted, or that by reason of a change in circumstances the basis for such postponement no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such postponement.

"(b) Subject to the other provisions of this section—

"(1) any color additive which, on the day preceding the enactment date [July 12, 1960], was listed and certifiable for any use or uses under section 406(b), 504, or 604 [section 346(b), 354, or 364 of this title], or under the third proviso of section 402(c) [section 342(c) of this title], of the basic Act, and of which a batch or batches had been certified for such use or uses prior to the enactment date [July 12, 1960], and

"(2) any color additive which was commercially used or sold prior to the enactment date [July 12, 1960] for any use or uses in or on any food, drug, or cosmetic, and which either, (A), on the day preceding the enactment date [July 12, 1960], was not a material within the purview of any of the provisions of the basic Act enumerated in paragraph (1) of this subsection, or (B) is the color additive known as synthetic beta-carotene,

shall, beginning on the enactment date [July 12, 1960], be deemed to be provisionally listed under this section as a color additive for such use or uses.

"(c) Upon request of any person, the Secretary, by regulations issued under subsection (d), shall without delay, if on the basis of the data before him he deems such action consistent with the protection of the public health, provisionally list a material as a color additive for any use for which it was listed, and for which a batch or batches of such material had been certified, under section 406(b), 504, or 604 of the basic Act [section 346(b), 354, or 364 of this title] prior to the enactment date [July 12, 1960], although such color was no longer listed and certifiable for such use under such sections on the day preceding the enactment date. Such provisional listing shall take effect on the date of publication.

"(d)(1) The Secretary shall, by regulations issued or amended from time to time under this section—

"(A) insofar as practicable promulgate and keep current a list or lists of the color additives, and of the particular uses thereof, which he finds are deemed provisionally listed under subsection (b), and the presence of a color additive on such a list with respect to a particular use shall, in any proceeding under the basic Act, be conclusive evidence that such provisional listing is in effect;

"(B) provide for the provisional listing of the color additives and particular uses thereof specified in subsection (c);

"(C) provide, with respect to particular uses for which color additives are or are deemed to be provisionally listed, such temporary tolerance limitations (including such limitations at zero level) and other conditions of use and labeling or packaging requirements, if any, as in his judgment are necessary to protect the public health pending listing under section 706 [now 721] of the basic Act [this section];

"(D) provide for the certification of batches of such color additives (with or without diluents) for the uses for which they are so listed or deemed to be listed under this section, except that such an additive which is a color additive deemed provisionally listed under subsection (b)(2) of this section shall be deemed exempt from the requirement of such certification while not subject to a tolerance limitation; and

"(E) provide for the termination of a provisional listing (or deemed provisional listing) of a color additive or particular use thereof forthwith whenever in his judgment such action is necessary to protect the public health.

"(2)(A) Except as provided in subparagraph (C) of this paragraph, regulations under this section shall, from time to time, be issued, amended, or repealed by the Secretary without regard to the requirements of the basic Act [subsec. (e) of this section], but for the purposes of the application of section 706(e) [now 721(e)] of the basic Act (relating to fees) and of determining the availability of appropriations of fees (and of advance deposits to cover fees), proceedings, regulations, and certifications under this section shall be deemed to be proceedings, regulations, and certifications under such section 706 [now 721, this section]. Regulations providing for fees (and advance deposits to cover fees), which on the day preceding the enactment date [July 12, 1960] were in effect pursuant to section 706 [now 721] of the basic Act [this section], shall be deemed to be regulations under such section 706 [now 721, this section] as amended by this Act, and appropriations of fees (and advance deposits) available for the purposes specified in such section 706 [now 721] as in effect prior to the enactment date [July 12, 1960] shall be available for the purposes specified in such section 706 [now 721, this section] as so amended.

"(B) If the Secretary, by regulation—

"(i) has terminated a provisional listing (or deemed provisional listing) of a color additive or particular use thereof pursuant to paragraph (1)(E) of this subsection; or

"(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of this subsection, initially established or rendered more restrictive a tolerance limitation or other restriction or requirement with respect to a provisional listing (or deemed provisional listing) which listing had become effective prior to such action,

any person adversely affected by such action may, prior to the expiration of the period specified in clause (A) of subsection (a)(2) of this section, file with the Secretary a petition for amendment of such regulation so as to revoke or modify such action of the Secretary, but the filing of such petition shall not operate to stay or suspend the effectiveness of such action. Such petition shall, in accordance with regulations, set forth the proposed amendment and shall contain data (or refer to data which are before the Secretary or of which he will take official notice), which show that the revocation or modification proposed is consistent with the protection of the public health. The Secretary shall, after publishing such proposal and affording all interested persons an opportunity to present their views thereon orally or in writing, act upon such proposal by published order.

"(C) Any person adversely affected by an order entered under subparagraph (B) of this paragraph may, within thirty days after its publication, file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds for such objections, and requesting a public hearing upon such objections. The Secretary shall hold a public hearing on such objections and shall, on the basis of the evidence adduced at such hearing, act on such objections by published order. Such order may reinstate a terminated provisional listing, or increase or dispense with a previously established temporary tolerance limitation, or make less restrictive any other limitation established by him under paragraph (1) or (3) of this subsection, only if in his judgment the evidence so adduced shows that such action will be consistent with the protection of the public health. An order entered under this subparagraph shall be subject to judicial review in accordance with section 701(f) of the basic Act [section 371(f) of this title] except that the findings and order of the Secretary shall be sustained only if based upon a fair evaluation of the entire record at such hearing. No stay or suspension of such order shall be ordered by the court pending conclusion of such judicial review.

"(D) On and after the enactment date [July 12, 1960], regulations, provisional listings, and certifications (or exemptions from certification) in effect under this section shall, for the purpose of determining whether an article is adulterated or misbranded within the meaning of the basic Act by reason of its being, bearing, or containing a color additive, have the same effect as would regulations, listings, and certifications (or exemptions from certification) under section 706 [now 721] of the basic Act [this section]. A regulation, provisional listing or termination thereof, tolerance limitation, or certification or exemption therefrom, under this section shall not be the basis for any presumption or inference in any proceeding under section 706(b) or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of this section].

"(3) For the purpose of enabling the Secretary to carry out his functions under paragraphs (1)(A) and (C) of this subsection with respect to color additives deemed provisionally listed, he shall, as soon as practicable after enactment of this Act [July 12, 1960], afford by public notice a reasonable opportunity to interested persons to submit data relevant thereto. If the data so submitted or otherwise before him do not, in his judgment, establish a reliable basis for including such a color additive or particular use or uses thereof in a list or lists promulgated under paragraph (1)(A), or for determining the prevailing level or levels of use thereof prior to the enactment date [July 12, 1960] with a view to prescribing a temporary tolerance or tolerances for such use or uses under paragraph (1)(C), the Secretary shall establish a temporary tolerance limitation at zero level for such use or uses until such time as he finds that it would not be inconsistent with the protection of the public health to increase or dispense with such temporary tolerance limitation.

"Sec. 204. [Effect on Meat Inspection and Poultry Products Inspection Acts.] Nothing in this Act [amending this section and sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of this title and repealing sections 354 and 364 of this title] shall be construed to exempt any meat or meat food product, poultry or poultry product, or any person from any requirement imposed by or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended or extended (21 U.S.C. 71 and the following) [see section 601 et seq. of this title] or the Poultry Products Inspection Act (21 U.S.C. 451 and the following)."

Effective Date; Acceleration

This section was made "immediately effective" by act May 2, 1939, ch. 107, title I, §1, 53 Stat. 631.

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

Part C—Fees

subpart 1—freedom of information fees

§379f. Recovery and retention of fees for freedom of information requests

(a) In general

The Secretary, acting through the Commissioner of Food and Drugs, may—

(1) set and charge fees, in accordance with section 552(a)(4)(A) of title 5, to recover all reasonable costs incurred in processing requests made under section 552 of title 5 for records obtained or created under this chapter or any other Federal law for which responsibility for administration has been delegated to the Commissioner by the Secretary;

(2) retain all fees charged for such requests; and

(3) establish an accounting system and procedures to control receipts and expenditures of fees received under this section.

(b) Use of fees

The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made to carry out other provisions of this chapter.

(c) Waiver of fees

Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to section 552(a)(4)(A) of title 5.

(June 25, 1938, ch. 675, §731, formerly §711, as added Pub. L. 101–635, title II, §201, Nov. 28, 1990, 104 Stat. 4584; renumbered §731, Pub. L. 102–571, title I, §106(6), Oct. 29, 1992, 106 Stat. 4499.)

Editorial Notes

Codification

Section was formerly classified to section 379c of this title prior to renumbering by Pub. L. 102–571.

subpart 2—fees relating to drugs

§379g. Definitions

For purposes of this subpart:

(1) The term "human drug application" means an application for—

(A) approval of a new drug submitted under section 355(b) of this title, or

(B) licensure of a biological product under subsection (a) of section 262 of title 42.

Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (B), of a large volume biological product intended for single dose injection for intravenous use or infusion.

(2) The term "supplement" means a request to the Secretary to approve a change in a human drug application which has been approved.

(3)(A) The term "prescription drug product" means a specific strength or potency of a drug in final dosage form—

(i) for which a human drug application has been approved,

(ii) which may be dispensed only under prescription pursuant to section 353(b) of this title, and

(iii) which is on the list of products described in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42 (not including the discontinued section of such list).

(B) Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, or an in vitro diagnostic biologic product licensed under section 262 of title 42. Such term does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.

(C)(i) If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 379h(a)(2) of this title, the Secretary shall consider such product to have been included in the discontinued section on the later of—

(I) the date such request was received; or

(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.

(ii) For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.

(4) The term "final dosage form" means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).

(5) The term "prescription drug establishment" means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term "manufactured" does not include packaging.

(6) The term "process for the review of human drug applications" means the following activities of the Secretary with respect to the review of human drug applications and supplements:

(A) The activities necessary for the review of human drug applications and supplements.

(B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.

(C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary's review of pending human drug applications and supplements.

(D) Activities necessary for the review of applications for licensure of establishments subject to section 262 of title 42 and for the release of lots of biologics under such section.

(E) Monitoring of research conducted in connection with the review of human drug applications.

(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:

(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.

(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies).

(v) Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities).

(7) The term "costs of resources allocated for the process for the review of human drug applications" means the expenses in connection with the process for the review of human drug applications for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors,

(B) management of information, and the acquisition, maintenance, and repair of computer resources,

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and

(D) collecting fees under section 379h of this title and accounting for resources allocated for the review of human drug applications and supplements.

(8) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 1996.

(9) The term "person" includes an affiliate thereof.

(10) The term "active", with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.

(11) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(12) The term "skin-test diagnostic product"—

(A) means a product—

(i) for prick, scratch, intradermal, or subcutaneous administration;

(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;

(iii) not intended to be a preventive or therapeutic intervention; and

(iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—

(I) an allergy to an antimicrobial agent;

(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or

(III) infection with fungal or mycobacterial pathogens; and

(B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A).

(June 25, 1938, ch. 675, §735, as added Pub. L. 102–571, title I, §103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105–115, title I, §§102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat. 2298, 2326; Pub. L. 107–188, title V, §503, June 12, 2002, 116 Stat. 688; Pub. L. 110–85, title I, §102, Sept. 27, 2007, 121 Stat. 825; Pub. L. 111–148, title VII, §7002(f)(3)(A), Mar. 23, 2010, 124 Stat. 818; Pub. L. 112–144, title I, §102, title IV, §407, July 9, 2012, 126 Stat. 996, 1039; Pub. L. 117–180, div. F, title I, §1002, Sept. 30, 2022, 136 Stat. 2140.)

Termination of Section

For termination of section by section 1005(a) of Pub. L. 117–180, see Termination Date note below.

Editorial Notes

Amendments

2022—Par. (1). Pub. L. 117–180, §1002(a), substituted "does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to" for "an allergenic extract product, or" in concluding provisions.

Par. (3). Pub. L. 117–180, §1002(b), substituted "(3)(A) The term" for "(3) The term", redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), designated concluding provisions as subpar. (B) and substituted "an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022," for "an allergenic extract product,", and added subpar. (C).

Par. (12). Pub. L. 117–180, §1002(c), added par. (12).

2012—Par. (1)(B). Pub. L. 112–144, §407, struck out "or (k)" after "subsection (a)".

Par. (7). Pub. L. 112–144, §102, substituted "expenses in connection with" for "expenses incurred in connection with".

2010—Par. (1)(B). Pub. L. 111–148 substituted "subsection (a) or (k) of section 262 of title 42" for "section 262 of title 42".

2007—Pub. L. 110–85, §102(1), in introductory provisions, substituted "For purposes of this subpart" for "For purposes of this part".

Par. (1). Pub. L. 110–85, §102(2)(D), substituted "subparagraph (B)" for "subparagraph (C)" in concluding provisions.

Par. (1)(A). Pub. L. 110–85, §102(2)(A), substituted "355(b) of this title, or" for "355(b)(1) of this title,".

Par. (1)(B), (C). Pub. L. 110–85, §102(2)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: "approval of a new drug submitted under section 355(b)(2) of this title after September 30, 1992, which requests approval of—

"(i) a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or

"(ii) an indication for a use,

that had not been approved under an application submitted under section 355(b) of this title, or".

Par. (3)(C). Pub. L. 110–85, §102(3), substituted "355(j)(7)(A) of this title (not including the discontinued section of such list)" for "355(j)(7)(A) of this title" and inserted "(not including the discontinued section of such list)" before period at end.

Par. (4). Pub. L. 110–85, §102(4), inserted "(such as capsules, tablets, or lyophilized products before reconstitution)" before period at end.

Par. (6)(F). Pub. L. 110–85, §102(5), amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: "In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years."

Par. (8). Pub. L. 110–85, §102(6), substituted "October of the preceding fiscal year" for "April of the preceding fiscal year" and "October 1996" for "April 1997".

Pars. (9) to (11). Pub. L. 110–85, §102(7), (8), added pars. (9) and (10) and redesignated former par. (9) as (11).

2002—Par. (1). Pub. L. 107–188, §503(1), substituted "licensure, as described in subparagraph (C)" for "licensure, as described in subparagraph (D)" in concluding provisions.

Par. (3). Pub. L. 107–188, §503(2)(D), which directed the amendment of concluding provisions of par. (3) by striking "section 262 of title 42" and all that follows through "biological product" and inserting "section 262 of title 42. Such term does not include a biological product", was executed by striking language ending with "biological product" the first time appearing, thereby making the substitution for "section 262 of title 42, does not include a large volume parenteral drug product approved before September 1, 1992, does not include a biological product", to reflect the probable intent of Congress.

Par. (3)(C). Pub. L. 107–188, §503(2)(A)–(C), added subpar. (C).

Par. (6)(F). Pub. L. 107–188, §503(3), added subpar. (F).

Par. (8). Pub. L. 107–188, §503(4), struck out designations of subpars. (A) and (B) and text of subpar. (B) and concluding provisions, substituting definition of "adjustment factor" as the Consumer Price Index for definition of Index as the lower of the Consumer Price Index or the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year divided by such budget authority for fiscal year 1997.

1997—Par. (1). Pub. L. 105–115, §102(1), in closing provisions, struck out "and" before "does not include an application" and substituted "September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion" for "September 1, 1992" before period at end.

Par. (1)(B) to (D). Pub. L. 105–115, §125(b)(2)(M), inserted "or" at end of subpar. (B), redesignated subpar. (D) as (C), and struck out former subpar. (C) which read as follows: "initial certification or initial approval of an antibiotic drug under section 357 of this title, or".

Par. (3). Pub. L. 105–115, §102(2), in closing provisions, struck out "and" before "does not include a large volume parenteral drug" and substituted "September 1, 1992, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion" for "September 1, 1992" before period at end.

Par. (4). Pub. L. 105–115, §102(3), substituted "without substantial further manufacturing" for "without further manufacturing".

Par. (5). Pub. L. 105–115, §102(4), amended first sentence generally. Prior to amendment, first sentence read as follows: "The term 'prescription drug establishment' means a foreign or domestic place of business which is—

"(A) at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more prescription drug products are manufactured in final dosage form, and

"(B) under the management of a person that is listed as the applicant in a human drug application for a prescription drug product with respect to at least one such product."

Par. (7)(A). Pub. L. 105–115, §102(5), substituted "contractors of the Food and Drug Administration," for "employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration," and "and committees and to contracts with such contractors," for "and committees,".

Par. (8)(A). Pub. L. 105–115, §102(6)(A), substituted "April of the preceding fiscal year" for "August of the preceding fiscal year" and "April 1997" for "August 1992".

Par. (8)(B). Pub. L. 105–115, §102(6)(B), substituted "section 254(c)" for "section 254(d)", "fiscal year 1997" for "fiscal year 1992", and "105th Congress, 1st Session" for "102d Congress, 2d Session".

Par. (9). Pub. L. 105–115, §102(7), added par. (9).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–180, div. F, title I, §1006, Sept. 30, 2022, 136 Stat. 2147, provided that: "The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act."

Effective Date of 2017 Amendment

Pub. L. 115–52, title I, §105, Aug. 18, 2017, 131 Stat. 1012, provided that: "The amendments made by this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.] shall be assessed for all human drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective Date of 2012 Amendment

Pub. L. 112–144, title I, §106, July 9, 2012, 126 Stat. 1002, provided that: "The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2012, or the date of the enactment of this Act [July 9, 2012], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all human drug applications received on or after October 1, 2012, regardless of the date of the enactment of this Act."

Amendment by section 407 of Pub. L. 112–144 effective Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.

Effective and Termination Dates of 2007 Amendment

Pub. L. 110–85, title I, §106(a), Sept. 27, 2007, 121 Stat. 842, which provided that the amendments made by sections 102, 103, and 104 of Pub. L. 110–85 (enacting section 379h–1 of this title and amending this section and section 379h of this title) would cease to be effective Oct. 1, 2012, was repealed by Pub. L. 112–144, title I, §105(c)(1), July 9, 2012, 126 Stat. 1001.

Pub. L. 110–85, title I, §107, Sept. 27, 2007, 121 Stat. 842, provided that: "The amendments made by this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title] shall take effect on October 1, 2007, or the date of the enactment of this Act [Sept. 27, 2007], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all human drug applications received on or after October 1, 2007, regardless of the date of the enactment of this Act."

Effective and Termination Dates of 2002 Amendment

Amendment by Pub. L. 107–188 effective Oct. 1, 2002, see section 508 of Pub. L. 107–188, set out as an Effective Date of 2002 Amendment note under section 356b of this title.

Pub. L. 107–188, title V, §509, June 12, 2002, 116 Stat. 694, which provided that the amendments made by sections 503 and 504 of Pub. L. 107–188 (amending this section and section 379h of this title) would cease to be effective Oct. 1, 2007, and the amendment by section 505 of Pub. L. 107–188 (enacting provisions set out as a note below) would cease to be effective 120 days after Oct. 1, 2007, was repealed by Pub. L. 112–144, title I, §105(d)(1)(A), July 9, 2012, 126 Stat. 1001.

[Pub. L. 112–144, title I, §105(d)(1), July 9, 2012, 126 Stat. 1001, provided that the repeal of section 509 of Pub. L. 107–188, formerly set out above, is effective Sept. 30, 2007.]

Effective and Termination Dates of 1997 Amendment

Pub. L. 105–115, title I, §106, Nov. 21, 1997, 111 Stat. 2305, provided that: "The amendments made by this subtitle [subtitle A (§§101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] shall take effect October 1, 1997."

Pub. L. 105–115, title I, §107, Nov. 21, 1997, 111 Stat. 2305, which provided that the amendments by sections 102 and 103 of Pub. L. 105–115 (amending this section and section 379h of this title) would cease to be effective Oct. 1, 2002, and the amendment by section 104 (enacting provisions set out as a note below) would cease to be effective 120 days after Oct. 1, 2002, was repealed by Pub. L. 112–144, title I, §105(d)(2)(A), July 9, 2012, 126 Stat. 1001.

[Pub. L. 112–144, title I, §105(d)(2), July 9, 2012, 126 Stat. 1001, provided that the repeal of section 107 of Pub. L. 105–115, formerly set out above, is effective Sept. 30, 2002.]

Termination Date

Pub. L. 117–180, div. F, title I, §1005(a), Sept. 30, 2022, 136 Stat. 2147, provided that: "Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective October 1, 2027."

Pub. L. 115–52, title I, §104(a), Aug. 18, 2017, 131 Stat. 1012, which provided that this section and section 379h of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147.

[Pub. L. 117–180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147, provided that the repeal of section 104(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title I, §105(a), July 9, 2012, 126 Stat. 1001, which provided that this section and section 379h of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat. 1012.

[Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat. 1012, provided that the repeal of section 105(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 102–571, title I, §105, Oct. 29, 1992, 106 Stat. 4498, which provided that the amendment by section 103 of Pub. L. 102–571 (enacting this subpart) would not be in effect after Oct. 1, 1997, and the amendment by section 104 of Pub. L. 102–571 (enacting provisions set out as a note below) would not be in effect after 120 days after Oct. 1, 1997, was repealed by Pub. L. 112–144, title I, §105(d)(3), July 9, 2012, 126 Stat. 1002.

[Pub. L. 112–144, title I, §105(d)(3), July 9, 2012, 126 Stat. 1002, provided that the repeal of section 105 of Pub. L. 102–571, formerly set out above, is effective Sept. 30, 1997.]

Savings Provision

Pub. L. 117–180, div. F, title I, §1007, Sept. 30, 2022, 136 Stat. 2147, provided that: "Notwithstanding the amendments made by this title [amending this section and section 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023."

Pub. L. 115–52, title I, §106, Aug. 18, 2017, 131 Stat. 1013, provided that: "Notwithstanding the amendments made by this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.], as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Pub. L. 112–144, title I, §107, July 9, 2012, 126 Stat. 1002, provided that: "Notwithstanding the amendments made by this title [amending this section and section 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2012."

Pub. L. 112–144, title IV, §406, July 9, 2012, 126 Stat. 1039, provided that: "Notwithstanding the amendments made by this title [enacting sections 379j–51 to 379j–53 of this title and amending this section and section 379d–4 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2007, but before October 1, 2012, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013."

Pub. L. 110–85, title I, §108, Sept. 27, 2007, 121 Stat. 842, provided that: "Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 [Pub. L. 107–188] ([former] 21 U.S.C. 379g note), and notwithstanding the amendments made by this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [Sept. 27, 2007], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008."

Pub. L. 107–188, title V, §507, June 12, 2002, 116 Stat. 694, provided that: "Notwithstanding section 107 of the Food and Drug Administration Modernization Act of 1997 [section 107 of Pub. L. 105–115, formerly set out as an Effective and Termination Dates of 1997 Amendment note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending this section and sections 356b and 379h of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this Act [June 12, 2002], continues to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that, on or after October 1, 1997, but before October 1, 2002, were accepted by the Food and Drug Administration for filing and with respect to assessing and collecting any fee required by such Act for a fiscal year prior to fiscal year 2003."

Pub. L. 105–115, title I, §105, Nov. 21, 1997, 111 Stat. 2305, provided that: "Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992 [section 105 of Pub. L. 102–571, formerly set out as a Termination Date note above], the Secretary shall retain the authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] for a human drug application or supplement accepted for filing prior to October 1, 1997, and to assess and collect any product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998."

Accountability and Reports

Pub. L. 107–188, title V, §505, June 12, 2002, 116 Stat. 692, provided that:

"(a) Public Accountability.—

"(1) Consultation.—In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of human drug applications for the fiscal years after fiscal year 2007, and for the reauthorization of sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g, 379h], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.

"(2) Recommendations.—The Secretary shall publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations.

"(b) Performance Report.—Beginning with fiscal year 2003, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare and submit to the President, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 502(4) [section 502(4) of Pub. L. 107–188, set out below] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

"(c) Fiscal Report.—Beginning with fiscal year 2003, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (b), the Secretary of Health and Human Services shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made."

Congressional Findings Concerning Fees Relating to Drugs

Pub. L. 117–180, div. F, title I, §1001(b), Sept. 30, 2022, 136 Stat. 2140, provided that: "Congress finds that the fees authorized by the amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 115–52, title I, §101(b), Aug. 18, 2017, 131 Stat. 1006, provided that: "The Congress finds that the fees authorized by the amendments made in this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title I, §101(b), July 9, 2012, 126 Stat. 996, provided that: "The Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 110–85, title I, §101(c), Sept. 27, 2007, 121 Stat. 825, provided that: "The Congress finds that the fees authorized by the amendments made in this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 107–188, title V, §502, June 12, 2002, 116 Stat. 687, provided that: "The Congress finds that—

"(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;

"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of human drug applications and the assurance of drug safety;

"(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title], as amended by the Food and Drug Administration Modernization Act of 1997 [see Short Title of 1997 Amendment note set out under section 301 of this title], have been successful in substantially reducing review times for human drug applications and should be—

"(A) reauthorized for an additional 5 years, with certain technical improvements; and

"(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration, including—

"(i) strengthening and improving the review and monitoring of drug safety;

"(ii) considering greater interaction between the agency and sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and

"(iii) developing principles for improving first-cycle reviews; and

"(4) the fees authorized by amendments made in this subtitle [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending this section and sections 356b and 379h of this title] will be dedicated towards expediting the drug development process and the process for the review of human drug applications as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Energy and Commerce of the House of Representatives and the chairman of the Committee on Health, Education, Labor and Pensions of the Senate, as set forth in the Congressional Record."

Pub. L. 105–115, title I, §101, Nov. 21, 1997, 111 Stat. 2298, provided that: "Congress finds that—

"(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;

"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications;

"(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title] have been successful in substantially reducing review times for human drug applications and should be—

"(A) reauthorized for an additional 5 years, with certain technical improvements; and

"(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration; and

"(4) the fees authorized by amendments made in this subtitle [subtitle A (§§101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] will be dedicated toward expediting the drug development process and the review of human drug applications as set forth in the goals identified, for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Commerce of the House of Representatives and the chairman of the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate, as set forth in the Congressional Record."

Pub. L. 102–571, title I, §102, Oct. 29, 1992, 106 Stat. 4491, provided that: "The Congress finds that—

"(1) prompt approval of safe and effective new drugs is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;

"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications; and

"(3) the fees authorized by this title [see Short Title of 1992 Amendment note, set out under section 301 of this title] will be dedicated toward expediting the review of human drug applications as set forth in the goals identified in the letters of September 14, 1992, and September 21, 1992, from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate, as set forth at 138 Cong. Rec. H9099–H9100 (daily ed. September 22, 1992) [Cong. Rec., vol. 138, pt. 18, p. 26928, Sept. 22, 1992]."

Annual Reports

Pub. L. 105–115, title I, §104, Nov. 21, 1997, 111 Stat. 2304, provided that:

"(a) Performance Report.—Beginning with fiscal year 1998, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(4) [section 101(4) of Pub. L. 105–115, set out above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

"(b) Fiscal Report.—Beginning with fiscal year 1998, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (a), the Secretary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made."

Pub. L. 102–571, title I, §104, Oct. 29, 1992, 106 Stat. 4498, provided that:

"(a) First Report.—Within 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], the Secretary of Health and Human Services shall submit a report stating the Food and Drug Administration's progress in achieving the goals identified in section 102(3) of this Act [set out as a note above] during such fiscal year and that agency's future plans for meeting such goals.

"(b) Second Report.—Within 120 days after the end of each fiscal year during which such fees are collected, the Secretary of Health and Human Services shall submit a report on the implementation of the authority for such fees during such fiscal year and on the use the Food and Drug Administration made of the fees collected during such fiscal year for which the report is made.

"(c) Committees.—The reports described in subsections (a) and (b) shall be submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate."

Animal Drug User Fee Study

Pub. L. 102–571, title I, §108, Oct. 29, 1992, 106 Stat. 4500, directed Secretary, in consultation with manufacturers of animal drug products and other interested persons, to undertake study to evaluate whether, and under what conditions, to impose user fees to supplement appropriated funds in order to improve process of reviewing applications (including abbreviated and supplemental applications) for new animal drugs under section 360b of this title, and further provided for submission of study to Congress no later than Jan. 4, 1994.

§379h. Authority to assess and use drug fees

(a) Types of fees

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Human drug application fee

(A) In general

Each person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows:

(i) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval.

(ii) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).

(B) Payment

The fee required by subparagraph (A) shall be due upon submission of the application.

(C) Exception for previously filed application

If a human drug application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a human drug application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(D) Refund of fee if application refused for filing or withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any application which is refused for filing or withdrawn without a waiver before filing.

(E) Fees for applications previously refused for filing or withdrawn before filing

A human drug application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).

(F) Exception for designated orphan drug

A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to section 360bb of this title shall not be subject to a fee under subparagraph (A), unless the human drug application includes an indication for other than a rare disease or condition.

(G) Refund of fee if application withdrawn

If an application is withdrawn after the application was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.

(H) Exception for skin-test diagnostic products

A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).

(2) Prescription drug program fee

(A) In general

(i) Payment of fees

Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.

(ii) Special rule for previously discontinued drug products

If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.

(B) Exception for certain prescription drug products

A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 355(j)(7) of this title;

(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under section 355(j)(7) of this title (not including the discontinued section of such list); or

(iii) a skin-test diagnostic product.

(C) Limitation

A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.

(b) Fee revenue amounts

(1) In general

For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—

(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

(C) the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2));

(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));

(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));

(F) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and

(G) additional dollar amounts for each fiscal year as follows:

(i) $65,773,693 for fiscal year 2023.

(ii) $25,097,671 for fiscal year 2024.

(iii) $14,154,169 for fiscal year 2025.

(iv) $4,864,860 for fiscal year 2026.

(v) $1,314,620 for fiscal year 2027.

(2) Types of fees

Of the total revenue amount determined for a fiscal year under paragraph (1)—

(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and

(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2).

(3) Annual base revenue

For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

(A) for fiscal year 2023, $1,151,522,958; and

(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).

(c) Adjustments; annual fee setting

(1) Inflation adjustment

(A) In general

For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and

(ii) the inflation adjustment percentage under subparagraph (B).

(B) Inflation adjustment percentage

The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years; and

(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years.

(2) Strategic hiring and retention adjustment

For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by the following amounts:

(A) For fiscal year 2023, $9,000,000.

(B) For each of fiscal years 2024 through 2027, $4,000,000.

(3) Capacity planning adjustment

(A) In general

For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs (1) and (2), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.

(B) Methodology

For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled "Prescription Drug User Fee Rates for Fiscal Year 2021" published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.

(C) Limitation

Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment for the fiscal year).

(D) Publication in Federal Register

The Secretary shall publish in the Federal Register notice under paragraph (6) of ¹ the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

(4) Operating reserve adjustment

(A) Increase

For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts:

(i) For fiscal year 2023, at least 8 weeks of operating reserves.

(ii) For fiscal year 2024, at least 9 weeks of operating reserves.

(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.

(B) Decrease

If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves.

(C) Notice of rationale

If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (6) establishing fee revenue and fees for the fiscal year involved.

(5) Additional direct cost adjustment

(A) Increase

The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees—

(i) for fiscal year 2023, by $44,386,150; and

(ii) for each of fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv) of subparagraph (B), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021.

(B) Applicable amounts

The amounts referred to in subparagraph (A)(ii) are the following:

(i) For fiscal year 2024, $60,967,993.

(ii) For fiscal year 2025, $35,799,314.

(iii) For fiscal year 2026, $35,799, 314.

(iv) For fiscal year 2027, $35,799,314.

(6) Annual fee setting

The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2022—

(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(B) publish such fee revenue and fees in the Federal Register.

(7) Limit

The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.

(d) Fee waiver or reduction

(1) In general

The Secretary shall grant to a person who is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) where the Secretary finds that—

(A) such waiver or reduction is necessary to protect the public health,

(B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, or

(C) the applicant involved is a small business submitting its first human drug application to the Secretary for review.

(2) Considerations

In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.

(3) Rules relating to small businesses

(A) "Small business" defined

In paragraph (1)(C), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce.

(B) Waiver of application fee

The Secretary shall waive under paragraph (1)(C) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business.

(e) Effect of failure to pay fees

A human drug application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.

(f) Limitations

(1) In general

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 1997 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for human drug applications and prescription drug program fees at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(3) Limitation

Beginning on October 1, 2023, the authorities under section 379g(7)(C) of this title shall include only expenditures for leasing and necessary scientific equipment.

(g) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and

(ii) shall be available—

(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor; and

(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.

(B) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable—

(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and

(II) such costs are not more than 5 percent below the level specified in such subparagraph.

(C) Provision for early payments

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).

(h) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(i) Written requests for waivers, reductions, exemptions, and returns; disputes concerning fees

To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall—

(1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and

(2) include in the request any legal authorities under which the request is made.

(j) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of human drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(k) Orphan drugs

(1) Exemption

A drug designated under section 360bb of this title for a rare disease or condition and approved under section 355 of this title or under section 262 of title 42 shall be exempt from prescription drug program fees under this section, if the drug meets all of the following conditions:

(A) The drug meets the public health requirements contained in this chapter as such requirements are applied to requests for waivers for prescription drug program fees.

(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue as determined under paragraph (2).

(2) Evidence of qualification

An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that the applicant's gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. Such certification shall be supported by—

(A) tax returns submitted to the United States Internal Revenue Service; or

(B) as necessary, other appropriate financial information.

(June 25, 1938, ch. 675, §736, as added Pub. L. 102–571, title I, §103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105–115, title I, §103(a)–(g), Nov. 21, 1997, 111 Stat. 2299–2304; Pub. L. 107–109, §5(a), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107–188, title V, §504, June 12, 2002, 116 Stat. 689; Pub. L. 110–85, title I, §103(a)–(h)(1), Sept. 27, 2007, 121 Stat. 826–832; Pub. L. 112–144, title I, §103, July 9, 2012, 126 Stat. 996; Pub. L. 115–52, title I, §102(a)(1), (b)–(h), title IX, §905(b)(1), Aug. 18, 2017, 131 Stat. 1007–1012, 1090; Pub. L. 117–180, div. F, title I, §1003, Sept. 30, 2022, 136 Stat. 2142; Pub. L. 117–328, div. FF, title III, §3625(a), Dec. 29, 2022, 136 Stat. 5880.)

Termination of Section

For termination of section by section 1005(a) of Pub. L. 117–180, see Termination Date note below.

Editorial Notes

References in Text

Section 357 of this title, referred to in subsec. (a)(2)(B)(iii), was repealed by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (a)(2)(B)(iv), is Pub. L. 98–417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables.

Section 101(b) of the Prescription Drug User Fee Amendments of 2017, referred to in subsec. (c)(2)(B)(ii)(III), is section 101(b) of Pub. L. 115–52, set out as a note under section 379g of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–180, §1003(a)(1)(A), substituted "fiscal year 2023" for "fiscal year 2018" in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 117–180, §1003(a)(1)(B), substituted "(c)(6)" for "(c)(5)" in cls. (i) and (ii).

Subsec. (a)(1)(C). Pub. L. 117–180, §1003(a)(1)(C), inserted "prior to approval" after "or was withdrawn".

Subsec. (a)(1)(H). Pub. L. 117–180, §1003(a)(1)(D), added subpar. (H).

Subsec. (a)(2)(A). Pub. L. 117–180, §1003(a)(2)(A), designated existing provisions as cl. (i) and inserted heading, substituted "subsection (c)(6)" for "subsection (c)(5)", and added cl. (ii).

Subsec. (a)(2)(B). Pub. L. 117–180, §1003(a)(2)(B), amended subpar. (B) generally. Prior to amendment, text read as follows: "A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

"(i) identified on the list compiled under section 355(j)(7) of this title with a potency described in terms of per 100 mL;

"(ii) the same product as another product that—

"(I) was approved under an application filed under section 355(b) or 355(j) of this title; and

"(II) is not in the list of discontinued products compiled under section 355(j)(7) of this title;

"(iii) the same product as another product that was approved under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997); or

"(iv) the same product as another product that was approved under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984."

Subsec. (b)(1). Pub. L. 117–180, §1003(b)(1), amended par. (1) generally. Prior to amendment, par. (1) related to fees for fiscal years 2018 through 2022.

Subsec. (b)(3). Pub. L. 117–180, §1003(b)(2), amended par. (3) generally. Prior to amendment, par. (3) related to annual base revenue for fiscal years 2018 through 2022.

Subsec. (c)(1)(B)(ii). Pub. L. 117–180, §1003(c)(1), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV".

Subsec. (c)(2). Pub. L. 117–180, §1003(c)(2)(B), added par. (2). Former par. (2) redesignated (3).

Subsec. (c)(3). Pub. L. 117–180, §1003(c)(2)(A), (3), redesignated par. (2) as (3) and amended it generally. Prior to amendment, par. related to establishment of a capacity planning methodology and interim methodology. Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 117–180, §1003(c)(2)(A), redesignated par. (3) as (4). Former par. (4) redesignated (5).

Subsec. (c)(4)(A). Pub. L. 117–180, §1003(c)(4)(A), amended subpar. (A) generally. Prior to amendment, text read as follows: "For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications."

Subsec. (c)(4)(C). Pub. L. 117–180, §1003(c)(4)(B), substituted "paragraph (6)" for "paragraph (5)".

Subsec. (c)(5). Pub. L. 117–180, §1003(c)(2)(A), (5), redesignated par. (4) as (5) and amended it generally. Prior to amendment, par. related to additional direct cost adjustment for fiscal years 2018, 2019, and subsequent fiscal years. Former par. (5) redesignated (6).

Subsec. (c)(6). Pub. L. 117–180, §1003(c)(2)(A), (6), redesignated par. (5) as (6) and substituted "September 30, 2022" for "September 30, 2017" in introductory provisions. Former par. (6) redesignated (7).

Subsec. (c)(7). Pub. L. 117–180, §1003(c)(2)(A), redesignated par. (6) as (7).

Subsec. (g)(2)(A)(ii). Pub. L. 117–328, §3625(a)(1), substituted "shall be available—" for "shall be available to defray", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023, to defray" before "increases in the costs", and added subcl. (II).

Subsec. (g)(2)(B). Pub. L. 117–328, §3625(a)(2), substituted "as described in subclause (I) or (II) of such subparagraph, as applicable" for "for the process for the review of human drug applications" in introductory provisions.

Subsec. (g)(3). Pub. L. 117–180, §1003(d), substituted "fiscal years 2023 through 2027" for "fiscal years 2018 through 2022".

Subsec. (i). Pub. L. 117–180, §1003(e), amended subsec. (i) generally. Prior to amendment, text read as follows: "To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due."

Subsec. (k)(1)(B). Pub. L. 117–180, §1003(f)(1), substituted "as determined under paragraph (2)" for "during the previous year".

Subsec. (k)(2). Pub. L. 117–180, §1003(f)(2), amended par. (2) generally. Prior to amendment, text read as follows: "An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested."

2017—Subsec. (a). Pub. L. 115–52, §102(a)(1)(A), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.

Subsec. (a)(1). Pub. L. 115–52, §102(a)(1)(B), (C), struck out "and supplement" before "fee" in heading and struck out "or a supplement" and "or supplement" wherever appearing in text.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, §102(a)(1)(D)(i), substituted "(c)(5)" for "(c)(4)".

Subsec. (a)(1)(A)(ii). Pub. L. 115–52, §102(a)(1)(C), (D)(ii), substituted "A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval." for "A fee established under subsection (c)(4) for a human drug application for which clinical data with respect to safety or effectiveness are not required for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required."

Subsec. (a)(1)(C). Pub. L. 115–52, §102(a)(1)(E), struck out "or supplement" after "application" in heading.

Subsec. (a)(1)(F). Pub. L. 115–52, §102(a)(1)(F), struck out "or indication" after "drug" in heading and "A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designated pursuant to section 360bb of this title as a drug for a rare disease or condition with regard to the indication proposed in such supplement." in text.

Subsec. (a)(2). Pub. L. 115–52, §102(a)(1)(G)–(I), redesignated par. (3) as (2), substituted "Prescription drug program fee" for "Prescription drug product fee" in heading, and struck out former par. (2) which related to prescription drug establishment fee.

Subsec. (a)(2)(A). Pub. L. 115–52, §102(a)(1)(J), substituted "Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year." for "Except as provided in subparagraph (B), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay for each such prescription drug product the annual fee established under subsection (c)(4)."

Subsec. (a)(2)(B). Pub. L. 115–52, §102(a)(1)(K), inserted "for certain prescription drug products" after "Exception" in heading and substituted "A prescription drug program fee shall not be assessed for a prescription drug product" for "A prescription drug product shall not be assessed a fee" in introductory provisions.

Subsec. (a)(2)(C). Pub. L. 115–52, §102(a)(1)(L), added subpar. (C).

Subsec. (a)(3). Pub. L. 115–52, §102(a)(1)(H), redesignated par. (3) as (2).

Subsec. (b). Pub. L. 115–52, §102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee revenue amounts for fiscal years 2013 through 2017.

Subsec. (c). Pub. L. 115–52, §102(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to adjustment of revenues for inflation and changes in workload, final year adjustment, setting of annual fee, and limit on total amount of fees charged.

Subsec. (d)(1)(C), (D). Pub. L. 115–52, §102(d)(1), redesignated subpar. (D) as (C) and struck out former subpar. (C) which read as follows: "the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of human drug applications for such person, or".

Subsec. (d)(3). Pub. L. 115–52, §102(d)(2), (3), redesignated par. (4) as (3) and struck out former par. (3). Text read as follows: "In making the finding in paragraph (1)(C), the Secretary may use standard costs."

Subsec. (d)(3)(A). Pub. L. 115–52, §102(d)(4)(A), substituted "paragraph (1)(C)" for "paragraph (1)(D)".

Subsec. (d)(3)(B). Pub. L. 115–52, §102(d)(4), substituted "paragraph (1)(C)" for "paragraph (1)(D)", struck out cl. (i) designation before "application fees", substituted a period for "; and" after "qualify as a small business", and struck out cl. (ii), which read as follows: "all supplement fees for all supplements to human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business."

Subsec. (d)(4). Pub. L. 115–52, §102(d)(3), redesignated par. (4) as (3).

Subsec. (e). Pub. L. 115–52, §102(e), substituted "all such fees" for "all fees".

Subsec. (f)(2). Pub. L. 115–52, §102(f), substituted "prescription drug program fees" for "supplements, prescription drug establishments, and prescription drug products".

Subsec. (f)(3). Pub. L. 115–52, §905(b)(1), added par. (3).

Subsec. (g)(3). Pub. L. 115–52, §102(g)(1), substituted "2018 through 2022" for "2013 through 2017" and struck out "and paragraph (4) of this subsection" after "subsection (c)".

Subsec. (g)(4). Pub. L. 115–52, §102(g)(2), struck out par. (4). Prior to amendment, text read as follows: "If the sum of the cumulative amount of fees collected under this section for the fiscal years 2013 through 2015 and the amount of fees estimated to be collected under this section for fiscal year 2016 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2013 through 2016, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017."

Subsec. (k)(1). Pub. L. 115–52, §102(h), substituted "prescription drug program fees" for "product and establishment fees" in two places.

2012—Subsec. (a). Pub. L. 112–144, §103(1)(A), substituted "fiscal year 2013" for "fiscal year 2008" in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 112–144, §103(1)(B), substituted "(c)(4)" for "(c)(5)" in cls. (i) and (ii).

Subsec. (a)(2)(A). Pub. L. 112–144, §103(1)(C), substituted "(c)(4)" for "(c)(5)" and "due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section" for "payable on or before October 1 of each year" in concluding provisions.

Subsec. (a)(3)(A). Pub. L. 112–144, §103(1)(D)(i), substituted "subsection (c)(4)" for "subsection (c)(5)" and "due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section." for "payable on or before October 1 of each year."

Subsec. (a)(3)(B). Pub. L. 112–144, §103(1)(D)(ii), amended subpar. (B) generally. Prior to amendment, text read as follows: "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 355(b) or 355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984."

Subsec. (b)(1). Pub. L. 112–144, §103(2)(A)(i), substituted "fiscal years 2013 through 2017" for "fiscal years 2008 through 2012" in introductory provisions.

Subsec. (b)(1)(A). Pub. L. 112–144, §103(2)(A)(ii), substituted "$693,099,000;" for "$392,783,000; and".

Subsec. (b)(1)(B), (C). Pub. L. 112–144, §103(2)(A)(iii), added subpars. (B) and (C) and struck out former subpar. (B) which read as follows: "an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3))."

Subsec. (b)(3), (4). Pub. L. 112–144, §103(2)(B), added par. (3) and struck out former pars. (3) and (4) which related to the modified workload adjustment factor for fiscal year 2007 and additional fee revenues for drug safety for fiscal years 2008 through 2012, respectively.

Subsec. (c). Pub. L. 112–144, §103(3), added subsec. (c) and struck out former subsec. (c) which related to inflation adjustment for fiscal year 2009 and subsequent fiscal years, workload adjustment for fiscal year 2009 and subsequent fiscal years, rent and rent-related cost adjustment for fiscal year 2010 and each subsequent fiscal year, final year adjustment for fiscal year 2012, annual fee setting for each fiscal year that began after Sept. 30, 2007, and the limit on the total amount of fees charged for a fiscal year.

Subsec. (g)(1). Pub. L. 112–144, §103(4)(A), substituted "Subject to paragraph (2)(C), fees authorized" for "Fees authorized".

Subsec. (g)(2)(A)(i). Pub. L. 112–144, §103(4)(B)(i), substituted "subject to subparagraph (C), shall be collected and available" for "shall be retained".

Subsec. (g)(2)(A)(ii). Pub. L. 112–144, §103(4)(B)(ii), substituted "shall be available" for "shall only be collected and available".

Subsec. (g)(2)(C). Pub. L. 112–144, §103(4)(B)(iii), added subpar. (C).

Subsec. (g)(3). Pub. L. 112–144, §103(4)(C), substituted "fiscal years 2013 through 2017" for "fiscal years 2008 through 2012".

Subsec. (g)(4). Pub. L. 112–144, §103(4)(D), substituted "fiscal years 2013 through 2015" for "fiscal years 2008 through 2010", "fiscal year 2016" for "fiscal year 2011", "fiscal years 2013 through 2016" for "fiscal years 2008 through 2011", and "fiscal year 2017" for "fiscal year 2012".

2007—Subsec. (a). Pub. L. 110–85, §103(a)(1), substituted "2008" for "2003" in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 110–85, §103(g), substituted "(c)(5)" for "(c)(4)" in cls. (i) and (ii).

Subsec. (a)(1)(D). Pub. L. 110–85, §103(a)(2)(A), inserted "or withdrawn before filing" after "refused for filing" in heading and "or withdrawn without a waiver before filing" before period at end of text.

Subsec. (a)(1)(E) to (G). Pub. L. 110–85, §103(a)(2)(B), (C), added subpar. (E) and redesignated former subpars. (E) and (F) as (F) and (G), respectively.

Subsec. (a)(2)(A). Pub. L. 110–85, §103(a)(3)(A), (g), substituted "subparagraphs (B) and (C)" for "subparagraph (B)" in introductory provisions and "(c)(5)" for "(c)(4)" in concluding provisions.

Subsec. (a)(2)(C). Pub. L. 110–85, §103(a)(3)(B), added subpar. (C).

Subsec. (a)(3)(A). Pub. L. 110–85, §103(g), substituted "(c)(5)" for "(c)(4)".

Subsec. (b). Pub. L. 110–85, §103(b), amended subsec. (b) generally, substituting provisions contained in pars. (1) to (4) relating to fee revenue amounts for fiscal years 2008 through 2012 for undesignated provisions relating to fee schedules for fiscal years 2003 to 2007.

Subsec. (c)(1). Pub. L. 110–85, §103(c)(1), amended par. (1) by substituting "For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)" for "The revenues established in subsection (b)" in introductory provisions, adding subpar. (C), and substituting "fiscal year 2008" for "fiscal year 2003" in concluding provisions.

Subsec. (c)(2). Pub. L. 110–85, §103(c)(2)(A), substituted "For fiscal year 2009 and subsequent fiscal years," for "Beginning with fiscal year 2004," in introductory provisions.

Subsec. (c)(2)(A). Pub. L. 110–85, §103(c)(2)(B), substituted "human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available." for "human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary." in first sentence.

Subsec. (c)(2)(B). Pub. L. 110–85, §103(c)(2)(C), inserted at end "Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities."

Subsec. (c)(2)(C). Pub. L. 110–85, §103(c)(2)(D), added subpar. (C).

Subsec. (c)(3). Pub. L. 110–85, §103(c)(3), added par. (3). Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 110–85, §103(c)(3)(A), (4), redesignated par. (3) as (4) and amended it generally. Prior to amendment, text read as follows: "For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) of this section if such an adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of human drug applications for the first three months of fiscal year 2008. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made." Former par. (4) redesignated (5).

Subsec. (c)(5). Pub. L. 110–85, §103(c)(3)(A), (5), redesignated par. (4) as (5) and substituted "2007" for "2002". Former par. (5) redesignated (6).

Subsec. (c)(6). Pub. L. 110–85, §103(c)(3)(A), redesignated par. (5) as (6).

Subsec. (d)(1). Pub. L. 110–85, §103(d)(1), inserted "to a person who is named as the applicant in a human drug application" after "The Secretary shall grant" and "to that person" after "one or more fees assessed" in introductory provisions.

Subsec. (d)(2), (3). Pub. L. 110–85, §103(d)(2), (3), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4).

Subsec. (d)(4). Pub. L. 110–85, §103(d)(2), redesignated par. (3) as (4).

Subsec. (d)(4)(A). Pub. L. 110–85, §103(d)(4), inserted before period at end ", and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce".

Subsec. (g)(1). Pub. L. 110–85, §103(h)(1), substituted "Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended." for "Fees collected for a fiscal year pursuant to subsection (a) of this section shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriation Acts until expended without fiscal year limitation."

Subsec. (g)(3). Pub. L. 110–85, §103(e)(1), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2003 to 2007.

Subsec. (g)(4). Pub. L. 110–85, §103(e)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."

Subsec. (k). Pub. L. 110–85, §103(f), added subsec. (k).

2002—Subsec. (a). Pub. L. 107–188, §504(a)(1), substituted "fiscal year 2003" for "fiscal year 1998" in introductory provisions.

Subsec. (a)(1)(A)(i). Pub. L. 107–188, §504(a)(2)(A), substituted "under subsection (c)(4)" for "in subsection (b)".

Subsec. (a)(1)(A)(ii). Pub. L. 107–188, §504(a)(2), substituted "under subsection (c)(4)" for "in subsection (b)" and inserted "Such fee shall be half of the amount of the fee established under clause (i)." at end.

Subsec. (a)(1)(F), (G). Pub. L. 107–109 redesignated subpar. (G) as (F) and struck out heading and text of former subpar. (F). Text read as follows: "A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A)."

Subsec. (a)(2)(A). Pub. L. 107–188, §504(a)(3), in concluding provisions, substituted "under subsection (c)(4)" for "in subsection (b)" and "payable on or before October 1" for "payable on or before January 31".

Subsec. (a)(3)(A). Pub. L. 107–188, §504(a)(4)(A), amended heading and text of subpar. (A) generally. Prior to amendment, text read as follows: "Except as provided in subparagraph (B), each person—

"(i) who is named as the applicant in a human drug application for a prescription drug product which has been submitted for listing under section 360 of this title, and

"(ii) who, after September 1, 1992, had pending before the Secretary a human drug application or supplement,

shall pay for each such prescription drug product the annual fee established in subsection (b) of this section. Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable."

Subsec. (a)(3)(B). Pub. L. 107–188, §504(a)(4)(B), substituted "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 355(b)" for "The listing of a prescription drug product under section 360 of this title shall not require the person who listed such product to pay the fee prescribed by subparagraph (A) if such product is the same product as a product approved under an application filed under section 355(b)(2)".

Subsec. (b). Pub. L. 107–188, §504(b), amended heading and text of subsec. (b) generally, substituting "Fee revenue amounts" for "Fee amounts" in heading and substituting fee schedules for fiscal years 2003 to 2007 for fee provisions relating to fiscal years 1998 to 2002.

Subsec. (c)(1). Pub. L. 107–188, §504(c)(1)(A), (D), substituted "revenues" for "fees and total fee revenues" in introductory provisions and "fiscal year 2003" for "fiscal year 1997" in concluding provisions.

Subsec. (c)(1)(A). Pub. L. 107–188, §504(c)(1)(B), struck out "during the preceding fiscal year" before "in the Consumer Price Index" and substituted "for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or" for ", or".

Subsec. (c)(1)(B). Pub. L. 107–188, §504(c)(1)(C), substituted "for the previous fiscal year" for "for such fiscal year".

Subsec. (c)(2) to (5). Pub. L. 107–188, §504(c)(2)–(4), added pars. (2) and (3), redesignated former pars. (2) and (3) as (4) and (5), respectively, and amended heading and text of par. (4) generally. Prior to amendment, text of par. (4) read as follows: "Subject to the amount appropriated for a fiscal year under subsection (g) of this section, the Secretary shall, within 60 days after the end of each fiscal year beginning after September 30, 1997, adjust the establishment and product fees described in subsection (b) of this section for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) of this section shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b) of this section."

Subsec. (d)(1)(C) to (E). Pub. L. 107–188, §504(d)(1), inserted "or" at end of subpar. (C), redesignated subpar. (E) as (D), and struck out former subpar. (D) which read as follows: "assessment of the fee for an application or a supplement filed under section 355(b)(1) of this title pertaining to a drug containing an active ingredient would be inequitable because an application for a product containing the same active ingredient filed by another person under section 355(b)(2) of this title could not be assessed fees under subsection (a)(1) of this section, or".

Subsec. (d)(3)(A), (B). Pub. L. 107–188, §504(d)(2), substituted "paragraph (1)(D)" for "paragraph (1)(E)".

Subsec. (f). Pub. L. 107–188, §504(e)(1), substituted "Limitations" for "Assessment of fees" in heading.

Subsec. (f)(1). Pub. L. 107–188, §504(e)(2), substituted "In general" for "Limitation" in heading and "Fees under subsection (a) shall be refunded for a fiscal year beginning" for "Fees may not be assessed under subsection (a) for a fiscal year beginning" in text.

Subsec. (g)(1). Pub. L. 107–188, §504(f)(1), which directed the amendment of par. (1) by striking "Fees collected for a fiscal year" and all that follows through "fiscal year limitation." and inserting "Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.", was not executed because the phrase "fiscal year limitation." appeared in two places and because of the corrective amendment by Pub. L. 110–85, §103(h)(1), which is effective as if included in Pub. L. 107–188, §504. See 2007 Amendment note above and Effective Date of 2007 Amendment note below.

Subsec. (g)(2). Pub. L. 107–188, §504(f)(2), amended par. (2) by designating existing provisions as subpar. (A), inserting subpar. (A) heading, adding subpar. (B), redesignating former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), substituting "shall be retained in each fiscal year in an amount not to exceed the amount specified" for "shall be collected in each fiscal year in an amount equal to the amount specified" in cl. (i), and realigning margin of cl. (ii).

Subsec. (g)(3)(A) to (E). Pub. L. 107–188, §504(f)(3), added subpars. (A) to (E) and struck out former subpars. (A) to (E) which read as follows:

"(A) $106,800,000 for fiscal year 1998;

"(B) $109,200,000 for fiscal year 1999;

"(C) $109,200,000 for fiscal year 2000;

"(D) $114,000,000 for fiscal year 2001; and

"(E) $110,100,000 for fiscal year 2002,".

1997—Subsec. (a). Pub. L. 105–115, §103(a)(1), substituted "Beginning in fiscal year 1998" for "Beginning in fiscal year 1993" in introductory provisions.

Subsec. (a)(1)(B). Pub. L. 105–115, §103(a)(2)(A), amended heading and text of subpar. (B) generally. Prior to amendment, text read as follows:

"(i) First payment.—50 percent of the fee required by subparagraph (A) shall be due upon submission of the application or supplement.

"(ii) Final payment.—The remaining 50 percent of the fee required by subparagraph (A) shall be due upon—

"(I) the expiration of 30 days from the date the Secretary sends to the applicant a letter designated by the Secretary as an action letter described in section 379g(6)(B) of this title, or

"(II) the withdrawal of the application or supplement after it is filed unless the Secretary waives the fee or a portion of the fee because no substantial work was performed on such application or supplement after it was filed.

The designation under subclause (I) or the waiver under subclause (II) shall be solely in the discretion of the Secretary and shall not be reviewable."

Subsec. (a)(1)(D). Pub. L. 105–115, §103(a)(2)(B), substituted "refused" for "not accepted" in heading and "75 percent" for "50 percent", "subparagraph (B)" for "subparagraph (B)(i)", and "refused" for "not accepted" in text.

Subsec. (a)(1)(E) to (G). Pub. L. 105–115, §103(a)(2)(C), added subpars. (E) to (G).

Subsec. (a)(2). Pub. L. 105–115, §103(a)(3), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Each person that—

"(A) owns a prescription drug establishment, at which is manufactured at least 1 prescription drug product which is not the, or not the same as a, product approved under an application filed under section 355(b)(2) or 355(j) of this title, and

"(B) after September 1, 1992, had pending before the Secretary a human drug application or supplement,

shall be subject to the annual fee established in subsection (b) of this section for each such establishment, payable on or before January 31 of each year."

Subsec. (a)(3)(A). Pub. L. 105–115, §103(a)(4)(A), substituted, in cl. (i), "has been submitted for listing" for "is listed" and, in closing provisions, "Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable." for "Such fee shall be payable at the time of the first such listing of such product in each calendar year. Such fee shall be paid only once each year for each listed prescription drug product irrespective of the number of times such product is listed under section 360 of this title."

Subsec. (a)(3)(B). Pub. L. 105–115, §103(a)(4)(B), substituted "355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984." for "355(j) of this title.".

Subsec. (b). Pub. L. 105–115, §103(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts, including a schedule of fees in par. (1) and fee exceptions for certain small businesses in par. (2).

Subsec. (c). Pub. L. 105–115, §103(c)(1), substituted "Adjustments" for "Increases and adjustments" in heading.

Subsec. (c)(1). Pub. L. 105–115, §103(c)(2), substituted "Inflation adjustment" for "Revenue increase" in heading, "The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary" for "The total fee revenues established by the schedule in subsection (b)(1) shall be increased by the Secretary" in introductory provisions, and "change" for "increase" after "total percentage" in subpars. (A) and (B), and inserted at end "The adjustment made each fiscal year by this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 1997 under this subsection."

Subsec. (c)(2). Pub. L. 105–115, §103(c)(3), substituted "September 30, 1997, adjust the establishment and product fees described in subsection (b) for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b)." for "October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) for the following fiscal year to achieve the total fee revenues, as may be increased under paragraph (1). Such fees shall be adjusted under this paragraph to maintain the proportions established in such schedule."

Subsec. (c)(3). Pub. L. 105–115, §103(c)(4), substituted "this subsection" for "paragraph (2)".

Subsec. (d). Pub. L. 105–115, §103(d), struck out introductory provisions which read "The Secretary shall grant a waiver from or a reduction of 1 or more fees under subsection (a) of this section where the Secretary finds that—" and closing provisions which read "In making the finding in paragraph (3), the Secretary may use standard costs.", inserted designation, heading, and introductory provisions of par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, of par. (1), and added pars. (1)(E), (2), and (3).

Subsec. (f)(1). Pub. L. 105–115, §103(e), substituted "fiscal year 1997" for "fiscal year 1993" and "fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)" for "fiscal year 1992".

Subsec. (g)(1). Pub. L. 105–115, §103(f)(1), inserted at end "Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications."

Subsec. (g)(2)(A). Pub. L. 105–115, §103(f)(2)(A), substituted "Acts, or otherwise made available for obligation," for "Acts".

Subsec. (g)(2)(B). Pub. L. 105–115, §103(f)(2)(B), substituted "over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997" for "over such costs for fiscal year 1992".

Subsec. (g)(3), (4). Pub. L. 105–115, §103(f)(3), added pars. (3) and (4) and struck out heading and text of former par. (3). Text read as follows: "There are authorized to be appropriated for fees under this section—

"(A) $36,000,000 for fiscal year 1993,

"(B) $54,000,000 for fiscal year 1994,

"(C) $75,000,000 for fiscal year 1995,

"(D) $78,000,000 for fiscal year 1996, and

"(E) $84,000,000 for fiscal year 1997,

as adjusted to reflect increases in the total fee revenues made under subsection (c)(1) of this section."

Subsecs. (i), (j). Pub. L. 105–115, §103(g), added subsec. (i) and redesignated former subsec. (i) as (j).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

Effective Date of 2017 Amendment

Amendment by section 102 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2012, see section 106 of Pub. L. 112–144, set out as a note under section 379g of this title.

Effective Date of 2007 Amendment

Pub. L. 110–85, title I, §103(h)(2), Sept. 27, 2007, 121 Stat. 832, provided that: "Paragraph (1) [amending this section] shall take effect as if included in section 504 of the Prescription Drug User Fee Amendments of 2002 (Public Law 107–188; 116 Stat. 687) [amending this section]."

Amendment by Pub. L. 110–85 effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.

Effective Date of 2002 Amendment

Amendment by Pub. L. 107–188 effective Oct. 1, 2002, see section 508 of Pub. L. 107–188, set out as a note under section 356b of this title.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective Oct. 1, 1997, see section 106 of Pub. L. 105–115, set out as an Effective and Termination Dates of 1997 Amendment note under section 379g of this title.

Termination Date

Section ceases to be effective Oct. 1, 2027, see section 1005(a) of Pub. L. 117–180, set out as a note under section 379g of this title.

Special Rule for Waivers and Refunds

Pub. L. 105–115, title I, §103(h), Nov. 21, 1997, 111 Stat. 2304, provided that: "Any requests for waivers or refunds for fees assessed under section 736 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the date of enactment of this Act [Nov. 21, 1997] shall be submitted in writing to the Secretary of Health and Human Services within 1 year after the date of enactment of this Act. Any requests for waivers or refunds pertaining to a fee for a human drug application or supplement accepted for filing prior to October 1, 1997 or to a product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998, shall be evaluated according to the terms of the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title] (as in effect on September 30, 1997) and part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.] (as in effect on September 30, 1997). The term 'person' in such Acts shall continue to include an affiliate thereof."

¹ So in original. The word "of" probably should not appear. See sections 379j–42(c)(2)(D) and 379j–52(c)(3)(D) of this title.

§379h–1. Fees relating to advisory review of prescription-drug television advertising

(a) Types of direct-to-consumer television advertisement review fees

Beginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Advisory review fee

(A) In general

With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a "DTC advertisement"), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3).

(B) Exception for required submissions

A DTC advertisement that is required to be submitted to the Secretary prior to initial public dissemination is not subject to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for advisory review.

(C) Notice to Secretary of number of advertisements

Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of DTC advertisements the person intends to submit for advisory review in the next fiscal year. Notwithstanding the preceding sentence, for fiscal year 2008, the Secretary shall publish such a notice in the Federal Register not later than 30 days after September 27, 2007.

(D) Payment

(i) In general

The fee required by subparagraph (A) (referred to in this section as "an advisory review fee") shall be due not later than October 1 of the fiscal year in which the DTC advertisement involved is intended to be submitted for advisory review, subject to subparagraph (F)(i). Notwithstanding the preceding sentence, the advisory review fee for any DTC advertisement that is intended to be submitted for advisory review during fiscal year 2008 shall be due not later than 120 days after September 27, 2007, or an earlier date as specified by the Secretary.

(ii) Effect of submission

Notification of the Secretary under subparagraph (C) of the number of DTC advertisements a person intends to submit for advisory review is a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted. Notwithstanding the preceding sentence, the commitment shall be a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions for fiscal year 2008 by the date specified in clause (i).

(iii) Notice regarding carryover submissions

In making a notification under subparagraph (C), the person involved shall in addition notify the Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertisement submitted by the person for advisory review in the fiscal year involved shall be subject to the advisory review fee.

(E) Modification of advisory review fee

(i) Late payment

If a person has submitted a notification under subparagraph (C) with respect to a fiscal year and has not paid all advisory review fees due under subparagraph (D) not later than November 1 of such fiscal year (or, in the case of such a notification submitted with respect to fiscal year 2008, not later than 150 days after September 27, 2007, or an earlier date specified by the Secretary), the fees shall be regarded as late and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, all advisory review fees for such fiscal year shall be due and payable 20 days before any direct-to-consumer advertisement is submitted to the Secretary for advisory review, and each such fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).

(ii) Exceeding identified number of submissions

If a person submits a number of DTC advertisements for advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (C), an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC advertisement, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the Secretary, and the fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).

(F) Limits

(i) Submissions

For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over not more than one paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.

(ii) No refunds

Except as provided by subsections (d)(4) and (f), fees paid under this section shall not be refunded.

(iii) No waivers, exemptions, or reductions

The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.

(iv) Right to advisory review not transferable

The right to an advisory review under this paragraph is not transferable, except to a successor in interest.

(2) Operating reserve fee

(A) In general

Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to fee ¹ established under subsection (d)(2) (referred to in this section as an "operating reserve fee") for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year.

(B) Payment

Except as provided in subparagraph (C), the operating reserve fee shall be due no later than—

(i) October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1); or

(ii) for fiscal year 2008, 120 days after September 27, 2007, or an earlier date specified by the Secretary.

(C) Late notice of submission

If, in the first fiscal year of a person's participation in the program under this section, that person submits any DTC advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(E)(ii). Fees required by this subparagraph shall be in addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.

(D) Late payment

(i) In general

Notwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee shall be regarded as late if the person required to pay the fee has not paid the complete operating reserve fee by—

(I) for fiscal year 2008, 150 days after September 27, 2007, or an earlier date specified by the Secretary; or

(II) in any subsequent year, November 1.

(ii) Complete payment

The complete operating reserve fee shall be due and payable 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.

(iii) Amount

Notwithstanding any other provision of this section, an operating reserve fee that is regarded as late under this subparagraph shall be equal to 150 percent of the operating reserve fee that otherwise would have applied pursuant to subsection (d).

(b) Advisory review fee revenue amounts

Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsections (c) and (g)(4).

(c) Adjustments

(1) Inflation adjustment

Beginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of—

(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;

(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; or

(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 fiscal years of the previous 6 fiscal years.

The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.

(2) Workload adjustment

Beginning with fiscal year 2009, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with respect to the submission of DTC advertisements for advisory review prior to initial dissemination. With respect to such adjustment:

(A) The adjustment shall be determined by the Secretary based upon the number of DTC advertisements identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid carry over submissions. The adjustment shall be determined by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with paragraph (1)). The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.

(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.

(3) Annual fee setting for advisory review

(A) In general

Not later than August 1 of each fiscal year (or, with respect to fiscal year 2008, not later than 90 days after September 27, 2007), the Secretary shall establish for the next fiscal year the DTC advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under paragraphs (1) and (2), and the number of DTC advertisements identified pursuant to subsection (a)(1)(C), excluding allowable previously-paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of DTC advertisements so identified, excluding allowable previously-paid carry over submissions under subsection (a)(1)(F)(i).

(B) Fiscal year 2008 fee limit

Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.

(C) Annual fee limit

Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.

(D) Limit

The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of prescription drug advertising.

(d) Operating reserves

(1) In general

The Secretary shall establish in the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the program under this section in the event the fees collected in any subsequent fiscal year pursuant to subsection (a)(1) do not generate the fee revenue amount established for that fiscal year.

(2) Fee setting

The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of DTC advertisements identified by that person pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year, except that in no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated in the program under this section in fiscal year 2008.

(3) Use of operating reserve

The Secretary may use funds from the reserves only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsections (b) and (c) and the amount of fees actually collected for that fiscal year pursuant to subsection (a)(1), or to pay costs of ending the program under this section if it is terminated pursuant to subsection (f) or not reauthorized beyond fiscal year 2012.

(4) Refund of operating reserves

Within 120 days after the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the program under this section, shall refund all amounts remaining in the operating reserve on a pro rata basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).

(e) Effect of failure to pay fees

Notwithstanding any other requirement, a submission for advisory review of a DTC advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.

(f) Effect of inadequate funding of program

(1) Initial funding

If on November 1, 2007, or 120 days after September 27, 2007, whichever is later, the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded.

(2) Later fiscal years

Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section shall terminate, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the program, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year.

(g) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section—

(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and

(ii) shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of full-time equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007.

(B) Review employees

For purposes of subparagraph (A)(ii), the term "full-time equivalent review employees" means the total combined number of full-time equivalent employees in—

(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and

(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration.

(3) Authorization of appropriations

For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, plus amounts collected for the reserve fund under subsection (d).

(4) Offset

Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.

(h) Definitions

For purposes of this section:

(1) The term "advisory review" means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this chapter prior to its initial public dissemination.

(2) The term "advisory review fee" has the meaning indicated for such term in subsection (a)(1)(D).

(3) The term "carry over submission" means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.

(4) The term "direct-to-consumer television advertisement" means an advertisement for a prescription drug product (as defined in section 379g(3) of this title) intended to be displayed on any television channel for less than 3 minutes.

(5) The term "DTC advertisement" has the meaning indicated for such term in subsection (a)(1)(A).

(6) The term "operating reserve fee" has the meaning indicated for such term in subsection (a)(2)(A).

(7) The term "person" includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest.

(8) The term "process for the advisory review of prescription drug advertising" means the activities necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.

(9) The term "resources allocated for the process for the advisory review of prescription drug advertising" means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, and to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;

(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; and

(E) terminating the program under this section pursuant to subsection (f)(2) if that becomes necessary.

(10) The term "resubmission" means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary's comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.

(11) The term "submission for advisory review" means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.

(June 25, 1938, ch. 675, §736A, as added Pub. L. 110–85, title I, §104, Sept. 27, 2007, 121 Stat. 832.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.

¹ So in original. Probably should be "the fee".

§379h–2. Reauthorization; reporting requirements

(a) Performance report

(1) In general

Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning—

(A) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, including the status of the independent assessment described in such letters; and

(B) the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving the goals, and future plans for meeting the goals, including, for each review division—

(i) the number of original standard new drug applications and biologics license applications filed per fiscal year for each review division;

(ii) the number of original priority new drug applications and biologics license applications filed per fiscal year for each review division;

(iii) the number of standard efficacy supplements filed per fiscal year for each review division;

(iv) the number of priority efficacy supplements filed per fiscal year for each review division;

(v) the number of applications filed for review under accelerated approval per fiscal year for each review division;

(vi) the number of applications filed for review as fast track products per fiscal year for each review division;

(vii) the number of applications filed for orphan-designated products per fiscal year for each review division;

(viii) the number of breakthrough designations for a fiscal year for each review division; and

(ix) the number of investigational new drug applications submitted per fiscal year, including for each review division.

Nothing in subparagraph (B) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5.

(2) Inclusion

The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.

(3) Real time reporting

(A) In general

Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual performance report under this subsection.

(B) Data

The Secretary shall post the following data in accordance with subparagraph (A):

(i) The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022.

(ii) The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022.

(iii) The number of new drug applications and biological licensing applications approved.

(iv) The number of new drug applications and biological licensing applications filed.

(v) For fiscal years 2023 and 2024, of the meeting requests from sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall prescribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary, with both such numbers disaggregated by the relevant agency center.

(4) Rationale for PDUFA program changes

The Secretary shall include in the annual report under paragraph (1)—

(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 1001(b) of the Prescription Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379h of this title, and the number of full-time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying—

(i) drivers of such changes; and

(ii) changes in the average total cost per full-time equivalent in the prescription drug review program;

(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and

(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application.

(5) Analysis

For each fiscal year, the Secretary shall include in the report under paragraph (1) an analysis of the following:

(A) The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—

(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;

(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.

(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance enhancement goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.

(C) The most common causes and trends of external or other circumstances affecting the ability of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and the Food and Drug Administration to meet the review time and performance enhancement goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022.

(b) Fiscal report

Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c) Corrective action report

For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(1) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the human drug application review process.

(2) Goals missed

For any of the goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and

(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.

(d) Enhanced communication

(1) Communications with Congress

Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

(2) Participation in congressional hearing

Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.

(e) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(C) scientific and academic experts;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Updates to Congress

The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this subpart to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(5) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(7) Minutes of negotiation meetings

(A) Public availability

The Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.

(B) Content

The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §736B, as added Pub. L. 110–85, title I, §105, Sept. 27, 2007, 121 Stat. 840; amended Pub. L. 112–144, title I, §104, July 9, 2012, 126 Stat. 1000; Pub. L. 115–52, title I, §103, title IX, §§903(a), 904(a), Aug. 18, 2017, 131 Stat. 1012, 1077, 1082; Pub. L. 117–180, div. F, title I, §1004, Sept. 30, 2022, 136 Stat. 2146; Pub. L. 117–328, div. FF, title III, §3626(a), Dec. 29, 2022, 136 Stat. 5883.)

Termination of Section

For termination of section by section 1005(b) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 1001(b) of the Prescription Drug User Fee Amendments of 2022, title I of div. F of Pub. L. 117–180, which is set out as a note under section 379g of this title. The Prescription Drug User Fee Amendments of 2022 does not contain a section 101(b).

Section 1001(b) of the Prescription Drug User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 1001(b) of title I of div. F of Pub. L. 117–180, which is set out as a note under section 379g of this title.

Amendments

2022—Pub. L. 117–180, §1004(2), substituted "Prescription Drug User Fee Amendments of 2022" for "Prescription Drug User Fee Amendments of 2017" wherever appearing.

Subsec. (a)(1). Pub. L. 117–328, §3626(a)(1)(A)(ii), inserted concluding provisions.

Pub. L. 117–180, §1004(1), substituted "Not" for "Beginning with fiscal year 2018, not" in introductory provisions.

Subsec. (a)(1)(B)(ix). Pub. L. 117–328, §3626(a)(1)(A)(i), added cl. (ix).

Subsec. (a)(3)(A). Pub. L. 117–180, §1004(3), substituted "Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart" for "Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter".

Subsec. (a)(3)(B)(v). Pub. L. 117–328, §3626(a)(1)(B), added cl. (v).

Subsec. (a)(4). Pub. L. 117–180, §1004(4), substituted "The" for "Beginning with fiscal year 2020, the" in introductory provisions.

Subsec. (a)(4)(A). Pub. L. 117–328, §3626(a)(1)(C)(i), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;".

Subsec. (a)(4)(B). Pub. L. 117–328, §3626(a)(1)(C)(ii), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drugs, including identifying drivers of such changes; and".

Subsec. (a)(4)(D). Pub. L. 117–328, §3626(a)(1)(C)(iii), (iv), added subpar. (D).

Subsec. (b). Pub. L. 117–180, §1004(5), substituted "Not" for "Beginning with fiscal year 2018, not".

Subsec. (c). Pub. L. 117–180, §1004(6), substituted "For" for "Beginning with fiscal year 2018, for" in introductory provisions.

Subsec. (f)(1). Pub. L. 117–180, §1004(7)(A), substituted "fiscal year 2027" for "fiscal year 2022" in introductory provisions.

Subsec. (f)(4). Pub. L. 117–328, §3626(a)(2)(B), added par. (4). Former par. (4) redesignated (5).

Subsec. (f)(5). Pub. L. 117–328, §3626(a)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).

Pub. L. 117–180, §1004(7)(B), substituted "January 15, 2027" for "January 15, 2022".

Subsec. (f)(6), (7). Pub. L. 117–328, §3626(a)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.

Subsec. (f)(7)(A). Pub. L. 117–328, §3626(a)(2)(C)(i), substituted "The" for "Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the" and inserted ", not later than 30 days after each such negotiation meeting" before period at end.

Subsec. (f)(7)(B). Pub. L. 117–328, §3626(a)(2)(C)(ii), inserted ", in sufficient detail," after "shall summarize".

2017—Subsec. (a)(1). Pub. L. 115–52, §103(a)(1), substituted "2018" for "2013".

Subsec. (a)(1)(A). Pub. L. 115–52, §103(1)(B), substituted "Prescription Drug User Fee Amendments of 2017" for "Prescription Drug User Fee Amendments of 2012".

Subsec. (a)(3), (4). Pub. L. 115–52, §903(a), added pars. (3) and (4).

Subsec. (a)(5). Pub. L. 115–52, §904(a)(1), added par. (5).

Subsec. (b). Pub. L. 115–52, §103(2), substituted "2018" for "2013".

Subsec. (c). Pub. L. 115–52, §904(a)(2)(B), added subsec. (c). Former subsec. (c) redesignated (e).

Subsec. (d). Pub. L. 115–52, §904(a)(2)(B), added subsec. (d). Former subsec. (d) redesignated (f).

Pub. L. 115–52, §103(3), substituted "2022" for "2017" in pars. (1) and (5).

Subsecs. (e), (f). Pub. L. 115–52, §904(a)(2)(A), redesignated subsecs. (c) and (d) as (e) and (f), respectively.

2012—Subsec. (a). Pub. L. 112–144, §104(1), amended subsec. (a) generally. Prior to amendment, text read as follows: "Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort."

Subsec. (b). Pub. L. 112–144, §104(2), substituted "2013" for "2008".

Subsec. (d)(1), (5). Pub. L. 112–144, §104(3), substituted "2017" for "2012".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

Effective Date of 2017 Amendment

Amendment by section 103 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2012, see section 106 of Pub. L. 112–144, set out as a note under section 379g of this title.

Effective and Termination Dates

Pub. L. 117–180, div. F, title I, §1005(b), Sept. 30, 2022, 136 Stat. 2147, provided that: "Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2028."

Pub. L. 115–52, title I, §104(b), Aug. 18, 2017, 131 Stat. 1012, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147.

[Pub. L. 117–180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147, provided that the repeal of section 104(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title I, §105(b), July 9, 2012, 126 Stat. 1001, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat 1012.

[Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat. 1012, provided that the repeal of section 105(b) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 110–85, title I, §106(b), Sept. 27, 2007, 121 Stat. 842, which provided that the amendment made by section 105 of Pub. L. 110–85 (enacting this section) would cease to be effective Jan. 31, 2013, was repealed by Pub. L. 112–144, title I, §105(c)(1), July 9, 2012, 126 Stat. 1001.

Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.

¹ See References in Text note below.

subpart 3—fees relating to devices

§379i. Definitions

For purposes of this subpart:

(1) The term "premarket application" means—

(A) an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or

(B) a product development protocol described in section 360e(f) of this title.

Such term does not include a supplement, a premarket report, or a premarket notification submission.

(2) The term "premarket report" means a report submitted under section 360e(c)(2) of this title.

(3) The term "premarket notification submission" means a report submitted under section 360(k) of this title.

(4)(A) The term "supplement", with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which—

(i) an application or report has been approved under section 360e(d) of this title, or an application has been approved under section 262 of title 42; or

(ii) a notice of completion has become effective under section 360e(f) of this title.

(B) The term "panel-track supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness.

(C) The term "180-day supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling.

(D) The term "real-time supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.

(E) The term "efficacy supplement" means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.

(5) The term "30-day notice" means a notice under section 360e(d)(5) of this title that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.

(6) The term "request for classification information" means a request made under section 360c(g) of this title for information respecting the class in which a device has been classified or the requirements applicable to a device.

(7) The term "annual fee", for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.

(8) The term "de novo classification request" means a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device.

(9) The term "process for the review of device applications" means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests:

(A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.

(B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval.

(C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary's review of pending premarket applications, premarket reports, and supplements.

(D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, submissions, and de novo classification requests.

(E) Review of device applications subject to section 262 of title 42 for an investigational new drug application under section 355(i) of this title or for an investigational device exemption under section 360j(g) of this title and activities conducted in anticipation of the submission of such applications under section 355(i) or 360j(g) of this title.

(F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests.

(G) The development of voluntary test methods, consensus standards, or mandatory performance standards under section 360d of this title in connection with the review of such applications, reports, supplements, submissions, or requests and related activities.

(H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, submissions, or requests.

(I) Any activity undertaken under section 360c or 360e(i) of this title in connection with the initial classification or reclassification of a device or under section 360e(b) of this title in connection with any requirement for approval of a device.

(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.

(K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, premarket notification submissions, or de novo classification requests.

(10) The term "costs of resources allocated for the process for the review of device applications" means the expenses in connection with the process for the review of device applications for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.

(11) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2021.

(12) The term "person" includes an affiliate thereof.

(13) The term "affiliate" means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(14) The term "establishment subject to a registration fee" means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.

(June 25, 1938, ch. 675, §737, as added Pub. L. 107–250, title I, §102(a), Oct. 26, 2002, 116 Stat. 1589; amended Pub. L. 108–214, §2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572, 577; Pub. L. 110–85, title II, §211, Sept. 27, 2007, 121 Stat. 843; Pub. L. 112–144, title II, §202, July 9, 2012, 126 Stat. 1002; Pub. L. 114–255, div. A, title III, §3051(c)(2), Dec. 13, 2016, 130 Stat. 1124; Pub. L. 115–52, title II, §202(a), Aug. 18, 2017, 131 Stat. 1013; Pub. L. 117–180, div. F, title II, §2002, Sept. 30, 2022, 136 Stat. 2148.)

Termination of Section

For termination of section by section 2007(a) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

Amendments

2022—Par. (9). Pub. L. 117–180, §2002(1)(A), substituted "premarket notification submissions, and de novo classification requests" for "and premarket notification submissions" in introductory provisions.

Par. (9)(D). Pub. L. 117–180, §2002(1)(B), substituted "submissions, and de novo classification requests" for "and submissions".

Par. (9)(F). Pub. L. 117–180, §2002(1)(C), substituted "premarket notification submissions, and de novo classification requests" for "and premarket notification submissions".

Par. (9)(G), (H). Pub. L. 117–180, §2002(1)(D), substituted "submissions, or requests" for "or submissions".

Par. (9)(K). Pub. L. 117–180, §2002(1)(E), substituted "premarket notification submissions, or de novo classification requests" for "or premarket notification submissions".

Par. (11). Pub. L. 117–180, §2002(2), substituted "2021" for "2016".

2017—Par. (8). Pub. L. 115–52, §202(a)(2), added par. (8). Former par. (8) redesignated (9).

Par. (9). Pub. L. 115–52, §202(a)(1), redesignated par. (8) as (9). Former par. (9) redesignated (10).

Par. (10). Pub. L. 115–52, §202(a)(1), (3), redesignated par. (9) as (10) and substituted "submissions, and de novo classification requests" for "and submissions" in subpar. (D). Former par. (10) redesignated (11).

Par. (11). Pub. L. 115–52, §202(a)(1), (4), redesignated par. (10) as (11) and substituted "2016" for "2011".

Pars. (12) to (14). Pub. L. 115–52, §202(a)(1), redesignated pars. (11) to (13) as (12) to (14), respectively.

2016—Par. (5). Pub. L. 114–255 substituted "360e(d)(5)" for "360e(d)(6)".

2012—Par. (9). Pub. L. 112–144, §202(1), struck out "incurred" after "expenses" in introductory provisions.

Par. (10). Pub. L. 112–144, §202(2), substituted "October 2011" for "October 2001".

Par. (13). Pub. L. 112–144, §202(3), substituted "is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device." for "is required to register with the Secretary under section 360 of this title and is one of the following types of establishments:" and struck out subpars. (A) to (C) which related to manufacturer, single-use device reprocessor, and specification developer establishments.

2007—Pub. L. 110–85, §211(1), substituted "For purposes of this subpart" for "For purposes of this part" in introductory provisions.

Pars. (5) to (9). Pub. L. 110–85, §211(2), (3), added pars. (5) to (7) and redesignated former pars. (5) and (6) as (8) and (9), respectively. Former pars. (7) and (8) redesignated (10) and (12), respectively.

Par. (10). Pub. L. 110–85, §211(2), (4), redesignated par. (7) as (10) and substituted "October of the preceding fiscal year" for "April of the preceding fiscal year" and "October 2001" for "April 2002".

Par. (11). Pub. L. 110–85, §211(5), added par. (11).

Par. (12). Pub. L. 110–85, §211(2), redesignated par. (8) as (12).

Par. (13). Pub. L. 110–85, §211(6), added par. (13).

2004—Pub. L. 108–214, §2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, §102(a), which enacted this section.

Par. (4)(B). Pub. L. 108–214, §2(a)(1)(A), substituted "and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness" for "and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness".

Par. (4)(D). Pub. L. 108–214, §2(a)(1)(B), struck out "manufacturing," after "software,".

Par. (5)(J). Pub. L. 108–214, §2(a)(1)(C), substituted "a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42." for "a premarket application under section 360e of this title or section 262 of title 42."

Par. (8). Pub. L. 108–214, §2(a)(1)(D), substituted "The term 'affiliate' means a business entity that has a relationship with a second business entity (whether domestic or international)" for "The term 'affiliate' means a business entity that has a relationship with a second business entity".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

Effective Date of 2017 Amendment

Pub. L. 115–52, title II, §209, Aug. 18, 2017, 131 Stat. 1020, provided that: "The amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i et seq.] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective Date of 2012 Amendment

Pub. L. 112–144, title II, §206, July 9, 2012, 126 Stat. 1007, provided that: "The amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] shall take effect on October 1, 2012, or the date of the enactment of this Act [July 9, 2012], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2012, regardless of the date of the enactment of this Act."

Effective and Termination Dates of 2007 Amendment

Pub. L. 110–85, title II, §216, Sept. 27, 2007, 121 Stat. 852, provided that: "The amendments made by this subtitle [subtitle A (§§211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title] shall take effect on October 1, 2007, or the date of the enactment of this Act [Sept. 27, 2007], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all premarket applications, premarket reports, supplements, 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the date of the enactment of this Act."

Pub. L. 110–85, title II, §217, Sept. 27, 2007, 121 Stat. 852, which provided that the amendments by sections 211 to 217 of Pub. L. 110–85 (amending this section and section 379j of this title) would cease to be effective Oct. 1, 2012, and that section 379j–1 of this title would cease to be effective Jan. 31, 2013, was repealed by Pub. L. 112–144, title II, §207(b)(1), July 9, 2012, 126 Stat. 1007.

Effective and Termination Dates

Pub. L. 117–180, div. F, title II, §2007(a), Sept. 30, 2022, 136 Stat. 2154, provided that: "Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be effective October 1, 2027."

Pub. L. 115–52, title II, §210(a), Aug. 18, 2017, 131 Stat. 1020, which provided that this section and section 379j of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title II, §2007(c), Sept. 30, 2022, 136 Stat. 2154.

[Pub. L. 117–180, div. F, title II, §2007(c), Sept. 30, 2022, 136 Stat. 2154, provided that the repeal of section 210(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title II, §207(a), July 9, 2012, 126 Stat. 1007, which provided that sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) would cease to be effective Oct. 1, 2017, and that section 738A (21 U.S.C. 379j–1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title II, §210(c), Aug. 18, 2017, 131 Stat. 1020.

[Pub. L. 115–52, title II, §210(c), Aug. 18, 2017, 131 Stat. 1020, provided that the repeal of section 207(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 107–250, title I, §106, Oct. 26, 2002, 116 Stat. 1602, provided that: "The amendments made by this title [enacting this subpart] shall take effect on the date of the enactment of this Act [Oct. 26, 2002], except that fees shall be assessed for all premarket applications, premarket reports, supplements, and premarket notification submissions received on or after October 1, 2002, regardless of the date of enactment."

Pub. L. 107–250, title I, §107, Oct. 26, 2002, 116 Stat. 1602, which provided that the amendments made by title I of Pub. L. 107–250 (enacting this subpart) would cease to be effective Oct. 1, 2007, except that section 103 of Pub. L. 107–250, set out as a note below, would cease to be effective Jan. 31, 2008, was repealed by Pub. L. 112–144, title II, §207(c)(1), July 9, 2012, 126 Stat. 1007.

[Pub. L. 112–144, title II, §207(c), July 9, 2012, 126 Stat. 1007, provided that the repeal of section 107 of Pub. L. 107–250, formerly set out above, is effective Sept. 30, 2007.]

Savings Provisions

Pub. L. 117–180, div. F, title II, §2009, Sept. 30, 2022, 136 Stat. 2155, provided that: "Notwithstanding the amendments made by this title [amending this section and sections 379j and 379j–1 of this title and repealing provisions set out as notes under this section and section 379j–1 of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (as defined in such part as of such day) that on or after October 1, 2017, but before October 1, 2022, were received by the Food and Drug Administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023."

Pub. L. 115–52, title II, §208, Aug. 18, 2017, 131 Stat. 1019, provided that: "Notwithstanding the amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Pub. L. 112–144, title II, §205, July 9, 2012, 126 Stat. 1007, provided that: "Notwithstanding the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (in effect as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013."

Pub. L. 110–85, title II, §214, Sept. 27, 2007, 121 Stat. 852, provided that: "Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) [formerly set out as an Effective and Termination Dates note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this subtitle [Sept. 27, 2007], shall continue to be in effect with respect to premarket applications, premarket reports, premarket notification submissions, and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008."

Congressional Findings Concerning Fees Relating to Devices

Pub. L. 117–180, div. F, title II, §2001(b), Sept. 30, 2022, 136 Stat. 2147, provided that: "Congress finds that the fees authorized under the amendments made by this title [amending this section and sections 379j and 379j–1 of this title and repealing provisions set out as notes under this section and section 379j–1 of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 115–52, title II, §201(b), Aug. 18, 2017, 131 Stat. 1013, provided that: "The Congress finds that the fees authorized under the amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title II, §201(b), July 9, 2012, 126 Stat. 1002, provided that: "The Congress finds that the fees authorized under the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 110–85, title II, §201(c), Sept. 27, 2007, 121 Stat. 842, provided that: "The Congress finds that the fees authorized under the amendments made by this title [enacting section 379j–1 of this title and amending this section and sections 333, 360, 360i, 360m, 374, and 379j of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i et seq.] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 107–250, title I, §101, Oct. 26, 2002, 116 Stat. 1589, provided that: "The Congress finds that—

"(1) prompt approval and clearance of safe and effective devices is critical to the improvement of the public health so that patients may enjoy the benefits of devices to diagnose, treat, and prevent disease;

"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met; and

"(3) the fees authorized by this title [enacting this subpart and provisions set out as notes under this section and section 379j of this title] will be dedicated to meeting the goals identified in the letters from the Secretary of Health and Human Services to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record."

Annual Reports

Pub. L. 107–250, title I, §103, Oct. 26, 2002, 116 Stat. 1600, as amended by Pub. L. 109–43, §2(b), Aug. 1, 2005, 119 Stat. 441, provided that:

"(a) In General.—Beginning with fiscal year 2003, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report concerning—

"(1) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) [set out as a note above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part [title I of Pub. L. 107–250 does not contain parts]; and

"(2) the implementation of the authority for such fees during such fiscal year, and the use, by the Food and Drug Administration, of the fees collected during such fiscal year, not later than 120 days after the end of each fiscal year during which fees are collected under the medical device user-fee program established under the amendment made by section 102 [enacting this subpart].

"(b) Additional Information.—For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include—

"(1) information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and

"(2) a certification by the Secretary that the amounts appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year and obligated by the Secretary for the performance of any function relating to devices that is not for the process for the review of device applications, as defined in paragraph (5) [now (8)] of section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not less than such amounts for fiscal year 2002 multiplied by the adjustment factor, as defined in paragraph (7) [now (10)] of such section 737."

Study

Pub. L. 107–250, title I, §104(b), Oct. 26, 2002, 116 Stat. 1601, directed the Secretary of Health and Human Services to conduct a study for the purpose of making certain determinations regarding the medical device user-fee program established under the amendment made by section 102 of Pub. L. 107–250 and to submit a report to Congress by Jan. 10, 2007.

Consultation

Pub. L. 107–250, title I, §105, Oct. 26, 2002, 116 Stat. 1601, provided that:

"(a) In General.—In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of medical device applications for fiscal years after fiscal year 2007, and for the reauthorization of sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i, 379j], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.

"(b) Recommendations.—The Secretary shall publish in the Federal Register recommendations under subsection (a), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations."

§379j. Authority to assess and use device fees

(a) Types of fees

(1) In general

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section.

(2) Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device

(A) In general

Except as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2022, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following:

(i) A premarket application.

(ii) For a premarket report, a fee equal to the fee that applies under clause (i).

(iii) For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i).

(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).

(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).

(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).

(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).

(viii) For a premarket notification submission, a fee equal to 4.5 percent of the fee that applies under clause (i).

(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).

(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).

(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).

(B) Exceptions

(i) Humanitarian device exemption

An application under section 360j(m) of this title is not subject to any fee under subparagraph (A).

(ii) Further manufacturing use

No fee shall be required under subparagraph (A) for the submission of a premarket application under section 262 of title 42 for a product licensed for further manufacturing use only.

(iii) State or Federal Government sponsors

No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.

(iv) Premarket notifications by third parties

No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 360m of this title.

(v) Pediatric conditions of use

(I) In general

No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.

(II) Subsequent proposal of adult conditions of use

In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.

(C) Payment

The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.

(D) Refunds

(i) Application refused for filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for filing.

(ii) Application withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.

(iii) Application withdrawn before first action

After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.

(iv) Modular applications withdrawn before first action

The Secretary shall refund 75 percent of the application fee paid for an application submitted under section 360e(c)(4) of this title that is withdrawn before a second portion is submitted and before a first action on the first portion.

(v) Later withdrawn modular applications

If an application submitted under section 360e(c)(4) of this title is withdrawn after a second or subsequent portion is submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of the portions submitted.

(vi) Sole discretion to refund

The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.

(3) Annual establishment registration fee

(A) In general

Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 360 of this title beginning with its registration for fiscal year 2008.

(B) Exception

(i) In general

No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act ¹ [25 U.S.C. 5301 et seq.]), unless a device manufactured by the establishment is to be distributed commercially.

(ii) Small businesses fee waiver

(I) Definition of small business

For purposes of this clause, the term "small business" means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(II) Waiver

The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, beginning on October 1, 2024, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined by the Secretary.

(III) Firms submitting tax returns to the United States Internal Revenue Service

The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates.

(IV) Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The establishment shall also submit a statement signed by the head of the establishment's firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates.

(V) Request for waiver

An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subparagraph (C). The decision of the Secretary regarding whether an entity may receive the waiver for such year is not reviewable.

(C) Payment

The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of—

(i) the initial or annual registration (as applicable) of the establishment under section 360 of this title; or

(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(b) Fee Amounts

(1) In general

Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2023 through 2027, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).

(2) Base fee amounts specified

For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:

Fee Type	Fiscal Year 2023	Fiscal Year 2024	Fiscal Year 2025	Fiscal Year 2026	Fiscal Year 2027
Premarket Application	$425,000	$435,000	$445,000	$455,000	$470,000
Establishment Registration	$6,250	$6,875	$7,100	$7,575	$8,465

(3) Total revenue amounts specified

For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:

(A) $312,606,000 for fiscal year 2023.

(B) $335,750,000 for fiscal year 2024.

(C) $350,746,400 for fiscal year 2025.

(D) $366,486,300 for fiscal year 2026.

(E) $418,343,000 for fiscal year 2027.

(c) Annual fee setting; adjustments

(1) In general

The Secretary shall, 60 days before the start of each fiscal year after September 30, 2022, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register.

(2) Inflation adjustments

(A) Adjustment to total revenue amounts

For fiscal year 2023 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year.

(B) Applicable inflation adjustment

The applicable inflation adjustment for fiscal year 2023 and each subsequent fiscal year is the product of—

(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and

(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2022.

(C) Base inflation adjustment

(i) In general

Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—

(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by 0.60; and

(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by 0.40.

(ii) Limitations

For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)—

(I) is less than 1, such adjustment shall be considered to be equal to 1; or

(II) is greater than 1.04, such adjustment shall be considered to be equal to 1.04.

(D) Adjustment to base fee amounts

For each of fiscal years 2023 through 2027, the Secretary shall—

(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and

(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).

(3) Volume-based adjustments to establishment registration base fees

For each of fiscal years 2023 through 2027, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be increased, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).

(4) Performance improvement adjustment

(A) In general

For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2) and (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year equal to the following amounts, as applicable:

(i) For fiscal year 2025, the product of—

(I) the amount determined under subparagraph (B)(i)(I); and

(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

(ii) For fiscal year 2026, the product of—

(I) the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and

(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

(iii) For fiscal year 2027, the product of—

(I) the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and

(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

(B) Amounts

(i) Presubmission amount

For purposes of subparagraph (A), with respect to the Presubmission Written Feedback goal, the amounts determined under this subparagraph are as follows:

(I) For fiscal year 2025, $15,396,600 if such goal for fiscal year 2023 is met.

(II) For fiscal year 2026:

(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.

(bb) $36,792,200 if such goal for fiscal year 2024 is met.

(III) For fiscal year 2027:

(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for each of fiscal years 2024 and 2025 is not met.

(bb) $36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met.

(cc) $40,572,600 if such goal for fiscal year 2025 is met.

(ii) De novo classification request amount

For purposes of subparagraph (A), with respect to the De Novo Decision goal, the amounts determined under this subparagraph are as follows:

(I) For fiscal year 2026, $6,323,500 if such goal for fiscal year 2023 is met.

(II) For fiscal year 2027:

(aa) $6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.

(bb) $11,765,400 if such goal for fiscal year 2024 is met.

(iii) Premarket notification and premarket approval amount

For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal, the amounts determined under this subparagraph are as follows:

(I) For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met.

(II) For fiscal year 2027:

(aa) $1,020,000 if the 4 goals for fiscal year 2023 are met and one or more of the 4 goals for fiscal year 2024 are not met.

(bb) $3,906,000 if the 4 goals for fiscal year 2024 are met.

(C) Performance calculation

For purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and based on data available, as follows:

(i) The performance of the Presubmission Written Feedback goal shall be based on data available as of—

(I) for fiscal year 2023, March 31, 2024;

(II) for fiscal year 2024, March 31, 2025; and

(III) for fiscal year 2025, March 31, 2026.

(ii) The performance of the De Novo Decision goal, 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal shall be based on data available as of—

(I) for fiscal year 2023, March 31, 2025; and

(II) for fiscal year 2024, March 31, 2026.

(D) Goals defined

For purposes of this paragraph, the terms "Presubmission Written Feedback goal", "De Novo Decision goal", "510(k) decision goal", "510(k) Shared Outcome Total Time to Decision goal", "PMA decision goal", and "PMA Shared Outcome Total Time to Decision goal" refer to the goals identified by the same names in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.

(5) Hiring adjustment

(A) In general

For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2), (3), and (4), if applicable, if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph (B) for the applicable fiscal years, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (C).

(B) Thresholds

The thresholds specified in this subparagraph are as follows:

(i) For fiscal year 2025, the threshold is 123 hires for fiscal year 2023.

(ii) For fiscal year 2026, the threshold is 38 hires for fiscal year 2024.

(iii) For fiscal year 2027, the threshold is—

(I) 22 hires for fiscal year 2025 if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or

(II) 75 hires for fiscal year 2025 if such fees are so increased.

(C) Hiring adjustment amount

The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of—

(i) the number of hires by which the hiring goal specified in subparagraph (D) for the fiscal year before the prior fiscal year was not met;

(ii) $72,877; and

(iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met.

(D) Hiring goals

The hiring goals for each of fiscal years 2023 through 2025 are as follows:

(i) For fiscal year 2023, 144 hires.

(ii) For fiscal year 2024, 42 hires.

(iii) For fiscal year 2025:

(I) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i).

(II) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i).

(E) Number of hires

For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary as set forth in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.

(6) Operating reserve adjustment

(A) In general

For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (2), (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves.

(B) Designated amount

Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of—

(i) 13 weeks of operating reserves of carryover user fees; and

(ii) 1 month of operating reserves maintained pursuant to paragraph (8).

(C) Excluded amount

For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph (B) and shall not be subject to the decrease under subparagraph (A).

(7) Limit

The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications.

(8) Supplement

(A) In general

The Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of the next fiscal year.

(B) Notice to Congress

Not later than 14 days before the Secretary anticipates the use of funds described in subparagraph (A), the Secretary shall provide notice to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.

(d) Small businesses; fee waiver and fee reduction regarding premarket approval fees

(1) In general

The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term "small business" means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).

(2) Rules relating to premarket approval fees

(A) Definition

For purposes of this paragraph, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(B) Evidence of qualification

(i) In general

An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for a waiver of the fee or the lower fee rate.

(ii) Firms submitting tax returns to the United States Internal Revenue Service

The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.

(iii) Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.

(C) Reduced fees

Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—

(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and

(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.

(D) Request for fee waiver or reduction

An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable.

(e) Small businesses; fee reduction regarding premarket notification submissions

(1) In general

For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(2)(A)(viii) may be paid at a reduced rate in accordance with paragraph (2)(C).

(2) Rules relating to premarket notification submissions

(A) Definition

For purposes of this subsection, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(B) Evidence of qualification

(i) In general

An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate.

(ii) Firms submitting tax returns to the United States Internal Revenue Service

The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.

(iii) Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.

(C) Reduced fees

For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 25 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).

(D) Request for reduction

An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.

(f) Effect of failure to pay fees

(1) No acceptance of submissions

A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.

(2) No registration

Registration information submitted under section 360 of this title by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted by the Secretary until the registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 360 of this title.

(g) Conditions

(1) Performance goals; termination of program

With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—

(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $398,566,000 multiplied by the adjustment factor applicable to such fiscal year; or

(B) fees were not assessed under subsection (a) for the previous fiscal year.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(3) Limitation

Beginning on October 1, 2023, the authorities under section 379i(10)(C) of this title shall include only leasing and necessary scientific equipment.

(h) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and

(ii) shall be available—

(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor; and

(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.

(B) Compliance

(i) In general

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable—

(I) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(II)(aa) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and

(bb) such costs are not more than 5 percent below the level specified in such subparagraph.

(ii) More than 5 percent

To the extent such costs are more than 5 percent below the specified level in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.

(C) Provision for early payments

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

(A) In general

For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph (B), less the amount of reductions determined under subparagraph (C).

(B) Revenue amount

For purposes of this paragraph, the revenue amount for each fiscal year is the sum of—

(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs (2) and (3) of subsection (c); and

(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable.

(C) Amount of reductions

For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of—

(i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and

(ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.

(i) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(j) Written requests for refunds

To qualify for consideration for a refund under subsection (a)(2)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.

(k) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(June 25, 1938, ch. 675, §738, as added Pub. L. 107–250, title I, §102(a), Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108–214, §2(a)(2), (d)(2)(A), (B), (3)(A), Apr. 1, 2004, 118 Stat. 572, 576, 577; Pub. L. 109–43, §2(a), Aug. 1, 2005, 119 Stat. 439; Pub. L. 110–85, title II, §212, Sept. 27, 2007, 121 Stat. 844; Pub. L. 112–144, title II, §203(a)–(f), July 9, 2012, 126 Stat. 1002; Pub. L. 112–193, §2(b)(1), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 115–52, title II, §203(a)–(f)(1), (2)(B)–(i), title IX, §905(b)(2), Aug. 18, 2017, 131 Stat. 1013–1016, 1090; Pub. L. 117–180, div. F, title II, §2003, Sept. 30, 2022, 136 Stat. 2148; Pub. L. 117–328, div. FF, title III, §§3309, 3625(d), (e)(1), Dec. 29, 2022, 136 Stat. 5836, 5882.)

Termination of Section

For termination of section by section 2007(a) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

The Indian Self Determination and Educational Assistance Act, referred to in subsec. (a)(3)(B)(i), probably means the Indian Self-Determination and Education Assistance Act, Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

Section 2001(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (c)(4)(A), (C), (D), (5)(E), is section 2001(b) of title II of div. F of Pub. L. 117–180, which is set out as a note under section 379i of this title.

510(k), referred to in subsec. (c)(4)(B)(iii), (C)(ii), (D), means section 510(k) of the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, which is classified to section 360(k) of this title.

Amendments

2022—Subsec. (a)(1). Pub. L. 117–180, §2003(a)(1), substituted "fiscal year 2023" for "fiscal year 2018".

Subsec. (a)(2)(A). Pub. L. 117–180, §2003(a)(2)(A)(i), substituted "October 1, 2022" for "October 1, 2017" in introductory provisions.

Subsec. (a)(2)(A)(iii). Pub. L. 117–180, §2003(a)(2)(A)(ii), substituted "80 percent" for "75 percent".

Subsec. (a)(2)(A)(viii). Pub. L. 117–180, §2003(a)(2)(A)(iii), substituted "4.5 percent" for "3.4 percent".

Subsec. (a)(2)(B)(iii). Pub. L. 117–180, §2003(a)(2)(B), substituted "premarket notification submission, or de novo classification request" for "or premarket notification submission".

Subsec. (a)(2)(C). Pub. L. 117–180, §2003(a)(2)(C), substituted "periodic reporting concerning a class III device, or de novo classification request" for "or periodic reporting concerning a class III device".

Subsec. (a)(3)(B). Pub. L. 117–328, §3309(a), designated existing provisions as cl. (i), inserted heading, and added cl. (ii).

Subsec. (b)(1). Pub. L. 117–180, §2003(b)(1), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (b)(2). Pub. L. 117–180, §2003(b)(2), amended par. (2) generally. Prior to amendment, par. (2) specified base fee amounts for fiscal years 2018 to 2022.

Subsec. (b)(3). Pub. L. 117–180, §2003(b)(3), amended par. (3) generally. Prior to amendment, par. (3) specified total revenue amounts for fiscal years 2018 to 2022.

Subsec. (c)(1). Pub. L. 117–180, §2003(c)(1), substituted "2022" for "2017".

Subsec. (c)(2)(A). Pub. L. 117–180, §2003(c)(2)(A), substituted "2023" for "2018".

Subsec. (c)(2)(B). Pub. L. 117–180, §2003(c)(2)(B)(i), substituted "fiscal year 2023" for "fiscal year 2018" in introductory provisions.

Subsec. (c)(2)(B)(ii). Pub. L. 117–180, §2003(c)(2)(B)(ii), substituted "fiscal year 2022" for "fiscal year 2016".

Subsec. (c)(2)(C)(i)(II). Pub. L. 117–180, §2003(c)(2)(C), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV".

Subsec. (c)(2)(D). Pub. L. 117–180, §2003(c)(2)(D), substituted "fiscal years 2023 through 2027" for "fiscal years 2018 through 2022" in introductory provisions.

Subsec. (c)(3). Pub. L. 117–180, §2003(c)(3), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (c)(4) to (8). Pub. L. 117–180, §2003(c)(4), (5), added pars. (4) to (6) and redesignated former pars. (4) and (5) as (7) and (8), respectively.

Subsec. (d)(2)(B)(iii). Pub. L. 117–328, §3309(b), inserted ", if extant," after "national taxing authority".

Subsec. (e)(2)(B)(iii). Pub. L. 117–328, §3625(d)(1), inserted ", if extant," after "national taxing authority".

Subsec. (g)(1)(A). Pub. L. 117–180, §2003(d)(1), substituted "$398,566,000" for "$320,825,000".

Subsec. (g)(2). Pub. L. 117–180, §2003(d)(2), inserted "de novo classification requests," after "class III device,".

Subsec. (g)(3). Pub. L. 117–328, §3625(e)(1), which directed technical correction to directory language of Pub. L. 115–52, §905(b)(2), was executed by making technical correction to that section as if the amendment were retroactive to the effective date of the amendment by Pub. L. 115–52 to reflect the probable intent of Congress. See 2017 Amendment note below.

Pub. L. 117–328, §3625(d)(3), substituted "379i(10)(C) of this title" for "section 379i(9)(C) of this title".

Subsec. (h)(2)(A)(ii). Pub. L. 117–328, §3625(d)(2)(A), substituted "shall be available—" for "shall be available to defray", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023, to defray" before "increases in the costs", and added subcl. (II).

Subsec. (h)(2)(B)(i). Pub. L. 117–328, §3625(d)(2)(B), substituted "as described in subclause (I) or (II) of such subparagraph, as applicable" for "for the process for the review of device applications" in introductory provisions.

Subsec. (h)(3). Pub. L. 117–180, §2003(e), amended par. (3) generally. Prior to amendment, text read as follows: "For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c)."

2017—Subsec. (a)(1). Pub. L. 115–52, §203(a)(1), substituted "fiscal year 2018" for "fiscal year 2013".

Subsec. (a)(2)(A). Pub. L. 115–52, §203(f)(2)(B)(ii), substituted "(d) and (e)" for "(d), (e), and (f)" in introductory provisions.

Pub. L. 115–52, §203(a)(2)(A)(i), substituted "October 1, 2017" for "October 1, 2012" in introductory provisions.

Subsec. (a)(2)(A)(viii). Pub. L. 115–52, §203(a)(2)(A)(ii), substituted "3.4 percent" for "2 percent".

Subsec. (a)(2)(A)(xi). Pub. L. 115–52, §203(a)(2)(A)(iii), added cl. (xi).

Subsec. (a)(2)(B)(v)(I). Pub. L. 115–52, §203(a)(2)(B), substituted "premarket notification submission, or de novo classification request" for "or premarket notification submission".

Subsec. (a)(3)(A). Pub. L. 115–52, §203(f)(2)(B)(iii), struck out "and subsection (f)" after "subparagraph (B)".

Subsec. (b). Pub. L. 115–52, §203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2013 to 2017.

Subsec. (c)(1). Pub. L. 115–52, §203(c)(1), substituted "2017" for "2012".

Subsec. (c)(2)(A). Pub. L. 115–52, §203(c)(2)(A), substituted "2018" for "2014".

Subsec. (c)(2)(B). Pub. L. 115–52, §203(c)(2)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: "The applicable inflation adjustment for a fiscal year is—

"(i) for fiscal year 2014, the base inflation adjustment under subparagraph (C) for such fiscal year; and

"(ii) for fiscal year 2015 and each subsequent fiscal year, the product of—

"(I) the base inflation adjustment under subparagraph (C) for such fiscal year; and

"(II) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014."

Subsec. (c)(2)(C). Pub. L. 115–52, §203(c)(2)(C), struck out "to total revenue amounts" after "adjustment" in heading.

Subsec. (c)(2)(D). Pub. L. 115–52, §203(c)(2)(D), amended subpar. (D) generally. Prior to amendment, text read as follows: "For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A)."

Subsec. (c)(3). Pub. L. 115–52, §203(c)(3), substituted "2018 through 2022" for "2014 through 2017" and "increased" for "further adjusted".

Subsec. (d)(1). Pub. L. 115–52, §203(d)(1), substituted "specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)" for "specified in clauses (i) through (v) and clauses (vii), (ix), and (x)".

Subsec. (d)(2)(C)(i). Pub. L. 115–52, §203(d)(2), substituted "supplement," for "supplement, or" and inserted ", or a de novo classification request" after "class III device".

Subsec. (e)(2)(C). Pub. L. 115–52, §203(e), substituted "25 percent" for "50 percent".

Subsec. (f). Pub. L. 115–52, §203(f)(1), (2)(B)(i), redesignated subsec. (g) as (f) and struck out former subsec. (f) which authorized the Secretary to grant waivers or reductions of fees under subsec. (a)(2) or (3) until Oct. 1, 2017.

Subsec. (f)(1). Pub. L. 115–52, §203(g), substituted "periodic reporting concerning a class III device, or de novo classification request" for "or periodic reporting concerning a class III device" and "all such fees" for "all fees".

Subsec. (g). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f).

Subsec. (g)(1)(A). Pub. L. 115–52, §203(h), substituted "$320,825,000" for "$280,587,000".

Subsec. (h). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g).

Subsec. (h)(3). Pub. L. 115–52, §203(i)(1), substituted "2018 through 2022" for "2013 through 2017" and "subsection (c)." for "subsection (c) and, for fiscal year 2017 only, as further adjusted under paragraph (4)."

Pub. L. 115–52, §905(b)(2), as amended by Pub. L. 117–328, §3625(e)(1), added par. (3), effective Aug. 18, 2017. Subsec. (h) subsequently redesignated (g) effective Oct. 1, 2017, by Pub. L. 115–52, §203(f)(2)(B)(i). See Amendment note above.

Subsec. (h)(4). Pub. L. 115–52, §203(i)(2), struck out par. (4). Text read as follows: "If the cumulative amount of fees collected during fiscal years 2013, 2014, and 2015, added to the amount estimated to be collected for fiscal year 2016, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2016, exceeds the cumulative amount appropriated pursuant to paragraph (3) for these four fiscal years, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017."

Subsecs. (i) to (l). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsecs. (j) to (l) as (i) to (k), respectively. Former subsec. (i) redesignated (h).

2012—Subsec. (a)(1). Pub. L. 112–144, §203(a)(1), substituted "fiscal year 2013" for "fiscal year 2008".

Subsec. (a)(2)(A). Pub. L. 112–144, §203(a)(2)(A), substituted "subsections (d), (e), and (f)" for "subsections (d) and (e)", "October 1, 2012" for "October 1, 2002", and "subsection (c)" for "subsection (c)(1)" in introductory provisions.

Subsec. (a)(2)(A)(viii). Pub. L. 112–144, §203(a)(2)(B), substituted "2" for "1.84".

Subsec. (a)(3)(A). Pub. L. 112–144, §203(a)(3)(A), inserted "and subsection (f)" after "subparagraph (B)".

Subsec. (a)(3)(C). Pub. L. 112–144, §203(a)(3)(B), substituted "later of—" for "initial registration of the establishment or upon the annual registration under section 360 of this title." and added cls. (i) and (ii).

Subsec. (b). Pub. L. 112–144, §203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2008 to 2012.

Subsec. (c). Pub. L. 112–144, §203(c), inserted "; adjustments" after "setting" in heading, added pars. (1) to (3), redesignated former pars. (3) and (4) as (4) and (5), respectively, and struck out former pars. (1) and (2) which related to annual publication and adjustment of fees.

Subsecs. (f) to (h). Pub. L. 112–144, §203(d), added subsec. (f) and redesignated former subsecs. (f) and (g) as (g) and (h), respectively. Former subsec. (h) redesignated (i).

Subsec. (h)(1)(A). Pub. L. 112–144, §203(e), substituted "$280,587,000" for "$205,720,000".

Subsec. (i). Pub. L. 112–144, §203(d)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j).

Subsec. (i)(1). Pub. L. 112–144, §203(f)(1), substituted "Subject to paragraph (2)(C), fees authorized" for "Fees authorized".

Subsec. (i)(2)(A)(i). Pub. L. 112–144, §203(f)(2)(A)(i), substituted "subject to subparagraph (C), shall be collected and available" for "shall be retained".

Subsec. (i)(2)(A)(ii). Pub. L. 112–193 substituted "shall be available" for "shall only be available".

Pub. L. 112–144, §203(f)(2)(A)(ii), substituted "shall only be available" for "shall only be collected and available" and "fiscal year 2009" for "fiscal year 2002".

Subsec. (i)(2)(C). Pub. L. 112–144, §203(f)(2)(B), added subpar. (C).

Subsec. (i)(3). Pub. L. 112–144, §203(f)(3), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2008 to 2012.

Subsec. (i)(4). Pub. L. 112–144, §203(f)(4), substituted "fiscal years 2013, 2014, and 2015" for "fiscal years 2008, 2009, and 2010", "fiscal year 2016" for "fiscal year 2011", "June 30, 2016" for "June 30, 2011", "the cumulative amount appropriated pursuant to" for "the amount of fees specified in aggregate in", and "fiscal year 2017" for "fiscal year 2012" and struck out "aggregate amount in" before "excess shall be credited".

Subsecs. (j) to (l). Pub. L. 112–144, §203(d)(1), redesignated subsecs. (i) to (k) as (j) to (l), respectively.

2007—Subsec. (a)(1). Pub. L. 110–85, §212(a)(1)(A), substituted "Beginning in fiscal year 2008" for "Beginning on October 26, 2002".

Subsec. (a)(2). Pub. L. 110–85, §212(a)(1)(B), amended heading generally. Prior to amendment, heading read as follows: "Premarket application, premarket report, supplement, and submission fee".

Subsec. (a)(2)(A)(iii). Pub. L. 110–85, §212(a)(2)(A), substituted "a fee equal to 75 percent of the fee that applies" for "a fee equal to the fee that applies".

Subsec. (a)(2)(A)(iv). Pub. L. 110–85, §212(a)(2)(B), substituted "15 percent" for "21.5 percent".

Subsec. (a)(2)(A)(v). Pub. L. 110–85, §212(a)(2)(C), substituted "7 percent" for "7.2 percent".

Subsec. (a)(2)(A)(vi), (vii). Pub. L. 110–85, §212(a)(2)(D), (E), added cl. (vi) and redesignated former cl. (vi) as (vii). Former cl. (vii) redesignated (viii).

Subsec. (a)(2)(A)(viii). Pub. L. 110–85, §212(a)(2)(D), (F), redesignated cl. (vii) as (viii), substituted "1.84 percent" for "1.42 percent", and struck out ", subject to any adjustment under subsection (e)(2)(C)(ii) of this section" before period at end.

Subsec. (a)(2)(A)(ix), (x). Pub. L. 110–85, §212(a)(2)(G), added cls. (ix) and (x).

Subsec. (a)(2)(C). Pub. L. 110–85, §212(a)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: "The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted between October 1, 2002, and October 26, 2002, shall be payable on October 30, 2002. Applicants submitting portions of applications pursuant to section 360e(c)(3) of this title shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall include all fees payable from October 1, 2002, through September 30, 2003."

Subsec. (a)(2)(D)(iii). Pub. L. 110–85, §212(a)(4)(A), struck out at end "The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable."

Subsec. (a)(2)(D)(iv) to (vi). Pub. L. 110–85, §212(a)(4)(B), added cls. (iv) to (vi).

Subsec. (a)(3). Pub. L. 110–85, §212(a)(5), added par. (3).

Subsec. (b). Pub. L. 110–85, §212(b), amended subsec. (b) generally. Prior to amendment, text read as follows: "Except as provided in subsections (c), (d), (e), (g), and (h) of this section, the fees under subsection (a) of this section shall be established to generate the following revenue amounts: $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004; and $29,785,000 in fiscal year 2005. If legislation is enacted after October 26, 2002, requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts under this subsection shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of device applications."

Subsec. (c). Pub. L. 110–85, §212(c)(1)(A), made technical amendment to heading.

Subsec. (c)(1). Pub. L. 110–85, §212(c)(1)(B), struck out at end "The fees established for fiscal year 2006 shall be based on a premarket application fee of $259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600."

Subsec. (c)(2), (3). Pub. L. 110–85, §212(c)(2)(A), (B), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 110–85, §212(c)(2)(A), (C), redesignated par. (3) as (4) and substituted in subpar. (A) "The Secretary" for "For fiscal years 2006 and 2007, the Secretary" and "for the first month of the next fiscal year" for "for the first month of fiscal year 2008".

Subsec. (d)(1). Pub. L. 110–85, §212(d)(1), struck out ", partners, and parent firms" after "affiliates" and substituted "clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)" for "clauses (i) through (vi) of subsection (a)(2)(A) of this section".

Subsec. (d)(2)(A). Pub. L. 110–85, §212(d)(2)(A), struck out ", partners, and parent firms" before period at end.

Subsec. (d)(2)(B). Pub. L. 110–85, §212(d)(2)(B)(i), (ii), designated first sentence as cl. (i) and second to fourth sentences as cl. (ii) and inserted cl. headings.

Subsec. (d)(2)(B)(ii). Pub. L. 110–85, §212(d)(2)(B)(iii), (iv), struck out ", partners, and parent firms" after "its affiliates" and after "such affiliates" and substituted "If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates." for "If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively."

Subsec. (d)(2)(B)(iii). Pub. L. 110–85, §212(d)(2)(B)(v), added cl. (iii).

Subsec. (d)(2)(C). Pub. L. 110–85, §212(d)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: "Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) of this section may be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement."

Subsec. (e)(1). Pub. L. 110–85, §212(e)(1), substituted "2008" for "2004" and "(a)(2)(A)(viii)" for "(a)(2)(A)(vii)".

Subsec. (e)(2)(A). Pub. L. 110–85, §212(e)(2)(A), struck out ", partners, and parent firms" before period at end.

Subsec. (e)(2)(B). Pub. L. 110–85, §212(e)(2)(B)(i), (ii), inserted cl. headings and designated first sentence as cl. (i) and second to fourth sentences as cl. (ii).

Subsec. (e)(2)(B)(ii). Pub. L. 110–85, §212(e)(2)(B)(iii), (iv), struck out ", partners, and parent firms" after "its affiliates" and after "such affiliates" and substituted "If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates." for "If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively."

Subsec. (e)(2)(B)(iii). Pub. L. 110–85, §212(e)(2)(B)(v), added cl. (iii).

Subsec. (e)(2)(C). Pub. L. 110–85, §212(e)(3), amended subpar. (C) generally. Prior to amendment, subpar. (C) contained provisions, for fiscal year 2004 and each subsequent fiscal year, authorizing in cl. (i) a reduced fee for a premarket notification submission, and directing in cl. (ii) the Secretary how to determine an adjustment per fee revenue amount.

Subsec. (f). Pub. L. 110–85, §212(f), amended subsec. (f) generally. Prior to amendment, text read as follows: "A premarket application, premarket report, supplement, or premarket notification submission submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid."

Subsec. (g)(1). Pub. L. 110–85, §212(g)(1), added par. (1) and struck out former par. (1). Prior to amendment, par. (1) related to performance goals for fiscal years 2003 through 2005, with respect to the amount appropriated under the salaries and expenses account of the Food and Drug Administration, for devices and radiological products, and termination of the program after fiscal year 2005.

Subsec. (g)(2). Pub. L. 110–85, §212(g)(2), amended par. (2) generally. Prior to amendment, text read as follows: "If the Secretary does not assess fees under subsection (a) of this section during any portion of a fiscal year because of subparagraph (C) or (D) of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, and premarket notification submissions, and at any time in such fiscal year, notwithstanding the provisions of subsection (a) of this section relating to the date fees are to be paid."

Subsec. (h)(3). Pub. L. 110–85, §212(h)(1), amended par. (3) generally, substituting provisions authorizing appropriations for fiscal years 2008 to 2012 for provisions authorizing appropriations for fiscal years 2003 to 2007.

Subsec. (h)(4). Pub. L. 110–85, §212(h)(2), amended par. (4) generally. Prior to amendment, text read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."

2005—Subsec. (a)(2)(A). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)".

Subsec. (b). Pub. L. 109–43, §2(a)(1), inserted "and" after "2004;" and substituted "2005" for "2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal year 2007".

Subsec. (c). Pub. L. 109–43, §2(a)(2)(A), substituted "Annual fee setting" for "Adjustments" in heading.

Subsec. (c)(1). Pub. L. 109–43, §2(a)(2)(B)–(D), redesignated par. (5) as (1), substituted "In general" for "Annual fee setting" in heading, "publish in the Federal Register fees under subsection (a) of this section. The fees" for "establish, for the next fiscal year, and publish in the Federal Register, fees under subsection (a) of this section, based on the revenue amounts established under subsection (b) of this section and the adjustment provided under this subsection and subsection (e)(2)(C)(ii) of this section, except that the fees", "2006" for "2003", and "$259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600." for "$154,000." in text, and struck out former par. (1) which required an annual inflation adjustment of the revenues established in subsec. (b).

Subsec. (c)(2). Pub. L. 109–43, §2(a)(2)(B), (C), redesignated par. (6) as (2) and struck out former par. (2) which required an annual adjustment of the fee revenues established in subsec. (b) to reflect changes in the workload of the Secretary for the process for the review of device applications.

Subsec. (c)(3). Pub. L. 109–43, §2(a)(2)(B), (E), added par. (3) and struck out former par. (3) which required an annual compensating adjustment of the fee revenues established in subsec. (b).

Subsec. (c)(4). Pub. L. 109–43, §2(a)(2)(B), struck out par. (4) which provided for a fiscal year 2007 adjustment of the fee revenues established in subsec. (b) to provide for operating reserves of carryover user fees.

Subsec. (c)(5), (6). Pub. L. 109–43, §2(a)(2)(C), redesignated pars. (5) and (6) as (1) and (2), respectively.

Subsec. (d)(1). Pub. L. 109–43, §2(a)(3)(A), inserted after first sentence "For the purposes of this paragraph, the term 'small business' means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms."

Subsec. (d)(2)(A). Pub. L. 109–43, §2(a)(3)(B), struck out cl. (i) designation and heading before "For purposes", substituted "paragraph," for "subsection," and "$100,000,000" for "$30,000,000", and struck out heading and text of clause (ii). Text read as follows: "The Secretary may adjust the $30,000,000 threshold established in clause (i) if the Secretary has evidence from actual experience that this threshold results in a reduction in revenues from premarket applications, premarket reports, and supplements that is 16 percent or more than would occur without small business exemptions and lower fee rates. To adjust this threshold, the Secretary shall publish a notice in the Federal Register setting out the rationale for the adjustment, and the new threshold."

Subsec. (d)(2)(C). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)".

Subsec. (e)(2)(A). Pub. L. 109–43, §2(a)(4), substituted "$100,000,000" for "$30,000,000".

Subsec. (e)(2)(C). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)" in cls. (i) and (ii).

Subsec. (g)(1)(B)(i). Pub. L. 109–43, §2(a)(5)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows: "For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is equal to or greater than the sum of—

"(I) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2003;

"(II) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2004; and

"(III) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2005."

Subsec. (g)(1)(B)(ii). Pub. L. 109–43, §2(a)(5)(A)(ii), added introductory provisions and struck out former introductory provisions which read as follows: "For fiscal year 2005, if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is less than the sum that applies under clause (i) for fiscal year 2005, the following applies:".

Subsec. (g)(1)(C). Pub. L. 109–43, §2(a)(5)(B)(i), substituted "2005 and" for "2003 through" and inserted "more than 1 percent" after "years, is".

Subsec. (g)(1)(C)(ii). Pub. L. 109–43, §2(a)(5)(B)(ii), substituted "amount that applies" for "sum that applies".

Subsec. (g)(1)(D)(i). Pub. L. 109–43, §2(a)(5)(C), inserted "more than 1 percent" after "year, is".

Subsec. (h)(3)(D), (E). Pub. L. 109–43, §2(a)(6), added subpar. (D) and struck out former subpars. (D) and (E) which read as follows:

"(D) $32,615,000 for fiscal year 2006; and

"(E) $35,000,000 for fiscal year 2007,".

2004—Pub. L. 108–214, §2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, §102(a), which enacted this section.

Subsec. (a). Pub. L. 108–214, §2(d)(2)(A), designated introductory provisions of subsec. (a) as par. (1), inserted heading, substituted "this section." for "this section as follows:", and redesignated former par. (1) as (2).

Subsec. (a)(1)(A). Pub. L. 108–214, §2(a)(2)(A)(i), substituted, in introductory provisions, "subsections (d) and (e)" for "subsection (d)", in cl. (iv), "clause (i)" for "clause (i), subject to any adjustment under subsection (c)(3) of this section", and, in cl. (vii), "clause (i), subject to any adjustment under subsection (e)(2)(C)(ii)" for "clause (i), subject to any adjustment under subsection (c)(3) of this section and any adjustment under subsection (e)(2)(C)(ii)".

Subsec. (a)(1)(D)(i), (ii). Pub. L. 108–214, §2(a)(2)(A)(ii), substituted "application, report," for "application".

Subsec. (d)(1). Pub. L. 108–214, §2(d)(2)(B)(i), substituted "subsection (a)(2)(A)" for "subsection (a)(1)(A)" in last sentence.

Subsec. (d)(2)(B). Pub. L. 108–214, §2(a)(2)(B), substituted "firms, which show" for "firms. which show" in second sentence.

Subsec. (e)(1). Pub. L. 108–214, §2(a)(2)(C)(i), (d)(2)(B)(ii), substituted "For fiscal year 2004 and each subsequent fiscal year, where" for "Where" and "subsection (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)".

Subsec. (e)(2)(B). Pub. L. 108–214, §2(a)(2)(C)(ii)(I), substituted "firms, which show" for "firms. which show".

Subsec. (e)(2)(C). Pub. L. 108–214, §2(a)(2)(C)(ii)(II), (d)(2)(B)(iii), substituted "For fiscal year 2004 and each subsequent fiscal year, where" for "Where" in cl. (i), "subsection (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)" in cls. (i) and (ii), and "subsection (a)(2)(A)(i)" for "subsection (a)(1)(A)(i)" in cl. (ii).

Subsec. (f). Pub. L. 108–214, §2(a)(2)(D), struck out "for filing" after "accepted".

Subsec. (h)(2)(B). Pub. L. 108–214, §2(a)(2)(E), designated existing provisions as cl. (i), inserted heading, redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i), redesignated former subcls. (I) and (II) of cl. (i) as items (aa) and (bb), respectively, of cl. (i)(II), and added cl. (ii).

Subsec. (j). Pub. L. 108–214, §2(d)(2)(B)(iv), substituted "subsection (a)(2)(D)" for "subsection (a)(1)(D)".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: "The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017]."

Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

Effective Date of 2017 Amendment

Amendment by section 203 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all submissions listed in subsection (a)(2)(A) of this section received on or after Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Effective Date of 2007 Amendment

Amendment by Pub. L. 110–85 effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379i of this title.

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2027, see section 2007(a) of Pub. L. 117–180, set out as a note under section 379i of this title.

Section effective Oct. 26, 2002, except for certain premarket fees, see section 106 of Pub. L. 107–250, set out as a note under section 379i of this title.

Fee Exemption for Certain Entities Submitting Premarket Reports

Pub. L. 107–250, title I, §102(b), Oct. 26, 2002, 116 Stat. 1600, as amended by Pub. L. 108–214, §2(d)(2)(C), (3)(B), Apr. 1, 2004, 118 Stat. 577, provided that: "A person submitting a premarket report to the Secretary of Health and Human Services is exempt from the fee under section 738(a)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j(a)(2)(A)(ii)] (as added by subsection (a) of this section) if—

"(1) the premarket report is the first such report submitted to the Secretary by the person; and

"(2) before October 1, 2002, the person submitted a premarket application to the Secretary for the same device as the device for which the person is submitting the premarket report."

¹ See References in Text note below.

§379j–1. Reauthorization; reporting requirements

(a) Reports

(1) Performance report

(A) In general

(i) General requirements

Beginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(ii) Additional information

Beginning with fiscal year 2023, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—

(I) the number of premarket applications filed under section 360e of this title per fiscal year for each review division;

(II) the number of reports submitted under section 360(k) of this title per fiscal year for each review division;

(III) the number of expedited development and priority review designations under section 360e–3 ¹ of this title per fiscal year;

(IV) the number of investigational device exemption applications submitted under section 360j(g) of this title per fiscal year, including for each review division; and

(V) the number of expedited development and priority review requests and designations under section 360e–3 of this title per fiscal year, including for each review division.

 Nothing in this clause shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5.

(iii) Real time reporting

(I) In general

Not later than 30 calendar days after the end of the second quarter of fiscal year 2023, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph.

(II) Data

The Secretary shall post the following data in accordance with subclause (I):

(aa) The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022; and

(bb) The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022.

(iv) Rationale for MDUFA program changes

Beginning with fiscal year 2023, the Secretary shall include in the annual report under paragraph (1)—

(I) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying—

(aa) drivers of such changes; and

(bb) changes in the average total cost per full-time equivalent in the medical device review program;

(III) for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and

(IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types.

(v) Analysis

For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:

(I) The difference between the aggregate number of premarket applications filed under section 360e of this title and aggregate reports submitted under section 360(k) of this title and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for—

(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

(bb) the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year.

(II) Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year.

(III) The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022.

(B) Publication

With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b).

(C) Updates

The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.

(2) Corrective action report

Beginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(A) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the medical device application review process.

(B) Goals missed

For each of the goals identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(i) a justification for such determination;

(ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under section 360e of this title or notifications submitted under section 360(k) of this title missed the review goal times but were approved during the first cycle review, as applicable;

(iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and

(iv) the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such ² fiscal year.

(3) Enhanced communication

(A) Communications with Congress

Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

(B) Participation in congressional hearing

Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.

(4) Fiscal report

For fiscal years 2023 through 2027, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.

(5) Public availability

The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration.

(b) Reauthorization

(1) Consultation

In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(C) scientific and academic experts;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a)(1);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Updates to Congress

The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(5) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

Not later than January 15, 2027, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(7) Minutes of negotiation meetings

(A) Public availability

The Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.

(B) Content

The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §738A, as added Pub. L. 110–85, title II, §213, Sept. 27, 2007, 121 Stat. 850; amended Pub. L. 112–144, title II, §204, July 9, 2012, 126 Stat. 1006; Pub. L. 115–52, title II, §204, title IX, §§903(b), 904(b), Aug. 18, 2017, 131 Stat. 1016, 1078, 1083; Pub. L. 117–180, div. F, title II, §2004, Sept. 30, 2022, 136 Stat. 2153; Pub. L. 117–328, div. FF, title III, §3626(b), Dec. 29, 2022, 136 Stat. 5884.)

Termination of Section

For termination of section by section 2007(b) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 201(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (a)(1)(A), (B), (2), probably should be a reference to section 2001(b) of the Medical Device User Fee Amendments of 2022, title II of div. F of Pub. L. 117–180, which is set out as a note under section 379i of this title. The Medical Device User Fee Amendments of 2022 does not contain a section 201(b).

Section 360e–3 of this title, referred to in subsec. (a)(1)(A)(ii)(III), was in the original a reference to section 515C of act June 25, 1938, which was renumbered section 515B by Pub. L. 115–52, title IX, §901(f)(2), Aug. 18, 2017, 131 Stat. 1077.

Section 2001(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (a)(1)(A)(iv)(I), is section 2001(b) of title II of div. F of Pub. L. 117–180, which is set out as a note under section 379i of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–180, §2004(a)(1), (2), substituted "fiscal year 2023" for "fiscal year 2018" and "Medical Device User Fee Amendments of 2022" for "Medical Device User Fee Amendments of 2017" wherever appearing.

Subsec. (a)(1)(A)(ii). Pub. L. 117–328, §3626(b)(1)(A)(iii), inserted concluding provisions.

Subsec. (a)(1)(A)(ii)(IV), (V). Pub. L. 117–328, §3626(b)(1)(A), added subcls. (IV) and (V).

Subsec. (a)(1)(A)(iv). Pub. L. 117–180, §2004(a)(3)(B), substituted "fiscal year 2023" for "fiscal year 2020" in introductory provisions of cl. (iv) relating to rationale for MDUFA program changes.

Subsec. (a)(1)(A)(iv)(I). Pub. L. 117–328, §3626(b)(1)(B)(i), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: "data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;".

Subsec. (a)(1)(A)(iv)(II). Pub. L. 117–328, §3626(b)(1)(B)(ii), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: "data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and".

Subsec. (a)(1)(A)(iv)(IV). Pub. L. 117–328, §3626(b)(1)(B)(iii), (iv), added subcl. (IV).

Subsec. (a)(1)(A)(v). Pub. L. 117–180, §2004(a)(3)(A), redesignated cl. (iv) relating to analysis to be included in report as (v).

Subsec. (a)(4). Pub. L. 117–180, §2004(a)(4), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (b)(1). Pub. L. 117–180, §2004(b)(1), substituted "2027" for "2022" in introductory provisions.

Subsec. (b)(4). Pub. L. 117–328, §3626(b)(2)(B), added par. (4). Former par. (4) redesignated (5).

Subsec. (b)(5). Pub. L. 117–328, §3626(b)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).

Pub. L. 117–180, §2004(b)(2), substituted "2027" for "2022".

Subsec. (b)(6), (7). Pub. L. 117–328, §3626(b)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.

Subsec. (b)(7)(A). Pub. L. 117–328, §3626(b)(2)(C)(i), substituted "The" for "Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the" and inserted ", not later than 30 days after each such negotiation meeting" before period at end.

Subsec. (b)(7)(B). Pub. L. 117–328, §3626(b)(2)(C)(ii), inserted ", in sufficient detail," after "shall summarize".

2017—Subsec. (a)(1)(A). Pub. L. 115–52, §903(b), designated existing provisions as cl. (i), inserted heading, and added cls. (ii), (iii), and (iv) related to rationale for MDUFA program changes.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, §204(a)(1)(A), substituted "2018" for "2013" and "the Medical Device User Fee Amendments of 2017" for "the Medical Device User Fee Amendments of 2012".

Subsec. (a)(1)(A)(iv). Pub. L. 115–52, §904(b)(1), added cl. (iv) relating to analysis to be included in report.

Subsec. (a)(1)(B). Pub. L. 115–52, §204(a)(1)(B), substituted "the Medical Device User Fee Amendments of 2017" for "the Medical Device User Fee Amendments Act of 2012".

Subsec. (a)(2), (3). Pub. L. 115–52, §904(b)(2)(B), added pars. (2) and (3). Former pars. (2) and (3) redesignated (4) and (5), respectively.

Subsec. (a)(4). Pub. L. 115–52, §904(b)(2)(A), redesignated par. (2) as (4).

Pub. L. 115–52, §204(a)(2), which directed amendment of par. (2), effective Oct. 1, 2017, by substituting "2018 through 2022" for "2013 through 2017", was executed by making the substitution in par. (4) to reflect the probable intent of Congress and the redesignation of par. (2) as (4), effective Aug. 18, 2017, by Pub. L. 115–52, §904(b)(2)(A). See Amendment note above.

Subsec. (a)(5). Pub. L. 115–52, §904(b)(2)(A), redesignated par. (3) as (5).

Subsec. (b)(1). Pub. L. 115–52, §204(b)(1), substituted "2022" for "2017" in introductory provisions.

Subsec. (b)(5). Pub. L. 115–52, §204(b)(2), substituted "2022" for "2017".

2012—Subsec. (a)(1). Pub. L. 112–144, §204(b)(1), added par. (1) and struck out former par. (1). Prior to amendment, text read as follows: "For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort."

Subsec. (a)(2). Pub. L. 112–144, §204(b)(2), substituted "2013 through 2017" for "2008 through 2012".

Subsec. (b)(1). Pub. L. 112–144, §204(a)(1), substituted "2017" for "2012".

Subsec. (b)(5). Pub. L. 112–144, §204(a)(2), substituted "2017" for "2012".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

Effective Date of 2017 Amendment

Amendment by section 204 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Effective and Termination Dates

Pub. L. 117–180, div. F, title II, §2007(b), Sept. 30, 2022, 136 Stat. 2154, provided that: "Section 738A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1) shall cease to be effective January 31, 2028."

Pub. L. 115–52, title II, §210(b), Aug. 18, 2017, 131 Stat. 1020, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title II, §2007(c), Sept. 30, 2022, 136 Stat. 2154.

[Pub. L. 117–180, div. F, title II, §2007(c), Sept. 30, 2022, 136 Stat. 2154, provided that the repeal of section 210(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Section effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379i of this title.

¹ See References in Text note below.

² So in original.

subpart 4—fees relating to animal drugs

Termination of Subpart

For termination of subpart by section 2307(a), (b) of Pub. L. 118–15, see Termination Date note set out under section 379j–11 of this title and Effective and Termination Dates note set out under section 379j–13 of this title.

§379j–11. Definitions

For purposes of this subpart:

(1)(A) The term "animal drug application" means—

(i) an application for approval of any new animal drug submitted under section 360b(b)(1) of this title; or

(ii) an application for conditional approval of a new animal drug submitted under section 360ccc of this title.

(B) Such term does not include either a new animal drug application submitted under section 360b(b)(2) of this title or a supplemental animal drug application.

(2) The term "supplemental animal drug application" means—

(A) a request to the Secretary to approve a change in an animal drug application which has been approved; or

(B) a request to the Secretary to approve a change to an application approved under section 360b(c)(2) of this title for which data with respect to safety or effectiveness are required.

(3) The term "animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an animal drug application or a supplemental animal drug application has been approved.

(4) The term "animal drug establishment" means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.

(5) The term "investigational animal drug submission" means—

(A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a new animal drug intended to be the subject of an animal drug application or a supplemental animal drug application; or

(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of an animal drug application or supplemental animal drug application in the event of their filing.

(6) The term "animal drug sponsor" means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary.

(7) The term "final dosage form" means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds.

(8) The term "process for the review of animal drug applications" means the following activities of the Secretary with respect to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions:

(A) The activities necessary for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(B) The issuance of action letters which approve animal drug applications or supplemental animal drug applications or which set forth in detail the specific deficiencies in animal drug applications, supplemental animal drug applications, or investigational animal drug submissions and, where appropriate, the actions necessary to place such applications, supplements or submissions in condition for approval.

(C) The inspection of animal drug establishments and other facilities undertaken as part of the Secretary's review of pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(D) Monitoring of research conducted in connection with the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(E) The development of regulations and policy related to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(F) Development of standards for products subject to review.

(G) Meetings between the agency and the animal drug sponsor.

(H) Review of advertising and labeling prior to approval of an animal drug application or supplemental animal drug application, but not after such application has been approved.

(I) The activities necessary for implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to animal drug products subject to review, including implementation activities prior to and following product approval.

(9) The term "costs of resources allocated for the process for the review of animal drug applications" means the expenses in connection with the process for the review of animal drug applications for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific animal drug applications, supplemental animal drug applications, or investigational animal drug submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;

(B) management of information and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under section 379j–12 of this title and accounting for resources allocated for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(10) The term "adjustment factor" applicable to a fiscal year refers to the formula set forth in section 379g(8) of this title with the base or comparator month being October 2002.

(11) The term "person" includes an affiliate thereof.

(12) The term "affiliate" refers to the definition set forth in section 379g(11) of this title.

(June 25, 1938, ch. 675, §739, as added Pub. L. 108–130, §3, Nov. 18, 2003, 117 Stat. 1361; amended Pub. L. 110–85, title I, §109, Sept. 27, 2007, 121 Stat. 842; Pub. L. 110–316, title I, §102, Aug. 14, 2008, 122 Stat. 3510; Pub. L. 113–14, title I, §102, June 13, 2013, 127 Stat. 452; Pub. L. 115–234, title I, §102, Aug. 14, 2018, 132 Stat. 2428; Pub. L. 118–15, div. B, title III, §2302, Sept. 30, 2023, 137 Stat. 86.)

Termination of Section

For termination of section by section 2307(a) of Pub. L. 118–15, see Termination Date note below.

Editorial Notes

Amendments

2023—Par. (3). Pub. L. 118–15, §2302(1), substituted "National Drug Code" for "national drug code".

Par. (8)(I). Pub. L. 118–15, §2302(2), amended subpar. (I) generally. Prior to amendment, subpar. (I) read as follows: "The activities necessary for implementation of the United States and European Union Good Manufacturing Practice Mutual Inspection Agreement with respect to animal drug products subject to review, including implementation activities prior to and following product approval."

2018—Par. (1). Pub. L. 115–234, §102(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "The term 'animal drug application' means an application for approval of any new animal drug submitted under section 360b(b)(1) of this title. Such term does not include either a new animal drug application submitted under section 360b(b)(2) of this title or a supplemental animal drug application."

Par. (8)(I). Pub. L. 115–234, §102(2), added subpar. (I).

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section consisted of pars. (1) to (12) defining similar terms for this subpart.

2008—Par. (6). Pub. L. 110–316, §102(1), substituted "that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary" for ", except for an approved application for which all subject products have been removed from listing under section 360 of this title".

Par. (8)(H). Pub. L. 110–316, §102(2), substituted "but not after such application has been approved" for "but not such activities after an animal drug has been approved".

Par. (10). Pub. L. 110–316, §102(3), substituted "month being October 2002" for "year being 2003".

Pars. (11), (12). Pub. L. 110–316, §102(4), (5), added par. (11) and redesignated former par. (11) as (12).

2007—Pub. L. 110–85, §109(a), substituted "subpart" for "part" in introductory provisions.

Par. (11). Pub. L. 110–85, §109(b), substituted "379g(11)" for "379g(9)".

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Pub. L. 118–15, div. B, title III, §2306, Sept. 30, 2023, 137 Stat. 89, provided that: "The amendments made by this chapter [chapter 1 (§§2301–2307) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title] shall take effect on October 1, 2023, or the date of the enactment of this Act [Sept. 30, 2023], whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amended by this chapter, shall be assessed for animal drug applications and supplemental animal drug applications received on or after October 1, 2023, regardless of the date of the enactment of this Act."

Effective Date of 2018 Amendment

Pub. L. 115–234, title I, §106, Aug. 14, 2018, 132 Stat. 2432, provided that: "The amendments made by this title [see section 101(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title] shall take effect on October 1, 2018, or the date of the enactment of this Act [Aug. 14, 2018], whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], as amended by this title, shall be assessed for animal drug applications and supplemental animal drug applications received on or after October 1, 2018, regardless of the date of the enactment of this Act."

Effective Date of 2013 Amendment

Pub. L. 113–14, title I, §106, June 13, 2013, 127 Stat. 464, provided that: "The amendments made by this title [amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under this section] shall take effect on October 1, 2013, or the date of enactment of this Act [June 13, 2013], whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], as amended by this title, shall be assessed for all animal drug applications and supplemental animal drug applications received on or after October 1, 2013, regardless of the date of the enactment of this Act."

Effective and Termination Dates of 2008 Amendment

Pub. L. 110–316, title I, §107, Aug. 14, 2008, 122 Stat. 3514, provided that: "The amendments made by sections 102, 103, and 104 [enacting section 379j–13 of this title and amending this section and section 379j–12 of this title] shall take effect on October 1, 2008, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], as amended by this title, shall be assessed for all animal drug applications and supplemental animal drug applications received on or after such date, regardless of the date of the enactment of this title [Aug. 14, 2008]."

Pub. L. 110–316, title I, §108, Aug. 14, 2008, 122 Stat. 3515, which provided that the amendments made by sections 102 and 103 of Pub. L. 110–316 (amending this section and section 379j–12 of this title) would cease to be effective Oct. 1, 2013, and that the amendment made by section 104 of Pub. L. 110–316 (enacting section 379j–13 of this title) would cease to be effective Jan. 31, 2014, was repealed by Pub. L. 113–14, title I, §107(c)(1), June 13, 2013, 127 Stat. 464.

Effective Date of 2007 Amendment

Amendment by Pub. L. 110–85 effective Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.

Termination Date

Pub. L. 118–15, div. B, title III, §2307(a), Sept. 30, 2023, 137 Stat. 89, provided that: "Sections 739 and 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. [sic] 21 U.S.C. 379j–11; 379j–12) shall cease to be effective October 1, 2028."

Pub. L. 108–130, §5, Nov. 18, 2003, 117 Stat. 1371, which provided that the amendments made by section 3 of Pub. L. 108–130 (enacting this subpart) would not be in effect after Oct. 1, 2008, and that section 4 of Pub. L. 108–130 (enacting provisions set out as a note below) would not be in effect after 120 days after Oct. 1, 2008, was repealed by Pub. L. 113–14, title I, §107(d), June 13, 2013, 127 Stat. 464, effective Nov. 18, 2003.

Savings Provisions

Pub. L. 118–15, div. B, title III, §2305, Sept. 30, 2023, 137 Stat. 89, provided that: "Notwithstanding the amendments made by this chapter [chapter 1 (§§2301–2307) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of enactment of this chapter [Sept. 30, 2023], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024."

Pub. L. 115–234, title I, §105, Aug. 14, 2018, 132 Stat. 2431, provided that: "Notwithstanding the amendments made by this title [see section 101(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of enactment of this title [Aug. 14, 2018], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019."

Pub. L. 113–14, title I, §105, June 13, 2013, 127 Stat. 463, provided that: "Notwithstanding the amendments made by this title [amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under this section], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of the enactment of this title [June 13, 2013], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2008, but before October 1, 2013, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2014."

Pub. L. 110–316, title I, §106, Aug. 14, 2008, 122 Stat. 3514, provided that: "Notwithstanding section 5 of the Animal Drug User Fee Act of 2003 [Pub. L. 108–130] ([former] 21 U.S.C. 379j–11 note), and notwithstanding the amendments made by this title [enacting section 379j–13 of this title and amending this section and sections 360b and 379j–12 of this title], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of the enactment of this title [Aug. 14, 2008], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after September 1, 2003, but before October 1, 2008, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2009."

Findings

Pub. L. 118–15, div. B, title III, §2301(b), Sept. 30, 2023, 137 Stat. 86, provided that: "Congress finds that the fees authorized by the amendments made in this chapter [chapter 1 (§§2301–2307) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title] will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record."

Similar provisions were contained in the following prior acts:

Pub. L. 115–234, title I, §101(b), Aug. 14, 2018, 132 Stat. 2428.

Pub. L. 113–14, title I, §101(b), June 13, 2013, 127 Stat. 451.

Pub. L. 110–316, title I, §101(b), Aug. 14, 2008, 122 Stat. 3509.

Pub. L. 108–130, §2, Nov. 18, 2003, 117 Stat. 1361.

Accountability and Reports

Pub. L. 108–130, §4, Nov. 18, 2003, 117 Stat. 1370, provided that:

"(a) Public Accountability.—

"(1) Consultation.—In developing recommendations to Congress for the goals and plans for meeting the goals for the process for the review of animal drug applications for the fiscal years after fiscal year 2008, and for the reauthorization of sections 739 and 740 of the Federal Food, Drug, and Cosmetic Act (as added by section 3) [21 U.S.C. 379j–11, 379j–12], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, veterinary professionals, representatives of consumer advocacy groups, and the regulated industry.

"(2) Recommendations.—The Secretary shall—

"(A) publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry;

"(B) present the recommendations to the Committees referred to in that paragraph;

"(C) hold a meeting at which the public may comment on the recommendations; and

"(D) provide for a period of 30 days for the public to provide written comments on the recommendations.

"(b) Performance Reports.—Beginning with fiscal year 2004, not later than 60 days after the end of each fiscal year during which fees are collected under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 2(3) of this Act [set out as a note above] toward expediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submissions during such fiscal year, the future plans of the Food and Drug Administration for meeting the goals, the review times for abbreviated new animal drug applications, and the administrative procedures adopted by the Food and Drug Administration to ensure that review times for abbreviated new animal drug applications are not increased from their current level due to activities under the user fee program.

"(c) Fiscal Report.—Beginning with fiscal year 2004, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (b), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made."

§379j–12. Authority to assess and use animal drug fees

(a) Types of fees

Beginning in fiscal year 2004, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Animal drug application and supplement fee

(A) In general

Each person that submits, on or after September 1, 2003, an animal drug application or a supplemental animal drug application shall be subject to a fee as follows:

(i) A fee established in subsection (c) for an animal drug application, except an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title.

(ii) A fee established in subsection (c), in an amount that is equal to 50 percent of the amount of the fee under clause (i), for—

(I) a supplemental animal drug application for which safety or effectiveness data are required;

(II) an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title; and

(III) an application for conditional approval under section 360ccc of this title of a new animal drug for which an animal drug application submitted under section 360b(b)(1) of this title has been previously approved under section 360b(d)(1) of this title for another intended use.

(B) Payment

The fee required by subparagraph (A) shall be due upon submission of the animal drug application or supplemental animal drug application.

(C) Exceptions for previously filed application or supplement

(i) If an animal drug application or a supplemental animal drug application was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an animal drug application or a supplemental animal drug application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(ii) Beginning with fiscal year 2019, in the case of an animal drug application submitted by a person under section 360b(b)(1) of this title, where such person (or their licensor, assignor, or predecessor-in-interest) previously submitted an application for conditional approval under section 360ccc of this title for the same product and paid the applicable fee under subparagraph (A), the application under section 360b(b)(1) of this title shall not be subject to a fee under subparagraph (A) if submitted within the timeframe specified in section 360ccc(h) of this title.

(D) Refund of fee if application refused for filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any animal drug application or supplemental animal drug application which is refused for filing.

(E) Refund of fee if application withdrawn

If an animal drug application or a supplemental animal drug application is withdrawn after the application or supplement was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the sole discretion to refund the fee under this paragraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.

(2) Animal drug product fee

(A) In general

Each person—

(i) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section 360 of this title; and

(ii) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,

shall pay for each such animal drug product the annual fee established in subsection (c).

(B) Payment; fee due date

Such fee shall be payable for the fiscal year in which the animal drug product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be due each subsequent fiscal year that the product remains listed, upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Limitation

Such fee shall be paid only once for each animal drug product for a fiscal year in which the fee is payable.

(3) Animal drug establishment fee

(A) In general

Each person—

(i) who owns or operates, directly or through an affiliate, an animal drug establishment;

(ii) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section 360 of this title; and

(iii) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,

shall be assessed an annual establishment fee as established in subsection (c) for each animal drug establishment listed in its approved animal drug application as an establishment that manufactures the animal drug product named in the application.

(B) Payment; fee due date

The annual establishment fee shall be assessed in each fiscal year in which the animal drug product named in the application is assessed a fee under paragraph (2) unless the animal drug establishment listed in the application does not engage in the manufacture of the animal drug product during the fiscal year. The fee under this paragraph for a fiscal year shall be due upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Limitation

An establishment shall be assessed only one fee per fiscal year under this section.

(4) Animal drug sponsor fee

(A) In general

Each person—

(i) who meets the definition of an animal drug sponsor within a fiscal year; and

(ii) who, after September 1, 2003, had pending before the Secretary an animal drug application, a supplemental animal drug application, or an investigational animal drug submission,

shall be assessed an annual sponsor fee as established under subsection (c).

(B) Payment; fee due date

The fee under this paragraph for a fiscal year shall be due upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Limitation

Each animal drug sponsor shall pay only one such fee each fiscal year.

(b) Fee revenue amounts

(1) In general

Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2024 through 2028, the fees required under subsection (a) shall be established to generate a total revenue amount of $33,500,000.

(2) Types of fees

Of the total revenue amount established for a fiscal year under paragraph (1)—

(A) 20 percent shall be derived from fees under subsection (a)(1) (relating to animal drug applications and supplements);

(B) 27 percent shall be derived from fees under subsection (a)(2) (relating to animal drug products);

(C) 26 percent shall be derived from fees under subsection (a)(3) (relating to animal drug establishments); and

(D) 27 percent shall be derived from fees under subsection (a)(4) (relating to animal drug sponsors).

(c) Annual fee setting; adjustments

(1) Annual fee setting

Not later than 60 days before the start of each fiscal year beginning after September 30, 2023, the Secretary shall—

(A) establish for that fiscal year animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(B) publish such fee revenue amounts and fees in the Federal Register.

(2) Inflation adjustment

(A) For fiscal year 2025 and subsequent fiscal years, the revenue amounts established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—

(i) one;

(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available; and

(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 years of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available.

(B) Compounded basis.—The adjustment made each fiscal year after fiscal year 2025 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year.

(3) Workload adjustments

(A) In general

For fiscal year 2025 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications, subject to subparagraph (B). With respect to such adjustment—

(i) such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary;

(ii) such adjustment shall be made for each fiscal year that the adjustment determined by the Secretary is greater than 3 percent, except for the first fiscal year that the adjustment is greater than 3 percent; and

(iii) the Secretary shall publish in the Federal Register notice under paragraph (1) the amount of such adjustment and the supporting methodologies.

(B) Rule of application

Under no circumstances shall the workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).

(4) Operating reserve adjustment

(A) In general

For fiscal year 2025 and each subsequent fiscal year, after the fee revenue amount established under subsection (b) is adjusted in accordance with paragraphs (2) and (3), the Secretary shall—

(i) increase the fee revenue amount for such fiscal year, if necessary to provide an operating reserve of not less than 12 weeks; or

(ii) if the Secretary has an operating reserve in excess of the number of weeks specified in subparagraph (C) for that fiscal year, the Secretary shall decrease the fee revenue amount to provide not more than the number of weeks specified in subparagraph (C) for that fiscal year.

(B) Carryover user fees

For purposes of this paragraph, the operating reserve of carryover user fees for the process for the review of animal drug applications does not include carryover user fees that have not been appropriated.

(C) Number of weeks of operating reserves

The number of weeks of operating reserves specified in this subparagraph is—

(i) 22 weeks for fiscal year 2025;

(ii) 20 weeks for fiscal year 2026;

(iii) 18 weeks for fiscal year 2027; and

(iv) 16 weeks for fiscal year 2028.

(D) Publication

If an adjustment to the operating reserve is made under this paragraph, the Secretary shall publish in the Federal Register notice under paragraph (1) the rationale for the amount of the adjustment and the supporting methodologies.

(5) Limit

The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of animal drug applications.

(d) Fee waiver or reduction; exemptions from fees

(1) Waiver or reduction

The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that—

(A) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances;

(B) the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of animal drug applications for such person;

(C) the animal drug application or supplemental animal drug application is intended solely to provide for use of the animal drug in—

(i) a Type B medicated feed (as defined in section 558.3(b)(3) of title 21, Code of Federal Regulations (or any successor regulation)) intended for use in the manufacture of Type C free-choice medicated feeds; or

(ii) a Type C free-choice medicated feed (as defined in section 558.3(b)(4) of title 21, Code of Federal Regulations (or any successor regulation));

(D) the animal drug application or supplemental animal drug application is intended solely to provide for a minor use or minor species indication; or

(E) the sponsor involved is a small business submitting its first animal drug application to the Secretary for review.

(2) Use of standard costs

In making the finding in paragraph (1)(B), the Secretary may use standard costs.

(3) Rules for small businesses

(A) Definition

In paragraph (1)(E), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates.

(B) Waiver of application fee

The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business.

(C) Certification

The Secretary shall require any person who applies for a waiver under paragraph (1)(E) to certify their qualification for the waiver. The Secretary shall periodically publish in the Federal Register a list of persons making such certifications.

(4) Exemption from fees

Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 379h, 379j, 379j–42, or 379j–52 of this title.

(e) Effect of failure to pay fees

An animal drug application or supplemental animal drug application submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. An investigational animal drug submission under section 379j–11(5)(B) of this title that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any animal drug application, supplemental animal drug application or investigational animal drug submission from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due.

(f) Assessment of fees

(1) Limitation

Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2003 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for animal drug applications, supplemental animal drug applications, investigational animal drug submissions, animal drug sponsors, animal drug establishments and animal drug products at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(g) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of animal drug applications.

(2) Collections and appropriation Acts

(A) In general

The fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year, and

(ii) shall be available to defray increases in the costs of the resources allocated for the process for the review of animal drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2003 multiplied by the adjustment factor.

(B) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of animal drug applications—

(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in subparagraph (A)(ii); and

(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii).

(C) Provision for early payments

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

For each of the fiscal years 2024 through 2028, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).

(4) Excess collections

If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).

(h) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(i) Written requests for waivers, reductions, and refunds

To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.

(j) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of animal drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(k) Abbreviated new animal drug applications

The Secretary shall—

(1) to the extent practicable, segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications; and

(2) adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program.

(June 25, 1938, ch. 675, §740, as added Pub. L. 108–130, §3, Nov. 18, 2003, 117 Stat. 1363; amended Pub. L. 110–316, title I, §103, Aug. 14, 2008, 122 Stat. 3510; Pub. L. 113–14, title I, §103, June 13, 2013, 127 Stat. 454; Pub. L. 115–52, title I, §102(a)(2), Aug. 18, 2017, 131 Stat. 1008; Pub. L. 115–234, title I, §103, title III, §304(b), Aug. 14, 2018, 132 Stat. 2428, 2438; Pub. L. 118–15, div. B, title III, §2303, Sept. 30, 2023, 137 Stat. 87.)

Termination of Section

For termination of section by section 2307(a) of Pub. L. 118–15, see Termination Date note below.

Editorial Notes

Amendments

2023—Subsec. (a)(1)(A)(ii)(III). Pub. L. 118–15, §2303(a), added subcl. (III).

Subsec. (b)(1). Pub. L. 118–15, §2303(b), amended par. (1) generally. Prior to amendment, text read as follows: "Subject to subsections (c), (d), (f), and (g)—

"(A) for fiscal year 2019, the fees required under subsection (a) shall be established to generate a total revenue amount of $30,331,240; and

"(B) for each of fiscal years 2020 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $29,931,240."

Subsec. (c)(1). Pub. L. 118–15, §2303(c)(1), amended par. (1) generally. Prior to amendment, text read as follows: "The Secretary shall establish, 60 days before the start of each fiscal year beginning after September 30, 2003, for that fiscal year, animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection."

Subsec. (c)(2)(A). Pub. L. 118–15, §2303(c)(2)(A)(i), substituted "2025" for "2020" in introductory provisions.

Subsec. (c)(2)(A)(iii). Pub. L. 118–15, §2303(c)(2)(A)(ii), substituted "Arlington-Alexandria" for "Baltimore".

Subsec. (c)(2)(B). Pub. L. 118–15, §2303(c)(2)(B), substituted "2025" for "2020".

Subsec. (c)(3)(A). Pub. L. 118–15, §2303(c)(3)(A)(i), substituted "2025" for "2020" and "subparagraph (B)" for "subparagraphs (B) and (C)" in introductory provisions.

Subsec. (c)(3)(A)(ii), (iii). Pub. L. 118–15, §2303(c)(3)(A)(ii), (iii), added cls. (ii) and (iii) and struck out former cl. (ii) which read as follows: "the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies."

Subsec. (c)(3)(B), (C). Pub. L. 118–15, §2303(c)(3)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: "For each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase."

Subsec. (c)(4). Pub. L. 118–15, §2303(c)(4), amended par. (4) generally. Prior to amendment, text read as follows: "For fiscal year 2023, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of animal drug applications for the first 3 months of fiscal year 2024. If the Food and Drug Administration has carryover balances for the process for the review of animal drug applications in excess of 3 months of such operating reserves, then this adjustment will not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2023."

Subsec. (d)(4). Pub. L. 118–15, §2303(d), amended par. (4) generally. Prior to amendment, par. (4) related to exemptions from fees for certain labeling supplements to add number of approved application and for certain animal drug applications.

Subsec. (g)(3). Pub. L. 118–15, §2303(e)(1), (2)(A), substituted "2024 through 2028" for "2019 through 2023" and struck out "and paragraph (5)" after "under subsection (c)".

Subsec. (g)(5). Pub. L. 118–15, §2303(e)(2)(B), struck out par. (5) which related to recovery of collection shortfalls.

2018—Subsec. (a)(1)(C). Pub. L. 115–234, §304(b), substituted "Exceptions" for "Exception" in heading, designated existing provisions as cl. (i), and added cl. (ii).

Subsec. (b)(1)(A). Pub. L. 115–234, §103(a)(1)(A), substituted "2019" for "2014" and "$30,331,240" for "$23,600,000".

Subsec. (b)(1)(B). Pub. L. 115–234, §103(a)(1)(B), substituted "2020 through 2023" for "2015 through 2018" and "$29,931,240" for "$21,600,000".

Subsec. (b)(2). Pub. L. 115–234, §103(a)(2), substituted "established" for "determined" in introductory provisions.

Subsec. (c)(2). Pub. L. 115–234, §103(b)(1), substituted "(A) For fiscal year 2020" for "For fiscal year 2015", redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), added subpar. (B), and struck out concluding provisions which read as follows: "The adjustment made each fiscal year under this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under this paragraph."

Subsec. (c)(3). Pub. L. 115–234, §103(b)(2), amended par. (3) generally. Prior to amendment, text read as follows: "For fiscal year 2015 and subsequent fiscal years, after the revenue amounts established in subsection (b) are adjusted for inflation in accordance with paragraph (2), the revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications. With respect to such adjustment—

"(A) such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary;

"(B) the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies; and

"(C) under no circumstances shall such adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted for inflation under paragraph (2)."

Subsec. (c)(4). Pub. L. 115–234, §103(b)(3), substituted "2023" for "2018" in two places and "2024" for "2019".

Subsec. (d). Pub. L. 115–234, §103(c)(1), inserted "; exemptions from fees" after "reduction" in heading.

Subsec. (d)(1). Pub. L. 115–234, §103(c)(2), substituted "Waiver or reduction" for "In general" in heading.

Subsec. (d)(4). Pub. L. 115–234, §103(c)(3), added par. (4).

Subsec. (g)(3). Pub. L. 115–234, §103(d)(1), substituted "2019 through 2023" for "2014 through 2018", "established" for "determined", and "paragraph (5)" for "paragraph (4)".

Subsec. (g)(4), (5). Pub. L. 115–234, §103(d)(2), added pars. (4) and (5) and struck out former par. (4) which related to offset of overcollections and recovery of collection shortfalls for certain fiscal years.

2017—Subsec. (a)(3)(C). Pub. L. 115–52 amended subpar. (C) generally. Prior to amendment, text read as follows:

"(i) In general.—An establishment shall be assessed only one fee per fiscal year under this section, subject to clause (ii).

"(ii) Certain manufacturers.—If a single establishment manufactures both animal drug products and prescription drug products, as defined in section 379g(3) of this title, such establishment shall be assessed both the animal drug establishment fee and the prescription drug establishment fee, as set forth in section 379h(a)(2) of this title, within a single fiscal year."

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to authority to assess and use animal drug fees.

2008—Subsec. (a)(1)(A)(i). Pub. L. 110–316, §103(a)(1), inserted ", except an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title" after "for an animal drug application".

Subsec. (a)(1)(A)(ii). Pub. L. 110–316, §103(a)(2), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: "A fee established in subsection (b) of this section for a supplemental animal drug application for which safety or effectiveness data are required, in an amount that is equal to 50 percent of the amount of the fee under clause (i)."

Subsec. (b)(1). Pub. L. 110–316, §103(b)(1), substituted "and supplemental and other animal drug application fees" for "and supplemental animal drug application fees" and "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008."

Subsec. (b)(2). Pub. L. 110–316, §103(b)(2), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008."

Subsec. (b)(3). Pub. L. 110–316, §103(b)(3), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008."

Subsec. (b)(4). Pub. L. 110–316, §103(b)(4), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008."

Subsec. (c)(1). Pub. L. 110–316, §103(c)(1)–(3), redesignated par. (2) as (1), substituted "The fee revenues shall be adjusted each fiscal year after fiscal year 2009" for "After the fee revenues are adjusted for inflation in accordance with paragraph (1), the fee revenues shall be further adjusted each fiscal year after fiscal year 2004" in introductory provisions, struck out ", as adjusted for inflation under paragraph (1)" before period in subpar. (B), and struck out former par. (1) relating to inflation adjustment.

Subsec. (c)(2). Pub. L. 110–316, §103(c)(2), (4), redesignated par. (3) as (2) and substituted "2013" for "2008" in two places and "2014" for "2009". Former par. (2) redesignated (1).

Subsec. (c)(3) to (5). Pub. L. 110–316, §103(c)(2), redesignated pars. (4) and (5) as (3) and (4), respectively. Former par. (3) redesignated (2).

Subsec. (g)(3)(A) to (E). Pub. L. 110–316, §103(d), amended subpars. (A) to (E) generally. Prior to amendment, subpars. (A) to (E) read as follows:

"(A) $5,000,000 for fiscal year 2004;

"(B) $8,000,000 for fiscal year 2005;

"(C) $10,000,000 for fiscal year 2006;

"(D) $10,000,000 for fiscal year 2007; and

"(E) $10,000,000 for fiscal year 2008;".

Subsec. (g)(4). Pub. L. 110–316, §103(e), amended par. (4) generally. Prior to amendment, par. (4) read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriations Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Amendment by Pub. L. 118–15 effective Oct. 1, 2023, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amended, to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2023, see section 2306 of Pub. L. 118–15, set out as a note under section 379j–11 of this title.

Effective Date of 2018 Amendment

Amendment by Pub. L. 115–234 effective Oct. 1, 2018, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.) to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2018, see section 106 of Pub. L. 115–234, set out as a note under section 379j–11 of this title.

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 2 of this part to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2013 Amendment

Amendment by Pub. L. 113–14 effective Oct. 1, 2013, see section 106 of Pub. L. 113–14, set out as a note under section 379j–11 of this title.

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–316 effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2008, see section 107 of Pub. L. 110–316, set out as an Effective and Termination Dates of 2008 Amendment note under section 379j–11 of this title.

Termination Date

Section to cease to be effective Oct. 1, 2028, see section 2307(a) of Pub. L. 118–15, set out as a note under section 379j–11 of this title.

Pub. L. 115–234, title I, §107(a), Aug. 14, 2018, 132 Stat. 2432, which provided that section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) would cease to be effective Oct. 1, 2023, was repealed by Pub. L. 118–15, div. B, title III, §2307(c), Sept. 30, 2023, 137 Stat. 89, effective Oct. 1, 2023.

Pub. L. 113–14, title I, §107(a), June 13, 2013, 127 Stat. 464, which provided that section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) would cease to be effective Oct. 1, 2018, was repealed by Pub. L. 115–234, title I, §107(c), Aug. 14, 2018, 132 Stat. 2432, effective Oct. 1, 2018.

§379j–13. Reauthorization; reporting requirements

(a) Performance report

Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) ¹ of the Animal Drug User Fee Amendments of 2023 toward expediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submissions during such fiscal year, the future plans of the Food and Drug Administration for meeting the goals, the review times for abbreviated new animal drug applications, and the administrative procedures adopted by the Food and Drug Administration to ensure that review times for abbreviated new animal drug applications are not increased from their current level due to activities under the user fee program.

(b) Fiscal report

Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.

(c) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(d) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of animal drug applications for the first 5 fiscal years after fiscal year 2028, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Health, Education, Labor, and Pensions of the Senate;

(B) the Committee on Energy and Commerce of the House of Representatives;

(C) scientific and academic experts;

(D) veterinary professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(5) Transmittal of recommendations

Not later than January 15, 2028, the Secretary shall transmit to Congress the revised recommendations under paragraph (4) ² a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(6) Minutes of negotiation meetings

(A) Public availability

Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.

(B) Content

The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §740A, as added Pub. L. 110–316, title I, §104, Aug. 14, 2008, 122 Stat. 3511; amended Pub. L. 113–14, title I, §104, June 13, 2013, 127 Stat. 462; Pub. L. 115–234, title I, §104, Aug. 14, 2018, 132 Stat. 2431; Pub. L. 118–15, div. B, title III, §2304, Sept. 30, 2023, 137 Stat. 89.)

Termination of Section

For termination of section by section 2307(b) of Pub. L. 118–15, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 101(b) of the Animal Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2301(b) of the Animal Drug User Fee Amendments of 2023, chapter 1 of subtitle A of title III of div. B of Pub. L. 118–15, which is set out as a note under section 379j–11 of this title. The Animal Drug User Fee Amendments of 2023 does not contain a section 101(b).

Amendments

2023—Subsec. (a). Pub. L. 118–15, §2304(1), (2), substituted "2024" for "2019" and "2023" for "2018".

Subsec. (b). Pub. L. 118–15, §2304(2), substituted "2024" for "2019".

Subsec. (d)(1), (5). Pub. L. 118–15, §2304(3), substituted "2028" for "2023".

2018—Subsec. (a). Pub. L. 115–234, §104(1), (2), substituted "2019" for "2014" and "2018" for "2013".

Subsec. (b). Pub. L. 115–234, §104(2), substituted "2019" for "2014".

Subsec. (d)(1), (5). Pub. L. 115–234, §104(3), substituted "2023" for "2018".

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to reauthorization of this subpart and reporting requirements.

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Amendment by Pub. L. 118–15 effective Oct. 1, 2023, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amended, to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2023, see section 2306 of Pub. L. 118–15, set out as a note under section 379j–11 of this title.

Effective Date of 2018 Amendment

Amendment by Pub. L. 115–234 effective Oct. 1, 2018, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.) to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2018, see section 106 of Pub. L. 115–234, set out as a note under section 379j–11 of this title.

Effective Date of 2013 Amendment

Amendment by Pub. L. 113–14 effective Oct. 1, 2013, see section 106 of Pub. L. 113–14, set out as a note under section 379j–11 of this title.

Effective and Termination Dates

Pub. L. 118–15, div. B, title III, §2307(b), Sept. 30, 2023, 137 Stat. 89, provided that: "Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) shall cease to be effective January 31, 2029."

Pub. L. 115–234, title I, §107(b), Aug. 14, 2018, 132 Stat. 2432, which provided that section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) would cease to be effective Jan. 31, 2024, was repealed by Pub. L. 118–15, div. B, title III, §2307(c), Sept. 30, 2023, 137 Stat. 89, effective Oct. 1, 2023.

Pub. L. 113–14, title I, §107(b), June 13, 2013, 127 Stat. 464, which provided that section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) would cease to be effective Jan. 31, 2019, was repealed by Pub. L. 115–234, title I, §107(c), Aug. 14, 2018, 132 Stat. 2432, effective Oct. 1, 2018.

Section effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2008, see section 107 of Pub. L. 110–316, set out as an Effective and Termination Dates of 2008 Amendment note under section 379j–11 of this title.

¹ See References in Text note below.

² So in original. Probably should be followed by a comma.

subpart 5—fees relating to generic new animal drugs

Termination of Subpart

For termination of subpart by section 2316(a), (b) of Pub. L. 118–15, see Termination Date notes set out under sections 379j–21 and 379j–22 of this title.

§379j–21. Authority to assess and use generic new animal drug fees

(a) Types of fees

Beginning with respect to fiscal year 2009, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Abbreviated application fee

(A) In general

Each person that submits, on or after July 1, 2008, an abbreviated application for a generic new animal drug shall be subject to a fee as established in subsection (c) for such an application.

(B) Payment

The fee required by subparagraph (A) shall be due upon submission of the abbreviated application.

(C) Exceptions

(i) Previously filed application

If an abbreviated application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an abbreviated application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(ii) Certain abbreviated applications involving combination animal drugs

An abbreviated application which is subject to the criteria in section 360b(d)(4) of this title and submitted on or after October 1, 2013 shall be subject to a fee equal to 50 percent of the amount of the abbreviated application fee established in subsection (c).

(D) Refund of fee if application refused for filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any abbreviated application which is refused for filing.

(E) Refund of fee if application withdrawn

If an abbreviated application is withdrawn after the application was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.

(2) Generic new animal drug product fee

(A) In general

Each person—

(i) who is named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product which has been submitted for listing under section 360 of this title; and

(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application or supplemental abbreviated application,

shall pay for each such generic new animal drug product the annual fee established in subsection (c).

(B) Payment; fee due date

Such fee shall be payable for the fiscal year in which the generic new animal drug product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the generic new animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be due each subsequent fiscal year that the product remains listed, upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Limitation

Such fee shall be paid only once for each generic new animal drug product for a fiscal year in which the fee is payable.

(3) Generic new animal drug sponsor fee

(A) In general

Each person—

(i) who meets the definition of a generic new animal drug sponsor within a fiscal year; and

(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application, a supplemental abbreviated application, or an investigational submission,

shall be assessed an annual generic new animal drug sponsor fee as established under subsection (c).

(B) Payment; fee due date

Such fee shall be due each fiscal year upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Amount of fee

Each generic new animal drug sponsor shall pay only 1 such fee each fiscal year, as follows:

(i) 100 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with more than 6 approved abbreviated applications.

(ii) 75 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with more than 1 and fewer than 7 approved abbreviated applications.

(iii) 50 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with 1 or fewer approved abbreviated applications.

(4) Generic investigational new animal drug file fee

(A) In general

(i) New file request

Each person that submits a request to establish a generic investigational new animal drug file on or after October 1, 2023, shall be assessed a fee as established under subsection (c).

(ii) New submission to established file

Each person that makes a submission to a generic investigational new animal drug file on or after October 1, 2023, where such file was established prior to October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c).

(B) Payment

(i) New file request

The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file.

(ii) New submission to established file

The fee required by subparagraph (A)(ii) shall be due upon the first submission to the generic investigational new animal drug file.

(C) Exceptions

(i) Terminating an existing generic investigational new animal drug file

If a person makes a submission to the generic investigational new animal drug file to terminate that file, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.

(ii) Transferring an existing generic investigational new animal drug file

If a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.

(b) Fee revenue amounts

(1) In general

Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2024 through 2028, the fees required under subsection (a) shall be established to generate a total revenue amount of $25,000,000.

(2) Types of fees

Of the total revenue amount established for a fiscal year under paragraph (1)—

(A) 20 percent shall be derived from fees under subsection (a)(1) (relating to abbreviated applications for a generic new animal drug) and fees under subsection (a)(4) (relating to generic investigational new animal drug files);

(B) 40 percent shall be derived from fees under subsection (a)(2) (relating to generic new animal drug products); and

(C) 40 percent shall be derived from fees under subsection (a)(3) (relating to generic new animal drug sponsors).

(c) Annual fee setting; adjustments

(1) Annual fee setting

The Secretary shall establish, not later than 60 days before the start of each fiscal year beginning after September 30, 2023, for that fiscal year—

(A) abbreviated application fees that are based on the revenue amounts established under subsection (b), the adjustments provided under this subsection, and the amount of fees anticipated to be collected under subsection (a)(4) during that fiscal year;

(B) generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(C) a generic investigational new animal drug file fee of $50,000 for each request or submission described in subsection (a)(4)(A).

(2) Inflation adjustment

(A) In general

For fiscal year 2025 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—

(i) one;

(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available; and

(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available.

(B) Compounded basis

The adjustment made each fiscal year after fiscal year 2025 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year.

(3) Workload adjustments

(A) In general

For fiscal year 2025 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment—

(i) this adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests submitted to the Secretary;

(ii) if the workload adjustment calculated by the Secretary under clause (i) exceeds 25 percent, the Secretary shall use 25 percent for the adjustment; and

(iii) the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.

(B) Reduction of workload-based increase by amount of certain excess collections

For each of fiscal years 2026 through 2028, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.

(C) Rule of application

Under no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).

(4) Final year adjustment

For fiscal year 2028, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of abbreviated applications for generic new animal drugs for the first 3 months of fiscal year 2029. If the Food and Drug Administration has carryover balances for the process for the review of abbreviated applications for generic new animal drugs in excess of 3 months of such operating reserves, then this adjustment shall not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2028.

(5) Limit

The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of abbreviated applications for generic new animal drugs.

(d) Fee waiver or reduction

The Secretary shall grant a waiver from, or a reduction of, one or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.

(e) Effect of failure to pay fees

An abbreviated application for a generic new animal drug submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. An investigational submission for a generic new animal drug that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due.

(f) Assessment of fees

(1) Limitation

Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2008 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for abbreviated applications, generic new animal drug products, generic new animal drug sponsors, and generic investigational new animal drug files at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(g) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of abbreviated applications for generic new animal drugs.

(2) Collections and appropriation Acts

(A) In general

The fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and

(ii) shall be available to defray increases in the costs of the resources allocated for the process for the review of abbreviated applications for generic new animal drugs (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2008 multiplied by the adjustment factor.

(B) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of abbreviated applications for generic new animal drugs—

(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in subparagraph (A)(ii); and

(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii).

(C) Provision for early payments

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

For each of the fiscal years 2024 through 2028, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).

(4) Excess collections

If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).

(5) Recovery of collection shortfalls

The amount of fees otherwise authorized to be collected under this section shall be increased—

(A) for fiscal year 2026, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2024 falls below the amount of fees authorized for fiscal year 2024 under paragraph (3);

(B) for fiscal year 2027, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2025 falls below the amount of fees authorized for fiscal year 2025 under paragraph (3); and

(C) for fiscal year 2028, by the amount, if any, by which the amount collected under this section and appropriated for fiscal years 2026 and 2027 (including estimated collections for fiscal year 2027) falls below the amount of fees authorized for such fiscal years under paragraph (3).

(h) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(i) Written requests for waivers, reductions, and refunds

To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.

(j) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of abbreviated applications for generic new animal drugs, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(k) Definitions

In this section and section 379j–22 of this title:

(1) Abbreviated application for a generic new animal drug

The terms "abbreviated application for a generic new animal drug" and "abbreviated application" mean an abbreviated application for the approval of any generic new animal drug submitted under section 360b(b)(2) of this title. Such term does not include a supplemental abbreviated application for a generic new animal drug.

(2) Adjustment factor

The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by—

(A) for purposes of subsection (f)(1), such Index for October 2002; and

(B) for purposes of subsection (g)(2)(A)(ii), such Index for October 2007.

(3) Costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs

The term "costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs" means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific abbreviated applications, supplemental abbreviated applications, or investigational submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under this section and accounting for resources allocated for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(4) Final dosage form

The term "final dosage form" means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes generic new animal drug products intended for mixing in animal feeds.

(5) Generic new animal drug

The term "generic new animal drug" means a new animal drug that is the subject of an abbreviated application.

(6) Generic new animal drug product

The term "generic new animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved.

(7) Generic new animal drug sponsor

The term "generic new animal drug sponsor" means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary.

(8) Generic investigational new animal drug meeting request

The term "generic investigational new animal drug meeting request" means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug.

(9) Investigational submission for a generic new animal drug

The terms "investigational submission for a generic new animal drug" and "investigational submission" mean—

(A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application; or

(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug.

(10) Person

The term "person" includes an affiliate thereof (as such term is defined in section 379g(11) of this title).

(11) Process for the review of abbreviated applications for generic new animal drugs

The term "process for the review of abbreviated applications for generic new animal drugs" means the following activities of the Secretary with respect to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions:

(A) The activities necessary for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(B) The issuance of action letters which approve abbreviated applications or supplemental abbreviated applications or which set forth in detail the specific deficiencies in abbreviated applications, supplemental abbreviated applications, or investigational submissions and, where appropriate, the actions necessary to place such applications, supplemental applications, or submissions in condition for approval.

(C) The inspection of generic new animal drug establishments and other facilities undertaken as part of the Secretary's review of pending abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(D) Monitoring of research conducted in connection with the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(E) The development of regulations and policy related to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(F) Development of standards for products subject to review.

(G) Meetings between the agency and the generic new animal drug sponsor.

(H) Review of advertising and labeling prior to approval of an abbreviated application or supplemental abbreviated application, but not after such application has been approved.

(I) The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval.

(12) Request to establish a generic investigational new animal drug file

The term "request to establish a generic investigational new animal drug file" means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug.

(13) Supplemental abbreviated application for generic new animal drug

The terms "supplemental abbreviated application for a generic new animal drug" and "supplemental abbreviated application" mean a request to the Secretary to approve a change in an approved abbreviated application.

(June 25, 1938, ch. 675, §741, as added Pub. L. 110–316, title II, §202(b), Aug. 14, 2008, 122 Stat. 3515; amended Pub. L. 113–14, title II, §202, June 13, 2013, 127 Stat. 465; Pub. L. 115–234, title II, §202, Aug. 14, 2018, 132 Stat. 2432; Pub. L. 118–15, div. B, title III, §2312, Sept. 30, 2023, 137 Stat. 90.)

Termination of Section

For termination of section by section 2316(a) of Pub. L. 118–15, see Termination Date note below.

Editorial Notes

Prior Provisions

A prior section 741 of act June 25, 1938, was renumbered section 745 and is classified to section 379k of this title.

Amendments

2023—Subsec. (a)(4). Pub. L. 118–15, §2312(a), added par. (4).

Subsec. (b)(1). Pub. L. 118–15, §2312(b)(1), substituted "2024 through 2028" for "2019 through 2023" and "$25,000,000" for "$18,336,340".

Subsec. (b)(2)(A). Pub. L. 118–15, §2312(b)(2)(A), substituted "20 percent" for "25 percent" and inserted before semicolon at end "and fees under subsection (a)(4) (relating to generic investigational new animal drug files)".

Subsec. (b)(2)(B), (C). Pub. L. 118–15, §2312(b)(2)(B), (C), substituted "40 percent" for "37.5 percent".

Subsec. (c)(1). Pub. L. 118–15, §2312(c)(1), amended par. (1) generally. Prior to amendment, text read as follows: "The Secretary shall establish, 60 days before the start of each fiscal year beginning after September 30, 2008, for that fiscal year, abbreviated application fees, generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection."

Subsec. (c)(2)(A). Pub. L. 118–15, §2312(c)(2)(A), substituted "2025" for "2020" in introductory provisions.

Subsec. (c)(2)(A)(iii). Pub. L. 118–15, §2312(c)(2)(A)(ii), substituted "Arlington-Alexandria" for "Baltimore".

Subsec. (c)(2)(B). Pub. L. 118–15, §2312(c)(2)(B), substituted "2025" for "2020".

Subsec. (c)(3)(A). Pub. L. 118–15, §2312(c)(3)(A)(i), substituted "2025" for "2020" in introductory provisions.

Subsec. (c)(3)(A)(i). Pub. L. 118–15, §2312(c)(3)(A)(ii)(I), substituted "investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests" for "and investigational generic new animal drug protocol submissions".

Subsec. (c)(3)(A)(ii), (iii). Pub. L. 118–15, §2312(c)(3)(A)(ii)(II)–(iv), added cl. (ii) and redesignated former cl. (ii) as (iii).

Subsec. (c)(3)(B). Pub. L. 118–15, §2312(c)(3)(B), substituted "2026 through 2028" for "2021 through 2023".

Subsec. (c)(4). Pub. L. 118–15, §2312(c)(4), substituted "2028" for "2023" in two places and "2029" for "2024".

Subsec. (d). Pub. L. 118–15, §2312(d), amended subsec. (d) generally. Prior to amendment, subsec. (d) related to fee waiver or reduction and exemption from fees.

Subsec. (e). Pub. L. 118–15, §2312(e), substituted "A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue" for "The Secretary may discontinue".

Subsec. (f)(2). Pub. L. 118–15, §2312(f), substituted "products, generic new animal drug sponsors, and generic investigational new animal drug files at any time" for "sponsors, and generic new animal drug products at any time".

Subsec. (g)(3). Pub. L. 118–15, §2312(g)(1), substituted "2024 through 2028" for "2019 through 2023".

Subsec. (g)(4). Pub. L. 118–15, §2312(g)(2), struck out par. (4) relating to offset. Text read as follows: "If the sum of the cumulative amount of fees collected under this section for the fiscal years 2014 through 2016 and the amount of fees estimated to be collected under this section for fiscal year 2017 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2014 through 2017, the excess amount shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2018."

Subsec. (g)(5). Pub. L. 118–15, §2312(g)(3), added par. (5).

Subsec. (k)(8) to (11). Pub. L. 118–15, §2312(h)(1), (2), added par. (8) and redesignated former pars. (8) to (10) as (9) to (11), respectively. Former par. (11) redesignated (13).

Subsec. (k)(11)(I). Pub. L. 118–15, §2312(h)(3), added subpar. (I).

Subsec. (k)(12), (13). Pub. L. 118–15, §2312(h)(1), (4), added par. (12) and redesignated par. (11) as (13).

2018—Subsec. (b). Pub. L. 115–234, §202(a), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts for fiscal years 2014 to 2018.

Subsec. (c)(2). Pub. L. 115–234, §202(b)(1)(B), added par. (2). Former par. (2) redesignated (3).

Subsec. (c)(3). Pub. L. 115–234, §202(b)(1)(A), (2), redesignated par. (2) as (3) and amended it generally. Prior to amendment, text read as follows: "The fee revenues shall be adjusted each fiscal year after fiscal year 2014 to reflect changes in review workload. With respect to such adjustment:

"(A) This adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary. The Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.

"(B) Under no circumstances shall this workload adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b)."

Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 115–234, §202(b)(1)(A), (3), redesignated par. (3) as (4) and substituted "2023" for "2018" in two places and "2024" for "2019". Former par. (4) redesignated (5).

Subsec. (c)(5). Pub. L. 115–234, §202(b)(1)(A), redesignated par. (4) as (5).

Subsec. (d). Pub. L. 115–234, §202(c), amended subsec. (d) generally. Prior to amendment, text read as follows: "The Secretary shall grant a waiver from or a reduction of 1 or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication."

Subsec. (g)(3), (4). Pub. L. 115–234, §202(d), added par. (3) and par. (4) relating to excess collections and struck out former par. (3) which related to authorization of appropriations for fiscal years 2014 to 2018.

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to authority to assess and use generic new animal drug fees.

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Pub. L. 118–15, div. B, title III, §2315, Sept. 30, 2023, 137 Stat. 94, provided that: "The amendments made by this chapter [chapter 2 (§§2311–2316) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title] shall take effect on October 1, 2023, or the date of the enactment of this Act [Sept. 30, 2023], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended by this chapter, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2023, regardless of the date of enactment of this Act."

Effective Date of 2018 Amendment

Pub. L. 115–234, title II, §205, Aug. 14, 2018, 132 Stat. 2435, provided that: "The amendments made by this title [see section 201(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title] shall take effect on October 1, 2018, or the date of the enactment of this Act [Aug. 14, 2018], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as amended by this title, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2018, regardless of the date of enactment of this Act."

Effective Date of 2013 Amendment

Pub. L. 113–14, title II, §205, June 13, 2013, 127 Stat. 474, provided that: "The amendments made by this title [amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title] shall take effect on October 1, 2013, or the date of enactment of this Act [June 13, 2013], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as amended by this title, shall be assessed for all abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2013, regardless of the date of enactment of this Act."

Termination Date

Pub. L. 118–15, div. B, title III, §2316(a), Sept. 30, 2023, 137 Stat. 94, provided that: "Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall cease to be effective October 1, 2028."

Pub. L. 115–234, title II, §206(a), Aug. 14, 2018, 132 Stat. 2435, which provided that section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) would cease to be effective Oct. 1, 2023, was repealed by Pub. L. 118–15, div. B, title III, §2316(c), Sept. 30, 2023, 137 Stat. 94, effective Oct. 1, 2023.

Pub. L. 113–14, title II, §206(a), June 13, 2013, 127 Stat. 474, which provided that section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) would cease to be effective Oct. 1, 2018, was repealed by Pub. L. 115–234, title II, §206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018.

Pub. L. 110–316, title II, §204(a), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendments made by section 202 of Pub. L. 110–316 (enacting this section and amending sections 379k, 379l, and 379o of this title) would cease to be effective Oct. 1, 2013, was repealed by Pub. L. 113–14, title II, §206(c)(1), June 13, 2013, 127 Stat. 474.

Savings Provisions

Pub. L. 118–15, div. B, title III, §2314, Sept. 30, 2023, 137 Stat. 94, provided that: "Notwithstanding the amendments made by this chapter [chapter 2 (§§2311–2316) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this chapter [Sept. 30, 2023], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024."

Pub. L. 115–234, title II, §204, Aug. 14, 2018, 132 Stat. 2435, provided that: "Notwithstanding the amendments made by this title [see section 201(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this title [Aug. 14, 2018], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019."

Pub. L. 113–14, title II, §204, June 13, 2013, 127 Stat. 474, provided that: "Notwithstanding the amendments made by this title [amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as in effect on the day before the date of enactment of this title [June 13, 2013], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2008, but before October 1, 2013, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2014."

Findings

Pub. L. 118–15, div. B, title III, §2311(b), Sept. 30, 2023, 137 Stat. 90, provided that: "Congress finds that the fees authorized by the amendments made in this chapter [chapter 2 (§§2311–2316) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title] will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record."

Similar provisions were contained in the following prior acts:

Pub. L. 115–234, title II, §201(b), Aug. 14, 2018, 132 Stat. 2432.

Pub. L. 113–14, title II, §201(b), June 13, 2013, 127 Stat. 464.

Pub. L. 110–316, title II, §201(b), Aug. 14, 2008, 122 Stat. 3515.

§379j–22. Reauthorization; reporting requirements

(a) Performance reports

Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) ¹ of the Animal Generic Drug User Fee Amendments of 2023 toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs during such fiscal year.

(b) Fiscal report

Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.

(c) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(d) Reauthorization

(1) Consultation

In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of abbreviated applications for generic new animal drugs for the first 5 fiscal years after fiscal year 2028, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(C) scientific and academic experts;

(D) veterinary professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(5) Transmittal of recommendations

Not later than January 15, 2028, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(6) Minutes of negotiation meetings

(A) Public availability

Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.

(B) Content

The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §742, as added Pub. L. 110–316, title II, §203, Aug. 14, 2008, 122 Stat. 3522; amended Pub. L. 113–14, title II, §203, June 13, 2013, 127 Stat. 472; Pub. L. 115–234, title II, §203, Aug. 14, 2018, 132 Stat. 2435; Pub. L. 118–15, div. B, title III, §2313, Sept. 30, 2023, 137 Stat. 93.)

Termination of Section

For termination of section by section 2316(b) of Pub. L. 118–15, see Termination Date note below.

Editorial Notes

References in Text

Section 201(b) of the Animal Generic Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2311(b) of the Animal Generic Drug User Fee Amendments of 2023, chapter 2 of subtitle A of title III of div. B of Pub. L. 118–15, which is set out as a note under section 379j–21 of this title. The Animal Generic Drug User Fee Amendments of 2023 does not contain a section 201(b).

Prior Provisions

A prior section 742 of act June 25, 1938, was renumbered section 746 and is classified to section 379l of this title.

Amendments

2023—Subsec. (a). Pub. L. 118–15, §2313(1), (2), substituted "2024" for "2019" and "2023" for "2018".

Subsec. (b). Pub. L. 118–15, §2313(2), substituted "2024" for "2019".

Subsec. (d)(1), (5). Pub. L. 118–15, §2313(3), substituted "2028" for "2023".

2018—Subsec. (a). Pub. L. 115–234, §203(1), (3), substituted "2019" for "2014" and "2018" for "2013".

Subsec. (b). Pub. L. 115–234, §203(2), (3), substituted "2019" for "2014" and "to the Committee on Health, Education, Labor and Pensions" for "to Committee on Health, Education, Labor, and Pensions".

Subsec. (d)(1), (5). Pub. L. 115–234, §203(4), substituted "2023" for "2018".

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to reauthorization of this subpart and reporting requirements.

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Amendment by Pub. L. 118–15 effective Oct. 1, 2023, and fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended, to be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after Oct. 1, 2023, see section 2315 of Pub. L. 118–15, set out as a note under section 379j–21 of this title.

Effective Date of 2018 Amendment

Amendment by Pub. L. 115–234 effective on Oct. 1, 2018, and fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended, to be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after Oct. 1, 2018, see section 205 of Pub. L. 115–234, set out as a note under section 379j–21 of this title.

Effective Date of 2013 Amendment

Amendment by Pub. L. 113–14 effective Oct. 1, 2013, see section 205 of Pub. L. 113–14, set out as a note under section 379j–21 of this title.

Termination Date

Pub. L. 118–15, div. B, title III, §2316(b), Sept. 30, 2023, 137 Stat. 94, provided that: "Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2029."

Pub. L. 115–234, title II, §206(b), Aug. 14, 2018, 132 Stat. 2435, which provided that section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) would cease to be effective Jan. 31, 2024, was repealed by Pub. L. 118–15, div. B, title III, §2316(c), Sept. 30, 2023, 137 Stat. 94, effective Oct. 1, 2023.

Pub. L. 113–14, title II, §206(b), June 13, 2013, 127 Stat. 474, which provided that section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) would cease to be effective Jan. 31, 2019, was repealed by Pub. L. 115–234, title II, §206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018.

Pub. L. 110–316, title II, §204(b), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendment made by section 203 of Pub. L. 110–316 (enacting this section) would cease to be effective Jan. 31, 2014, was repealed by Pub. L. 113–14, title II, §206(c)(1), June 13, 2013, 127 Stat. 474.

¹ See References in Text note below.

subpart 6—fees related to food

§379j–31. Authority to collect and use fees

(a) In general

(1) Purpose and authority

For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from—

(A) the responsible party for each domestic facility (as defined in section 350d(b) ¹ of this title) and the United States agent for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;

(B) the responsible party for a domestic facility (as defined in section 350d(b) ¹ of this title) and an importer who does not comply with a recall order under section 350l of this title or under section 350a(f) of this title in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year;

(C) each importer participating in the voluntary qualified importer program under section 384b of this title in such year, to cover the administrative costs of such program for such year; and

(D) each importer subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year.

(2) Definitions

For purposes of this section—

(A) the term "reinspection" means—

(i) with respect to domestic facilities (as defined in section 350d(b) ¹ of this title), 1 or more inspections conducted under section 374 of this title subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary's satisfaction; and

(ii) with respect to importers, 1 or more examinations conducted under section 381 of this title subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary's satisfaction;

(B) the term "reinspection-related costs" means all expenses, including administrative expenses, incurred in connection with—

(i) arranging, conducting, and evaluating the results of reinspections; and

(ii) assessing and collecting reinspection fees under this section; and

(C) the term "responsible party" has the meaning given such term in section 350f(a)(1) of this title.

(b) Establishment of fees

(1) In general

Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.

(2) Fee methodology

(A) Fees

Fees amounts established for collection—

(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year;

(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year;

(iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (C) for such year; and

(iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (D) for such year.

(B) Other considerations

(i) Voluntary qualified importer program

In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 384b(c) of this title informing the Secretary of the intent of such importer to participate in the program under section 384b of this title in such fiscal year.

(II) ² Recoupment

In establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal years after January 4, 2011, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under section 384b of this title.

(ii) Crediting of fees

In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.

(iii) Published guidelines

Not later than 180 days after January 4, 2011, the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. Such consideration may include reduced fee amounts for small businesses. The Secretary shall provide for a period of public comment on such guidelines. The Secretary shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking.

(3) Use of fees

The Secretary shall make all of the fees collected pursuant to clause ³ (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively.

(c) Limitations

(1) In general

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless the amount of the total appropriations for food safety activities at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) is equal to or greater than the amount of appropriations for food safety activities at the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year), multiplied by the adjustment factor under paragraph (3).

(2) Authority

If—

(A) the Secretary does not assess fees under subsection (a) for a portion of a fiscal year because paragraph (1) applies; and

(B) at a later date in such fiscal year, such paragraph (1) ceases to apply,

the Secretary may assess and collect such fees under subsection (a), without any modification to the rate of such fees, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(3) Adjustment factor

(A) In general

The adjustment factor described in paragraph (1) shall be the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative.

(B) Compounded basis

The adjustment under subparagraph (A) made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2009.

(4) Limitation on amount of certain fees

(A) In general

Notwithstanding any other provision of this section and subject to subparagraph (B), the Secretary may not collect fees in a fiscal year such that the amount collected—

(i) under subparagraph (B) of subsection (a)(1) exceeds $20,000,000; and

(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined.

(B) Exception

If a domestic facility (as defined in section 350d(b) ¹ of this title) or an importer becomes subject to a fee described in subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of fees has been collected by the Secretary under subparagraph (A), the Secretary may collect a fee from such facility or importer.

(d) Crediting and availability of fees

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees.

(e) Collection of fees

(1) In general

The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time and manner in which fees assessed under this section shall be collected.

(2) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31.

(f) Annual report to Congress

Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage.

(g) Authorization of appropriations

For fiscal year 2010 and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.

(June 25, 1938, ch. 675, §743, as added Pub. L. 111–353, title I, §107(a), Jan. 4, 2011, 124 Stat. 3906.)

Editorial Notes

References in Text

Section 350d(b) of this title, referred to in subsecs. (a)(1)(A), (B), (2)(A)(i) and (c)(4)(B), was redesignated section 350d(c) by Pub. L. 111–353, title I, §102(b)(1)(B), Jan. 4, 2011, 124 Stat. 3887.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

¹ See References in Text note below.

² So in original. No subcl. (I) has been enacted.

³ So in original. Probably should be "clauses".

subpart 7—fees relating to generic drugs

§379j–41. Definitions

For purposes of this subpart:

(1) The term "abbreviated new drug application"—

(A) means an application submitted under section 355(j) of this title, an abbreviated application submitted under section 357 of this title (as in effect on the day before November 21, 1997), or an abbreviated new drug application submitted pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and

(B) does not include an application—

(i) for a positron emission tomography drug; or

(ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially.

(2) The term "active pharmaceutical ingredient" means—

(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended—

(i) to be used as a component of a drug; and

(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or

(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).

(3) The term "adjustment factor" means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011.

(4) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(5) The term "contract manufacturing organization facility" means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.

(6)(A) The term "facility"—

(i) means a business or other entity—

(I) under one management, either direct or indirect; and

(II) at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and

(ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.

(B) For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are—

(i) closely related to the same business enterprise;

(ii) under the supervision of the same local management; and

(iii) capable of being inspected by the Food and Drug Administration during a single inspection.

(C) If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.

(7) The term "finished dosage form" means—

(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;

(B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or

(C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).

(8) The term "generic drug submission" means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application.

(9) The term "human generic drug activities" means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:

(A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.

(B) The issuance of—

(i) approval letters which approve abbreviated new drug applications or supplements to such applications; or

(ii) complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.

(C) The issuance of letters related to Type II active pharmaceutical drug master files which—

(i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or

(ii) document that no deficiencies need to be addressed.

(D) Inspections related to generic drugs.

(E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.

(F) Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:

(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.

(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies) insofar as those activities relate to abbreviated new drug applications.

(v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).

(G) Regulatory science activities related to generic drugs.

(10) The term "positron emission tomography drug" has the meaning given to the term "compounded positron emission tomography drug" in section 321(ii) of this title, except that paragraph (1)(B) of such section shall not apply.

(11) The term "prior approval supplement" means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.

(12) The term "resources allocated for human generic drug activities" means the expenses for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers and employees and to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under subsection (a) and accounting for resources allocated for the review of abbreviated new drug applications and supplements and inspection related to generic drugs.

(13) The term "Type II active pharmaceutical ingredient drug master file" means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.

(June 25, 1938, ch. 675, §744A, as added Pub. L. 112–144, title III, §302, July 9, 2012, 126 Stat. 1008; amended Pub. L. 115–52, title III, §302, Aug. 18, 2017, 131 Stat. 1020.)

Termination of Section

For termination of section by section 3004(a) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

References in Text

Section 357 of this title, referred to in par. (1)(A), was repealed by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in par. (1)(A), is Pub. L. 98–417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables.

Amendments

2017—Par. (1)(B). Pub. L. 115–52, §302(1), substituted "application—" for "application for a positron emission tomography drug." and added cls. (i) and (ii).

Pars. (5) to (13). Pub. L. 115–52, §302(2), (3), added par. (5) and redesignated former pars. (5) to (12) as (6) to (13), respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–180, div. F, title III, §3005, Sept. 30, 2022, 136 Stat. 2159, provided that: "The amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.) shall be assessed for all abbreviated new drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act."

Effective Date of 2017 Amendment

Pub. L. 115–52, title III, §306, Aug. 18, 2017, 131 Stat. 1027, provided that: "The amendments made by this title [see section 301(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–41 et seq.] shall be assessed for all abbreviated new drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective and Termination Dates

Pub. L. 117–180, div. F, title III, §3004(a), Sept. 30, 2022, 136 Stat. 2159, provided that: "Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall cease to be effective October 1, 2027."

Pub. L. 115–52, title III, §305(a), Aug. 18, 2017, 131 Stat. 1027, which provided that this section and section 379j–42 of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title III, §3004(c), Sept. 30, 2022, 136 Stat. 2159.

[Pub. L. 117–180, div. F, title III, §3004(c), Sept. 30, 2022, 136 Stat. 2159, provided that the repeal of section 305(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title III, §304(a), July 9, 2012, 126 Stat. 1024, which provided that this section and section 379j–42 of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title III, §305(c)(1), Aug. 18, 2017, 131 Stat. 1027.

[Pub. L. 115–52, title III, §305(c)(1), Aug. 18, 2017, 131 Stat. 1027, provided that the repeal of section 304(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 112–144, title III, §305, July 9, 2012, 126 Stat. 1024, provided that: "The amendments made by this title [enacting this section and sections 379d–4, 379j–42, and 379j–43 of this title and amending sections 352 and 379d–3 of this title] shall take effect on October 1, 2012, or the date of the enactment of this title [July 9, 2012], whichever is later, except that fees under section 302 [enacting this section and sections 379j–42 and 379j–43 of this title] shall be assessed for all human generic drug submissions and Type II active pharmaceutical drug master files received on or after October 1, 2012, regardless of the date of enactment of this title."

Savings Clause

Pub. L. 117–180, div. F, title III, §3006, Sept. 30, 2022, 136 Stat. 2159, provided that: "Notwithstanding the amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title], part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023."

Pub. L. 115–52, title III, §307, Aug. 18, 2017, 131 Stat. 1027, provided that: "Notwithstanding the amendments made by this title [amending this section and sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title], part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–41 et seq.], as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Congressional Findings Concerning Fees Relating to Human Generic Drugs

Pub. L. 117–180, div. F, title III, §3001(b), Sept. 30, 2022, 136 Stat. 2155, provided that: "Congress finds that the fees authorized by the amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title] will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 115–52, title III, §301(b), Aug. 18, 2017, 131 Stat. 1020, provided that: "The Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title] will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–41 et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title III, §301(b), July 9, 2012, 126 Stat. 1008, provided that: "The Congress finds that the fees authorized by the amendments made in this title [enacting this section and sections 379d–4, 379j–42, and 379j–43 of this title and amending sections 352 and 379d–3 of this title] will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

§379j–42. Authority to assess and use human generic drug fees

(a) Types of fees

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) One-time backlog fee for abbreviated new drug applications pending on October 1, 2012

(A) In general

Each person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date, shall be subject to a fee for each such application, as calculated under subparagraph (B).

(B) Method of fee amount calculation

The amount of each one-time backlog fee shall be calculated by dividing $50,000,000 by the total number of abbreviated new drug applications pending on October 1, 2012, that have not received a tentative approval as of that date.

(C) Notice

Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the fee required by subparagraph (A).

(D) Fee due date

The fee required by subparagraph (A) shall be due no later than 30 calendar days after the date of the publication of the notice specified in subparagraph (C).

(E) Sunset

This paragraph shall cease to be effective October 1, 2022.

(2) Drug master file fee

(A) In general

Each person that owns a Type II active pharmaceutical ingredient drug master file that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a drug master file fee.

(B) One-time payment

If a person has paid a drug master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required to pay a subsequent drug master file fee when that Type II active pharmaceutical ingredient drug master file is subsequently referenced in generic drug submissions.

(C) Notice

Not later than 60 days before the start of each of fiscal years 2023 through 2027, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year.

(D) Availability for reference

(i) In general

Subject to subsection (g)(2)(C), for a generic drug submission to reference a Type II active pharmaceutical ingredient drug master file, the drug master file must be deemed available for reference by the Secretary.

(ii) Conditions

A drug master file shall be deemed available for reference by the Secretary if—

(I) the person that owns a Type II active pharmaceutical ingredient drug master file has paid the fee required under subparagraph (A) within 20 calendar days after the applicable due date under subparagraph (E); and

(II) the drug master file has not failed an initial completeness assessment by the Secretary, in accordance with criteria to be published by the Secretary.

(iii) List

The Secretary shall make publicly available on the Internet Web site of the Food and Drug Administration a list of the drug master file numbers that correspond to drug master files that have successfully undergone an initial completeness assessment, in accordance with criteria to be published by the Secretary, and are available for reference.

(E) Fee due date

(i) In general

Subject to clause (ii), a drug master file fee shall be due on the earlier of—

(I) the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file; or

(II) the date on which the drug master file holder requests the initial completeness assessment.

(ii) Limitation

No fee shall be due under subparagraph (A) for a fiscal year until the later of—

(I) 30 calendar days after publication of the notice provided for in subparagraph (C); or

(II) 30 calendar days after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(3) Abbreviated new drug application filing fee

(A) In general

Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application shall be subject to a fee for each such submission in the amount established under subsection (d).

(B) Notice

Not later than 60 days before the start of each of fiscal years 2023 through 2027, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(C) Fee due date

The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.

(D) Refund of fee if abbreviated new drug application is not considered to have been received, is withdrawn prior to being received, or is no longer received

(i) Applications not considered to have been received and applications withdrawn prior to being received

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 355(j)(5)(A) of this title for a cause other than failure to pay fees, or that has been withdrawn prior to being received within the meaning of section 355(j)(5)(A) of this title.

(ii) Applications no longer received

The Secretary shall refund 100 percent of the fee paid under subparagraph (A) for any abbreviated new drug application if the Secretary initially receives the application under section 355(j)(5)(A) of this title and subsequently determines that an exclusivity period for a listed drug should have prevented the Secretary from receiving such application, such that the abbreviated new drug application is no longer received within the meaning of section 355(j)(5)(A) of this title.

(E) Fee for an application the Secretary considers not to have been received, or that has been withdrawn

An abbreviated new drug application that was submitted on or after October 1, 2012, and that the Secretary considers not to have been received, or that has been withdrawn, shall, upon resubmission of the application or a subsequent new submission following the applicant's withdrawal of the application, be subject to a full fee under subparagraph (A).

(F) Additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file

An applicant that submits a generic drug submission on or after October 1, 2017, shall pay a fee, in the amount determined under subsection (d)(2), in addition to the fee required under subparagraph (A), if—

(i) such submission contains information concerning the manufacture of an active pharmaceutical ingredient at a facility by means other than reference by a letter of authorization to a Type II active pharmaceutical drug master file; and

(ii) a fee in the amount equal to the drug master file fee established in paragraph (2) has not been previously paid with respect to such information.

(4) Generic drug facility fee and active pharmaceutical ingredient facility fee

(A) In general

Facilities identified in at least one generic drug submission that is approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees as follows:

(i) Generic drug facility

Each person that owns a facility which is identified in at least one generic drug submission that is approved to produce one or more finished dosage forms of a human generic drug shall be assessed an annual fee for each such facility.

(ii) Active pharmaceutical ingredient facility

Each person that owns a facility which is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such generic drug submission, shall be assessed an annual fee for each such facility.

(iii) Facilities producing both active pharmaceutical ingredients and finished dosage forms

Each person that owns a facility identified in at least one generic drug submission that is approved to produce both one or more finished dosage forms subject to clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject only to the fee attributable to the manufacture of the finished dosage forms for that facility.

(B) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (d).

(C) Notice

Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(D) Fee due date

For each of fiscal years 2023 through 2027, the fees under subparagraph (A) for such fiscal year shall be due on the later of—

(i) the first business day on or after October 1 of each such year; or

(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year.

(5) Generic drug applicant program fee

(A) In general

A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E).

(B) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (d).

(C) Notice

Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(D) Fee due date

For each of fiscal years 2023 through 2027, the fees under subparagraph (A) for such fiscal year shall be due on the later of—

(i) the first business day on or after October 1 of each such fiscal year; or

(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year.

(6) Date of submission

For purposes of this chapter, a generic drug submission or Type II pharmaceutical master file is deemed to be "submitted" to the Food and Drug Administration—

(A) if it is submitted via a Food and Drug Administration electronic gateway, on the day when transmission to that electronic gateway is completed, except that a submission or master file that arrives on a weekend, Federal holiday, or day when the Food and Drug Administration office that will review that submission is not otherwise open for business shall be deemed to be submitted on the next day when that office is open for business; or

(B) if it is submitted in physical media form, on the day it arrives at the appropriate designated document room of the Food and Drug Administration.

(b) Fee revenue amounts

(1) In general

(A) Fiscal year 2023

For fiscal year 2023, fees under subsection (a) shall be established to generate a total estimated revenue amount under such subsection of $582,500,000.

(B) Fiscal years 2024 through 2027

(i) In general

For each of the fiscal years 2024 through 2027, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause (ii), as adjusted pursuant to subsection (c).

(ii) Base revenue amount

The base revenue amount for a fiscal year referred to in clause (i) is equal to the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3).

(2) Types of fees

In establishing fees under paragraph (1) to generate the revenue amounts specified in such paragraph for a fiscal year, such fees shall be derived from the fees under paragraphs (2) through (5) of subsection (a) as follows:

(A) Five percent shall be derived from fees under subsection (a)(2) (relating to drug master files).

(B) Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications).

(C) Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to twenty-four percent of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions.

(D) Six percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States, including its territories and possessions.

(E)(i) Thirty-six percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary shall determine the fees as follows:

(I) If a person (including its affiliates) owns at least one but not more than 5 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee.

(II) If a person (including its affiliates) owns at least 6 but not more than 19 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee.

(III) If a person (including its affiliates) owns 20 or more approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee.

(ii) For purposes of this subparagraph, an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.

(c) Adjustments

(1) Inflation adjustment

For fiscal year 2024 and subsequent fiscal years, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied by an amount equal to the sum of—

(A) one;

(B) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years multiplied by the proportion of personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years; and

(C) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years.

(2) Capacity planning adjustment

(A) In general

Beginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities.

(B) Capacity planning methodology

The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—

(i) be derived from the methodology and recommendations made in the report titled "Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations" announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and

(ii) incorporate approaches and attributes determined appropriate by the Secretary, including approaches and attributes made in such report, except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section VIII.B.2.e. of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022.

(C) Limitations

(i) In general

Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection (b)(1)(B)(ii) (the base revenue amount for the fiscal year) and paragraph (1) (the dollar amount of the inflation adjustment for the fiscal year).

(ii) Additional limitation

An adjustment under this paragraph shall not exceed 3 percent of the sum described in clause (i) for the fiscal year, except that such limitation shall be 4 percent if—

(I) for purposes of a fiscal year 2024 adjustment, the Secretary determines that during the period from April 1, 2021, through March 31, 2023—

(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or

(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022);

(II) for purposes of a fiscal year 2025 adjustment, the Secretary determines that during the period from April 1, 2022, through March 31, 2024—

(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined);

(III) for purposes of a fiscal year 2026 adjustment, the Secretary determines that during the period from April 1, 2023, through March 31, 2025—

(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and

(IV) for purposes of a fiscal year 2027 adjustment, the Secretary determines that during the period from April 1, 2024, through March 31, 2026—

(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined).

(D) Publication in Federal Register

The Secretary shall publish in the Federal Register notice referred to in subsection (a) the fee revenue and fees resulting from the adjustment and the methodology under this paragraph.

(3) Operating reserve adjustment

(A) In general

For fiscal year 2024 and each subsequent fiscal year, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees under this section for such fiscal year if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B) with respect to that fiscal year.

(B) Number of weeks

The number of weeks specified in this subparagraph is—

(i) 8 weeks for fiscal year 2024;

(ii) 9 weeks for fiscal year 2025; and

(iii) 10 weeks for each of fiscal year 2026 and 2027.

(C) Decrease

If the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves.

(D) Rationale for adjustment

If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under subsection (a) publishing the fee revenue and fees for the fiscal year involved.

(d) Annual fee setting

(1) Fiscal years 2023 through 2027

Not later than 60 days before the first day of each of fiscal years 2023 through 2027, the Secretary shall establish the fees described in paragraphs (2) through (5) of subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c).

(2) Fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file

In establishing the fee under paragraph (1), the amount of the fee under subsection (a)(3)(F) shall be determined by multiplying—

(A) the sum of—

(i) the total number of such active pharmaceutical ingredients in such submission; and

(ii) for each such ingredient that is manufactured at more than one such facility, the total number of such additional facilities; and

(B) the amount equal to the drug master file fee established in subsection (a)(2) for such submission.

(e) Limitations

(1) In general

The total amount of fees charged, as adjusted under subsection (c), for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for human generic drug activities.

(2) Leasing and necessary equipment

Beginning on October 1, 2023, the authorities under section 379j–41(12)(C) of this title shall include only leasing and necessary scientific equipment.

(f) Identification of facilities

(1) Required submission of facility identification

Each person that owns a facility described in subsection (a)(4)(A) or a site or organization required to be identified by paragraph (3) shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.

(2) Information required to be submitted

At a minimum, the submission required by paragraph (1) shall include for each such facility—

(A) identification of a facility identified in an approved or pending generic drug submission;

(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both;

(C) whether or not the facility is located within the United States and its territories and possessions;

(D) whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs;

(E) whether the facility manufactures drugs that are not generic drugs; and

(F) whether the facility is a contract manufacturing organization facility.

(3) Certain sites and organizations

(A) In general

Any person that owns or operates a site or organization described in subparagraph (B) shall submit to the Secretary information concerning the ownership, name, and address of the site or organization.

(B) Sites and organizations

A site or organization is described in this subparagraph if it is identified in a generic drug submission and is—

(i) a site in which a bioanalytical study is conducted;

(ii) a clinical research organization;

(iii) a contract analytical testing site; or

(iv) a contract repackager site.

(C) Notice

The Secretary may, by notice published in the Federal Register, specify the means and format for submission of the information under subparagraph (A) and may specify, as necessary for purposes of this section, any additional information to be submitted.

(D) Inspection authority

The Secretary's inspection authority under section 374(a)(1) of this title shall extend to all such sites and organizations.

(g) Effect of failure to pay fees

(1) Generic drug backlog fee

Failure to pay the fee under subsection (a)(1) shall result in the Secretary placing the person that owns the abbreviated new drug application subject to that fee on a publicly available arrears list, such that no new abbreviated new drug applications or supplement submitted on or after October 1, 2012, from that person, or any affiliate of that person, will be received within the meaning of section 355(j)(5)(A) of this title until such outstanding fee is paid. This paragraph shall cease to be effective on October 1, 2022.

(2) Drug master file fee

(A) Failure to pay the fee under subsection (a)(2) within 20 calendar days after the applicable due date under subparagraph (E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall result in the Type II active pharmaceutical ingredient drug master file not being deemed available for reference.

(B)(i) Any generic drug submission submitted on or after October 1, 2012, that references, by a letter of authorization, a Type II active pharmaceutical ingredient drug master file that has not been deemed available for reference shall not be received within the meaning of section 355(j)(5)(A) of this title unless the condition specified in clause (ii) is met.

(ii) The condition specified in this clause is that the fee established under subsection (a)(2) has been paid within 20 calendar days of the Secretary providing the notification to the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the drug master file fee as specified in subparagraph (C).

(C)(i) If an abbreviated new drug application or supplement to an abbreviated new drug application references a Type II active pharmaceutical ingredient drug master file for which a fee under subsection (a)(2)(A) has not been paid by the applicable date under subsection (a)(2)(E), the Secretary shall notify the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the applicable fee.

(ii) If such fee is not paid within 20 calendar days of the Secretary providing the notification, the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of section 355(j)(5)(A) of this title.

(3) Abbreviated new drug application fee

Failure to pay a fee under subparagraph (A) or (F) of subsection (a)(3) within 20 calendar days of the applicable due date under subparagraph (C) of such subsection shall result in the abbreviated new drug application or the prior approval supplement to an abbreviated new drug application not being received within the meaning of section 355(j)(5)(A) of this title until such outstanding fee is paid.

(4) Generic drug facility fee and active pharmaceutical ingredient facility fee

(A) In general

Failure to pay the fee under subsection (a)(4) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:

(i) The Secretary shall place the facility on a publicly available arrears list, such that no new abbreviated new drug application or supplement submitted on or after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that person, will be received within the meaning of section 355(j)(5)(A) of this title.

(ii) Any new generic drug submission submitted on or after October 1, 2012, that references such a facility shall not be received, within the meaning of section 355(j)(5)(A) of this title if the outstanding facility fee is not paid within 20 calendar days of the Secretary providing the notification to the sponsor of the failure of the owner of the facility to pay the facility fee under subsection (a)(4)(C).

(iii) All drugs or active pharmaceutical ingredients manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(aa) of this title.

(B) Application of penalties

The penalties under this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility.

(C) Nonreceival for nonpayment

(i) Notice

If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay the facility fee.

(ii) Nonreceival

If the facility fee is not paid within 20 calendar days of the Secretary providing the notification under clause (i), the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of section 355(j)(5)(A) of this title.

(5) Generic drug applicant program fee

(A) In general

A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following:

(i) The Secretary shall place the person on a publicly available arrears list.

(ii) Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of section 355(j)(5)(A) of this title.

(iii) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section 352(aa) of this title.

(B) Application of penalties

The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.

(h) Limitations

(1) In general

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2012, unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor (as defined in section 379j–41 of this title) applicable to the fiscal year involved.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(i) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, subject to paragraph (2). Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for human generic drug activities.

(2) Collections and appropriation Acts

(A) In general

The fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and

(ii) shall be available—

(I) for fiscal year 2023, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor defined in section 379j–41(3) of this title applicable to such fiscal year; and

(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with human generic drug activities, is no less than $97,000,000 multiplied by the adjustment factor defined in section 379j–41(3) of this title applicable to the fiscal year involved.

(B) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable, are not more than 10 percent below the level specified in such subparagraph.

(C) Provision for early payments

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equivalent to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted under subsection (c), if applicable, or as otherwise affected under paragraph (2) of this subsection.

(j) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(k) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(l) Positron emission tomography drugs

(1) Exemption from fees

Submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee under this section. Facilities that solely produce positron emission tomography drugs shall not be required to pay a facility fee as established in subsection (a)(4).

(2) Identification requirement

Facilities that produce positron emission tomography drugs or active pharmaceutical ingredients of such drugs are required to be identified pursuant to subsection (f).

(m) Disputes concerning fees

To qualify for the return of a fee claimed to have been paid in error under this section, a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.

(n) Substantially complete applications

An abbreviated new drug application that is not considered to be received within the meaning of section 355(j)(5)(A) of this title because of failure to pay an applicable fee under this provision within the time period specified in subsection (g) shall be deemed not to have been "substantially complete" on the date of its submission within the meaning of section 355(j)(5)(B)(iv)(II)(cc) of this title. An abbreviated new drug application that is not substantially complete on the date of its submission solely because of failure to pay an applicable fee under the preceding sentence shall be deemed substantially complete and received within the meaning of section 355(j)(5)(A) of this title as of the date such applicable fee is received.

(o) Information on abbreviated new drug applications owned by applicants and their affiliates

(1) In general

By April 1 of each year, each person that owns an abbreviated new drug application, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Secretary a list of—

(A) all approved abbreviated new drug applications owned by such person; and

(B) if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate.

(2) Format and method

The Secretary shall specify in guidance the format and method for submission of lists under this subsection.

(June 25, 1938, ch. 675, §744B, as added Pub. L. 112–144, title III, §302, July 9, 2012, 126 Stat. 1011; amended Pub. L. 112–193, §2(b)(2), (3), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 115–52, title III, §303, title IX, §905(b)(3), Aug. 18, 2017, 131 Stat. 1021, 1090; Pub. L. 117–180, div. F, title III, §3002, Sept. 30, 2022, 136 Stat. 2155; Pub. L. 117–328, div. FF, title III, §3625(c), Dec. 29, 2022, 136 Stat. 5881.)

Termination of Section

For termination of section by section 3004(a) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 3001(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsec. (c)(2)(B)(ii), (C)(ii)(I)(bb), is section 3001(b) of title III of div. F of Pub. L. 117–180, which is set out as a note under section 379j–41 of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–180, §3002(a)(1), substituted "2023" for "2018" in introductory provisions.

Subsec. (a)(2)(C). Pub. L. 117–180, §3002(a)(2), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (a)(3)(B). Pub. L. 117–180, §3002(a)(3), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (a)(4)(D). Pub. L. 117–180, §3002(a)(4), substituted "2023 through 2027" for "2018 through 2022" in introductory provisions.

Subsec. (a)(5)(D). Pub. L. 117–180, §3002(a)(5), substituted "2023 through 2027" for "2018 through 2022" in introductory provisions.

Subsec. (b)(1)(A). Pub. L. 117–180, §3002(b)(1)(A), substituted "2023" for "2018" in heading and "2023" for "2018" and "$582,500,000" for "$493,600,000" in text.

Subsec. (b)(1)(B). Pub. L. 117–180, §3002(b)(1)(B), amended subpar. (B) generally. Prior to amendment, text read as follows: "For each of the fiscal years 2019 through 2022, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to $493,600,000, as adjusted pursuant to subsection (c)."

Subsec. (b)(2)(C). Pub. L. 117–180, §3002(b)(2)(A), substituted "twenty-four percent" for "one-third the amount".

Subsec. (b)(2)(D). Pub. L. 117–180, §3002(b)(2)(B), substituted "Six percent" for "Seven percent".

Subsec. (b)(2)(E)(i). Pub. L. 117–180, §3002(b)(2)(C), substituted "Thirty-six percent" for "Thirty-five percent".

Subsec. (c)(1). Pub. L. 117–180, §3002(c)(1)(A), in introductory provisions, substituted "2024" for "2019" and "to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied" for "to equal the product of the total revenues established in such notice for the prior fiscal year multiplied".

Subsec. (c)(1)(C). Pub. L. 117–180, §3002(c)(1)(B), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV".

Subsec. (c)(2), (3). Pub. L. 117–180, §3002(c)(2), added pars. (2) and (3) and struck out former par. (2) which provided for increases in fees in fiscal year 2022 if needed to provide for not more than 3 months of operating reserves for the first 3 months of fiscal year 2023.

Subsec. (d)(1). Pub. L. 117–180, §3002(d), substituted "2023 through 2027" for "2018 through 2022" in heading and "later than 60 days before the first day of each of fiscal years 2023 through 2027" for "more than 60 days before the first day of each of fiscal years 2018 through 2022" in text.

Subsec. (e)(2). Pub. L. 117–328, §3625(c)(1), substituted "379j–41(12)(C) of this title" for "379j–41(11)(C) of this title".

Subsec. (g)(3). Pub. L. 117–180, §3002(e), struck out "and prior approval supplement fee" after "application fee" in heading.

Subsec. (i)(2)(A)(ii). Pub. L. 117–328, §3625(c)(2)(A), substituted "available—" for "available for a fiscal year beginning after fiscal year 2012", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023," before "to defray the costs", substituted "such fiscal year; and" for "the fiscal year involved.", and added subcl. (II).

Subsec. (i)(2)(B). Pub. L. 117–328, §3625(c)(2)(B), substituted "as described in subclause (I) or (II) of such subparagraph, as applicable," for "for human generic activities".

Subsec. (i)(3). Pub. L. 117–180, §3002(f), substituted "fiscal years 2023 through 2027" for "fiscal years 2018 through 2022".

2017—Subsec. (a). Pub. L. 115–52, §303(a)(1), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.

Subsec. (a)(1)(E). Pub. L. 115–52, §303(a)(2), added subpar. (E).

Subsec. (a)(2)(C). Pub. L. 115–52, §303(a)(3)(A), amended subpar. (C) generally. Prior to amendment, subpar. (C) related to publication of notice for fiscal years 2013 to 2017.

Subsec. (a)(2)(E)(i). Pub. L. 115–52, §303(a)(3)(B)(i), substituted "on the earlier of—" for "no later than", inserted subcl. (I) designation before "the date", substituted "; or" for period at end, and added subcl. (II).

Subsec. (a)(2)(E)(ii)(I). Pub. L. 115–52, §303(a)(3)(B)(ii), substituted "notice provided for in subparagraph (C)" for "notice provided for in clause (i) or (ii) of subparagraph (C), as applicable".

Subsec. (a)(3). Pub. L. 115–52, §303(a)(4)(A), struck out "and prior approval supplement" after "application" in heading.

Subsec. (a)(3)(A). Pub. L. 115–52, §303(a)(4)(B), struck out "or a prior approval supplement to an abbreviated new drug application" after "application".

Subsec. (a)(3)(B), (C). Pub. L. 115–52, §303(a)(4)(C), amended subpars. (B) and (C) generally. Prior to amendment, subpars. (B) and (C) related to notice for fiscal years 2013 to 2017 and fee due dates, respectively.

Subsec. (a)(3)(D). Pub. L. 115–52, §303(a)(4)(D), inserted in heading ", is withdrawn prior to being received, or is no longer received" after "received" and in text substituted cls. (i) and (ii) for "The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application or prior approval supplement to an abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 355(j)(5)(A) of this title for a cause other than failure to pay fees."

Subsec. (a)(3)(E). Pub. L. 115–52, §303(a)(4)(E), struck out "or prior approval supplement" after "new drug application".

Subsec. (a)(3)(F). Pub. L. 115–52, §303(a)(4)(F), substituted "2017" for "2012" and "subsection (d)(2)" for "subsection (d)(3)" in introductory provisions.

Subsec. (a)(4)(A). Pub. L. 115–52, §303(a)(5)(A)(i), substituted "in at least one generic drug submission that is" for ", or intended to be identified, in at least one generic drug submission that is pending or" in introductory provisions.

Subsec. (a)(4)(A)(i). Pub. L. 115–52, §303(a)(5)(A)(ii), substituted "in at least one generic drug submission that is" for "or intended to be identified in at least one generic drug submission that is pending or".

Subsec. (a)(4)(A)(ii). Pub. L. 115–52, §303(a)(5)(A)(iii), substituted "is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such" for "produces, or which is pending review to produce, one or more active pharmaceutical ingredients identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II active pharmaceutical ingredient drug master file referenced in such a".

Subsec. (a)(4)(A)(iii). Pub. L. 115–52, §303(a)(5)(A)(i), (iv), substituted "in at least one generic drug submission that is" for ", or intended to be identified, in at least one generic drug submission that is pending or" and "only to the fee attributable to the manufacture of the finished dosage forms" for "to fees under both such clauses".

Subsec. (a)(4)(C), (D). Pub. L. 115–52, §303(a)(5)(B), amended subpars. (C) and (D) generally. Prior to amendment, subpars. (C) and (D) related to notice and fee due date for fiscal years 2013 to 2017, respectively.

Subsec. (a)(5), (6). Pub. L. 115–52, §303(a)(6), (7), added par. (5) and redesignated former par. (5) as (6).

Subsec. (b)(1)(A). Pub. L. 115–52, §303(b)(1)(A), substituted "2018" for "2013" in heading and "2018" for "2013" and "$493,600,000" for "$299,000,000" in text and struck out at end "Of that amount—

"(i) $50,000,000 shall be generated by the one-time backlog fee for generic drug applications pending on October 1, 2012, established in subsection (a)(1); and

"(ii) $249,000,000 shall be generated by the fees under paragraphs (2) through (4) of subsection (a)."

Subsec. (b)(1)(B). Pub. L. 115–52, §303(b)(1)(B), substituted "2019 through 2022" for "2014 through 2017" in heading and "2019 through 2022" for "2014 through 2017", "paragraphs (2) through (5)" for "paragraphs (2) through (4)", and "$493,600,000" for "$299,000,000" in text.

Subsec. (b)(2). Pub. L. 115–52, §303(b)(2)(A), substituted "such paragraph for a fiscal year" for "paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017" and "through (5)" for "through (4)" in introductory provisions.

Subsec. (b)(2)(A). Pub. L. 115–52, §303(b)(2)(B), substituted "Five percent" for "Six percent".

Subsec. (b)(2)(B), (C). Pub. L. 115–52, §303(b)(2)(C), amended subpars. (B) and (C) generally. Prior to amendment, subpars. (B) and (C) read as follows:

"(B) Twenty-four percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications and supplements). The amount of a fee for a prior approval supplement shall be half the amount of the fee for an abbreviated new drug application.

"(C) Fifty-six percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States, including its territories and possessions, and those located outside of the United States and its territories and possessions."

Subsec. (b)(2)(D). Pub. L. 115–52, §303(b)(2)(D), substituted "Seven percent" for "Fourteen percent", "$15,000" for "not less than $15,000 and not more than $30,000", and "possessions." for "possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States and its territories and possessions and those located outside of the United States and its territories and possessions."

Subsec. (b)(2)(E). Pub. L. 115–52, §303(b)(2)(E), added subpar. (E).

Subsec. (c)(1). Pub. L. 115–52, §303(c)(1), substituted "2019" for "2014" and inserted "to equal the product of the total revenues established in such notice for the prior fiscal year multiplied" after "a fiscal year," in introductory provisions and struck out concluding provisions which read as follows: "The adjustment made each fiscal year under this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this subsection."

Subsec. (c)(2). Pub. L. 115–52, §303(c)(2), substituted "2022" for "2017" in two places, substituted "the first 3 months of fiscal year 2023" for "the first 3 months of fiscal year 2018", and struck out "Such fees may only be used in fiscal year 2018." before "If such an adjustment".

Subsec. (d)(1). Pub. L. 115–52, §303(d)(1), added par. (1) and struck out former par. (1) which related to setting fees for fiscal year 2013.

Subsec. (d)(2), (3). Pub. L. 115–52, §303(d), redesignated par. (3) as (2), substituted "fee under paragraph (1)" for "fees under paragraphs (1) and (2)" in introductory provisions, and struck out former par. (2) which related to setting fees for fiscal years 2014 through 2017.

Subsec. (e). Pub. L. 115–52, §905(b)(3), substituted "Limitations" for "Limit" in heading, designated existing provisions as par. (1) and inserted heading, and added par. (2).

Subsec. (f)(1). Pub. L. 115–52, §303(e)(3), substituted "paragraph (3)" for "paragraph (4)" and "Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year." for "Such information shall—

"(A) for fiscal year 2013, be submitted not later than 60 days after the publication of the notice under paragraph (1); and

"(B) for each subsequent fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous year."

Pub. L. 115–52, §303(e)(1), (2), redesignated par. (2) as (1) and struck out former par. (1). Prior to amendment, text of par. (1) read as follows: "Not later than October 1, 2012, the Secretary shall publish in the Federal Register a notice requiring each person that owns a facility described in subsection (a)(4)(A), or a site or organization required to be identified by paragraph (4), to submit to the Secretary information on the identity of each such facility, site, or organization. The notice required by this paragraph shall specify the type of information to be submitted and the means and format for submission of such information."

Subsec. (f)(2). Pub. L. 115–52, §303(e)(4)(A), (B), substituted "Information required to be submitted" for "Contents of notice" in heading and "paragraph (1)" for "paragraph (2)" in introductory provisions.

Pub. L. 115–52, §303(e)(2), redesignated par. (3) as (2). Former par. (2) redesignated (1).

Subsec. (f)(2)(A). Pub. L. 115–52, §303(e)(4)(C), struck out "or intended to be identified" after "facility identified".

Subsec. (f)(2)(F). Pub. L. 115–52, §303(e)(4)(D)–(F), added subpar. (F).

Subsec. (f)(3), (4). Pub. L. 115–52, §303(e)(2), redesignated par. (4) as (3). Former par. (3) redesignated (2).

Subsec. (g)(1). Pub. L. 115–52, §303(f)(1), inserted at end "This paragraph shall cease to be effective on October 1, 2022."

Subsec. (g)(2)(C)(ii). Pub. L. 115–52, §303(f)(2), substituted "of section 355(j)(5)(A)" for "of 355(j)(5)(A)".

Subsec. (g)(5). Pub. L. 115–52, §303(f)(3), added par. (5).

Subsec. (h)(2). Pub. L. 115–52, §303(g), struck out "for Type II active pharmaceutical ingredient drug master files, abbreviated new drug applications and prior approval supplements, and generic drug facilities and active pharmaceutical ingredient facilities" after "in the rate,".

Subsec. (i)(2)(A)(i). Pub. L. 115–52, §303(h)(1)(A), substituted "subparagraph (C)" for "subparagraphs (C) and (D)".

Subsec. (i)(2)(C). Pub. L. 115–52, §303(h)(1)(B), (D), redesignated subpar. (D) as (C) and struck out former subpar. (C). Prior to amendment, text of subpar. (C) read as follows: "Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain available until expended."

Subsec (i)(2)(D). Pub. L. 115–52, §303(h)(1)(D), redesignated subpar. (D) as (C).

Pub. L. 115–52, §303(h)(1)(C), struck out "in subsequent years" after "payments" in heading and "(after fiscal year 2013)" after "fiscal year" in text.

Subsec. (i)(3). Pub. L. 115–52, §303(h)(2), substituted "fiscal years 2018 through 2022" for "fiscal years 2013 through 2017".

Subsec. (o). Pub. L. 115–52, §303(i), added subsec. (o).

2012—Subsec. (a). Pub. L. 112–193, §2(b)(2), inserted "for such year" after "obligation of fees" wherever appearing.

Subsec. (i)(2)(C). Pub. L. 112–193, §2(b)(3), inserted comma after "September 30, 2013" and struck out comma after "for fiscal year 2013".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2022, see section 3005 of Pub. L. 117–180, set out as a note under section 379j–41 of this title.

Effective Date of 2017 Amendment

Amendment by section 303 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2017, see section 306 of Pub. L. 115–52, set out as a note under section 379j–41 of this title.

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2027, see section 3004(a) of Pub. L. 117–180, set out as a note under section 379j–41 of this title.

Section effective Oct. 1, 2012, with fees under this section and section 379j–41 of this title to be assessed for all human generic drug submissions and Type II active pharmaceutical drug master files received on or after Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as a note under section 379j–41 of this title.

Fees Authorized for Fiscal Year 2013

Pub. L. 112–193, §2(c), Oct. 5, 2012, 126 Stat. 1443, provided that:

"(1) Notwithstanding section 744B(a)(2)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(a)(2)(E)(ii)), the fee authorized under section 744B(a)(2) of such Act for fiscal year 2013 shall be due 30 calendar days after publication of the notice provided for in section 744B(a)(2)(C)(i) of such Act.

"(2) Notwithstanding section 744B(a)(3)(C)(ii) of such Act, the fee authorized under section 744B(a)(3) of such Act for fiscal year 2013 shall be due on the later of—

"(A) the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies; or

"(B) 30 calendar days after publication of the notice referred to in section 744B(a)(3)(B)(i) of such Act.

"(3) Notwithstanding section 744B(a)(4)(D)(i) of such Act, the fee authorized under section 744B(a)(4) of such Act for fiscal year 2013 shall be due not later than 45 days after the publication of the notice under section 744B(a)(4)(C)(i) of such Act."

§379j–43. Reauthorization; reporting requirements

(a) Performance report

(1) General requirements

Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(2) Real time reporting

(A) In general

Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.

(B) Data

The Secretary shall post the following data in accordance with subparagraph (A):

(i) The number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022.

(ii) The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022.

(3) Rationale for GDUFA program changes

The Secretary shall include in the annual report under paragraph (1)—

(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j–42 of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including—

(i) identifying drivers of such changes; and

(ii) changes in the total average cost per full-time equivalent in the generic drug review program;

(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and

(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of abbreviated new drug application.

(4) Analysis

For each fiscal year, the Secretary shall include in the report an analysis of the following:

(A) The difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency, accounting for—

(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year.

(B) Relevant data to determine whether the Food and Drug Administration has met the performance enhancement goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year.

(C) The most common causes and trends for external or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022.

(b) Fiscal report

Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c) Corrective action report

For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(1) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(4), that each of the goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the abbreviated new drug application review process.

(2) Goals missed

For each of the goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

(B) with respect to performance enhancement goals that were not achieved, a detailed description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such ² fiscal year.

(d) Enhanced communication

(1) Communications with Congress

Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

(2) Participation in congressional hearing

Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.

(e) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for human generic drug activities for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(C) scientific and academic experts;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the generic drug industry.

(2) Prior public input

Prior to beginning negotiations with the generic drug industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every month during negotiations with the generic drug industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Updates to Congress

The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(5) Public review of recommendations

After negotiations with the generic drug industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(7) Minutes of negotiation meetings

(A) Public availability

The Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the generic drug industry, not later than 30 days after each such negotiation meeting.

(B) Content

The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §744C, as added Pub. L. 112–144, title III, §303, July 9, 2012, 126 Stat. 1022; amended Pub. L. 115–52, title III, §304, title IX, §§903(c), 904(c), Aug. 18, 2017, 131 Stat. 1027, 1080, 1085; Pub. L. 117–180, div. F, title III, §3003, Sept. 30, 2022, 136 Stat. 2158; Pub. L. 117–328, div. FF, title III, §3626(c), Dec. 29, 2022, 136 Stat. 5885.)

Termination of Section

For termination of section by section 3004(b) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

References in Text

Section 301(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 3001(b) of the Generic Drug User Fee Amendments of 2022, title III of div. F of Pub. L. 117–180, which is set out as a note under section 379j–41 of this title. The Generic Drug User Fee Amendments of 2022 does not contain a section 301(b).

Section 3001(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsec. (a)(3)(A), is section 3001(b) of title III of div. F of Pub. L. 117–180, which is set out as a note under section 379j–41 of this title.

Amendments

2022—Pub. L. 117–180, §3003(2), substituted "Generic Drug User Fee Amendments of 2022" for "Generic Drug User Fee Amendments of 2017" wherever appearing.

Subsec. (a)(1). Pub. L. 117–180, §3003(1), substituted "Not later" for "Beginning with fiscal year 2018, not later".

Subsec. (a)(2). Pub. L. 117–180, §3003(3), substituted "Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart" for "Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter".

Subsec. (a)(3). Pub. L. 117–180, §3003(4), substituted "The Secretary" for "Beginning with fiscal year 2020, the Secretary" in introductory provisions.

Subsec. (a)(3)(A). Pub. L. 117–328, §3626(c)(1)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;".

Subsec. (a)(3)(B). Pub. L. 117–328, §3626(c)(1)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including identifying drivers of such changes; and".

Subsec. (a)(3)(D). Pub. L. 117–328, §3626(c)(1)(C), (D), added subpar. (D).

Subsec. (b). Pub. L. 117–180, §3003(5), substituted "Not later" for "Beginning with fiscal year 2018, not later".

Subsec. (c). Pub. L. 117–180, §3003(6), substituted "For each" for "Beginning with fiscal year 2018, for each" in introductory provisions.

Subsec. (f)(1). Pub. L. 117–180, §3003(7)(A), substituted "fiscal year 2027" for "fiscal year 2022" in introductory provisions.

Subsec. (f)(4). Pub. L. 117–328, §3626(c)(2)(B), added par. (4). Former par. (4) redesignated (5).

Subsec. (f)(5). Pub. L. 117–328, §3626(c)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).

Pub. L. 117–180, §3003(7)(B), substituted "January 15, 2027" for "January 15, 2022".

Subsec. (f)(6), (7). Pub. L. 117–328, §3626(c)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.

Subsec. (f)(7)(A). Pub. L. 117–328, §3626(c)(2)(C)(i), substituted "The" for "Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the" and inserted ", not later than 30 days after each such negotiation meeting" before period at end.

Subsec. (f)(7)(B). Pub. L. 117–328, §3626(c)(2)(C)(ii), inserted ", in sufficient detail," after "shall summarize".

2017—Subsec. (a). Pub. L. 115–52, §903(c), designated existing provisions as par. (1), inserted heading, and added pars. (2) and (3).

Pub. L. 115–52, §304(1), substituted "2018" for "2013" and "Generic Drug User Fee Amendments of 2017" for "Generic Drug User Fee Amendments of 2012".

Subsec. (a)(4). Pub. L. 115–52, §904(c)(1), added par. (4).

Subsec. (b). Pub. L. 115–52, §304(2), substituted "2018" for "2013".

Subsecs. (c) to (e). Pub. L. 115–52, §904(c)(2), added subsecs. (c) and (d) and redesignated former subsec. (c) as (e). Former subsec. (d) redesignated (f).

Subsec. (f). Pub. L. 115–52, §904(c)(2)(A), redesignated subsec. (d) as (f).

Pub. L. 115–52, §304(3), which directed amendment of subsec. (d), effective Oct. 1, 2017, by substituting "2022" for "2017" wherever appearing, was executed by making the substitution in subsec. (f) to reflect the probable intent of Congress and the redesignation of subsec. (d) as (f), effective Aug. 18, 2017, by Pub. L. 115–52, §904(c)(2). See Amendment note above.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2022, see section 3005 of Pub. L. 117–180, set out as a note under section 379j–41 of this title.

Effective Date of 2017 Amendment

Amendment by section 304 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2017, see section 306 of Pub. L. 115–52, set out as a note under section 379j–41 of this title.

Effective and Termination Dates

Pub. L. 117–180, div. F, title III, §3004(b), Sept. 30, 2022, 136 Stat. 2159, provided that: "Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to be effective January 31, 2028."

Pub. L. 115–52, title III, §305(b), Aug. 18, 2017, 131 Stat. 1027, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title III, §3004(c), Sept. 30, 2022, 136 Stat. 2159.

[Pub. L. 117–180, div. F, title III, §3004(c), Sept. 30, 2022, 136 Stat. 2159, provided that the repeal of section 305(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title III, §304(b), July 9, 2012, 126 Stat. 1024, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title III, §305(c)(1), Aug. 18, 2017, 131 Stat. 1027.

[Pub. L. 115–52, title III, §305(c)(1), Aug. 18, 2017, 131 Stat. 1027, provided that the repeal of section 304(b) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Section effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as a note under section 379j–41 of this title.

¹ See References in Text note below.

² So in original.

subpart 8—fees relating to biosimilar biological products

§379j–51. Definitions

For purposes of this subpart:

(1) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items) for September of the preceding fiscal year divided by such Index for September 2011.

(2) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(3) The term "biosimilar biological product" means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved.

(4)(A) Subject to subparagraph (B), the term "biosimilar biological product application" means an application for licensure of a biological product under section 262(k) of title 42.

(B) Such term does not include—

(i) a supplement to such an application;

(ii) an application filed under section 262(k) of title 42 that cites as the reference product a bovine blood product for topical application licensed before September 1, 1992, or a large volume parenteral drug product approved before such date;

(iii) an application filed under section 262(k) of title 42 with respect to—

(I) whole blood or a blood component for transfusion;

(II) an in vitro diagnostic biological product; or

(III) a biological product for further manufacturing use only; or

(iv) an application for licensure under section 262(k) of title 42 that is submitted by a State or Federal Government entity for a product that is not distributed commercially.

(5) The term "biosimilar biological product development meeting" means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.

(6) The term "biosimilar biological product development program" means the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development.

(7)(A) The term "biosimilar biological product establishment" means a foreign or domestic place of business—

(i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and

(ii) at which one or more biosimilar biological products are manufactured in final dosage form.

(B) For purposes of subparagraph (A)(ii), the term "manufactured" does not include packaging.

(8) The term "biosimilar initial advisory meeting"—

(A) means a meeting, if requested, that is limited to—

(i) a general discussion regarding whether licensure under section 262(k) of title 42 may be feasible for a particular product; and

(ii) if so, general advice on the expected content of the development program; and

(B) does not include any meeting that involves substantive review of summary data or full study reports.

(9) The term "costs of resources allocated for the process for the review of biosimilar biological product applications" means the expenses in connection with the process for the review of biosimilar biological product applications for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers employees and committees and to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under section 379j–52 of this title and accounting for resources allocated for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.

(10) The term "final dosage form" means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).

(11) The term "financial hold"—

(A) means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of section 379j–52(a)(1) of this title; and

(B) does not mean that any of the bases for a "clinical hold" under section 355(i)(3) of this title have been determined by the Secretary to exist concerning the investigation.

(12) The term "person" includes an affiliate of such person.

(13) The term "process for the review of biosimilar biological product applications" means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements:

(A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.

(B) Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the actions necessary to place such applications in condition for approval.

(C) The inspection of biosimilar biological product establishments and other facilities undertaken as part of the Secretary's review of pending biosimilar biological product applications and supplements.

(D) Activities necessary for the release of lots of biosimilar biological products under section 262(k) of title 42.

(E) Monitoring of research conducted in connection with the review of biosimilar biological product applications.

(F) Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:

(i) Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.

(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies).

(v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).

(14) The term "supplement" means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 262(k)(4) of title 42.

(June 25, 1938, ch. 675, §744G, as added Pub. L. 112–144, title IV, §402, July 9, 2012, 126 Stat. 1026; amended Pub. L. 115–52, title IV, §402, Aug. 18, 2017, 131 Stat. 1028; Pub. L. 117–180, div. F, title IV, §4002, Sept. 30, 2022, 136 Stat. 2160.)

Termination of Section

For termination of section by section 4005(a) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

Amendments

2022—Par. (1). Pub. L. 117–180, §4002(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "The term 'adjustment factor' applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) for October of the preceding fiscal year divided by such Index for October 2011."

Par. (4)(B)(iii)(II) to (IV). Pub. L. 117–180, §4002(b), redesignated subcls. (III) and (IV) as (II) and (III), respectively, and struck out former subcl. (II) which read as follows: "an allergenic extract product;".

2017—Par. (1). Pub. L. 115–52, §402(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "The term 'adjustment factor' applicable to a fiscal year that is the Consumer Price Index for all urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) of the preceding fiscal year divided by such Index for September 2011."

Par. (3). Pub. L. 115–52, §402(b), substituted "means a specific strength of a biological product in final dosage form" for "means a product".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–180, div. F, title IV, §4006, Sept. 30, 2022, 136 Stat. 2166, provided that: "The amendments made by this title [see section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under section 301 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.) shall be assessed for all biosimilar biological product applications received on or after October 1, 2022, regardless of the date of the enactment of this Act."

Effective Date of 2017 Amendment

Pub. L. 115–52, title IV, §406, Aug. 18, 2017, 131 Stat. 1035, provided that: "The amendments made by this title [see section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–51 et seq.] shall be assessed for all biosimilar biological product applications received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective and Termination Dates

Pub. L. 117–180, div. F, title IV, §4005(a), Sept. 30, 2022, 136 Stat. 2166, provided that: "Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51, 379j–52) shall cease to be effective October 1, 2027."

Pub. L. 115–52, title IV, §405(a), Aug. 18, 2017, 131 Stat. 1035, which provided that this section and section 379j–52 of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166.

[Pub. L. 117–180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166, provided that the repeal of section 405(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title IV, §404(a), July 9, 2012, 126 Stat. 1038, which provided that this section and section 379j–52 of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title IV, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035.

[Pub. L. 115–52, title III, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 112–144, title IV, §405, July 9, 2012, 126 Stat. 1039, provided that:

"(a) In General.—Except as provided under subsection (b), the amendments made by this title [enacting this section and sections 379j–52 and 379j–53 of this title and amending sections 379d–4 and 379g of this title] shall take effect on the later of—

"(1) October 1, 2012; or

"(2) the date of the enactment of this title [July 9, 2012].

"(b) Exception.—Fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as added by this title, shall be assessed for all biosimilar biological product applications received on or after October 1, 2012, regardless of the date of the enactment of this title."

Savings

Pub. L. 117–180, div. F, title IV, §4007, Sept. 30, 2022, 136 Stat. 2167, provided that: "Notwithstanding the amendments made by this title [see section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under section 301 of this title], part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023."

Pub. L. 115–52, title IV, §407, Aug. 18, 2017, 131 Stat. 1035, provided that: "Notwithstanding the amendments made by this title [see section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–51 et seq.], as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Congressional Findings Concerning Fees Relating to Biosimilar Biological Products

Pub. L. 117–180, div. F, title IV, §4001(b), Sept. 30, 2022, 136 Stat. 2160, provided that: "Congress finds that the fees authorized by the amendments made by this title [see section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under section 301 of this title] will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 115–52, title IV, §401(b), Aug. 18, 2017, 131 Stat. 1028, provided that: "The Congress finds that the fees authorized by the amendments made in this title [see section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–51 et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title IV, §401(b), July 9, 2012, 126 Stat. 1026, provided that: "The Congress finds that the fees authorized by the amendments made in this title [enacting this section and sections 379j–52 and 379j–53 of this title and amending sections 379d–4 and 379g of this title] will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

§379j–52. Authority to assess and use biosimilar biological product fees

(a) Types of fees

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Biosimilar biological product development program fees

(A) Initial biosimilar biological product development fee

(i) In general

Each person that submits to the Secretary a meeting request described under clause (ii) or a clinical protocol for an investigational new drug protocol described under clause (iii) shall pay for the product named in the meeting request or the investigational new drug application the initial biosimilar biological product development fee established under subsection (c)(5).

(ii) Meeting request

The meeting request described in this clause is a request for a biosimilar biological product development meeting for a product.

(iii) Clinical protocol for IND

A clinical protocol for an investigational new drug protocol described in this clause is a clinical protocol consistent with the provisions of section 355(i) of this title, including any regulations promulgated under section 355(i) of this title, (referred to in this section as "investigational new drug application") describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for a product.

(iv) Due date

The initial biosimilar biological product development fee shall be due by the earlier of the following:

(I) Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.

(II) The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application.

(v) Transition rule

Each person that has submitted an investigational new drug application prior to July 9, 2012, shall pay the initial biosimilar biological product development fee by the earlier of the following:

(I) Not later than 60 days after July 9, 2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar biological product application.

(II) Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.

(B) Annual biosimilar biological product development fee

(i) In general

A person that pays an initial biosimilar biological product development fee for a product shall pay for such product, beginning in the fiscal year following the fiscal year in which the initial biosimilar biological product development fee was paid, an annual fee established under subsection (c)(5) for the biosimilar biological product development program (referred to in this section as "annual biosimilar biological product development fee"), except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee.

(ii) Due date

The annual biosimilar biological product development fee for each fiscal year will be due on the later of—

(I) the first business day on or after October 1 of each such year; or

(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(iii) Exception

The annual biosimilar biological product development fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—

(I) submitted a marketing application for the biological product that was accepted for filing;

(II) discontinued participation in the biosimilar biological product development program for the product under subparagraph (C); or

(III) been administratively removed from the biosimilar biological product development program for the product under subparagraph (E)(v).

(iv) Refund

If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is subsequently accepted for filing, the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing.

(C) Discontinuation of fee obligation

A person may discontinue participation in the biosimilar biological product development program for a product, effective October 1 of a fiscal year, by, not later than August 1 of the preceding fiscal year—

(i) if no investigational new drug application concerning the product has been submitted, submitting to the Secretary a written declaration that the person has no present intention of further developing the product as a biosimilar biological product; or

(ii) if an investigational new drug application concerning the product has been submitted, withdrawing the investigational new drug application in accordance with part 312 of title 21, Code of Federal Regulations (or any successor regulations).

(D) Reactivation fee

(i) In general

A person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C), or who has been administratively removed from such program for a product under subparagraph (E)(v), shall, if the person seeks to resume participation in such program, pay all annual biosimilar biological product development fees previously assessed for such product and still owed and a fee (referred to in this section as "reactivation fee") by the earlier of the following:

(I) Not later than 7 days after the Secretary grants a request by such person for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued or the date of administrative removal, as applicable).

(II) Upon the date of submission (after the date on which such participation was discontinued or the date of administrative removal, as applicable) by such person of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product.

(ii) Application of annual fee

A person that pays a reactivation fee for a product shall pay for such product, beginning in the next fiscal year, the annual biosimilar biological product development fee under subparagraph (B), except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee.

(E) Effect of failure to pay fees

(i) No biosimilar biological product development meetings

If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), the Secretary shall not provide a biosimilar biological product development meeting relating to the product for which fees are owed.

(ii) No receipt of investigational new drug applications

Except in extraordinary circumstances, the Secretary shall not consider an investigational new drug application to have been received under section 355(i)(2) of this title if—

(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and

(II) the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D).

(iii) Financial hold

Notwithstanding section 355(i)(2) of this title, except in extraordinary circumstances, the Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if—

(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and

(II) the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee for the product as required under subparagraph (D).

(iv) No acceptance of biosimilar biological product applications or supplements

If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), any biosimilar biological product application or supplement submitted by that person shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.

(v) Administrative removal from the biosimilar biological product development program

If a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph (B) for a period of 2 consecutive fiscal years, the Secretary may administratively remove such person from the biosimilar biological product development program for the product. At least 30 days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause, the Secretary shall provide written notice to such person of the intended administrative removal.

(F) Limits regarding fees

(i) Refunds

Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).

(ii) No waivers, exemptions, or reductions

The Secretary shall not grant a waiver, exemption, or reduction of any initial or annual biosimilar biological product development fee due or payable under subparagraph (A) or (B), or any reactivation fee due or payable under subparagraph (D).

(2) Biosimilar biological product application fee

(A) In general

Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees:

(i) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval.

(ii) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i).

(B) Rule of applicability; treatment of certain previously paid fees

Any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall—

(i) be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and

(ii) be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).

(C) Payment due date

Any fee required by subparagraph (A) shall be due upon submission of the application for which such fee applies.

(D) Exception for previously filed application

If a biosimilar biological product application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a biosimilar biological product application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(E) Refund of application fee if application refused for filing or withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under this paragraph for any application which is refused for filing or withdrawn without a waiver before filing.

(F) Fees for applications previously refused for filing or withdrawn before filing

A biosimilar biological product application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived under subsection (d).

(3) Biosimilar biological product program fee

(A) In general

Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that—

(i) is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year;

(ii) may be dispensed only under prescription pursuant to section 353(b) of this title; and

(iii) as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products.

(B) Due date

The biosimilar biological product program fee for a fiscal year shall be due on the later of—

(i) the first business day on or after October 1 of each such year; or

(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(C) One fee per product per year

The biosimilar biological product program fee shall be paid only once for each product for each fiscal year.

(D) Limitation

A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.

(E) Movement to discontinued list

(i) Date of inclusion

If a written request to place a product on the list referenced in subparagraph (A) of discontinued biosimilar biological products is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the biosimilar biological product program fee, the Secretary shall consider such product to have been included on such list on the later of—

(I) the date such request was received; or

(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.

(ii) Treatment as withdrawn from sale

For purposes of clause (i), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.

(iii) Special rule for products removed from discontinued list

If a biosimilar biological product that is identified in a biosimilar biological product application approved as of October 1 of a fiscal year appears, as of October 1 of such fiscal year, on the list referenced in subparagraph (A) of discontinued biosimilar biological products, and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, except as provided in subparagraph (D), each person who is named as the applicant in a biosimilar biological product application with respect to such product shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for each fiscal year.

(b) Fee revenue amounts

(1) In general

For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—

(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

(C) the dollar amount equal to the strategic hiring and retention adjustment (as determined under subsection (c)(2));

(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));

(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));

(F) for fiscal year 2023 an additional amount of $4,428,886; and

(G) for fiscal year 2024 an additional amount of $320,569.

(2) Allocation of revenue amount among fees

(A) Allocation

The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—

(i) initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1);

(ii) biosimilar biological product application fees under subsection (a)(2); and

(iii) biosimilar biological product program fees under subsection (a)(3).

(B) Biosimilar biological product development fees

The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.

(C) Reactivation fee

The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.

(3) Annual base revenue

For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

(A) for fiscal year 2023, $43,376,922; and

(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(4).

(c) Adjustments; annual fee setting

(1) Inflation adjustment

(A) In general

For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and

(ii) the inflation adjustment percentage under subparagraph (B).

(B) Inflation adjustment percentage

The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 379j–51(13) of this title) for the first 3 years of the preceding 4 fiscal years; and

(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 379j–51(13) of this title) for the first 3 years of the preceding 4 fiscal years.

(2) Strategic hiring and retention adjustment

For each fiscal year, after the annual base revenue under subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by $150,000.

(3) Capacity planning adjustment

(A) In general

For each fiscal year, the Secretary shall, in addition to the adjustments under paragraphs (1) and (2), further adjust the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.

(B) Methodology

For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled "Biosimilar User Fee Rates for Fiscal Year 2021" published in the Federal Register on August 4, 2020 (85 Fed. Reg. 47220). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of biosimilar biological product applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved biosimilar biological products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.

(C) Limitations

Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment).

(D) Publication in Federal Register

The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

(4) Operating reserve adjustment

(A) Increase

For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.

(B) Decrease

(i) Fiscal year 2023

For fiscal year 2023, if the Secretary has carryover balances for such process in excess of 33 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves.

(ii) Fiscal year 2024

For fiscal year 2024, if the Secretary has carryover balances for such process in excess of 27 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves.

(iii) Fiscal year 2025 and subsequent fiscal years

For fiscal year 2025 and subsequent fiscal years, if the Secretary has carryover balances for such process in excess of 21 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves.

(C) Federal Register notice

If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.

(5) Annual fee setting

For fiscal year 2023 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year—

(A) establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(B) publish such fee revenue and fees in the Federal Register.

(6) Limit

The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications.

(d) Application fee waiver for small business

(1) Waiver of application fee

The Secretary shall grant to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that person under subsection (a)(2)(A) for the first biosimilar biological product application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business.

(2) Considerations

In determining whether to grant a waiver of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.

(3) Small business defined

In this subsection, the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in section 379g of this title) or a biosimilar biological product application (as defined in section 379j–51(4) of this title) and introduced or delivered for introduction into interstate commerce.

(e) Effect of failure to pay fees

A biosimilar biological product application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.

(f) Crediting and availability of fees

(1) In general

Subject to paragraph (2), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of biosimilar biological product applications.

(2) Collections and appropriation Acts

(A) In general

Subject to subparagraphs (C) and (D), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year.

(B) Use of fees and limitations

(i) In general

The fees authorized by this section shall be available—

(I) for fiscal year 2023, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $20,000,000, multiplied by the adjustment factor applicable to such fiscal year; and

(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.

(ii) Leasing and necessary equipment

Beginning on October 1, 2023, the authorities under section 379j–51(9)(C) of this title shall include only leasing and necessary scientific equipment.

(C) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable, are not more than 15 percent below the level specified in such subparagraph.

(D) Provision for early payments

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.

(g) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(h) Written requests for waivers and returns; disputes concerning fees

To qualify for consideration for a waiver under subsection (d), or for the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver or return and, except as otherwise specified in this section, such written request shall be submitted to the Secretary not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made.

(i) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of biosimilar biological product applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(June 25, 1938, ch. 675, §744H, as added Pub. L. 112–144, title IV, §402, July 9, 2012, 126 Stat. 1029; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(V), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 115–52, title IV, §403, title IX, §905(b)(4), Aug. 18, 2017, 131 Stat. 1028, 1090; Pub. L. 116–136, div. A, title III, §3856(b)(1), Mar. 27, 2020, 134 Stat. 458; Pub. L. 117–180, div. F, title IV, §4003, Sept. 30, 2022, 136 Stat. 2160; Pub. L. 117–328, div. FF, title III, §3625(b), Dec. 29, 2022, 136 Stat. 5880.)

Termination of Section

For termination of section by section 4005(a) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–180, §4003(a)(1), substituted "fiscal year 2023" for "fiscal year 2018" in introductory provisions.

Subsec. (a)(1)(A)(iv)(I), (v)(II). Pub. L. 117–180, §4003(a)(2), substituted "7 days" for "5 days".

Subsec. (a)(1)(B)(i). Pub. L. 117–180, §4003(a)(3)(A), inserted before period at end ", except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee".

Subsec. (a)(1)(B)(iii)(III). Pub. L. 117–180, §4003(a)(3)(B), added subcl. (III).

Subsec. (a)(1)(B)(iv). Pub. L. 117–180, §4003(a)(3)(C), substituted "is subsequently accepted for filing" for "is accepted for filing on or after October 1 of such fiscal year".

Subsec. (a)(1)(D). Pub. L. 117–180, §4003(a)(4), amended subpar. (D) generally. Prior to amendment, subpar. (D) related to payment of a reactivation fee for resuming participation in the biosimilar biological product development program and application of annual biosimilar biological product development fee for a person paying a reactivation fee.

Subsec. (a)(1)(E)(v). Pub. L. 117–180, §4003(a)(5), added cl. (v).

Subsec. (a)(2)(D). Pub. L. 117–180, §4003(a)(6), inserted "prior to approval" after "or was withdrawn".

Subsec. (a)(3)(A)(ii), (iii). Pub. L. 117–180, §4003(a)(7)(A), added cl. (ii) and redesignated former cl. (ii) as (iii).

Subsec. (a)(3)(E). Pub. L. 117–180, §4003(a)(7)(B), added subpar. (E).

Subsec. (a)(4). Pub. L. 117–180, §4003(a)(8), struck out par. (4) which related to the annual fee for each biosimilar biological product in a biosimilar biological product application.

Subsec. (b)(1). Pub. L. 117–180, §4003(b)(2), (3), redesignated par. (2) as (1) and amended it generally. Prior to amendment, par. related to fee revenue amounts for fiscal years 2019 through 2022. Former par. (1) struck out.

Pub. L. 117–180, §4003(b)(1), struck out par. (1) which related to fee revenue amounts for fiscal year 2018.

Subsec. (b)(2). Pub. L. 117–180, §4003(b)(2), (4)(A), redesignated par. (3) as (2) and struck out "; limitations on fee amounts" after "among fees" in heading. Former par. (2) redesignated (1).

Subsec. (b)(2)(B) to (D). Pub. L. 117–180, §4003(b)(4)(B), (C), redesignated subpars. (C) and (D) as (B) and (C), respectively, and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: "Until the first fiscal year for which the capacity planning adjustment under subsection (c)(2) is effective, the amount of any fee under subsection (a) for a fiscal year after fiscal year 2018 shall not exceed 125 percent of the amount of such fee for fiscal year 2018."

Subsec. (b)(3), (4). Pub. L. 117–180, §4003(b)(2), (5), redesignated par. (4) as (3) and amended it generally. Prior to amendment, text read as follows: "For purposes of paragraph (2), the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(3)." Former par. (3) redesignated (2).

Subsec. (c)(1)(A). Pub. L. 117–180, §4003(c)(1)(A)(i), substituted "subsection (b)(1)(B)" for "subsection (b)(2)(B)" in introductory provisions.

Subsec. (c)(1)(A)(i). Pub. L. 117–180, §4003(c)(1)(A)(ii), substituted "subsection (b)(1)(A)" for "subsection (b)".

Subsec. (c)(1)(B)(ii). Pub. L. 117–180, §4003(c)(1)(B), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV".

Subsec. (c)(2) to (4). Pub. L. 117–180, §4003(c)(2), added pars. (2) to (4) and struck out former pars. (2) to (4) which related to application and methodology of capacity planning adjustment, operating reserve adjustment, and fiscal year 2018 adjustment, respectively.

Subsec. (c)(5). Pub. L. 117–180, §4003(c)(3), substituted "2023" for "2018" in introductory provisions.

Subsec. (f)(2)(B)(i). Pub. L. 117–328, §3625(b)(1), substituted "available—" for "available for a fiscal year beginning after fiscal year 2012", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023," before "to defray the costs", substituted "such fiscal year; and" for "the fiscal year involved.", and added subcl. (II).

Subsec. (f)(2)(C). Pub. L. 117–328, §3625(b)(2), substituted "subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable," for "subparagraph (B) in any fiscal year if the costs described in such subparagraph".

Subsec. (f)(3). Pub. L. 117–180, §4003(d), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (h). Pub. L. 117–180, §4003(e), amended subsec. (h) generally. Prior to amendment, text read as follows: "To qualify for consideration for a waiver under subsection (d), or for a refund of any fee collected in accordance with subsection (a)(2)(A), a person shall submit to the Secretary a written request for such waiver or refund not later than 180 days after such fee is due."

2020—Subsec. (f)(2)(B). Pub. L. 116–136, §3856(b)(1), amended Pub. L. 115–52, §905(b)(4). See 2017 Amendment note below.

2017—Subsec. (a). Pub. L. 115–52, §403(a)(1), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.

Subsec. (a)(1). Pub. L. 115–52, §403(a)(2), substituted "Biosimilar biological product" for "Biosimilar" in heading.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, §403(a)(3), substituted "(c)(5)" for "(b)(1)(A)".

Subsec. (a)(1)(B)(i). Pub. L. 115–52, §403(a)(4), substituted "(c)(5) for the biosimilar biological product development program" for "(b)(1)(B) for biosimilar biological product development".

Subsec. (a)(1)(B)(ii). Pub. L. 115–52, §403(a)(5), substituted "annual biosimilar biological product development fee" for "annual biosimilar biological product development program fee" in introductory provisions.

Subsec. (a)(1)(B)(iii). Pub. L. 115–52, §403(a)(6), substituted "annual biosimilar biological product development fee" for "annual biosimilar development program fee".

Subsec. (a)(1)(B)(iv). Pub. L. 115–52, §403(a)(7), added cl. (iv).

Subsec. (a)(1)(C). Pub. L. 115–52, §403(a)(8), substituted "for a product, effective October 1 of a fiscal year, by," for "for a product effective October 1 of a fiscal year by," in introductory provisions.

Subsec. (a)(1)(D)(i). Pub. L. 115–52, §403(a)(9)(A), inserted ", if the person seeks to resume participation in such program," before "pay a fee" in introductory provisions.

Subsec. (a)(1)(D)(i)(I). Pub. L. 115–52, §403(a)(9)(B), inserted "by such person" after "grants a request".

Subsec. (a)(1)(D)(i)(II). Pub. L. 115–52, §403(a)(9)(C), inserted "by such person" after "discontinued)".

Subsec. (a)(1)(E). Pub. L. 115–52, §403(a)(10), struck out "biosimilar development program" after "pay" in heading.

Subsec. (a)(1)(F). Pub. L. 115–52, §403(a)(11)(A), struck out "biosimilar development program" after "regarding" in heading.

Subsec. (a)(1)(F)(i). Pub. L. 115–52, §403(a)(11)(B), amended cl. (i) generally. Prior to amendment, text read as follows: "The Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D)."

Subsec. (a)(2). Pub. L. 115–52, §403(a)(12)(A), struck out "and supplement" after "application" in heading.

Subsec. (a)(2)(A), (B). Pub. L. 115–52, §403(a)(12)(B), amended subpars. (A) and (B) generally. Prior to amendment, subpars. (A) and (B) related to the fee for a biosimilar biological product application or a supplement submitted on or after Oct. 1, 2012, and to a reduction in certain fees, respectively.

Subsec. (a)(2)(C). Pub. L. 115–52, §403(a)(12)(D), struck out "or supplement" after "application".

Subsec. (a)(2)(D). Pub. L. 115–52, §403(a)(12)(C)–(E), in heading, struck out "or supplement" after "application" and in text, substituted "application was submitted" for "application or supplement was submitted", "application, was accepted" for "application or supplement, was accepted", and "application for the same product" for "application or a supplement for the same product".

Subsec. (a)(2)(E). Pub. L. 115–52, §403(a)(12)(D), struck out "or supplement" after "application".

Subsec. (a)(2)(F). Pub. L. 115–52, §403(c)(2), substituted "subsection (d)" for "subsection (c)".

Pub. L. 115–52, §403(a)(12)(D), struck out "or supplement" after "application".

Subsec. (a)(3). Pub. L. 115–52, §403(a)(13), amended par. (3) generally. Prior to amendment, par. (3) consisted of subpars. (A) to (E) which related to biosimilar biological product establishment fee, assessment, due date, assessment and division of fee for a biosimilar biological product establishment that manufactures for multiple applicants, and exception for new products, respectively.

Subsec. (a)(4)(A). Pub. L. 115–52, §403(c)(3), substituted "subsection (c)(5)" for "subsection (b)(1)(F)".

Subsec. (b). Pub. L. 115–52, §403(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) consisted of pars. (1) and (2) which related to fee amounts and limit to total amount of fees, respectively.

Subsec. (c). Pub. L. 115–52, §403(c)(4), added subsec. (c). Former subsec. (c) redesignated (d).

Subsec. (d). Pub. L. 115–52, §403(c)(1), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (e).

Subsec. (d)(1). Pub. L. 115–52, §403(d), substituted "affiliate shall pay" for "affiliate shall pay—" and "not a small business." for "not a small business; and", struck out subpar. (A) designation before "application fees for all", and struck out subpar. (B) which read as follows: "all supplement fees for all supplements to biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business."

Subsec. (e). Pub. L. 115–52, §403(e), substituted "all such fees" for "all fees".

Pub. L. 115–52, §403(c)(1), redesignated subsec. (d) as (e). Former subsec. (e) redesignated (f).

Subsec. (f). Pub. L. 115–52, §403(c)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g).

Subsec. (f)(2)(B). Pub. L. 115–52, §905(b)(4), as amended by Pub. L. 116–136, §3856(b)(1), substituted "limitations" for "limitation" in heading, designated existing provisions as cl. (i) and inserted heading, and added cl. (ii).

Subsec. (f)(2)(C). Pub. L. 115–52, §403(f)(1)(A), added subpar. (C) and struck out former subpar. (C). Prior to amendment, text read as follows: "Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain available until expended."

Subsec. (f)(2)(D). Pub. L. 115–52, §403(f)(1)(B), struck out "in subsequent years" after "payments" in heading and "(after fiscal year 2013)" after "fiscal year" in text.

Subsec. (f)(3). Pub. L. 115–52, §403(f)(2), substituted "2018 through 2022" for "2013 through 2017".

Subsec. (g). Pub. L. 115–52, §403(c)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h).

Subsec. (h). Pub. L. 115–52, §403(c)(2), substituted "subsection (d)" for "subsection (c)".

Pub. L. 115–52, §403(c)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i).

Subsec. (i). Pub. L. 115–52, §403(c)(1), redesignated subsec. (h) as (i).

2016—Subsec. (a)(1)(A)(v). Pub. L. 114–255, §3101(a)(2)(V)(i), which directed technical amendment in paragraph (1)(A)(v) to reference in original act which appears in text as reference to July 9, 2012, was executed by making the amendment in introductory provisions and in subcl. (I), to reflect the probable intent of Congress.

Subsec. (a)(2)(B). Pub. L. 114–255, §3101(a)(2)(V)(ii), substituted "Biosimilar User Fee Act of 2012" for "Biosimilars User Fee Act of 2012".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2022, see section 4006 of Pub. L. 117–180, set out as a note under section 379j–51 of this title.

Effective Date of 2020 Amendment

Pub. L. 116–136, div. A, title III, §3856(b)(2), Mar. 27, 2020, 134 Stat. 458, provided that: "The amendment made by paragraph (1) [amending Pub. L. 115–52 which amended this section] shall take effect as of the enactment of the FDA Reauthorization Act of 2017 (Public Law 115–52)."

Effective Date of 2017 Amendment

Amendment by section 403 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2017, see section 406 of Pub. L. 115–52, set out as a note under section 379j–51 of this title.

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2027, see section 4005(a) of Pub. L. 117–180, set out as a note under section 379j–51 of this title.

Section effective Oct. 1, 2012, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.

§379j–53. Reauthorization; reporting requirements

(a) Performance report

(1) General requirements

Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort.

(2) Additional information

The report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—

(A) information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort;

(B) the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and

(C) the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals ² letters issued by the agency for such applications.

(3) Real time reporting

(A) In general

Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.

(B) Data

The Secretary shall post the following data in accordance with subparagraph (A):

(i) The number and titles of draft and final guidance on topics related to the process for the review of biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022.

(ii) The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022.

(4) Rationale for BSUFA program changes

Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 4001(b) of the Biosimilar User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j–52 of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying—

(i) drivers of such changes; and

(ii) changes in the average total cost per full-time equivalent in the biosimilar biological product review program;

(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and

(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application.

(5) Analysis

For each fiscal year, the Secretary shall include in the report an analysis of the following:

(A) The difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency, accounting for—

(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year.

(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance enhancement goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year.

(C) The most common causes and trends for external or other circumstances affecting the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022.

(b) Fiscal report

Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c) Corrective action report

For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(1) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the biosimilar biological product application review process.

(2) Goals missed

For each of the goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(A) a justification for such determination and a description of the types of circumstances and trends, as applicable, under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such ² fiscal year.

(d) Enhanced communication

(1) Communications with Congress

Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

(2) Participation in congressional hearing

Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.

(e) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for the process for the review of biosimilar biological product applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(C) scientific and academic experts;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization;

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and

(D) publish the comments on the Food and Drug Administration's website.

(3) Periodic consultation

Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Updates to Congress

The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this subpart to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(5) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(7) Minutes of negotiation meetings

(A) Public availability

The Secretary shall make publicly available, on the public website of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.

(B) Content

The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §744I, as added Pub. L. 112–144, title IV, §403, July 9, 2012, 126 Stat. 1037; amended Pub. L. 115–52, title IV, §404, title IX, §§903(d), 904(d), Aug. 18, 2017, 131 Stat. 1035, 1081, 1087; Pub. L. 117–180, div. F, title IV, §4004, Sept. 30, 2022, 136 Stat. 2166; Pub. L. 117–328, div. FF, title III, §3626(d), Dec. 29, 2022, 136 Stat. 5886.)

Termination of Section

For termination of section by section 4005(b) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

References in Text

Section 401(b) of the Biosimilar User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 4001(b) of the Biosimilar User Fee Amendments of 2022, title IV of div. F of Pub. L. 117–180, which is set out as a note under section 379j–51 of this title. The Biosimilar User Fee Amendments of 2022 does not contain a section 401(b).

Section 4001(b) of the Biosimilar User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 4001(b) of title IV of div. F of Pub. L. 117–180, which is set out as a note under section 379j–51 of this title.

Codification

Amendments made by section 904(d)(2) of Pub. L. 115–52, effective Aug. 18, 2017, were executed after the amendments made by section 404(3)–(5) of Pub. L. 115–52, effective Oct. 1, 2017, to reflect the probable intent of Congress and the directory language of section 904(d)(2) of Pub. L. 115–52, which expressly amended this section "as amended by section 404" of Pub. L. 115–52. See 2017 Amendment notes below.

Amendments

2022—Pub. L. 117–180, §4004(2), substituted "Biosimilar User Fee Amendments of 2022" for "Biosimilar User Fee Amendments of 2017" wherever appearing.

Subsec. (a)(1). Pub. L. 117–180, §4004(1), substituted "Not" for "Beginning with fiscal year 2018, not".

Subsec. (a)(2). Pub. L. 117–180, §4004(3), substituted "The" for "Beginning with fiscal year 2018, the" in introductory provisions.

Subsec. (a)(3)(A). Pub. L. 117–180, §4004(4), substituted "Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart" for "Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter".

Subsec. (a)(4)(A). Pub. L. 117–328, §3626(d)(1)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;".

Subsec. (a)(4)(B). Pub. L. 117–328, §3626(d)(1)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying drivers of such changes; and".

Subsec. (a)(4)(D). Pub. L. 117–328, §3626(d)(1)(C), (D), added subpar. (D).

Subsec. (b). Pub. L. 117–180, §4004(5), substituted "Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart" for "Not later than 120 days after the end of fiscal year 2018 and each subsequent fiscal year for which fees are collected under this subpart".

Subsec. (c). Pub. L. 117–180, §4004(6), substituted "For" for "Beginning with fiscal year 2018, and for" in introductory provisions.

Subsec. (f)(1). Pub. L. 117–180, §4004(7)(A), substituted "fiscal year 2027" for "fiscal year 2022" in introductory provisions.

Subsec. (f)(2). Pub. L. 117–328, §3626(d)(2)(B), added par. (2). Former par. (2) redesignated (5).

Subsec. (f)(3). Pub. L. 117–328, §3626(d)(2)(B), added par. (3). Former par. (3) redesignated (6).

Pub. L. 117–180, §4004(7)(B), substituted "January 15, 2027" for "January 15, 2022".

Subsec. (f)(4) to (7). Pub. L. 117–328, §3626(d)(2), added pars. (4) and (7) and redesignated formers pars. (2) and (3) as (5) and (6), respectively.

2017—Subsec. (a). Pub. L. 115–52, §903(d), designated existing provisions as par. (1), inserted heading, and added pars. (2) to (4).

Pub. L. 115–52, §404(1), substituted "2018" for "2013" and "Biosimilar User Fee Amendments of 2017" for "Biosimilar User Fee Act of 2012".

Subsec. (a)(5). Pub. L. 115–52, §904(d)(1), added par. (5).

Subsec. (b). Pub. L. 115–52, §404(2), substituted "2018" for "2013".

Subsec. (c). Pub. L. 115–52, §904(d)(2), added subsec. (c). Former subsec. (c) redesignated (e).

Subsecs. (d), (e). Pub. L. 115–52, §904(d)(2), added subsec. (d) and redesignated subsec. (c) as (e). Former subsec. (d), as redesignated by section 404(4) of Pub. L. 115–52, redesignated (f). See Amendment notes below.

Pub. L. 115–52, §404(3)–(5), redesignated subsec. (e) as (d), substituted "2022" for "2017" in pars. (1) and (3), and struck out former subsec. (d) which related to a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications.

Subsec. (f). Pub. L. 115–52, §904(d)(2), redesignated subsec. (d) as (f).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2022, see section 4006 of Pub. L. 117–180, set out as a note under section 379j–51 of this title.

Effective Date of 2017 Amendment

Amendment by section 404 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2017, see section 406 of Pub. L. 115–52, set out as a note under section 379j–51 of this title.

Effective and Termination Dates

Pub. L. 117–180, div. F, title IV, §4005(b), Sept. 30, 2022, 136 Stat. 2166, provided that: "Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) shall cease to be effective January 31, 2028."

Pub. L. 115–52, title IV, §405(b), Aug. 18, 2017, 131 Stat. 1035, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166.

[Pub. L. 117–180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166, provided that the repeal of section 405(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title IV, §404(b), July 9, 2012, 126 Stat. 1038, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title IV, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035.

[Pub. L. 115–52, title III, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(b) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Section effective Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.

¹ See References in Text note below.

² So in original.

subpart 9—fees relating to outsourcing facilities

§379j–61. Definitions

In this subpart:

(1) The term "affiliate" has the meaning given such term in section 379g(11) of this title.

(2) The term "gross annual sales" means the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility.

(3) The term "outsourcing facility" has the meaning given to such term in section 353b(d)(4) of this title.

(4) The term "reinspection" means, with respect to an outsourcing facility, 1 or more inspections conducted under section 374 of this title subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary's satisfaction.

(June 25, 1938, ch. 675, §744J, as added Pub. L. 113–54, title I, §102(b), Nov. 27, 2013, 127 Stat. 593.)

§379j–62. Authority to assess and use outsourcing facility fees

(a) Establishment and reinspection fees

(1) In general

For fiscal year 2015 and each subsequent fiscal year, the Secretary shall, in accordance with this subsection, assess and collect—

(A) an annual establishment fee from each outsourcing facility; and

(B) a reinspection fee from each outsourcing facility subject to a reinspection in such fiscal year.

(2) Multiple reinspections

An outsourcing facility subject to multiple reinspections in a fiscal year shall be subject to a reinspection fee for each reinspection.

(b) Establishment and reinspection fee setting

The Secretary shall—

(1) establish the amount of the establishment fee and reinspection fee to be collected under this section for each fiscal year based on the methodology described in subsection (c); and

(2) publish such fee amounts in a Federal Register notice not later than 60 calendar days before the start of each such year.

(c) Amount of establishment fee and reinspection fee

(1) In general

For each outsourcing facility in a fiscal year—

(A) except as provided in paragraph (4), the amount of the annual establishment fee under subsection (b) shall be equal to the sum of—

(i) $15,000, multiplied by the inflation adjustment factor described in paragraph (2); plus

(ii) the small business adjustment factor described in paragraph (3); and

(B) the amount of any reinspection fee (if applicable) under subsection (b) shall be equal to $15,000, multiplied by the inflation adjustment factor described in paragraph (2).

(2) Inflation adjustment factor

(A) In general

For fiscal year 2015 and subsequent fiscal years, the fee amounts established in paragraph (1) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of—

(i) 1;

(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years; plus

(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (U.S. City Average; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years.

(B) Compounded basis

The adjustment made each fiscal year under subparagraph (A) shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under subparagraph (A).

(3) Small business adjustment factor

The small business adjustment factor described in this paragraph shall be an amount established by the Secretary for each fiscal year based on the Secretary's estimate of—

(A) the number of small businesses that will pay a reduced establishment fee for such fiscal year; and

(B) the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the Secretary would have collected if no entity qualified for the small business exception in paragraph (4).

(4) Exception for small businesses

(A) In general

In the case of an outsourcing facility with gross annual sales of $1,000,000 or less in the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which the fees under this section are assessed, the amount of the establishment fee under subsection (b) for a fiscal year shall be equal to \1/3\ of the amount calculated under paragraph (1)(A)(i) for such fiscal year.

(B) Application

To qualify for the exception under this paragraph, a small business shall submit to the Secretary a written request for such exception, in a format specified by the Secretary in guidance, certifying its gross annual sales for the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed. Any such application shall be submitted to the Secretary not later than April 30 of such immediately preceding fiscal year.

(5) Crediting of fees

In establishing the small business adjustment factor under paragraph (3) for a fiscal year, the Secretary shall—

(A) provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of the small business adjustment factor for such previous fiscal year; and

(B) consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.

(d) Use of fees

The Secretary shall make all of the fees collected pursuant to subparagraphs (A) and (B) of subsection (a)(1) available solely to pay for the costs of oversight of outsourcing facilities.

(e) Supplement not supplant

Funds received by the Secretary pursuant to this section shall be used to supplement and not supplant any other Federal funds available to carry out the activities described in this section.

(f) Crediting and availability of fees

Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the costs of oversight of outsourcing facilities.

(g) Collection of fees

(1) Establishment fee

An outsourcing facility shall remit the establishment fee due under this section in a fiscal year when submitting a registration pursuant to section 353b(b) of this title for such fiscal year.

(2) Reinspection fee

The Secretary shall specify in the Federal Register notice described in subsection (b)(2) the manner in which reinspection fees assessed under this section shall be collected and the timeline for payment of such fees. Such a fee shall be collected after the Secretary has conducted a reinspection of the outsourcing facility involved.

(3) Effect of failure to pay fees

(A) Registration

An outsourcing facility shall not be considered registered under section 353b(b) of this title in a fiscal year until the date that the outsourcing facility remits the establishment fee under this subsection for such fiscal year.

(B) Misbranding

All drugs manufactured, prepared, propagated, compounded, or processed by an outsourcing facility for which any establishment fee or reinspection fee has not been paid, as required by this section, shall be deemed misbranded under section 352 of this title until the fees owed for such outsourcing facility under this section have been paid.

(4) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under this section within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31.

(h) Annual report to Congress

Not later than 120 calendar days after each fiscal year in which fees are assessed and collected under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for such year, a summary description of entities paying the fees, a description of the hiring and placement of new staff, a description of the use of fee resources to support inspecting outsourcing facilities, and the number of inspections and reinspections of such facilities performed each year.

(i) Authorization of appropriations

For fiscal year 2014 and each subsequent fiscal year, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.

(June 25, 1938, ch. 675, §744K, as added Pub. L. 113–54, title I, §102(b), Nov. 27, 2013, 127 Stat. 594.)

subpart 10—fees relating to over-the-counter drugs

§379j–71. Definitions

In this subpart:

(1) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(2) The term "contract manufacturing organization facility" means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

(3) The term "costs of resources allocated for OTC monograph drug activities" means the expenses in connection with OTC monograph drug activities for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and costs related to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under section 379j–72 of this title and accounting for resources allocated for OTC monograph drug activities.

(4) The term "FDA establishment identifier" is the unique number automatically generated by Food and Drug Administration's Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).

(5) The term "OTC monograph drug" means a nonprescription drug without an approved new drug application which is governed by the provisions of section 355h of this title.

(6) The term "OTC monograph drug activities" means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities:

(A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including—

(i) orders proposing or finalizing applicable conditions of use for OTC monograph drugs;

(ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use;

(iii) all OTC monograph drug development and review activities, including intra-agency collaboration;

(iv) regulation and policy development activities related to OTC monograph drugs;

(v) development of product standards for products subject to review and evaluation;

(vi) meetings referred to in section 355h(i) of this title;

(vii) review of labeling prior to issuance of orders related to OTC monograph drugs or conditions of use; and

(viii) regulatory science activities related to OTC monograph drugs.

(B) Inspections related to OTC monograph drugs.

(C) Monitoring of clinical and other research conducted in connection with OTC monograph drugs.

(D) Safety activities with respect to OTC monograph drugs, including—

(i) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;

(ii) developing and using improved adverse event data-collection systems, including information technology systems; and

(iii) developing and using improved analytical tools to assess potential safety risks, including access to external databases.

(E) Other activities necessary for implementation of section 355h of this title.

(7) The term "OTC monograph order request" means a request for an order submitted under section 355h(b)(5) of this title.

(8) The term "Tier 1 OTC monograph order request" means any OTC monograph order request not determined to be a Tier 2 OTC monograph order request.

(9)(A) The term "Tier 2 OTC monograph order request" means, subject to subparagraph (B), an OTC monograph order request for—

(i) the reordering of existing information in the drug facts label of an OTC monograph drug;

(ii) the addition of information to the other information section of the drug facts label of an OTC monograph drug, as limited by section 201.66(c)(7) of title 21, Code of Federal Regulations (or any successor regulations);

(iii) modification to the directions for use section of the drug facts label of an OTC monograph drug, if such changes conform to changes made pursuant to section 355h(c)(3)(A) of this title;

(iv) the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;

(v) a change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or

(vi) addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).

(B) The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any OTC monograph order request as a Tier 2 OTC monograph order request (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 355h of this title.

(10)(A) The term "OTC monograph drug facility" means a foreign or domestic business or other entity that—

(i) is—

(I) under one management, either direct or indirect; and

(II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;

(ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and

(iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.

(B) For purposes of subparagraph (A)(i)(II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are—

(i) closely related to the same business enterprise;

(ii) under the supervision of the same local management; and

(iii) under a single FDA establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection.

(C) If a business or other entity would meet criteria specified in subparagraph (A), but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.

(11) The term "OTC monograph drug meeting" means any meeting regarding the content of a proposed OTC monograph order request.

(12) The term "person" includes an affiliate of a person.

(13) The terms "requestor" and "sponsor" have the meanings given such terms in section 355h of this title.

(June 25, 1938, ch. 675, §744L, as added Pub. L. 116–136, div. A, title III, §3862, Mar. 27, 2020, 134 Stat. 459.)

Statutory Notes and Related Subsidiaries

Finding

Pub. L. 116–136, div. A, title III, §3861, Mar. 27, 2020, 134 Stat. 458, provided that: "The Congress finds that the fees authorized by the amendments made in this part [part II of subtitle F of title III of div. A of Pub. L. 116–136, enacting this subpart] will be dedicated to OTC monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

§379j–72. Authority to assess and use OTC monograph fees

(a) Types of fees

Beginning with fiscal year 2021, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Facility fee

(A) In general

Each person that owns a facility identified as an OTC monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility as determined under subsection (c).

(B) Exceptions

(i) Facilities that cease activities

A fee shall not be assessed under subparagraph (A) if the identified OTC monograph drug facility—

(I) has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and

(II) has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 360 of this title.

(ii) Contract manufacturing organizations

The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an OTC monograph drug facility that is not a contract manufacturing organization facility.

(C) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (c).

(D) Due date

(i) For first program year

For fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—

(I) the first business day of July of 2020; or

(II) 45 calendar days after publication of the Federal Register notice provided for under subsection (c)(4)(A).

(ii) Subsequent fiscal years

For each fiscal year after fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—

(I) the first business day of June of such year; or

(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.

(2) OTC monograph order request fee

(A) In general

Each person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—

(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and

(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).

(B) Due date

The OTC monograph order request fees required under subparagraph (A) shall be due on the date of submission of the OTC monograph order request.

(C) Exception for certain safety changes

A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—

(i) a contraindication, warning, or precaution;

(ii) a statement about risk associated with misuse or abuse; or

(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.

(D) Refund of fee if order request is recategorized as a Tier 2 OTC monograph order request

If the Secretary determines that an OTC monograph request initially characterized as Tier 1 shall be re-characterized as a Tier 2 OTC monograph order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively.

(E) Refund of fee if order request refused for filing or withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any order request which is refused for filing or was withdrawn before being accepted or refused for filing.

(F) Fees for order requests previously refused for filing or withdrawn before filing

An OTC monograph order request that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest.

(G) Refund of fee if order request withdrawn

If an order request is withdrawn after the order request was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.

(3) Refunds

(A) In general

Other than refunds provided pursuant to any of subparagraphs (D) through (G) of paragraph (2), the Secretary shall not refund any fee paid under paragraph (1) except as provided in subparagraph (B).

(B) Disputes concerning fees

To qualify for the return of a fee claimed to have been paid in error under paragraph (1) or (2), a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.

(4) Notice

Within the timeframe specified in subsection (c), the Secretary shall publish in the Federal Register the amount of the fees under paragraph (1) for such fiscal year.

(b) Fee revenue amounts

(1) Fiscal year 2021

For fiscal year 2021, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—

(A) the annual base revenue for fiscal year 2021 (as determined under paragraph (3));

(B) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2)); and

(C) additional direct cost adjustments (as determined under subsection (c)(3)).

(2) Subsequent fiscal years

For each of the fiscal years 2022 through 2025, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—

(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

(C) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));

(D) additional direct cost adjustments (as determined under subsection (c)(3)); and

(E) additional dollar amounts for each fiscal year as follows:

(i) $7,000,000 for fiscal year 2022.

(ii) $6,000,000 for fiscal year 2023.

(iii) $7,000,000 for fiscal year 2024.

(iv) $3,000,000 for fiscal year 2025.

(3) Annual base revenue

For purposes of paragraphs (1)(A) and (2)(A), the dollar amount of the annual base revenue for a fiscal year shall be—

(A) for fiscal year 2021, $8,000,000; and

(B) for fiscal years 2022 through 2025, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made under subsection (c)(2) or (c)(3).

(c) Adjustments; annual fee setting

(1) Inflation adjustment

(A) In general

For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—

(i) such annual base revenue for the fiscal year under subsection (b)(2); and

(ii) the inflation adjustment percentage under subparagraph (C).

(B) OTC monograph order request fees

For purposes of subsection (a)(2), the dollar amount of the inflation adjustment to the fee for OTC monograph order requests for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—

(i) the applicable fee under subsection (a)(2) for the preceding fiscal year; and

(ii) the inflation adjustment percentage under subparagraph (C).

(C) Inflation adjustment percentage

The inflation adjustment percentage under this subparagraph for a fiscal year is equal to—

(i) for each of fiscal years 2022 and 2023, the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data; and

(ii) for each of fiscal years 2024 and 2025, the sum of—

(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years; and

(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years.

(2) Operating reserve adjustment

(A) In general

For fiscal year 2021 and subsequent fiscal years, for purposes of subsections (b)(1)(B) and (b)(2)(C), the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for OTC monograph drug activities for not more than the number of weeks specified in subparagraph (B).

(B) Number of weeks

The number of weeks specified in this subparagraph is—

(i) 3 weeks for fiscal year 2021;

(ii) 7 weeks for fiscal year 2022;

(iii) 10 weeks for fiscal year 2023;

(iv) 10 weeks for fiscal year 2024; and

(v) 10 weeks for fiscal year 2025.

(C) Decrease

If the Secretary has carryover balances for such process in excess of 10 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 10 weeks of such operating reserves.

(D) Rationale for adjustment

If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (4) establishing fee revenue and fees for the fiscal year involved.

(3) Additional direct cost adjustment

The Secretary shall, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees for purposes of subsection (b)(2)(D) by an amount equal to—

(A) $14,000,000 for fiscal year 2021;

(B) $7,000,000 for fiscal year 2022;

(C) $4,000,000 for fiscal year 2023;

(D) $3,000,000 for fiscal year 2024; and

(E) $3,000,000 for fiscal year 2025.

(4) Annual fee setting

(A) Fiscal year 2021

The Secretary shall, not later than the second Monday in May of 2020—

(i) establish OTC monograph drug facility fees for fiscal year 2021 under subsection (a), based on the revenue amount for such year under subsection (b) and the adjustments provided under this subsection; and

(ii) publish fee revenue, facility fees, and OTC monograph order requests in the Federal Register.

(B) Subsequent fiscal years

The Secretary shall, for each fiscal year that begins after September 30, 2021, not later than the second Monday in March that precedes such fiscal year—

(i) establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—

(I) OTC monograph drug facility fees under subsection (a)(1); and

(II) OTC monograph order request fees under subsection (a)(2); and

(ii) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.

(d) Identification of facilities

Each person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—

(1) be submitted as part of the requirements for drug establishment registration set forth in section 360 of this title; and

(2) include for each such facility, at a minimum, identification of the facility's business operation as that of an OTC monograph drug facility.

(e) Effect of failure to pay fees

(1) OTC monograph drug facility fee

(A) In general

Failure to pay the fee under subsection (a)(1) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:

(i) The Secretary shall place the facility on a publicly available arrears list.

(ii) All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(ff) of this title.

(B) Application of penalties

The penalties under this paragraph shall apply until the fee established by subsection (a)(1) is paid.

(2) Order requests

An OTC monograph order request submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person under this section have been paid.

(3) Meetings

A person subject to fees under this section shall be considered ineligible for OTC monograph drug meetings until all such fees owed by such person have been paid.

(f) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for OTC monograph drug activities.

(2) Collections and appropriation Acts

(A) In general

Subject to subparagraph (C), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year.

(B) Use of fees and limitation

The fees authorized by this section shall be available to defray increases in the costs of the resources allocated for OTC monograph drug activities (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $12,000,000, multiplied by the adjustment factor applicable to the fiscal year involved under subsection (c)(1).

(C) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs funded by appropriations and allocated for OTC monograph drug activities are not more than 15 percent below the level specified in such subparagraph.

(D) Provision for early payments in subsequent years

Payment of fees authorized under this section for a fiscal year (after fiscal year 2021), prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

For each of the fiscal years 2021 through 2025, there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section.

(g) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(h) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in OTC monograph drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(June 25, 1938, ch. 675, §744M, as added Pub. L. 116–136, div. A, title III, §3862, Mar. 27, 2020, 134 Stat. 461.)

§379j–73. Reauthorization; reporting requirements

(a) Performance report

Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafter for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 3861(b) ¹ of the CARES Act during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals.

(b) Fiscal report

Not later than 120 calendar days after the end of fiscal year 2021 and each subsequent fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the internet website of the Food and Drug Administration.

(d) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for OTC monograph drug activities for the first 5 fiscal years after fiscal year 2025, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(C) scientific and academic experts;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 calendar days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(3) Transmittal of recommendations

Not later than January 15, 2025, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(June 25, 1938, ch. 675, §744N, as added Pub. L. 116–136, div. A, title III, §3862, Mar. 27, 2020, 134 Stat. 468.)

Editorial Notes

References in Text

Section 3861(b) of the CARES Act, referred to in subsec. (a), probably means section 3861 of Pub. L. 116–136, div. A, title III, Mar. 27, 2020, 134 Stat. 458, which is set out as a note under section 379j–71 of this title. Section 3861 of Pub. L. 116–136 does not contain subsecs.

¹ See References in Text note below.

Part D—Information and Education

§379k. Information system

The Secretary shall establish and maintain an information system to track the status and progress of each application or submission (including a petition, notification, or other similar form of request) submitted to the Food and Drug Administration requesting agency action.

(June 25, 1938, ch. 675, §745, formerly §741, as added Pub. L. 105–115, title IV, §407(a), Nov. 21, 1997, 111 Stat. 2370; renumbered §745, Pub. L. 110–316, title II, §202(a), Aug. 14, 2008, 122 Stat. 3515.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Report on Status of System

Pub. L. 105–115, title IV, §407(b), Nov. 21, 1997, 111 Stat. 2370, provided that not later than 1 year after Nov. 21, 1997, Secretary of Health and Human Services was to submit report to Congress on status of system to be established under this section, including projected costs of system and concerns about confidentiality.

§379k–1. Electronic format for submissions

(a) Drugs and biologics

(1) In general

Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall be submitted in such electronic format as specified by the Secretary in such guidance.

(2) Guidance contents

In the guidance under paragraph (1), the Secretary may—

(A) provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and

(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.

(3) Exception

This subsection shall not apply to submissions described in section 360bbb of this title.

(b) Devices

(1) In general

Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 of this title or section 262 of title 42, and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.

(2) Guidance contents

In the guidance under paragraph (1), the Secretary may—

(A) provide standards for the electronic copy required under such paragraph; and

(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.

(3) Presubmissions and submissions solely in electronic format

(A) In general

Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.

(B) Draft guidance

The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—

(i) any further standards for the submission by electronic format required under subparagraph (A);

(ii) a timetable for the establishment by the Secretary of such further standards; and

(iii) criteria for waivers of and exemptions from the requirements of this subsection.

(C) Final guidance

The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.

(June 25, 1938, ch. 675, §745A, as added Pub. L. 112–144, title XI, §1136, July 9, 2012, 126 Stat. 1123; amended Pub. L. 115–52, title II, §207, Aug. 18, 2017, 131 Stat. 1019.)

Editorial Notes

Amendments

2017—Subsec. (b)(3). Pub. L. 115–52 added par. (3).

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Amendment by title II of Pub. L. 115–52, effective Oct. 1, 2017, except that fees under subpart 3 of part C of this subchapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

§379l. Education

(a) In general

The Secretary shall conduct training and education programs for the employees of the Food and Drug Administration relating to the regulatory responsibilities and policies established by this chapter, including programs for—

(1) scientific training;

(2) training to improve the skill of officers and employees authorized to conduct inspections under section 374 of this title;

(3) training to achieve product specialization in such inspections; and

(4) training in administrative process and procedure and integrity issues.

(b) Intramural fellowships and other training programs

The Secretary, acting through the Commissioner, may, through fellowships and other training programs, conduct and support intramural research training for predoctoral and postdoctoral scientists and physicians. Any such fellowships and training programs under this section or under section 379dd(d)(2)(A)(ix) of this title may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services.

(June 25, 1938, ch. 675, §746, formerly §742, as added Pub. L. 105–115, title IV, §408(a), Nov. 21, 1997, 111 Stat. 2371; amended Pub. L. 110–85, title VI, §601(c), Sept. 27, 2007, 121 Stat. 897; renumbered §746, Pub. L. 110–316, title II, §202(a), Aug. 14, 2008, 122 Stat. 3515.)

Editorial Notes

Prior Provisions

A prior section 746 of act June 25, 1938, was renumbered section 749 and is classified to section 379o of this title.

Amendments

2007—Subsec. (b). Pub. L. 110–85 inserted at end "Any such fellowships and training programs under this section or under section 379dd(d)(2)(A)(ix) of this title may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services."

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Part E—Environmental Impact Review

§379o. Environmental impact

Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the regulations published in part 25 of title 21, Code of Federal Regulations (as in effect on August 31, 1997) in connection with an action carried out under (or a recommendation or report relating to) this chapter, shall be considered to meet the requirements for a detailed statement under section 4332(2)(C) of title 42.

(June 25, 1938, ch. 675, §749, formerly §746, as added Pub. L. 105–115, title IV, §411, Nov. 21, 1997, 111 Stat. 2373; renumbered §749, Pub. L. 110–316, title II, §202(a), Aug. 14, 2008, 122 Stat. 3515.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Part F—National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics

§379r. National uniformity for nonprescription drugs

(a) In general

Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement—

(1) that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title; and

(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

(b) Exemption

(1) In general

Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement that—

(A) protects an important public interest that would otherwise be unprotected, including the health and safety of children;

(B) would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and

(C) would not unduly burden interstate commerce.

(2) Timely action

The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under paragraph (1).

(c) Scope

(1) In general

This section shall not apply to—

(A) any State or political subdivision requirement that relates to the practice of pharmacy; or

(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.

(2) Safety or effectiveness

For purposes of subsection (a), a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug.

(d) Exceptions

(1) In general

In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under section 355 of this title or section 357 of this title (as in effect on the day before November 21, 1997) or a final order under section 355h of this title by the Secretary establishing conditions under which the drug is generally recognized as safe and effective, subsection (a) shall apply only with respect to a requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with—

(A) a regulation or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or

(B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after November 21, 1997.

(2) State initiatives

This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.

(e) No effect on product liability law

Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(f) State enforcement authority

Nothing in this section shall prevent a State or political subdivision thereof from enforcing, under any relevant civil or other enforcement authority, a requirement that is identical to a requirement of this chapter.

(June 25, 1938, ch. 675, §751, as added Pub. L. 105–115, title IV, §412(a), Nov. 21, 1997, 111 Stat. 2373; amended Pub. L. 116–136, div. A, title III, §3851(c), Mar. 27, 2020, 134 Stat. 454.)

Editorial Notes

References in Text

The Poison Prevention Packaging Act of 1970, referred to in subsec. (a)(2), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1471 of Title 15 and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (a)(2), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables.

Amendments

2020—Subsec. (d)(1). Pub. L. 116–136, §3851(c)(1), in introductory provisions, substituted "final order under section 355h of this title" for "final regulation promulgated" and struck out "and not misbranded" after "safe and effective".

Subsec. (d)(1)(A). Pub. L. 116–136, §3851(c)(2), substituted "regulation or order in effect" for "regulation in effect".

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§379s. Preemption for labeling or packaging of cosmetics

(a) In general

Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

(b) Exemption

Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement for labeling or packaging that—

(1) protects an important public interest that would otherwise be unprotected;

(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and

(3) would not unduly burden interstate commerce.

(c) Scope

For purposes of subsection (a), a reference to a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relating to public information or any other form of public communication.

(d) No effect on product liability law

Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(e) State initiative

This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.

(June 25, 1938, ch. 675, §752, as added Pub. L. 105–115, title IV, §412(d), Nov. 21, 1997, 111 Stat. 2376.)

Editorial Notes

References in Text

The Poison Prevention Packaging Act of 1970, referred to in subsec. (a), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1471 of Title 15 and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (a), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Part G—Safety Reports

§379v. Safety report disclaimers

With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.

(June 25, 1938, ch. 675, §756, as added Pub. L. 105–115, title IV, §420, Nov. 21, 1997, 111 Stat. 2379.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Part H—Serious Adverse Event Reports

§379aa. Serious adverse event reporting for nonprescription drugs

(a) Definitions

In this section:

(1) Adverse event

The term "adverse event" means any health-related event associated with the use of a nonprescription drug that is adverse, including—

(A) an event occurring from an overdose of the drug, whether accidental or intentional;

(B) an event occurring from abuse of the drug;

(C) an event occurring from withdrawal from the drug; and

(D) any failure of expected pharmacological action of the drug.

(2) Nonprescription drug

The term "nonprescription drug" means a drug that is—

(A) not subject to section 353(b) of this title; and

(B) not subject to approval in an application submitted under section 355 of this title.

(3) Serious adverse event

The term "serious adverse event" is an adverse event that—

(A) results in—

(i) death;

(ii) a life-threatening experience;

(iii) inpatient hospitalization;

(iv) a persistent or significant disability or incapacity; or

(v) a congenital anomaly or birth defect; or

(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

(4) Serious adverse event report

The term "serious adverse event report" means a report that is required to be submitted to the Secretary under subsection (b).

(b) Reporting requirement

(1) In general

The manufacturer, packer, or distributor whose name (pursuant to section 352(b)(1) of this title) appears on the label of a nonprescription drug marketed in the United States (referred to in this section as the "responsible person") shall submit to the Secretary any report received of a serious adverse event associated with such drug when used in the United States, accompanied by a copy of the label on or within the retail package of such drug.

(2) Retailer

A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the nonprescription drug to submit the required reports for such drugs to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such drug that are reported to the retailer through the address or telephone number described in section 352(x) of this title.

(c) Submission of reports

(1) Timing of reports

The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in section 352(x) of this title.

(2) New medical information

The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.

(3) Consolidation of reports

The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.

(4) Exemption

The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health.

(d) Contents of reports

Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for nonprescription drugs, and may be accompanied by additional information.

(e) Maintenance and inspection of records

(1) Maintenance

The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years.

(2) Records inspection

(A) In general

The responsible person shall permit an authorized person to have access to records required to be maintained under this section, during an inspection pursuant to section 374 of this title.

(B) Authorized person

For purposes of this paragraph, the term "authorized person" means an officer or employee of the Department of Health and Human Services who has—

(i) appropriate credentials, as determined by the Secretary; and

(ii) been duly designated by the Secretary to have access to the records required under this section.

(f) Protected information

A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be—

(1) a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and

(2) a record about an individual under section 552a of title 5 (commonly referred to as the "Privacy Act of 1974") and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the "Freedom of Information Act"), and shall not be publicly disclosed unless all personally identifiable information is redacted.

(g) Rule of construction

The submission of any adverse event report in compliance with this section shall not be construed as an admission that the nonprescription drug involved caused or contributed to the adverse event.

(h) Preemption

(1) In general

No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for nonprescription drugs, that is different from, in addition to, or otherwise not identical to, this section.

(2) Effect of section

(A) In general

Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.

(B) Personally-identifiable information

Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—

(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

(C) Use of safety reports

Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with subsection (g) or section 379v of this title.

(i) Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary.

(June 25, 1938, ch. 675, §760, as added Pub. L. 109–462, §2(a), Dec. 22, 2006, 120 Stat. 3469.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109–462, set out as an Effective Date of 2006 Amendment note under section 352 of this title.

Modifications

Pub. L. 109–462, §2(b), Dec. 22, 2006, 120 Stat. 3472, provided that: "The Secretary of Health and Human Services may modify requirements under the amendments made by this section [enacting this section and amending sections 331 and 352 of this title] in accordance with section 553 of title 5, United States Code, to maintain consistency with international harmonization efforts over time."

Guidance

Pub. L. 109–462, §2(e)(3), Dec. 22, 2006, 120 Stat. 3472, provided that: "Not later than 270 days after the date of enactment of this Act [Dec. 22, 2006], the Secretary of Health and Human Services shall issue guidance on the minimum data elements that should be included in a serious adverse event report described under the amendments made by this Act [see Short Title of 2006 Amendment note set out under section 301 of this title]."

Pub. L. 109–462, §3(d)(3), Dec. 22, 2006, 120 Stat. 3475, enacted provisions substantially identical to those enacted by Pub. L. 109–462, §2(e)(3), set out above.

§379aa–1. Serious adverse event reporting for dietary supplements

(a) Definitions

In this section:

(1) Adverse event

The term "adverse event" means any health-related event associated with the use of a dietary supplement that is adverse.

(2) Serious adverse event

The term "serious adverse event" is an adverse event that—

(A) results in—

(i) death;

(ii) a life-threatening experience;

(iii) inpatient hospitalization;

(iv) a persistent or significant disability or incapacity; or

(v) a congenital anomaly or birth defect; or

(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

(3) Serious adverse event report

The term "serious adverse event report" means a report that is required to be submitted to the Secretary under subsection (b).

(b) Reporting requirement

(1) In general

The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to section 343(e)(1) of this title) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the "responsible person") shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.

(2) Retailer

A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such dietary supplement that are reported to the retailer through the address or telephone number described in section 343(y) of this title.

(c) Submission of reports

(1) Timing of reports

The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in section 343(y) of this title.

(2) New medical information

The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.

(3) Consolidation of reports

The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.

(4) Exemption

The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health.

(d) Contents of reports

Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for dietary supplements, and may be accompanied by additional information.

(e) Maintenance and inspection of records

(1) Maintenance

The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years.

(2) Records inspection

(A) In general

The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 374 of this title.

(B) Authorized person

For purposes of this paragraph, the term "authorized person" means an officer or employee of the Department of Health and Human Services, who has—

(i) appropriate credentials, as determined by the Secretary; and

(ii) been duly designated by the Secretary to have access to the records required under this section.

(f) Protected information

A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be—

(1) a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and

(2) a record about an individual under section 552a of title 5 (commonly referred to as the "Privacy Act of 1974") and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the "Freedom of Information Act"), and shall not be publicly disclosed unless all personally identifiable information is redacted.

(g) Rule of construction

The submission of any adverse event report in compliance with this section shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event.

(h) Preemption

(1) In general

No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for dietary supplements, that is different from, in addition to, or otherwise not identical to, this section.

(2) Effect of section

(A) In general

Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.

(B) Personally-identifiable information

Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—

(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

(C) Use of safety reports

Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with subsection (g) or section 379v of this title.

(i) Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary.

(June 25, 1938, ch. 675, §761, as added Pub. L. 109–462, §3(a), Dec. 22, 2006, 120 Stat. 3472.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 1 year after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109–462, set out as an Effective Date of 2006 Amendment note under section 343 of this title.

Part I—Reagan-Udall Foundation for the Food and Drug Administration

§379dd. Establishment and functions of the Foundation

(a) In general

A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (referred to in this part as the "Foundation") shall be established in accordance with this section. The Foundation shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e).¹ The Foundation shall not be an agency or instrumentality of the United States Government.

(b) Purpose of Foundation

The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

(c) Duties of the Foundation

The Foundation shall—

(1) taking into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics, and including the incorporation of more sensitive and predictive tools and devices to measure safety;

(2) establish goals and priorities in order to meet the unmet needs identified in paragraph (1);

(3) in consultation with the Secretary, identify existing and proposed Federal intramural and extramural research and development programs relating to the goals and priorities established under paragraph (2), coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts;

(4) award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements with, scientists and entities, which may include the Food and Drug Administration, university consortia, public-private partnerships, institutions of higher education, entities described in section 501(c)(3) of title 26 (and exempt from tax under section 501(a) of such title), and industry, to efficiently and effectively advance the goals and priorities established under paragraph (2);

(5) recruit meeting participants and hold or sponsor (in whole or in part) meetings as appropriate to further the goals and priorities established under paragraph (2);

(6) release and publish information and data and, to the extent practicable, license, distribute, and release material, reagents, and techniques to maximize, promote, and coordinate the availability of such material, reagents, and techniques for use by the Food and Drug Administration, nonprofit organizations, and academic and industrial researchers to further the goals and priorities established under paragraph (2);

(7) ensure that—

(A) action is taken as necessary to obtain patents for inventions developed by the Foundation or with funds from the Foundation;

(B) action is taken as necessary to enable the licensing of inventions developed by the Foundation or with funds from the Foundation; and

(C) executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial applications of licensed and patented inventions of the Foundation to further the goals and priorities established under paragraph (2);

(8) provide objective clinical and scientific information to the Food and Drug Administration and, upon request, to other Federal agencies to assist in agency determinations of how to ensure that regulatory policy accommodates scientific advances and meets the agency's public health mission;

(9) conduct annual assessments of the unmet needs identified in paragraph (1); and

(10) carry out such other activities consistent with the purposes of the Foundation as the Board determines appropriate.

(d) Board of Directors

(1) Establishment

(A) In general

The Foundation shall have a Board of Directors (referred to in this part as the "Board"), which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members.

(B) Ex officio members

The ex officio members of the Board shall be the following individuals or their designees:

(i) The Commissioner.

(ii) The Director of the National Institutes of Health.

(iii) The Director of the Centers for Disease Control and Prevention.

(iv) The Director of the Agency for Healthcare Research and Quality.

(C) Appointed members

(i) In general

The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 14 individuals, of which 9 shall be from a list of candidates to be provided by the National Academy of Sciences and 5 shall be from lists of candidates provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations. Of such appointed members—

(I) 4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries;

(II) 3 shall be representatives of academic research organizations;

(III) 2 shall be representatives of patient or consumer advocacy organizations;

(IV) 1 shall be a representative of health care providers; and

(V) 4 shall be at-large members with expertise or experience relevant to the purpose of the Foundation.

(ii) Additional members

The Board, through amendments to the bylaws of the Foundation, may provide that the number of voting members of the Board shall be a number (to be specified in such amendment) greater than 14. Any Board positions that are established by any such amendment shall be appointed (by majority vote) by the individuals who, as of the date of such amendment, are voting members of the Board and persons so appointed may represent any of the categories specified in subclauses (I) through (V) of clause (i), so long as no more than 30 percent of the total voting members of the Board (including members whose positions are established by such amendment) are representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries.

(iii) Requirements

(I) Expertise

The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure the Board membership includes individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.

(II) Federal employees

No employee of the Federal Government shall be appointed as a member of the Board under this subparagraph or under paragraph (3)(B). For purposes of this section, the term "employee of the Federal Government" does not include a special Government employee, as that term is defined in section 202(a) of title 18.

(D) Initial meeting

(i) In general

Not later than 30 days after September 27, 2007, the Secretary shall convene a meeting of the ex officio members of the Board to—

(I) incorporate the Foundation; and

(II) appoint the members of the Board in accordance with subparagraph (C).

(ii) Service of ex officio members

Upon the appointment of the members of the Board under clause (i)(II)—

(I) the terms of service of the Director of the Centers for Disease Control and Prevention and of the Director of the Agency for Healthcare Research and Quality as ex officio members of the Board shall terminate; and

(II) the Commissioner and the Director of the National Institutes of Health shall continue to serve as ex officio members of the Board, but shall be nonvoting members.

(iii) Chair

The ex officio members of the Board under subparagraph (B) shall designate an appointed member of the Board to serve as the Chair of the Board.

(2) Duties of Board

The Board shall—

(A) establish bylaws for the Foundation that—

(i) are published in the Federal Register and available for public comment;

(ii) establish policies for the selection of the officers, employees, agents, and contractors of the Foundation;

(iii) establish policies, including ethical standards, for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation, including appropriate limits on the ability of donors to designate, by stipulation or restriction, the use or recipient of donated funds;

(iv) establish policies that would subject all employees, fellows, and trainees of the Foundation to the conflict of interest standards under section 208 of title 18;

(v) establish licensing, distribution, and publication policies that support the widest and least restrictive use by the public of information and inventions developed by the Foundation or with Foundation funds to carry out the duties described in paragraphs (6) and (7) of subsection (c), and may include charging cost-based fees for published material produced by the Foundation;

(vi) specify principles for the review of proposals and awarding of grants and contracts that include peer review and that are consistent with those of the Foundation for the National Institutes of Health, to the extent determined practicable and appropriate by the Board;

(vii) specify a cap on administrative expenses for recipients of a grant, contract, or cooperative agreement from the Foundation;

(viii) establish policies for the execution of memoranda of understanding and cooperative agreements between the Foundation and other entities, including the Food and Drug Administration;

(ix) establish policies for funding training fellowships, whether at the Foundation, academic or scientific institutions, or the Food and Drug Administration, for scientists, doctors, and other professionals who are not employees of regulated industry, to foster greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic research into clinical and regulatory practice;

(x) specify a process for annual Board review of the operations of the Foundation; and

(xi) establish specific duties of the Executive Director;

(B) prioritize and provide overall direction to the activities of the Foundation;

(C) evaluate the performance of the Executive Director; and

(D) carry out any other necessary activities regarding the functioning of the Foundation.

(3) Terms and vacancies

(A) Term

The term of office of each member of the Board appointed under paragraph (1)(C)(i), and the term of office of any member of the Board whose position is established pursuant to paragraph (1)(C)(ii), shall be 4 years, except that—

(i) the terms of offices for the members of the Board initially appointed under paragraph (1)(C)(i) shall expire on a staggered basis as determined by the ex officio members; and

(ii) the terms of office for the persons initially appointed to positions established pursuant to paragraph (1)(C)(ii) may be made to expire on a staggered basis, as determined by the individuals who, as of the date of the amendment establishing such positions, are members of the Board.

(B) Vacancy

Any vacancy in the membership of the Board—

(i) shall not affect the power of the remaining members to execute the duties of the Board; and

(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.

(C) Partial term

If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.

(D) Serving past term

A member of the Board may continue to serve after the expiration of the term of the member until a successor is appointed.

(4) Compensation

Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board, as set forth in the bylaws issued by the Board.

(e) Incorporation

The ex officio members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation.

(f) Nonprofit status

In carrying out subsection (b), the Board shall establish such policies and bylaws under subsection (d), and the Executive Director shall carry out such activities under subsection (g), as may be necessary to ensure that the Foundation maintains status as an organization that—

(1) is described in subsection (c)(3) of section 501 of title 26; and

(2) is, under subsection (a) of such section, exempt from taxation.

(g) Executive Director

(1) In general

The Board shall appoint an Executive Director who shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe.

(2) Compensation

The compensation of the Executive Director shall be fixed by the Board.

(h) Administrative powers

In carrying out this part, the Board, acting through the Executive Director, may—

(1) adopt, alter, and use a corporate seal, which shall be judicially noticed;

(2) hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary, and define their duties;

(3) prescribe the manner in which—

(A) real or personal property of the Foundation is acquired, held, and transferred;

(B) general operations of the Foundation are to be conducted; and

(C) the privileges granted to the Board by law are exercised and enjoyed;

(4) with the consent of the applicable executive department or independent agency, use the information, services, and facilities of such department or agencies in carrying out this section;

(5) enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material;

(6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Foundation under subsection (i);

(7) enter into such other contracts, leases, cooperative agreements, and other transactions as the Board considers appropriate to conduct the activities of the Foundation;

(8) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an interest under this part;

(9) take such action as may be necessary to obtain patents and licenses for devices and procedures developed by the Foundation and its employees;

(10) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;

(11) appoint other groups of advisors as may be determined necessary to carry out the functions of the Foundation; and

(12) exercise other powers as set forth in this section, and such other incidental powers as are necessary to carry out its powers, duties, and functions in accordance with this part.

(i) Acceptance of funds from other sources

The Executive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or bequests of real or personal property made to the Foundation, including from private entities, for the purposes of carrying out the duties of the Foundation.

(j) Service of Federal employees

Federal Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its functions, so long as such employees do not direct or control Foundation activities.

(k) Detail of Government employees; fellowships

(1) Detail from Federal agencies

Federal Government employees may be detailed from Federal agencies with or without reimbursement to those agencies to the Foundation at any time, and such detail shall be without interruption or loss of civil service status or privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards applicable to the employees of the agency from which such employee is detailed and those of the Foundation.

(2) Voluntary service; acceptance of Federal employees

(A) Foundation

The Executive Director of the Foundation may accept the services of employees detailed from Federal agencies with or without reimbursement to those agencies.

(B) Food and Drug Administration

The Commissioner may accept the uncompensated services of Foundation fellows or trainees. Such services shall be considered to be undertaking an activity under contract with the Secretary as described in section 379 of this title.

(l) Annual reports

(1) Reports to Foundation

Any recipient of a grant, contract, fellowship, memorandum of understanding, or cooperative agreement from the Foundation under this section shall submit to the Foundation a report on an annual basis for the duration of such grant, contract, fellowship, memorandum of understanding, or cooperative agreement, that describes the activities carried out under such grant, contract, fellowship, memorandum of understanding, or cooperative agreement.

(2) Report to Congress and the FDA

Beginning with fiscal year 2009, the Executive Director shall submit to Congress and the Commissioner an annual report that—

(A) describes the activities of the Foundation and the progress of the Foundation in furthering the goals and priorities established under subsection (c)(2), including the practical impact of the Foundation on regulated product development;

(B) provides a specific accounting of the source and use of all funds used by the Foundation to carry out such activities; and

(C) provides information on how the results of Foundation activities could be incorporated into the regulatory and product review activities of the Food and Drug Administration.

(m) Separation of funds

The Executive Director shall ensure that the funds received from the Treasury are managed as individual programmatic funds under subsection (i), according to best accounting practices.

(n) Funding

From amounts appropriated to the Food and Drug Administration for each fiscal year, the Commissioner shall transfer not less than $1,250,000 and not more than $5,000,000, to the Foundation to carry out subsections (a), (b), and (d) through (m).

(June 25, 1938, ch. 675, §770, as added Pub. L. 110–85, title VI, §601(a), Sept. 27, 2007, 121 Stat. 890; amended Pub. L. 114–255, div. A, title III, §3076, Dec. 13, 2016, 130 Stat. 1139; Pub. L. 117–101, §2(a), Mar. 15, 2022, 136 Stat. 47.)

Editorial Notes

Amendments

2022—Subsec. (n). Pub. L. 117–101 substituted "$1,250,000 and not more than $5,000,000" for "$500,000 and not more than $1,250,000".

2016—Subsec. (d)(1)(C)(ii). Pub. L. 114–255, §3076(a)(1)(B), added cl. (ii). Former cl. (ii) redesignated (iii).

Subsec. (d)(1)(C)(iii). Pub. L. 114–255, §3076(a)(1)(A), redesignated cl. (ii) as (iii).

Subsec. (d)(1)(C)(iii)(I). Pub. L. 114–255, §3076(a)(1)(C), substituted "The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure" for "The ex officio members shall ensure".

Subsec. (d)(1)(C)(iii)(II). Pub. L. 114–255, §3076(a)(2), inserted at end "For purposes of this section, the term 'employee of the Federal Government' does not include a special Government employee, as that term is defined in section 202(a) of title 18."

Subsec. (d)(3)(A). Pub. L. 114–255, §3076(a)(3), amended subpar. (A) generally. Prior to amendment, text read as follows: "The term of office of each member of the Board appointed under paragraph (1)(C) shall be 4 years, except that the terms of offices for the initial appointed members of the Board shall expire on a staggered basis as determined by the ex officio members."

Subsec. (g)(2). Pub. L. 114–255, §3076(b), struck out before period at end "but shall not be greater than the compensation of the Commissioner".

Subsec. (m). Pub. L. 114–255, §3076(c), substituted "are managed as individual programmatic funds under subsection (i), according to best accounting practices" for "are held in separate accounts from funds received from entities under subsection (i)".

¹ So in original. Probably should be "subsection (g)."

§379dd–1. Location of Foundation

The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.

(June 25, 1938, ch. 675, §771, as added Pub. L. 110–85, title VI, §601(b), Sept. 27, 2007, 121 Stat. 897.)

§379dd–2. Activities of the Food and Drug Administration

(a) In general

The Commissioner shall receive and assess the report submitted to the Commissioner by the Executive Director of the Foundation under section 379dd(l)(2) of this title.

(b) Report to Congress

Beginning with fiscal year 2009, the Commissioner shall submit to Congress an annual report summarizing the incorporation of the information provided by the Foundation in the report described under section 379dd(l)(2) of this title and by other recipients of grants, contracts, memoranda of understanding, or cooperative agreements into regulatory and product review activities of the Food and Drug Administration.

(c) Extramural grants

The provisions of this part and section 360bbb–5 of this title shall have no effect on any grant, contract, memorandum of understanding, or cooperative agreement between the Food and Drug Administration and any other entity entered into before, on, or after September 27, 2007.

(June 25, 1938, ch. 675, §772, as added Pub. L. 110–85, title VI, §601(b), Sept. 27, 2007, 121 Stat. 897.)

SUBCHAPTER VIII—IMPORTS AND EXPORTS

§381. Imports and exports

(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission

The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, or is a controlled substance subject to an order under section 360bbb–8d of this title, or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article or ¹ (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission, except as provided in subsection (b) of this section. If it appears from the examination of such samples or otherwise that the article is a counterfeit drug or counterfeit device, such article shall be refused admission. With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a requirement under section 364a, 379aa, or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) has not complied with a requirement of such section 364a, 379aa, or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 364a, 379aa, or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee. Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act [21 U.S.C. 951 et seq.].

(b) Disposition of refused articles

Pending decision as to the admission of an article being imported or offered for import, the Secretary of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury. If it appears to the Secretary of Health and Human Services that (1) an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with this chapter or rendered other than a food, drug, device, or cosmetic, or (2) with respect to an article described in subsection (a) relating to the requirements of section 364a, 379aa, or 379aa–1 of this title, the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 364a, 379aa, or 379aa–1 of this title, as the case may be, final determination as to admission of such article may be deferred and, upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant, or, with respect to clause (2), the responsible person, to perform such relabeling or other action specified in such authorization (including destruction or export of rejected articles or portions thereof, as may be specified in the Secretary's authorization). All such relabeling or other action pursuant to such authorization shall in accordance with regulations be under the supervision of an officer or employee of the Department of Health and Human Services designated by the Secretary, or an officer or employee of the Department of the Treasury designated by the Secretary of the Treasury.

(c) Charges concerning refused articles

All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cartage, or labor with respect to any article refused admission under subsection (a) of this section, shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any future importations made by such owner or consignee.

(d) Reimportation

(1)(A) Except as provided in paragraph (2) and section 384 of this title, no drug subject to section 353(b) of this title or composed wholly or partly of insulin which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug.

(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 356e of this title or in the case of importation pursuant to section 384 of this title, no drug that is subject to section 353(b)(1) of this title may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.

(2) The Secretary may authorize the importation of a drug the importation of which is prohibited by paragraph (1) if the drug is required for emergency medical care.

(3)(A) Subject to subparagraph (B), no component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no article of a food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) if each of the following conditions is met:

(i) The importer of such article of a drug or device or importer of such article of a food additive, color additive, or dietary supplement submits to the Secretary, at the time of initial importation, a statement in accordance with the following:

(I) Such statement provides that such article is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) or section 382 of this title, or with section 351(h) of the Public Health Service Act [42 U.S.C. 262(h)].

(II) The statement identifies the manufacturer of such article and each processor, packer, distributor, or other entity that had possession of the article in the chain of possession of the article from the manufacturer to such importer of the article.

(III) The statement is accompanied by such certificates of analysis as are necessary to identify such article, unless the article is a device or is an article described in paragraph (4).

(ii) At the time of initial importation and before the delivery of such article to the importer or the initial owner or consignee, such owner or consignee executes a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury.

(iii) Such article is used and exported by the initial owner or consignee in accordance with the intent described under clause (i)(I), except for any portions of the article that are destroyed.

(iv) The initial owner or consignee maintains records on the use or destruction of such article or portions thereof, as the case may be, and submits to the Secretary any such records requested by the Secretary.

(v) Upon request of the Secretary, the initial owner or consignee submits a report that provides an accounting of the exportation or destruction of such article or portions thereof, and the manner in which such owner or consignee complied with the requirements of this subparagraph.

(B) Notwithstanding subparagraph (A), the Secretary may refuse admission to an article that otherwise would be imported into the United States under such subparagraph if the Secretary determines that there is credible evidence or information indicating that such article is not intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) or section 382 of this title, or with section 351(h) of the Public Health Service Act [42 U.S.C. 262(h)].

(C) This section may not be construed as affecting the responsibility of the Secretary to ensure that articles imported into the United States under authority of subparagraph (A) meet each of the conditions established in such subparagraph for importation.

(4) The importation into the United States of blood, blood components, source plasma, or source leukocytes or of a component, accessory, or part thereof is not permitted pursuant to paragraph (3) unless the importation complies with section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] or the Secretary permits the importation under appropriate circumstances and conditions, as determined by the Secretary. The importation of tissue or a component or part of tissue is not permitted pursuant to paragraph (3) unless the importation complies with section 361 of the Public Health Service Act [42 U.S.C. 264].

(e) Exports

(1) A food, drug, device, tobacco product or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this chapter, and a tobacco product intended for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title, if it—

(A) accords to the specifications of the foreign purchaser,

(B) is not in conflict with the laws of the country to which it is intended for export,

(C) is labeled on the outside of the shipping package that it is intended for export, and

(D) is not sold or offered for sale in domestic commerce.

(2) Paragraph (1) does not apply to any device—

(A) which does not comply with an applicable requirement of section 360d or 360e of this title,

(B) which under section 360j(g) of this title is exempt from either such section, or

(C) which is a banned device under section 360f of this title,

unless, in addition to the requirements of paragraph (1), either (i) the Secretary has determined that the exportation of the device is not contrary to public health and safety and has the approval of the country to which it is intended for export or (ii) the device is eligible for export under section 382 of this title.

(3) A new animal drug that requires approval under section 360b of this title shall not be exported pursuant to paragraph (1) if such drug has been banned in the United States.

(4)(A) Any person who exports a food, drug, animal drug, or device may request that the Secretary—

(i) certify in writing that the exported food, drug, animal drug, or device meets the requirements of paragraph (1) or section 382 of this title; or

(ii) certify in writing that the food, drug, animal drug, or device being exported meets the applicable requirements of this chapter upon a showing that the food, drug or device meets the applicable requirements of this chapter.

The Secretary shall issue such a certification within 20 days of the receipt of a request for such certification.

(B) If the Secretary issues a written export certification within the 20 days prescribed by subparagraph (A), a fee for such certification may be charged but shall not exceed $175 for each certification. Fees collected for a fiscal year pursuant to this subparagraph shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriations Acts until expended without fiscal year limitation. Such fees shall be collected in each fiscal year in an amount equal to the amount specified in appropriations Acts for such fiscal year and shall only be collected and available for the costs of the Food and Drug Administration.

(C) For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form (including a publicly available listing) as the Secretary determines appropriate.

(D) With regard to fees pursuant to subparagraph (B) in connection with written export certifications for food:

(i) Such fees shall be collected and available solely for the costs of the Food and Drug Administration associated with issuing such certifications.

(ii) Such fees may not be retained in an amount that exceeds such costs for the respective fiscal year.

(E)(i)(I) If the Secretary denies a request for certification under subparagraph (A)(ii) with respect to a device manufactured in an establishment (foreign or domestic) registered under section 360 of this title, the Secretary shall provide in writing to the person seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based.

(II) If the denial of a request as described in subclause (I) is based on grounds other than an injunction proceeding pursuant to section 332 of this title, seizure action pursuant to section 334 of this title, or a recall designated Class I or Class II pursuant to part 7, title 21, Code of Federal Regulations, and is based on the facility being out of compliance with part 820 of title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the Secretary.

(III) With respect to a device manufactured in an establishment that has received a report under section 374(b) of this title, the Secretary shall not deny a request for certification as described in subclause (I) with respect to a device based solely on the issuance of that report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report.

(ii)(I) The Secretary shall provide a process for a person who is denied a certification as described in clause (i)(I) to request a review that conforms to the standards of section 360g–1(b) of this title.

(II) Notwithstanding any previous review conducted pursuant to subclause (I), a person who has been denied a certification as described in clause (i)(I) may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for the denial of certification, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the Secretary.

(III) Not later than 1 year after August 18, 2017, the Secretary shall issue guidance providing for a process to carry out this subparagraph. Not later than 1 year after the close of the comment period for such guidance, the Secretary shall issue final guidance.

(F)(i) This paragraph applies to requests for certification under this subparagraph of a device manufactured by a device establishment located outside of the United States that is registered under section 360 of this title, if the device is listed pursuant to section 360(j) of this title, the device has been cleared, approved, or is not required to submit a premarket report pursuant to subsection (l) or (m) of section 360 of this title, and the device is imported or offered for import into the United States.

(ii) The Secretary shall issue the certification as described in clause (iii) if the device or devices for which certification is requested under this subparagraph meet the applicable requirements of this chapter.

(iii)(I) A certification for a device described in clause (i) shall be subject to the fee described in subparagraph (B).

(II) Notwithstanding subparagraph (C), a certification for a device described in clause (i) shall address and include the same material information as a "Certificate to Foreign Government" and shall have a document title including the words "Certificate to Foreign Government".

(iv) The requirements and procedures of subparagraph (E) shall apply to a denial of a certification under this subparagraph.

(f) Labeling of exported drugs

(1) If a drug (other than insulin, an antibiotic drug, an animal drug, or a drug exported under section 382 of this title) being exported in accordance with subsection (e) is being exported to a country that has different or additional labeling requirements or conditions for use and such country requires the drug to be labeled in accordance with those requirements or uses, such drug may be labeled in accordance with such requirements and conditions for use in the country to which such drug is being exported if it also is labeled in accordance with the requirements of this chapter.

(2) If, pursuant to paragraph (1), the labeling of an exported drug includes conditions for use that have not been approved under this chapter, the labeling must state that such conditions for use have not been approved under this chapter. A drug exported under section 382 of this title is exempt from this section.

(g) Warning notice of importation in violation of chapter

(1) With respect to a prescription drug being imported or offered for import into the United States, the Secretary, in the case of an individual who is not in the business of such importations, may not send a warning notice to the individual unless the following conditions are met:

(A) The notice specifies, as applicable to the importation of the drug, that the Secretary has made a determination that—

(i) importation is in violation of subsection (a) because the drug is or appears to be adulterated, misbranded, or in violation of section 355 of this title;

(ii) importation is in violation of subsection (a) because the drug is or appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported;

(iii) importation is or appears to be in violation of subsection (d)(1); or

(iv) importation otherwise is or appears to be in violation of Federal law.

(B) The notice does not specify any provision described in subparagraph (A) that is not applicable to the importation of the drug.

(C) The notice states the reasons underlying such determination by the Secretary, including a brief application to the principal facts involved of the provision of law described in subparagraph (A) that is the basis of the determination by the Secretary.

(2) For purposes of this section, the term "warning notice", with respect to the importation of a drug, means a communication from the Secretary (written or otherwise) notifying a person, or clearly suggesting to the person, that importing the drug for personal use is, or appears to be, a violation of this chapter.

(h) Protection against adulteration of food

(1) The Secretary shall give high priority to increasing the number of inspections under this section for the purpose of enabling the Secretary to inspect food offered for import at ports of entry into the United States, with the greatest priority given to inspections to detect the intentional adulteration of food.

(2) The Secretary shall give high priority to making necessary improvements to the information management systems of the Food and Drug Administration that contain information related to foods imported or offered for import into the United States for purposes of improving the ability of the Secretary to allocate resources, detect the intentional adulteration of food, and facilitate the importation of food that is in compliance with this chapter.

(3) The Secretary shall improve linkages with other regulatory agencies of the Federal Government that share responsibility for food safety, and shall with respect to such safety improve linkages with the States and Indian tribes (as defined in section 5304(e) of title 25).

(i) Testing for rapid detection of adulteration of food

(1) For use in inspections of food under this section, the Secretary shall provide for research on the development of tests and sampling methodologies—

(A) whose purpose is to test food in order to rapidly detect the adulteration of the food, with the greatest priority given to detect the intentional adulteration of food; and

(B) whose results offer significant improvements over the available technology in terms of accuracy, timing, or costs.

(2) In providing for research under paragraph (1), the Secretary shall give priority to conducting research on the development of tests that are suitable for inspections of food at ports of entry into the United States.

(3) In providing for research under paragraph (1), the Secretary shall as appropriate coordinate with the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, the Administrator of the Environmental Protection Agency, and the Secretary of Agriculture.

(4) The Secretary shall annually submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the progress made in research under paragraph (1), including progress regarding paragraph (2).

(j) Temporary holds at ports of entry

(1) If an officer or qualified employee of the Food and Drug Administration has credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals, and such officer or qualified employee is unable to inspect, examine, or investigate such article upon the article being offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Treasury to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, for the purpose of enabling the Secretary to inspect, examine, or investigate the article as appropriate.

(2) The Secretary shall request the Secretary of Treasury to remove an article held pursuant to paragraph (1) to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held.

(3) An officer or qualified employee of the Food and Drug Administration may make a request under paragraph (1) only if the Secretary or an official designated by the Secretary approves the request. An official may not be so designated unless the official is the director of the district under this chapter in which the article involved is located, or is an official senior to such director.

(4) With respect to an article of food for which a request under paragraph (1) is made, the Secretary, promptly after the request is made, shall notify the State in which the port of entry involved is located that the request has been made, and as applicable, that such article is being held under this subsection.

(k) Importation by debarred persons

(1) If an article of food is being imported or offered for import into the United States, and the importer, owner, or consignee of the article is a person who has been debarred under section 335a(b)(3) of this title, such article shall be held at the port of entry for the article, and may not be delivered to such person. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

(2) An article of food held under paragraph (1) may be delivered to a person who is not a debarred person under section 335a(b)(3) of this title if such person affirmatively establishes, at the expense of the person, that the article complies with the requirements of this chapter, as determined by the Secretary.

(l) Failure to register

(1) ² If an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary under section 350d of this title (or for which a registration has been suspended under such section), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

(m) Prior notice of imported food shipments

(1) In the case of an article of food that is being imported or offered for import into the United States, the Secretary, after consultation with the Secretary of the Treasury, shall by regulation require, for the purpose of enabling such article to be inspected at ports of entry into the United States, the submission to the Secretary of a notice providing the identity of each of the following: The article; the manufacturer and shipper of the article; if known within the specified period of time that notice is required to be provided, the grower of the article; the country from which the article originates; the country from which the article is shipped; any country to which the article has been refused entry; and the anticipated port of entry for the article. An article of food imported or offered for import without submission of such notice in accordance with the requirements under this paragraph shall be refused admission into the United States. Nothing in this section may be construed as a limitation on the port of entry for an article of food.

(2)(A) Regulations under paragraph (1) shall require that a notice under such paragraph be provided by a specified period of time in advance of the time of the importation of the article of food involved or the offering of the food for import, which period shall be no less than the minimum amount of time necessary for the Secretary to receive, review, and appropriately respond to such notification, but may not exceed five days. In determining the specified period of time required under this subparagraph, the Secretary may consider, but is not limited to consideration of, the effect on commerce of such period of time, the locations of the various ports of entry into the United States, the various modes of transportation, the types of food imported into the United States, and any other such consideration. Nothing in the preceding sentence may be construed as a limitation on the obligation of the Secretary to receive, review, and appropriately respond to any notice under paragraph (1).

(B)(i) If an article of food is being imported or offered for import into the United States and a notice under paragraph (1) is not provided in advance in accordance with the requirements under paragraph (1), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such notice is submitted to the Secretary, and the Secretary examines the notice and determines that the notice is in accordance with the requirements under paragraph (1). Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

(ii) In carrying out clause (i) with respect to an article of food, the Secretary shall determine whether there is in the possession of the Secretary any credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.

(3)(A) This subsection may not be construed as limiting the authority of the Secretary to obtain information under any other provision of this chapter.

(B) This subsection may not be construed as authorizing the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

(n) Labeling of food refused admission

(1) If a food has been refused admission under subsection (a), other than such a food that is required to be destroyed, the Secretary may require the owner or consignee of the food to affix to the container of the food a label that clearly and conspicuously bears the statement: "UNITED STATES: REFUSED ENTRY".

(2) All expenses in connection with affixing a label under paragraph (1) shall be paid by the owner or consignee of the food involved, and in default of such payment, shall constitute a lien against future importations made by such owner or consignee.

(3) A requirement under paragraph (1) remains in effect until the Secretary determines that the food involved has been brought into compliance with this chapter.

(o) Registration statement

If an article that is a device is being imported or offered for import into the United States, and the importer, owner, or consignee of such article does not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 360(i) of this title of each establishment that with respect to such article is required under such section to register with the Secretary, the article may be refused admission. If the article is refused admission for failure to submit such a statement, the article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such a statement is submitted to the Secretary. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

(p) Report

(1) Not later than 36 months after June 22, 2009, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report regarding—

(A) the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this chapter;

(B) the public health implications of such exports, including any evidence of a negative public health impact; and

(C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports.

(2) The Secretary is authorized to establish appropriate information disclosure requirements to carry out this subsection.

(q) Certifications concerning imported foods

(1) In general

The Secretary may require, as a condition of granting admission to an article of food imported or offered for import into the United States, that an entity described in paragraph (3) provide a certification, or such other assurances as the Secretary determines appropriate, that the article of food complies with applicable requirements of this chapter. Such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified facilities that manufacture, process, pack, or hold such food, or in such other form as the Secretary may specify.

(2) Factors to be considered in requiring certification

The Secretary shall base the determination that an article of food is required to have a certification described in paragraph (1) on the risk of the food, including—

(A) known safety risks associated with the food;

(B) known food safety risks associated with the country, territory, or region of origin of the food;

(C) a finding by the Secretary, supported by scientific, risk-based evidence, that—

(i) the food safety programs, systems, and standards in the country, territory, or region of origin of the food are inadequate to ensure that the article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter; and

(ii) the certification would assist the Secretary in determining whether to refuse or admit the article of food under subsection (a); and

(D) information submitted to the Secretary in accordance with the process established in paragraph (7).

(3) Certifying entities

For purposes of paragraph (1), entities that shall provide the certification or assurances described in such paragraph are—

(A) an agency or a representative of the government of the country from which the article of food at issue originated, as designated by the Secretary; or

(B) such other persons or entities accredited pursuant to section 384d of this title to provide such certification or assurance.

(4) Renewal and refusal of certifications

The Secretary may—

(A) require that any certification or other assurance provided by an entity specified in paragraph (2) be renewed by such entity at such times as the Secretary determines appropriate; and

(B) refuse to accept any certification or assurance if the Secretary determines that such certification or assurance is not valid or reliable.

(5) Electronic submission

The Secretary shall provide for the electronic submission of certifications under this subsection.

(6) False statements

Any statement or representation made by an entity described in paragraph (2) to the Secretary shall be subject to section 1001 of title 18.

(7) Assessment of food safety programs, systems, and standards

If the Secretary determines that the food safety programs, systems, and standards in a foreign region, country, or territory are inadequate to ensure that an article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter, the Secretary shall, to the extent practicable, identify such inadequacies and establish a process by which the foreign region, country, or territory may inform the Secretary of improvements made to such food safety program, system, or standard and demonstrate that those controls are adequate to ensure that an article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter.

(r) Standards for admission of imported drugs

(1) The Secretary may require, pursuant to the regulations promulgated under paragraph (4)(A), as a condition of granting admission to a drug imported or offered for import into the United States, that the importer electronically submit information demonstrating that the drug complies with applicable requirements of this chapter.

(2) The information described under paragraph (1) may include—

(A) information demonstrating the regulatory status of the drug, such as the new drug application, abbreviated new drug application, or investigational new drug or drug master file number;

(B) facility information, such as proof of registration and the unique facility identifier;

(C) indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and

(D) any other information deemed necessary and appropriate by the Secretary to assess compliance of the article being offered for import.

(3) Information requirements referred to in paragraph (2)(C) may, at the discretion of the Secretary, be satisfied—

(A) through representation by a foreign government, if an inspection is conducted by a foreign government using standards and practices as determined appropriate by the Secretary;

(B) through representation by a foreign government or an agency of a foreign government recognized under section 384e of this title; or

(C) other appropriate documentation or evidence as described by the Secretary.

(4)(A) Not later than 18 months after July 9, 2012, the Secretary shall adopt final regulations implementing this subsection. Such requirements shall be appropriate for the type of import, such as whether the drug is for import into the United States for use in preclinical research or in a clinical investigation under an investigational new drug exemption under 355(i) ³ of this title.

(B) In promulgating the regulations under subparagraph (A), the Secretary—

(i) may, as appropriate, take into account differences among importers and types of imports, and, based on the level of risk posed by the imported drug, provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls, including sourcing of foreign manufacturing inputs, and plant inspections; and

(ii) shall—

(I) issue a notice of proposed rulemaking that includes the proposed regulation;

(II) provide a period of not less than 60 days for comments on the proposed regulation; and

(III) publish the final regulation not less than 30 days before the effective date of the regulation.

(C) Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this subsection only as described in subparagraph (B).

(s) Registration of commercial importers

(1) Registration

The Secretary shall require a commercial importer of drugs—

(A) to be registered with the Secretary in a form and manner specified by the Secretary; and

(B) subject to paragraph (4), to submit, at the time of registration, a unique identifier for the principal place of business for which the importer is required to register under this subsection.

(2) Regulations

(A) In general

The Secretary, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, shall promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure imported drugs are in compliance with the requirements of this chapter and the Public Health Service Act [42 U.S.C. 201 et seq.].

(B) Procedure

In promulgating a regulation under subparagraph (A), the Secretary shall—

(i) issue a notice of proposed rulemaking that includes the proposed regulation;

(ii) provide a period of not less than 60 days for comments on the proposed regulation; and

(iii) publish the final regulation not less than 30 days before the regulation's effective date.

(C) Restrictions

Notwithstanding any other provision of Federal law, in implementing this subsection, the Secretary shall only promulgate regulations as described in subparagraph (B).

(D) Effective date

In establishing the effective date of the regulations under subparagraph (A), the Secretary shall, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, as determined appropriate by the Secretary of Health and Human Services, provide a reasonable period of time for an importer of a drug to comply with good importer practices, taking into account differences among importers and types of imports, including based on the level of risk posed by the imported product.

(3) Discontinuance of registration

The Secretary shall discontinue the registration of any commercial importer of drugs that fails to comply with the regulations promulgated under this subsection.

(4) Unique facility identifier

The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.

(5) Exemptions

The Secretary, by notice in the Federal Register, may establish exemptions from the requirements of this subsection.

(t) Single source pattern of imported illegal drugs

If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 335a(b)(3)(D) of this title, and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise.

(u) Illicit articles containing active pharmaceutical ingredients

(1) In general

For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article—

(A) is not—

(i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and

(ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, a dietary supplement, or other product that is regulated under this chapter); and

(B) is an ingredient that presents significant public health concern and is, or contains—

(i) an active ingredient in a drug—

(I) that is approved under section 355 of this title or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262]; or

(II) for which—

(aa) an investigational use exemption has been authorized under section 355(i) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; and

(bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or

(ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i).

(2) Effect

This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 321(g) of this title, other than for the purposes described in paragraph (1).

(June 25, 1938, ch. 675, §801, 52 Stat. 1058; Oct. 18, 1949, ch. 696, §§1–3, 63 Stat. 882; Pub. L. 87–781, title III, §306, Oct. 10, 1962, 76 Stat. 796; Pub. L. 90–399, §106, July 13, 1968, 82 Stat. 353; Pub. L. 91–513, title II, §701(h), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 94–295, §§3(f), 4(b)(3), May 28, 1976, 90 Stat. 578, 580; Pub. L. 100–293, §3, Apr. 22, 1988, 102 Stat. 96; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102–353, §5, Aug. 26, 1992, 106 Stat. 943; Pub. L. 103–80, §3(cc), (dd)(1), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 104–134, title II, §2102(a)–(c), Apr. 26, 1996, 110 Stat. 1321–313, 1321-314; Pub. L. 104–180, title VI, §603(a), (b), Aug. 6, 1996, 110 Stat. 1594, 1595; Pub. L. 105–115, title I, §125(a)(2)(D), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 106–387, §1(a) [title VII, §§745(c)(1), 746(c)], Oct. 28, 2000, 114 Stat. 1549, 1549A-36, 1549A-40; Pub. L. 107–188, title III, §§302(a)–(d), 303(c), 304(e), 305(c), 307(a), 308(a), 321(b)(1), 322(a), June 12, 2002, 116 Stat. 662, 663, 665, 667, 668, 670, 672, 676; Pub. L. 109–462, §5(a), Dec. 22, 2006, 120 Stat. 3475; Pub. L. 110–85, title IX, §912(b)(2), Sept. 27, 2007, 121 Stat. 952; Pub. L. 111–31, div. A, title I, §103(l), June 22, 2009, 123 Stat. 1837; Pub. L. 111–353, title I, §§102(b)(3), 107(b), title II, §204(j)(2), title III, §§301(c), 303(a)–(c), 304(a), Jan. 4, 2011, 124 Stat. 3889, 3910, 3937, 3955-3957; Pub. L. 112–144, title VII, §§708(a), (b), 713, 714(b), July 9, 2012, 126 Stat. 1068, 1072, 1073; Pub. L. 114–255, div. A, title III, §3101(a)(2)(W)(i), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 115–52, title VI, §604(a), title VII, §704, Aug. 18, 2017, 131 Stat. 1048, 1056; Pub. L. 115–271, title III, §§3012(c), 3013, 3022(c), (d), Oct. 24, 2018, 132 Stat. 3936, 3939, 3940; Pub. L. 116–136, div. A, title III, §3856(a), Mar. 27, 2020, 134 Stat. 458; Pub. L. 116–304, §2(a), Jan. 5, 2021, 134 Stat. 4915; Pub. L. 117–328, div. FF, title III, §§3304, 3503(a)(4)(C), (D), Dec. 29, 2022, 136 Stat. 5832, 5858.)

Editorial Notes

References in Text

The Controlled Substances Import and Export Act, referred to in subsec. (a), is title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285, which is classified principally to subchapter II (§951 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 951 of this title and Tables.

The Federal Meat Inspection Act, referred to in subsec. (m)(3)(B), is titles I to V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, §11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

The Poultry Products Inspection Act, referred to in subsec. (m)(3)(B), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.

The Egg Products Inspection Act, referred to in subsec. (m)(3)(B), is Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to chapter 15 (§1031 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The Public Health Service Act, referred to in subsec. (s)(2)(A), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2022—Subsec. (a). Pub. L. 117–328, §3503(a)(4)(C), substituted "under section 364a, 379aa, or 379aa–1 of this title" for "under section 379aa or 379aa–1 of this title", "defined in section 364, 379aa, or 379aa–1 of this title" for "defined in such section 379aa or 379aa–1 of this title", "of such section 364a, 379aa, or 379aa–1 of this title" for "of such section 379aa or 379aa–1 of this title", and "described in such section 364a, 379aa, or 379aa–1 of this title" for "described in such section 379aa or 379aa–1 of this title".

Subsec. (b). Pub. L. 117–328, §3503(a)(4)(D), substituted "requirements of section 364a, 379aa, or 379aa–1 of this title" for "requirements of sections 379aa or 379aa–1 of this title,", "as defined in section 364, 379aa, or 379aa–1 of this title" for "defined in section 379aa or 379aa–1 of this title", and "with section 364a, 379aa, or 379aa–1 of this title" for "with section 379aa or 379aa–1 of this title".

Subsec. (e)(4)(E)(iii). Pub. L. 117–328, §3304(1), struck out cl. (iii) which applied to requests for certification on behalf of any device establishment registered under section 360 of this title, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States.

Subsec. (e)(4)(F). Pub. L. 117–328, §3304(2), added subpar. (F).

2021—Subsec. (a). Pub. L. 116–304 inserted "or counterfeit device" after "counterfeit drug" in fourth sentence, and substituted "The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c)." for "The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b).. The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c)."

2020—Subsec. (e)(4)(E)(iii). Pub. L. 116–136 substituted "paragraph" for "subparagraph" in subcls. (I) and (II).

2018—Subsec. (a). Pub. L. 115–271, §3022(c)(2), (3), inserted "If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission." after third sentence, and substituted "Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act." for "Clause (2) of the third sentence of this paragraph shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act."

Pub. L. 115–271, §3022(c)(1), which directed substitution of "or (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission" for ", then such article shall be refused admission", was executed by making the substitution only in the third sentence, to reflect the probable intent of Congress.

Pub. L. 115–271, §3012(c), inserted ", or is a controlled substance subject to an order under section 360bbb–8d of this title" before "or (4)" in third sentence.

Subsec. (t). Pub. L. 115–271, §3013, added subsec. (t).

Subsec. (u). Pub. L. 115–271, §3022(d), added subsec. (u).

2017—Subsec. (d)(1). Pub. L. 115–52, §604(a), designated existing provisions as subpar. (A) and added subpar. (B).

Subsec. (e)(4)(C), (D). Pub. L. 115–52, §704(2), realigned margins.

Subsec. (e)(4)(E). Pub. L. 115–52, §704(1), added subpar. (E).

2016—Subsec. (s)(2)(D). Pub. L. 114–255 added subpar. (D).

2012—Subsec. (a). Pub. L. 112–144, §708(b), inserted "The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee." after "described under subsection (b).."

Pub. L. 112–144, §708(a), inserted ", except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19 and was not brought into compliance as described under subsection (b)." after "pursuant to such regulations".

Subsec. (o). Pub. L. 112–144, §713(1), struck out "drug or" after "If an article that is a".

Subsec. (r). Pub. L. 112–144, §713(2), added subsec. (r).

Subsec. (s). Pub. L. 112–144, §714(b), added subsec. (s).

2011—Subsec. (a). Pub. L. 111–353, §301(c), inserted "or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title" after "or in violation of section 355 of this title".

Pub. L. 111–353, §§204(j)(2), 303(a), inserted "or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article," in the third sentence before "then such article shall be refused admission" and inserted after the third sentence "With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission."

Subsec. (b). Pub. L. 111–353, §303(c), substituted "with respect to an article described in subsection (a) relating to the requirements of sections 379aa or 379aa–1 of this title," for "with respect to an article included within the provision of the fourth sentence of subsection (a)" in second sentence.

Subsec. (e)(4)(A). Pub. L. 111–353, §107(b)(1)(A), substituted "a food, drug" for "a drug" in introductory provisions.

Subsec. (e)(4)(A)(i). Pub. L. 111–353, §107(b)(1)(B), substituted "exported food, drug" for "exported drug".

Subsec. (e)(4)(A)(ii). Pub. L. 111–353, §107(b)(1)(C), substituted "the food, drug" for "the drug" in two places.

Subsec. (e)(4)(C). Pub. L. 111–353, §107(b)(2), added subpar. (C).

Subsec. (e)(4)(D). Pub. L. 111–353, §107(b)(3), added subpar. (D).

Subsec. (l). Pub. L. 111–353, §102(b)(3), inserted "(or for which a registration has been suspended under such section)" after "section 350d of this title".

Subsec. (m)(1). Pub. L. 111–353, §304(a), inserted "any country to which the article has been refused entry;" after "the country from which the article is shipped;".

Subsec. (q). Pub. L. 111–353, §303(b), added subsec. (q).

2009—Subsec. (a). Pub. L. 111–31, §103(l)(1)(C), which directed substitution of "drugs, devices, or tobacco products" for "drugs or devices" wherever appearing, was executed by making the substitution for "drugs and devices" in two places in second sentence, to reflect the probable intent of Congress.

Pub. L. 111–31, §103(l)(1)(A), (B), inserted "tobacco products," after "devices," in first sentence and "or section 387e(h)" after "section 360" in second sentence.

Subsec. (e)(1). Pub. L. 111–31, §103(l)(2), in introductory provisions, inserted "tobacco product" after "drug, device," and ", and a tobacco product intended for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title," after "chapter".

Subsec. (p). Pub. L. 111–31, §103(l)(3), added subsec. (p).

2007—Subsec. (a). Pub. L. 110–85 substituted "is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title," for "is adulterated, misbranded, or in violation of section 355 of this title,".

2006—Subsec. (a). Pub. L. 109–462, §5(a)(1), inserted after third sentence "If such article is subject to a requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of such section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section."

Subsec. (b). Pub. L. 109–462, §5(a)(2), in second sentence, inserted "(1)" before "an article included", "or (2) with respect to an article included within the provision of the fourth sentence of subsection (a), the responsible person (as defined in section 379aa or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 379aa or 379aa–1 of this title, as the case may be," before "final determination", and ", or, with respect to clause (2), the responsible person," before "to perform".

2002—Subsec. (d)(3). Pub. L. 107–188, §322(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: "No component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) of this section if—

"(A) the importer of such article of a drug or device or importer of the food additive, color additive, or dietary supplement submits a statement to the Secretary, at the time of initial importation, that such article of a drug or device, food additive, color additive, or dietary supplement is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by such owner or consignee from the United States in accordance with subsection (e) of this section or section 382 of this title or section 262(h) of title 42;

"(B) the initial owner or consignee responsible for such imported article maintains records that identify the use of such imported article and upon request of the Secretary submits a report that provides an accounting of the exportation or the disposition of the imported article, including portions that have been destroyed, and the manner in which such person complied with the requirements of this paragraph; and

"(C) any imported component, part, article, or accessory of a drug or device and any food additive, color additive, or dietary supplement not incorporated or further processed as described in subparagraph (A) is destroyed or exported by the owner or consignee."

Subsec. (h). Pub. L. 107–188, §302(a)–(c), added subsec. (h).

Subsec. (i). Pub. L. 107–188, §302(d), added subsec. (i).

Subsec. (j). Pub. L. 107–188, §303(c), added subsec. (j).

Subsec. (k). Pub. L. 107–188, §304(e), added subsec. (k).

Subsec. (l). Pub. L. 107–188, §305(c), added subsec. (l).

Subsec. (m). Pub. L. 107–188, §307(a), added subsec. (m).

Subsec. (n). Pub. L. 107–188, §308(a), added subsec. (n).

Subsec. (o). Pub. L. 107–188, §321(b)(1), added subsec. (o).

2000—Subsec. (d)(1). Pub. L. 106–387, §1(a) [title VII, §745(c)(1)], inserted "and section 384 of this title" after "paragraph (2)".

Subsec. (g). Pub. L. 106–387, §1(a) [title VII, §746(c)], added subsec. (g).

1997—Subsec. (d)(1). Pub. L. 105–115 inserted "or composed wholly or partly of insulin" after "353(b) of this title".

1996—Subsec. (d)(3). Pub. L. 104–180, §603(a), substituted "accessory of a device, or other article of device requiring further processing, which is ready" for "accessory of a device which is ready" in introductory provisions, inserted "further processed by the initial owner or consignee, or" after "is intended to be" in subpar. (A), and inserted "article," after "part," and "or further processed" after "incorporated" in subpar. (C).

Pub. L. 104–134, §2102(a)(1), added par. (3)

Subsec. (d)(4). Pub. L. 104–134, §2102(a)(1), added par. (4).

Subsec. (e)(1). Pub. L. 104–134, §2102(b)(1), struck out concluding provisions which read as follows: "This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title."

Subsec. (e)(2). Pub. L. 104–134, §2102(b)(2), in concluding provisions, substituted "either (i) the Secretary" for "the Secretary" and added cl. (ii).

Subsec. (e)(3), (4). Pub. L. 104–134, §2102(b)(3), added pars. (3) and (4).

Subsec. (f). Pub. L. 104–180, §603(b), inserted "(other than insulin, an antibiotic drug, an animal drug, or a drug exported under section 382 of this title)" after "If a drug" in par. (1) and "A drug exported under section 382 of this title is exempt from this section." at end of par. (2).

Pub. L. 104–134, §2102(c), added subsec. (f).

1993—Subsec. (a). Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture" after "Secretary of" in two places in first sentence.

Subsec. (b). Pub. L. 103–80, §3(cc), substituted "Secretary of Health and Human Services" for "Administrator" after "If it appears to the", "Secretary" for "Administrator" after "provisions of this subsection, the", "Secretary's" for "Administrator's" after "as may be specified in the", "Department of Health and Human Services" for "Federal Security Agency", and "Secretary" for "Administrator" after "designated by the".

1992—Subsecs. (a), (b). Pub. L. 102–300, which directed the substitution of "Health and Human Services" for "Health, Education, and Welfare" wherever appearing, was executed in second sentence of subsec. (a), but could not be executed in first sentence of subsec. (a) or in subsec. (b) because such words did not appear. See 1993 Amendment note above and Transfer of Functions note below.

Subsec. (d)(1). Pub. L. 102–353 substituted "manufacturer of" for "person who manufactured".

1988—Subsecs. (d), (e). Pub. L. 100–293 added subsec. (d) and redesignated former subsec. (d) as (e).

1976—Subsec. (a). Pub. L. 94–295, §§3(f)(2), 4(b)(3), expanded provisions requiring the Secretary of Health, Education, and Welfare to request that the Secretary of the Treasury deliver to the Secretary of Health, Education, and Welfare items imported or offered for import into the United States that were manufactured, prepared, propagated, compounded, or processed in non-registered establishments by extending the provisions to include devices imported or offered for import, and, in cl. (1), inserted reference to devices which were manufactured, packed, stored, or installed using methods, facilities, or controls not conforming to the requirements of section 360j(f) of this title.

Subsec. (d). Pub. L. 94–295, §3(f)(1), designated existing provisions as par. (1) and added par. (2).

1970—Subsec. (a). Pub. L. 91–513 substituted "Clause (2) of the third sentence of this paragraph" for "This paragraph" and "the Controlled Substances Import and Export Act" for "section 173 of this title" in last sentence.

1968—Subsec. (d). Pub. L. 90–399 provided that nothing in subsec. (d) shall authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.

1962—Subsec. (a). Pub. L. 87–781 inserted provisions requiring the Secretary of Health, Education, and Welfare to furnish the Secretary of the Treasury a list of establishments registered under section 360(i) of this title, and to request that samples of any drugs from any establishments not so registered be delivered to the Secretary of Health, Education, and Welfare, with notice of delivery to the consignee who may appear before the Secretary to testify.

1949—Subsec. (a). Act Oct. 18, 1949, §1, inserted before period at end of second sentence ", except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury within ninety days of the notice of such refusal or within such additional time as may be permitted pursuant to such regulations".

Subsec. (b). Act Oct. 18, 1949, §2, provided for express statutory authority for the long-standing administrative practice of releasing imported articles that do not comply with the requirements of the law so that they may be relabeled or given appropriate treatment to bring them into compliance.

Subsec. (c). Act Oct. 18, 1949, §3, charged all costs, including salaries and travel and subsistence expenses of officers and employees, against importers.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by section 3503(a)(4)(C), (D) of Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

Effective Date of 2012 Amendment; Applicability

Pub. L. 112–144, title VII, §708(c), July 9, 2012, 126 Stat. 1069, provided that: "The amendment made by subsection (a) [amending this section] shall apply beginning on the effective date of the regulations promulgated pursuant to the amendment made by subsection (b) [amending this section]."

Effective Date of 2011 Amendment

Amendment by section 301(c) of Pub. L. 111–353 effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as a note under section 331 of this title.

Pub. L. 111–353, title III, §304(c), Jan. 4, 2011, 124 Stat. 3958, provided that: "The amendment made by this section [amending this section] shall take effect 180 days after the date of enactment of this Act [Jan. 4, 2011]."

Effective Date of 2006 Amendment

Pub. L. 109–462, §5(b), Dec. 22, 2006, 120 Stat. 3476, provided that: "The amendments made by this section [amending this section] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006]."

Effective Date of 2002 Amendment

Amendment by section 321(b)(1) of Pub. L. 107–188 effective upon the expiration of the 180-day period beginning June 12, 2002, see section 321(c) of Pub. L. 107–188, set out as a note under section 331 of this title.

Amendment by section 322(a) of Pub. L. 107–188 effective upon the expiration of the 90-day period beginning June 12, 2002, see section 322(c) of Pub. L. 107–188, set out as a note under section 331 of this title.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–293 effective upon expiration of 90 days after Apr. 22, 1988, see section 8(a) of Pub. L. 100–293, set out as a note under section 353 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1968 Amendment

Amendment of subsec. (d) by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Regulations

Pub. L. 112–144, title VII, §708(d), July 9, 2012, 126 Stat. 1069, provided that:

"(1) In general.—Not later than 2 years after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall adopt final regulations implementing the amendments made this section [amending this section].

"(2) Procedure.—In promulgating a regulation implementing the amendments made by this section, the Secretary of Health and Human Services shall—

"(A) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;

"(B) provide a period of not less than 60 days for comments on the proposed regulation; and

"(C) publish the final regulation not less than 30 days before the effective date of the regulation.

"(3) Restrictions.—Notwithstanding any other provision of law, the Secretary of Health and Human Services shall promulgate regulations implementing the amendments made by this section only as described in paragraph (2)."

Pub. L. 112–144, title VII, §714(d), July 9, 2012, 126 Stat. 1074, provided that, within 36 months after July 9, 2012, the Secretary of Homeland Security acting through U.S. Customs and Border Protection, was to promulgate regulations required to carry out subsection (s) of this section relating to registration of commercial importers and specified procedures for promulgating regulations and their effective date, prior to repeal by Pub. L. 114–255, div. A, title III, §3101(a)(2)(W)(ii), Dec. 13, 2016, 130 Stat. 1156.

Pub. L. 111–353, title III, §304(b), Jan. 4, 2011, 124 Stat. 3958, provided that: "Not later than 120 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall issue an interim final rule amending subpart I of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section [amending this section]."

Pub. L. 107–188, title III, §307(c), June 12, 2002, 116 Stat. 672, provided that:

"(1) In general.—Not later than 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and Human Services shall promulgate proposed and final regulations for the requirement of providing notice in accordance with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(m)] (as added by subsection (a) of this section). Such requirement of notification takes effect—

"(A) upon the effective date of such final regulations; or

"(B) upon the expiration of such 18-month period if the final regulations have not been made effective as of the expiration of such period, subject to compliance with the final regulations when the final regulations are made effective.

"(2) Default; minimum period of advance notice.—If under paragraph (1) the requirement for providing notice in accordance with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(m)] takes effect without final regulations having been made effective, then for purposes of such requirement, the specified period of time that the notice is required to be made in advance of the time of the importation of the article of food involved or the offering of the food for import shall be not fewer than eight hours and not more than five days, which shall remain in effect until the final regulations are made effective."

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any civil seizure or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotic and Dangerous Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Construction; Confidentiality

Nothing in amendment made by section 3503(a)(4)(C), (D) of Pub. L. 117–328 to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

Construction of 2011 Amendment

Pub. L. 111–353, title III, §303(d), Jan. 4, 2011, 124 Stat. 3957, provided that: "Nothing in the amendments made by this section [amending this section] shall limit the authority of the Secretary to conduct inspections of imported food or to take such other steps as the Secretary deems appropriate to determine the admissibility of imported food."

Nothing in amendments by sections 107(b), 204(j)(2), 301(c), and 303(a)–(c) of Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, see section 2206 of this title.

Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

Construction of Amendments by Pub. L. 107–188

Pub. L. 107–188, title III, §308(c), June 12, 2002, 116 Stat. 673, provided that: "With respect to articles of food that are imported or offered for import into the United States, nothing in this section [amending this section and section 343 of this title] shall be construed to limit the authority of the Secretary of Health and Human Services or the Secretary of the Treasury to require the marking of refused articles of food under any other provision of law."

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

Port Shopping

Pub. L. 111–353, title I, §115, Jan. 4, 2011, 124 Stat. 3922, as amended by Pub. L. 114–125, title VIII, §802(d)(2), Feb. 24, 2016, 130 Stat. 210, provided that: "Until the date on which the Secretary promulgates a final rule that implements the amendments made by section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (Public Law 107–188) [amending this section and section 343 of this title], the Secretary shall notify the Secretary of Homeland Security of all instances in which the Secretary refuses to admit a food into the United States under section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) so that the Secretary of Homeland Security, acting through the Commissioner of U.S. Customs and Border Protection, may prevent food refused admittance into the United States by a United States port of entry from being admitted by another United States port of entry, through the notification of other such United States ports of entry."

["Commissioner of U.S. Customs and Border Protection" substituted for "Commissioner of Customs and Border Protection" in section 115 of Pub. L. 111–353, set out above, to reflect the probable intent of section 802(d)(2) of Pub. L. 114–125, set out as a note under section 211 of Title 6, Domestic Security, which provided that on or after Feb. 24, 2016, any reference to the "Commissioner of Customs" or the "Commissioner of the Customs Service" would be deemed to be a reference to the Commissioner of U.S. Customs and Border Protection.]

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

Study and Report on Trade in Pharmaceuticals

Pub. L. 108–173, title XI, §1123, Dec. 8, 2003, 117 Stat. 2469, provided that: "The President's designees shall conduct a study and report on issues related to trade and pharmaceuticals."

Findings

Pub. L. 106–387, §1(a) [title VII, §746(b)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40, provided that: "The Congress finds as follows:

"(1) Patients and their families sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Administration ('FDA').

"(2) There have been circumstances in which—

"(A) an individual seeking to import such a drug has received a notice from FDA that importing the drug violates or may violate the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]; and

"(B) the notice failed to inform the individual of the reasons underlying the decision to send the notice.

"(3) FDA should not send a warning notice regarding the importation of a drug without providing to the individual involved a statement of the underlying reasons for the notice."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

¹ So in original. Probably should be preceded by a comma.

² So in original. No par. (2) has been enacted.

³ So in original. Probably should be preceded by "section".

§382. Exports of certain unapproved products

(a) Drugs or devices intended for human or animal use which require approval or licensing

A drug or device—

(1) which, in the case of a drug—

(A)(i) requires approval by the Secretary under section 355 of this title before such drug may be introduced or delivered for introduction into interstate commerce; or

(ii) requires licensing by the Secretary under section 262 of title 42 or by the Secretary of Agriculture under the Act of March 4, 1913 [21 U.S.C. 151 et seq.] (known as the Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into interstate commerce;

(B) does not have such approval or license; and

(C) is not exempt from such sections or Act; and

(2) which, in the case of a device—

(A) does not comply with an applicable requirement under section 360d or 360e of this title;

(B) under section 360j(g) of this title is exempt from either such section; or

(C) is a banned device under section 360f of this title, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug or device is, except as provided in subsection (f), authorized under subsection (b), (c), (d), or (e) or section 381(e)(2) of this title. If a drug or device described in paragraphs (1) and (2) may be exported under subsection (b) and if an application for such drug or device under section 355 or 360e of this title or section 262 of title 42 was disapproved, the Secretary shall notify the appropriate public health official of the country to which such drug will be exported of such disapproval.

(b) List of eligible countries for export; criteria for addition to list; direct export; petition for exemption

(1)(A) A drug or device described in subsection (a) may be exported to any country, if the drug or device complies with the laws of that country and has valid marketing authorization by the appropriate authority—

(i) in Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa; or

(ii) in the European Union or a country in the European Economic Area (the countries in the European Union and the European Free Trade Association) if the drug or device is marketed in that country or the drug or device is authorized for general marketing in the European Economic Area.

(B) The Secretary may designate an additional country to be included in the list of countries described in clauses (i) and (ii) of subparagraph (A) if all of the following requirements are met in such country:

(i) Statutory or regulatory requirements which require the review of drugs and devices for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs and devices which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs and devices on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs and devices.

(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for—

(I) the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength; and

(II) the manufacture, preproduction design validation, packing, storage, and installation of a device are adequate to assure that the device will be safe and effective.

(iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and devices and procedures to withdraw approval and remove drugs and devices found not to be safe or effective.

(iv) Statutory or regulatory requirements that the labeling and promotion of drugs and devices must be in accordance with the approval of the drug or device.

(v) The valid marketing authorization system in such country or countries is equivalent to the systems in the countries described in clauses (i) and (ii) of subparagraph (A).

The Secretary shall not delegate the authority granted under this subparagraph.

(C) An appropriate country official, manufacturer, or exporter may request the Secretary to take action under subparagraph (B) to designate an additional country or countries to be added to the list of countries described in clauses (i) and (ii) of subparagraph (A) by submitting documentation to the Secretary in support of such designation. Any person other than a country requesting such designation shall include, along with the request, a letter from the country indicating the desire of such country to be designated.

(2) A drug described in subsection (a) may be directly exported to a country which is not listed in clause (i) or (ii) of paragraph (1)(A) if—

(A) the drug complies with the laws of that country and has valid marketing authorization by the responsible authority in that country; and

(B) the Secretary determines that all of the following requirements are met in that country:

(i) Statutory or regulatory requirements which require the review of drugs for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs.

(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength.

(iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective.

(iv) Statutory or regulatory requirements that the labeling and promotion of drugs must be in accordance with the approval of the drug.

(3) The exporter of a drug described in subsection (a) which would not meet the conditions for approval under this chapter or conditions for approval of a country described in clause (i) or (ii) of paragraph (1)(A) may petition the Secretary for authorization to export such drug to a country which is not described in clause (i) or (ii) of paragraph (1)(A) or which is not described in paragraph (2). The Secretary shall permit such export if—

(A) the person exporting the drug—

(i) certifies that the drug would not meet the conditions for approval under this chapter or the conditions for approval of a country described in clause (i) or (ii) of paragraph (1)(A); and

(ii) provides the Secretary with credible scientific evidence, acceptable to the Secretary, that the drug would be safe and effective under the conditions of use in the country to which it is being exported; and

(B) the appropriate health authority in the country to which the drug is being exported—

(i) requests approval of the export of the drug to such country;

(ii) certifies that the health authority understands that the drug is not approved under this chapter or in a country described in clause (i) or (ii) of paragraph (1)(A); and

(iii) concurs that the scientific evidence provided pursuant to subparagraph (A) is credible scientific evidence that the drug would be reasonably safe and effective in such country.

The Secretary shall take action on a request for export of a drug under this paragraph within 60 days of receiving such request.

(c) Investigational use exemption

A drug or device intended for investigational use in any country described in clause (i) or (ii) of subsection (b)(1)(A) may be exported in accordance with the laws of that country and shall be exempt from regulation under section 355(i) or 360j(g) of this title.

(d) Anticipation of market authorization

A drug or device intended for formulation, filling, packaging, labeling, or further processing in anticipation of market authorization in any country described in clause (i) or (ii) of subsection (b)(1)(A) may be exported for use in accordance with the laws of that country.

(e) Diagnosis, prevention, or treatment of tropical disease

(1) A drug or device which is used in the diagnosis, prevention, or treatment of a tropical disease or another disease not of significant prevalence in the United States and which does not otherwise qualify for export under this section shall, upon approval of an application, be permitted to be exported if the Secretary finds that the drug or device will not expose patients in such country to an unreasonable risk of illness or injury and the probable benefit to health from the use of the drug or device (under conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling of the drug or device) outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available drug or device treatment.

(2) The holder of an approved application for the export of a drug or device under this subsection shall report to the Secretary—

(A) the receipt of any credible information indicating that the drug or device is being or may have been exported from a country for which the Secretary made a finding under paragraph (1)(A) to a country for which the Secretary cannot make such a finding; and

(B) the receipt of any information indicating adverse reactions to such drug.

(3)(A) If the Secretary determines that—

(i) a drug or device for which an application is approved under paragraph (1) does not continue to meet the requirements of such paragraph; or

(ii) the holder of an approved application under paragraph (1) has not made the report required by paragraph (2),

the Secretary may, after providing the holder of the application an opportunity for an informal hearing, withdraw the approved application.

(B) If the Secretary determines that the holder of an approved application under paragraph (1) or an importer is exporting a drug or device from the United States to an importer and such importer is exporting the drug or device to a country for which the Secretary cannot make a finding under paragraph (1) and such export presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug or device to such importer, provide the person exporting the drug or device from the United States prompt notice of the prohibition, and afford such person an opportunity for an expedited hearing.

(f) Prohibition of export of drug or device

A drug or device may not be exported under this section—

(1) if the drug or device is not manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements or does not meet international standards as certified by an international standards organization recognized by the Secretary;

(2) if the drug or device is adulterated under clause (1), (2)(A), or (3) of section 351(a) or subsection (c) or (d) of section 351 of this title;

(3) if the requirements of subparagraphs (A) through (D) of section 381(e)(1) of this title have not been met;

(4)(A) if the drug or device is the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the probability of reimportation of the exported drug or device would present an imminent hazard to the public health and safety of the United States and the only means of limiting the hazard is to prohibit the export of the drug or device; or

(B) if the drug or device presents an imminent hazard to the public health of the country to which the drug or device would be exported;

(5) if the labeling of the drug or device is not—

(A) in accordance with the requirements and conditions for use in—

(i) the country in which the drug or device received valid marketing authorization under subsection (b); and

(ii) the country to which the drug or device would be exported; and

(B) in the language and units of measurement of the country to which the drug or device would be exported or in the language designated by such country; or

(6) if the drug or device is not promoted in accordance with the labeling requirements set forth in paragraph (5).

In making a finding under paragraph (4)(B), (5), or (6) the Secretary shall consult with the appropriate public health official in the affected country.

(g) Notification of Secretary

The exporter of a drug or device exported under subsection (b)(1) shall provide a simple notification to the Secretary identifying the drug or device when the exporter first begins to export such drug or device to any country listed in clause (i) or (ii) of subsection (b)(1)(A). When an exporter of a drug or device first begins to export a drug or device to a country which is not listed in clause (i) or (ii) of subsection (b)(1)A),¹ the exporter shall provide a simple notification to the Secretary identifying the drug or device and the country to which such drug or device is being exported. Any exporter of a drug or device shall maintain records of all drugs or devices exported and the countries to which they were exported.

(h) References to Secretary and term "drug"

For purposes of this section—

(1) a reference to the Secretary shall in the case of a biological product which is required to be licensed under the Act of March 4, 1913 [21 U.S.C. 151 et seq.] (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act) be considered to be a reference to the Secretary of Agriculture, and

(2) the term "drug" includes drugs for human use as well as biologicals under section 262 of title 42 or the Act of March 4, 1913 (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act).

(i) Exportation

Insulin and antibiotic drugs may be exported without regard to the requirements in this section if the insulin and antibiotic drugs meet the requirements of section 381(e)(1) of this title.

(June 25, 1938, ch. 675, §802, as added Pub. L. 99–660, title I, §102(2), Nov. 14, 1986, 100 Stat. 3743; amended Pub. L. 104–134, title III, §2102(d)(1), Apr. 26, 1996, 110 Stat. 1321–315; Pub. L. 104–180, title VI, §603(c), Aug. 6, 1996, 110 Stat. 1595; Pub. L. 105–115, title I, §125(c), Nov. 21, 1997, 111 Stat. 2326.)

Editorial Notes

References in Text

Act of March 4, 1913 (known as the Virus-Serum Toxin Act), referred to in subsecs. (a)(1)(A)(ii), (C), (2)(C) and (h), is the eighth paragraph under the heading "Bureau of Animal Industry" of act Mar. 4, 1913, ch. 145, 37 Stat. 832, which is classified generally to chapter 5 (§151 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 151 of this title and Tables.

Amendments

1997—Subsec. (i). Pub. L. 105–115 added subsec. (i).

1996—Pub. L. 104–134 reenacted section catchline without change and amended text generally. Prior to amendment, text related to exports of certain unapproved products, including provisions relating to drugs intended for human or animal use which required approval or licensing, conditions for export, active pursuit of drug approval or licensing, application for export, contents, approval or disapproval, list of eligible countries for export, and criteria for list change, report to Secretary by holder of approved application, events requiring report, and annual report to Secretary on pursuit of approval of drug, export of drug under approved application prohibited under certain conditions, determination by Secretary of noncompliance, failure of active pursuit of drug approval, imminent hazard of drug to public health, or exportation of drug to noneligible country, notices, hearings, and prohibition on exportation of drug under certain circumstances, drugs used in prevention or treatment of tropical disease, and reference to Secretary and holder of application.

Subsec. (f)(5). Pub. L. 104–180 substituted "if the labeling of the drug or device is not" for "if the drug or device is not labeled".

¹ So in original. Probably should be subsection "(b)(1)(A),".

§383. Office of International Relations

(a) Establishment

There is established in the Department of Health and Human Services an Office of International Relations.

(b) Agreements with foreign countries

In carrying out the functions of the office under subsection (a), the Secretary may enter into agreements with foreign countries to facilitate commerce in devices between the United States and such countries consistent with the requirements of this chapter. In such agreements, the Secretary shall encourage the mutual recognition of—

(1) good manufacturing practice regulations promulgated under section 360j(f) of this title, and

(2) other regulations and testing protocols as the Secretary determines to be appropriate.

(c) Harmonizing regulatory requirements

(1) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the Secretary determines that such harmonization continues consumer protections consistent with the purposes of this chapter.

(2) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States.

(3)(A) The Secretary shall regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements.

(B) In carrying out subparagraph (A), the Secretary may participate in appropriate fora, including the International Medical Device Regulators Forum, and may—

(i) provide guidance to such fora on strategies, policies, directions, membership, and other activities of a forum as appropriate;

(ii) to the extent appropriate, solicit, review, and consider comments from industry, academia, health care professionals, and patient groups regarding the activities of such fora; and

(iii) to the extent appropriate, inform the public of the Secretary's activities within such fora, and share with the public any documentation relating to a forum's strategies, policies, and other activities of such fora.

(4) With respect to devices, the Secretary may, when appropriate, enter into arrangements with nations regarding methods and approaches to harmonizing regulatory requirements for activities, including inspections and common international labeling symbols.

(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 321(ff) of this title.

(June 25, 1938, ch. 675, §803, as added Pub. L. 101–629, §15(a), Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105–115, title IV, §410(b), Nov. 21, 1997, 111 Stat. 2373; Pub. L. 112–144, title VI, §§609, 610, July 9, 2012, 126 Stat. 1059.)

Editorial Notes

Amendments

2012—Subsec. (c)(3). Pub. L. 112–144, §610, designated existing provisions as subpar. (A) and added subpar. (B).

Subsec. (c)(4). Pub. L. 112–144, §609, amended par. (4) generally. Prior to amendment, par. (4) read as follows: "The Secretary shall, not later than 180 days after November 21, 1997, make public a plan that establishes a framework for achieving mutual recognition of good manufacturing practices inspections."

1997—Subsec. (c). Pub. L. 105–115 added subsec. (c).

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Report on Activities of Office of International Relations

Pub. L. 101–629, §15(b), Nov. 28, 1990, 104 Stat. 4525, directed Secretary of Health and Human Services, not later than 2 years after Nov. 28, 1990, to prepare and submit to the appropriate committees of Congress a report on the activities of the Office of International Relations under 21 U.S.C. 383.

§384. Importation of prescription drugs

(a) Definitions

In this section:

(1) Importer

The term "importer" means a pharmacist or wholesaler.

(2) Pharmacist

The term "pharmacist" means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs.

(3) Prescription drug

The term "prescription drug" means a drug subject to section 353(b) of this title, other than—

(A) a controlled substance (as defined in section 802 of this title);

(B) a biological product (as defined in section 262 of title 42);

(C) an infused drug (including a peritoneal dialysis solution);

(D) an intravenously injected drug;

(E) a drug that is inhaled during surgery; or

(F) a drug which is a parenteral drug, the importation of which pursuant to subsection (b) is determined by the Secretary to pose a threat to the public health, in which case section 381(d)(1) of this title shall continue to apply.

(4) Qualifying laboratory

The term "qualifying laboratory" means a laboratory in the United States that has been approved by the Secretary for the purposes of this section.

(5) Wholesaler

(A) In general

The term "wholesaler" means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 353(e)(2)(A) of this title.

(B) Exclusion

The term "wholesaler" does not include a person authorized to import drugs under section 381(d)(1) of this title.

(b) Regulations

The Secretary, after consultation with the United States Trade Representative and the Commissioner of U.S. Customs and Border Protection, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.

(c) Limitation

The regulations under subsection (b) shall—

(1) require that safeguards be in place to ensure that each prescription drug imported under the regulations complies with section 355 of this title (including with respect to being safe and effective for the intended use of the prescription drug), with sections 351 and 352 of this title, and with other applicable requirements of this chapter;

(2) require that an importer of a prescription drug under the regulations comply with subsections (d)(1) and (e); and

(3) contain any additional provisions determined by the Secretary to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of prescription drugs.

(d) Information and records

(1) In general

The regulations under subsection (b) shall require an importer of a prescription drug under subsection (b) to submit to the Secretary the following information and documentation:

(A) The name and quantity of the active ingredient of the prescription drug.

(B) A description of the dosage form of the prescription drug.

(C) The date on which the prescription drug is shipped.

(D) The quantity of the prescription drug that is shipped.

(E) The point of origin and destination of the prescription drug.

(F) The price paid by the importer for the prescription drug.

(G) Documentation from the foreign seller specifying—

(i) the original source of the prescription drug; and

(ii) the quantity of each lot of the prescription drug originally received by the seller from that source.

(H) The lot or control number assigned to the prescription drug by the manufacturer of the prescription drug.

(I) The name, address, telephone number, and professional license number (if any) of the importer.

(J)(i) In the case of a prescription drug that is shipped directly from the first foreign recipient of the prescription drug from the manufacturer:

(I) Documentation demonstrating that the prescription drug was received by the recipient from the manufacturer and subsequently shipped by the first foreign recipient to the importer.

(II) Documentation of the quantity of each lot of the prescription drug received by the first foreign recipient demonstrating that the quantity being imported into the United States is not more than the quantity that was received by the first foreign recipient.

(III)(aa) In the case of an initial imported shipment, documentation demonstrating that each batch of the prescription drug in the shipment was statistically sampled and tested for authenticity and degradation.

(bb) In the case of any subsequent shipment, documentation demonstrating that a statistically valid sample of the shipment was tested for authenticity and degradation.

(ii) In the case of a prescription drug that is not shipped directly from the first foreign recipient of the prescription drug from the manufacturer, documentation demonstrating that each batch in each shipment offered for importation into the United States was statistically sampled and tested for authenticity and degradation.

(K) Certification from the importer or manufacturer of the prescription drug that the prescription drug—

(i) is approved for marketing in the United States and is not adulterated or misbranded; and

(ii) meets all labeling requirements under this chapter.

(L) Laboratory records, including complete data derived from all tests necessary to ensure that the prescription drug is in compliance with established specifications and standards.

(M) Documentation demonstrating that the testing required by subparagraphs (J) and (L) was conducted at a qualifying laboratory.

(N) Any other information that the Secretary determines is necessary to ensure the protection of the public health.

(2) Maintenance by the Secretary

The Secretary shall maintain information and documentation submitted under paragraph (1) for such period of time as the Secretary determines to be necessary.

(e) Testing

The regulations under subsection (b) shall require—

(1) that testing described in subparagraphs (J) and (L) of subsection (d)(1) be conducted by the importer or by the manufacturer of the prescription drug at a qualified laboratory;

(2) if the tests are conducted by the importer—

(A) that information needed to—

(i) authenticate the prescription drug being tested; and

(ii) confirm that the labeling of the prescription drug complies with labeling requirements under this chapter;

be supplied by the manufacturer of the prescription drug to the pharmacist or wholesaler; and

(B) that the information supplied under subparagraph (A) be kept in strict confidence and used only for purposes of testing or otherwise complying with this chapter; and

(3) may include such additional provisions as the Secretary determines to be appropriate to provide for the protection of trade secrets and commercial or financial information that is privileged or confidential.

(f) Registration of foreign sellers

Any establishment within Canada engaged in the distribution of a prescription drug that is imported or offered for importation into the United States shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment.

(g) Suspension of importation

The Secretary shall require that importations of a specific prescription drug or importations by a specific importer under subsection (b) be immediately suspended on discovery of a pattern of importation of that specific prescription drug or by that specific importer of drugs that are counterfeit or in violation of any requirement under this section, until an investigation is completed and the Secretary determines that the public is adequately protected from counterfeit and violative prescription drugs being imported under subsection (b).

(h) Approved labeling

The manufacturer of a prescription drug shall provide an importer written authorization for the importer to use, at no cost, the approved labeling for the prescription drug.

(i) Charitable contributions

Notwithstanding any other provision of this section, section 381(d)(1) of this title continues to apply to a prescription drug that is donated or otherwise supplied at no charge by the manufacturer of the drug to a charitable or humanitarian organization (including the United Nations and affiliates) or to a government of a foreign country.

(j) Waiver authority for importation by individuals

(1) Declarations

Congress declares that in the enforcement against individuals of the prohibition of importation of prescription drugs and devices, the Secretary should—

(A) focus enforcement on cases in which the importation by an individual poses a significant threat to public health; and

(B) exercise discretion to permit individuals to make such importations in circumstances in which—

(i) the importation is clearly for personal use; and

(ii) the prescription drug or device imported does not appear to present an unreasonable risk to the individual.

(2) Waiver authority

(A) In general

The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate.

(B) Guidance on case-by-case waivers

The Secretary shall publish, and update as necessary, guidance that accurately describes circumstances in which the Secretary will consistently grant waivers on a case-by-case basis under subparagraph (A), so that individuals may know with the greatest practicable degree of certainty whether a particular importation for personal use will be permitted.

(3) Drugs imported from Canada

In particular, the Secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug that—

(A) is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply;

(B) is accompanied by a copy of a valid prescription;

(C) is imported from Canada, from a seller registered with the Secretary;

(D) is a prescription drug approved by the Secretary under subchapter V;

(E) is in the form of a final finished dosage that was manufactured in an establishment registered under section 360 of this title; and

(F) is imported under such other conditions as the Secretary determines to be necessary to ensure public safety.

(k) Construction

Nothing in this section limits the authority of the Secretary relating to the importation of prescription drugs, other than with respect to section 381(d)(1) of this title as provided in this section.

(l) Effectiveness of section

(1) Commencement of program

This section shall become effective only if the Secretary certifies to the Congress that the implementation of this section will—

(A) pose no additional risk to the public's health and safety; and

(B) result in a significant reduction in the cost of covered products to the American consumer.

(2) Termination of program

(A) In general

If, after the date that is 1 year after the effective date of the regulations under subsection (b) and before the date that is 18 months after the effective date, the Secretary submits to Congress a certification that, in the opinion of the Secretary, based on substantial evidence obtained after the effective date, the benefits of implementation of this section do not outweigh any detriment of implementation of this section, this section shall cease to be effective as of the date that is 30 days after the date on which the Secretary submits the certification.

(B) Procedure

The Secretary shall not submit a certification under subparagraph (A) unless, after a hearing on the record under sections 556 and 557 of title 5, the Secretary—

(i)(I) determines that it is more likely than not that implementation of this section would result in an increase in the risk to the public health and safety;

(II) identifies specifically, in qualitative and quantitative terms, the nature of the increased risk;

(III) identifies specifically the causes of the increased risk; and

(IV)(aa) considers whether any measures can be taken to avoid, reduce, or mitigate the increased risk; and

(bb) if the Secretary determines that any measures described in item (aa) would require additional statutory authority, submits to Congress a report describing the legislation that would be required;

(ii) identifies specifically, in qualitative and quantitative terms, the benefits that would result from implementation of this section (including the benefit of reductions in the cost of covered products to consumers in the United States, allowing consumers to procure needed medication that consumers might not otherwise be able to procure without foregoing other necessities of life); and

(iii)(I) compares in specific terms the detriment identified under clause (i) with the benefits identified under clause (ii); and

(II) determines that the benefits do not outweigh the detriment.

(m) Authorization of appropriations

There are authorized to be appropriated such sums as are necessary to carry out this section.

(June 25, 1938, ch. 675, §804, as added Pub. L. 108–173, title XI, §1121(a), Dec. 8, 2003, 117 Stat. 2464; amended Pub. L. 114–125, title VIII, §802(d)(2), Feb. 24, 2016, 130 Stat. 210.)

Editorial Notes

Prior Provisions

A prior section 384, act June 25, 1938, ch. 675, §804, as added Pub. L. 106–387, §1(a) [title VII, §745(c)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-36, related to importation of covered products, prior to repeal by Pub. L. 108–173, title XI, §1121(a), Dec. 8, 2003, 117 Stat. 2464.

Statutory Notes and Related Subsidiaries

Change of Name

"Commissioner of U.S. Customs and Border Protection" substituted for "Commissioner of Customs" in subsec. (b) on authority of section 802(d)(2) of Pub. L. 114–125, set out as a note under section 211 of Title 6, Domestic Security.

Effective Date

For certification by Secretary of Health and Human Services pursuant to subsec. (l)(1) of this section, see 85 F.R. 62094, 62096 (Oct. 1, 2020); 166 Cong. Rec. S6652 (daily ed. Nov. 10, 2020) (citing Executive Communication EC–5822); 166 Cong. Rec. H5866 (daily ed. Nov. 17, 2020) (citing Executive Communication EC–5624).

Transfer of Functions

For transfer of functions, personnel, assets, and liabilities of the United States Customs Service of the Department of the Treasury, including functions of the Secretary of the Treasury relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections 203(1), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6. For establishment of U.S. Customs and Border Protection in the Department of Homeland Security, treated as if included in Pub. L. 107–296 as of Nov. 25, 2002, see section 211 of Title 6, as amended generally by Pub. L. 114–125, and section 802(b) of Pub. L. 114–125, set out as a note under section 211 of Title 6.

Study and Report on Importation of Drugs

Pub. L. 108–173, title XI, §1122, Dec. 8, 2003, 117 Stat. 2469, directed the Secretary of Health and Human Services to conduct a study on the importation of drugs into the United States pursuant to this section and to submit to Congress, not later than 12 months after Dec. 8, 2003, a report providing the findings of such study.

Executive Documents

Ex. Ord. No. 13938. Increasing Drug Importation To Lower Prices for American Patients

Ex. Ord. No. 13938, July 24, 2020, 85 F.R. 45757, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Purpose. Americans spend more per capita on pharmaceutical drugs than residents of any other developed country. Americans often pay more for the exact same drugs, even when they are produced and shipped from the exact same facilities.

One way to minimize international disparities in price is to increase the trade of prescription drugs between nations with lower prices and those with persistently higher ones. Over time, reducing trade barriers and increasing the exchange of drugs will likely result in lower prices for the country that is paying more for drugs. For example, in the European Union, a market characterized by price controls and significant barriers to entry, the parallel trade of drugs has existed for decades and has been estimated to reduce the price of certain drugs by up to 20 percent. Accordingly, my Administration supports the goal of safe importation of prescription drugs.

Sec. 2. Permitting the Importation of Safe Prescription Drugs from Other Countries. The Secretary of Health and Human Services shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by:

(a) facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2);

(b) authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and

(c) completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow importation of certain prescription drugs from Canada.

Sec. 3. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

Donald J. Trump.      

§384a. Foreign supplier verification program

(a) In general

(1) Verification requirement

Except as provided under subsections (e) and (f), each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of an importer is—

(A) produced in compliance with the requirements of section 350g of this title or section 350h of this title, as appropriate; and

(B) is not adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(2) Importer defined

For purposes of this section, the term "importer" means, with respect to an article of food—

(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or

(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.

(b) Guidance

Not later than 1 year after January 4, 2011, the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs.

(c) Regulations

(1) In general

Not later than 1 year after January 4, 2011, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a).

(2) Requirements

The regulations promulgated under paragraph (1)—

(A) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food in compliance with—

(i) processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under section 350g of this title or section 350h of this title (taking into consideration variances granted under section 350h of this title), as appropriate; and

(ii) section 342 of this title and section 343(w) of this title.¹

(B) shall include such other requirements as the Secretary deems necessary and appropriate to verify that food imported into the United States is as safe as food produced and sold within the United States.

(3) Considerations

In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food.

(4) Activities

Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

(d) Record maintenance and access

Records of an importer related to a foreign supplier verification program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly authorized representative of the Secretary upon request.

(e) Exemption of seafood, juice, and low-acid canned food facilities in compliance with HACCP

This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:

(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).

The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter ² 21, Code of Federal Regulations (or any successor regulations).

(f) Additional exemptions

The Secretary, by notice published in the Federal Register, shall establish an exemption from the requirements of this section for articles of food imported in small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for retail sale and are not sold or distributed to the public.

(g) Publication of list of participants

The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.

(June 25, 1938, ch. 675, §805, as added Pub. L. 111–353, title III, §301(a), Jan. 4, 2011, 124 Stat. 3953.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as an Effective Date of 2011 Amendment note under section 331 of this title.

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

¹ So in original.

² So in original. Probably should be "title".

§384b. Voluntary qualified importer program

(a) In general

Beginning not later than 18 months after January 4, 2011, the Secretary shall—

(1) establish a program, in consultation with the Secretary of Homeland Security—

(A) to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program; and

(B) consistent with section 384d of this title, establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program; and

(2) issue a guidance document related to participation in, revocation of such participation in, reinstatement in, and compliance with, such program.

(b) Voluntary participation

An importer may request the Secretary to provide for the expedited review and importation of designated foods in accordance with the program established by the Secretary under subsection (a).

(c) Notice of intent to participate

An importer that intends to participate in the program under this section in a fiscal year shall submit a notice and application to the Secretary of such intent at the time and in a manner established by the Secretary.

(d) Eligibility

Eligibility shall be limited to an importer offering food for importation from a facility that has a certification described in subsection (a). In reviewing the applications and making determinations on such applications, the Secretary shall consider the risk of the food to be imported based on factors, such as the following:

(1) The known safety risks of the food to be imported.

(2) The compliance history of foreign suppliers used by the importer, as appropriate.

(3) The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food.

(4) The compliance of the importer with the requirements of section 384a of this title.

(5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.

(6) The potential risk for intentional adulteration of the food.

(7) Any other factor that the Secretary determines appropriate.

(e) Review and revocation

Any importer qualified by the Secretary in accordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria.

(f) False statements

Any statement or representation made by an importer to the Secretary shall be subject to section 1001 of title 18.

(g) Definition

For purposes of this section, the term "importer" means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.

(June 25, 1938, ch. 675, §806, as added Pub. L. 111–353, title III, §302, Jan. 4, 2011, 124 Stat. 3955.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

§384c. Inspection of foreign food facilities

(a) Inspection

The Secretary—

(1) may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 350d of this title; and

(2) shall direct resources to inspections of foreign facilities, suppliers, and food types, especially such facilities, suppliers, and food types that present a high risk (as identified by the Secretary), to help ensure the safety and security of the food supply of the United States.

(b) Effect of inability to inspect

Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment. For purposes of this subsection, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after such request is submitted, or after such other time period, as agreed upon by the Secretary and the foreign factory, warehouse, or other establishment.

(June 25, 1938, ch. 675, §807, as added Pub. L. 111–353, title III, §306(a), Jan. 4, 2011, 124 Stat. 3958.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

§384d. Accreditation of third-party auditors

(a) Definitions

In this section:

(1) Audit agent

The term "audit agent" means an individual who is an employee or agent of an accredited third-party auditor and, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party auditor.

(2) Accreditation body

The term "accreditation body" means an authority that performs accreditation of third-party auditors.

(3) Third-party auditor

The term "third-party auditor" means a foreign government, agency of a foreign government, foreign cooperative, or any other third party, as the Secretary determines appropriate in accordance with the model standards described in subsection (b)(2), that is eligible to be considered for accreditation to conduct food safety audits to certify that eligible entities meet the applicable requirements of this section. A third-party auditor may be a single individual. A third-party auditor may employ or use audit agents to help conduct consultative and regulatory audits.

(4) Accredited third-party auditor

The term "accredited third-party auditor" means a third-party auditor accredited by an accreditation body to conduct audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section. An accredited third-party auditor may be an individual who conducts food safety audits to certify that eligible entities meet the applicable requirements of this section.

(5) Consultative audit

The term "consultative audit" means an audit of an eligible entity—

(A) to determine whether such entity is in compliance with the provisions of this chapter and with applicable industry standards and practices; and

(B) the results of which are for internal purposes only.

(6) Eligible entity

The term "eligible entity" means a foreign entity, including a foreign facility registered under section 350d of this title, in the food import supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor.

(7) Regulatory audit

The term "regulatory audit" means an audit of an eligible entity—

(A) to determine whether such entity is in compliance with the provisions of this chapter; and

(B) the results of which determine—

(i) whether an article of food manufactured, processed, packed, or held by such entity is eligible to receive a food certification under section 381(q) of this title; or

(ii) whether a facility is eligible to receive a facility certification under section 384b(a) of this title for purposes of participating in the program under section 384b of this title.

(b) Accreditation system

(1) Accreditation bodies

(A) Recognition of accreditation bodies

(i) In general

Not later than 2 years after January 4, 2011, the Secretary shall establish a system for the recognition of accreditation bodies that accredit third-party auditors to certify that eligible entities meet the applicable requirements of this section.

(ii) Direct accreditation

If, by the date that is 2 years after the date of establishment of the system described in clause (i), the Secretary has not identified and recognized an accreditation body to meet the requirements of this section, the Secretary may directly accredit third-party auditors.

(B) Notification

Each accreditation body recognized by the Secretary shall submit to the Secretary a list of all accredited third-party auditors accredited by such body and the audit agents of such auditors.

(C) Revocation of recognition as an accreditation body

The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section.

(D) Reinstatement

The Secretary shall establish procedures to reinstate recognition of an accreditation body if the Secretary determines, based on evidence presented by such accreditation body, that revocation was inappropriate or that the body meets the requirements for recognition under this section.

(2) Model accreditation standards

Not later than 18 months after January 4, 2011, the Secretary shall develop model standards, including requirements for regulatory audit reports, and each recognized accreditation body shall ensure that third-party auditors and audit agents of such auditors meet such standards in order to qualify such third-party auditors as accredited third-party auditors under this section. In developing the model standards, the Secretary shall look to standards in place on January 4, 2011, for guidance, to avoid unnecessary duplication of efforts and costs.

(c) Third-party auditors

(1) Requirements for accreditation as a third-party auditor

(A) Foreign governments

Prior to accrediting a foreign government or an agency of a foreign government as an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of food safety programs, systems, and standards of the government or agency of the government as the Secretary deems necessary, including requirements under the model standards developed under subsection (b)(2), to determine that the foreign government or agency of the foreign government is capable of adequately ensuring that eligible entities or foods certified by such government or agency meet the requirements of this chapter with respect to food manufactured, processed, packed, or held for import into the United States.

(B) Foreign cooperatives and other third parties

Prior to accrediting a foreign cooperative that aggregates the products of growers or processors, or any other third party to be an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of the training and qualifications of audit agents used by that cooperative or party and conduct such reviews of internal systems and such other investigation of the cooperative or party as the Secretary deems necessary, including requirements under the model standards developed under subsection (b)(2), to determine that each eligible entity certified by the cooperative or party has systems and standards in use to ensure that such entity or food meets the requirements of this chapter.

(2) Requirement to issue certification of eligible entities or foods

(A) In general

An accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) may not accredit a third-party auditor unless such third-party auditor agrees to issue a written and, as appropriate, electronic food certification, described in section 381(q) of this title, or facility certification under section 384b(a) of this title, as appropriate, to accompany each food shipment for import into the United States from an eligible entity, subject to requirements set forth by the Secretary. Such written or electronic certification may be included with other documentation regarding such food shipment. The Secretary shall consider certifications under section 381(q) of this title and participation in the voluntary qualified importer program described in section 384b of this title when targeting inspection resources under section 350j of this title.

(B) Purpose of certification

The Secretary shall use certification provided by accredited third-party auditors to—

(i) determine, in conjunction with any other assurances the Secretary may require under section 381(q) of this title, whether a food satisfies the requirements of such section; and

(ii) determine whether a facility is eligible to be a facility from which food may be offered for import under the voluntary qualified importer program under section 384b of this title.

(C) Requirements for issuing certification

(i) In general

An accredited third-party auditor shall issue a food certification under section 381(q) of this title or a facility certification described under subparagraph (B) only after conducting a regulatory audit and such other activities that may be necessary to establish compliance with the requirements of such sections.

(ii) Provision of certification

Only an accredited third-party auditor or the Secretary may provide a facility certification under section 384b(a) of this title. Only those parties described in ¹ 381(q)(3) of this title or the Secretary may provide a food certification under ¹ 381(q) ² of this title.

(3) Audit report submission requirements

(A) Requirements in general

As a condition of accreditation, not later than 45 days after conducting an audit, an accredited third-party auditor or audit agent of such auditor shall prepare, and, in the case of a regulatory audit, submit, the audit report for each audit conducted, in a form and manner designated by the Secretary, which shall include—

(i) the identity of the persons at the audited eligible entity responsible for compliance with food safety requirements;

(ii) the dates of the audit;

(iii) the scope of the audit; and

(iv) any other information required by the Secretary that relates to or may influence an assessment of compliance with this chapter.

(B) Records

Following any accreditation of a third-party auditor, the Secretary may, at any time, require the accredited third-party auditor to submit to the Secretary an onsite audit report and such other reports or documents required as part of the audit process, for any eligible entity certified by the third-party auditor or audit agent of such auditor. Such report may include documentation that the eligible entity is in compliance with any applicable registration requirements.

(C) Limitation

The requirement under subparagraph (B) shall not include any report or other documents resulting from a consultative audit by the accredited third-party auditor, except that the Secretary may access the results of a consultative audit in accordance with section 350c of this title.

(4) Requirements of accredited third-party auditors and audit agents of such auditors

(A) Risks to public health

If, at any time during an audit, an accredited third-party auditor or audit agent of such auditor discovers a condition that could cause or contribute to a serious risk to the public health, such auditor shall immediately notify the Secretary of—

(i) the identification of the eligible entity subject to the audit; and

(ii) such condition.

(B) Types of audits

An accredited third-party auditor or audit agent of such auditor may perform consultative and regulatory audits of eligible entities.

(C) Limitations

(i) In general

An accredited third party auditor may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 13-month period.

(ii) Waiver

The Secretary may waive the application of clause (i) if the Secretary determines that there is insufficient access to accredited third-party auditors in a country or region.

(5) Conflicts of interest

(A) Third-party auditors

An accredited third-party auditor shall—

(i) not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor;

(ii) in carrying out audits of eligible entities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a financial conflict of interest regarding an eligible entity to be certified by such auditor; and

(iii) annually make available to the Secretary disclosures of the extent to which such auditor and the officers and employees of such auditor have maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.

(B) Audit agents

An audit agent shall—

(i) not own or operate an eligible entity to be audited by such agent;

(ii) in carrying out audits of eligible entities under this section, have procedures to ensure that such agent does not have a financial conflict of interest regarding an eligible entity to be audited by such agent; and

(iii) annually make available to the Secretary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.

(C) Regulations

The Secretary shall promulgate regulations not later than 18 months after January 4, 2011, to implement this section and to ensure that there are protections against conflicts of interest between an accredited third-party auditor and the eligible entity to be certified by such auditor or audited by such audit agent. Such regulations shall include—

(i) requiring that audits performed under this section be unannounced;

(ii) a structure to decrease the potential for conflicts of interest, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors; and

(iii) appropriate limits on financial affiliations between an accredited third-party auditor or audit agents of such auditor and any person that owns or operates an eligible entity to be certified by such auditor, as described in subparagraphs (A) and (B).

(6) Withdrawal of accreditation

(A) In general

The Secretary shall withdraw accreditation from an accredited third-party auditor—

(i) if food certified under section 381(q) of this title or from a facility certified under paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health consequences or death in humans or animals;

(ii) following an evaluation and finding by the Secretary that the third-party auditor no longer meets the requirements for accreditation; or

(iii) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements set forth in this section.

(B) Additional basis for withdrawal of accreditation

The Secretary may withdraw accreditation from an accredited third-party auditor in the case that such third-party auditor is accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked, if the Secretary determines that there is good cause for the withdrawal.

(C) Exception

The Secretary may waive the application of subparagraph (A)(i) if the Secretary—

(i) conducts an investigation of the material facts related to the outbreak of human or animal illness; and

(ii) reviews the steps or actions taken by the third party auditor to justify the certification and determines that the accredited third-party auditor satisfied the requirements under section 381(q) of this title of certifying the food, or the requirements under paragraph (2)(B) of certifying the entity.

(7) Reaccreditation

The Secretary shall establish procedures to reinstate the accreditation of a third-party auditor for which accreditation has been withdrawn under paragraph (6)—

(A) if the Secretary determines, based on evidence presented, that the third-party auditor satisfies the requirements of this section and adequate grounds for revocation no longer exist; and

(B) in the case of a third-party auditor accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked—

(i) if the third-party auditor becomes accredited not later than 1 year after revocation of accreditation under paragraph (6)(A), through direct accreditation under subsection (b)(1)(A)(ii) or by an accreditation body in good standing; or

(ii) under such conditions as the Secretary may require for a third-party auditor under paragraph (6)(B).

(8) Neutralizing costs

The Secretary shall establish by regulation a reimbursement (user fee) program, similar to the method described in section 1622(h) of title 7,² by which the Secretary assesses fees and requires accredited third-party auditors and audit agents to reimburse the Food and Drug Administration for the work performed to establish and administer the accreditation system under this section. The Secretary shall make operating this program revenue-neutral and shall not generate surplus revenue from such a reimbursement mechanism. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to remain available until expended.

(d) Recertification of eligible entities

An eligible entity shall apply for annual recertification by an accredited third-party auditor if such entity—

(1) intends to participate in ³ voluntary qualified importer program under section 384b of this title; or

(2) is required to provide to the Secretary a certification under section 381(q) of this title for any food from such entity.

(e) False statements

Any statement or representation made—

(1) by an employee or agent of an eligible entity to an accredited third-party auditor or audit agent; or

(2) by an accredited third-party auditor to the Secretary,

shall be subject to section 1001 of title 18.

(f) Monitoring

To ensure compliance with the requirements of this section, the Secretary shall—

(1) periodically, or at least once every 4 years, reevaluate the accreditation bodies described in subsection (b)(1);

(2) periodically, or at least once every 4 years, evaluate the performance of each accredited third-party auditor, through the review of regulatory audit reports by such auditors, the compliance history as available of eligible entities certified by such auditors, and any other measures deemed necessary by the Secretary;

(3) at any time, conduct an onsite audit of any eligible entity certified by an accredited third-party auditor, with or without the auditor present; and

(4) take any other measures deemed necessary by the Secretary.

(g) Publicly available registry

The Secretary shall establish a publicly available registry of accreditation bodies and of accredited third-party auditors, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies and auditors.

(h) Limitations

(1) No effect on section 374 inspections

The audits performed under this section shall not be considered inspections under section 374 of this title.

(2) No effect on inspection authority

Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this chapter.

(June 25, 1938, ch. 675, §808, as added Pub. L. 111–353, title III, §307, Jan. 4, 2011, 124 Stat. 3959.)

Editorial Notes

References in Text

Section 381(q) of this title, referred to in subsec. (c)(2)(C)(ii), was in the original "301(g)", and was translated as reading "801(q)", meaning section 801(q) of act June 25, 1938, ch. 675, which is classified to section 381(q) of this title, to reflect the probable intent of Congress, because section 381(q) of this title relates to food certification, whereas section 301(g) of act June 25, 1938, ch. 675, which is classified to section 331(g) of this title, does not relate to food certification.

Section 1622(h) of title 7, referred to in subsec. (c)(8), was in the original "section 203(h) of the Agriculture Marketing Act of 1946", and was translated as reading "section 203(h) of the Agricultural Marketing Act of 1946", meaning section 203(h) of act Aug. 14, 1946, ch. 966, which is classified to section 1622(h) of Title 7, Agriculture, to reflect the probable intent of Congress.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

¹ So in original. Probably should be followed by "section".

² See References in Text note below.

³ So in original. Probably should be followed by "the".

§384e. Recognition of foreign government inspections

(a) Inspection

The Secretary—

(1) may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under section 360(i) of this title in order to facilitate preapproval or risk-based inspections in accordance with the schedule established in paragraph (2) or (3) of section 360(h) of this title;

(2) may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conducting inspections that meet the applicable requirements of this chapter; and

(3) shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this chapter.

(b) Results of inspection

The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as—

(1) evidence of compliance with section 351(a)(2)(B) of this title or section 381(r) of this title; and

(2) for any other purposes as determined appropriate by the Secretary.

(c) Periodic review

(1) In general

Beginning not later than 1 year after December 29, 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate.

(2) Reports to Congress

Beginning not later than 4 years after December 29, 2022, and every 4 years thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under paragraph (1).

(June 25, 1938, ch. 675, §809, as added Pub. L. 112–144, title VII, §712, July 9, 2012, 126 Stat. 1072; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(X), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title VII, §701(b), Aug. 18, 2017, 131 Stat. 1055; Pub. L. 117–328, div. FF, title III, §3613(c), Dec. 29, 2022, 136 Stat. 5872.)

Editorial Notes

Amendments

2022—Subsec. (a)(1). Pub. L. 117–328, §3613(c)(1), inserted "preapproval or" before "risk-based inspections".

Subsec. (c). Pub. L. 117–328, §3613(c)(2), added subsec. (c).

2017—Subsec. (a)(1). Pub. L. 115–52 substituted "paragraph (2) or (3) of section 360(h)" for "section 360(h)(3)".

2016—Subsec. (a)(2). Pub. L. 114–255 substituted "conducting" for "conduction".

§384f. Strengthening FDA and CBP coordination and capacity

(a) In general

The Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection.

(b) FDA import facilities and inspection capacity

(1) In general

In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include—

(A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate—

(i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;

(ii) improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction;

(iii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods;

(iv) upgrades to the security of import facilities; and

(v) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and

(B) innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate.

(2) Innovative technology

Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable.

(c) Report

Not later than 6 months after October 24, 2018, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate on the implementation of this section, including a summary of progress made toward near-real-time information sharing and the interoperability of such technologies.

(Pub. L. 115–271, title III, §3014, Oct. 24, 2018, 132 Stat. 3937.)

Statutory Notes and Related Subsidiaries

Codification

Section was enacted as part of the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, also known as the SCREEN Act, and also as part of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§384g. Restricting entrance of illicit drugs

(a) Food and Drug Administration and U.S. Customs and Border Protection cooperation

(1) In general

The Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.).

(2) Report

Not later than 9 months after October 24, 2018, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section.

(Pub. L. 115–271, title III, §3022(a), Oct. 24, 2018, 132 Stat. 3938.)

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (a)(1), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Controlled Substances Import and Export Act, referred to in subsec. (a)(1), is title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285, which is classified principally to subchapter II (§951 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 951 of this title and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Codification

Section was enacted as part of the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, also known as the SCREEN Act, and also as part of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

SUBCHAPTER IX—TOBACCO PRODUCTS

Editorial Notes

Prior Provisions

A prior subchapter IX of this chapter, consisting of sections 391 to 399a of this title, was redesignated subchapter X by Pub. L. 111–31, div. A, title I, §101(b)(1), June 22, 2009, 123 Stat. 1784.

§387. Definitions

In this subchapter:

(1) Additive

The term "additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.

(2) Brand

The term "brand" means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name, identifiable pattern of colors, or any combination of such attributes.

(3) Cigarette

The term "cigarette"—

(A) means a product that—

(i) is a tobacco product; and

(ii) meets the definition of the term "cigarette" in section 1332(1) of title 15; and

(B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.

(4) Cigarette tobacco

The term "cigarette tobacco" means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this subchapter shall also apply to cigarette tobacco.

(5) Commerce

The term "commerce" has the meaning given that term by section 1332(2) of title 15.

(6) Counterfeit tobacco product

The term "counterfeit tobacco product" means a tobacco product (or the container or labeling of such a product) that, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a tobacco product listed in a registration under section 387e(i)(1) of this title.

(7) Distributor

The term "distributor" as regards a tobacco product means any person who furthers the distribution of a tobacco product, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for purposes of this subchapter.

(8) Illicit trade

The term "illicit trade" means any practice or conduct prohibited by law which relates to production, shipment, receipt, possession, distribution, sale, or purchase of tobacco products including any practice or conduct intended to facilitate such activity.

(9) Indian country

The term "Indian country" has the meaning given such term in section 1151 of title 18.

(10) Indian tribe

The term "Indian tribe" has the meaning given such term in section 5304(e) of title 25.

(11) Little cigar

The term "little cigar" means a product that—

(A) is a tobacco product; and

(B) meets the definition of the term "little cigar" in section 1332(7) of title 15.

(12) Nicotine

The term "nicotine" means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt or complex of nicotine.

(13) Package

The term "package" means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers.

(14) Retailer

The term "retailer" means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted.

(15) Roll-your-own tobacco

The term "roll-your-own tobacco" means any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.

(16) Small tobacco product manufacturer

The term "small tobacco product manufacturer" means a tobacco product manufacturer that employs fewer than 350 employees. For purposes of determining the number of employees of a manufacturer under the preceding sentence, the employees of a manufacturer are deemed to include the employees of each entity that controls, is controlled by, or is under common control with such manufacturer.

(17) Smoke constituent

The term "smoke constituent" means any chemical or chemical compound in mainstream or sidestream tobacco smoke that either transfers from any component of the cigarette to the smoke or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product.

(18) Smokeless tobacco

The term "smokeless tobacco" means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity.

(19) State; Territory

The terms "State" and "Territory" shall have the meanings given to such terms in section 321 of this title.

(20) Tobacco product manufacturer

The term "tobacco product manufacturer" means any person, including any repacker or relabeler, who—

(A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or

(B) imports a finished tobacco product for sale or distribution in the United States.

(21) Tobacco warehouse

(A) Subject to subparagraphs (B) and (C), the term "tobacco warehouse" includes any person—

(i) who—

(I) removes foreign material from tobacco leaf through nothing other than a mechanical process;

(II) humidifies tobacco leaf with nothing other than potable water in the form of steam or mist; or

(III) de-stems, dries, and packs tobacco leaf for storage and shipment;

(ii) who performs no other actions with respect to tobacco leaf; and

(iii) who provides to any manufacturer to whom the person sells tobacco all information related to the person's actions described in clause (i) that is necessary for compliance with this chapter.

(B) The term "tobacco warehouse" excludes any person who—

(i) reconstitutes tobacco leaf;

(ii) is a manufacturer, distributor, or retailer of a tobacco product; or

(iii) applies any chemical, additive, or substance to the tobacco leaf other than potable water in the form of steam or mist.

(C) The definition of the term "tobacco warehouse" in subparagraph (A) shall not apply to the extent to which the Secretary determines, through rulemaking, that regulation under this subchapter of the actions described in such subparagraph is appropriate for the protection of the public health.

(22) United States

The term "United States" means the 50 States of the United States of America and the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the United States.

(June 25, 1938, ch. 675, §900, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1784.)

Statutory Notes and Related Subsidiaries

Severability

Pub. L. 111–31, div. A, §5, June 22, 2009, 123 Stat. 1782, provided that: "If any provision of this division [see Short Title of 2009 Amendment note set out under section 301 of this title], of the amendments made by this division, or of the regulations promulgated under this division (or under such amendments), or the application of any such provision to any person or circumstance is held to be invalid, the remainder of this division, such amendments and such regulations, and the application of such provisions to any other person or circumstance shall not be affected and shall continue to be enforced to the fullest extent possible."

Construction

Pub. L. 111–31, div. A, §4, June 22, 2009, 123 Stat. 1782, provided that:

"(a) Intended Effect.—Nothing in this division [see Short Title of 2009 Amendment note set out under section 301 of this title] (or an amendment made by this division) shall be construed to—

"(1) establish a precedent with regard to any other industry, situation, circumstance, or legal action; or

"(2) affect any action pending in Federal, State, or tribal court, or any agreement, consent decree, or contract of any kind.

"(b) Agricultural Activities.—The provisions of this division (or an amendment made by this division) which authorize the Secretary to take certain actions with regard to tobacco and tobacco products shall not be construed to affect any authority of the Secretary of Agriculture under existing law regarding the growing, cultivation, or curing of raw tobacco.

"(c) Revenue Activities.—The provisions of this division (or an amendment made by this division) which authorize the Secretary to take certain actions with regard to tobacco products shall not be construed to affect any authority of the Secretary of the Treasury under chapter 52 of the Internal Revenue Code of 1986 [26 U.S.C. 5701 et seq.]."

Findings

Pub. L. 111–31, div. A, §2, June 22, 2009, 123 Stat. 1776, provided that: "The Congress finds the following:

"(1) The use of tobacco products by the Nation's children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults.

"(2) A consensus exists within the scientific and medical communities that tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects.

"(3) Nicotine is an addictive drug.

"(4) Virtually all new users of tobacco products are under the minimum legal age to purchase such products.

"(5) Tobacco advertising and marketing contribute significantly to the use of nicotine-containing tobacco products by adolescents.

"(6) Because past efforts to restrict advertising and marketing of tobacco products have failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale, promotion, and distribution of such products are needed.

"(7) Federal and State governments have lacked the legal and regulatory authority and resources they need to address comprehensively the public health and societal problems caused by the use of tobacco products.

"(8) Federal and State public health officials, the public health community, and the public at large recognize that the tobacco industry should be subject to ongoing oversight.

"(9) Under article I, section 8 of the Constitution, the Congress is vested with the responsibility for regulating interstate commerce and commerce with Indian tribes.

"(10) The sale, distribution, marketing, advertising, and use of tobacco products are activities in and substantially affecting interstate commerce because they are sold, marketed, advertised, and distributed in interstate commerce on a nationwide basis, and have a substantial effect on the Nation's economy.

"(11) The sale, distribution, marketing, advertising, and use of such products substantially affect interstate commerce through the health care and other costs attributable to the use of tobacco products.

"(12) It is in the public interest for Congress to enact legislation that provides the Food and Drug Administration with the authority to regulate tobacco products and the advertising and promotion of such products. The benefits to the American people from enacting such legislation would be significant in human and economic terms.

"(13) Tobacco use is the foremost preventable cause of premature death in America. It causes over 400,000 deaths in the United States each year, and approximately 8,600,000 Americans have chronic illnesses related to smoking.

"(14) Reducing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today's children from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobacco-induced disease. Such a reduction in youth smoking would also result in approximately $75,000,000,000 in savings attributable to reduced health care costs.

"(15) Advertising, marketing, and promotion of tobacco products have been especially directed to attract young persons to use tobacco products, and these efforts have resulted in increased use of such products by youth. Past efforts to oversee these activities have not been successful in adequately preventing such increased use.

"(16) In 2005, the cigarette manufacturers spent more than $13,000,000,000 to attract new users, retain current users, increase current consumption, and generate favorable long-term attitudes toward smoking and tobacco use.

"(17) Tobacco product advertising often misleadingly portrays the use of tobacco as socially acceptable and healthful to minors.

"(18) Tobacco product advertising is regularly seen by persons under the age of 18, and persons under the age of 18 are regularly exposed to tobacco product promotional efforts.

"(19) Through advertisements during and sponsorship of sporting events, tobacco has become strongly associated with sports and has become portrayed as an integral part of sports and the healthy lifestyle associated with rigorous sporting activity.

"(20) Children are exposed to substantial and unavoidable tobacco advertising that leads to favorable beliefs about tobacco use, plays a role in leading young people to overestimate the prevalence of tobacco use, and increases the number of young people who begin to use tobacco.

"(21) The use of tobacco products in motion pictures and other mass media glamorizes its use for young people and encourages them to use tobacco products.

"(22) Tobacco advertising expands the size of the tobacco market by increasing consumption of tobacco products including tobacco use by young people.

"(23) Children are more influenced by tobacco marketing than adults: more than 80 percent of youth smoke three heavily marketed brands, while only 54 percent of adults, 26 and older, smoke these same brands.

"(24) Tobacco company documents indicate that young people are an important and often crucial segment of the tobacco market. Children, who tend to be more price sensitive than adults, are influenced by advertising and promotion practices that result in drastically reduced cigarette prices.

"(25) Comprehensive advertising restrictions will have a positive effect on the smoking rates of young people.

"(26) Restrictions on advertising are necessary to prevent unrestricted tobacco advertising from undermining legislation prohibiting access to young people and providing for education about tobacco use.

"(27) International experience shows that advertising regulations that are stringent and comprehensive have a greater impact on overall tobacco use and young people's use than weaker or less comprehensive ones.

"(28) Text only requirements, although not as stringent as a ban, will help reduce underage use of tobacco products while preserving the informational function of advertising.

"(29) It is in the public interest for Congress to adopt legislation to address the public health crisis created by actions of the tobacco industry.

"(30) The final regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615–44618) for inclusion as part 897 of title 21, Code of Federal Regulations, are consistent with the first amendment to the United States Constitution and with the standards set forth in the amendments made by this subtitle [probably means this division, see Short Title of 2009 Amendment note set out under section 301 of this title] for the regulation of tobacco products by the Food and Drug Administration, and the restriction on the sale and distribution of, including access to and the advertising and promotion of, tobacco products contained in such regulations are substantially related to accomplishing the public health goals of this division.

"(31) The regulations described in paragraph (30) will directly and materially advance the Federal Government's substantial interest in reducing the number of children and adolescents who use cigarettes and smokeless tobacco and in preventing the life-threatening health consequences associated with tobacco use. An overwhelming majority of Americans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in those products before reaching the age of 18. Tobacco advertising and promotion play a crucial role in the decision of these minors to begin using tobacco products. Less restrictive and less comprehensive approaches have not [been] and will not be effective in reducing the problems addressed by such regulations. The reasonable restrictions on the advertising and promotion of tobacco products contained in such regulations will lead to a significant decrease in the number of minors using and becoming addicted to those products.

"(32) The regulations described in paragraph (30) impose no more extensive restrictions on communication by tobacco manufacturers and sellers than are necessary to reduce the number of children and adolescents who use cigarettes and smokeless tobacco and to prevent the life-threatening health consequences associated with tobacco use. Such regulations are narrowly tailored to restrict those advertising and promotional practices which are most likely to be seen or heard by youth and most likely to entice them into tobacco use, while affording tobacco manufacturers and sellers ample opportunity to convey information about their products to adult consumers.

"(33) Tobacco dependence is a chronic disease, one that typically requires repeated interventions to achieve long-term or permanent abstinence.

"(34) Because the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely.

"(35) Tobacco products have been used to facilitate and finance criminal activities both domestically and internationally. Illicit trade of tobacco products has been linked to organized crime and terrorist groups.

"(36) It is essential that the Food and Drug Administration review products sold or distributed for use to reduce risks or exposures associated with tobacco products and that it be empowered to review any advertising and labeling for such products. It is also essential that manufacturers, prior to marketing such products, be required to demonstrate that such products will meet a series of rigorous criteria, and will benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.

"(37) Unless tobacco products that purport to reduce the risks to the public of tobacco use actually reduce such risks, those products can cause substantial harm to the public health to the extent that the individuals, who would otherwise not consume tobacco products or would consume such products less, use tobacco products purporting to reduce risk. Those who use products sold or distributed as modified risk products that do not in fact reduce risk, rather than quitting or reducing their use of tobacco products, have a substantially increased likelihood of suffering disability and premature death. The costs to society of the widespread use of products sold or distributed as modified risk products that do not in fact reduce risk or that increase risk include thousands of unnecessary deaths and injuries and huge costs to our health care system.

"(38) As the National Cancer Institute has found, many smokers mistakenly believe that 'low tar' and 'light' cigarettes cause fewer health problems than other cigarettes. As the National Cancer Institute has also found, mistaken beliefs about the health consequences of smoking 'low tar' and 'light' cigarettes can reduce the motivation to quit smoking entirely and thereby lead to disease and death.

"(39) Recent studies have demonstrated that there has been no reduction in risk on a population-wide basis from 'low tar' and 'light' cigarettes, and such products may actually increase the risk of tobacco use.

"(40) The dangers of products sold or distributed as modified risk tobacco products that do not in fact reduce risk are so high that there is a compelling governmental interest in ensuring that statements about modified risk tobacco products are complete, accurate, and relate to the overall disease risk of the product.

"(41) As the Federal Trade Commission has found, consumers have misinterpreted advertisements in which one product is claimed to be less harmful than a comparable product, even in the presence of disclosures and advisories intended to provide clarification.

"(42) Permitting manufacturers to make unsubstantiated statements concerning modified risk tobacco products, whether express or implied, even if accompanied by disclaimers would be detrimental to the public health.

"(43) The only way to effectively protect the public health from the dangers of unsubstantiated modified risk tobacco products is to empower the Food and Drug Administration to require that products that tobacco manufacturers sold or distributed for risk reduction be reviewed in advance of marketing, and to require that the evidence relied on to support claims be fully verified.

"(44) The Food and Drug Administration is a regulatory agency with the scientific expertise to identify harmful substances in products to which consumers are exposed, to design standards to limit exposure to those substances, to evaluate scientific studies supporting claims about the safety of products, and to evaluate the impact of labels, labeling, and advertising on consumer behavior in order to reduce the risk of harm and promote understanding of the impact of the product on health. In connection with its mandate to promote health and reduce the risk of harm, the Food and Drug Administration routinely makes decisions about whether and how products may be marketed in the United States.

"(45) The Federal Trade Commission was created to protect consumers from unfair or deceptive acts or practices, and to regulate unfair methods of competition. Its focus is on those marketplace practices that deceive or mislead consumers, and those that give some competitors an unfair advantage. Its mission is to regulate activities in the marketplace. Neither the Federal Trade Commission nor any other Federal agency except the Food and Drug Administration possesses the scientific expertise needed to implement effectively all provisions of the Family Smoking Prevention and Tobacco Control Act [div. A of Pub. L. 111–31, see Short Title of 2009 Amendment note set out under section 301 of this title].

"(46) If manufacturers state or imply in communications directed to consumers through the media or through a label, labeling, or advertising, that a tobacco product is approved or inspected by the Food and Drug Administration or complies with Food and Drug Administration standards, consumers are likely to be confused and misled. Depending upon the particular language used and its context, such a statement could result in consumers being misled into believing that the product is endorsed by the Food and Drug Administration for use or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval, or compliance.

"(47) In August 2006 a United States district court judge found that the major United States cigarette companies continue to target and market to youth. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 99–2496 (GK), August 17, 2006).

"(48) In August 2006 a United States district court judge found that the major United States cigarette companies dramatically increased their advertising and promotional spending in ways that encourage youth to start smoking subsequent to the signing of the Master Settlement Agreement in 1998. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 99–2496 (GK), August 17, 2006).

"(49) In August 2006 a United States district court judge found that the major United States cigarette companies have designed their cigarettes to precisely control nicotine delivery levels and provide doses of nicotine sufficient to create and sustain addiction while also concealing much of their nicotine-related research. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 99–2496 (GK), August 17, 2006)."

Purpose

Pub. L. 111–31, div. A, §3, June 22, 2009, 123 Stat. 1781, provided that: "The purposes of this division [see Short Title of 2009 Amendment note set out under section 301 of this title] are—

"(1) to provide authority to the Food and Drug Administration to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products as provided for in this division;

"(2) to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco;

"(3) to authorize the Food and Drug Administration to set national standards controlling the manufacture of tobacco products and the identity, public disclosure, and amount of ingredients used in such products;

"(4) to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry's efforts to develop, introduce, and promote less harmful tobacco products;

"(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products;

"(6) in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products;

"(7) to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers;

"(8) to impose appropriate regulatory controls on the tobacco industry;

"(9) to promote cessation to reduce disease risk and the social costs associated with tobacco-related diseases; and

"(10) to strengthen legislation against illicit trade in tobacco products."

Modification of Deadlines for Secretarial Action

Pub. L. 111–31, div. A, §6, June 22, 2009, 123 Stat. 1783, provided that:

"(a) Delayed Commencement of Dates for Secretarial Action.—

"(1) In general.—Except as provided in subsection (c), with respect to any time periods specified in this division [see Short Title of 2009 Amendment note set out under section 301 of this title] (or in an amendment made by this division) that begin on the date of enactment of this Act [June 22, 2009], within which the Secretary of Health and Human Services is required to carry out and complete specified activities, the calculation of such time periods shall commence on the date described in subsection (b).

"(2) Limitation.—Subsection (a) shall only apply with respect to obligations of the Secretary of Health and Human Services that must be completed within a specified time period and shall not apply to the obligations of any other person or to any other provision of this division (including the amendments made by this division) that do not create such obligations of the Secretary and are not contingent on actions by the Secretary.

"(b) Date Described.—The date described in this subsection is the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary of Health and Human Services has collected fees under section 919 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387s] (as added by section 101).

"(c) Exception.—Subsection (a) shall not apply to any time period (or date) contained—

"(1) in section 102 [21 U.S.C. 387a–1], except that the reference to '180 days' in subsection (a)(1) of such section shall be deemed to be '270 days'; and

"(2) in sections 201 through 204 [amending sections 1333, 1334, and 4402 of Title 15, Commerce and Trade, and enacting provisions set out as notes under sections 1333 and 4402 of Title 15] (or the amendments made by any such sections).

"(d) Adjustment.—The Secretary of Health and Human Services may extend or reduce the duration of one or more time periods to which subsection (a) applies if the Secretary determines appropriate [sic], except that no such period shall be extended for more than 90 days."

§387a. FDA authority over tobacco products

(a) In general

Tobacco products, including modified risk tobacco products for which an order has been issued in accordance with section 387k of this title, shall be regulated by the Secretary under this subchapter and shall not be subject to the provisions of subchapter V.

(b) Applicability

This subchapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this subchapter. This subchapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco.

(c) Scope

(1) In general

Nothing in this subchapter, or any policy issued or regulation promulgated thereunder, or in sections 101(a), 102, or 103 of title I, title II, or title III of the Family Smoking Prevention and Tobacco Control Act, shall be construed to affect, expand, or limit the Secretary's authority over (including the authority to determine whether products may be regulated), or the regulation of, products under this chapter that are not tobacco products under subchapter V or any other subchapter.

(2) Limitation of authority

(A) In general

The provisions of this subchapter shall not apply to tobacco leaf that is not in the possession of a manufacturer of tobacco products, or to the producers of tobacco leaf, including tobacco growers, tobacco warehouses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Administration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such producer.

(B) Exception

Notwithstanding subparagraph (A), if a producer of tobacco leaf is also a tobacco product manufacturer or controlled by a tobacco product manufacturer, the producer shall be subject to this subchapter in the producer's capacity as a manufacturer. The exception in this subparagraph shall not apply to a producer of tobacco leaf who grows tobacco under a contract with a tobacco product manufacturer and who is not otherwise engaged in the manufacturing process.

(C) Rule of construction

Nothing in this subchapter shall be construed to grant the Secretary authority to promulgate regulations on any matter that involves the production of tobacco leaf or a producer thereof, other than activities by a manufacturer affecting production.

(d) Rulemaking procedures

Each rulemaking under this subchapter shall be in accordance with chapter 5 of title 5. This subsection shall not be construed to affect the rulemaking provisions of section 102(a) of the Family Smoking Prevention and Tobacco Control Act [21 U.S.C. 387a–1(a)].

(e) Center for tobacco products

Not later than 90 days after June 22, 2009, the Secretary shall establish within the Food and Drug Administration the Center for Tobacco Products, which shall report to the Commissioner of Food and Drugs in the same manner as the other agency centers within the Food and Drug Administration. The Center shall be responsible for the implementation of this subchapter and related matters assigned by the Commissioner.

(f) Office to assist small tobacco product manufacturers

The Secretary shall establish within the Food and Drug Administration an identifiable office to provide technical and other nonfinancial assistance to small tobacco product manufacturers to assist them in complying with the requirements of this chapter.

(g) Consultation prior to rulemaking

Prior to promulgating rules under this subchapter, the Secretary shall endeavor to consult with other Federal agencies as appropriate.

(June 25, 1938, ch. 675, §901, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1786; amended Pub. L. 117–103, div. P, title I, §111(b), Mar. 15, 2022, 136 Stat. 789.)

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (c)(1), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. Section 101(a) of title I of the Act amended section 321 of this title. Section 102 of title I of the Act enacted section 387a–1 of this title. Section 103 of title I of the Act amended sections 331, 333, 334, 355, 360m, 372 to 374, 375, 379a, 381, 393, 399, and 679 of this title and enacted provisions set out as notes under sections 331, 333, and 387c of this title. Title II of the Act amended sections 1333, 1334, 4402, and 4406 of Title 15, Commerce and Trade, and enacted provisions set out as notes under sections 1333 and 4402 of Title 15. Title III of the Act enacted section 387t of this title. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Prior Provisions

A prior section 901 of act June 25, 1938, was renumbered section 1001 and is classified to section 391 of this title.

Amendments

2022—Subsec. (b). Pub. L. 117–103 inserted at end "This subchapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco."

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–103 effective 30 days after Mar. 15, 2022, see section 111(c) of Pub. L. 117–103, div. P, title I, Mar. 15, 2022, 136 Stat. 789, set out as a note under section 321 of this title.

§387a–1. Final rule

(a) Cigarettes and smokeless tobacco

(1) In general

On the first day of publication of the Federal Register that is 180 days or more after June 22, 2009, the Secretary of Health and Human Services shall publish in the Federal Register a final rule regarding cigarettes and smokeless tobacco, which—

(A) is deemed to be issued under chapter 9 ¹ of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387 et seq.], as added by section 101 of this division; and

(B) shall be deemed to be in compliance with all applicable provisions of chapter 5 of title 5 and all other provisions of law relating to rulemaking procedures.

(2) Contents of rule

Except as provided in this subsection, the final rule published under paragraph (1),² shall be identical in its provisions to part 897 of the regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615–44618). Such rule shall—

(A) provide for the designation of jurisdictional authority that is in accordance with this subsection in accordance with this division and the amendments made by this division;

(B) strike Subpart C—Labels and section 897.32(c);

(C) strike paragraphs (a), (b), and (i) of section 897.3 and insert definitions of the terms "cigarette", "cigarette tobacco", and "smokeless tobacco" as defined in section 900 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387];

(D) insert "or roll-your-own paper" in section 897.34(a) after "other than cigarettes or smokeless tobacco";

(E) include such modifications to section 897.30(b), if any, that the Secretary determines are appropriate in light of governing First Amendment case law, including the decision of the Supreme Court of the United States in Lorillard Tobacco Co. v. Reilly (533 U.S. 525 (2001));

(F) become effective on the date that is 1 year after June 22, 2009; and

(G) amend paragraph (d) of section 897.16 to read as follows:

"(d)(1) Except as provided in subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes, smokeless tobacco, or other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act).

"(2)(A) Subparagraph (1) does not prohibit a manufacturer, distributor, or retailer from distributing or causing to be distributed free samples of smokeless tobacco in a qualified adult-only facility.

"(B) This subparagraph does not affect the authority of a State or local government to prohibit or otherwise restrict the distribution of free samples of smokeless tobacco.

"(C) For purposes of this paragraph, the term 'qualified adult-only facility' means a facility or restricted area that—

"(i) requires each person present to provide to a law enforcement officer (whether on or off duty) or to a security guard licensed by a governmental entity government-issued identification showing a photograph and at least the minimum age established by applicable law for the purchase of smokeless tobacco;

"(ii) does not sell, serve, or distribute alcohol;

"(iii) is not located adjacent to or immediately across from (in any direction) a space that is used primarily for youth-oriented marketing, promotional, or other activities;

"(iv) is a temporary structure constructed, designated, and operated as a distinct enclosed area for the purpose of distributing free samples of smokeless tobacco in accordance with this subparagraph;

"(v) is enclosed by a barrier that—

"(I) is constructed of, or covered with, an opaque material (except for entrances and exits);

"(II) extends from no more than 12 inches above the ground or floor (which area at the bottom of the barrier must be covered with material that restricts visibility but may allow airflow) to at least 8 feet above the ground or floor (or to the ceiling); and

"(III) prevents persons outside the qualified adult-only facility from seeing into the qualified adult-only facility, unless they make unreasonable efforts to do so; and

"(vi) does not display on its exterior—

"(I) any tobacco product advertising;

"(II) a brand name other than in conjunction with words for an area or enclosure to identify an adult-only facility; or

"(III) any combination of words that would imply to a reasonable observer that the manufacturer, distributor, or retailer has a sponsorship that would violate section 897.34(c).

"(D) Distribution of samples of smokeless tobacco under this subparagraph permitted to be taken out of the qualified adult-only facility shall be limited to 1 package per adult consumer containing no more than 0.53 ounces (15 grams) of smokeless tobacco. If such package of smokeless tobacco contains individual portions of smokeless tobacco, the individual portions of smokeless tobacco shall not exceed 8 individual portions and the collective weight of such individual portions shall not exceed 0.53 ounces (15 grams). Any manufacturer, distributor, or retailer who distributes or causes to be distributed free samples also shall take reasonable steps to ensure that the above amounts are limited to one such package per adult consumer per day.

"(3) Notwithstanding subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of smokeless tobacco—

"(A) to a sports team or entertainment group; or

"(B) at any football, basketball, baseball, soccer, or hockey event or any other sporting or entertainment event determined by the Secretary to be covered by this subparagraph.

"(4) The Secretary shall implement a program to ensure compliance with this paragraph and submit a report to the Congress on such compliance not later than 18 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act.

"(5) Nothing in this paragraph shall be construed to authorize any person to distribute or cause to be distributed any sample of a tobacco product to any individual who has not attained the minimum age established by applicable law for the purchase of such product.".

(3) Amendments to rule

Prior to making amendments to the rule published under paragraph (1), the Secretary shall promulgate a proposed rule in accordance with chapter 5 of title 5.

(4) Rule of construction

Except as provided in paragraph (3), nothing in this section shall be construed to limit the authority of the Secretary to amend, in accordance with chapter 5 of title 5, the regulation promulgated pursuant to this section, including the provisions of such regulation relating to distribution of free samples.

(5) Enforcement of retail sale provisions

The Secretary of Health and Human Services shall ensure that the provisions of this division, the amendments made by this division, and the implementing regulations (including such provisions, amendments, and regulations relating to the retail sale of tobacco products) are enforced with respect to the United States and Indian tribes.

(6) Qualified adult-only facility

A qualified adult-only facility (as such term is defined in section 897.16(d) of the final rule published under paragraph (1)) that is also a retailer and that commits a violation as a retailer shall not be subject to the limitations in section 103(q) ³ and shall be subject to penalties applicable to a qualified adult-only facility.

(7) Congressional review provisions

Section 801 of title 5 shall not apply to the final rule published under paragraph (1).

(b) Limitation on advisory opinions

As of June 22, 2009, the following documents issued by the Food and Drug Administration shall not constitute advisory opinions under section 10.85(d)(1) of title 21, Code of Federal Regulations, except as they apply to tobacco products, and shall not be cited by the Secretary of Health and Human Services or the Food and Drug Administration as binding precedent:

(1) The preamble to the proposed rule in the document titled "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents" (60 Fed. Reg. 41314–41372 (August 11, 1995)).

(2) The document titled "Nicotine in Cigarettes and Smokeless Tobacco Products is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act" (60 Fed. Reg. 41453–41787 (August 11, 1995)).

(3) The preamble to the final rule in the document titled "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents" (61 Fed. Reg. 44396–44615 (August 28, 1996)).

(4) The document titled "Nicotine in Cigarettes and Smokeless Tobacco is a Drug and These Products are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act; Jurisdictional Determination" (61 Fed. Reg. 44619–45318 (August 28, 1996)).

(Pub. L. 111–31, div. A, title I, §102, June 22, 2009, 123 Stat. 1830.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. Chapter 9 [IX] of the Act is classified generally to this subchapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This division, referred to in subsec. (a)(2)(A), (5), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776, known as the Family Smoking Prevention and Tobacco Control Act. For complete classification of division A to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

The date of enactment of the Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (a)(2)(G), is the date of enactment of Pub. L. 111–31, which was approved June 22, 2009.

Section 103(q), referred to in subsec. (a)(6), is section 103(q) of Pub. L. 111–31, which enacted provisions set out as notes under sections 333 and 387c of this title.

Codification

Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

For provision deeming reference to "180 days" in subsec. (a)(1) to be "270 days", see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

¹ So in original. Probably should be "chapter IX".

² So in original. The comma probably should not appear.

³ So in original. See References in Text note below.

§387b. Adulterated tobacco products

A tobacco product shall be deemed to be adulterated if—

(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;

(2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;

(3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(4) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;

(5) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 387g of this title unless such tobacco product is in all respects in conformity with such standard;

(6)(A) it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or

(B) it is in violation of an order under section 387j(c)(1)(A) of this title;

(7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or

(8) it is in violation of section 387k of this title.

(June 25, 1938, ch. 675, §902, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1787.)

Editorial Notes

Prior Provisions

A prior section 902 of act June 25, 1938, was renumbered section 1002. Subsec. (a) of section 1002 is set out as a note under section 301 of this title. Subsecs. (b) and (c) of section 1002 are classified to section 392 of this title. Subsec. (d) of section 1002 is set out as a note under section 392 of this title.

§387c. Misbranded tobacco products

(a) In general

A tobacco product shall be deemed to be misbranded—

(1) if its labeling is false or misleading in any particular;

(2) if in package form unless it bears a label containing—

(A) the name and place of business of the tobacco product manufacturer, packer, or distributor;

(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;

(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and

(D) the statement required under section 387t(a) of this title,

except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary;

(3) if any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(4) if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;

(5) if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations;

(6) if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 387e(b), 387e(c), 387e(d), or 387e(h) of this title, if it was not included in a list required by section 387e(i) of this title, if a notice or other information respecting it was not provided as required by such section or section 387e(j) of this title, or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under section 387e(e) of this title as the Secretary by regulation requires;

(7) if, in the case of any tobacco product distributed or offered for sale in any State—

(A) its advertising is false or misleading in any particular; or

(B) it is sold or distributed in violation of section 387f(d)(5) of this title or of regulations prescribed under section 387f(d) of this title;

(8) unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product—

(A) a true statement of the tobacco product's established name as described in paragraph (4), printed prominently; and

(B) a brief statement of—

(i) the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications; and

(ii) in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appropriate to protect the public health, a full description of the components of such tobacco product or the formula showing quantitatively each ingredient of such tobacco product to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing;

(9) if it is a tobacco product subject to a tobacco product standard established under section 387g of this title, unless it bears such labeling as may be prescribed in such tobacco product standard; or

(10) if there was a failure or refusal—

(A) to comply with any requirement prescribed under section 387d or 387h of this title; or

(B) to furnish any material or information required under section 387i of this title.

(b) Prior approval of label statements

The Secretary may, by regulation, require prior approval of statements made on the label of a tobacco product to ensure that such statements do not violate the misbranding provisions of subsection (a) and that such statements comply with other provisions of the Family Smoking Prevention and Tobacco Control Act (including the amendments made by such Act). No regulation issued under this subsection may require prior approval by the Secretary of the content of any advertisement, except for modified risk tobacco products as provided in section 387k of this title. No advertisement of a tobacco product published after June 22, 2009, shall, with respect to the language of label statements as prescribed under section 1333 of title 15 and section 4402 of title 15 or the regulations issued under such sections, be subject to the provisions of sections 52 through 55 of title 15.

(June 25, 1938, ch. 675, §903, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1788; amended Pub. L. 116–94, div. N, title I, §603(d)(3), Dec. 20, 2019, 133 Stat. 3124.)

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (b), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Prior Provisions

A prior section 903 of act June 25, 1938, was renumbered section 1003 and is classified to section 393 of this title.

Another prior section 903 of act June 25, 1938, was renumbered section 1004 and is classified to section 394 of this title.

Amendments

2019—Subsec. (a)(7)(B). Pub. L. 116–94 inserted "section 387f(d)(5) of this title or of" after "violation of".

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 111–31, div. A, title I, §103(q)(5), (6), June 22, 2009, 123 Stat. 1840, provided that:

"(5) Package label requirements.—The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387c(a)] (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act [June 22, 2009]. The package label requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333[(d)]), as amended by section 201 of this division. The package label requirements of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 903(a)(2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387t(a)].

"(6) Advertising requirements.—The advertising requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387c(a)(8)] (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act [June 22, 2009]."

§387d. Submission of health information to the Secretary

(a) Requirement

Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary the following information:

(1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.

(2) A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accordance with regulations promulgated by the Secretary in accordance with section 1333(e) of title 15.

(3) Beginning 3 years after June 22, 2009, a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 3 years after June 22, 2009, the manufacturer, importer, or agent shall comply with regulations promulgated under section 387o of this title in reporting information under this paragraph, where applicable.

(4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.

(b) Data submission

At the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the following:

(1) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents (including smoke constituents), ingredients, components, and additives.

(2) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer.

(3) Any or all documents (including underlying scientific or financial information) relating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors.

An importer of a tobacco product not manufactured in the United States shall supply the information required of a tobacco product manufacturer under this subsection.

(c) Time for submission

(1) In general

At least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product not on the market on June 22, 2009, the manufacturer of such product shall provide the information required under subsection (a).

(2) Disclosure of additive

If at any time a tobacco product manufacturer adds to its tobacco products a new tobacco additive or increases the quantity of an existing tobacco additive, the manufacturer shall, except as provided in paragraph (3), at least 90 days prior to such action so advise the Secretary in writing.

(3) Disclosure of other actions

If at any time a tobacco product manufacturer eliminates or decreases an existing additive, or adds or increases an additive that has by regulation been designated by the Secretary as an additive that is not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use, the manufacturer shall within 60 days of such action so advise the Secretary in writing.

(d) Data list

(1) In general

Not later than 3 years after June 22, 2009, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading to a lay person, and place on public display (in a manner determined by the Secretary) the list established under subsection (e).

(2) Consumer research

The Secretary shall conduct periodic consumer research to ensure that the list published under paragraph (1) is not misleading to lay persons. Not later than 5 years after June 22, 2009, the Secretary shall submit to the appropriate committees of Congress a report on the results of such research, together with recommendations on whether such publication should be continued or modified.

(e) Data collection

Not later than 24 months after June 22, 2009, the Secretary shall establish, and periodically revise as appropriate, a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand. The Secretary shall publish a public notice requesting the submission by interested persons of scientific and other information concerning the harmful and potentially harmful constituents in tobacco products and tobacco smoke.

(June 25, 1938, ch. 675, §904, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1790.)

Editorial Notes

Prior Provisions

A prior section 904 of act June 25, 1938, was renumbered section 1004 and is classified to section 394 of this title.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387e. Annual registration

(a) Definitions

In this section:

(1) Manufacture, preparation, compounding, or processing

The term "manufacture, preparation, compounding, or processing" shall include repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.

(2) Name

The term "name" shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.

(b) Registration by owners and operators

On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person. If enactment of the Family Smoking Prevention and Tobacco Control Act occurs in the second half of the calendar year, the Secretary shall designate a date no later than 6 months into the subsequent calendar year by which registration pursuant to this subsection shall occur.

(c) Registration by new owners and operators

Every person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person's name, place of business, and such establishment.

(d) Registration of added establishments

Every person required to register under subsection (b) or (c) shall immediately register with the Secretary any additional establishment which that person owns or operates in any State and in which that person begins the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products.

(e) Uniform product identification system

The Secretary may by regulation prescribe a uniform system for the identification of tobacco products and may require that persons who are required to list such tobacco products under subsection (i) shall list such tobacco products in accordance with such system.

(f) Public access to registration information

The Secretary shall make available for inspection, to any person so requesting, any registration filed under this section.

(g) Biennial inspection of registered establishments

Every establishment registered with the Secretary under this section shall be subject to inspection under section 374 of this title or subsection (h), and every such establishment engaged in the manufacture, compounding, or processing of a tobacco product or tobacco products shall be so inspected by 1 or more officers or employees duly designated by the Secretary at least once in the 2-year period beginning with the date of registration of such establishment under this section and at least once in every successive 2-year period thereafter.

(h) Registration by foreign establishments

Any establishment within any foreign country engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products, shall register under this section under regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (i) and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether tobacco products manufactured, prepared, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.

(i) Registration information

(1) Product list

Every person who registers with the Secretary under subsection (b), (c), (d), or (h) shall, at the time of registration under any such subsection, file with the Secretary a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which have not been included in any list of tobacco products filed by that person with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by—

(A) in the case of a tobacco product contained in the applicable list with respect to which a tobacco product standard has been established under section 387g of this title or which is subject to section 387j of this title, a reference to the authority for the marketing of such tobacco product and a copy of all labeling for such tobacco product;

(B) in the case of any other tobacco product contained in an applicable list, a copy of all consumer information and other labeling for such tobacco product, a representative sampling of advertisements for such tobacco product, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular tobacco product; and

(C) if the registrant filing a list has determined that a tobacco product contained in such list is not subject to a tobacco product standard established under section 387g of this title, a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular tobacco product.

(2) Consultation with respect to forms

The Secretary shall consult with the Secretary of the Treasury in developing the forms to be used for registration under this section to minimize the burden on those persons required to register with both the Secretary and the Tax and Trade Bureau of the Department of the Treasury.

(3) Biannual report of any change in product list

Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following:

(A) A list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the Secretary under this subparagraph or paragraph (1). A list under this subparagraph shall list a tobacco product by its established name and shall be accompanied by the other information required by paragraph (1).

(B) If since the date the registrant last made a report under this paragraph that person has discontinued the manufacture, preparation, compounding, or processing for commercial distribution of a tobacco product included in a list filed under subparagraph (A) or paragraph (1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name.

(C) If since the date the registrant reported under subparagraph (B) a notice of discontinuance that person has resumed the manufacture, preparation, compounding, or processing for commercial distribution of the tobacco product with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such tobacco product by established name, and other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this subparagraph.

(D) Any material change in any information previously submitted under this paragraph or paragraph (1).

(j) Report preceding introduction of certain substantially equivalent products into interstate commerce

(1) In general

Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)—

(A) the basis for such person's determination that—

(i) the tobacco product is substantially equivalent, within the meaning of section 387j of this title, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 387j of this title, is substantially equivalent and that is in compliance with the requirements of this chapter; or

(ii) the tobacco product is modified within the meaning of paragraph (3), the modifications are to a product that is commercially marketed and in compliance with the requirements of this chapter, and all of the modifications are covered by exemptions granted by the Secretary pursuant to paragraph (3); and

(B) action taken by such person to comply with the requirements under section 387g of this title that are applicable to the tobacco product.

(2) Application to certain post–February 15, 2007, products

A report under this subsection for a tobacco product that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009, shall be submitted to the Secretary not later than 21 months after June 22, 2009.

(3) Exemptions

(A) In general

The Secretary may exempt from the requirements of this subsection relating to the demonstration that a tobacco product is substantially equivalent within the meaning of section 387j of this title, tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines that—

(i) such modification would be a minor modification of a tobacco product that can be sold under this chapter;

(ii) a report under this subsection is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and

(iii) an exemption is otherwise appropriate.

(B) Regulations

Not later than 15 months after June 22, 2009, the Secretary shall issue regulations to implement this paragraph.

(June 25, 1938, ch. 675, §905, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1792.)

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (b), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Prior Provisions

A prior section 905 of act June 25, 1938, was renumbered section 1005 and is classified to section 395 of this title.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387f. General provisions respecting control of tobacco products

(a) In general

Any requirement established by or under section 387b, 387c, 387e, or 387i of this title applicable to a tobacco product shall apply to such tobacco product until the applicability of the requirement to the tobacco product has been changed by action taken under section 387g of this title, section 387j of this title, section 387k of this title, or subsection (d) of this section, and any requirement established by or under section 387b, 387c, 387e, or 387i of this title which is inconsistent with a requirement imposed on such tobacco product under section 387g of this title, section 387j of this title, section 387k of this title, or subsection (d) of this section shall not apply to such tobacco product.

(b) Information on public access and comment

Each notice of proposed rulemaking or other notification under section 387g, 387h, 387i, 387j, or 387k of this title or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—

(1) the manner in which interested persons may examine data and other information on which the notice or findings is ¹ based; and

(2) the period within which interested persons may present their comments on the notice or findings (including the need therefore) orally or in writing, which period shall be at least 60 days but may not exceed 90 days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefore.

(c) Limited confidentiality of information

Any information reported to or otherwise obtained by the Secretary or the Secretary's representative under section 387c, 387d, 387g, 387h, 387i, 387j, 387k, or 374 of this title, or under subsection (e) or (f) of this section, which is exempt from disclosure under subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of that section shall be considered confidential and shall not be disclosed, except that the information may be disclosed to other officers or employees concerned with carrying out this subchapter, or when relevant in any proceeding under this subchapter.

(d) Restrictions

(1) In general

The Secretary may by regulation require restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. The Secretary may by regulation impose restrictions on the advertising and promotion of a tobacco product consistent with and to full extent permitted by the first amendment to the Constitution. The finding as to whether such regulation would be appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—

(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

No such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authorization of a practitioner licensed by law to prescribe medical products.

(2) Label statements

The label of a tobacco product shall bear such appropriate statements of the restrictions required by a regulation under subsection (a) as the Secretary may in such regulation prescribe.

(3) Limitations

(A) In general

No restrictions under paragraph (1) may—

(i) prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets; or

(ii) establish a minimum age of sale of tobacco products to any person older than 21 years of age.

(B) Matchbooks

For purposes of any regulations issued by the Secretary, matchbooks of conventional size containing not more than 20 paper matches, and which are customarily given away for free with the purchase of tobacco products, shall be considered as adult-written publications which shall be permitted to contain advertising. Notwithstanding the preceding sentence, if the Secretary finds that such treatment of matchbooks is not appropriate for the protection of the public health, the Secretary may determine by regulation that matchbooks shall not be considered adult-written publications.

(4) Remote sales

(A) In general

The Secretary shall—

(i) within 18 months after June 22, 2009, promulgate regulations regarding the sale and distribution of tobacco products that occur through means other than a direct, face-to-face exchange between a retailer and a consumer in order to prevent the sale and distribution of tobacco products to individuals who have not attained the minimum age established by applicable law for the purchase of such products, including requirements for age verification; and

(ii) within 2 years after June 22, 2009, issue regulations to address the promotion and marketing of tobacco products that are sold or distributed through means other than a direct, face-to-face exchange between a retailer and a consumer in order to protect individuals who have not attained the minimum age established by applicable law for the purchase of such products.

(B) Relation to other authority

Nothing in this paragraph limits the authority of the Secretary to take additional actions under the other paragraphs of this subsection.

(5) Minimum age of sale

It shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age.

(e) Good manufacturing practice requirements

(1) Methods, facilities, and controls to conform

(A) In general

In applying manufacturing restrictions to tobacco, the Secretary shall, in accordance with subparagraph (B), prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice, or hazard analysis and critical control point methodology, as prescribed in such regulations to assure that the public health is protected and that the tobacco product is in compliance with this subchapter. Such regulations may provide for the testing of raw tobacco for pesticide chemical residues regardless of whether a tolerance for such chemical residues has been established.

(B) Requirements

The Secretary shall—

(i) before promulgating any regulation under subparagraph (A), afford the Tobacco Products Scientific Advisory Committee an opportunity to submit recommendations with respect to the regulation proposed to be promulgated;

(ii) before promulgating any regulation under subparagraph (A), afford opportunity for an oral hearing;

(iii) provide the Tobacco Products Scientific Advisory Committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A);

(iv) in establishing the effective date of a regulation promulgated under this subsection, take into account the differences in the manner in which the different types of tobacco products have historically been produced, the financial resources of the different tobacco product manufacturers, and the state of their existing manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices; and

(v) not require any small tobacco product manufacturer to comply with a regulation under subparagraph (A) for at least 4 years following the effective date established by the Secretary for such regulation.

(2) Exemptions; variances

(A) Petition

Any person subject to any requirement prescribed under paragraph (1) may petition the Secretary for a permanent or temporary exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as the Secretary shall prescribe and shall—

(i) in the case of a petition for an exemption from a requirement, set forth the basis for the petitioner's determination that compliance with the requirement is not required to assure that the tobacco product will be in compliance with this subchapter;

(ii) in the case of a petition for a variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, facilities, and controls prescribed by the requirement; and

(iii) contain such other information as the Secretary shall prescribe.

(B) Referral to the Tobacco Products Scientific Advisory Committee

The Secretary may refer to the Tobacco Products Scientific Advisory Committee any petition submitted under subparagraph (A). The Tobacco Products Scientific Advisory Committee shall report its recommendations to the Secretary with respect to a petition referred to it within 60 days after the date of the petition's referral. Within 60 days after—

(i) the date the petition was submitted to the Secretary under subparagraph (A); or

(ii) the day after the petition was referred to the Tobacco Products Scientific Advisory Committee,

whichever occurs later, the Secretary shall by order either deny the petition or approve it.

(C) Approval

The Secretary may approve—

(i) a petition for an exemption for a tobacco product from a requirement if the Secretary determines that compliance with such requirement is not required to assure that the tobacco product will be in compliance with this subchapter; and

(ii) a petition for a variance for a tobacco product from a requirement if the Secretary determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, facilities, and controls prescribed by the requirement are sufficient to assure that the tobacco product will be in compliance with this subchapter.

(D) Conditions

An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, and storage of the tobacco product to be granted the variance under the petition as may be necessary to assure that the tobacco product will be in compliance with this subchapter.

(E) Hearing

After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order.

(3) Compliance

Compliance with requirements under this subsection shall not be required before the end of the 3-year period following June 22, 2009.

(f) Research and development

The Secretary may enter into contracts for research, testing, and demonstrations respecting tobacco products and may obtain tobacco products for research, testing, and demonstration purposes.

(June 25, 1938, ch. 675, §906, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1795; amended Pub. L. 116–94, div. N, title I, §603(a), Dec. 20, 2019, 133 Stat. 3123.)

Editorial Notes

Prior Provisions

A prior section 906 of act June 25, 1938, was renumbered section 1006 and is classified to section 396 of this title.

Amendments

2019—Subsec. (d)(3)(A)(ii). Pub. L. 116–94, §603(a)(1), substituted "21 years" for "18 years".

Subsec. (d)(5). Pub. L. 116–94, §603(a)(2), added par. (5).

Statutory Notes and Related Subsidiaries

Regulations

Pub. L. 116–94, div. N, title I, §603(b), Dec. 20, 2019, 133 Stat. 3123, provided that:

"(1) In general.—Not later than 180 days after the date of enactment of this Act [Dec. 20, 2019], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall publish in the Federal Register a final rule to update the regulations issued under chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 et seq.) as appropriate, only to carry out the amendments made by subsection (a) [amending this section], including to update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations, and to update the relevant age verification requirements under such part 1140 to require age verification for individuals under the age of 30. Such final rule shall—

"(A) take full effect not later than 90 days after the date on which such final rule is published; and

"(B) be deemed to be in compliance with all applicable provisions of chapter 5 of title 5, United States Code[,] and all other provisions of law relating to rulemaking procedures.

"(2) Other regulations.—Prior to making amendments to part 1140 of title 21, Code of Federal Regulations[,] other than the amendments described in paragraph (1), the Secretary shall promulgate a proposed rule in accordance with chapter 5 of title 5, United States Code."

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

¹ So in original. Probably should be "are".

§387f–1. Enforcement action plan for advertising and promotion restrictions

(a) Action plan

(1) Development

Not later than 6 months after June 22, 2009, the Secretary of Health and Human Services (in this section referred to as the "Secretary") shall develop and publish an action plan to enforce restrictions adopted pursuant to section 387f of this title, as added by section 101(b) of this division, or pursuant to section 387a–1(a) of this title, on promotion and advertising of menthol and other cigarettes to youth.

(2) Consultation

The action plan required by paragraph (1) shall be developed in consultation with public health organizations and other stakeholders with demonstrated expertise and experience in serving minority communities.

(3) Priority

The action plan required by paragraph (1) shall include provisions designed to ensure enforcement of the restrictions described in paragraph (1) in minority communities.

(b) State and local activities

(1) Information on authority

Not later than 3 months after June 22, 2009, the Secretary shall inform State, local, and tribal governments of the authority provided to such entities under section 1334(c) of title 15, as added by section 203 of this division, or preserved by such entities under section 387p of this title, as added by section 101(b) of this division.

(2) Community assistance

At the request of communities seeking assistance to prevent underage tobacco use, the Secretary shall provide such assistance, including assistance with strategies to address the prevention of underage tobacco use in communities with a disproportionate use of menthol cigarettes by minors.

(Pub. L. 111–31, div. A, title I, §105, June 22, 2009, 123 Stat. 1841.)

Editorial Notes

Codification

Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387g. Tobacco product standards

(a) In general

(1) Special rules

(A) Special rule for cigarettes

Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary's authority to take action under this section or other sections of this chapter applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this subparagraph.

(B) Additional special rule

Beginning 2 years after June 22, 2009, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.

(2) Revision of tobacco product standards

The Secretary may revise the tobacco product standards in paragraph (1) in accordance with subsection (c).

(3) Tobacco product standards

(A) In general

The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health.

(B) Determinations

(i) Considerations

In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning—

(I) the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard;

(II) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

(III) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

(ii) Additional considerations

In the event that the Secretary makes a determination, set forth in a proposed tobacco product standard in a proposed rule, that it is appropriate for the protection of public health to require the reduction or elimination of an additive, constituent (including a smoke constituent), or other component of a tobacco product because the Secretary has found that the additive, constituent, or other component is or may be harmful, any party objecting to the proposed standard on the ground that the proposed standard will not reduce or eliminate the risk of illness or injury may provide for the Secretary's consideration scientific evidence that demonstrates that the proposed standard will not reduce or eliminate the risk of illness or injury.

(4) Content of tobacco product standards

A tobacco product standard established under this section for a tobacco product—

(A) shall include provisions that are appropriate for the protection of the public health, including provisions, where appropriate—

(i) for nicotine yields of the product;

(ii) for the reduction or elimination of other constituents, including smoke constituents, or harmful components of the product; or

(iii) relating to any other requirement under subparagraph (B);

(B) shall, where appropriate for the protection of the public health, include—

(i) provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product;

(ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the tobacco product;

(iii) provisions for the measurement of the tobacco product characteristics of the tobacco product;

(iv) provisions requiring that the results of each or of certain of the tests of the tobacco product required to be made under clause (ii) show that the tobacco product is in conformity with the portions of the standard for which the test or tests were required; and

(v) a provision requiring that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title;

(C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper use of the tobacco product; and

(D) shall require tobacco products containing foreign-grown tobacco to meet the same standards applicable to tobacco products containing domestically grown tobacco.

(5) Periodic reevaluation of tobacco product standards

The Secretary shall provide for periodic evaluation of tobacco product standards established under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. The Secretary may provide for testing under paragraph (4)(B) by any person.

(6) Involvement of other agencies; informed persons

In carrying out duties under this section, the Secretary shall endeavor to—

(A) use personnel, facilities, and other technical support available in other Federal agencies;

(B) consult with other Federal agencies concerned with standard setting and other nationally or internationally recognized standard-setting entities; and

(C) invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural, or consumer organizations who in the Secretary's judgment can make a significant contribution.

(b) Considerations by Secretary

(1) Technical achievability

The Secretary shall consider information submitted in connection with a proposed standard regarding the technical achievability of compliance with such standard, including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class containing nicotine not made or derived from tobacco and products containing nicotine made or derived from tobacco.

(2) Other considerations

The Secretary shall consider all other information submitted in connection with a proposed standard, including information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements of this subchapter and the significance of such demand.

(c) Proposed standards

(1) In general

The Secretary shall publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any tobacco product standard.

(2) Requirements of notice

A notice of proposed rulemaking for the establishment or amendment of a tobacco product standard for a tobacco product shall—

(A) set forth a finding with supporting justification that the tobacco product standard is appropriate for the protection of the public health;

(B) invite interested persons to submit a draft or proposed tobacco product standard for consideration by the Secretary;

(C) invite interested persons to submit comments on structuring the standard so that it does not advantage foreign-grown tobacco over domestically grown tobacco; and

(D) invite the Secretary of Agriculture to provide any information or analysis which the Secretary of Agriculture believes is relevant to the proposed tobacco product standard.

(3) Finding

A notice of proposed rulemaking for the revocation of a tobacco product standard shall set forth a finding with supporting justification that the tobacco product standard is no longer appropriate for the protection of the public health.

(4) Comment

The Secretary shall provide for a comment period of not less than 60 days.

(d) Promulgation

(1) In general

After the expiration of the period for comment on a notice of proposed rulemaking published under subsection (c) respecting a tobacco product standard and after consideration of comments submitted under subsections (b) and (c) and any report from the Tobacco Products Scientific Advisory Committee, the Secretary shall—

(A) if the Secretary determines that the standard would be appropriate for the protection of the public health, promulgate a regulation establishing a tobacco product standard and publish in the Federal Register findings on the matters referred to in subsection (c); or

(B) publish a notice terminating the proceeding for the development of the standard together with the reasons for such termination.

(2) Effective date

A regulation establishing a tobacco product standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before 1 year after the date of its publication unless the Secretary determines that an earlier effective date is necessary for the protection of the public health. Such date or dates shall be established so as to minimize, consistent with the public health, economic loss to, and disruption or dislocation of, domestic and international trade. In establishing such effective date or dates, the Secretary shall consider information submitted in connection with a proposed product standard by interested parties, including manufacturers and tobacco growers, regarding the technical achievability of compliance with the standard, and including information concerning the existence of patents that make it impossible to comply in the timeframe envisioned in the proposed standard. If the Secretary determines, based on the Secretary's evaluation of submitted comments, that a product standard can be met only by manufacturers requiring substantial changes to the methods of farming the domestically grown tobacco used by the manufacturer, the effective date of that product standard shall be not less than 2 years after the date of publication of the final regulation establishing the standard.

(3) Limitation on power granted to the Food and Drug Administration

Because of the importance of a decision of the Secretary to issue a regulation—

(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or

(B) requiring the reduction of nicotine yields of a tobacco product to zero,

the Secretary is prohibited from taking such actions under this chapter.

(4) Amendment; revocation

(A) Authority

The Secretary, upon the Secretary's own initiative or upon petition of an interested person, may by a regulation, promulgated in accordance with the requirements of subsection (c) and paragraph (2), amend or revoke a tobacco product standard.

(B) Effective date

The Secretary may declare a proposed amendment of a tobacco product standard to be effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if the Secretary determines that making it so effective is in the public interest.

(5) Referral to Advisory Committee

(A) In general

The Secretary may refer a proposed regulation for the establishment, amendment, or revocation of a tobacco product standard to the Tobacco Products Scientific Advisory Committee for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment.

(B) Initiation of referral

The Secretary may make a referral under this paragraph—

(i) on the Secretary's own initiative; or

(ii) upon the request of an interested person that—

(I) demonstrates good cause for the referral; and

(II) is made before the expiration of the period for submission of comments on the proposed regulation.

(C) Provision of data

If a proposed regulation is referred under this paragraph to the Tobacco Products Scientific Advisory Committee, the Secretary shall provide the Advisory Committee with the data and information on which such proposed regulation is based.

(D) Report and recommendation

The Tobacco Products Scientific Advisory Committee shall, within 60 days after the referral of a proposed regulation under this paragraph and after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation respecting such regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation.

(E) Public availability

The Secretary shall make a copy of each report and recommendation under subparagraph (D) publicly available.

(e) Menthol cigarettes

(1) Referral; considerations

Immediately upon the establishment of the Tobacco Products Scientific Advisory Committee under section 387q(a) of this title, the Secretary shall refer to the Committee for report and recommendation, under section 387q(c)(4) of this title, the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsections (a)(3)(B)(i) and (b).

(2) Report and recommendation

Not later than 1 year after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1).

(3) Rule of construction

Nothing in this subsection shall be construed to limit the Secretary's authority to take action under this section or other sections of this chapter applicable to menthol.

(f) Dissolvable tobacco products

(1) Referral; considerations

The Secretary shall refer to the Tobacco Products Scientific Advisory Committee for report and recommendation, under section 387q(c)(4) of this title, the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsection (a)(3)(B)(i).

(2) Report and recommendation

Not later than 2 years after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1).

(3) Rule of construction

Nothing in this subsection shall be construed to limit the Secretary's authority to take action under this section or other sections of this chapter at any time applicable to any dissolvable tobacco product.

(June 25, 1938, ch. 675, §907, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1799; amended Pub. L. 117–103, div. P, title I, §111(f), Mar. 15, 2022, 136 Stat. 790.)

Editorial Notes

Prior Provisions

A prior section 907 of act June 25, 1938, was renumbered section 1007 and is classified to section 397 of this title.

Amendments

2022—Subsec. (b)(1). Pub. L. 117–103 inserted before period at end ", including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class containing nicotine not made or derived from tobacco and products containing nicotine made or derived from tobacco".

§387h. Notification and other remedies

(a) Notification

If the Secretary determines that—

(1) a tobacco product which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health; and

(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this subchapter (other than this section) to eliminate such risk,

the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all persons who should properly receive such notification in order to eliminate such risk. The Secretary may order notification by any appropriate means, including public service announcements. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order.

(b) No exemption from other liability

Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided under such order shall be taken into account.

(c) Recall authority

(1) In general

If the Secretary finds that there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such tobacco product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

(2) Amendment of order to require recall

(A) In general

If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the tobacco product with respect to which the order was issued, the Secretary shall, except as provided in subparagraph (B), amend the order to require a recall. The Secretary shall specify a timetable in which the tobacco product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.

(B) Notice

An amended order under subparagraph (A)—

(i) shall not include recall of a tobacco product from individuals; and

(ii) shall provide for notice to persons subject to the risks associated with the use of such tobacco product.

In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons under section 375(b) of this title.

(3) Remedy not exclusive

The remedy provided by this subsection shall be in addition to remedies provided by subsection (a).

(June 25, 1938, ch. 675, §908, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1804.)

Editorial Notes

Prior Provisions

A prior section 908 of act June 25, 1938, was renumbered section 1008 and is classified to section 398 of this title.

§387i. Records and reports on tobacco products

(a) In general

Every person who is a tobacco product manufacturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence—

(1) may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience;

(2) shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported;

(3) shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this subchapter;

(4) when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information;

(5) when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information; and

(6) may not require that the identity of any patient or user be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine risks to public health of a tobacco product, or to verify a record, report, or information submitted under this subchapter.

In prescribing regulations under this subsection, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (6) continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.

(b) Reports of removals and corrections

(1) In general

Except as provided in paragraph (2), the Secretary shall by regulation require a tobacco product manufacturer or importer of a tobacco product to report promptly to the Secretary any corrective action taken or removal from the market of a tobacco product undertaken by such manufacturer or importer if the removal or correction was undertaken—

(A) to reduce a risk to health posed by the tobacco product; or

(B) to remedy a violation of this subchapter caused by the tobacco product which may present a risk to health.

A tobacco product manufacturer or importer of a tobacco product who undertakes a corrective action or removal from the market of a tobacco product which is not required to be reported under this subsection shall keep a record of such correction or removal.

(2) Exception

No report of the corrective action or removal of a tobacco product may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a).

(June 25, 1938, ch. 675, §909, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1805.)

Editorial Notes

Prior Provisions

A prior section 909 of act June 25, 1938, was renumbered section 1009 and is classified to section 399 of this title.

§387j. Application for review of certain tobacco products

(a) In general

(1) New tobacco product defined

For purposes of this section the term "new tobacco product" means—

(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or

(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

(2) Premarket review required

(A) New products

An order under subsection (c)(1)(A)(i) for a new tobacco product is required unless—

(i) the manufacturer has submitted a report under section 387e(j) of this title; and the Secretary has issued an order that the tobacco product—

(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and

(II) is in compliance with the requirements of this chapter; or

(ii) the tobacco product is exempt from the requirements of section 387e(j) of this title pursuant to a regulation issued under section 387e(j)(3) of this title.

(B) Application to certain post-February 15, 2007, products

Subparagraph (A) shall not apply to a tobacco product—

(i) that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009; and

(ii) for which a report was submitted under section 387e(j) of this title within such 21-month period,

except that subparagraph (A) shall apply to the tobacco product if the Secretary issues an order that the tobacco product is not substantially equivalent.

(3) Substantially equivalent defined

(A) In general

In this section and section 387e(j) of this title, the term "substantially equivalent" or "substantial equivalence" means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product—

(i) has the same characteristics as the predicate tobacco product; or

(ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.

(B) Characteristics

In subparagraph (A), the term "characteristics" means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.

(C) Limitation

A tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated.

(4) Health information

(A) Summary

As part of a submission under section 387e(j) of this title respecting a tobacco product, the person required to file a premarket notification under such section shall provide an adequate summary of any health information related to the tobacco product or state that such information will be made available upon request by any person.

(B) Required information

Any summary under subparagraph (A) respecting a tobacco product shall contain detailed information regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such tobacco product is substantially equivalent to another tobacco product.

(b) Application

(1) Contents

An application under this section shall contain—

(A) full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;

(B) a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product;

(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product;

(D) an identifying reference to any tobacco product standard under section 387g of this title which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;

(E) such samples of such tobacco product and of components thereof as the Secretary may reasonably require;

(F) specimens of the labeling proposed to be used for such tobacco product; and

(G) such other information relevant to the subject matter of the application as the Secretary may require.

(2) Referral to Tobacco Products Scientific Advisory Committee

Upon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary—

(A) may, on the Secretary's own initiative; or

(B) may, upon the request of an applicant,

refer such application to the Tobacco Products Scientific Advisory Committee for reference and for submission (within such period as the Secretary may establish) of a report and recommendation respecting the application, together with all underlying data and the reasons or basis for the recommendation.

(c) Action on application

(1) Deadline

(A) In general

As promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall—

(i) issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or

(ii) issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.

(B) Restrictions on sale and distribution

An order under subparagraph (A)(i) may require that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title.

(2) Denial of application

The Secretary shall deny an application submitted under subsection (b) if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that—

(A) there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health;

(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 387f(e) of this title;

(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or

(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 387g of this title, and there is a lack of adequate information to justify the deviation from such standard.

(3) Denial information

Any denial of an application shall, insofar as the Secretary determines to be practicable, be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form (which measures may include further research by the applicant in accordance with 1 or more protocols prescribed by the Secretary).

(4) Basis for finding

For purposes of this section, the finding as to whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—

(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

(5) Basis for action

(A) Investigations

For purposes of paragraph (2)(A), whether permitting a tobacco product to be marketed would be appropriate for the protection of the public health shall, when appropriate, be determined on the basis of well-controlled investigations, which may include 1 or more clinical investigations by experts qualified by training and experience to evaluate the tobacco product.

(B) Other evidence

If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A)) which is sufficient to evaluate the tobacco product, the Secretary may authorize that the determination for purposes of paragraph (2)(A) be made on the basis of such evidence.

(d) Withdrawal and temporary suspension

(1) In general

The Secretary shall, upon obtaining, where appropriate, advice on scientific matters from the Tobacco Products Scientific Advisory Committee, and after due notice and opportunity for informal hearing for a tobacco product for which an order was issued under subsection (c)(1)(A)(i), issue an order withdrawing the order if the Secretary finds—

(A) that the continued marketing of such tobacco product no longer is appropriate for the protection of the public health;

(B) that the application contained or was accompanied by an untrue statement of a material fact;

(C) that the applicant—

(i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 387i of this title;

(ii) has refused to permit access to, or copying or verification of, such records as required by section 374 of this title; or

(iii) has not complied with the requirements of section 387e of this title;

(D) on the basis of new information before the Secretary with respect to such tobacco product, evaluated together with the evidence before the Secretary when the application was reviewed, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such tobacco product do not conform with the requirements of section 387f(e) of this title and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity;

(E) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when the application was reviewed, that the labeling of such tobacco product, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or

(F) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such order was issued, that such tobacco product is not shown to conform in all respects to a tobacco product standard which is in effect under section 387g of this title, compliance with which was a condition to the issuance of an order relating to the application, and that there is a lack of adequate information to justify the deviation from such standard.

(2) Appeal

The holder of an application subject to an order issued under paragraph (1) withdrawing an order issued pursuant to subsection (c)(1)(A)(i) may, by petition filed on or before the 30th day after the date upon which such holder receives notice of such withdrawal, obtain review thereof in accordance with section 387l of this title.

(3) Temporary suspension

If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a tobacco product under an order would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market, the Secretary shall by order temporarily suspend the authority of the manufacturer to market the product. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application.

(e) Service of order

An order issued by the Secretary under this section shall be served—

(1) in person by any officer or employee of the department designated by the Secretary; or

(2) by mailing the order by registered mail or certified mail addressed to the applicant at the applicant's last known address in the records of the Secretary.

(f) Records

(1) Additional information

In the case of any tobacco product for which an order issued pursuant to subsection (c)(1)(A)(i) for an application filed under subsection (b) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, as the Secretary may by regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination of, whether there is or may be grounds for withdrawing or temporarily suspending such order.

(2) Access to records

Each person required under this section to maintain records, and each person in charge of custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(g) Investigational tobacco product exemption for investigational use

The Secretary may exempt tobacco products intended for investigational use from the provisions of this subchapter under such conditions as the Secretary may by regulation prescribe.

(June 25, 1938, ch. 675, §910, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1807.)

Editorial Notes

Prior Provisions

A prior section 910 of act June 25, 1938, was renumbered section 1010 and is classified to section 399a of this title.

Statutory Notes and Related Subsidiaries

Submission of Applications for Previously Marketed Products

Pub. L. 117–103, div. P, title I, §111(d), Mar. 15, 2022, 136 Stat. 789, provided that:

"(1) Transition period for all products.—With respect to a tobacco product that contains nicotine from any source other than tobacco and that was being marketed in the United States within 30 days after the date of enactment of this Act [Mar. 15, 2022], such product shall not be considered to be in violation of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j) (relating to applications for review of certain tobacco products) during the 60-day period following the date of enactment of this Act.

"(2) Submission of applications.—

"(A) In general.—As a condition for continuing to market a product described in paragraph (1) after the 60-day period specified in such paragraph, during the 30-day period beginning on the effective date specified in subsection (c) [21 U.S.C. 321 note], the manufacturer shall submit a new tobacco product application under section 910(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(b)) with respect to such product.

"(B) Transition period.—Except as provided in subparagraph (C), with respect to a tobacco product for which an application is submitted as described in subparagraph (A), the manufacturer of such product may continue to market such product during the 90-day period beginning on the effective date specified in subsection (c).

"(C) Exception.—If the Secretary of Health and Human Services previously denied an application under section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(c)(2)), refused to file an application under section 910(b) of such Act, or withdrew an order under section 910(d) of such Act for a previous version of a tobacco product that used nicotine made or derived from tobacco, such product is not eligible for continued marketing under subparagraph (B).

"(3) End of transition period.—Beginning on the date that is 90 days after the effective date specified in subsection (c), a tobacco product described in paragraph (1) (including such a tobacco product that is the subject of a pending application under section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j)) is in violation of such section 910 if such tobacco product does not have an order in effect under subsection (c)(1)(A)(i) of such section."

§387k. Modified risk tobacco products

(a) In general

No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.

(b) Definitions

In this section:

(1) Modified risk tobacco product

The term "modified risk tobacco product" means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.

(2) Sold or distributed

(A) In general

With respect to a tobacco product, the term "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products" means a tobacco product—

(i) the label, labeling, or advertising of which represents explicitly or implicitly that—

(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;

(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or

(III) the tobacco product or its smoke does not contain or is free of a substance;

(ii) the label, labeling, or advertising of which uses the descriptors "light", "mild", or "low" or similar descriptors; or

(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

(B) Limitation

No tobacco product shall be considered to be "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products", except as described in subparagraph (A).

(C) Smokeless tobacco product

No smokeless tobacco product shall be considered to be "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products" solely because its label, labeling, or advertising uses the following phrases to describe such product and its use: "smokeless tobacco", "smokeless tobacco product", "not consumed by smoking", "does not produce smoke", "smokefree", "smoke-free", "without smoke", "no smoke", or "not smoke".

(3) Effective date

The provisions of paragraph (2)(A)(ii) shall take effect 12 months after June 22, 2009, for those products whose label, labeling, or advertising contains the terms described in such paragraph on June 22, 2009. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with paragraph (2)(A)(ii).

(c) Tobacco dependence products

A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is subject to the requirements of subchapter V.

(d) Filing

Any person may file with the Secretary an application for a modified risk tobacco product. Such application shall include—

(1) a description of the proposed product and any proposed advertising and labeling;

(2) the conditions for using the product;

(3) the formulation of the product;

(4) sample product labels and labeling;

(5) all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health;

(6) data and information on how consumers actually use the tobacco product; and

(7) such other information as the Secretary may require.

(e) Public availability

The Secretary shall make the application described in subsection (d) publicly available (except matters in the application which are trade secrets or otherwise confidential, commercial information) and shall request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying such application.

(f) Advisory Committee

(1) In general

The Secretary shall refer to the Tobacco Products Scientific Advisory Committee any application submitted under this section.

(2) Recommendations

Not later than 60 days after the date an application is referred to the Tobacco Products Scientific Advisory Committee under paragraph (1), the Advisory Committee shall report its recommendations on the application to the Secretary.

(g) Marketing

(1) Modified risk products

Except as provided in paragraph (2), the Secretary shall, with respect to an application submitted under this section, issue an order that a modified risk product may be commercially marketed only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will—

(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and

(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

(2) Special rule for certain products

(A) In general

The Secretary may issue an order that a tobacco product may be introduced or delivered for introduction into interstate commerce, pursuant to an application under this section, with respect to a tobacco product that may not be commercially marketed under paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that—

(i) such order would be appropriate to promote the public health;

(ii) any aspect of the label, labeling, and advertising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b) is limited to an explicit or implicit representation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;

(iii) scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and

(iv) the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.

(B) Additional findings required

To issue an order under subparagraph (A) the Secretary must also find that the applicant has demonstrated that—

(i) the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;

(ii) the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users;

(iii) testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product—

(I) is or has been demonstrated to be less harmful; or

(II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products; and

(iv) issuance of an order with respect to the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

(C) Conditions of marketing

(i) In general

Applications subject to an order under this paragraph shall be limited to a term of not more than 5 years, but may be renewed upon a finding by the Secretary that the requirements of this paragraph continue to be satisfied based on the filing of a new application.

(ii) Agreements by applicant

An order under this paragraph shall be conditioned on the applicant's agreement to conduct postmarket surveillance and studies and to submit to the Secretary the results of such surveillance and studies to determine the impact of the order on consumer perception, behavior, and health and to enable the Secretary to review the accuracy of the determinations upon which the order was based in accordance with a protocol approved by the Secretary.

(iii) Annual submission

The results of such postmarket surveillance and studies described in clause (ii) shall be submitted annually.

(3) Basis

The determinations under paragraphs (1) and (2) shall be based on—

(A) the scientific evidence submitted by the applicant; and

(B) scientific evidence and other information that is made available to the Secretary.

(4) Benefit to health of individuals and of population as a whole

In making the determinations under paragraphs (1) and (2), the Secretary shall take into account—

(A) the relative health risks to individuals of the tobacco product that is the subject of the application;

(B) the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application;

(C) the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application;

(D) the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved under subchapter V to treat nicotine dependence; and

(E) comments, data, and information submitted by interested persons.

(h) Additional conditions for marketing

(1) Modified risk products

The Secretary shall require for the marketing of a product under this section that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products.

(2) Comparative claims

(A) In general

The Secretary may require for the marketing of a product under this subsection that a claim comparing a tobacco product to 1 or more other commercially marketed tobacco products shall compare the tobacco product to a commercially marketed tobacco product that is representative of that type of tobacco product on the market (for example the average value of the top 3 brands of an established regular tobacco product).

(B) Quantitative comparisons

The Secretary may also require, for purposes of subparagraph (A), that the percent (or fraction) of change and identity of the reference tobacco product and a quantitative comparison of the amount of the substance claimed to be reduced shall be stated in immediate proximity to the most prominent claim.

(3) Label disclosure

(A) In general

The Secretary may require the disclosure on the label of other substances in the tobacco product, or substances that may be produced by the consumption of that tobacco product, that may affect a disease or health-related condition or may increase the risk of other diseases or health-related conditions associated with the use of tobacco products.

(B) Conditions of use

If the conditions of use of the tobacco product may affect the risk of the product to human health, the Secretary may require the labeling of conditions of use.

(4) Time

An order issued under subsection (g)(1) shall be effective for a specified period of time.

(5) Advertising

The Secretary may require, with respect to a product for which an applicant obtained an order under subsection (g)(1), that the product comply with requirements relating to advertising and promotion of the tobacco product.

(i) Postmarket surveillance and studies

(1) In general

The Secretary shall require, with respect to a product for which an applicant obtained an order under subsection (g)(1), that the applicant conduct postmarket surveillance and studies for such a tobacco product to determine the impact of the order issuance on consumer perception, behavior, and health, to enable the Secretary to review the accuracy of the determinations upon which the order was based, and to provide information that the Secretary determines is otherwise necessary regarding the use or health risks involving the tobacco product. The results of postmarket surveillance and studies shall be submitted to the Secretary on an annual basis.

(2) Surveillance protocol

Each applicant required to conduct a surveillance of a tobacco product under paragraph (1) shall, within 30 days after receiving notice that the applicant is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance. The Secretary, within 60 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and experience to conduct such surveillance and if such protocol will result in collection of the data or other information designated by the Secretary as necessary to protect the public health.

(j) Withdrawal of authorization

The Secretary, after an opportunity for an informal hearing, shall withdraw an order under subsection (g) if the Secretary determines that—

(1) the applicant, based on new information, can no longer make the demonstrations required under subsection (g), or the Secretary can no longer make the determinations required under subsection (g);

(2) the application failed to include material information or included any untrue statement of material fact;

(3) any explicit or implicit representation that the product reduces risk or exposure is no longer valid, including if—

(A) a tobacco product standard is established pursuant to section 387g of this title;

(B) an action is taken that affects the risks presented by other commercially marketed tobacco products that were compared to the product that is the subject of the application; or

(C) any postmarket surveillance or studies reveal that the order is no longer consistent with the protection of the public health;

(4) the applicant failed to conduct or submit the postmarket surveillance and studies required under subsection (g)(2)(C)(ii) or subsection (i); or

(5) the applicant failed to meet a condition imposed under subsection (h).

(k) Subchapter IV or V

A product for which the Secretary has issued an order pursuant to subsection (g) shall not be subject to subchapter IV or V.

(l) Implementing regulations or guidance

(1) Scientific evidence

Not later than 2 years after June 22, 2009, the Secretary shall issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products. Such regulations or guidance shall—

(A) to the extent that adequate scientific evidence exists, establish minimum standards for scientific studies needed prior to issuing an order under subsection (g) to show that a substantial reduction in morbidity or mortality among individual tobacco users occurs for products described in subsection (g)(1) or is reasonably likely for products described in subsection (g)(2);

(B) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appropriate;

(C) establish minimum standards for postmarket studies, that shall include regular and long-term assessments of health outcomes and mortality, intermediate clinical endpoints, consumer perception of harm reduction, and the impact on quitting behavior and new use of tobacco products, as appropriate;

(D) establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception;

(E) require that data from the required studies and surveillance be made available to the Secretary prior to the decision on renewal of a modified risk tobacco product; and

(F) establish a reasonable timetable for the Secretary to review an application under this section.

(2) Consultation

The regulations or guidance issued under paragraph (1) shall be developed in consultation with the Institute of Medicine, and with the input of other appropriate scientific and medical experts, on the design and conduct of such studies and surveillance.

(3) Revision

The regulations or guidance under paragraph (1) shall be revised on a regular basis as new scientific information becomes available.

(4) New tobacco products

Not later than 2 years after June 22, 2009, the Secretary shall issue a regulation or guidance that permits the filing of a single application for any tobacco product that is a new tobacco product under section 387j of this title and which the applicant seeks to commercially market under this section.

(m) Distributors

Except as provided in this section, no distributor may take any action, after June 22, 2009, with respect to a tobacco product that would reasonably be expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

(June 25, 1938, ch. 675, §911, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1812.)

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387l. Judicial review

(a) Right to review

(1) In general

Not later than 30 days after—

(A) the promulgation of a regulation under section 387g of this title establishing, amending, or revoking a tobacco product standard; or

(B) a denial of an application under section 387j(c) of this title,

any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.

(2) Requirements

(A) Copy of petition

A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary.

(B) Record of proceedings

On receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed—

(i) the record of the proceedings on which the regulation or order was based; and

(ii) a statement of the reasons for the issuance of such a regulation or order.

(C) Definition of record

In this section, the term "record" means—

(i) all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;

(ii) all information submitted to the Secretary with respect to such regulation or order;

(iii) proceedings of any panel or advisory committee with respect to such regulation or order;

(iv) any hearing held with respect to such regulation or order; and

(v) any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.

(b) Standard of review

Upon the filing of the petition under subsection (a) for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5 and to grant appropriate relief, including interim relief, as provided for in such chapter. A regulation or denial described in subsection (a) shall be reviewed in accordance with section 706(2)(A) of title 5.

(c) Finality of judgment

The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28.

(d) Other remedies

The remedies provided for in this section shall be in addition to, and not in lieu of, any other remedies provided by law.

(e) Regulations and orders must recite basis in record

To facilitate judicial review, a regulation or order issued under section 387f, 387g, 387h, 387i, 387j, or 387p of this title shall contain a statement of the reasons for the issuance of such regulation or order in the record of the proceedings held in connection with its issuance.

(June 25, 1938, ch. 675, §912, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1819.)

§387m. Equal treatment of retail outlets

The Secretary shall issue regulations to require that retail establishments for which the predominant business is the sale of tobacco products comply with any advertising restrictions applicable to retail establishments accessible to individuals under the age of 18.

(June 25, 1938, ch. 675, §913, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1820.)

§387n. Jurisdiction of and coordination with the Federal Trade Commission

(a) Jurisdiction

(1) In general

Except where expressly provided in this subchapter, nothing in this subchapter shall be construed as limiting or diminishing the authority of the Federal Trade Commission to enforce the laws under its jurisdiction with respect to the advertising, sale, or distribution of tobacco products.

(2) Enforcement

Any advertising that violates this subchapter or a provision of the regulations referred to in section 387a–1 of this title, is an unfair or deceptive act or practice under section 45(a) of title 15 and shall be considered a violation of a rule promulgated under section 57a of title 15.

(b) Coordination

With respect to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act [15 U.S.C. 1333] and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 [15 U.S.C. 4402]—

(1) the Chairman of the Federal Trade Commission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or deceptive acts or practices in the advertising of cigarettes or smokeless tobacco; and

(2) the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such sections.

(June 25, 1938, ch. 675, §914, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1820.)

Editorial Notes

References in Text

The Federal Cigarette Labeling and Advertising Act, referred to in subsec. (b), is Pub. L. 89–92, July 27, 1965, 79 Stat. 282, which is classified generally to chapter 36 (§1331 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1331 of Title 15 and Tables.

The Comprehensive Smokeless Tobacco Health Education Act of 1986, referred to in subsec. (b), is Pub. L. 99–252, Feb. 27, 1986, 100 Stat. 30, which is classified principally to chapter 70 (§4401 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 4401 of Title 15 and Tables.

§387o. Regulation requirement

(a) Testing, reporting, and disclosure

Not later than 36 months after June 22, 2009, the Secretary shall promulgate regulations under this chapter that meet the requirements of subsection (b).

(b) Contents of rules

The regulations promulgated under subsection (a)—

(1) shall require testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, by brand and subbrand that the Secretary determines should be tested to protect the public health, provided that, for purposes of the testing requirements of this paragraph, tobacco products manufactured and sold by a single tobacco product manufacturer that are identical in all respects except the labels, packaging design, logo, trade dress, trademark, brand name, or any combination thereof, shall be considered as a single brand; and

(2) may require that tobacco product manufacturers, packagers, or importers make disclosures relating to the results of the testing of tar and nicotine through labels or advertising or other appropriate means, and make disclosures regarding the results of the testing of other constituents, including smoke constituents, ingredients, or additives, that the Secretary determines should be disclosed to the public to protect the public health and will not mislead consumers about the risk of tobacco-related disease.

(c) Authority

The Secretary shall have the authority under this subchapter to conduct or to require the testing, reporting, or disclosure of tobacco product constituents, including smoke constituents.

(d) Small tobacco product manufacturers

(1) First compliance date

The initial regulations promulgated under subsection (a) shall not impose requirements on small tobacco product manufacturers before the later of—

(A) the end of the 2-year period following the final promulgation of such regulations; and

(B) the initial date set by the Secretary for compliance with such regulations by manufacturers that are not small tobacco product manufacturers.

(2) Testing and reporting initial compliance period

(A) 4-year period

The initial regulations promulgated under subsection (a) shall give each small tobacco product manufacturer a 4-year period over which to conduct testing and reporting for all of its tobacco products. Subject to paragraph (1), the end of the first year of such 4-year period shall coincide with the initial date of compliance under this section set by the Secretary with respect to manufacturers that are not small tobacco product manufacturers or the end of the 2-year period following the final promulgation of such regulations, as described in paragraph (1)(A). A small tobacco product manufacturer shall be required—

(i) to conduct such testing and reporting for 25 percent of its tobacco products during each year of such 4-year period; and

(ii) to conduct such testing and reporting for its largest-selling tobacco products (as determined by the Secretary) before its other tobacco products, or in such other order of priority as determined by the Secretary.

(B) Case-by-case delay

Notwithstanding subparagraph (A), the Secretary may, on a case-by-case basis, delay the date by which an individual small tobacco product manufacturer must conduct testing and reporting for its tobacco products under this section based upon a showing of undue hardship to such manufacturer. Notwithstanding the preceding sentence, the Secretary shall not extend the deadline for a small tobacco product manufacturer to conduct testing and reporting for all of its tobacco products beyond a total of 5 years after the initial date of compliance under this section set by the Secretary with respect to manufacturers that are not small tobacco product manufacturers.

(3) Subsequent and additional testing and reporting

The regulations promulgated under subsection (a) shall provide that, with respect to any subsequent or additional testing and reporting of tobacco products required under this section, such testing and reporting by a small tobacco product manufacturer shall be conducted in accordance with the timeframes described in paragraph (2)(A), except that, in the case of a new product, or if there has been a modification described in section 387j(a)(1)(B) of this title of any product of a small tobacco product manufacturer since the last testing and reporting required under this section, the Secretary shall require that any subsequent or additional testing and reporting be conducted in accordance with the same timeframe applicable to manufacturers that are not small tobacco product manufacturers.

(4) Joint laboratory testing services

The Secretary shall allow any 2 or more small tobacco product manufacturers to join together to purchase laboratory testing services required by this section on a group basis in order to ensure that such manufacturers receive access to, and fair pricing of, such testing services.

(e) Extensions for limited laboratory capacity

(1) In general

The regulations promulgated under subsection (a) shall provide that a small tobacco product manufacturer shall not be considered to be in violation of this section before the deadline applicable under paragraphs (3) and (4), if—

(A) the tobacco products of such manufacturer are in compliance with all other requirements of this subchapter; and

(B) the conditions described in paragraph (2) are met.

(2) Conditions

Notwithstanding the requirements of this section, the Secretary may delay the date by which a small tobacco product manufacturer must be in compliance with the testing and reporting required by this section until such time as the testing is reported if, not later than 90 days before the deadline for reporting in accordance with this section, a small tobacco product manufacturer provides evidence to the Secretary demonstrating that—

(A) the manufacturer has submitted the required products for testing to a laboratory and has done so sufficiently in advance of the deadline to create a reasonable expectation of completion by the deadline;

(B) the products currently are awaiting testing by the laboratory; and

(C) neither that laboratory nor any other laboratory is able to complete testing by the deadline at customary, nonexpedited testing fees.

(3) Extension

The Secretary, taking into account the laboratory testing capacity that is available to tobacco product manufacturers, shall review and verify the evidence submitted by a small tobacco product manufacturer in accordance with paragraph (2). If the Secretary finds that the conditions described in such paragraph are met, the Secretary shall notify the small tobacco product manufacturer that the manufacturer shall not be considered to be in violation of the testing and reporting requirements of this section until the testing is reported or until 1 year after the reporting deadline has passed, whichever occurs sooner. If, however, the Secretary has not made a finding before the reporting deadline, the manufacturer shall not be considered to be in violation of such requirements until the Secretary finds that the conditions described in paragraph (2) have not been met, or until 1 year after the reporting deadline, whichever occurs sooner.

(4) Additional extension

In addition to the time that may be provided under paragraph (3), the Secretary may provide further extensions of time, in increments of no more than 1 year, for required testing and reporting to occur if the Secretary determines, based on evidence properly and timely submitted by a small tobacco product manufacturer in accordance with paragraph (2), that a lack of available laboratory capacity prevents the manufacturer from completing the required testing during the period described in paragraph (3).

(f) Rule of construction

Nothing in subsection (d) or (e) shall be construed to authorize the extension of any deadline, or to otherwise affect any timeframe, under any provision of this chapter or the Family Smoking Prevention and Tobacco Control Act other than this section.

(June 25, 1938, ch. 675, §915, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1820.)

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (f), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387p. Preservation of State and local authority

(a) In general

(1) Preservation

Except as provided in paragraph (2)(A), nothing in this subchapter, or rules promulgated under this subchapter, shall be construed to limit the authority of a Federal agency (including the Armed Forces), a State or political subdivision of a State, or the government of an Indian tribe to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, requirements established under this subchapter, including a law, rule, regulation, or other measure relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of tobacco products by individuals of any age, information reporting to the State, or measures relating to fire safety standards for tobacco products. No provision of this subchapter shall limit or otherwise affect any State, tribal, or local taxation of tobacco products.

(2) Preemption of certain State and local requirements

(A) In general

No State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this subchapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products.

(B) Exception

Subparagraph (A) does not apply to requirements relating to the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products by individuals of any age, or relating to fire safety standards for tobacco products. Information disclosed to a State under subparagraph (A) that is exempt from disclosure under section 552(b)(4) of title 5 shall be treated as a trade secret and confidential information by the State.

(b) Rule of construction regarding product liability

No provision of this subchapter relating to a tobacco product shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(June 25, 1938, ch. 675, §916, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1823.)

§387q. Tobacco Products Scientific Advisory Committee

(a) Establishment

Not later than 6 months after June 22, 2009, the Secretary shall establish a 12-member advisory committee, to be known as the Tobacco Products Scientific Advisory Committee (in this section referred to as the "Advisory Committee").

(b) Membership

(1) In general

(A) Members

The Secretary shall appoint as members of the Tobacco Products Scientific Advisory Committee individuals who are technically qualified by training and experience in medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products, who are of appropriately diversified professional backgrounds. The committee shall be composed of—

(i) 7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty;

(ii) 1 individual who is an officer or employee of a State or local government or of the Federal Government;

(iii) 1 individual as a representative of the general public;

(iv) 1 individual as a representative of the interests of the tobacco manufacturing industry;

(v) 1 individual as a representative of the interests of the small business tobacco manufacturing industry, which position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee; and

(vi) 1 individual as a representative of the interests of the tobacco growers.

(B) Nonvoting members

The members of the committee appointed under clauses (iv), (v), and (vi) of subparagraph (A) shall serve as consultants to those described in clauses (i) through (iii) of subparagraph (A) and shall be nonvoting representatives.

(C) Conflicts of interest

No members of the committee, other than members appointed pursuant to clauses (iv), (v), and (vi) of subparagraph (A) shall, during the member's tenure on the committee or for the 18-month period prior to becoming such a member, receive any salary, grants, or other payments or support from any business that manufactures, distributes, markets, or sells cigarettes or other tobacco products.

(2) Limitation

The Secretary may not appoint to the Advisory Committee any individual who is in the regular full-time employ of the Food and Drug Administration or any agency responsible for the enforcement of this chapter. The Secretary may appoint Federal officials as ex officio members.

(3) Chairperson

The Secretary shall designate 1 of the members appointed under clauses (i), (ii), and (iii) of paragraph (1)(A) to serve as chairperson.

(c) Duties

The Tobacco Products Scientific Advisory Committee shall provide advice, information, and recommendations to the Secretary—

(1) as provided in this subchapter;

(2) on the effects of the alteration of the nicotine yields from tobacco products;

(3) on whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved; and

(4) on its review of other safety, dependence, or health issues relating to tobacco products as requested by the Secretary.

(d) Compensation; support; chapter 10 of title 5

(1) Compensation and travel

Members of the Advisory Committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which may not exceed the daily equivalent of the rate in effect under the Senior Executive Schedule under section 5382 of title 5, for each day (including travel time) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently.

(2) Administrative support

The Secretary shall furnish the Advisory Committee clerical and other assistance.

(3) Nonapplication of chapter 10 of title 5

Section 1013 of title 5 does not apply to the Advisory Committee.

(e) Proceedings of advisory panels and committees

The Advisory Committee shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made under this subsection information which is exempt from disclosure under section 552(b) of title 5.

(June 25, 1938, ch. 675, §917, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1824; amended Pub. L. 117–286, §4(a)(160), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

Amendments

2022—Subsec. (d). Pub. L. 117–286, §4(a)(160)(A), substituted "chapter 10 of title 5" for "FACA" in heading.

Subsec. (d)(3). Pub. L. 117–286, §4(a)(160)(B), substituted "chapter 10 of title 5" for "FACA" in heading and "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in text.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387r. Drug products used to treat tobacco dependence

(a) In general

The Secretary shall—

(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 356 of this title;

(2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and

(3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.

(b) Report on innovative products

(1) In general

Not later than 3 years after June 22, 2009, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health—

(A) total abstinence from tobacco use;

(B) reductions in consumption of tobacco; and

(C) reductions in the harm associated with continued tobacco use.

(2) Recommendations

The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and Drug Administration should coordinate and facilitate the exchange of information on such innovative products and treatments among relevant offices and centers within the Administration and within the National Institutes of Health, the Centers for Disease Control and Prevention, and other relevant agencies.

(June 25, 1938, ch. 675, §918, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1825.)

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387s. User fees

(a) Establishment of quarterly fee

Beginning on June 22, 2009, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to this subchapter. The fees shall be assessed and collected with respect to each quarter of each fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subsection (b)(1) for such year, subject to subsection (c).

(b) Assessment of user fee

(1) Amount of assessment

The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is the following, as applicable to the fiscal year involved:

(A) For fiscal year 2009, $85,000,000 (subject to subsection (e)).

(B) For fiscal year 2010, $235,000,000.

(C) For fiscal year 2011, $450,000,000.

(D) For fiscal year 2012, $477,000,000.

(E) For fiscal year 2013, $505,000,000.

(F) For fiscal year 2014, $534,000,000.

(G) For fiscal year 2015, $566,000,000.

(H) For fiscal year 2016, $599,000,000.

(I) For fiscal year 2017, $635,000,000.

(J) For fiscal year 2018, $672,000,000.

(K) For fiscal year 2019 and each subsequent fiscal year, $712,000,000.

(2) Allocations of assessment by class of tobacco products

(A) In general

The total user fees assessed and collected under subsection (a) each fiscal year with respect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year.

(B) Applicable percentage

(i) In general

For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accordance with clause (ii):

(I) Cigarettes.

(II) Cigars, including small cigars and cigars other than small cigars.

(III) Snuff.

(IV) Chewing tobacco.

(V) Pipe tobacco.

(VI) Roll-your-own tobacco.

(ii) Allocations

The applicable percentage of each class of tobacco product described in clause (i) for a fiscal year shall be the percentage determined under section 518d(c) of title 7 for each such class of product for such fiscal year.

(iii) Requirement of regulations

Notwithstanding clause (ii), no user fees shall be assessed on a class of tobacco products unless such class of tobacco products is listed in section 387a(b) of this title or is deemed by the Secretary in a regulation under section 387a(b) of this title to be subject to this subchapter.

(iv) Reallocations

In the case of a class of tobacco products that is not listed in section 387a(b) of this title or deemed by the Secretary in a regulation under section 387a(b) of this title to be subject to this subchapter, the amount of user fees that would otherwise be assessed to such class of tobacco products shall be reallocated to the classes of tobacco products that are subject to this subchapter in the same manner and based on the same relative percentages otherwise determined under clause (ii).

(3) Determination of user fee by company

(A) In general

The total user fee to be paid by each manufacturer or importer of a particular class of tobacco products shall be determined for each quarter by multiplying—

(i) such manufacturer's or importer's percentage share as determined under paragraph (4); by

(ii) the portion of the user fee amount for the current quarter to be assessed on all manufacturers and importers of such class of tobacco products as determined under paragraph (2).

(B) No fee in excess of percentage share

No manufacturer or importer of tobacco products shall be required to pay a user fee in excess of the percentage share of such manufacturer or importer.

(4) Allocation of assessment within each class of tobacco product

The percentage share of each manufacturer or importer of a particular class of tobacco products of the total user fee to be paid by all manufacturers or importers of that class of tobacco products shall be the percentage determined for purposes of allocations under subsections (e) through (h) of section 518d of title 7.

(5) Allocation for cigars

Notwithstanding paragraph (4), if a user fee assessment is imposed on cigars, the percentage share of each manufacturer or importer of cigars shall be based on the excise taxes paid by such manufacturer or importer during the prior fiscal year.

(6) Timing of assessment

The Secretary shall notify each manufacturer and importer of tobacco products subject to this section of the amount of the quarterly assessment imposed on such manufacturer or importer under this subsection for each quarter of each fiscal year. Such notifications shall occur not later than 30 days prior to the end of the quarter for which such assessment is made, and payments of all assessments shall be made by the last day of the quarter involved.

(7) Memorandum of understanding

(A) In general

The Secretary shall request the appropriate Federal agency to enter into a memorandum of understanding that provides for the regular and timely transfer from the head of such agency to the Secretary of the information described in paragraphs (2)(B)(ii) and (4) and all necessary information regarding all tobacco product manufacturers and importers required to pay user fees. The Secretary shall maintain all disclosure restrictions established by the head of such agency regarding the information provided under the memorandum of understanding.

(B) Assurances

Beginning not later than fiscal year 2015, and for each subsequent fiscal year, the Secretary shall ensure that the Food and Drug Administration is able to determine the applicable percentages described in paragraph (2) and the percentage shares described in paragraph (4). The Secretary may carry out this subparagraph by entering into a contract with the head of the Federal agency referred to in subparagraph (A) to continue to provide the necessary information.

(c) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, subject to paragraph (2)(D). Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.

(2) Availability

(A) In general

Fees appropriated under paragraph (3) are available only for the purpose of paying the costs of the activities of the Food and Drug Administration related to the regulation of tobacco products under this subchapter and the Family Smoking Prevention and Tobacco Control Act (referred to in this subsection as "tobacco regulation activities"), except that such fees may be used for the reimbursement specified in subparagraph (C).

(B) Prohibition against use of other funds

(i) In general

Except as provided in clause (ii), fees collected under subsection (a) are the only funds authorized to be made available for tobacco regulation activities.

(ii) Startup costs

Clause (i) does not apply until October 1, 2009. Until such date, any amounts available to the Food and Drug Administration (excluding user fees) shall be available and allocated as needed to pay the costs of tobacco regulation activities.

(C) Reimbursement of start-up amounts

(i) In general

Any amounts allocated for the start-up period pursuant to subparagraph (B)(ii) shall be reimbursed through any appropriated fees collected under subsection (a), in such manner as the Secretary determines appropriate to ensure that such allocation results in no net change in the total amount of funds otherwise available, for the period from October 1, 2008, through September 30, 2010, for Food and Drug Administration programs and activities (other than tobacco regulation activities) for such period.

(ii) Treatment of reimbursed amounts

Amounts reimbursed under clause (i) shall be available for the programs and activities for which funds allocated for the start-up period were available, prior to such allocation, until September 30, 2010, notwithstanding any otherwise applicable limits on amounts for such programs or activities for a fiscal year.

(D) Fee collected during start-up period

Notwithstanding the first sentence of paragraph (1), fees under subsection (a) may be collected through September 30, 2009 under subparagraph (B)(ii) and shall be available for obligation and remain available until expended. Such offsetting collections shall be credited to the salaries and expenses account of the Food and Drug Administration.

(E) Obligation of start-up costs in anticipation of available fee collections

Notwithstanding any other provision of law, following the enactment of an appropriation for fees under this section for fiscal year 2010, or any portion thereof, obligations for costs of tobacco regulation activities during the start-up period may be incurred in anticipation of the receipt of offsetting fee collections through procedures specified in section 1534 of title 31.

(3) Authorization of appropriations

For fiscal year 2009 and each subsequent fiscal year, there is authorized to be appropriated for fees under this section an amount equal to the amount specified in subsection (b)(1) for the fiscal year.

(d) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(e) Applicability to fiscal year 2009

If the date of enactment of the Family Smoking Prevention and Tobacco Control Act occurs during fiscal year 2009, the following applies, subject to subsection (c):

(1) The Secretary shall determine the fees that would apply for a single quarter of such fiscal year according to the application of subsection (b) to the amount specified in paragraph (1)(A) of such subsection (referred to in this subsection as the "quarterly fee amounts").

(2) For the quarter in which such date of enactment occurs, the amount of fees assessed shall be a pro rata amount, determined according to the number of days remaining in the quarter (including such date of enactment) and according to the daily equivalent of the quarterly fee amounts. Fees assessed under the preceding sentence shall not be collected until the next quarter.

(3) For the quarter following the quarter to which paragraph (2) applies, the full quarterly fee amounts shall be assessed and collected, in addition to collection of the pro rata fees assessed under paragraph (2).

(June 25, 1938, ch. 675, §919, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1826.)

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (c)(2)(A), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title.

The date of enactment of the Family Smoking Prevention and Tobacco Control Act and such date of enactment, referred to in subsec. (e), is the date of enactment of Pub. L. 111–31, which was approved June 22, 2009.

§387t. Labeling, recordkeeping, records inspection

(a) Origin labeling

(1) Requirement

Beginning 1 year after June 22, 2009, the label, packaging, and shipping containers of tobacco products other than cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement "sale only allowed in the United States". Beginning 15 months after the issuance of the regulations required by section 1333(d) of title 15, as amended by section 201 of Family ¹ Smoking Prevention and Tobacco Control Act, the label, packaging, and shipping containers of cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement "Sale only allowed in the United States".

(2) Effective date

The effective date specified in paragraph (1) shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with such paragraph.

(b) Regulations concerning recordkeeping for tracking and tracing

(1) In general

The Secretary shall promulgate regulations regarding the establishment and maintenance of records by any person who manufactures, processes, transports, distributes, receives, packages, holds, exports, or imports tobacco products.

(2) Inspection

In promulgating the regulations described in paragraph (1), the Secretary shall consider which records are needed for inspection to monitor the movement of tobacco products from the point of manufacture through distribution to retail outlets to assist in investigating potential illicit trade, smuggling, or counterfeiting of tobacco products.

(3) Codes

The Secretary may require codes on the labels of tobacco products or other designs or devices for the purpose of tracking or tracing the tobacco product through the distribution system.

(4) Size of business

The Secretary shall take into account the size of a business in promulgating regulations under this section.

(5) Recordkeeping by retailers

The Secretary shall not require any retailer to maintain records relating to individual purchasers of tobacco products for personal consumption.

(c) Records inspection

If the Secretary has a reasonable belief that a tobacco product is part of an illicit trade or smuggling or is a counterfeit product, each person who manufactures, processes, transports, distributes, receives, holds, packages, exports, or imports tobacco products shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times and within reasonable limits and in a reasonable manner, upon the presentation of appropriate credentials and a written notice to such person, to have access to and copy all records (including financial records) relating to such article that are needed to assist the Secretary in investigating potential illicit trade, smuggling, or counterfeiting of tobacco products. The Secretary shall not authorize an officer or employee of the government of any of the several States to exercise authority under the preceding sentence on Indian country without the express written consent of the Indian tribe involved.

(d) Knowledge of illegal transaction

(1) Notification

If the manufacturer or distributor of a tobacco product has knowledge which reasonably supports the conclusion that a tobacco product manufactured or distributed by such manufacturer or distributor that has left the control of such person may be or has been—

(A) imported, exported, distributed, or offered for sale in interstate commerce by a person without paying duties or taxes required by law; or

(B) imported, exported, distributed, or diverted for possible illicit marketing,

the manufacturer or distributor shall promptly notify the Attorney General and the Secretary of the Treasury of such knowledge.

(2) Knowledge defined

For purposes of this subsection, the term "knowledge" as applied to a manufacturer or distributor means—

(A) the actual knowledge that the manufacturer or distributor had; or

(B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.

(e) Consultation

In carrying out this section, the Secretary shall consult with the Attorney General of the United States and the Secretary of the Treasury, as appropriate.

(June 25, 1938, ch. 675, §920, as added Pub. L. 111–31, div. A, title III, §301, June 22, 2009, 123 Stat. 1850.)

Editorial Notes

References in Text

Section 201 of the Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (a)(1), is section 201 of div. A of Pub. L. 111–31.

¹ So in original. Probably should be "the Family".

§387u. Studies of progress and effectiveness

(a) FDA report

Not later than 3 years after June 22, 2009, and not less than every 2 years thereafter, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning—

(1) the progress of the Food and Drug Administration in implementing this division, including major accomplishments, objective measurements of progress, and the identification of any areas that have not been fully implemented;

(2) impediments identified by the Food and Drug Administration to progress in implementing this division and to meeting statutory timeframes;

(3) data on the number of new product applications received under section 387j of this title and modified risk product applications received under section 387k of this title, and the number of applications acted on under each category; and

(4) data on the number of full time equivalents engaged in implementing this division.

(b) GAO report

Not later than 5 years after June 22, 2009, the Comptroller General of the United States shall conduct a study of, and submit to the Committees described in subsection (a) a report concerning—

(1) the adequacy of the authority and resources provided to the Secretary of Health and Human Services for this division to carry out its goals and purposes; and

(2) any recommendations for strengthening that authority to more effectively protect the public health with respect to the manufacture, marketing, and distribution of tobacco products.

(c) Public availability

The Secretary of Health and Human Services and the Comptroller General of the United States, respectively, shall make the reports required under subsection ¹ (a) and (b) available to the public, including by posting such reports on the respective Internet websites of the Food and Drug Administration and the Government Accountability Office.

(Pub. L. 111–31, div. A, title I, §106, June 22, 2009, 123 Stat. 1841.)

Editorial Notes

References in Text

This division, referred to in subsecs. (a)(1), (2), (4) and (b)(1), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776, known as Family Smoking Prevention and Tobacco Control Act. For complete classification of division A to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Codification

Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

¹ So in original. Probably should be plural.

§387v. Reporting on tobacco regulation activities

(a) In general

For fiscal year 2022 and each subsequent fiscal year for which fees are collected under section 387s of this title, the Secretary of Health and Human Services shall, not later than 180 days after the end of the fiscal year, prepare and submit to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, an annual report that contains the information required under subsection (b).

(b) Required information

Each report submitted under subsection (a) shall contain the following information for the previous fiscal year:

(1) Total annual user fee collections.

(2) Total amount of fees obligated.

(3) The amount of unobligated carryover balance from fees collected.

(4) The amount obligated by the Center for Tobacco Products for each of the following activities:

(A) Compliance and enforcement.

(B) Public education campaigns.

(C) Scientific research and research infrastructure.

(D) Communications.

(E) Leadership, management oversight, and administrative services.

(F) Related overhead activities.

(5) The numbers of applications, categorized by class of tobacco product and review pathway under sections 387e, 387j, and 387k of this title, that were—

(A) submitted;

(B) pending;

(C) accepted;

(D) refused to file;

(E) withdrawn;

(F) denied;

(G) authorized for marketing under an order;

(H) issued a deficiency letter or environmental information request letter; or

(I) referred to the Tobacco Products Scientific Advisory Committee.

(6) The number and titles of draft and final guidance documents and proposed and final regulations issued on topics related to the process for the review of tobacco product applications, whether such regulations and guidance documents were issued as required by statute or by other legal or regulatory requirements, and whether the issuance met the deadlines set forth by the applicable statute or other requirements.

(7) The number and titles of public meetings related to the review of tobacco product applications by the Center for Tobacco Products or other offices or centers within the Food and Drug Administration.

(8) The number of pre-submission meetings relating to applications under section 387j of this title, including the number of meeting requests received, the number of meetings held, and the median amount of time between when such meeting requests were made and when the requests were granted or denied.

(9) The number of full-time equivalent employees funded pursuant to fees collected under section 387s of this title, including identification of the centers and offices within the Food and Drug Administration in which such positions are located.

(10) The number of inspections and investigations conducted at domestic and foreign establishments required to register under section 387e of this title.

(11) The total number of compliance and enforcement actions issued or taken with respect to tobacco products, including warning letters, civil money penalties, no-tobacco-sale orders, and other enforcement actions (including seizures, injunctions, and criminal prosecution).

(c) Public availability

The Secretary of Health and Human Services shall make the reports required under this section available to the public on the website of the Food and Drug Administration.

(d) Limitations

Reporting under this section shall include best estimates for any reporting category for which the Food and Drug Administration does not have precise calculations. Such best estimates shall be accompanied with an explanatory statement for why the Food and Drug Administration does not have access to, or cannot calculate, the exact figure and a date by which the Food and Drug Administration will update its internal accounting procedures to allow for such reporting. If a category is successfully reported by the Food and Drug Administration with regard to another type of user fee but is provided a best estimate by the Center for Tobacco Products, the explanatory statement shall include information regarding how the Food and Drug Administration will align systems and apply learning across the agency to allow for accurate reporting.

(Pub. L. 117–103, div. P, title I, §112, Mar. 15, 2022, 136 Stat. 790.)

Editorial Notes

Codification

Section was enacted as part of the Consolidated Appropriations Act, 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

SUBCHAPTER X—MISCELLANEOUS

Editorial Notes

Codification

Former subchapter IX of this chapter was redesignated as this subchapter.

§391. Separability clause

If any provision of this chapter is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the chapter and the applicability thereof to other persons and circumstances shall not be affected thereby.

(June 25, 1938, ch. 675, §1001, formerly §901, 52 Stat. 1059; renumbered §1001, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

§392. Exemption of meats and meat food products

(a) Law determinative of exemption

Meats and meat food products shall be exempt from the provisions of this chapter to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended [21 U.S.C. 601 et seq.].

(b) Laws unaffected

Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act [42 U.S.C. 262] (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833) [21 U.S.C. 151 et seq.]; the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), the Filled Milk Act of March 4, 1923 [21 U.S.C. 61 et seq.]; or the Import Milk Act of February 15, 1927 [21 U.S.C. 141 et seq.].

(June 25, 1938, ch. 675, §1002(b), (c), formerly §902(b), (c), 52 Stat. 1059; Pub. L. 90–399, §107, July 13, 1968, 82 Stat. 353; renumbered §1002(b), (c), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

Editorial Notes

References in Text

The Meat Inspection Act, approved March 4, 1907, as amended, referred to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90–201, 81 Stat. 584, which are classified generally to subchapters I to IV (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4, 1913, ch. 145, 37 Stat. 828. The provisions of such act referred to relating to viruses, etc., applicable to domestic animals, are contained in the eighth paragraph under the heading "Bureau of Animal Industry", 37 Stat. 832, as amended, popularly known as the Virus-Serum-Toxin Act, which is classified generally to chapter 5 (§151 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 151 of this title and Tables.

The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), referred to in subsec. (b), is act June 6, 1896, ch. 337, 29 Stat. 253, which had been classified to chapter 10 (§1000 et seq.) of Title 26, Internal Revenue, and included as chapter 17 (§2350 et seq.) of Title 26, Internal Revenue Code of 1939. Such chapter 17 was covered by section 4831 et seq. of Title 26, Internal Revenue Code, prior to the repeal of section 4831 et seq. of Title 26 by Pub. L. 93–490, §3(a)(1), Oct. 26, 1974, 88 Stat. 1466.

The Filled Milk Act of March 4, 1923, referred to in subsec. (b), is act Mar. 4, 1923, ch. 262, 42 Stat. 1486, which is classified generally to chapter 3 (§61 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 61 of this title and Tables.

The Import Milk Act of February 15, 1927, referred to in subsec. (b), is act Feb. 15, 1927, ch. 155, 44 Stat. 1101, which is classified generally to subchapter IV (§141 et seq.) of chapter 4 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 141 of this title and Tables.

Codification

Subsecs. (a) and (b) of this section comprise respectively subsecs. (b) and (c) of section 1002 of act June 25, 1938. Subsecs. (a) and (d) of section 1002 of act June 25, 1938, which prescribed the effective date of this chapter and made appropriations available, are set out as notes under section 301 of this title and this section, respectively.

Amendments

1968—Subsec. (b). Pub. L. 90–399 substituted "section 351 of Public Health Service Act (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833);" for "the virus, serum, and toxin Act of July 1, 1902 (U.S.C., 1934 ed., title 42, chap. 4);".

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Availability of Appropriations

Act June 25, 1938, ch. 675, §1002(d), formerly §902(d), 52 Stat. 1059; renumbered §1002(d), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, provided that: "In order to carry out the provisions of this Act which take effect [see section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title] prior to the repeal of the Food and Drugs Act of June 30, 1906, as amended [former sections 1 to 5 and 7 to 15 of this title], appropriations available for the enforcement of such Act of June 30, 1906, are also authorized to be made available to carry out such provisions."

§393. Food and Drug Administration

(a) In general

There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the "Administration").

(b) Mission

The Administration shall—

(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring that—

(A) foods are safe, wholesome, sanitary, and properly labeled;

(B) human and veterinary drugs are safe and effective;

(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use;

(D) cosmetics are safe and properly labeled; and

(E) public health and safety are protected from electronic product radiation;

(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and

(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.

(c) Interagency collaboration

The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.

(d) Commissioner

(1) Appointment

There shall be in the Administration a Commissioner of Food and Drugs (hereinafter in this section referred to as the "Commissioner") who shall be appointed by the President by and with the advice and consent of the Senate.

(2) General powers

The Secretary, through the Commissioner, shall be responsible for executing this chapter and for—

(A) providing overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the Food and Drug Administration;

(B) coordinating and overseeing the operation of all administrative entities within the Administration;

(C) research relating to foods, drugs, cosmetics, devices, and tobacco products in carrying out this chapter;

(D) conducting educational and public information programs relating to the responsibilities of the Food and Drug Administration; and

(E) performing such other functions as the Secretary may prescribe.

(e) Technical and scientific review groups

The Secretary through the Commissioner of Food and Drugs may, without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific review groups as are needed to carry out the functions of the Administration, including functions under this chapter, and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

(f) Agency plan for statutory compliance

(1) In general

Not later than 1 year after November 21, 1997, the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this chapter. The Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such persons.

(2) Objectives of agency plan

The plan required by paragraph (1) shall establish objectives and mechanisms to achieve such objectives, including objectives related to—

(A) maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this chapter;

(B) maximizing the availability and clarity of information for consumers and patients concerning new products;

(C) implementing inspection and postmarket monitoring provisions of this chapter;

(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1);

(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this chapter for the review of all applications and submissions described in subparagraph (A) and submitted after November 21, 1997; and

(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000.

(g) Annual report

The Secretary shall annually prepare and publish in the Federal Register and solicit public comment on a report that—

(1) provides detailed statistical information on the performance of the Secretary under the plan described in subsection (f);

(2) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; and

(3) identifies any regulatory policy that has a significant negative impact on compliance with any objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory policy.

(h) Annual report regarding food

Not later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding—

(1) information about food facilities including—

(A) the appropriations used to inspect facilities registered pursuant to section 350d of this title in the previous fiscal year;

(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year;

(C) the number of domestic facilities and the number of foreign facilities registered pursuant to section 350d of this title that the Secretary inspected in the previous fiscal year;

(D) the number of domestic facilities and the number of foreign facilities registered pursuant to section 350d of this title that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year;

(E) the number of high-risk facilities identified pursuant to section 350j of this title that the Secretary inspected in the previous fiscal year; and

(F) the number of high-risk facilities identified pursuant to section 350j of this title that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year.

(2) information about food imports including—

(A) the number of lines of food imported into the United States that the Secretary physically inspected or sampled in the previous fiscal year;

(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and

(C) the average cost of physically inspecting or sampling a line of food subject to this chapter that is imported or offered for import into the United States; and

(3) information on the foreign offices of the Food and Drug Administration including—

(A) the number of foreign offices established; and

(B) the number of personnel permanently stationed in each foreign office.

(i) Public availability of annual food reports

The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug Administration.

(June 25, 1938, ch. 675, §1003, formerly §903, as added Pub. L. 100–607, title V, §503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100–690, title II, §2631, Nov. 18, 1988, 102 Stat. 4244; Pub. L. 105–115, title IV, §§406, 414, Nov. 21, 1997, 111 Stat. 2369, 2377; renumbered §1003 and amended Pub. L. 111–31, div. A, title I, §§101(b)(2), 103(m), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, §201(b), Jan. 4, 2011, 124 Stat. 3925.)

Editorial Notes

Amendments

2011—Subsecs. (h), (i). Pub. L. 111–353 added subsecs. (h) and (i).

2009—Subsec. (d)(2)(C). Pub. L. 111–31, §103(m), struck out "and" after "cosmetics," and inserted ", and tobacco products" after "devices".

1997—Subsec. (b). Pub. L. 105–115, §406(a)(2), added subsec. (b). Former subsec. (b) redesignated (d).

Subsec. (c). Pub. L. 105–115, §414, added subsec. (c). Former subsec. (c) redesignated (e).

Subsecs. (d), (e). Pub. L. 105–115, §406(a)(1), redesignated subsecs. (b) and (c) as (d) and (e), respectively.

Subsecs. (f), (g). Pub. L. 105–115, §406(b), added subsecs. (f) and (g).

1988—Subsec. (b)(2). Pub. L. 100–690 substituted "shall be responsible for executing this chapter and" for "shall be responsible".

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date

Pub. L. 100–607, title V, §503(c), Nov. 4, 1988, 102 Stat. 3121, provided that:

"(1) Except as provided in paragraph (2), the amendments made by this title [enacting this section and amending sections 5315 and 5316 of Title 5, Government Organization and Employees] shall take effect on the date of enactment of this Act [Nov. 4, 1988].

"(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section) [now 1003(d)(1), 21 U.S.C. 393(b)(1)] shall apply to the appointments of Commissioners of Food and Drugs made after the date of enactment of this Act."

Improving FDA Guidance and Communication

Pub. L. 117–328, div. FF, title II, §2505, Dec. 29, 2022, 136 Stat. 5802, provided that:

"(a) FDA Report and Implementation of Good Guidance Practices.—The Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall develop, and publish on the website of the Food and Drug Administration—

"(1) a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, within centers, across the Food and Drug Administration, and across other applicable agencies; and

"(2) a plan for implementation of such best practices, including across other applicable agencies, which shall address—

"(A) streamlining development and review of guidance documents within centers and across the Food and Drug Administration;

"(B) streamlining processes for regulatory submissions to the Food and Drug Administration, including through the revision or issuance of guidance documents; and

"(C) implementing innovative guidance development processes and practices and transitioning or updating guidance issued during the COVID–19 public health emergency, as appropriate.

"(b) Report and Implementation of FDA Best Practices for Communicating With External Stakeholders.—The Secretary, acting through the Commissioner of Food and Drugs, shall develop and publish on the website of the Food and Drug Administration a report on the practices of the Food and Drug Administration to broadly communicate with external stakeholders, other than through guidance documents, which shall include—

"(1) a review of the types and methods of public communication that the Food and Drug Administration uses to communicate and interact with medical product sponsors and other external stakeholders;

"(2) the identification of best practices for the efficient development, issuance, and use of such communications; and

"(3) a plan for implementation of best practices for communication with external stakeholders, which shall address—

"(A) advancing the use of innovative forms of communication, including novel document types and formats, to provide increased regulatory clarity to product sponsors and other stakeholders, and advancing methods of communicating and interacting with medical product sponsors and other external stakeholders, including the use of tools such as product submission templates, webinars, and frequently asked questions communications;

"(B) streamlining processes for regulatory submissions; and

"(C) implementing innovative communication development processes and transitioning or updating communication practices used during the COVID–19 public health emergency, as appropriate.

"(c) Consultation.—In developing and publishing the report and implementation plan under this section, the Secretary shall consult with stakeholders, including researchers, academic organizations, pharmaceutical, biotechnology, and medical device developers, clinical research organizations, clinical laboratories, health care providers, patient groups, and other appropriate stakeholders.

"(d) Manner of Issuance.—For purposes of carrying out this section, the Secretary may update an existing report or plan, and may combine the reports and implementation plans described in subsections (a) and (b) into one or more documents.

"(e) Timing.—The Secretary shall—

"(1) not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], publish a draft of the reports and plans required under this section; and

"(2) not later than 180 days after publication of the draft reports and plans under paragraph (1)—

"(A) publish a final report and plan; and

"(B) begin implementation of the best practices pursuant to such final plan."

Improving Information Technology Systems of the Food and Drug Administration

Pub. L. 117–328, div. FF, title III, §3627(a), Dec. 29, 2022, 136 Stat. 5888, provided that:

"(a) FDA Strategic Information Technology Plan.—

"(1) In general.—Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary [of Health and Human Services] shall develop and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated information technology strategic plan to modernize the information technology systems of the Food and Drug Administration. Each such report shall be known as the 'Food and Drug Administration Strategic Information Technology Plan'. The first such report may include the Data and Technology Modernization Strategy, as set forth in the letters described in section 1001(b) of the FDA User Fee Reauthorization Act of 2022 (division F of Public Law 117–180) [21 U.S.C. 379g note].

"(2) Content of strategic plan.—The Food and Drug Administration Strategic Information Technology Plan under paragraph (1) shall include—

"(A) agency-wide strategic goals and priorities for modernizing the information technology systems of the Food and Drug Administration to maximize the efficiency and effectiveness of such systems for enabling the Food and Drug Administration to fulfill its public health mission;

"(B) specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and specific milestones, metrics, and performance measures for assessing progress against such strategic goals and priorities;

"(C) specific activities and strategies for improving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of potential public health concerns;

"(D) challenges and risks the Food and Drug Administration will face in meeting its strategic goals and priorities, and the activities the Food and Drug Administration will undertake to overcome those challenges and mitigate those risks;

"(E) the ways in which the Food and Drug Administration will use the Plan to guide and coordinate the projects and activities of the Food and Drug Administration across its offices and centers; and

"(F) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning.

"(3) Evaluation of progress.—Each Food and Drug Administration Strategic Information Technology Plan issued pursuant to this subsection, with the exception of the first such Food and Drug Administration Strategic Information Technology Plan, shall include an evaluation of—

"(A) the progress the Secretary has made, based on the metrics, benchmarks, and other milestones that measure successful development and implementation of information technology systems; and

"(B) whether actions taken in response to the previous Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities set forth in such previous Plans."

Office of Minor Use and Minor Species Animal Drug Development

Pub. L. 108–282, title I, §102(b)(7), Aug. 2, 2004, 118 Stat. 905, provided that: "The Secretary of Health and Human Services shall establish within the Center for Veterinary Medicine (of the Food and Drug Administration), an Office of Minor Use and Minor Species Animal Drug Development that reports directly to the Director of the Center for Veterinary Medicine. This office shall be responsible for overseeing the development and legal marketing of new animal drugs for minor uses and minor species. There is authorized to be appropriated to carry out this subsection $1,200,000 for fiscal year 2004 and such sums as may be necessary for each fiscal year thereafter."

Regulations for Sunscreen Products

Pub. L. 105–115, title I, §129, Nov. 21, 1997, 111 Stat. 2331, provided that: "Not later than 18 months after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall issue regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn."

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Advancing Regulatory Science To Promote Public Health Innovation

Pub. L. 112–144, title XI, §1124, July 9, 2012, 126 Stat. 1114, provided that:

"(a) In General.—Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall develop a strategy and implementation plan for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decisionmaking.

"(b) Requirements.—The strategy and implementation plan developed under subsection (a) shall be consistent with the user fee performance goals in the Prescription Drug User Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment letter, and the Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to Congress on January 13, 2012, and the Medical Device User Fee Agreement commitment letter transmitted by the Secretary to Congress on April 20, 2012, and shall—

"(1) identify a clear vision of the fundamental role of efficient, consistent, and predictable, science-based decisions throughout regulatory decisionmaking of the Food and Drug Administration with respect to medical products;

"(2) identify the regulatory science priorities of the Food and Drug Administration directly related to fulfilling the mission of the agency with respect to decisionmaking concerning medical products and allocation of resources toward such regulatory science priorities;

"(3) identify regulatory and scientific gaps that impede the timely development and review of, and regulatory certainty with respect to, the approval, licensure, or clearance of medical products, including with respect to companion products and new technologies, and facilitating the timely introduction and adoption of new technologies and methodologies in a safe and effective manner;

"(4) identify clear, measurable metrics by which progress on the priorities identified under paragraph (2) and gaps identified under paragraph (3) will be measured by the Food and Drug Administration, including metrics specific to the integration and adoption of advances in regulatory science described in paragraph (5) and improving medical product decisionmaking, in a predictable and science-based manner; and

"(5) set forth how the Food and Drug Administration will ensure that advances in regulatory science for medical products are adopted, as appropriate, on an ongoing basis and in an [sic] manner integrated across centers, divisions, and branches of the Food and Drug Administration, including by senior managers and reviewers, including through the—

"(A) development, updating, and consistent application of guidance documents that support medical product decisionmaking; and

"(B) adoption of the tools, methods, and processes under section 566 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5).

"(c) Performance Reports.—The annual performance reports submitted to Congress under sections 736B(a) [21 U.S.C. 379h–2(a)] (as amended by section 104 of this Act), 738A(a) [21 U.S.C. 379j–1(a)] (as amended by section 204 of this Act), 744C(a) [21 U.S.C. 379j–43(a)] (as added by section 303 of this Act), and 744I(a) [21 U.S.C. 379j–53(a)] (as added by section 403 of this Act) of the Federal Food, Drug, and Cosmetic Act for each of fiscal years 2014 and 2016, shall include a report from the Secretary on the progress made with respect to—

"(1) advancing the regulatory science priorities identified under paragraph (2) of subsection (b) and resolving the gaps identified under paragraph (3) of such subsection, including reporting on specific metrics identified under paragraph (4) of such subsection;

"(2) the integration and adoption of advances in regulatory science as set forth in paragraph (5) of such subsection; and

"(3) the progress made in advancing the regulatory science goals outlined in the Prescription Drug User Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment letter, and the Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to Congress on January 13, 2012, and the Medical Device User Fee Agreement transmitted by the Secretary to Congress on April 20, 2012.

"(d) Medical Product.—In this section, the term 'medical product' means a drug, as defined in subsection (g) of section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)]."

Information Technology

Pub. L. 112–144, title XI, §1125, July 9, 2012, 126 Stat. 1115, provided that:

"(a) HHS Report.—Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall—

"(1) report to Congress on—

"(A) the milestones and a completion date for developing and implementing a comprehensive information technology strategic plan to align the information technology systems modernization projects with the strategic goals of the Food and Drug Administration, including results-oriented goals, strategies, milestones, performance measures;

"(B) efforts to finalize and approve a comprehensive inventory of the information technology systems of the Food and Drug Administration that includes information describing each system, such as costs, system function or purpose, and status information, and incorporate use of the system portfolio into the information investment management process of the Food and Drug Administration;

"(C) the ways in which the Food and Drug Administration uses the plan described in subparagraph (A) to guide and coordinate the modernization projects and activities of the Food and Drug Administration, including the interdependencies among projects and activities; and

"(D) the extent to which the Food and Drug Administration has fulfilled or is implementing recommendations of the Government Accountability Office with respect to the Food and Drug Administration and information technology; and

"(2) develop—

"(A) a documented enterprise architecture program management plan that includes the tasks, activities, and timeframes associated with developing and using the architecture and addresses how the enterprise architecture program management will be performed in coordination with other management disciplines, such as organizational strategic planning, capital planning and investment control, and performance management; and

"(B) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning.

"(b) GAO Report.—Not later than January 1, 2016, the Comptroller General of the United States shall issue a report regarding the strategic plan described in subsection (a)(1)(A) and related actions carried out by the Food and Drug Administration. Such report shall assess the progress the Food and Drug Administration has made on—

"(1) the development and implementation of a comprehensive information technology strategic plan, including the results-oriented goals, strategies, milestones, and performance measures identified in subsection (a)(1)(A);

"(2) the effectiveness of the comprehensive information technology strategic plan described in subsection (a)(1)(A), including the results-oriented goals and performance measures; and

"(3) the extent to which the Food and Drug Administration has fulfilled recommendations of the Government Accountability Office with respect to such agency and information technology."

FDA Study of Mercury Compounds in Drugs and Food

Pub. L. 105–115, title IV, §413, Nov. 21, 1997, 111 Stat. 2376, provided that:

"(a) List and Analysis.—The Secretary of Health and Human Services shall, acting through the Food and Drug Administration—

"(1) compile a list of drugs and foods that contain intentionally introduced mercury compounds, and

"(2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).

The Secretary shall compile the list required by paragraph (1) within 2 years after the date of enactment of the Food and Drug Administration Modernization Act of 1997 [Nov. 21, 1997] and shall provide the analysis required by paragraph (2) within 2 years after such date of enactment.

"(b) Study.—The Secretary of Health and Human Services, acting through the Food and Drug Administration, shall conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study shall include data from other studies that have been made of such use.

"(c) Study of Mercury Sales.—

"(1) Study.—The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate—

"(A) the scope of mercury use as a drug or dietary supplement; and

"(B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or ingestion or inhalation of, mercury when so used.

In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any other Federal or private entity.

"(2) Regulations.—If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall be designed to protect the health of children and other sensitive populations from adverse effects resulting from exposure to, or ingestion or inhalation of, mercury. Such regulations, to the extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious ceremonies."

Management Activities Study

Pub. L. 102–571, title II, §205, Oct. 29, 1992, 106 Stat. 4502, directed Comptroller General to conduct a study of management of activities of the Food and Drug Administration that are related to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances and submit an interim report to Congress, not later than 6 months after Oct. 29, 1992, with a final report to be submitted not later than 12 months after Oct. 29, 1992.

Congressional Findings

Pub. L. 100–607, title V, §502, Nov. 4, 1988, 102 Stat. 3120, provided that: "Congress finds that—

"(1) the public health has been effectively protected by the presence of the Food and Drug Administration during the last eighty years;

"(2) the presence and importance of the Food and Drug Administration must be guaranteed; and

"(3) the independence and integrity of the Food and Drug Administration need to be enhanced in order to ensure the continuing protection of the public health."

§393a. Office of Pediatric Therapeutics

(a) Establishment

The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.

(b) Duties

The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, including increasing pediatric access to medical devices.

(c) Staff

The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include—

(1) one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population;

(2) subject to subsection (d), one or more additional individuals with necessary expertise in a pediatric subpopulation that is, as determined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States, less likely to be studied as a part of a written request issued under section 355a of this title or an assessment under section 355c of this title;

(3) one or more additional individuals with expertise in pediatric epidemiology; and

(4) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b).

(d) Neonatology expertise

At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.

(Pub. L. 107–109, §6, Jan. 4, 2002, 115 Stat. 1414; Pub. L. 110–85, title III, §306(a), Sept. 27, 2007, 121 Stat. 864; Pub. L. 112–144, title V, §511, July 9, 2012, 126 Stat. 1050; Pub. L. 115–52, title V, §505(d)(1), Aug. 18, 2017, 131 Stat. 1047.)

Editorial Notes

Codification

Section was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

2017—Subsec. (d). Pub. L. 115–52 substituted "At least" for "For the 5-year period beginning on July 9, 2012, at least".

2012—Subsec. (c)(2) to (4). Pub. L. 112–144, §511(1), added pars. (2) and (3) and redesignated former par. (2) as (4).

Subsec. (d). Pub. L. 112–144, §511(2), added subsec. (d).

2007—Subsec. (b). Pub. L. 110–85 inserted ", including increasing pediatric access to medical devices" before period at end.

§394. Scientific review groups

Without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may—

(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this chapter); and

(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

(June 25, 1938, ch. 675, §1004, formerly §903, as added Pub. L. 101–635, title III, §301, Nov. 28, 1990, 104 Stat. 4584; renumbered §904, Pub. L. 103–43, title XX, §2006(1), June 10, 1993, 107 Stat. 209; renumbered §1004, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

§395. Loan repayment program

(a) In general

(1) Authority for program

Subject to paragraph (2), the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct research, as employees of the Food and Drug Administration, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.

(2) Limitation

The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—

(A) has a substantial amount of educational loans relative to income; and

(B) agrees to serve as an employee of the Food and Drug Administration for purposes of paragraph (1) for a period of not less than 3 years.

(b) Applicability of certain provisions

With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of the Public Health Service Act [42 U.S.C. 254l et seq.], the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in such subsection in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.

(c) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996.

(June 25, 1938, ch. 675, §1005, formerly §905, as added Pub. L. 103–43, title XX, §2006(2), June 10, 1993, 107 Stat. 210; renumbered §1005, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b), is act July 1, 1944, ch. 373, 58 Stat. 682. Subpart III of part D of title III of the Act is classified generally to subpart III [§254l et seq.] of part D of subchapter II of chapter 6A of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

§396. Practice of medicine

Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

(June 25, 1938, ch. 675, §1006, formerly §906, as added Pub. L. 105–115, title II, §214, Nov. 21, 1997, 111 Stat. 2348; renumbered §1006, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§397. Contracts for expert review

(a) In general

(1) Authority

The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this chapter for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 379 of this title relating to the confidentiality of information.

(2) Increased efficiency and expertise through contracts

The Secretary may use the authority granted in paragraph (1) whenever the Secretary determines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission described in paragraph (1), unless using such authority would reduce the quality, or unduly increase the cost, of such review. The Secretary may use such authority whenever the Secretary determines that use of such a contract will improve the quality of the review of an application or submission described in paragraph (1), unless using such authority would unduly increase the cost of such review. Such improvement in timeliness or quality may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.

(b) Review of expert review

(1) In general

Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter in a timely manner.

(2) Limitation

A final decision by the Secretary on any such application or submission shall be made within the applicable prescribed time period for review of the matter as set forth in this chapter or in the Public Health Service Act (42 U.S.C. 201 et seq.).

(June 25, 1938, ch. 675, §1007, formerly §907, as added Pub. L. 105–115, title IV, §415, Nov. 21, 1997, 111 Stat. 2377; renumbered §1007, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§398. Notices to States regarding imported food

(a) In general

If the Secretary has credible evidence or information indicating that a shipment of imported food or portion thereof presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appropriate, if any, to protect the public health regarding the food involved.

(b) Rule of construction

Subsection (a) may not be construed as limiting the authority of the Secretary with respect to food under any other provision of this chapter.

(June 25, 1938, ch. 675, §1008, formerly §908, as added Pub. L. 107–188, title III, §310, June 12, 2002, 116 Stat. 673; renumbered §1008, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

§399. Grants to enhance food safety

(a) In general

The Secretary is authorized to make grants to eligible entities to—

(1) undertake examinations, inspections, and investigations, and related food safety activities under section 372 of this title;

(2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments;

(3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases;

(4) build the infrastructure and capacity of the food safety programs of such eligible entity to meet the standards as outlined in the grant application; and

(5) take appropriate action to protect the public health in response to—

(A) a notification under section 398 of this title, including planning and otherwise preparing to take such action; or

(B) a recall of food under this chapter.

(b) Eligible entities; application

(1) In general

In this section, the term "eligible entity" means an entity—

(A) that is—

(i) a State;

(ii) a locality;

(iii) a territory;

(iv) an Indian tribe (as defined in section 5304(e) of title 25); or

(v) a nonprofit food safety training entity that collaborates with 1 or more institutions of higher education; and

(B) that submits an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.

(2) Contents

Each application submitted under paragraph (1) shall include—

(A) an assurance that the eligible entity has developed plans to engage in the types of activities described in subsection (a);

(B) a description of the types of activities to be funded by the grant;

(C) an itemization of how grant funds received under this section will be expended;

(D) a description of how grant activities will be monitored; and

(E) an agreement by the eligible entity to report information required by the Secretary to conduct evaluations under this section.

(c) Limitations

The funds provided under subsection (a) shall be available to an eligible entity that receives a grant under this section only to the extent such entity funds the food safety programs of such entity independently of any grant under this section in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.

(d) Additional authority

The Secretary may—

(1) award a grant under this section in each subsequent fiscal year without reapplication for a period of not more than 3 years, provided the requirements of subsection (c) are met for the previous fiscal year; and

(2) award a grant under this section in a fiscal year for which the requirement of subsection (c) has not been met only if such requirement was not met because such funding was diverted for response to 1 or more natural disasters or in other extenuating circumstances that the Secretary may determine appropriate.

(e) Duration of awards

The Secretary may award grants to an individual grant recipient under this section for periods of not more than 3 years. In the event the Secretary conducts a program evaluation, funding in the second year or third year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.

(f) Progress and evaluation

(1) In general

The Secretary shall measure the status and success of each grant program authorized under the FDA Food Safety Modernization Act (and any amendment made by such Act), including the grant program under this section. A recipient of a grant described in the preceding sentence shall, at the end of each grant year, provide the Secretary with information on how grant funds were spent and the status of the efforts by such recipient to enhance food safety. To the extent practicable, the Secretary shall take the performance of such a grant recipient into account when determining whether to continue funding for such recipient.

(2) No duplication

In carrying out paragraph (1), the Secretary shall not duplicate the efforts of the Secretary under other provisions of this chapter or the FDA Food Safety Modernization Act that require measurement and review of the activities of grant recipients under either this chapter or such Act.

(g) Supplement not supplant

Grant funds received under this section shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this section.

(h) Authorization of appropriations

For the purpose of making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 2015.

(June 25, 1938, ch. 675, §1009, formerly §909, as added Pub. L. 107–188, title III, §311, June 12, 2002, 116 Stat. 673; renumbered §1009 and amended Pub. L. 111–31, div. A, title I, §§101(b)(2), 103(n), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, §210(a), Jan. 4, 2011, 124 Stat. 3948.)

Editorial Notes

References in Text

The FDA Food Safety Modernization Act, referred to in subsec. (f), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Amendments

2011—Pub. L. 111–353 amended section generally. Prior to amendment, section related to grants to States for inspections.

2009—Subsec. (b). Pub. L. 111–31, §103(n), made technical amendment to reference in original act which appears in text as reference to section 398 of this title.

Statutory Notes and Related Subsidiaries

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

§399a. Office of the Chief Scientist

(a) Establishment; appointment

The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.

(b) Duties of the Office

The Office of the Chief Scientist shall—

(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;

(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;

(3) develop and advocate for a budget to support intramural research;

(4) develop a peer review process by which intramural research can be evaluated;

(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include—

(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; and

(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and

(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

(June 25, 1938, ch. 675, §1010, formerly §910, as added Pub. L. 110–85, title VI, §602, Sept. 27, 2007, 121 Stat. 898; renumbered §1010, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

§399b. Office of Women's Health

(a) Establishment

There is established within the Office of the Commissioner, an office to be known as the Office of Women's Health (referred to in this section as the "Office"). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.

(b) Purpose

The Director of the Office shall—

(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the "Administration") levels of activity regarding women's participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;

(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women's health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;

(3) provide information to women and health care providers on those areas in which differences between men and women exist;

(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women's issues, consumer organizations, and women's health professionals on Administration policy with regard to women;

(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and

(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 237a(b)(4) of title 42).

(c) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.

(June 25, 1938, ch. 675, §1011, as added Pub. L. 111–148, title III, §3509(g), Mar. 23, 2010, 124 Stat. 536.)

Editorial Notes

Codification

Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–353, title II, §209(a), Jan. 4, 2011, 124 Stat. 3945, and subsequently renumbered section 1012 by Pub. L. 114–255, div. A, title III, §3073(b)(2), Dec. 13, 2016, 130 Stat. 1137, and is classified to section 399c of this title.

§399c. Improving the training of State, local, territorial, and tribal food safety officials

(a) Training

The Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this chapter, including programs for—

(1) scientific training;

(2) training to improve the skill of officers and employees authorized to conduct inspections under sections 372 and 374 of this title;

(3) training to achieve advanced product or process specialization in such inspections;

(4) training that addresses best practices;

(5) training in administrative process and procedure and integrity issues;

(6) training in appropriate sampling and laboratory analysis methodology; and

(7) training in building enforcement actions following inspections, examinations, testing, and investigations.

(b) Partnerships with State and local officials

(1) In general

The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, territorial, or tribal department or agency, is authorized and encouraged to conduct examinations, testing, and investigations for the purposes of determining compliance with the food safety provisions of this chapter through the officers and employees of such State, local, territorial, or tribal department or agency.

(2) Content

A contract or memorandum described under paragraph (1) shall include provisions to ensure adequate training of such officers and employees to conduct such examinations, testing, and investigations. The contract or memorandum shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations performed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency.

(3) Effect

Nothing in this subsection shall be construed to limit the authority of the Secretary under section 372 of this title.

(c) Extension service

The Secretary shall ensure coordination with the extension activities of the National Institute of Food and Agriculture of the Department of Agriculture in advising producers and small processors transitioning into new practices required as a result of the enactment of the FDA Food Safety Modernization Act and assisting regulated industry with compliance with such Act.

(d) National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program

(1) In general

In order to improve food safety and reduce the incidence of foodborne illness, the Secretary shall, not later than 180 days after January 4, 2011, enter into one or more memoranda of understanding, or enter into other cooperative agreements, with the Secretary of Agriculture to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to—

(A) owners and operators of farms;

(B) small food processors; and

(C) small fruit and vegetable merchant wholesalers.

(2) Implementation

The competitive grant program established under paragraph (1) shall be carried out in accordance with section 7625 of title 7.

(e) Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal years 2011 through 2015.

(June 25, 1938, ch. 675, §1012, formerly §1011, as added Pub. L. 111–353, title II, §209(a), Jan. 4, 2011, 124 Stat. 3945; renumbered §1012, Pub. L. 114–255, div. A, title III, §3073(b)(2), Dec. 13, 2016, 130 Stat. 1137.)

Editorial Notes

References in Text

The FDA Food Safety Modernization Act, referred to in subsec. (c), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Prior Provisions

A prior section 1012 of act June 25, 1938, was renumbered section 1013 and is classified to section 399d of this title.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

§399d. Employee protections

(a) In general

No entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may discharge an employee or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment because the employee, whether at the employee's initiative or in the ordinary course of the employee's duties (or any person acting pursuant to a request of the employee)—

(1) provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this chapter or any order, rule, regulation, standard, or ban under this chapter, or any order, rule, regulation, standard, or ban under this chapter; ¹

(2) testified or is about to testify in a proceeding concerning such violation;

(3) assisted or participated or is about to assist or participate in such a proceeding; or

(4) objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this chapter, or any order, rule, regulation, standard, or ban under this chapter.

(b) Process

(1) In general

A person who believes that he or she has been discharged or otherwise discriminated against by any person in violation of subsection (a) may, not later than 180 days after the date on which such violation occurs, file (or have any person file on his or her behalf) a complaint with the Secretary of Labor (referred to in this section as the "Secretary") alleging such discharge or discrimination and identifying the person responsible for such act. Upon receipt of such a complaint, the Secretary shall notify, in writing, the person named in the complaint of the filing of the complaint, of the allegations contained in the complaint, of the substance of evidence supporting the complaint, and of the opportunities that will be afforded to such person under paragraph (2).

(2) Investigation

(A) In general

Not later than 60 days after the date of receipt of a complaint filed under paragraph (1) and after affording the complainant and the person named in the complaint an opportunity to submit to the Secretary a written response to the complaint and an opportunity to meet with a representative of the Secretary to present statements from witnesses, the Secretary shall initiate an investigation and determine whether there is reasonable cause to believe that the complaint has merit and notify, in writing, the complainant and the person alleged to have committed a violation of subsection (a) of the Secretary's findings.

(B) Reasonable cause found; preliminary order

If the Secretary concludes that there is reasonable cause to believe that a violation of subsection (a) has occurred, the Secretary shall accompany the Secretary's findings with a preliminary order providing the relief prescribed by paragraph (3)(B). Not later than 30 days after the date of notification of findings under this paragraph, the person alleged to have committed the violation or the complainant may file objections to the findings or preliminary order, or both, and request a hearing on the record. The filing of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order. Any such hearing shall be conducted expeditiously. If a hearing is not requested in such 30-day period, the preliminary order shall be deemed a final order that is not subject to judicial review.

(C) Dismissal of complaint

(i) Standard for complainant

The Secretary shall dismiss a complaint filed under this subsection and shall not conduct an investigation otherwise required under subparagraph (A) unless the complainant makes a prima facie showing that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.

(ii) Standard for employer

Notwithstanding a finding by the Secretary that the complainant has made the showing required under clause (i), no investigation otherwise required under subparagraph (A) shall be conducted if the employer demonstrates, by clear and convincing evidence, that the employer would have taken the same unfavorable personnel action in the absence of that behavior.

(iii) Violation standard

The Secretary may determine that a violation of subsection (a) has occurred only if the complainant demonstrates that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.

(iv) Relief standard

Relief may not be ordered under subparagraph (A) if the employer demonstrates by clear and convincing evidence that the employer would have taken the same unfavorable personnel action in the absence of that behavior.

(3) Final order

(A) In general

Not later than 120 days after the date of conclusion of any hearing under paragraph (2), the Secretary shall issue a final order providing the relief prescribed by this paragraph or denying the complaint. At any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation.

(B) Content of order

If, in response to a complaint filed under paragraph (1), the Secretary determines that a violation of subsection (a) has occurred, the Secretary shall order the person who committed such violation—

(i) to take affirmative action to abate the violation;

(ii) to reinstate the complainant to his or her former position together with compensation (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and

(iii) to provide compensatory damages to the complainant.

(C) Penalty

If such an order is issued under this paragraph, the Secretary, at the request of the complainant, shall assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorneys' and expert witness fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.

(D) Bad faith claim

If the Secretary finds that a complaint under paragraph (1) is frivolous or has been brought in bad faith, the Secretary may award to the prevailing employer a reasonable attorneys' fee, not exceeding $1,000, to be paid by the complainant.

(4) Action in court

(A) In general

If the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination, the complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States with jurisdiction, which shall have jurisdiction over such an action without regard to the amount in controversy, and which action shall, at the request of either party to such action, be tried by the court with a jury. The proceedings shall be governed by the same legal burdens of proof specified in paragraph (2)(C).

(B) Relief

The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including—

(i) reinstatement with the same seniority status that the employee would have had, but for the discharge or discrimination;

(ii) the amount of back pay, with interest; and

(iii) compensation for any special damages sustained as a result of the discharge or discrimination, including litigation costs, expert witness fees, and reasonable attorney's fees.

(5) Review

(A) In general

Unless the complainant brings an action under paragraph (4), any person adversely affected or aggrieved by a final order issued under paragraph (3) may obtain review of the order in the United States Court of Appeals for the circuit in which the violation, with respect to which the order was issued, allegedly occurred or the circuit in which the complainant resided on the date of such violation. The petition for review must be filed not later than 60 days after the date of the issuance of the final order of the Secretary. Review shall conform to chapter 7 of title 5. The commencement of proceedings under this subparagraph shall not, unless ordered by the court, operate as a stay of the order.

(B) No judicial review

An order of the Secretary with respect to which review could have been obtained under subparagraph (A) shall not be subject to judicial review in any criminal or other civil proceeding.

(6) Failure to comply with order

Whenever any person has failed to comply with an order issued under paragraph (3), the Secretary may file a civil action in the United States district court for the district in which the violation was found to occur, or in the United States district court for the District of Columbia, to enforce such order. In actions brought under this paragraph, the district courts shall have jurisdiction to grant all appropriate relief including, but not limited to, injunctive relief and compensatory damages.

(7) Civil action to require compliance

(A) In general

A person on whose behalf an order was issued under paragraph (3) may commence a civil action against the person to whom such order was issued to require compliance with such order. The appropriate United States district court shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to enforce such order.

(B) Award

The court, in issuing any final order under this paragraph, may award costs of litigation (including reasonable attorneys' and expert witness fees) to any party whenever the court determines such award is appropriate.

(c) Effect of section

(1) Other laws

Nothing in this section preempts or diminishes any other safeguards against discrimination, demotion, discharge, suspension, threats, harassment, reprimand, retaliation, or any other manner of discrimination provided by Federal or State law.

(2) Rights of employees

Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement. The rights and remedies in this section may not be waived by any agreement, policy, form, or condition of employment.

(d) Enforcement

Any nondiscretionary duty imposed by this section shall be enforceable in a mandamus proceeding brought under section 1361 of title 28.

(e) Limitation

Subsection (a) shall not apply with respect to an employee of an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food who, acting without direction from such entity (or such entity's agent), deliberately causes a violation of any requirement relating to any violation or alleged violation of any order, rule, regulation, standard, or ban under this chapter.

(June 25, 1938, ch. 675, §1013, formerly §1012, as added Pub. L. 111–353, title IV, §402, Jan. 4, 2011, 124 Stat. 3968; renumbered §1013, Pub. L. 114–255, div. A, title III, §3073(b)(1), Dec. 13, 2016, 130 Stat. 1137.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

¹ So in original.

§399e. Nanotechnology

(a) In general

The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or other statutes administered by the Food and Drug Administration, to address issues relevant to the regulation of those products, including the potential toxicology of such nanomaterials, the potential benefit of new therapies derived from nanotechnology, the effects of such nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems.

(b) Activities

In conducting activities related to nanotechnology, the Secretary may—

(1) assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;

(2) in cooperation with other Federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;

(3) promote Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;

(4) promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;

(5) collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;

(6) build scientific expertise on nanomaterials within the Food and Drug Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;

(7) ensure ongoing training, as well as dissemination of new information within the centers of the Food and Drug Administration, and more broadly across the Food and Drug Administration, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;

(8) encourage the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and

(9) carry out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).

(Pub. L. 112–144, title XI, §1126, July 9, 2012, 126 Stat. 1116.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This Act, referred to in subsec. (b)(6), is Pub. L. 112–144, July 9, 2012, 126 Stat. 993, known as the Food and Drug Administration Safety and Innovation Act. For complete classification of this Act to the Code, see Tables.

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§399f. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups

(a) Communication plan

The Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs, shall review and modify, as necessary, the Food and Drug Administration's communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.

(b) Content

The communication plan described under subsection (a)—

(1) shall take into account—

(A) the goals and principles set forth in the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities issued by the Department of Health and Human Services;

(B) the nature of the medical product; and

(C) health and disease information available from other agencies within such Department, as well as any new means of communicating health and safety benefits and risks related to medical products;

(2) taking into account the nature of the medical product, shall address the best strategy for communicating safety alerts, labeled indications for the medical products, changes to the label or labeling of medical products (including black-box warnings, health advisories, health and safety benefits and risks), particular actions to be taken by health care professionals and patients, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication; and

(3) shall include a process for implementation of any improvements or other modifications determined to be necessary.

(c) Issuance and posting of communication plan

(1) Communication plan

Not later than 1 year after July 9, 2012, the Secretary, acting through the Commissioner of Food and Drugs, shall issue the communication plan described under this section.

(2) Posting of communication plan on the office of minority health web site

The Secretary, acting through the Commissioner of Food and Drugs, shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of the Food and Drug Administration, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan.

(Pub. L. 112–144, title XI, §1138, July 9, 2012, 126 Stat. 1125.)

Editorial Notes

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§399g. Food and Drug Administration Intercenter Institutes

(a) In general

The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an "Institute") for a major disease area or areas. With respect to the major disease area of focus of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major disease area or areas, among the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (for the purposes of this section, referred to as the "Centers"). Such activities may include—

(1) coordination of staff from the Centers with diverse product expertise in the diagnosis, cure, mitigation, treatment, or prevention of the specific diseases relevant to the major disease area of focus of the Institute;

(2) streamlining, where appropriate, the review of medical products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of the Institute, applying relevant standards under sections 355, 360(k), 360c(f)(2), and 360e of this title and section 262 of title 42, and other applicable authorities;

(3) promotion of scientific programs within the Centers related to the major disease area of focus of the Institute;

(4) development of programs and enhancement of strategies to recruit, train, and provide continuing education opportunities for the personnel of the Centers with expertise related to the major disease area of focus of the Institute;

(5) enhancement of the interactions of the Centers with patients, sponsors, and the external biomedical community regarding the major disease area of focus of the Institute; and

(6) facilitation of the collaborative relationships of the Centers with other agencies within the Department of Health and Human Services regarding the major disease area of focus of the Institute.

(b) Public process

The Secretary shall provide a period for public comment during the time that each Institute is being implemented.

(c) Timing

The Secretary shall establish at least one Institute under subsection (a) before the date that is 1 year after December 13, 2016.

(d) Termination of Institutes

The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public health. Not less than 60 days prior to so terminating an Institute, the Secretary shall provide public notice, including the rationale for such termination.

(June 25, 1938, ch. 675, §1014, as added Pub. L. 114–255, div. A, title III, §3073(a), Dec. 13, 2016, 130 Stat. 1136.)

§399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing

(a) In general

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—

(1) may, to support the advancement, development, and implementation of advanced and continuous pharmaceutical manufacturing—

(A) solicit requests for designation as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing (in this section referred to as a "National Center of Excellence");

(B) beginning not later than one year after December 29, 2022, designate as National Centers of Excellence institutions of higher education or consortia of institutions of higher education that—

(i) request such designation; and

(ii) meet the eligibility criteria specified in subsection (c); and

(C) award grants to such institutions or consortia of institutions; and

(2) shall so designate not more than 5 institutions of higher education or consortia of such institutions.

(b) Request for designation

A request for designation under subsection (a) shall be made to the Secretary at such time, in such manner, and containing such information as the Secretary may require.

(c) Eligibility criteria for designation

To be eligible to receive a designation under this section, an institution of higher education or consortium of institutions of higher education shall include in its request for designation a description of the institution's or consortium's—

(1) physical capacity and technical capabilities to conduct advanced research on, and to develop and implement, advanced and continuous pharmaceutical manufacturing;

(2) collaboration or partnerships with other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, contract manufacturers, and other relevant entities;

(3) proven capacity to design, develop, implement, and demonstrate new, highly effective technologies for use in advanced and continuous pharmaceutical manufacturing;

(4) proven ability to facilitate training of a qualified workforce for advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing; and

(5)(A) experience in participating in and leading advanced and continuous pharmaceutical manufacturing technology partnerships with other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, contract manufacturers, and other relevant entities to—

(i) support the implementation of advanced or continuous pharmaceutical manufacturing for companies manufacturing or seeking to manufacture in the United States;

(ii) support Federal agencies with technical assistance and workforce training, which may include regulatory and quality metric guidance as applicable, and hands-on training, for advanced and continuous pharmaceutical manufacturing;

(iii) organize and conduct advanced research and development activities, with respect to advanced or continuous pharmaceutical manufacturing, needed to develop new and more effective technology, and to develop and support technological leadership;

(iv) develop best practices for designing, developing, and implementing advanced and continuous pharmaceutical manufacturing processes; and

(v) identify and assess workforce needs for advanced and continuous pharmaceutical manufacturing, and address such workforce needs, which may include the development and implementing of training programs; or

(B) a plan, to be implemented within 2 years, to establish partnerships described in subparagraph (A).

(d) Termination of designation

The Secretary may terminate the designation of any National Center of Excellence designated under this section if the Secretary determines such National Center of Excellence no longer meets the criteria specified in subsection (c). Not later than 90 days before the effective date of such a termination, the Secretary shall provide written notice to the National Center of Excellence, including the rationale for such termination.

(e) Conditions for designation

As a condition of designation as a National Center of Excellence under this section, the Secretary shall require that an institution of higher education or consortium of institutions of higher education enter into an agreement with the Secretary under which the institution or consortium agrees—

(1) to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g);

(2) to share data with the Food and Drug Administration regarding best practices and research generated through the funding under subsection (f);

(3) to develop, along with industry partners (which may include large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, and contract research organizations or contract manufacturers that carry out drug development and manufacturing activities) and another institution or consortium designated under this section, if any, a strategic plan for developing an advanced and continuous pharmaceutical manufacturing workforce;

(4) to develop, along with industry partners and other institutions or consortia of such institutions designated under this section, a strategic plan for strengthening existing, and developing new, partnerships with other institutions of higher education or consortia thereof, or nonprofit organizations; and

(5) to provide an annual report to the Food and Drug Administration regarding the designee's activities under this section, including a description of how the designee continues to meet and make progress on the criteria specified in subsection (c).

(f) Funding

(1) In general

The Secretary shall award funding, through grants, contracts, or cooperative agreements, to the entities designated as National Centers of Excellence under this section for the purposes of supporting the advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing, and recommending improvements to advanced and continuous pharmaceutical manufacturing, including—

(A) expanding capacity for advanced research on, and development of, advanced and continuous pharmaceutical manufacturing; and

(B) implementing advanced research capacity and capabilities in advanced and continuous pharmaceutical manufacturing suitable for accelerating the development of drug products needed to respond to public health threats, mitigate or prevent drug shortages, address drug quality issues and supply chain disruptions, and other circumstances with respect to which the Secretary may determine the rapid development of new products or new manufacturing processes may be appropriate.

(2) Consistency with FDA mission

As a condition on receipt of funding under this subsection, a National Center of Excellence shall consider any input from the Secretary regarding the use of funding related to—

(A) best practices to increase, and provide for the advancement of, advanced and continuous pharmaceutical manufacturing through the National Center of Excellence; and

(B) the extent to which activities conducted by the National Center of Excellence are consistent with the mission of the Food and Drug Administration.

(3) Rule of construction

Nothing in this section shall be construed as precluding a National Center for Excellence designated under this section from receiving funds under any other provision of this Act or any other Federal law.

(g) Annual review and reports

(1) Annual report to Congress

Beginning not later than one year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall—

(A) submit to Congress a report describing the activities, partnerships and collaborations, Federal policy recommendations, previous and continuing funding, and findings of, and any other applicable information from, the National Centers of Excellence designated under this section;

(B) include in such report an accounting of the Federal administrative expenses described in subsection (i)(2) over the reporting period; and

(C) make such report available to the public in an easily accessible electronic format on the website of the Food and Drug Administration.

(2) Center of Excellence report

An entity receiving a grant under this section shall, not later than 1 year after receiving such grant, and annually thereafter for the duration of the grant period, submit to the Secretary a summary of programs and activities funded under the grant.

(3) Periodic review

The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such National Centers of Excellence continue to meet the criteria for designation under this section.

(4) Additional report to Congress

Not later than 1 year after the date on which the first designation is made under subsection (a), the Secretary, in consultation with the National Centers of Excellence designated under this section, shall submit a report to the Congress on the role of the Food and Drug Administration in supporting advanced and continuous pharmaceutical manufacturing, including—

(A) a national framework of principles related to the implementation of advanced and continuous pharmaceutical manufacturing;

(B) a plan for the development of Federal regulations and guidance to support and facilitate the incorporation of advanced or continuous manufacturing into the development of pharmaceuticals;

(C) a plan for development of Federal regulations or guidance related to the review of advanced and continuous pharmaceutical manufacturing, including how such manufacturing practices may be incorporated into the review of medical product applications; and

(D) a summary of relevant feedback related to improving advanced and continuous pharmaceutical manufacturing solicited from the public, which may include other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, and contract manufacturers, and other relevant entities.

(h) Definitions

In this section:

(1) Advanced and continuous pharmaceutical manufacturing

The term "advanced and continuous pharmaceutical manufacturing" refers to a method of pharmaceutical manufacturing, or a combination of pharmaceutical manufacturing methods—

(A) that incorporates a novel technology, or uses an established technique or technology in a new or innovative way, that enhances drug quality or improves the manufacturing process for a drug, including processes that may apply to advanced therapies and the production of biological products, such as cell and gene therapies; or

(B) for which the input materials are continuously fed into and transformed within the process, and the output materials are continuously removed from the system, utilizing an integrated manufacturing process that consists of a series of 2 or more simultaneous unit operations.

(2) Biological product

The term "biological product" has the meaning given such term in section 262(i) of title 42.

(3) Drug

The term "drug" has the meaning given such term in section 321(g) of this title.

(4) Institution of higher education

The term "institution of higher education" has the meaning given such term in section 1001(a) of title 20.

(5) Secretary

The term "Secretary" means the Secretary of Health and Human Services.

(i) Authorization of appropriations

(1) In general

There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027.

(2) Federal administrative expenses

Of the amounts made available to carry out this section for a fiscal year, the Secretary shall not use more than 8 percent for Federal administrative expenses, including training, technical assistance, reporting, and evaluation.

(Pub. L. 114–255, div. A, title III, §3016, Dec. 13, 2016, 130 Stat. 1095; Pub. L. 117–328, div. FF, title III, §3204(a), Dec. 29, 2022, 136 Stat. 5815.)

Editorial Notes

References in Text

This Act, referred to in subsec. (f)(3), is Pub. L. 114–255, Dec. 13, 2016, 130 Stat. 1033, known as the 21st Century Cures Act. For complete classification of this Act to the Code, see Short Title of 2016 Amendment note set out under section 201 of Title 42, The Public Health and Welfare, and Tables.

Codification

Section was enacted as part of the 21st Century Cures Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

2022—Pub. L. 117–328 amended section generally. Prior to amendment, section related to grants for studying continuous drug manufacturing.

Statutory Notes and Related Subsidiaries

Transition Rule

Pub. L. 117–328, div. FF, title III, §3204(b), Dec. 29, 2022, 136 Stat. 5819, provided that: "Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h), as in effect on the day before the date of the enactment of this section [Dec. 29, 2022], shall apply with respect to grants awarded under such section before such date of enactment."

§399i. Food and Drug Administration Working Capital Fund

(a) In general

There is hereby established in the Treasury of the United States a Working Capital Fund (the Fund) to be administered by the Food and Drug Administration (FDA), without fiscal year limitation, for the payment of salaries, travel, and other expenses necessary to the maintenance and operation of (1) a supply service for the purchase, storage, handling, issuance, packing, or shipping of stationery, supplies, materials, equipment, and blank forms, for which stocks may be maintained to meet, in whole or in part, the needs of the FDA and requisitions of other Government Offices, and (2) such other services as the Commissioner of the FDA, subject to review by the Secretary of Health and Human Services, determines may be performed more advantageously as central services. The Fund shall be reimbursed from applicable discretionary resources, notwithstanding any otherwise applicable purpose limitations, available when services are performed or stock furnished, or in advance, on a basis of rates which shall include estimated or actual charges for personal services, materials, equipment, information technology, and other expenses. Charges for equipment and information technology shall include costs associated with maintenance, repair, and depreciation (including improvement and replacement).

(b) Appropriations

Of any discretionary resources appropriated in this Act for fiscal year 2018 for "Department of Health and Human Services, Food and Drug Administration, Salaries and Expenses", not to exceed $5,000,000 of amounts available as of September 30 may be transferred to and merged with the Fund established under subsection (a), notwithstanding any otherwise applicable purpose limitations.

(c) Emergency funds excluded

No amounts may be transferred pursuant to this section that are designated by the Congress as an emergency requirement pursuant to a concurrent resolution on the budget or the Balanced Budget and Emergency Deficit Control Act of 1985.

(Pub. L. 115–141, div. A, title VII, §722, Mar. 23, 2018, 132 Stat. 387.)

Editorial Notes

References in Text

This Act, referred to in subsec. (b), is div. A of Pub. L. 115–141, Mar. 23, 2018, 132 Stat. 351, known as the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018. For complete classification of this Act to the Code, see Tables.

The Balanced Budget and Emergency Deficit Control Act of 1985, referred to in subsec. (c), is title II of Pub. L. 99–177, Dec. 12, 1985, 99 Stat. 1038, which enacted chapter 20 (§900 et seq.) and sections 654 to 656 of Title 2, The Congress, amended sections 602, 622, 631 to 642, and 651 to 653 of Title 2, sections 1104 to 1106, and 1109 of Title 31, Money and Finance, and section 911 of Title 42, The Public Health and Welfare, repealed section 661 of Title 2, enacted provisions set out as notes under section 900 of Title 2 and section 911 of Title 42, and amended provisions set out as a note under section 621 of Title 2. For complete classification of this Act to the Code, see Short Title note set out under section 900 of Title 2 and Tables.

Codification

Section was enacted as part of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018, and also as part of the Consolidated Appropriations Act, 2018, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

CHAPTER 10—POULTRY AND POULTRY PRODUCTS INSPECTION

        

§451. Congressional statement of findings

Poultry and poultry products are an important source of the Nation's total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential in the public interest that the health and welfare of consumers be protected by assuring that poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or misbranded poultry products impair the effective regulation of poultry products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged poultry products, and result in sundry losses to poultry producers and processors of poultry and poultry products, as well as injury to consumers. It is hereby found that all articles and poultry which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce, and that regulation by the Secretary of Agriculture and cooperation by the States and other jurisdictions as contemplated by this chapter are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.

(Pub. L. 85–172, §2, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90–492, §2, Aug. 18, 1968, 82 Stat. 791.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 inserted provisions stating it to be necessary that the health and welfare of consumers be protected by assuring that poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged, provisions that misbranded poultry products impair the effective regulation of poultry products and destroy markets for wholesome, not adulterated, and properly labeled and packaged poultry products, and result in sundry losses to poultry producers and processors of poultry and poultry products, as well as injury to consumers, and provisions that all articles and poultry which are regulated by this chapter are either in interstate or foreign commerce or substantially affect such commerce and that regulation by the Secretary of Agriculture and cooperation by the states and other jurisdictions as contemplated by this chapter are appropriate to serve the specified aims, and struck out provisions that all poultry and poultry products which have or are required to have inspection under this chapter are either in the current of interstate or foreign commerce or directly affect such commerce, provisions that that part entering directly into the current of interstate or foreign commerce cannot be effectively inspected and regulated without also inspecting and regulating all poultry and poultry products in the same establishment, and provisions authorizing the Secretary to designate major consuming areas.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Pub. L. 90–492, §20, Aug. 18, 1968, 82 Stat. 808, provided that: "This Act [see Short Title of 1968 Amendment note below] shall become effective upon enactment [Aug. 18, 1968] except as provided in paragraphs (a) through (c):

"(a) The provisions of subparagraphs (a)(2)(A) and (a)(3) of section 9 of the Poultry Products Inspection Act, as amended by section 9 of this Act [section 458(a)(2)(A) and (a)(3) of this title], shall become effective upon the expiration of sixty days after enactment hereof [Aug. 18, 1968].

"(b) Section 14 of this Act, amending section 15 of the Poultry Products Inspection Act [section 464 of this title], shall become effective upon the expiration of sixty days after enactment hereof [Aug. 18, 1968].

"(c) Paragraph 11(d) of the Poultry Products Inspection Act, as added by section 11 of this Act [section 460(d) of this title], shall become effective upon the expiration of sixty days after enactment hereof [Aug. 18, 1968]."

Effective Date

Pub. L. 85–172, §29, formerly §22, Aug. 28, 1957, 71 Stat. 449, as renumbered by Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805, provided that: "This Act [this chapter] shall take effect upon enactment [Aug. 28, 1957], except that no person shall be subject to the provisions of this Act [this chapter] prior to January 1, 1959, unless such person after January 1, 1958, applies for and receives inspection for poultry or poultry products in accordance with the provisions of this Act [this chapter] and pursuant to regulations promulgated by the Secretary hereunder, in any establishment processing poultry or poultry products in commerce or in a designated major consuming area. Any person who voluntarily applies for and receives such inspection after January 1, 1958, shall be subject, on and after the date he commences to receive such inspection, to all of the provisions and penalties provided for in this Act [this chapter] with respect to all poultry or poultry products handled in the establishment for which such said application for inspection is made."

Short Title of 1968 Amendment

Pub. L. 90–492, §1, Aug. 18, 1968, 82 Stat. 791, provided: "That this Act [enacting sections 467a to 467f and 470 of this title, amending this section and sections 452 to 461, 463 to 465, and 467 of this title, and enacting provisions set out as notes under this section] may be cited as the 'Wholesome Poultry Products Act'."

Short Title

Pub. L. 85–172, §1, Aug. 28, 1957, 71 Stat. 441, provided: "That this Act [enacting this chapter and provisions set out as notes under this section] may be cited as the 'Poultry Products Inspection Act'."

Separability

Pub. L. 90–492, §19, Aug. 18, 1968, 82 Stat. 808, provided that: "If any provisions of this Act or of the amendments made hereby [see Short Title of 1968 Amendment note above] or the application thereof to any person or circumstances is held invalid, the validity of the remainder of the Act and the remaining amendments and of the application of such provision to other persons and circumstances shall not be affected thereby."

Pub. L. 85–172, §28, formerly §21, Aug. 28, 1957, 71 Stat. 449, as renumbered by Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805, provided that: "If any provision of this Act [this chapter] or the application thereof to any person or circumstances is held invalid, the validity of the remainder of the Act and of the application of such provision to other persons and circumstances shall not be affected thereby."

Food Additives Amendment of 1958

Pub. L. 85–929, §7, Sept. 6, 1958, 72 Stat. 1789, provided that: "Nothing in this Act [amending sections 321, 331, 342, 346, and 348 of this title and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321 and 342 of this title] shall be construed to exempt any meat or meat food product or any person from any requirement imposed by or pursuant to the Poultry Products Inspection Act (21 U.S.C. 451 and the following) [this chapter] or the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended and extended (21 U.S.C. 71 and the following) [see section 601 et seq. of this title]."

§452. Congressional declaration of policy

It is hereby declared to be the policy of the Congress to provide for the inspection of poultry and poultry products and otherwise regulate the processing and distribution of such articles as hereinafter prescribed to prevent the movement or sale in interstate or foreign commerce of, or the burdening of such commerce by, poultry products which are adulterated or misbranded. It is the intent of Congress that when poultry and poultry products are condemned because of disease, the reason for condemnation in such instances shall be supported by scientific fact, information, or criteria, and such condemnation under this chapter shall be achieved through uniform inspection standards and uniform applications thereof.

(Pub. L. 85–172, §3, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90–492, §3, Aug. 18, 1968, 82 Stat. 792.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 inserted provisions declaring the policy of Congress to be to otherwise regulate the processing and distribution of poultry and poultry products as hereinafter prescribed so as to prevent the movement or sale in interstate commerce of, or the burdening of such commerce by poultry products which are adulterated or misbranded, and provisions that declared the policy of Congress to be that condemnation of diseased poultry and poultry products shall be achieved through uniform inspection standards and supported by scientific fact or criteria, and struck out provisions that declared the policy of Congress to be to provide for inspection by the inspection service to prevent the movement in interstate commerce or foreign commerce or in a designated major consuming area of poultry products which are unwholesome, adulterated, or otherwise unfit for human food.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§453. Definitions

For purposes of this chapter—

(a) The term "commerce" means commerce between any State, any territory, or the District of Columbia, and any place outside thereof; or within any territory not organized with a legislative body, or the District of Columbia.

(b) Except as otherwise provided in this chapter, the term "State" means any State of the United States and the Commonwealth of Puerto Rico.

(c) The term "territory" means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.

(d) The term "United States" means the States, the District of Columbia, and the territories of the United States.

(e) The term "poultry" means any domesticated bird, whether live or dead.

(f) The term "poultry product" means any poultry carcass, or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting products which contain poultry ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the poultry food industry, and which are exempted by the Secretary from definition as a poultry product under such conditions as the Secretary may prescribe to assure that the poultry ingredients in such products are not adulterated and that such products are not represented as poultry products.

(g) The term "adulterated" shall apply to any poultry product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;

(2)(A) if it bears or contains (by reason of administration of any substance to the live poultry or otherwise) any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food;

(B) if it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 346a of this title;

(C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title;

(D) if it bears or contains any color additive which is unsafe within the meaning of section 379e of this title: Provided, That an article which is not otherwise deemed adulterated under clause (B), (C), or (D) shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive in or on such article is prohibited by regulations of the Secretary in official establishments;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

(5) if it is, in whole or in part, the product of any poultry which has died otherwise than by slaughter;

(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title;

(8) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

(h) The term "misbranded" shall apply to any poultry product under one or more of the following circumstances:

(1) if its labeling is false or misleading in any particular;

(2) if it is offered for sale under the name of another food;

(3) if it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and immediately thereafter, the name of the food imitated;

(4) if its container is so made, formed, or filled as to be misleading;

(5) unless it bears a label showing (A) the name and the place of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the quantity of the product in terms of weight, measure, or numerical count: Provided, That under clause (B) of this subparagraph (5), reasonable variations may be permitted, and exemptions as to small packages or articles not in packages or other containers may be established by regulations prescribed by the Secretary;

(6) if any word, statement, or other information required by or under authority of this chapter to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(7) if it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by regulations of the Secretary under section 457 of this title unless (A) it conforms to such definition and standard, and (B) its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food;

(8) if it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations of the Secretary under section 457 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(9) if it is not subject to the provisions of subparagraph (7), unless its label bears (A) the common or usual name of the food, if any there be, and (B) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings may, when authorized by the Secretary, be designated as spices, flavorings, and colorings without naming each: Provided, That to the extent that compliance with the requirements of clause (B) of this subparagraph (9) is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary;

(10) if it purports to be or is represented for special dietary uses unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary, after consultation with the Secretary of Health and Human Services, determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses;

(11) if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative unless it bears labeling stating that fact: Provided, That, to the extent that compliance with the requirements of this subparagraph (11) is impracticable, exemptions shall be established by regulations promulgated by the Secretary; or

(12) if it fails to bear on its containers, and in the case of nonconsumer packaged carcasses (if the Secretary so requires) directly thereon, as the Secretary may by regulations prescribe, the official inspection legend and official establishment number of the establishment where the article was processed, and, unrestricted by any of the foregoing, such other information as the Secretary may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition.

(i) The term "Secretary" means the Secretary of Agriculture or his delegate.

(j) The term "person" means any individual, partnership, corporation, association, or other business unit.

(k) The term "inspector" means: (1) an employee or official of the United States Government authorized by the Secretary to inspect poultry and poultry products under the authority of this chapter, or (2) any employee or official of the government of any State or territory or the District of Columbia authorized by the Secretary to inspect poultry and poultry products under authority of this chapter, under an agreement entered into between the Secretary and the appropriate State or other agency.

(l) The term "official mark" means the official inspection legend or any other symbol prescribed by regulation of the Secretary to identify the status of any article or poultry under this chapter.

(m) The term "official inspection legend" means any symbol prescribed by regulations of the Secretary showing that an article was inspected for wholesomeness in accordance with this chapter.

(n) The term "official certificate" means any certificate prescribed by regulations of the Secretary for issuance by an inspector or other person performing official functions under this chapter.

(o) The term "official device" means any device prescribed or authorized by the Secretary for use in applying any official mark.

(p) The term "official establishment" means any establishment as determined by the Secretary at which inspection of the slaughter of poultry, or the processing of poultry products, is maintained under the authority of this chapter.

(q) The term "inspection service" means the official Government service within the Department of Agriculture designated by the Secretary as having the responsibility for carrying out the provisions of this chapter.

(r) The term "container" or "package" includes any box, can, tin, cloth, plastic, or other receptacle, wrapper, or cover.

(s) The term "label" means a display of written, printed, or graphic matter upon any article or the immediate container (not including packaged liners) of any article; and the term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(t) The term "shipping container" means any container used or intended for use in packaging the product packed in an immediate container.

(u) The term "immediate container" includes any consumer package; or any other container in which poultry products, not consumer packaged, are packed.

(v) The term "capable of use as human food" shall apply to any carcass, or part or product of a carcass, of any poultry, unless it is denatured or otherwise identified as required by regulations prescribed by the Secretary to deter its use as human food, or it is naturally inedible by humans.

(w) The term "processed" means slaughtered, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed.

(x) The term "Federal Food, Drug, and Cosmetic Act" means the Act so entitled, approved June 25, 1938 (52 Stat. 1040) [21 U.S.C. 301 et seq.], and Acts amendatory thereof or supplementary thereto.

(y) The terms "pesticide chemical", "food additive", "color additive", and "raw agricultural commodity" shall have the same meanings for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(z) The term "poultry products broker" means any person engaged in the business of buying or selling poultry products on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person.

(aa) The term "renderer" means any person engaged in the business of rendering carcasses, or parts or products of the carcasses, of poultry, except rendering conducted under inspection or exemption under this chapter.

(bb) The term "animal food manufacturer" means any person engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of poultry.

(Pub. L. 85–172, §4, Aug. 28, 1957, 71 Stat. 441; Pub. L. 87–498, June 25, 1962, 76 Stat. 110; Pub. L. 90–492, §4, Aug. 18, 1968, 82 Stat. 792; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–571, title I, §107(13), Oct. 29, 1992, 106 Stat. 4499.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in pars. (x) and (y), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

1992—Subsec. (g)(2)(D). Pub. L. 102–571 substituted "379e" for "376".

1968—Pub. L. 90–492 inserted definitions of "State", "territory", "United States", "misbranded", "official mark", "official inspection legend", "official certificate", "official device", "capable of use as human food", "processed", "Federal Food, Drug, and Cosmetic Act", "pesticide chemical", "poultry products broker", "renderer", and "animal food manufacturer", revised definitions of "commerce", "poultry", "poultry product", "adulterated", "Secretary", "inspector", "container" or "package", "label", and "immediate container", reenacted without change definitions of "person", "official establishment", "inspection service", and "shipping container", and deleted definition of "wholesome", "unwholesome", and "official inspection mark".

1962—Par. (a). Pub. L. 87–498 struck out references to Territories or possessions, and inserted definition of "State".

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in par. (h)(10) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§454. Federal and State cooperation in development and administration of State poultry product inspection programs

(a) State laws; planning, technical and financial assistance; advisory committees

It is the policy of the Congress to protect the consuming public from poultry products that are adulterated or misbranded and to assist in efforts by State and other government agencies to accomplish this objective. In furtherance of this policy—

(1) The Secretary is authorized, whenever he determines that it would effectuate the purposes of this chapter, to cooperate with the appropriate State agency in developing and administering a State poultry product inspection program in any State which has enacted a mandatory State poultry product inspection law that imposes ante mortem and post mortem inspection, reinspection and sanitation requirements that are at least equal to those under this chapter, with respect to all or certain classes of persons engaged in the State in slaughtering poultry or processing poultry products for use as human food solely for distribution within such State.

(2) The Secretary is further authorized, whenever he determines that it would effectuate the purposes of this chapter, to cooperate with appropriate State agencies in developing and administering State programs under State laws containing authorities at least equal to those provided in section 460 of this title; and to cooperate with other agencies of the United States in carrying out any provisions of this chapter. In carrying out the provisions of this chapter, the Secretary may conduct such examinations, investigations, and inspections as he determines practicable through any officer or employee of any State or Territory or the District of Columbia commissioned by the Secretary for such purpose.

(3) Cooperation with State agencies under this section may include furnishing to the appropriate State agency (i) advisory assistance in planning and otherwise developing an adequate State program under the State law; and (ii) technical and laboratory assistance and training (including necessary curricular and instructional materials and equipment), and financial and other aid for administration of such a program. The amount to be contributed to any State by the Secretary under this section from Federal funds for any year shall not exceed 50 per centum of the estimated total cost of the cooperative program; and the Federal funds shall be allocated among the States desiring to cooperate on an equitable basis. Such cooperation and payment shall be contingent at all times upon the administration of the State program in a manner which the Secretary, in consultation with the appropriate advisory committee appointed under subparagraph (4), deems adequate to effectuate the purposes of this section.

(4) The Secretary may appoint advisory committees consisting of such representatives of appropriate State agencies as the Secretary and the State agencies may designate to consult with him concerning State and Federal programs with respect to poultry product inspection and other matters within the scope of this chapter, including evaluating State programs for purposes of this chapter, and obtaining better coordination and more uniformity among the State programs and between the Federal and State programs and adequate protection of consumers.

(b) Appropriate State agency; performance of functions by subordinate governmental unit

The appropriate State agency with which the Secretary may cooperate under this chapter shall be a single agency in the State which is primarily responsible for the coordination of the State programs having objectives similar to those under this chapter. When the State program includes performance of certain functions by a municipality or other subordinate governmental unit, such unit shall be deemed to be a part of the State agency for purposes of this section.

(c) Intrastate activities; designation of State for regulation; publication of designation; exempted operations; termination of designation; review of operations in nondesignated States; annual report

(1) If the Secretary has reason to believe, by thirty days prior to the expiration of two years after August 18, 1968, that a State has failed to develop or is not enforcing, with respect to all establishments within its jurisdiction (except those that would be exempted from Federal inspection under subparagraph (2) of this paragraph (c)) at which poultry are slaughtered, or poultry products are processed for use as human food, solely for distribution within such State, and the products of such establishments, requirements at least equal to those imposed under sections 451 to 453, 455 to 459, 461 to 467d of this title, he shall promptly notify the Governor of the State of this fact. If the Secretary determines, after consultation with the Governor of the State, or representative selected by him, that such requirements have not been developed and activated, he shall promptly after the expiration of such two-year period designate such State as one in which the provisions of said sections of this chapter shall apply to operations and transactions wholly within such State: Provided, That if the Secretary has reason to believe that the State will activate such requirements within one additional year, he may delay such designation for said period, and not designate the State, if he determines at the end of the year that the State then has such requirements in effective operation. The Secretary shall publish any such designation in the Federal Register and, upon the expiration of thirty days after such publication, the provisions of said sections of this chapter shall apply to operations and transactions and to persons engaged therein in the State to the same extent and in the same manner as if such operations and transactions were conducted in or for commerce. However, notwithstanding any other provision of this section, if the Secretary determines that any establishment within a State is producing adulterated poultry products for distribution within such State which would clearly endanger the public health he shall notify the Governor of the State and the appropriate advisory committee provided for by subparagraph (a)(4) of this section of such fact for effective action under State or local law. If the State does not take action to prevent such endangering of the public health within a reasonable time after such notice, as determined by the Secretary, in light of the risk to public health, the Secretary may forthwith designate any such establishment as subject to the provisions of said sections of this chapter, and thereupon the establishment and operator thereof shall be subject to such provisions as though engaged in commerce until such time as the Secretary determines that such State has developed and will enforce requirements at least equal to those imposed under said sections.

(2) The provisions of this chapter requiring inspection of the slaughter of poultry and the processing of poultry products shall not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments if such establishments are subject to such inspection provisions only under this paragraph (c). For the purposes of this subparagraph, operations conducted at a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares poultry products that are ready to eat when they leave such facility and are served in meals or as entrees only to customers at restaurants owned or operated by the same person owning or operating such facility: Provided, That such facility shall be subject to the provisions of section 460(b) of this title: Provided further, That the facility may be subject to the inspection requirements of this chapter for as long as the Secretary deems necessary, if the Secretary determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its poultry products are rendered adulterated.

(3) Whenever the Secretary determines that any State designated under this paragraph (c) has developed and will enforce State poultry products inspection requirements at least equal to those imposed under the aforesaid sections of this chapter, with respect to the operations and transactions within such State which are regulated under subparagraph (1) of this paragraph (c), he shall terminate the designation of such State under this paragraph (c), but this shall not preclude the subsequent redesignation of the State at any time upon thirty days' notice to the Governor and publication in the Federal Register in accordance with this paragraph, and any State may be designated upon such notice and publication, at any time after the period specified in this paragraph whether or not the State has theretofore been designated, upon the Secretary determining that it is not effectively enforcing requirements at least equal to those imposed under said sections.

(4) The Secretary shall promptly upon August 18, 1968, and periodically thereafter, but at least annually, review the requirements, including the enforcement thereof, of the several States not designated under this paragraph (c), with respect to the slaughter, and the processing, storage, handling, and distribution of poultry products, and inspection of such operations, and annually report thereon to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate in the report required in section 470 ¹ of this title.

(d) "State" defined

As used in this section, the term "State" means any State (including the Commonwealth of Puerto Rico) or organized territory.

(Pub. L. 85–172, §5, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90–492, §5, Aug. 18, 1968, 82 Stat. 796; Pub. L. 98–487, §2, Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103–437, §8(1), Nov. 2, 1994, 108 Stat. 4588.)

Editorial Notes

References in Text

Section 470 of this title, referred to in subsec. (c)(4), was omitted from the Code.

Codification

In par. (c)(1), (4), "August 18, 1968" substituted for "enactment of the Wholesome Poultry Products Act".

Amendments

1994—Subsec. (c)(4). Pub. L. 103–437 substituted "Agriculture, Nutrition, and Forestry" for "Agriculture and Forestry".

1984—Par. (c)(2). Pub. L. 98–487 inserted provisions relating to operations conducted at a restaurant central kitchen facility.

1968—Pub. L. 90–492 substituted provisions authorizing the Secretary to cooperate with the appropriate state agency in the development and administration of state poultry product inspection programs in those states having mandatory poultry product inspection laws and those states having laws at least equal to the provisions of section 460 of this title, provisions authorizing planning, technical and financial assistance and the appointment of advisory committees, provisions designating the appropriate state agency with which the Secretary may cooperate, provisions authorizing the Secretary to designate states as subject to the regulatory provisions of this chapter when the requirements of the specified section have not been complied with or when the specified intrastate activities are present, provisions exempting from the requirements of this chapter operations of the types traditionally and usually conducted at retail stores and restaurants, provisions authorizing the Secretary to terminate the aforementioned designation of states as subject to the regulatory provisions of this chapter, and provisions authorizing the Secretary to review the operations in nondesignated states and make an annual report thereon, for provisions authorizing the Secretary, upon application by any appropriate state or local official or agency or by any appropriate local poultry industry group and after public hearing, to designate major consuming areas as subject to the regulatory provisions of this chapter where the Secretary finds that poultry or poultry products are handled or consumed in such volume as to affect, burden or obstruct the movement of inspected poultry products in interstate commerce.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

¹ See References in Text note below.

§455. Inspection in official establishments

(a) Ante mortem inspection

For the purpose of preventing the entry into or flow or movement in commerce of, or the burdening of commerce by, any poultry product which is capable of use as human food and is adulterated, the Secretary shall, where and to the extent considered by him necessary, cause to be made by inspectors ante mortem inspection of poultry in each official establishment processing poultry or poultry products for commerce or otherwise subject to inspection under this chapter.

(b) Post mortem inspection; quarantine, segregation, and reinspection

The Secretary, whenever processing operations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcass of each bird processed, and at any time such quarantine, segregation, and reinspection as he deems necessary of poultry and poultry products capable of use as human food in each official establishment processing such poultry or poultry products for commerce or otherwise subject to inspection under this chapter.

(c) Condemnation; appeal; reprocessing

All poultry carcasses and parts thereof and other poultry products found to be adulterated shall be condemned and shall, if no appeal be taken from such determination of condemnation, be destroyed for human food purposes under the supervision of an inspector: Provided, That carcasses, parts, and products, which may by reprocessing be made not adulterated, need not be so condemned and destroyed if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated. If an appeal be taken from such determination, the carcasses, parts, or products shall be appropriately marked and segregated pending completion of an appeal inspection, which appeal shall be at the cost of the appellant if the Secretary determines that the appeal is frivolous. If the determination of condemnation is sustained the carcasses, parts, and products shall be destroyed for human food purposes under the supervision of an inspector.

(Pub. L. 85–172, §6, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90–492, §6, Aug. 18, 1968, 82 Stat. 798.)

Editorial Notes

Amendments

1968—Par. (a). Pub. L. 90–492, §6(a), substituted "of, or the burdening of commerce by, any poultry product which is capable of use as human food and is adulterated," for "or a designated major consuming area of any poultry product which is unwholesome or adulterated," "each official establishment" for "any official establishment", and "otherwise subject to inspection under this chapter" for "in, or for marketing in a designated city or area".

Par. (b). Pub. L. 90–492, §6(b), substituted "segregation, and reinspection" for "segregation, reinspection", and "otherwise subject to inspection under this chapter" for "in, or for marketing in a designated city or area", and inserted "capable of use as human food" after "necessary of poultry and poultry products".

Par. (c). Pub. L. 90–492, §6(c), inserted "other" before "poultry products", and substituted "to be adulterated" for "to be unwholesome or adulterated", "made not adulterated" for "made not unwholesome and not adulterated", and "to be not adulterated" for "to be not unwholesome and not adulterated".

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

Applicability of Chapter Requirements to Birds of the Order Ratitae

Pub. L. 106–387, §1(a) [title VII, §752], Oct. 28, 2000, 114 Stat. 1549, 1549A-41, provided that: "Effective 180 days after the date of the enactment of this Act [Oct. 28, 2000] and continuing for the remainder of fiscal year 2001 and each subsequent fiscal year, establishments in the United States that slaughter or process birds of the order Ratitae, such as ostriches, emus and rheas, and squab, for distribution in commerce as human food shall be subject to the ante mortem and post mortem inspection, reinspection, and sanitation requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) rather than the voluntary poultry inspection program of the Department of Agriculture under section 203 of the Agricultural Marketing Act of 1946 (7 U.S.C. 1622)."

§456. Operation of premises, facilities and equipment

(a) Sanitary practices

Each official establishment slaughtering poultry or processing poultry products for commerce or otherwise subject to inspection under this chapter shall have such premises, facilities, and equipment, and be operated in accordance with such sanitary practices, as are required by regulations promulgated by the Secretary for the purpose of preventing the entry into or flow or movement in commerce or burdensome effect upon commerce, of poultry products which are adulterated.

(b) Refusal of inspection

The Secretary shall refuse to render inspection to any establishment whose premises, facilities, or equipment, or the operation thereof, fail to meet the requirements of this section.

(Pub. L. 85–172, §7, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90–492, §7, Aug. 18, 1968, 82 Stat. 799.)

Editorial Notes

Amendments

1968—Par. (a). Pub. L. 90–492 substituted "otherwise subject to inspection under this chapter" for "in or for marketing in a designated major consuming area", "burdensome effect upon commerce" for "in a designated major consuming area", and "which are adulterated" for "which are unwholesome or adulterated".

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§457. Labeling and container standards

(a) Requirements for shipping containers and immediate containers; nonconsumer packaged carcasses

All poultry products inspected at any official establishment under the authority of this chapter and found to be not adulterated, shall at the time they leave the establishment bear, in distinctly legible form, on their shipping containers and immediate containers as the Secretary may require, the information required under paragraph (h) of section 453 of this title. In addition, the Secretary whenever he determines such action is practicable and necessary for the protection of the public, may require nonconsumer packaged carcasses at the time they leave the establishment to bear directly thereon in distinctly legible form any information required under such paragraph (h).

(b) Labeling requirements; definitions and standards of identity or composition or articles and standards of fill of container; standards consistent with Federal Food, Drug, and Cosmetic Act; consistency between Federal and State standards

The Secretary, whenever he determines such action is necessary for the protection of the public, may prescribe: (1) the styles and sizes of type to be used with respect to material required to be incorporated in labeling to avoid false or misleading labeling in marking and labeling any articles or poultry subject to this chapter; (2) definitions and standards of identity or composition or articles subject to this chapter and standards of fill of container for such articles not inconsistent with any such standards established under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and there shall be consultation between the Secretary and the Secretary of Health and Human Services prior to the issuance of such standards under either Act relating to articles subject to this chapter to avoid inconsistency in such standards and possible impairment of the coordinated effective administration of this chapter and the Federal Food, Drug, and Cosmetic Act. There shall also be consultation between the Secretary and an appropriate advisory committee provided for in section 454 of this title, prior to the issuance of such standards under this chapter, to avoid, insofar as feasible, inconsistency between Federal and State standards.

(c) Use of trade names; false or misleading marking or labeling; misleading form or size of container

No article subject to this chapter shall be sold or offered for sale by any person in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size, but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted.

(d) Withholding use of false or misleading mark, label, or container size or form; modification; hearing; conclusiveness of determination; appeal

If the Secretary has reason to believe that any marking or labeling or the size or form of any container in use or proposed for use with respect to any article subject to this chapter is false or misleading in any particular, he may direct that such use be withheld unless the marking, labeling, or container is modified in such manner as he may prescribe so that it will not be false or misleading. If the person using or proposing to use the marking, labeling, or container does not accept the determination of the Secretary, such person may request a hearing, but the use of the marking, labeling, or container shall, if the Secretary so directs, be withheld pending hearing and final determination by the Secretary. Any such determination by the Secretary shall be conclusive unless, within thirty days after receipt of notice of such final determination, the person adversely affected thereby appeals to the United States Court of Appeals for the circuit in which such person has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. The provisions of section 194 of title 7 shall be applicable to appeals taken under this section.

(Pub. L. 85–172, §8, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90–492, §8, Aug. 18, 1968, 82 Stat. 799; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in par. (b), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

1968—Par. (a). Pub. L. 90–492 substituted provisions requiring shipping containers and immediate containers, as the Secretary may order, to bear the information required under section 453(h) of this title, and provisions, whenever the Secretary determines such action to be practicable and necessary, requiring nonconsumer packaged carcasses at the time they leave the official establishment to bear the information required under the aforementioned section, for provisions requiring shipping containers to bear the official mark and the approved plant number of the official establishment in which the contents were processed, provisions requiring immediate containers to bear the official inspection mark, the name of the product, a statement of ingredients, the net weight or other appropriate measure of the contents, the name and address of the processor, and the approved plant number of the official establishment in which the contents were processed, and provisions authorizing the Secretary to make reasonable variations and grant exemptions from the foregoing labeling requirements.

Par. (b). Pub. L. 90–492 added par. (b). Provisions of former par. (b) were redesignated as pars. (c) and (d).

Par. (c). Pub. L. 90–492 redesignated part of provisions of former par. (b) as (c) and made changes in phraseology.

Par. (d). Pub. L. 90–492 redesignated part of provisions of former par. (b) as (d) and extended the authority of the Secretary to withhold from use products which have false or misleading markings or containers.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in par. (b) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§458. Prohibited acts

(a) No person shall—

(1) slaughter any poultry or process any poultry products which are capable of use as human food at any establishment processing any such articles for commerce, except in compliance with the requirements of this chapter;

(2) sell, transport, offer for sale or transportation, or receive for transportation, in commerce, (A) any poultry products which are capable of use as human food and are adulterated or misbranded at the time of such sale, transportation, offer for sale or transportation, or receipt for transportation; or (B) any poultry products required to be inspected under this chapter unless they have been so inspected and passed;

(3) do, with respect to any poultry products which are capable of use as human food, any act while they are being transported in commerce or held for sale after such transportation, which is intended to cause or has the effect of causing such products to be adulterated or misbranded;

(4) sell, transport, offer for sale or transportation, or receive for transportation, in commerce or from an official establishment, any slaughtered poultry from which the blood, feathers, feet, head, or viscera have not been removed in accordance with regulations promulgated by the Secretary, except as may be authorized by regulations of the Secretary;

(5) use to his own advantage, or reveal other than to the authorized representatives of the United States Government or any State or other government in their official capacity, or as ordered by a court in any judicial proceedings, any information acquired under the authority of this chapter concerning any matter which is entitled to protection as a trade secret.

(b) No brand manufacturer, printer, or other person shall cast, print, lithograph, or otherwise make any device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, or any form of official certificate or simulation thereof, except as authorized by the Secretary.

(c) No person shall—

(1) forge any official device, mark, or certificate;

(2) without authorization from the Secretary use any official device, mark, or certificate, or simulation thereof, or alter, detach, deface, or destroy any official device, mark, or certificate;

(3) contrary to the regulations prescribed by the Secretary, fail to use, or to detach, deface, or destroy any official device, mark, or certificate;

(4) knowingly possess, without promptly notifying the Secretary or his representative, any official device or any counterfeit, simulated, forged, or improperly altered official certificate or any device or label or any carcass of any poultry, or part or product thereof, bearing any counterfeit, simulated, forged, or improperly altered official mark;

(5) knowingly make any false statement in any shipper's certificate or other nonofficial or official certificate provided for in the regulations prescribed by the Secretary; or

(6) knowingly represent that any article has been inspected and passed, or exempted, under this chapter when, in fact, it has respectively, not been so inspected and passed, or exempted.

(Pub. L. 85–172, §9, Aug. 28, 1957, 71 Stat. 445; Pub. L. 90–492, §9, Aug. 18, 1968, 82 Stat. 800.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 made revisions in form and phraseology, added to the enumerated prohibited acts slaughtering poultry or processing any poultry products capable of use as human food, except in compliance with the requirements of this chapter, selling and transporting adulterated or misbranded poultry products or uninspected poultry products, adulterating or misbranding poultry products while they are being transported in commerce or held for sale after such transportation, treating carcasses not in accordance with regulations promulgated by the Secretary, possessing, without notifying the Secretary, any official device or any counterfeit, simulated, etc., official certificate, or any device or label bearing any counterfeit, simulated, etc., official mark, and making false representations and statements, and clarified application to brand manufacturers and printers of existing provisions prohibiting the counterfeiting of official marks, labels, or certificates.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, except that amendment of pars. (a)(2)(A) and (a)(3) effective upon the expiration of sixty days after Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§459. Compliance by all establishments

(a) In general

No establishment processing poultry or poultry products for commerce otherwise subject to this chapter shall process any poultry or poultry product except in compliance with the requirements of this chapter.

(b) Notification

Any establishment subject to inspection under this chapter that believes, or has reason to believe, that an adulterated or misbranded poultry or poultry product received by or originating from the establishment has entered into commerce shall promptly notify the Secretary with regard to the type, amount, origin, and destination of the poultry or poultry product.

(c) Plans and reassessments

The Secretary shall require that each establishment subject to inspection under this chapter shall, at a minimum—

(1) prepare and maintain current procedures for the recall of all poultry or poultry products produced and shipped by the establishment;

(2) document each reassessment of the process control plans of the establishment; and

(3) upon request, make the procedures and reassessed process control plans available to inspectors appointed by the Secretary for review and copying.

(Pub. L. 85–172, §10, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, §10, Aug. 18, 1968, 82 Stat. 801; Pub. L. 110–234, title XI, §11017(b), May 22, 2008, 122 Stat. 1370; Pub. L. 110–246, §4(a), title XI, §11017(b), June 18, 2008, 122 Stat. 1664, 2132.)

Editorial Notes

Codification

Pub. L. 110–234 and Pub. L. 110–246 made identical amendments to this section. The amendments by Pub. L. 110–234 were repealed by section 4(a) of Pub. L. 110–246.

Amendments

2008—Pub. L. 110–246, §11017(b), inserted section catchline, designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).

1968—Pub. L. 90–492 substituted "otherwise subject to this chapter" for "in or for marketing in a designated major consuming area".

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as an Effective Date note under section 8701 of Title 7, Agriculture.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§460. Miscellaneous activities subject to regulation

(a) Prohibition of inspection of articles not intended for use as human food; denaturation or other identification prior to distribution in commerce; inedible articles

Inspection shall not be provided under this chapter at any establishment for the slaughter of poultry or the processing of any carcasses or parts or products of poultry, which are not intended for use as human food, but such articles shall, prior to their offer for sale or transportation in commerce, unless naturally inedible by humans, be denatured or otherwise identified as prescribed by regulations of the Secretary to deter their use for human food. No person shall buy, sell, transport, or offer for sale or transportation, or receive for transportation, in commerce, or import, any poultry carcasses or parts or products thereof which are not intended for use as human food unless they are denatured or otherwise identified as required by the regulations of the Secretary or are naturally inedible by humans.

(b) Recordkeeping requirements; persons liable; scope of disclosure; access to places of business; examination of records, facilities, and inventories; copies; samples

The following classes of persons shall, for such period of time as the Secretary may by regulations prescribe, not to exceed two years unless otherwise directed by the Secretary for good cause shown, keep such records as are properly necessary for the effective enforcement of this chapter in order to insure against adulterated or misbranded poultry products for the American consumer; and all persons subject to such requirements shall, at all reasonable times, upon notice by a duly authorized representative of the Secretary, afford such representative access to their places of business and opportunity to examine the facilities, inventory, and records thereof, to copy all such records, and to take reasonable samples of their inventory upon payment of the fair market value therefor—

(1) Any person that engages in the business of slaughtering any poultry or processing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any poultry, for commerce, for use as human food or animal food;

(2) Any person that engages in the business of buying or selling (as poultry products brokers, wholesalers or otherwise), or transporting, in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any poultry;

(3) Any person that engages in business, in or for commerce, as a renderer, or engages in the business of buying, selling, or transporting, in commerce, or importing, any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter.

(c) Registration of business, name of person, and trade names

No person shall engage in business, in or for commerce, as a poultry products broker, renderer, or animal food manufacturer, or engage in business in commerce as a wholesaler of any carcasses, or parts or products of the carcasses, of any poultry, whether intended for human food or other purposes, or engage in business as a public warehouseman storing any such articles in or for commerce, or engage in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased poultry, or parts of the carcasses of any poultry that died otherwise than by slaughter, unless when required by regulations of the Secretary, he has registered with the Secretary his name, and the address of each place of business at which, and all trade names under which, he conducts such business.

(d) Regulation of transactions, transportation, or importation of dead, dying, disabled or diseased poultry or carcasses to prevent use as human food

No person engaged in the business of buying, selling, or transporting in commerce, or importing, dead, dying, disabled, or diseased poultry, or any parts of the carcasses of any poultry that died otherwise than by slaughter, shall buy, sell, transport, offer for sale or transportation, or receive for transportation, in commerce, or import, any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter, unless such transaction, transportation or importation is made in accordance with such regulations as the Secretary may prescribe to assure that such poultry, or the unwholesome parts or products thereof, will be prevented from being used for human food.

(e) Federal provisions applicable to State or Territorial business transactions of a local nature and not subject to local authority

The authority conferred on the Secretary by paragraph (b), (c), or (d) of this section with respect to persons engaged in the specified kinds of business in or for commerce may be exercised with respect to persons engaged, in any State or organized territory, in such kinds of business but not in or for commerce, whenever the Secretary determines, after consultation with an appropriate advisory committee provided for in section 454 of this title, that the State or territory does not have at least equal authority under its laws or such authority is not exercised in a manner to effectuate the purposes of this chapter, including the State or territory providing for the Secretary or his representative being afforded access to such places of business and the facilities, inventories, and records thereof, and the taking of reasonable samples, where he determines necessary in carrying out his responsibilities under this chapter; and in such case the provisions of paragraph (b), (c), or (d) of this section, respectively, shall apply to such persons to the same extent and in the same manner as if they were engaged in such business in or for commerce and the transactions involved were in commerce.

(Pub. L. 85–172, §11, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, §11, Aug. 18, 1968, 82 Stat. 801.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 designated existing provisions as par. (b), added pars. (a), and (c) to (e), and in par. (b), as so designated, extended the types of persons required to maintain records necessary for the enforcement of this chapter, required such persons to give representatives of the Secretary access to their places of business, and opportunity to examine records, facilities, and inventories and to copy records and take inventory samples upon payment.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, except that par. (d) effective upon the expiration of sixty days after Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§461. Offenses and punishment

(a) Violations; liability of agents, employees, and employers

Any person who violates the provisions of section 458, 459, 460, 463, or 466 of this title shall be fined not more than $1,000 or imprisoned not more than one year, or both; but if such violation involves intent to defraud, or any distribution or attempted distribution of an article that is adulterated (except as defined in section 453(g)(8) of this title), such person shall be fined not more than $10,000 or imprisoned not more than three years, or both. When construing or enforcing the provisions of said sections the act, omission, or failure of any person acting for or employed by any individual, partnership, corporation, or association within the scope of his employment or office shall in every case be deemed the act, omission, or failure of such individual, partnership, corporation, or association, as well as of such person.

(b) Liability of carrier

No carrier shall be subject to the penalties of this chapter, other than the penalties for violation of section 460 of this title, by reason of his receipt, carriage, holding, or delivery, in the usual course of business, as a carrier, of poultry or poultry products, owned by another person unless the carrier has knowledge, or is in possession of facts which would cause a reasonable person to believe that such poultry or poultry products were not inspected or marked in accordance with the provisions of this chapter or were otherwise not eligible for transportation under this chapter or unless the carrier refuses to furnish on request of a representative of the Secretary the name and address of the person from whom he received such poultry or poultry products, and copies of all documents, if any there be, pertaining to the delivery of the poultry or poultry products to such carrier.

(c) Assaulting, resisting, or impeding certain persons; murder; punishments

Any person who forcibly assaults, resists, opposes, impedes, intimidates, or interferes with any person while engaged in or on account of the performance of his official duties under this chapter shall be fined not more than $5,000 or imprisoned not more than three years, or both. Whoever, in the commission of any such acts, uses a deadly or dangerous weapon, shall be fined not more than $10,000 or imprisoned not more than ten years, or both. Whoever kills any person while engaged in or on account of the performance of his official duties under this chapter shall be punished as provided under sections 1111 and 1114 of title 18.

(Pub. L. 85–172, §12, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, §12, Aug. 18, 1968, 82 Stat. 802.)

Editorial Notes

Amendments

1968—Par. (a). Pub. L. 90–492, §12(a), inserted reference to violations of section 463 of this title, and substituted provisions that violators of the enumerated sections shall be fined not more than $1,000 or imprisoned not more than one year, or both, but that in cases involving intent to defraud, or any distribution or attempt to distribute adulterated articles, except as defined in section 453(g) of this title, the violators shall be fined not more than $10,000 or imprisoned not more than three years, or both, for provisions that violators shall be guilty of a misdemeanor and subject to imprisonment for not more than six months or a fine of not more than $3,000, or both, with increased fines and imprisonment for any subsequent violations.

Par. (b). Pub. L. 90–492, §12(b), substituted "of poultry" for "of slaughtered poultry", "such poultry" for "such slaughtered poultry", and "otherwise not eligible" for "not otherwise eligible", and inserted provision that no carrier shall be subject to punishment unless the carrier refuses to furnish the name and address of the person from whom he received such poultry or poultry products, and copies of any documents pertaining to the delivery of the poultry or poultry products to such carrier.

Par. (c). Pub. L. 90–492, §12(c), added par. (c).

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§462. Reporting of violations; notice; opportunity to present views

Before any violation of this chapter is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given reasonable notice of the alleged violation and opportunity to present his views orally or in writing with regard to such contemplated proceeding. Nothing in this chapter shall be construed as requiring the Secretary to report for criminal prosecution violations of this chapter whenever he believes that the public interest will be adequately served and compliance with the chapter obtained by a suitable written notice or warning.

(Pub. L. 85–172, §13, Aug. 28, 1957, 71 Stat. 447.)

§463. Rules and regulations

(a) Storage and handling of poultry products; violation of regulations

The Secretary may by regulations prescribe conditions under which poultry products capable of use as human food, shall be stored or otherwise handled by any person engaged in the business of buying, selling, freezing, storing, or transporting, in or for commerce, or importing, such articles, whenever the Secretary deems such action necessary to assure that such articles will not be adulterated or misbranded when delivered to the consumer. Violation of any such regulation is prohibited.

(b) Other necessary rules and regulations

The Secretary shall promulgate such other rules and regulations as are necessary to carry out the provisions of this chapter.

(c) Oral presentation of views

In applying the provisions of section 553(c) of title 5 to proposed rule making under this chapter, an opportunity for the oral presentation of views shall be accorded all interested persons.

(Pub. L. 85–172, §14, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90–492, §13, Aug. 18, 1968, 82 Stat. 803.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 designated existing provisions as par. (b), added pars. (a) and (c), and in par. (b), as so designated, substituted "such other rules" for "such rules".

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§464. Exemptions

(a) Persons exempted

The Secretary shall, by regulation and under such conditions as to sanitary standards, practices, and procedures as he may prescribe, exempt from specific provisions of this chapter—

(1) retail dealers with respect to poultry products sold directly to consumers in individual retail stores, if the only processing operation performed by such retail dealers is the cutting up of poultry products on the premises where such sales to consumers are made;

(2) for such period of time as the Secretary determines that it would be impracticable to provide inspection and the exemption will aid in the effective administration of this chapter, any person engaged in the processing of poultry or poultry products for commerce and the poultry or poultry products processed by such person: Provided, however, That no such exemption shall continue in effect on and after January 1, 1970; and

(3) persons slaughtering, processing, or otherwise handling poultry or poultry products which have been or are to be processed as required by recognized religious dietary laws, to the extent that the Secretary determines necessary to avoid conflict with such requirements while still effectuating the purposes of this chapter.

(b) Territorial exemption

The Secretary may, under such sanitary conditions as he may by regulations prescribe, exempt from the inspection requirements of this chapter the slaughter of poultry, and the processing of poultry products, by any person in any Territory not organized with a legislative body, solely for distribution within such Territory, when the Secretary determines that it is impracticable to provide such inspection within the limits of funds appropriated for administration of this chapter and that such exemption will aid in the effective administration of this chapter.

(c) Personal slaughtering; custom slaughtering; name and address of the poultry producer or processor in lieu of other labeling requirements; small enterprises; slaughterers or processors of specified number of turkeys; poultry producers raising poultry on own farms

(1) The Secretary shall, by regulation and under such conditions, including sanitary standards, practices, and procedures, as he may prescribe, exempt from specific provisions of this chapter—

(A) the slaughtering by any person of poultry of his own raising, and the processing by him and transportation in commerce of the poultry products exclusively for use by him and members of his household and his nonpaying guests and employees;

(B) the custom slaughter by any person of poultry delivered by the owner thereof for such slaughter, and the processing by such slaughterer and transportation in commerce of the poultry products exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That such custom slaughterer does not engage in the business of buying or selling any poultry products capable of use as human food;

(C) the slaughtering and processing of poultry products in any State or Territory or the District of Columbia by any poultry producer on his own premises with respect to sound and healthy poultry raised on his premises and the distribution by any person solely within such jurisdiction of the poultry products derived from such operations, if, in lieu of other labeling requirements, such poultry products are identified with the name and address of such poultry producer, and if they are not otherwise misbranded, and are sound, clean, and fit for human food when so distributed; and

(D) the slaughtering of sound and healthy poultry or the processing of poultry products of such poultry in any State or territory or the District of Columbia by any poultry producer or other person for distribution by him solely within such jurisdiction directly to household consumers, restaurants, hotels, and boarding houses, for use in their own dining rooms, or in the preparation of meals for sales direct to consumers, if, in lieu of other labeling requirements, such poultry products are identified with the name and address of the processor, and if they are not otherwise misbranded and are sound, clean, and fit for human food when distributed by such processor.

The exemptions provided for in clauses (C) and (D) above shall not apply if the poultry producer or other person engages in the current calendar year in the business of buying or selling any poultry or poultry products other than as specified in such clauses.

(2) In addition to the specific exemptions provided herein, the Secretary shall, when he determines that the protection of consumers from adulterated or misbranded poultry products will not be impaired by such action, provide by regulation, consistent with subparagraph (3), for the exemption of the operation and products of small enterprises (including poultry producers), not exempted under subparagraph (1), which are engaged in any State or Territory or the District of Columbia in slaughtering and/or cutting up poultry for distribution as carcasses or parts thereof solely for distribution within such jurisdiction, from such provisions of this chapter as he deems appropriate, while still protecting the public from adulterated or misbranded products, under such conditions, including sanitary requirements, as he shall prescribe to effectuate the purposes of this chapter.

(3) No exemption under subparagraph (1)(C) or (D) or subparagraph (2) shall apply to any poultry producer or other person who, in the current calendar year—

(A) slaughters or processes the products of more than 20,000 poultry; or

(B) slaughters or processes the products of poultry at a facility used for slaughtering or processing of the products of poultry by any other poultry producer or person.

Notwithstanding clause (B), the Secretary may grant such exemption to any poultry producer or other person if the Secretary determines, upon application of such poultry producer or other person, that granting such exemption will not impair effectuating the purposes of this chapter.

(4) The provisions of this chapter shall not apply to poultry producers with respect to poultry of their own raising on their own farms if (i) such producers slaughter not more than 1,000 poultry during the calendar year for which this exemption is being determined; (ii) such poultry producers do not engage in buying or selling poultry products other than those produced from poultry raised on their own farms; and (iii) none of such poultry moves in commerce (as defined in section 453(a) of this title).

(d) Pizzas containing poultry products

(1) Under such terms and conditions as the Secretary shall prescribe through rules and regulations issued under this section that may be necessary to ensure food safety and protect public health such as special handling procedures, the Secretary shall exempt pizzas containing a poultry product from the inspection requirements of this chapter if—

(A) the poultry product components of the pizzas have been prepared, inspected, and passed in a cured or cooked form as ready-to-eat in compliance with the requirements of this chapter; and

(B) the pizzas are to be served in public or private nonprofit institutions.

(2) The Secretary may withdraw or modify any exemption under this subsection whenever the Secretary determines such action is necessary to ensure food safety and to protect public health. The Secretary may reinstate or further modify any exemption withdrawn or modified under this subsection.

(e) Applicability of adulteration and misbranding provisions to articles exempted from inspection

The adulteration and misbranding provisions of this chapter, other than the requirement of the inspection legend, shall apply to articles which are exempted from inspection under this section, except as otherwise specified under paragraphs (a) and (d).

(f) Suspension or termination of exemption

The Secretary may by order suspend or terminate any exemption under this section with respect to any person whenever he finds that such action will aid in effectuating the purposes of this chapter.

(Pub. L. 85–172, §15, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90–492, §14, Aug. 18, 1968, 82 Stat. 803; Pub. L. 97–206, June 30, 1982, 96 Stat. 136; Pub. L. 102–237, title X, §1016(b), Dec. 13, 1991, 105 Stat. 1903.)

Editorial Notes

Amendments

1991—Subsecs. (d) to (f). Pub. L. 102–237 added subsec. (d), redesignated former subsec. (d) as (e) and substituted "(d)" for "(c)", and redesignated former subsec. (e) as (f).

1982—Par. (c)(3). Pub. L. 97–206, §1, substituted provisions that no exemption would be given to persons who during the current calendar year either slaughter or process the products of more than 20,000 poultry, or slaughter or process such poultry at a facility of another poultry producer or person, but that, in the latter case, the Secretary may grant the exemption upon application of such poultry producer or person if granting such exemption would not impair the purposes of this chapter, for provisions that an exemption would not be granted to those who slaughter or process the products of more than 5,000 turkeys or an equivalent number of poultry of all species in the current calendar year (four birds of other species being deemed equivalent of one turkey).

Par. (c)(4)(i). Pub. L. 97–206, §2, substituted "1,000 poultry during the calendar year for which this exemption is being determined" for "250 turkeys, or not more than an equivalent number of birds of all species during the calendar year for which this exemption is being determined (four birds of other species being deemed the equivalent of one turkey)".

1968—Par. (a). Pub. L. 90–492, §14(a), (b), redesignated subpars. (2) to (4) as (1) to (3), respectively, and in subpar. (2), as so redesignated, substituted "January 1, 1970" for "July 1, 1960". Former subpar. (1), which exempted poultry producers with respect to poultry of their own raising on their own farms which they sold directly to household consumers, hotels, etc., for use in their own dining rooms or in the preparation of meals for sales direct to consumers only, provided that such producers did not engage in buying or selling poultry products other than those produced from poultry raised on their own farms, was struck out.

Pars. (b) to (e). Pub. L. 90–492, §14(c), added pars. (b) to (d) and redesignated former par. (b) as (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective upon the expiration of sixty days after Aug. 18, 1968, see section 20(b) of Pub. L. 90–492, set out as a note under section 451 of this title.

Regulations

Pub. L. 102–237, title X, §1016(c), Dec. 13, 1991, 105 Stat. 1903, provided that: "No later than August 1, 1992, the Secretary of Agriculture shall issue final rules, through prior notice and comment rulemaking procedures, to implement the exemption authorized by section 23(c) of the Federal Meat Inspection Act [21 U.S.C. 623(c)] (as added by subsection (a)) and the exemption authorized by section 15(d) of the Poultry Products Inspection Act [21 U.S.C. 464(d)] (as added by subsection (b)). Prior to the issuance of the final rules, the Secretary shall hold at least one public hearing examining the public health and food safety issues raised by the granting of each of the exemptions."

Studies Concerning Grant of Future Exemptions for Poultry and Meat Food Products

Pub. L. 102–237, title X, §1016(d), Dec. 13, 1991, 105 Stat. 1903, directed Secretary of Agriculture in consultation with National Academy of Sciences to conduct a study on meat food and poultry products inspection exemptions under Federal Meat Inspection Act and Poultry Products Inspection Act and a study on an exemption from requirements of such Acts for certain wholesale meat outlets selling to hotels and other similar institutional users not later than 24 months after Dec. 13, 1991, and on completion of each study to provide the results to Committee on Agriculture of House of Representatives and Committee on Agriculture, Nutrition, and Forestry of Senate.

§465. Limitations upon entry of poultry products and other materials into official establishments

The Secretary may limit the entry of poultry products and other materials into any official establishment, under such conditions as he may prescribe to assure that allowing the entry of such articles into such inspected establishments will be consistent with the purposes of this chapter.

(Pub. L. 85–172, §16, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90–492, §15, Aug. 18, 1968, 82 Stat. 805.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 substituted provisions authorizing the Secretary to limit the entry of poultry products and other materials into any official establishment for provisions that any person distributing unwholesome or adulterated exempted poultry or poultry products intended for human consumption shall be guilty of a misdemeanor and subject to penalties upon conviction thereof.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§466. Imports

(a) Compliance with standards and regulations; status after importation

No slaughtered poultry, or parts or products thereof, of any kind shall be imported into the United States unless they are healthful, wholesome, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingredient which renders them unhealthful, unwholesome, adulterated, or unfit for human food and unless they also comply with the rules and regulations made by the Secretary of Agriculture to assure that imported poultry or poultry products comply with the standards provided for in this chapter. All imported, slaughtered poultry, or parts or products thereof, shall after entry into the United States in compliance with such rules and regulations be deemed and treated as domestic slaughtered poultry, or parts or products thereof, within the meaning and subject to the provisions of this chapter and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and Acts amendatory of, supplemental to, or in substitution for such chapter and Act.

(b) Rules and regulations; destruction and exportation of refused imports

The Secretary of Agriculture is authorized to make rules and regulations to carry out the purposes of this section and in such rules and regulations the Secretary of Agriculture may prescribe the terms and conditions for the destruction of all slaughtered poultry, or parts or products thereof, offered for entry and refused admission into the United States unless such slaughtered poultry, or parts or products thereof, be exported by the consignee within the time fixed therefor in such rules and regulations.

(c) Storage, cartage and labor charges for imports refused admission

All charges for storage, cartage, and labor with respect to any product which is refused admission pursuant to this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any other products imported thereafter by or for such owner or consignee.

(d) Domestic standards and processing facilities applicable; enforcement

(1) Notwithstanding any other provision of law, all poultry, or parts or products of poultry, capable of use as human food offered for importation into the United States shall—

(A) be subject to inspection, sanitary, quality, species verification, and residue standards that achieve a level of sanitary protection equivalent to that achieved under United States standards; and

(B) have been processed in facilities and under conditions that achieve a level of sanitary protection equivalent to that achieved under United States standards.

(2)(A) The Secretary may treat as equivalent to a United States standard a standard of an exporting country described in paragraph (1) if the exporting country provides the Secretary with scientific evidence or other information, in accordance with risk assessment methodologies determined appropriate by the Secretary, to demonstrate that the standard of the exporting country achieves the level of sanitary protection achieved under the United States standard. For the purposes of this subsection, the term "sanitary protection" means protection to safeguard public health.

(B) The Secretary may—

(i) determine, on a scientific basis, that the standard of the exporting country does not achieve the level of protection that the Secretary considers appropriate; and

(ii) provide the basis for the determination in writing to the exporting country on request.

(3) Any such imported poultry article that does not meet such standards shall not be permitted entry into the United States.

(4) The Secretary shall enforce this subsection through—

(A) random inspections for such species verification and for residues; and

(B) random sampling and testing of internal organs and fat of carcasses for residues at the point of slaughter by the exporting country, in accordance with methods approved by the Secretary.

(Pub. L. 85–172, §17, Aug. 28, 1957, 71 Stat. 448; Pub. L. 99–198, title XVII, §1701(a), Dec. 23, 1985, 99 Stat. 1633; Pub. L. 103–182, title III, §361(e), Dec. 8, 1993, 107 Stat. 2123; Pub. L. 103–465, title IV, §431(k), Dec. 8, 1994, 108 Stat. 4969.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

1994—Subsec. (d)(1). Pub. L. 103–465, §431(k)(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Notwithstanding any other provision of law, except as provided in paragraph (2), all poultry, or parts or products thereof, capable of use as human food offered for importation into the United States shall—

"(A) be subject to the same inspection, sanitary, quality, species verification, and residue standards applied to products produced in the United States; and

"(B) have been processed in facilities and under conditions that are the same as those under which similar products are processed in the United States."

Subsec. (d)(2)(A). Pub. L. 103–465, §431(k)(2)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "Notwithstanding any other provision of law, all poultry, or parts or products of poultry, capable of use as human food offered for importation into the United States from Canada and Mexico shall—

"(i) comply with paragraph (1); or

"(ii)(I) be subject to inspection, sanitary, quality, species verification, and residue standards that are equivalent to United States standards; and

"(II) have been processed in facilities and under conditions that meet standards that are equivalent to United States standards."

Subsec. (d)(2)(B), (C). Pub. L. 103–465, §431(k)(2)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: "The Secretary may treat as equivalent to a United States standard a standard of Canada or Mexico described in subparagraph (A)(ii) if the exporting country provides the Secretary with scientific evidence or other information, in accordance with risk assessment methodologies agreed to by the Secretary and the exporting country, to demonstrate that the standard of the exporting country achieves the level of protection that the Secretary considers appropriate."

1993—Subsec. (d). Pub. L. 103–182, in par. (1), inserted "except as provided in paragraph (2)," before "all poultry" in introductory provisions, added par. (2), and redesignated former pars. (2) and (3) as (3) and (4), respectively.

1985—Par. (d). Pub. L. 99–198 added par. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–465 effective, except as otherwise provided, on the date of entry into force of the World Trade Organization Agreement with respect to the United States (Jan. 1, 1995), see section 451 of Pub. L. 103–465, set out as an Effective Date note under section 3601 of Title 19, Customs Duties.

Effective Date of 1985 Amendment

Pub. L. 99–198, title XVII, §1701(b), Dec. 23, 1985, 99 Stat. 1633, provided that: "The amendment made by this section [amending this section] shall become effective 6 months after the date of enactment of this Act [Dec. 23, 1985]."

§467. Inspection services

(a) Refusal or withdrawal; hearing; business unfitness based upon certain convictions; persons responsibly connected with the business

The Secretary may (for such period, or indefinitely, as he deems necessary to effectuate the purposes of this chapter) refuse to provide, or withdraw, inspection service under this chapter with respect to any establishment if he determines, after opportunity for a hearing is accorded to the applicant for, or recipient of, such service, that such applicant or recipient is unfit to engage in any business requiring inspection upon this chapter because the applicant or recipient or anyone responsibly connected with the applicant or recipient, has been convicted, in any Federal or State court, within the previous ten years of (1) any felony or more than one misdemeanor under any law based upon the acquiring, handling, or distributing of adulterated, mislabeled, or deceptively packaged food or fraud in connection with transactions in food; or (2) any felony, involving fraud, bribery, extortion, or any other act or circumstances indicating a lack of the integrity needed for the conduct of operations affecting the public health. For the purpose of this paragraph a person shall be deemed to be responsibly connected with the business if he was a partner, officer, director, holder, or owner of 10 per centum or more of its voting stock or employee in a managerial or executive capacity.

(b) Hearing to determine validity of withdrawal or refusal of inspection services; continuation of withdrawal or refusal

Upon the withdrawal of inspection service from any official establishment for failure to destroy condemned poultry products as required under section 455 of this title, or other failure of an official establishment to comply with the requirements as to premises, facilities, or equipment, or the operation thereof, as provided in section 456 of this title, or the refusal of inspection service to any applicant therefor because of failure to comply with any requirements under section 456 of this title, the applicant for, or recipient of, the service shall, upon request, be afforded opportunity for a hearing with respect to the merits or validity of such action; but such withdrawal or refusal shall continue in effect unless otherwise ordered by the Secretary.

(c) Finality and conclusiveness of determination; judicial review; record

The determination and order of the Secretary when made after opportunity for hearing, with respect to withdrawal or refusal of inspection service under this chapter shall be final and conclusive unless the affected applicant for, or recipient of, inspection service files application for judicial review within thirty days after the effective date of such order in the United States Court of Appeals as provided in section 457 of this title. Judicial review of any such order shall be upon the record upon which the determination and order are based. The provisions of section 194 of title 7 shall be applicable to appeals taken under this section.

(Pub. L. 85–172, §18, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90–492, §16, Aug. 18, 1968, 82 Stat. 805.)

Editorial Notes

Amendments

1968—Par. (a). Pub. L. 90–492 substituted provisions authorizing the Secretary to refuse or withdraw inspection services subsequent to a hearing determining that the applicant or recipient is unfit to engage in any business requiring inspection under this chapter based upon the specified considerations, for provisions granting the Secretary exclusive jurisdiction within the scope of this chapter and exempting poultry and poultry products from the provisions of the Federal Food, Drug, and Cosmetic Act, as amended, to the extent of the application or the extension thereof of the provisions of this chapter.

Par. (b). Pub. L. 90–492 substituted provisions granting a hearing, upon request by the applicant or recipient, to determine the merits and validity of the withdrawal or refusal of inspection services and continuing such withdrawal or refusal in effect, unless otherwise ordered by the Secretary, for provisions authorizing the Secretary to cooperate with other branches of government and with State agencies and to conduct examinations, investigations, and inspections through any officer or employee of a State commissioned by the Secretary for such purpose.

Par. (c). Pub. L. 90–492 added par. (c).

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

§467a. Administrative detention; duration; pending judicial proceedings; notification of government authorities; release; removal of official marks

Whenever any poultry product, or any product exempted from the definition of a poultry product, or any dead, dying, disabled, or diseased poultry is found by any authorized representative of the Secretary upon any premises where it is held for purposes of, or during or after distribution in, commerce or otherwise subject to this chapter, and there is reason to believe that any such article is adulterated or misbranded and is capable of use as human food, or that it has not been inspected, in violation of the provisions of this chapter or of any other Federal law or the laws of any State or Territory, or the District of Columbia, or that it has been or is intended to be, distributed in violation of any such provisions, it may be detained by such representative for a period not to exceed twenty days, pending action under section 467b of this title or notification of any Federal, State, or other governmental authorities having jurisdiction over such article or poultry, and shall not be moved by any person, from the place at which it is located when so detained, until released by such representative. All official marks may be required by such representative to be removed from such article or poultry before it is released unless it appears to the satisfaction of the Secretary that the article or poultry is eligible to retain such marks.

(Pub. L. 85–172, §19, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805.)

§467b. Seizure and condemnation

(a) Proceedings in rem; libel of information; jurisdiction; disposal by destruction or sale; proceeds into the Treasury; sales restrictions; bonds; court costs and fees, storage, and other expenses against claimants; jury trial; United States as plaintiff

(1) Any poultry product, or any dead, dying, disabled, or diseased poultry, that is being transported in commerce or otherwise subject to this chapter, or is held for sale in the United States after such transportation, and that (A) is or has been processed, sold, transported, or otherwise distributed or offered or received for distribution in violation of this chapter, or (B) is capable of use as human food and is adulterated or misbranded, or (C) in any other way is in violation of this chapter, shall be liable to be proceeded against and seized and condemned, at any time, on a libel of information in any United States district court or other proper court as provided in section 467c of this title within the jurisdiction of which the article or poultry is found.

(2) If the article or poultry is condemned it shall, after entry of the decree, (A) be distributed in accordance with paragraph (5), or (B) be disposed of by destruction or sale as the court may direct and the proceeds, if sold, less the court costs and fees, and storage and other proper expenses, shall be paid into the Treasury of the United States, but the article or poultry shall not be sold contrary to the provisions of this chapter, or the laws of the jurisdiction in which it is sold: Provided, That upon the execution and delivery of a good and sufficient bond conditioned that the article or poultry shall not be sold or otherwise disposed of contrary to the provisions of this chapter, or the laws of the jurisdiction in which disposal is made, the court may direct that such article or poultry be delivered to the owner thereof subject to such supervision by authorized representatives of the Secretary as is necessary to insure compliance with the applicable laws.

(3) When a decree of condemnation is entered against the article or poultry and it is released under bond, or destroyed, court costs and fees, and storage and other proper expenses shall be awarded against the person, if any, intervening as claimant of the article or poultry.

(4) The proceedings in such libel cases shall conform, as nearly as may be, to the proceedings in admiralty, except that either party may demand trial by jury of any issue of fact joined in any case, and all such proceedings shall be at the suit of and in the name of the United States.

(5)(A) An article that is condemned under paragraph (1) may as the court may direct, after entry of the decree, be distributed without charge to nonprofit, private entities or to Federal, State, or local government entities engaged in the distribution of food without charge to individuals, if such article—

(i) is capable of use as a human food;

(ii) has been inspected under this chapter and found to be wholesome and not to be adulterated within the meaning of paragraphs (1) through (7) of section 453(g) of this title and a determination is made at the time of the entry of the decree that such article is wholesome and not so adulterated; and

(iii) is plainly marked "Not for Sale" on such article or its container.

(B) The United States may not be held legally responsible for any article that is distributed under subparagraph (A) to a nonprofit, private entity or to a Federal, State, or local government entity, if such article—

(i) was found after inspection under this chapter to be wholesome and not adulterated within the meaning of paragraphs (1) through (7) of section 453(g) of this title and a determination was made at the time of the entry of the decree that such article was wholesome and not so adulterated; and

(ii) was plainly marked "Not for Sale" on such article or its container.

(C) The person from whom such article was seized and condemned may not be held legally responsible for such article, if such article—

(i) was found after inspection under this chapter to be wholesome and not adulterated within the meaning of paragraphs (1) through (7) of section 453(g) of this title and a determination was made at the time of entry of the decree that such article was wholesome and not so adulterated; and

(ii) was plainly marked "Not for Sale" on such article or its container.

(b) Condemnation or seizure under other provisions unaffected

The provisions of this section shall in no way derogate from authority for condemnation or seizure conferred by other provisions of this chapter, or other laws.

(Pub. L. 85–172, §20, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 806; amended Pub. L. 101–205, §2, Dec. 7, 1989, 103 Stat. 1830.)

Editorial Notes

Amendments

1989—Subsec. (a). Pub. L. 101–205 designated first sentence as par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C), respectively, designated second sentence as par. (2) and inserted "(A) be distributed in accordance with paragraph (5), or (B)" after "entry of the decree,", designated third and fourth sentences as pars. (3) and (4), respectively, and added par. (5).

§467c. Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plaintiff; subpenas

The United States district courts, the District Court of Guam, the District Court of the Virgin Islands, the highest court of American Samoa, and the United States courts of the other territories, are vested with jurisdiction specifically to enforce, and to prevent and restrain violations of, this chapter, and shall have jurisdiction in all other kinds of cases arising under this chapter, except as provided in section 457(d) or 467 of this title. All proceedings for the enforcement or to restrain violations of this chapter shall be by and in the name of the United States. Subpenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any such proceeding.

(Pub. L. 85–172, §21, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 806.)

§467d. Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts

For the efficient administration and enforcement of this chapter, the provision (including penalties) of sections 46, 48, 49 and 50 of title 15 (except paragraphs (c) through (h) of section 46 and the last paragraph of section 49 ¹ of title 15), and the provisions of section 409(l) ¹ of title 47, are made applicable to the jurisdiction, powers, and duties of the Secretary in administering and enforcing the provisions of this chapter and to any person with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections 49 and 50 of title 15 on the district courts of the United States may be exercised for the purposes of this chapter by any court designated in section 467c of this title.

(Pub. L. 85–172, §22, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 807.)

Editorial Notes

References in Text

The last paragraph of section 49 of title 15, and the provisions of section 409(l) of title 47, referred to in text, which related to immunity of witnesses, were repealed by sections 211 and 242, respectively, of Pub. L. 91–452, Oct. 15, 1970, title II, 84 Stat. 929, 930. For provisions relating to immunity of witnesses, see section 6001 et seq. of Title 18, Crimes and Criminal Procedure.

¹ See References in Text note below.

§467e. Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments with inspection services and as to marking, labeling, packaging, and ingredients; recordkeeping and related requirements; concurrent jurisdiction over distribution for human food purposes of adulterated or misbranded and imported articles; other matters

Requirements within the scope of this chapter with respect to premises, facilities and operations of any official establishment which are in addition to, or different than those made under this chapter may not be imposed by any State or Territory or the District of Columbia, except that any such jurisdiction may impose recordkeeping and other requirements within the scope of paragraph (b) of section 460 of this title, if consistent therewith, with respect to any such establishment. Marking, labeling, packaging, or ingredient requirements (or storage or handling requirements found by the Secretary to unduly interfere with the free flow of poultry products in commerce) in addition to, or different than, those made under this chapter may not be imposed by any State or Territory or the District of Columbia with respect to articles prepared at any official establishment in accordance with the requirements under this chapter, but any State or Territory or the District of Columbia may, consistent with the requirements under this chapter exercise concurrent jurisdiction with the Secretary over articles required to be inspected under this chapter for the purpose of preventing the distribution for human food purposes of any such articles which are adulterated or misbranded and are outside of such an establishment, or, in the case of imported articles which are not at such an establishment, after their entry into the United States. This chapter shall not preclude any State or Territory or the District of Columbia from making requirement or taking other action, consistent with this chapter, with respect to any other matters regulated under this chapter.

(Pub. L. 85–172, §23, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 807.)

§467f. Federal Food, Drug, and Cosmetic Act applications

(a) Exemptions; authorities under food, drug, and cosmetic provisions unaffected

Poultry and poultry products shall be exempt from the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] to the extent of the application or extension thereto of the provisions of this chapter, except that the provisions of this chapter shall not derogate from any authority conferred by the Federal Food, Drug, and Cosmetic Act prior to August 18, 1968.

(b) Enforcement proceedings; detainer authority of representatives of Secretary of Health and Human Services

The detainer authority conferred by section 467a of this title shall apply to any authorized representative of the Secretary of Health and Human Services for purposes of the enforcement of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with respect to any poultry carcass, or part or product thereof, that is outside any official establishment, and for such purposes the first reference to the Secretary in section 467a of this title shall be deemed to refer to the Secretary of Health and Human Services.

(Pub. L. 85–172, §24, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 807; amended Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in par. (b) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

§468. Cost of inspection; overtime

The cost of inspection rendered under the requirements of this chapter, shall be borne by the United States, except the cost of overtime and holiday pay paid pursuant to the ¹ section 2219a of title 7.

(Pub. L. 85–172, §25, formerly §19, Aug. 28, 1957, 71 Stat. 448, renumbered Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805; Pub. L. 107–171, title X, §10703(c)(1), May 13, 2002, 116 Stat. 517.)

Editorial Notes

References in Text

Section 2219a of title 7, referred to in text, was in the original "section 10703 of the Farm Security and Rural Investment Act of 2002", meaning section 10703 of Pub. L. 107–171, which enacted section 2219a of Title 7, Agriculture, amended this section, section 695 of this title, and section 5549 of Title 5, Government Organization and Employees, and repealed section 394 of Title 7.

Amendments

2002—Pub. L. 107–171 substituted "except the cost of overtime and holiday pay paid pursuant to the section 2219a of title 7." for "except that the cost of overtime and holiday work performed in establishments subject to the provisions of this chapter at such rates as the Secretary may determine shall be borne by such establishments. Sums received by the Secretary in reimbursement for sums paid out by him for such premium pay work shall be available without fiscal year limitation to carry out the purposes of this section."

¹ So in original. The word "the" probably should not appear.

§469. Authorization of appropriations

There is authorized to be appropriated such sums as are necessary to carry out the provisions of this chapter.

(Pub. L. 85–172, §26, formerly §20, Aug. 28, 1957, 71 Stat. 449, renumbered Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805.)

§470. Omitted

Editorial Notes

Codification

Section, Pub. L. 85–172, §27, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 807; amended Pub. L. 103–437, §8(1), Nov. 2, 1994, 108 Stat. 4588, which required the Secretary of Agriculture to report annually to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate on the slaughter of poultry and the processing and distribution of poultry parts and products, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, page 46 of House Document No. 103–7.

§471. Safe Meat and Poultry Inspection Panel

(a) Review and evaluation

The advisory panel known as the "Safe Meat and Poultry Inspection Panel" established by section 679a of this title shall review and evaluate, as the panel considers necessary, the adequacy, necessity, safety, cost-effectiveness, and scientific merit of—

(1) inspection procedures of, and work rules and worker relations involving Federal employees employed in, plants inspected under this chapter;

(2) informal petitions or proposals for changes in inspection procedures, processes, and techniques of plants inspected under this chapter;

(3) formal changes in poultry inspection regulations promulgated under this chapter, whether in notice, proposed, or final form; and

(4) such other matters as may be referred to the panel by the Secretary regarding the quality or effectiveness of a safe and cost-effective poultry inspection system under this chapter.

(b) Reports

(1) In general

The Safe Meat and Poultry Inspection Panel shall submit to the Secretary a report on the results of each review and evaluation carried out under paragraph (1), including such recommendations as the panel considers appropriate.

(2) Reports on formal changes

In the case of a report concerning a formal change in poultry inspection regulations, the report shall be made within the time limits prescribed for formal comments on such changes.

(Pub. L. 85–172, §30, as added Pub. L. 104–127, title IX, §918(a)(2), Apr. 4, 1996, 110 Stat. 1190.)

Statutory Notes and Related Subsidiaries

Use of Appropriated Funds

Pub. L. 113–235, div. A, title VII, §741, Dec. 16, 2014, 128 Stat. 2170, provided that: "Hereafter, none of the funds appropriated by this or any other Act may be used to carry out section 410 of the Federal Meat Inspection Act (21 U.S.C. 679a) or section 30 of the Poultry Products Inspection Act (21 U.S.C. 471)."

§472. Interstate shipment of poultry inspected by Federal and State agencies for certain small establishments

(a) Definitions

(1) Appropriate State agency

The term "appropriate State agency" means a State agency described in section 454(a)(1) of this title.

(2) Designated personnel

The term "designated personnel" means inspection personnel of a State agency that have undergone all necessary inspection training and certification to assist the Secretary in the administration and enforcement of this chapter, including rules and regulations issued under this chapter.

(3) Eligible establishment

The term "eligible establishment" means an establishment that is in compliance with—

(A) the State inspection program of the State in which the establishment is located; and

(B) this chapter, including rules and regulations issued under this chapter.

(4) Poultry item

The term "poultry item" means—

(A) a portion of poultry; and

(B) a poultry product.

(5) Selected establishment

The term "selected establishment" means an eligible establishment that is selected by the Secretary, in coordination with the appropriate State agency of the State in which the eligible establishment is located, under subsection (b) to ship poultry items in interstate commerce.

(b) Authority of Secretary to allow shipments

(1) In general

Subject to paragraph (2), the Secretary, in coordination with the appropriate State agency of the State in which an establishment is located, may select the establishment to ship poultry items in interstate commerce, and place on each poultry item shipped in interstate commerce a Federal mark, stamp, tag, or label of inspection, if—

(A) the poultry item qualifies for the Federal mark, stamp, tag, or label of inspection under the requirements of this chapter;

(B) the establishment is an eligible establishment; and

(C) inspection services for the establishment are provided by designated personnel.

(2) Prohibited establishments

In carrying out paragraph (1), the Secretary, in coordination with an appropriate State agency, shall not select an establishment that—

(A) on average, employs more than 25 employees (including supervisory and nonsupervisory employees), as defined by the Secretary;

(B) as of the date of the enactment of this section, ships in interstate commerce carcasses, portions of carcasses, or poultry items that are inspected by the Secretary in accordance with this chapter;

(C)(i) is a Federal establishment;

(ii) was a Federal establishment as of the date of the enactment of this section, and was reorganized on a later date under the same name or a different name or person by the person, firm, or corporation that controlled the establishment as of the date of the enactment of this section; or

(iii) was a State establishment as of the date of the enactment of this section that—

(I) as of the date of the enactment of this section, employed more than 25 employees; and

(II) was reorganized on a later date by the person, firm, or corporation that controlled the establishment as of the date of the enactment of this section;

(D) is in violation of this chapter;

(E) is located in a State that does not have a State inspection program; or

(F) is the subject of a transition carried out in accordance with a procedure developed by the Secretary under paragraph (3)(A).

(3) Establishments that employ more than 25 employees

(A) Development of procedure

The Secretary may develop a procedure to transition to a Federal establishment any establishment under this section that, on average, consistently employs more than 25 employees.

(B) Eligibility of certain establishments

(i) In general

A State establishment that employs more than 25 employees but less than 35 employees as of the date of the enactment of this section may be selected as a selected establishment under this subsection.

(ii) Procedures

A State establishment shall be subject to the procedures established under subparagraph (A) beginning on the date that is 3 years after the effective date described in subsection (i).

(c) Reimbursement of State costs

The Secretary shall reimburse a State for costs related to the inspection of selected establishments in the State in accordance with Federal requirements in an amount of not less than 60 percent of eligible State costs.

(d) Coordination between Federal and State agencies

(1) In general

The Secretary shall designate an employee of the Federal Government as State coordinator for each appropriate State agency—

(A) to provide oversight and enforcement of this section; and

(B) to oversee the training and inspection activities of designated personnel of the State agency.

(2) Supervision

A State coordinator shall be under the direct supervision of the Secretary.

(3) Duties of State coordinator

(A) In general

A State coordinator shall visit selected establishments with a frequency that is appropriate to ensure that selected establishments are operating in a manner that is consistent with this chapter (including regulations and policies under this chapter).

(B) Quarterly reports

A State coordinator shall, on a quarterly basis, submit to the Secretary a report that describes the status of each selected establishment that is under the jurisdiction of the State coordinator with respect to the level of compliance of each selected establishment with the requirements of this chapter.

(C) Immediate notification requirement

If a State coordinator determines that any selected establishment that is under the jurisdiction of the State coordinator is in violation of any requirement of this chapter, the State coordinator shall—

(i) immediately notify the Secretary of the violation; and

(ii) deselect the selected establishment or suspend inspection at the selected establishment.

(4) Performance evaluations

Performance evaluations of State coordinators designated under this subsection shall be conducted by the Secretary as part of the Federal agency management control system.

(e) Audits

(1) Periodic audits conducted by Inspector General of the Department of Agriculture

Not later than 2 years after the effective date described in subsection (i), and not less often than every 3 years thereafter, the Inspector General of the Department of Agriculture shall conduct an audit of each activity taken by the Secretary under this section for the period covered by the audit to determine compliance with this section.

(2) Audit conducted by Comptroller General of the United States

Not earlier than 3 years, nor later than 5 years, after the date of the enactment of this section, the Comptroller General of the United States shall conduct an audit of the implementation of this section to determine—

(A) the effectiveness of the implementation of this section; and

(B) the number of selected establishments selected by the Secretary to ship poultry items under this section.

(f) Transition grants

The Secretary may provide grants to appropriate State agencies to assist the appropriate State agencies in helping establishments covered by this chapter to transition to selected establishments.

(g) Violations

Any selected establishment that the Secretary determines to be in violation of any requirement of this chapter shall be transitioned to a Federal establishment in accordance with a procedure developed by the Secretary under subsection (b)(3)(A).

(h) Effect

Nothing in this section limits the jurisdiction of the Secretary with respect to the regulation of poultry and poultry products under this chapter.

(i) Effective date

(1) In general

This section takes effect on the date on which the Secretary, after providing a period of public comment (including through the conduct of public meetings or hearings), promulgates final regulations to carry out this section.

(2) Requirement

Not later than 18 months after the date of the enactment of this section, the Secretary shall promulgate final regulations in accordance with paragraph (1).

(Pub. L. 85–172, §31, as added Pub. L. 110–234, title XI, §11015(b), May 22, 2008, 122 Stat. 1365, and Pub. L. 110–246, §4(a), title XI, §11015(b), June 18, 2008, 122 Stat. 1664, 2127.)

Editorial Notes

References in Text

The date of the enactment of this section, referred to in subsecs. (b)(2)(B), (C)(ii), (iii), (3)(B)(i), (e)(2), and (i)(2), is the date of enactment of Pub. L. 110–246, which was approved June 18, 2008.

Final regulations to carry out this section, referred to in subsec. (i)(1), were published in the Federal Register on May 2, 2011, eff. July 1, 2011; see 76 F.R. 24756.

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.

§473. Grants for improvements to meat and poultry facilities to allow for interstate shipment

(a) In general

The Secretary shall make grants to meat and poultry slaughter and processing facilities described in subsection (b) (including such facilities operating under State inspection or such facilities that are exempt from Federal inspection) to assist such facilities with respect to costs incurred in making improvements to such facilities and carrying out other planning activities necessary—

(1) to obtain a Federal grant of inspection under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), as applicable; or

(2) to operate as a State-inspected facility that is compliant with—

(A) the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) under the cooperative interstate shipment program established under section 501 of that Act (21 U.S.C. 683); or

(B) the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) under the cooperative interstate shipment program established under section 31 of that Act (21 U.S.C. 472).

(b) Eligible facilities

To be eligible for a grant under this section, a meat or poultry slaughter or processing facility shall be—

(1) in operation as of the date on which the facility submits to the Secretary an application for the grant; and

(2) seeking—

(A) to obtain a Federal grant of inspection described in subsection (a)(1); or

(B) to be eligible for inspection under a cooperative interstate shipment program described in subparagraph (A) or (B), as applicable, of subsection (a)(2), in a State that participates in that program.

(c) Eligible activities

A facility that receives a grant under this section may use the grant amount for—

(1) the modernization or expansion of existing facilities;

(2) the modernization of equipment;

(3) compliance with packaging and labeling requirements under applicable law;

(4) compliance with safety requirements under applicable law;

(5) the development of processes to ensure food safety; and

(6) such other purposes as the Secretary determines to be appropriate.

(d) Grant requirements

(1) Amount

The amount of a grant under this section shall not exceed $200,000.

(2) Condition

As a condition of receiving a grant under this section, a grant recipient shall agree that the grant recipient shall make a payment (or payments) to the Secretary in an amount equal to the amount of the grant if the recipient, within 36 months of receiving such grant—

(A) as applicable—

(i) is not subject to inspection under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), as applicable; or

(ii) is not eligible for inspection under a cooperative interstate shipment program described in subparagraph (A) or (B), as applicable, of subsection (a)(2); or

(B) is not making a good faith effort to be subject to such inspection or to be eligible under such a cooperative interstate shipment program, as applicable.

(3) Matching funds

(A) In general

The Secretary shall require a recipient of a grant under this section to provide matching non-Federal funds in an amount equal to the amount of the grant.

(B) Exception

The Secretary shall not require any recipient of a grant under this section to provide matching funds with respect to a grant awarded in fiscal year 2021 and fiscal year 2022.

(e) Reports

(1) Reports on grants made

Beginning not later than 1 year after the date on which the first grant is awarded under this section, and continuing annually thereafter through the year that is 10 years after the date on which the final grant is awarded under this section, the Secretary shall submit to the Committee on Agriculture and the Committee on Appropriations of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry and the Committee on Appropriations of the Senate a report on grants made under this section, including—

(A) any facilities that used a grant awarded under this section to carry out eligible activities described in subsection (c) during the year covered by the report; and

(B) the operational status of facilities that were awarded grants under this section.

(2) Report on the cooperative interstate shipment program

Beginning not later than 1 year after December 27, 2020, the Secretary shall submit to the Committee on Agriculture and the Committee on Appropriations of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry and the Committee on Appropriations of the Senate a report describing any recommendations, developed in consultation with all States, for possible improvements to the cooperative interstate shipment programs under section 501 of the Federal Meat Inspection Act (21 U.S.C. 683) and section 31 of the Poultry Products Inspection Act (21 U.S.C. 472).

(f) Funding

Of the funds of the Treasury not otherwise appropriated, there is appropriated to carry out this section $60,000,000 for the period of fiscal years 2021 through 2023, to remain available until expended.

(Pub. L. 116–260, div. N, title VII, §764, Dec. 27, 2020, 134 Stat. 2115; Pub. L. 117–103, div. A, title VII, §776, Mar. 15, 2022, 136 Stat. 99.)

Editorial Notes

References in Text

The Federal Meat Inspection Act, referred to in subsecs. (a)(1), (2)(A), and (d)(2)(A)(i), is titles I to V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, §11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

The Poultry Products Inspection Act, referred to in subsecs. (a)(1), (2)(B), and (d)(2)(A)(i), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.

Codification

Section was enacted as part of the Consolidated Appropriations Act, 2021, and not as part of the Poultry Products Inspection Act which comprises this chapter.

Amendments

2022—Subsec. (d)(3)(B). Pub. L. 117–103 inserted "and fiscal year 2022" after "fiscal year 2021".

Statutory Notes and Related Subsidiaries

Definition

For definition of "Secretary" as used in this section, see section 760 of div. N of Pub. L. 116–260, set out as a note under section 5936a of Title 7, Agriculture.

CHAPTER 11—MANUFACTURE OF NARCOTIC DRUGS

§§501 to 517. Repealed. Pub. L. 91–513, title III, §1101(a)(10), Oct. 27, 1970, 84 Stat. 1292

Sections, Pub. L. 86–429, Apr. 22, 1960, 74 Stat. 55, provided for licensing and control of the manufacture of all narcotic drugs and was known as the "Narcotic Manufacturing Act of 1960". Sections 1 to 3 and 5 to 22 of said Pub. L. 86–429 were classified respectively to sections 501, 501 notes, and 502 to 517 of this title. Section 4 of Pub. L. 86–429 was classified to sections 4702, 4731, and 4731 note of Title 26, Internal Revenue Code. See section 801 et seq. of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91–513, set out as a note under section 951 of this title. For provisions postponing such effective date if the Attorney General postpones the effective date of section 826 of this title, see section 1105(c) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title.

CHAPTER 12—MEAT INSPECTION

SUBCHAPTER I—INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

        

SUBCHAPTER II—MEAT PROCESSORS AND RELATED INDUSTRIES

        

SUBCHAPTER III—FEDERAL AND STATE COOPERATION

        

SUBCHAPTER IV—AUXILIARY PROVISIONS

        

SUBCHAPTER IV–A—INSPECTIONS BY FEDERAL AND STATE AGENCIES

        

SUBCHAPTER V—MISCELLANEOUS PROVISIONS

        

SUBCHAPTER I—INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

§601. Definitions

As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below:

(a) The term "Secretary" means the Secretary of Agriculture of the United States or his delegate.

(b) The term "firm" means any partnership, association, or other unincorporated business organization.

(c) The term "meat broker" means any person, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation.

(d) The term "renderer" means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering conducted under inspection or exemption under this subchapter.

(e) The term "animal food manufacturer" means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines.

(f) The term "State" means any State of the United States and the Commonwealth of Puerto Rico.

(g) The term "Territory" means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.

(h) The term "commerce" means commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legislative body, or the District of Columbia.

(i) The term "United States" means the States, the District of Columbia, and the Territories of the United States.

(j) The term "meat food product" means any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and which are exempted from definition as a meat food product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat food products. This term as applied to food products of equines shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats.

(k) The term "capable of use as human food" shall apply to any carcass, or part or product of a carcass, of any animal, unless it is denatured or otherwise identified as required by regulations prescribed by the Secretary to deter its use as human food, or it is naturally inedible by humans.

(l) The term "prepared" means slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed.

(m) The term "adulterated" shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;

(2)(A) if it bears or contains (by reason of administration of any substance to the live animal or otherwise) any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food;

(B) if it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 346a of this title,

(C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title,

(D) if it bears or contains any color additive which is unsafe within the meaning of section 379e of this title: Provided, That an article which is not adulterated under clause (B), (C), or (D) shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive in or on such article is prohibited by regulations of the Secretary in establishments at which inspection is maintained under this subchapter;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

(5) if it is, in whole or in part, the product of an animal which has died otherwise than by slaughter;

(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title;

(8) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is; or

(9) if it is margarine containing animal fat and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance.

(n) The term "misbranded" shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if its labeling is false or misleading in any particular;

(2) if it is offered for sale under the name of another food;

(3) if it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and immediately thereafter, the name of the food imitated;

(4) if its container is so made, formed, or filled as to be misleading;

(5) if in a package or other container unless it bears a label showing (A) the name and place of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (B) of this subparagraph (5), reasonable variations may be permitted, and exemptions as to small packages may be established, by regulations prescribed by the Secretary;

(6) if any word, statement, or other information required by or under authority of this chapter to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(7) if it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by regulations of the Secretary under section 607 of this title unless (A) it conforms to such definition and standard, and (B) its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food;

(8) if it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations of the Secretary under section 607 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(9) if it is not subject to the provisions of subparagraph (7), unless its label bears (A) the common or usual name of the food, if any there be, and (B) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings may, when authorized by the Secretary, be designated as spices, flavorings, and colorings without naming each: Provided, That to the extent that compliance with the requirements of clause (B) of this subparagraph (9) is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary;

(10) if it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary, after consultation with the Secretary of Health and Human Services, determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses;

(11) if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: Provided, That, to the extent that compliance with the requirements of this subparagraph (11) is impracticable, exemptions shall be established by regulations promulgated by the Secretary; or

(12) if it fails to bear, directly thereon or on its container, as the Secretary may by regulations prescribe, the inspection legend and, unrestricted by any of the foregoing, such other information as the Secretary may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition.

(o) The term "label" means a display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article.

(p) The term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(q) The term "Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]" means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto.

(r) The terms "pesticide chemical," "food additive," "color additive," and "raw agricultural commodity" shall have the same meanings for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(s) The term "official mark" means the official inspection legend or any other symbol prescribed by regulations of the Secretary to identify the status of any article or animal under this chapter.

(t) The term "official inspection legend" means any symbol prescribed by regulations of the Secretary showing that an article was inspected and passed in accordance with this chapter.

(u) The term "official certificate" means any certificate prescribed by regulations of the Secretary for issuance by an inspector or other person performing official functions under this chapter.

(v) The term "official device" means any device prescribed or authorized by the Secretary for use in applying any official mark.

(w) The term "amenable species" means—

(1) those species subject to the provisions of this chapter on the day before November 10, 2005;

(2) all fish of the order Siluriformes; and

(3) any additional species of livestock that the Secretary considers appropriate.

(Mar. 4, 1907, ch. 2907, title I, §1, as added Pub. L. 90–201, §2, Dec. 15, 1967, 81 Stat. 584; amended Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–571, title I, §107(14), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 109–97, title VII, §798[(a)](2), Nov. 10, 2005, 119 Stat. 2166; Pub. L. 110–234, title XI, §11016(b)(1)(A), May 22, 2008, 122 Stat. 1369; Pub. L. 110–246, §4(a), title XI, §11016(b)(1)(A), June 18, 2008, 122 Stat. 1664, 2130; Pub. L. 113–79, title XII, §12106(a)(1), Feb. 7, 2014, 128 Stat. 980.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in pars. (q) and (r), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Pub. L. 110–234 and Pub. L. 110–246 made identical amendments to this section. The amendments by Pub. L. 110–234 were repealed by section 4(a) of Pub. L. 110–246.

Amendments

2014—Subsec. (w)(2). Pub. L. 113–79 added par. (2) and struck out former par. (2) which read as follows: "catfish, as defined by the Secretary; and".

2008—Subsec. (w)(2), (3). Pub. L. 110–246, §11016(b)(1)(A), added par. (2) and redesignated former par. (2) as (3).

2005—Par. (w). Pub. L. 109–97 added par. (w).

1992—Par. (m)(2)(D). Pub. L. 102–571 substituted "379e" for "376".

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in par. (n)(10) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 2014 Amendment

Pub. L. 113–79, title XII, §12106(c), Feb. 7, 2014, 128 Stat. 982, provided that: "This section [amending this section, sections 606 and 625 of this title, and section 1622 of Title 7, Agriculture, and enacting and repealing provisions set out as notes under this section] and the amendments made by this section shall take effect as if enacted as part of section 11016(b) of the Food, Conservation, and Energy Act of 2008 (Public Law 110–246; 122 Stat. 2130) [amending this section, enacting sections 606 and 625 of this title, repealing former section 606 of this title, and enacting provisions set out as notes below]."

Effective Date of 2008 Amendment

Amendment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, except as otherwise provided, see section 4 of Pub. L. 110–246, set out as an Effective Date note under section 8701 of Title 7, Agriculture.

Pub. L. 110–234, title XI, §11016(b)(2)(A), May 22, 2008, 122 Stat. 1369, and Pub. L. 110–246, §4(a), title XI, §11016(b)(2)(A), June 18, 2008, 122 Stat. 1664, 2131, provided that the amendments made by section 11016(b)(1) of Pub. L. 110–234 and section 11016(b)(1) of Pub. L. 110–246 (enacting sections 606 and 625 of this title, amending this section, and repealing former section 606 of this title) would not apply until the date on which the Secretary of Agriculture issued final regulations to carry out such amendments, prior to repeal by Pub. L. 113–79, title XII, §12106(b)(4), Feb. 7, 2014, 128 Stat. 981, effective as if enacted as part of section 11016(b) of the Food, Conservation, and Energy Act of 2008 (Public Law 110–246; 122 Stat. 2130), see Effective Date of 2014 Amendment note above.

[Pub. L. 110–234 and Pub. L. 110–246 enacted identical provisions. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.]

Effective Date of 2005 Amendment

Pub. L. 109–97, title VII, §798(b), Nov. 10, 2005, 119 Stat. 2166, provided that: "The amendments made by subsection (a) [amending this section and sections 603 to 605, 608, 609, 615, and 617 to 621 of this title] shall take effect on the day after the effective date of section 794 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006 [section 794 of Pub. L. 109–97, 119 Stat. 2164, effective 120 days after Nov. 10, 2005]."

Effective Date

Pub. L. 90–201, §20, Dec. 15, 1967, 81 Stat. 601, provided that: "This Act [see Short Title note below] shall become effective upon enactment [Dec. 15, 1967] except as provided in paragraphs (a) through (d):

"(a) The provisions of paragraph (b)(1) and (c) of section 10 and the provisions of section 20 of the Federal Meat Inspection Act, as amended by sections 7 and 10 of this Act [sections 610 and 620 of this title], and the provisions of section 18 of this Act repealing paragraph (b) of section 306 of the Tariff Act of 1930 [section 1306(b) of Title 19, Customs Duties], shall become effective upon the expiration of sixty days after enactment [Dec. 15, 1967], hereof.

"(b) The provisions of title I of the Federal Meat Inspection Act, as amended by this Act [this subchapter], shall become effective with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof upon the expiration of sixty days after enactment [Dec. 15, 1967] hereof.

"(c) Section 11 of this Act, amending section 23, of the Federal Meat Inspection Act [section 623 of this title], shall become effective upon the expiration of sixty days after enactment hereof [Dec. 15, 1967].

"(d) Section 204 of the Federal Meat Inspection Act, as added by section 14 of this Act [section 644 of this title], shall become effective upon the expiration of sixty days after enactment hereof [Dec. 15, 1967]."

Short Title of 1986 Amendment

Pub. L. 99–641, title IV, §401, Nov. 10, 1986, 100 Stat. 3567, provided that: "This title [amending sections 606, 609, 621, 671, and 676 of this title and enacting provisions set out as notes under sections 606, 609, 621, 671, and 676 of this title] may be cited as the 'Processed Products Inspection Improvement Act of 1986'."

Short Title of 1978 Amendment

Pub. L. 95–445, §1, Oct. 10, 1978, 92 Stat. 1069, provided: "That this Act [amending sections 603, 610, and 620 of this title and sections 1902 and 1904 of Title 7, Agriculture, repealing sections 1903 and 1905 of Title 7, and enacting provisions set out as notes under this section and section 603 of this title] may be cited as the 'Humane Methods of Slaughter Act of 1978'."

Short Title

Pub. L. 90–201, §1, Dec. 15, 1967, 81 Stat. 584, provided in part: "That this Act [enacting this section and sections 602, 624, 641 to 645, 661, 671 to 680, and 691 of this title, amending sections 603 to 623 of this title, repealing section 96 of this title and section 1306(b) of Title 19, Customs Duties, and enacting provisions set out as notes under this section] may be cited as the 'Wholesome Meat Act'."

Pub. L. 90–201, §1, Dec. 15, 1967, 81 Stat. 584, provided in part that the provisions of act Mar. 4, 1907, as amended, classified to subchapters I to IV–A of this chapter, are designated as the "Federal Meat Inspection Act".

Regulations

Pub. L. 113–79, title XII, §12106(b)(1)–(3), Feb. 7, 2014, 128 Stat. 981, provided that:

"(1) In general.—The Secretary shall—

"(A) not later than 60 days after the date of enactment of this Act [Feb. 7, 2014], issue final regulations to carry out the amendments made by section 11016(b)(1) of the Food, Conservation, and Energy Act of 2008 (Public Law 110–246; 122 Stat. 2130) [amending this section, enacting sections 606 and 625 of this title, and repealing former section 606 of this title], as further clarified by the amendments made by this section [amending this section, sections 606 and 625 of this title, and section 1622 of Title 7, Agriculture, and enacting and repealing provisions set out as notes under this section]; and

"(B) not later than 1 year after the date of enactment of this Act, implement the amendments described in subparagraph (A).

"(2) Notification.—Beginning 30 days after the date of enactment of this Act and every 30 days thereafter until the date of full implementation of the amendments described in paragraph (1)(A), the Secretary shall submit a report describing the status of implementation to—

"(A) the Committee on Agriculture of the House of Representatives;

"(B) the Committee on Agriculture, Nutrition and Forestry of the Senate;

"(C) the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of the Committee on Appropriations of the House of Representatives; and

"(D) the Subcommittee on Agriculture, Rural Development, and Related Agencies of the Committee on Appropriations of the Senate.

"(3) Procedure.—Section 1601(c)(2) [7 U.S.C. 9091(c)(2)] applies to the promulgation of the regulations and administration of this section and the amendments made by this section."

Pub. L. 110–246, title XI, §11016(b)(2), as added by Pub. L. 113–79, title XII, §12106(b)(4), Feb. 7, 2014, 128 Stat. 981, provided that:

"(A) Regulations.—Not later than 60 days after the date of enactment of the Agricultural Act of 2014 [Feb. 7, 2014], the Secretary [of Agriculture], in consultation with the Commissioner of Food and Drugs, shall issue final regulations to carry out the amendments made by paragraph (1) [amending this section, enacting sections 606 and 625 of this title, and repealing former section 606 of this title] and section 12106 of that Act [amending this section, sections 606 and 625 of this title, and section 1622 of Title 7, Agriculture, and enacting and repealing provisions set out as notes under this section] in a manner that ensures that there is no duplication in inspection activities.

"(B) Interagency coordination.—Not later than 60 days after the date of enactment of the Agricultural Act of 2014, the Secretary shall execute a memorandum of understanding with the Commissioner of Food and Drugs for the following purposes:

"(i) To improve interagency cooperation on food safety and fraud prevention, building upon any other prior agreements, including provisions, performance metrics, and timelines as appropriate.

"(ii) To maximize the effectiveness of limited personnel and resources by ensuring that—

"(I) inspections conducted by the Department satisfy requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);

"(II) inspections of shipments and processing facilities for fish of the order Siluriformes by the Department and the Food and Drug Administration are not duplicative; and

"(III) any information resulting from examination, testing, and inspections conducted is considered in making risk-based determinations, including the establishment of inspection priorities."

Pub. L. 110–234, title XI, §11016(b)(2)(B), May 22, 2008, 122 Stat. 1370, and Pub. L. 110–246, §4(a), title XI, §11016(b)(2)(B), June 18, 2008, 122 Stat. 1664, 2131, required the Secretary of Agriculture, in consultation with the Commissioner of Food and Drugs, to issue final regulations to carry out the amendments made by section 11016(b)(1) of Pub. L. 110–234 and section 11016(b)(1) of Pub. L. 110–246 (enacting sections 606 and 625 of this title, amending this section, and repealing former section 606 of this title) not later than 18 months after June 18, 2008, prior to repeal by Pub. L. 113–79, title XII, §12106(b)(4), Feb. 7, 2014, 128 Stat. 981, effective as if enacted as part of section 11016(b) of the Food, Conservation, and Energy Act of 2008 (Public Law 110–246; 122 Stat. 2130), see Effective Date of 2014 Amendment note above.

[Pub. L. 110–234 and Pub. L. 110–246 enacted identical provisions. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.]

Separability

Pub. L. 90–201, §19, Dec. 15, 1967, 81 Stat. 601, provided that: "If any provision of this Act or of the amendments made hereby [see Short Title note above] or the application thereof to any person or circumstances is held invalid, the validity of the remainder of the Act and the remaining amendments [see Short Title note above] and of the application of such provision to other persons and circumstances shall not be affected thereby."

§602. Congressional statement of findings

Meat and meat food products are an important source of the Nation's total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential in the public interest that the health and welfare of consumers be protected by assuring that meat and meat food products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or misbranded meat or meat food products impair the effective regulation of meat and meat food products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged meat and meat food products, and result in sundry losses to livestock producers and processors of meat and meat food products, as well as injury to consumers. The unwholesome, adulterated, mislabeled, or deceptively packaged articles can be sold at lower prices and compete unfairly with the wholesome, not adulterated, and properly labeled and packaged articles, to the detriment of consumers and the public generally. It is hereby found that all articles and animals which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce, and that regulation by the Secretary and cooperation by the States and other jurisdictions as contemplated by this chapter are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.

(Mar. 4, 1907, ch. 2907, title I, §2, as added Pub. L. 90–201, §2, Dec. 15, 1967, 81 Stat. 587.)

§603. Examination of animals prior to slaughter; use of humane methods

(a) Examination of animals before slaughtering; diseased animals slaughtered separately and carcasses examined

For the purpose of preventing the use in commerce of meat and meat food products which are adulterated, the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of all amenable species before they shall be allowed to enter into any slaughtering, packing, meat-canning, rendering, or similar establishment, in which they are to be slaughtered and the meat and meat food products thereof are to be used in commerce; and all amenable species found on such inspection to show symptoms of disease shall be set apart and slaughtered separately from all other cattle, sheep, swine, goats, horses, mules, or other equines, and when so slaughtered the carcasses of said cattle, sheep, swine, goats, horses, mules, or other equines shall be subject to a careful examination and inspection, all as provided by the rules and regulations to be prescribed by the Secretary, as provided for in this subchapter.

(b) Humane methods of slaughter

For the purpose of preventing the inhumane slaughtering of livestock, the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of the method by which amenable species are slaughtered and handled in connection with slaughter in the slaughtering establishments inspected under this chapter. The Secretary may refuse to provide inspection to a new slaughtering establishment or may cause inspection to be temporarily suspended at a slaughtering establishment if the Secretary finds that any cattle, sheep, swine, goats, horses, mules, or other equines have been slaughtered or handled in connection with slaughter at such establishment by any method not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901–1906) until the establishment furnishes assurances satisfactory to the Secretary that all slaughtering and handling in connection with slaughter of livestock shall be in accordance with such a method.

(Mar. 4, 1907, ch. 2907, title I, §3, formerly 1st par., 34 Stat. 1260; renumbered §3 and amended Pub. L. 90–201, §§1, 3, 12(a), (b), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 95–445, §2, Oct. 10, 1978, 92 Stat. 1069; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

References in Text

Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85–765, Aug. 27, 1958, 72 Stat. 862, which is classified generally to chapter 48 (§1901 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Tables.

Sections 1903 and 1905 of Title 7, included within reference to Act of August 27, 1958, were repealed by Pub. L. 95–445, §5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note below.

Codification

Section was formerly classified to section 71 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines" wherever appearing.

1978—Pub. L. 95–445 designated existing provisions as subsec. (a) and added subsec. (b).

1967—Pub. L. 90–201, §§3, 12(a), (b), struck out "interstate or foreign" before "commerce" in two places, substituted "Secretary shall" for "Secretary, at his discretion, may", and struck out "of Agriculture" after "Secretary", included horses, mules, and other equines, and horses, mules, or other equines in the list of animals, and substituted "adulterated" for "unsound, unhealthful, unwholesome, or otherwise unfit for human food", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1978 Amendment

Pub. L. 95–445, §7, Oct. 10, 1978, 92 Stat. 1070, provided that: "The provisions of this Act [see Short Title of 1978 Amendment note set out under section 601 of this title] shall become effective one year after the date of enactment [Oct. 10, 1978]. However, such provisions shall not apply to a person, firm, or corporation for such additional period of time, not to exceed eighteen months, as may be determined by the Secretary, if the Secretary, upon application, finds that compliance with the provisions of this Act on its effective date would cause undue hardship on such person, firm, or corporation."

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

Religious Freedom; Ritual Slaughter

Pub. L. 95–445, §6, Oct. 10, 1978, 92 Stat. 1070, provided that: "Nothing in this Act [see Short Title of 1978 Amendment note set out under section 601 of this title] shall be construed to prohibit, abridge, or in any way hinder the religious freedom of any person or group. Notwithstanding any other provision of this Act, in order to protect freedom of religion, ritual slaughter and the handling or other preparation of livestock for ritual slaughter are exempted from the terms of this Act. For the purposes of this section the term 'ritual slaughter' means slaughter in accordance with section 2(b) of the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1902(b))."

§604. Post mortem examination of carcasses and marking or labeling; destruction of carcasses condemned; reinspection

For the purposes hereinbefore set forth the Secretary shall cause to be made by inspectors appointed for that purpose a post mortem examination and inspection of the carcasses and parts thereof of all amenable species to be prepared at any slaughtering, meat-canning, salting, packing, rendering, or similar establishment in any State, Territory, or the District of Columbia as articles of commerce which are capable of use as human food; and the carcasses and parts thereof of all such animals found to be not adulterated shall be marked, stamped, tagged, or labeled as "Inspected and passed"; and said inspectors shall label, mark, stamp, or tag as "Inspected and condemned" all carcasses and parts thereof of animals found to be adulterated; and all carcasses and parts thereof thus inspected and condemned shall be destroyed for food purposes by the said establishment in the presence of an inspector, and the Secretary may remove inspectors from any such establishment which fails to so destroy any such condemned carcass or part thereof, and said inspectors, after said first inspection, shall, when they deem it necessary, reinspect said carcasses or parts thereof to determine whether since the first inspection the same have become adulterated, and if any carcass or any part thereof shall, upon examination and inspection subsequent to the first examination and inspection, be found to be adulterated, it shall be destroyed for food purposes by the said establishment in the presence of an inspector, and the Secretary may remove inspectors from any establishment which fails to so destroy any such condemned carcass or part thereof.

(Mar. 4, 1907, ch. 2907, title I, §4, formerly 2nd par., 34 Stat. 1260; renumbered §4 and amended Pub. L. 90–201, §§1, 3, 4, 12(a)–(d), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 72 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines".

1967—Pub. L. 90–201, §§3, 4, 12(a)–(d), struck out "interstate or foreign" before "commerce" and "of Agriculture" after "Secretary" in three places; struck out "for human consumption" before "at any slaughtering" and "for transportation or sale" after "District of Columbia" and inserted "which are capable of use as human food" after "commerce"; included horses, mules, and other equines in the list of animals; substituted "adulterated" for "unsound, unhealthful, unwholesome, or otherwise unfit for human food" after " 'Inspected and condemned,' all carcasses and parts thereof of animals found to be" and before ", it shall be destroyed"; substituted "not adulterated" for "sound, healthful, wholesome, and fit for human food"; and substituted "adulterated" for "unsound, unhealthful, unwholesome, or in any way unfit for human food" before "and if any carcass", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§605. Examination of carcasses brought into slaughtering or packing establishments, and of meat food products issued from and returned thereto; conditions for entry

The foregoing provisions shall apply to all carcasses or parts of carcasses of amenable species or the meat or meat products thereof which may be brought into any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, and such examination and inspection shall be had before the said carcasses or parts thereof shall be allowed to enter into any department wherein the same are to be treated and prepared for meat food products; and the foregoing provisions shall also apply to all such products, which, after having been issued from any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, shall be returned to the same or to any similar establishment where such inspection is maintained. The Secretary may limit the entry of carcasses, parts of carcasses, meat and meat food products, and other materials into any establishment at which inspection under this subchapter is maintained, under such conditions as he may prescribe to assure that allowing the entry of such articles into such inspected establishments will be consistent with the purposes of this chapter.

(Mar. 4, 1907, ch. 2907, title I, §5, formerly 3rd par., 34 Stat. 1261; renumbered §5 and amended Pub. L. 90–201, §§1, 5, 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 73 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines".

1967—Pub. L. 90–201, §§5, 12(a), limited entry of articles into establishments under such prescribed conditions as would be consistent with the purpose of this chapter and included horses, mules, and other equines in the list of animals, respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§606. Inspection and labeling of meat food products

(a) In general

For the purposes hereinbefore set forth the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of all meat food products prepared for commerce in any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, and for the purposes of any examination and inspection and inspectors shall have access at all times, by day or night, whether the establishment be operated or not, to every part of said establishment; and said inspectors shall mark, stamp, tag, or label as "Inspected and passed" all such products found to be not adulterated; and said inspectors shall label, mark, stamp, or tag as "Inspected and condemned" all such products found adulterated, and all such condemned meat food products shall be destroyed for food purposes, as hereinbefore provided, and the Secretary may remove inspectors from any establishment which fails to so destroy such condemned meat food products: Provided, That subject to the rules and regulations of the Secretary the provisions of this section in regard to preservatives shall not apply to meat food products for export to any foreign country and which are prepared or packed according to the specifications or directions of the foreign purchaser, when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is to be exported; but if said article shall be in fact sold or offered for sale for domestic use or consumption then this proviso shall not exempt said article from the operation of all the other provisions of this chapter.¹

(b) Certain fish

In the case of an examination and inspection under subsection (a) of a meat food product derived from any fish described in section 601(w)(2) of this title, the Secretary shall take into account the conditions under which the fish is raised and transported to a processing establishment.

(Mar. 4, 1907, ch. 2907, title I, §6, as added Pub. L. 110–234, title XI, §11016(b)(1)(B), May 22, 2008, 122 Stat. 1369, and Pub. L. 110–246, §4(a), title XI, §11016(b)(1)(B), June 18, 2008, 122 Stat. 1664, 2131; amended Pub. L. 113–79, title XII, §12106(a)(2), Feb. 7, 2014, 128 Stat. 981.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), probably should have been a reference to this Act in the original, meaning the Federal Meat Inspection Act, titles I to V of act Mar. 4, 1907, ch. 2907, as added Dec. 15, 1967, Pub. L. 90–201, 81 Stat. 584, which are classified generally to subchapters I to IV–A of this chapter.

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections and repealed former section 6 of act Mar. 4, 1907. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Prior Provisions

A prior section 606, acts Mar. 4, 1907, ch. 2907, title I, §6, formerly 4th par., 34 Stat. 1261; renumbered §6 and amended Pub. L. 90–201, §§1, 3, 12(e), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 99–641, title IV, §403(a), Nov. 10, 1986, 100 Stat. 3567, was formerly classified to section 74 of this title and was repealed by Pub. L. 110–234, title XI, §11016(b)(1)(B), May 22, 2008, 122 Stat. 1369, and Pub. L. 110–246, §4(a), title XI, §11016(b)(1)(B), June 18, 2008, 122 Stat. 1664, 2131. Prior to repeal, section read as follows: "For the purposes hereinbefore set forth the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of all meat food products prepared for commerce in any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, and for the purposes of any examination and inspection and inspectors shall have access at all times, by day or night, whether the establishment be operated or not, to every part of said establishment; and said inspectors shall mark, stamp, tag, or label as 'Inspected and passed' all such products found to be not adulterated; and said inspectors shall label, mark, stamp, or tag as 'Inspected and condemned' all such products found adulterated, and all such condemned meat food products shall be destroyed for food purposes, as hereinbefore provided, and the Secretary may remove inspectors from any establishment which fails to so destroy such condemned meat food products: Provided, That subject to the rules and regulations of the Secretary the provisions of this section in regard to preservatives shall not apply to meat food products for export to any foreign country and which are prepared or packed according to the specifications or directions of the foreign purchaser, when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is to be exported; but if said article shall be in fact sold or offered for sale for domestic use or consumption then this proviso shall not exempt said article from the operation of all the other provisions of this chapter."

Amendments

2014—Subsec. (b). Pub. L. 113–79 added subsec. (b) and struck out former subsec. (b). Prior to amendment, text read as follows: "In the case of an examination and inspection under subsection (a) of a meat food product derived from catfish, the Secretary shall take into account the conditions under which the catfish is raised and transported to a processing establishment."

Statutory Notes and Related Subsidiaries

Effective Date of 2014 Amendment

Amendment by Pub. L. 113–79 effective as if enacted as part of section 11016(b) of Pub. L. 110–246, see section 12106(c) of Pub. L. 113–79, set out as a note under section 601 of this title.

Effective Date

Enactment of this section and repeal of former section 6 of act Mar. 4, 1907, and Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, except as otherwise provided, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.

¹ See References in Text note below.

§607. Labeling, marking, and container requirements

(a) Labeling receptacles or coverings of meat or meat food products inspected and passed; supervision by inspectors

When any meat or meat food product prepared for commerce which has been inspected as hereinbefore provided and marked "Inspected and passed" shall be placed or packed in any can, pot, tin, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this chapter is maintained, the person, firm, or corporation preparing said product shall cause a label to be attached to said can, pot, tin, canvas, or other receptacle or covering, under the supervision of an inspector, which label shall state that the contents thereof have been "inspected and passed" under the provisions of this chapter; and no inspection and examination of meat or meat food products deposited or inclosed in cans, tins, pots, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this chapter is maintained shall be deemed to be complete until such meat or meat food products have been sealed or inclosed in said can, tin, pot, canvas, or other receptacle or covering under the supervision of an inspector.

(b) Information on articles or containers; legible form

All carcasses, parts of carcasses, meat and meat food products inspected at any establishment under the authority of this subchapter and found to be not adulterated, shall at the time they leave the establishment bear, in distinctly legible form, directly thereon or on their containers, as the Secretary may require, the information required under paragraph (n) of section 601 of this title.

(c) Labeling: type styles and sizes; definitions and standards of identity or composition; standards of fill of container; consistency of Federal and Federal-State standards

The Secretary, whenever he determines such action is necessary for the protection of the public, may prescribe: (1) the styles and sizes of type to be used with respect to material required to be incorporated in labeling to avoid false or misleading labeling in marketing and labeling any articles or animals subject to this subchapter or subchapter II of this chapter; (2) definitions and standards of identity or composition for articles subject to this subchapter and standards of fill of container for such articles not inconsistent with any such standards established under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and there shall be consultation between the Secretary and the Secretary of Health and Human Services prior to the issuance of such standards under either Act relating to articles subject to this chapter to avoid inconsistency in such standards and possible impairment of the coordinated effective administration of these Acts. There shall also be consultation between the Secretary and an appropriate advisory committee provided for in section 661 of this title, prior to the issuance of such standards under this chapter, to avoid, insofar as feasible, inconsistency between Federal and State standards.

(d) Sales under false or misleading name, other marking or labeling or in containers of misleading form or size; trade names, and other marking, labeling, and containers approved by Secretary

No article subject to this subchapter shall be sold or offered for sale by any person, firm, or corporation, in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size, but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted.

(e) Use withholding directive respecting false or misleading marking, labeling, or container; modification of false or misleading matter; hearing; withholding use pending proceedings; finality of Secretary's action; judicial review; application of section 194 of title 7

If the Secretary has reason to believe that any marking or labeling or the size or form of any container in use or proposed for use with respect to any article subject to this subchapter is false or misleading in any particular, he may direct that such use be withheld unless the marking, labeling, or container is modified in such manner as he may prescribe so that it will not be false or misleading. If the person, firm, or corporation using or proposing to use the marking, labeling or container does not accept the determination of the Secretary, such person, firm, or corporation may request a hearing, but the use of the marking, labeling, or container shall, if the Secretary so directs, be withheld pending hearing and final determination by the Secretary. Any such determination by the Secretary shall be conclusive unless, within thirty days after receipt of notice of such final determination, the person, firm, or corporation adversely affected thereby appeals to the United States court of appeals for the circuit in which such person, firm, or corporation has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. The provisions of section 194 of title 7 shall be applicable to appeals taken under this section.

(f) Lamb and mutton

The Secretary, consistent with United States international obligations, shall establish standards for the labeling of sheep carcasses, parts of sheep carcasses, sheepmeat, and sheepmeat food products.

(Mar. 4, 1907, ch. 2907, title I, §7, formerly 5th par., 34 Stat. 1262; renumbered §7 and amended Pub. L. 90–201, §§1, 3(a), 6, Dec. 15, 1967, 81 Stat. 584, 588; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 104–127, title II, §279, Apr. 4, 1996, 110 Stat. 979.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Either Act and these Acts, referred to in subsec. (c)(2), mean the Federal Meat Inspection Act and the Federal Food, Drug, and Cosmetic Act. The Federal Meat Inspection Act is titles I to V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, §11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§601 et seq.) of this chapter. For complete classification of this Act to the Code, see Short Title note under section 601 of this title and Tables.

Codification

Section was formerly classified to section 75 of this title.

Amendments

1996—Subsec. (f). Pub. L. 104–127 added subsec. (f).

1967—Subsec. (a). Pub. L. 90–201, §§3(a), 6(a), (b), struck out "interstate or foreign" before "commerce" and provisions prohibiting sales of meat or meat food products in interstate or foreign commerce under any false or deceptive names and permitting trade names or names which are usual to such products and are not false and deceptive and are approved by the Secretary of Agriculture, now incorporated in subsec. (d), and designated remaining provisions as subsecs. (a), respectively.

Subsecs. (b) to (e). Pub. L. 90–201, §6(c), added subsecs. (b) to (e).

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (c)(2) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§608. Sanitary inspection and regulation of slaughtering and packing establishments; rejection of adulterated meat or meat food products

The Secretary shall cause to be made, by experts in sanitation or by other competent inspectors, such inspection of all slaughtering, meat canning, salting, packing, rendering, or similar establishments in which amenable species are slaughtered and the meat and meat food products thereof are prepared for commerce as may be necessary to inform himself concerning the sanitary conditions of the same, and to prescribe the rules and regulations of sanitation under which such establishments shall be maintained; and where the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, he shall refuse to allow said meat or meat food products to be labeled, marked, stamped or tagged as "inspected and passed."

(Mar. 4, 1907, ch. 2907, title I, §8, formerly 6th par., 34 Stat. 1262; renumbered §8 and amended Pub. L. 90–201, §§1, 3, 12(a), (f), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 76 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines".

1967—Pub. L. 90–201, §§3, 12(a), (f), struck out "interstate or foreign" before "commerce" and "of Agriculture" after "Secretary", included horses, mules, and other equines in the list of animals, and substituted "adulterated" for "unclean, unsound, unhealthful, unwholesome, or otherwise unfit for human food", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§609. Examination of animals and food products thereof, slaughtered and prepared during nighttime

The Secretary shall cause an examination and inspection of all amenable species, and the food products thereof, slaughtered and prepared in the establishments hereinbefore described for the purposes of commerce to be made during the nighttime as well as during the daytime when the slaughtering of said amenable species, or the preparation of said food products is conducted during the nighttime.

(Mar. 4, 1907, ch. 2907, title I, §9, formerly 7th par., 34 Stat. 1262; renumbered §9 and amended Pub. L. 90–201, §§1, 3, 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 99–641, title IV, §403(d)(1), Nov. 10, 1986, 100 Stat. 3570; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 77 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines" in two places.

1986—Pub. L. 99–641 temporarily inserted ", except as provided in section 606 of this title," after first reference to "other equines, and". See Effective and Termination Dates of 1986 Amendment note below.

1967—Pub. L. 90–201, §§3, 12(a), struck out "interstate or foreign" before "commerce" and "of Agriculture" after "Secretary" and included horses, mules, and other equines in the list of animals, respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective and Termination Dates of 1986 Amendment

Pub. L. 99–641, title IV, §403(d)(1), Nov. 10, 1986, 100 Stat. 3570, provided that the amendment made by that section is effective only during the 6-year period beginning Nov. 10, 1986.

Pub. L. 99–641, title IV, §408, Nov. 10, 1986, 100 Stat. 3571, provided that:

"(a) General Effective Date.—Except as provided in subsection (b) of this section, this title and the amendments made by this title [amending this section and sections 606, 621, 671, and 676 of this title and enacting provisions set out as notes under this section and sections 606, 621, 671, and 676 of this title] shall become effective on the date of the enactment of this Act [Nov. 10, 1986].

"(b) Temporary Application of Existing Law.—Sections 6, 9, and 21 of the Federal Meat Inspection Act (21 U.S.C. 606, 609, and 621), as in effect immediately before the date of the enactment of this Act [Nov. 10, 1986], shall apply with respect to establishments until the Secretary of Agriculture first issues rules and regulations to implement the amendments made by section 403(a) [amending section 606 of this title]."

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

Savings Provision

Pub. L. 99–641, title IV, §404, Nov. 10, 1986, 100 Stat. 3571, provided that: "The expiration date provisions of section 403 [enacting provisions set out as notes under this section and sections 606, 621, 671, and 676 of this title] shall not have the effect of releasing or extinguishing any penalty, forfeiture, or liability incurred under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), as amended by section 403 [amending this section and sections 606, 621, 671, and 676 of this title], or under the rules or regulations issued under such Act."

Inspection Services for Establishments Not Participating in Total Plant Quality-Control Program

Pub. L. 99–641, title IV, §403(e), Nov. 10, 1986, 100 Stat. 3570, provided that: "The amendments made by this section [amending this section and sections 606, 621, 671, and 676 of this title] shall not be construed to authorize the Secretary of Agriculture to refuse to provide inspection under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) at an establishment solely because such establishment does not participate in a total plant quality-control program."

§610. Prohibited acts

No person, firm, or corporation shall, with respect to any cattle, sheep, swine, goats, horses, mules, or other equines, or any carcasses, parts of carcasses, meat or meat food products of any such animals—

(a) Slaughtering animals or preparation of articles capable of use as human food

slaughter any such animals or prepare any such articles which are capable of use as human food at any establishment preparing any such articles for commerce, except in compliance with the requirements of this chapter;

(b) Humane methods of slaughter

slaughter or handle in connection with slaughter any such animals in any manner not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901–1906);

(c) Sales, transportation, and other transactions

sell, transport, offer for sale or transportation, or receive for transportation, in commerce, (1) any such articles which (A) are capable of use as human food and (B) are adulterated or misbranded at the time of such sale, transportation, offer for sale or transportation, or receipt for transportation; or (2) any articles required to be inspected under this subchapter unless they have been so inspected and passed;

(d) Adulteration or misbranding

do, with respect to any such articles which are capable of use as human food, any act while they are being transported in commerce or held for sale after such transportation, which is intended to cause or has the effect of causing such articles to be adulterated or misbranded.

(Mar. 4, 1907, ch. 2907, title I, §10, formerly 8th par., 34 Stat. 1262; renumbered §10 and amended Pub. L. 90–201, §§1, 7, Dec. 15, 1967, 81 Stat. 584, 589; Pub. L. 95–445, §3, Oct. 10, 1978, 92 Stat. 1069.)

Editorial Notes

References in Text

Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85–765, Aug. 27, 1958, 72 Stat. 862, which is classified generally to chapter 48 (§1901 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Tables.

Sections 1903 and 1905 of Title 7, included within reference to Act of August 27, 1958, were repealed by Pub. L. 95–445, §5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note under section 603 of this title.

Codification

Section was formerly classified to section 78 of this title.

Amendments

1978—Subsecs. (b) to (d). Pub. L. 95–445 added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively.

1967—Pub. L. 90–201, §7, included the list of animals and prohibited, except in compliance with requirements of this chapter, slaughtering animals or preparation of articles capable of use as human food, sales, transportation, and other transactions, and acts of adulteration or misbranding, incorporating in subsec. (b)(2) existing prohibition on distributions in interstate or foreign commerce of noninspected articles.

Statutory Notes and Related Subsidiaries

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–445 effective one year after Oct. 10, 1978, and an additional eighteen month period thereafter in hardship cases, see section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note under section 603 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that subsecs. (b)(1) and (c) of this section effective upon expiration of sixty days after Dec. 15, 1967, see section 20(a) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§611. Devices, marks, labels, and certificates; simulations

(a) Devices to be made under authorization of Secretary

No brand manufacturer, printer, or other person, firm, or corporation shall cast, print, lithograph, or otherwise make any device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, or any form of official certificate or simulation thereof, except as authorized by the Secretary.

(b) Other misconduct

No person, firm, or corporation shall—

(1) forge any official device, mark, or certificate;

(2) without authorization from the Secretary use any official device, mark, or certificate, or simulation thereof, or alter, detach, deface, or destroy any official device, mark, or certificate;

(3) contrary to the regulations prescribed by the Secretary, fail to use, or to detach, deface, or destroy any official device, mark, or certificate;

(4) knowingly possess, without promptly notifying the Secretary or his representative, any official device or any counterfeit, simulated, forged, or improperly altered official certificate or any device or label or any carcass of any animal, or part or product thereof, bearing any counterfeit, simulated, forged, or improperly altered official mark;

(5) knowingly make any false statement in any shipper's certificate or other nonofficial or official certificate provided for in the regulations prescribed by the Secretary; or

(6) knowingly represent that any article has been inspected and passed, or exempted, under this chapter when, in fact, it has, respectively, not been so inspected and passed, or exempted.

(Mar. 4, 1907, ch. 2907, title I, §11, formerly 9th par., 34 Stat. 1263; renumbered §11 and amended Pub. L. 90–201, §§1, 8, Dec. 15, 1967, 81 Stat. 584, 589.)

Editorial Notes

Codification

Section was formerly classified to section 79 of this title.

Amendments

1967—Pub. L. 90–201, §8, clarified application to brand manufacturers and printers of existing prohibition against counterfeiting official marks, labels or certificates, the provisions with respect to forgery, unauthorized use or failure to use official marks, or similar items, and similar offenses, and existing prohibitions with respect to false statements in official or nonofficial certificates, and added restriction upon possession of official devices, or devices, labels, meat, or other articles bearing counterfeit official marks, counterfeit official certificates, or similar items, and prohibition against false representations.

Statutory Notes and Related Subsidiaries

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§612. Notification

Any establishment subject to inspection under this chapter that believes, or has reason to believe, that an adulterated or misbranded meat or meat food product received by or originating from the establishment has entered into commerce shall promptly notify the Secretary with regard to the type, amount, origin, and destination of the meat or meat food product.

(Mar. 4, 1907, ch. 2907, title I, §12, as added Pub. L. 110–234, title XI, §11017(a), May 22, 2008, 122 Stat. 1370, and Pub. L. 110–246, §4(a), title XI, §11017(a), June 18, 2008, 122 Stat. 1664, 2132.)

Editorial Notes

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Prior Provisions

A prior section 612, acts Mar. 4, 1907, ch. 2907, title I, §12, formerly 10th par., 34 Stat. 1263; renumbered §12 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, related to inspection of animals for export, prior to repeal by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508. Section was formerly classified to section 80 of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.

§613. Plans and reassessments

The Secretary shall require that each establishment subject to inspection under this chapter shall, at a minimum—

(1) prepare and maintain current procedures for the recall of all meat or meat food products produced and shipped by the establishment;

(2) document each reassessment of the process control plans of the establishment; and

(3) upon request, make the procedures and reassessed process control plans available to inspectors appointed by the Secretary for review and copying.

(Mar. 4, 1907, ch. 2907, title I, §13, as added Pub. L. 110–234, title XI, §11017(a), May 22, 2008, 122 Stat. 1370, and Pub. L. 110–246, §4(a), title XI, §11017(a), June 18, 2008, 122 Stat. 1664, 2132.)

Editorial Notes

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Prior Provisions

A prior section 613, acts Mar. 4, 1907, ch. 2907, title I, §13, formerly 11th par., 34 Stat. 1263; renumbered §13 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, related to inspectors of animals for export and certificates of condition, prior to repeal by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508. Section was formerly classified to section 81 of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.

§614. Repealed. Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508

Section, acts Mar. 4, 1907, ch. 2907, title I, §14, formerly 12th par., 34 Stat. 1263; renumbered §14 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, prohibited clearance to vessel carrying animals for export without inspector's certificate. Section was formerly classified to section 82 of this title.

§615. Inspection of carcasses, meat of which is intended for export

The Secretary shall also cause to be made a careful inspection of the carcasses and parts thereof of all amenable species, the meat of which, fresh, salted, canned, corned, packed, cured, or otherwise prepared, is intended and offered for export to any foreign country, at such times and places and in such manner as he may deem proper.

(Mar. 4, 1907, ch. 2907, title I, §15, formerly 13th par., 34 Stat. 1263; renumbered §15 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 83 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines".

1967—Pub. L. 90–201, §§3(b), 12(a), struck out "of Agriculture" after "Secretary" and included horses, mules, and other equines in the list of animals, respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§616. Inspectors of carcasses, etc., meat of which is intended for export; certificates of condition

For the purpose of section 615 of this title the Secretary may appoint inspectors who shall be authorized to give an official certificate stating the condition in which said cattle, sheep, swine, goats, horses, mules, or other equines, and the meat thereof, are found.

(Mar. 4, 1907, ch. 2907, title I, §16, formerly 14th par., 34 Stat. 1263; renumbered §16 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592.)

Editorial Notes

Codification

Section was formerly classified to section 84 of this title.

Amendments

1967—Pub. L. 90–201, §§3(b), 12(a), struck out "of Agriculture" after "Secretary", and included horses, mules, or other equines in the list of animals.

Statutory Notes and Related Subsidiaries

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§617. Clearance prohibited to vessel carrying meat for export without inspector's certificate

No clearance shall be given to any vessel having on board any fresh, salted, canned, corned, or packed beef, mutton, pork, goat or equine meat for export to and sale in a foreign country from any port in the United States, until the owner or shipper thereof shall obtain from an inspector appointed under the provisions of this chapter a certificate that the said amenable species were sound and healthy at the time of inspection, and that their meat is sound and wholesome, unless the Secretary shall have waived the requirements of such certificate for the country to which said amenable species or meats are to be exported.

(Mar. 4, 1907, ch. 2907, title I, §17, formerly 15th par., 34 Stat. 1263; renumbered §17 and amended Pub. L. 90–201, §§1, 3(b), 12(a), (g), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 85 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines" in two places.

1967—Pub. L. 90–201, §§3(b), 12(a), (g), struck out "of Agriculture" after "Secretary", included horses, mules, and other equines in the list of animals, and substituted "goat or equine meat" for "or goat meat, being the meat of animals killed after March 4, 1907, or except as hereinbefore provided", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§618. Delivery of inspectors' certificates, and of copies

The inspectors provided for under this subchapter shall be authorized to give official certificates of the condition of the carcasses and products of amenable species; and one copy of every certificate granted under the provisions of this chapter shall be filed in the Department of Agriculture, another copy shall be delivered to the owner or shipper, and when the amenable species, or their carcasses and products are sent abroad, a third copy shall be delivered to the chief officer of the vessel on which the shipment shall be made.

(Mar. 4, 1907, ch. 2907, title I, §18, formerly 16th par., 34 Stat. 1263; renumbered §18 and amended Pub. L. 90–201, §§1, 12(a), (h), Dec. 15, 1967, 81 Stat. 584, 592; Pub. L. 107–171, title X, §10418(b)(4), May 13, 2002, 116 Stat. 508; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

"Provided for under this subchapter" was in the original "provided for herein".

Section was formerly classified to section 86 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines" in two places.

2002—Pub. L. 107–171 substituted "of the carcasses and products of cattle, sheep, swine, goats, horses, mules, and other equines" for "of the cattle, sheep, swine, goats, horses, mules, and other equines, their carcasses and products as described in this subchapter".

1967—Pub. L. 90–201, §12(a), (h), included horses, mules, and other equines in the list of animals and struck out "sound and wholesome" before "conditions", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§619. Marking, labeling, or other identification to show kinds of animals from which derived; separate establishments for preparation and slaughtering activities

No person, firm, or corporation shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any carcasses of species designated by regulations in effect on the day before November 10, 2005, or parts of such carcasses, or the meat or meat food products thereof, unless they are plainly and conspicuously marked or labeled or otherwise identified as required by regulations prescribed by the Secretary to show the kinds of animals from which they were derived. When required by the Secretary, with respect to establishments at which inspection is maintained under this subchapter, such animals and their carcasses, parts thereof, meat and meat food products shall be prepared in establishments separate from those in which other amenable species are slaughtered or their carcasses, parts thereof, meat or meat food products are prepared.

(Mar. 4, 1907, ch. 2907, title I, §19, formerly 17th par., 34 Stat. 1264; renumbered §19 and amended Pub. L. 90–201, §§1, 9, Dec. 15, 1967, 81 Stat. 584, 590; Pub. L. 109–97, title VII, §798[(a)](3), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 87 of this title.

Amendments

2005—Pub. L. 109–97 substituted "species designated by regulations in effect on the day before November 10, 2005," for "horses, mules, or other equines" and "other amenable species" for "cattle, sheep, swine, or goats".

1967—Pub. L. 90–201, §9, substituted provisions for marking, labeling, or other identification of kinds of animals whence the articles are derived and for separate establishments for preparation and slaughtering activities for prohibition against transportation or sale of meat or meat food products without complying with inspection provisions. See section 610(b) of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L, 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration, of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§620. Imports

(a) Adulteration or misbranding prohibition; compliance with inspection, building construction standards, and other provisions; humane methods of slaughter; treatment as domestic articles subject to this chapter and food, drug, and cosmetic provisions; marking and labeling; personal consumption exemption

No carcasses, parts of carcasses, meat or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines which are capable of use as human food, shall be imported into the United States if such articles are adulterated or misbranded and unless they comply with all the inspection, building, construction standards, and all other provisions of this chapter and regulations issued thereunder applicable to such articles in commerce within the United States. No such carcasses, parts of carcasses, meat or meat food products shall be imported into the United States unless the livestock from which they were produced was slaughtered and handled in connection with slaughter in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901–1906). All such imported articles shall, upon entry into the United States, be deemed and treated as domestic articles subject to the other provisions of this chapter and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]: Provided, That they shall be marked and labeled as required by such regulations for imported articles: Provided further, That nothing in this section shall apply to any individual who purchases meat or meat products outside the United States for his own consumption except that the total amount of such meat or meat products shall not exceed fifty pounds.

(b) Terms and conditions for destruction

The Secretary may prescribe the terms and conditions for the destruction of all such articles which are imported contrary to this section, unless (1) they are exported by the consignee within the time fixed therefor by the Secretary, or (2) in the case of articles which are not in compliance with the chapter solely because of misbranding, such articles are brought into compliance with the chapter under supervision of authorized representatives of the Secretary.

(c) Payment of storage, cartage, and labor charges by owner or consignee; liens

All charges for storage, cartage, and labor with respect to any article which is imported contrary to this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against such article and any other article thereafter imported under this chapter by or for such owner or consignee.

(d) Prohibition

The knowing importation of any article contrary to this section is prohibited.

(e) Omitted

(f) Inspection and other standards; applicability, enforcement, etc.; certifications

Notwithstanding any other provision of law, all carcasses, parts of carcasses, meat, and meat food products of cattle, sheep, swine, goats, horses, mules, or other equines, capable of use as human food, offered for importation into the United States shall be subject to the inspection, sanitary, quality, species verification, and residue standards applied to products produced in the United States. Any such imported meat articles that do not meet such standards shall not be permitted entry in to the United States. The Secretary shall enforce this provision through (1) the imposition of random inspections for such species verification and for residues, and (2) random sampling and testing of internal organs and fat of the carcasses for residues at the point of slaughter by the exporting country in accordance with methods approved by the Secretary. Each foreign country from which such meat articles are offered for importation into the United States shall obtain a certification issued by the Secretary stating that the country maintains a program using reliable analytical methods to ensure compliance with the United States standards for residues in such meat articles. No such meat article shall be permitted entry into the United States from a country for which the Secretary has not issued such certification. The Secretary shall periodically review such certifications and shall revoke any certification if the Secretary determines that the country involved is not maintaining a program that uses reliable analytical methods to ensure compliance with United States standards for residues in such meat articles. The consideration of any application for a certification under this subsection and the review of any such certification, by the Secretary, shall include the inspection of individual establishments to ensure that the inspection program of the foreign country involved is meeting such United States standards.

(g) Administration of animal drugs or antibiotics; terms and conditions; entry order violations

The Secretary may prescribe terms and conditions under which amenable species that have been administered an animal drug or antibiotic banned for use in the United States may be imported for slaughter and human consumption. No person shall enter amenable species into the United States in violation of any order issued under this subsection by the Secretary.

(h) Reciprocal meat inspection requirement

(1) As used in this subsection:

(A) The term "meat articles" means carcasses, meat and meat food products of cattle, sheep, swine, goats, horses, mules, or other equines, that are capable of use as human food.

(B) The term "standards" means inspection, building construction, sanitary, quality, species verification, residue, and other standards that are applicable to meat articles.

(2) On request of the Committee on Agriculture or the Committee on Ways and Means of the House of Representatives or the Committee on Agriculture, Nutrition, and Forestry or the Committee on Finance of the Senate, or at the initiative of the Secretary, the Secretary shall, as soon as practicable, determine whether a particular foreign country applies standards for the importation of meat articles from the United States that are not related to public health concerns about end-product quality that can be substantiated by reliable analytical methods.

(3) If the Secretary determines that a foreign country applies standards described in paragraph (2)—

(A) the Secretary shall consult with the United States Trade Representative; and

(B) within 30 days after the determination of the Secretary under paragraph (2), the Secretary and the United States Trade Representative shall recommend to the President whether action should be taken under paragraph (4).

(4) Within 30 days after receiving a recommendation for action under paragraph (3), the President shall, if and for such time as the President considers appropriate, prohibit imports into the United States of any meat articles produced in such foreign country unless it is determined that the meat articles produced in that country meet the standards applicable to meat articles in commerce within the United States.

(5) The action authorized under paragraph (4) may be used instead of, or in addition to, any other action taken under any other law.

(Mar. 4, 1907, ch. 2907, title I, §20, formerly 18th par., 34 Stat. 1264; renumbered §20 and amended Pub. L. 90–201, §§1, 10, Dec. 15, 1967, 81 Stat. 584, 590; Pub. L. 95–445, §4, Oct. 10, 1978, 92 Stat. 1069; Pub. L. 97–98, title XI, §1122, Dec. 22, 1981, 95 Stat. 1273; Pub. L. 99–198, title XVII, §1702, Dec. 23, 1985, 99 Stat. 1634; Pub. L. 100–418, title IV, §4604, Aug. 23, 1988, 102 Stat. 1408; Pub. L. 103–182, title III, §361(f), Dec. 8, 1993, 107 Stat. 2124; Pub. L. 103–437, §8(2), Nov. 2, 1994, 108 Stat. 4588; Pub. L. 103–465, title IV, §431(l), Dec. 8, 1994, 108 Stat. 4970; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

References in Text

Act of August 27, 1958, referred to in subsec. (a), is Pub. L. 85–765, Aug. 27, 1958, 72 Stat. 862, which is classified generally to chapter 48 (§1901 et seq.) of Title 7, Agriculture. Sections 1903 and 1905 of Title 7, included within reference to Act of August 27, 1958, were repealed by Pub. L. 95–445, §5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note under section 603 of this title. For complete classification of this Act to the Code, see Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this act to the Code, see section 301 of this title and Tables.

Codification

Subsec. (e) of this section, which required the Secretary to submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a comprehensive and detailed written annual report on the administration of this section, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, page 46 of House Document No. 103–7.

Section was formerly classified to section 88 of this title.

Amendments

2005—Subsec. (g). Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines" in two places.

1994—Subsec. (e). Pub. L. 103–437 substituted "Agriculture, Nutrition, and Forestry" for "Agriculture and Forestry" in introductory provisions.

Subsec. (e)(1)(A), (B). Pub. L. 103–465, §431(l)(1), amended subpars. (A) and (B) generally. Prior to amendment, subpars. (A) and (B) read as follows:

"(A) Subject to subparagraphs (B) and (C), a certification by the Secretary that foreign plants in Canada and Mexico that export carcasses or meat or meat products referred to in subsection (a) of this section have complied with paragraph (2) or with requirements that are equivalent to United States requirements with regard to all inspection and building construction standards, and all other provisions of this chapter and regulations issued under this chapter.

"(B) Subject to subparagraph (C), the Secretary may treat as equivalent to a United States requirement a requirement described in subparagraph (A) if the exporting country provides the Secretary with scientific evidence or other information, in accordance with risk assessment methodologies agreed to by the Secretary and the exporting country, to demonstrate that the requirement or standard of the exporting country achieves the level of protection that the Secretary considers appropriate."

Subsec. (e)(2) to (7). Pub. L. 103–465, §431(l)(2), (3), redesignated pars. (3) to (7) as (2) to (6), respectively, and struck out former par. (2) which read as follows: "A certification by the Secretary that, except as provided in paragraph (1), foreign plants that export carcasses or meat or meat products referred to in subsection (a) of this section have complied with requirements that are at least equal to all inspection and building construction standards and all other provisions of this chapter and regulations issued under this chapter."

1993—Subsec. (e). Pub. L. 103–182, §361(f)(1), substituted "not be limited to the following:" for "not be limited to—" in introductory provisions.

Subsec. (e)(1) to (7). Pub. L. 103–182, §361(f)(2)–(7), added pars. (1) and (2), struck out former par. (1), redesignated pars. (2) to (6) as (3) to (7), respectively, substituted "The" for "the" at beginning of each par., substituted period for semicolon at end of pars. (3) to (5), and substituted period for "; and" at end of par. (6). Prior to amendment, former par. (1) read as follows: "a certification by the Secretary that foreign plants exporting carcasses or meat or meat products referred to in subsection (a) of this section have complied with requirements at least equal to all the inspection, building construction standards, and all other provisions of this chapter and regulations issued thereunder;".

1988—Subsec. (e)(6). Pub. L. 100–418, §4604(b), added par. (6).

Subsec. (h). Pub. L. 100–418, §4604(a), added subsec. (h).

1985—Subsec. (f). Pub. L. 99–198, §1702(a), struck out provision which had made this subsection effective six months after Dec. 22, 1981, and inserted provisions requiring that each foreign country from which meat articles are offered for importation into the United States obtain a certification issued by the Secretary stating that the country maintains a program using reliable analytical methods to ensure compliance with the United States standards for residues in such meat articles, that no meat article be permitted entry into the United States from a country for which the Secretary has not issued such certification, that the Secretary periodically review such certifications and revoke any certification if the Secretary determines that the country involved is not maintaining a program that uses reliable analytical methods to ensure compliance with United States standards for residues in such meat articles, and that the consideration of any application for a certification under this subsection and the review of any such certification, by the Secretary, include the inspection of individual establishments to ensure that the inspection program of the foreign country involved is meeting such United States standards.

Subsec. (g). Pub. L. 99–198, §1702(b), added subsec. (g).

1981—Subsec. (f). Pub. L. 97–98 added subsec. (f).

1978—Subsec. (a). Pub. L. 95–445 prohibited imports which do not comply with humane methods of slaughter.

1967—Pub. L. 90–201, §10, substituted imported articles provisions for penalty provisions deeming offenses as misdemeanors and punishable by fine of $10,000 or imprisonment for two years or both. See section 676(a) of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–465 effective, except as otherwise provided, on the date of entry into force of the World Trade Organization Agreement with respect to the United States (Jan. 1, 1995), see section 451 of Pub. L. 103–465, set out as an Effective Date note under section 3601 of Title 19, Customs Duties.

Effective Date of 1981 Amendment

Amendment by Pub. L. 97–98 effective Dec. 22, 1981, see section 1801 of Pub. L. 97–98, set out as an Effective Date note under section 4301 of Title 7, Agriculture.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–445 effective one year after Oct. 10, 1978, and an additional eighteen-month period thereafter in hardship cases, see section 7 of Pub. L. 95–445, set out as a note under section 603 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective upon expiration of sixty days after Dec. 15, 1967, see section 20(a) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§621. Inspectors to make examinations provided for; appointment; duties; regulations

The Secretary shall appoint from time to time inspectors to make examination and inspection of all amenable species, inspection of which is hereby provided for and of all carcasses and parts thereof, and of all meats and meat food products thereof, and of the sanitary conditions of all establishments in which such meat and meat food products hereinbefore described are prepared; and said inspectors shall refuse to stamp, mark, tag, or label any carcass or any part thereof, or meat food product therefrom, prepared in any establishment hereinbefore mentioned, until the same shall have actually been inspected and found to be not adulterated; and shall perform such other duties as are provided by this chapter and by the rules and regulations to be prescribed by said Secretary; and said Secretary shall, from time to time, make such rules and regulations as are necessary for the efficient execution of the provisions of this chapter, and all inspections and examinations made under this chapter, shall be such and made in such manner as described in the rules and regulations prescribed by said Secretary not inconsistent with provisions of this chapter.

(Mar. 4, 1907, ch. 2907, title I, §21, formerly 19th par., 34 Stat. 1264; renumbered §21 and amended Pub. L. 90–201, §§1, 3(b), 12(a), (i), Dec. 15, 1967, 81 Stat. 584, 588, 592, 593; Pub. L. 99–641, title IV, §403(d)(2), Nov. 10, 1986, 100 Stat. 3570; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 89 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines".

1986—Pub. L. 99–641 temporarily substituted "thereof, and of meat food products" for "and meat food products", which substitution was made for the first such reference as the probable intent of Congress. See Effective and Termination Dates of 1986 Amendment note below.

1967—Pub. L. 90–201, §§3(b), 12(a), (i), struck out "of Agriculture" after "Secretary" in four places, included horses, mules, and other equines in the list of animals, and substituted "not adulterated" for "sound, healthful, wholesome, and fit for human food, and to contain no dyes, chemicals, preservatives, or ingredients which render such meat food product unsound, unhealthful, unwholesome, or unfit for human food; and to have been prepared under proper sanitary conditions, hereinbefore provided for", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective and Termination Dates of 1986 Amendment

Pub. L. 99–641, title IV, §403(d)(2), Nov. 10, 1986, 100 Stat. 3570, provided that the amendment made by that section is effective only during the 6-year period beginning on Nov. 10, 1986.

Amendment by Pub. L. 99–641 effective Nov. 10, 1986, except that this section as in effect immediately before Nov. 10, 1986, applies with respect to establishments until the Secretary of Agriculture first issues rules and regulations to implement the amendments made by section 403(a) of Pub. L. 99–641 to section 606 of this title, see section 408 of Pub. L. 99–641, set out as a note under section 609 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

Construction and Effect of Amendments by Pub. L. 99–641

For provisions relating to construction and effect of temporary amendments by section 403 of Pub. L. 99–641, see sections 403(e) and 404 of Pub. L. 99–641, set out as notes entitled "Inspection Services for Establishments Not Participating in Total Plant Quality-Control Program" and "Savings Provision", respectively, under section 609 of this title.

§622. Bribery of or gifts to inspectors or other officers and acceptance of gifts

Any person, firm, or corporation, or any agent or employee of any person, firm, or corporation, who shall give, pay, or offer, directly or indirectly, to any inspector, deputy inspector, chief inspector, or any other officer or employee of the United States authorized to perform any of the duties prescribed by this chapter or by the rules and regulations of the Secretary any money or other thing of value, with intent to influence said inspector, deputy inspector, chief inspector, or other officer or employee of the United States in the discharge of any duty provided for in this chapter, shall be deemed guilty of a felony, and, upon conviction thereof, shall be punished by a fine not less than $5,000 nor more than $10,000 and by imprisonment not less than one year nor more than three years; and any inspector, deputy inspector, chief inspector, or other officer or employee of the United States authorized to perform any of the duties prescribed by this chapter who shall accept any money, gift, or other thing of value from any person, firm, or corporation, or officers, agents, or employees thereof, given with intent to influence his official action, or who shall receive or accept from any person, firm, or corporation engaged in commerce any gift, money, or other thing of value, given with any purpose or intent whatsoever, shall be deemed guilty of a felony and shall, upon conviction thereof, be summarily discharged from office and shall be punished by a fine not less than $1,000 nor more than $10,000 and by imprisonment not less than one year nor more than three years.

(Mar. 4, 1907, ch. 2907, title I, §22, formerly 20th par., 34 Stat. 1264; renumbered §22 and amended Pub. L. 90–201, §§1, 3, Dec. 15, 1967, 81 Stat. 584, 588.)

Editorial Notes

Codification

Section was formerly classified to section 90 of this title.

Amendments

1967—Pub. L. 90–201, §3, struck out "interstate or foreign" before "commerce" and "of Agriculture" after "Secretary".

Statutory Notes and Related Subsidiaries

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

§623. Exemptions from inspection requirements

(a) Personal slaughtering and custom slaughtering for personal, household, guest, and employee uses

The provisions of this subchapter requiring inspection of the slaughter of animals and the preparation of the carcasses, parts thereof, meat and meat food products at establishments conducting such operations for commerce shall not apply to the slaughtering by any person of animals of his own raising, and the preparation by him and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such animals exclusively for use by him and members of his household and his nonpaying guests and employees; nor to the custom slaughter by any person, firm, or corporation of cattle, sheep, swine or goats delivered by the owner thereof for such slaughter, and the preparation by such slaughterer and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such animals, exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees; nor to the custom preparation by any person, firm, or corporation of carcasses, parts thereof, meat or meat food products, derived from the slaughter by any person of cattle, sheep, swine, or goats of his own raising, or from game animals, delivered by the owner thereof for such custom preparation, and transportation in commerce of such custom prepared articles, exclusively for use in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That in cases where such person, firm, or corporation engages in such custom operations at an establishment at which inspection under this subchapter is maintained, the Secretary may exempt from such inspection at such establishment any animals slaughtered or any meat or meat food products otherwise prepared on such custom basis: Provided further, That custom operations at any establishment shall be exempt from inspection requirements as provided by this section only if the establishment complies with regulations which the Secretary is hereby authorized to promulgate to assure that any carcasses, parts thereof, meat or meat food products wherever handled on a custom basis, or any containers or packages containing such articles, are separated at all times from carcasses, parts thereof, meat or meat food products prepared for sale, and that all such articles prepared on a custom basis, or any containers or packages containing such articles, are plainly marked "Not for Sale" immediately after being prepared and kept so identified until delivered to the owner and that the establishment conducting the custom operation is maintained and operated in a sanitary manner.

(b) Territorial exemption; refusal, withdrawal, or modification

The Secretary may, under such sanitary conditions as he may by regulations prescribe, exempt from the inspection requirements of this subchapter the slaughter of animals, and the preparation of carcasses, parts thereof, meat and meat food products, by any person, firm, or corporation in any Territory not organized with a legislative body solely for distribution within such Territory when the Secretary determines that it is impracticable to provide such inspection within the limits of funds appropriated for administration of this chapter and that such exemption will otherwise facilitate enforcement of this chapter. The Secretary may refuse, withdraw, or modify any exemption under this subsection in his discretion whenever he determines such action is necessary to effectuate the purposes of this chapter.

(c) Pizzas containing meat food products

(1) Under such terms and conditions as the Secretary shall prescribe through rules and regulations issued under section 624 of this title that may be necessary to ensure food safety and protect public health such as special handling procedures, the Secretary shall exempt pizzas containing a meat food product from the inspection requirements of this chapter if—

(A) the meat food product components of the pizzas have been prepared, inspected, and passed in a cured or cooked form as ready-to-eat in compliance with the requirements of this chapter; and

(B) the pizzas are to be served in public or private nonprofit institutions.

(2) The Secretary may withdraw or modify any exemption under this subsection whenever the Secretary determines such action is necessary to ensure food safety and to protect public health. The Secretary may reinstate or further modify any exemption withdrawn or modified under this subsection.

(d) Adulteration and misbranding provisions applicable to inspection-free articles

The adulteration and misbranding provisions of this subchapter, other than the requirement of the inspection legend, shall apply to articles which are exempted from inspection or not required to be inspected under this section.

(Mar. 4, 1907, ch. 2907, title I, §23, formerly 21st, 22nd pars., 34 Stat. 1265; June 29, 1938, ch. 810, 52 Stat. 1235; renumbered §23 and amended Pub. L. 90–201, §§1, 11, Dec. 15, 1967, 81 Stat. 584, 591; Pub. L. 91–342, July 18, 1970, 84 Stat. 438; Pub. L. 102–237, title X, §1016(a), Dec. 13, 1991, 105 Stat. 1902.)

Editorial Notes

Codification

Section was formerly classified to sections 91 and 92 of this title.

Amendments

1991—Subsecs. (c), (d). Pub. L. 102–237 added subsec. (c) and redesignated former subsec. (c) as (d).

1970—Subsec. (a). Pub. L. 91–342 changed proviso so as to permit custom slaughterers to conduct a separate inspected meat business, continued the exemption for owners to slaughter and process their own animals for their own use, authorized the Secretary to exempt custom slaughtering and processing performed by an inspected establishment, and required that custom slaughtered articles be clearly marked "not for sale".

1967—Pub. L. 90–201, §11, substituted provisions for personal, custom, and territorial slaughtering exemptions and for application of adulteration and misbranding provisions to inspection-free articles for farmer definition and retail butcher and retail dealer exemption provisions.

1938—Act June 29, 1948, amended section generally.

Statutory Notes and Related Subsidiaries

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective upon expiration of sixty days after Dec. 15, 1967, see section 20(c) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

Regulations

Secretary to issue final rules no later than Aug. 1, 1992, to implement exemption authorized by subsec. (c) of this section, see section 1016(c) of Pub. L. 102–237, set out as a note under section 464 of this title.

§624. Storage and handling regulations; violations; exemption of establishments subject to non-Federal jurisdiction

The Secretary may by regulations prescribe conditions under which carcasses, parts of carcasses, meat, and meat food products of cattle, sheep, swine, goats, horses, mules, or other equines, capable of use as human food, shall be stored or otherwise handled by any person, firm, or corporation engaged in the business of buying, selling, freezing, storing, or transporting, in or for commerce, or importing, such articles, whenever the Secretary deems such action necessary to assure that such articles will not be adulterated or misbranded when delivered to the consumer. Violation of any such regulation is prohibited. However, such regulations shall not apply to the storage or handling of such articles at any retail store or other establishment in any State or organized Territory that would be subject to this section only because of purchases in commerce, if the storage and handling of such articles at such establishment is regulated under the laws of the State or Territory in which such establishment is located, in a manner which the Secretary, after consultation with the appropriate advisory committee provided for in section 661 of this title, determines is adequate to effectuate the purposes of this section.

(Mar. 4, 1907, ch. 2907, title I, §24, as added Pub. L. 90–201, §13, Dec. 15, 1967, 81 Stat. 593.)

§625. Inapplicability of certain requirements to catfish

Notwithstanding any other provision of this chapter, the requirements of sections 603, 604, 605, 610(b), and 623 of this title shall not apply to any fish described in section 601(w)(2) of this title.

(Mar. 4, 1907, ch. 2907, title I, §25, as added Pub. L. 110–234, title XI, §11016(b)(1)(C), May 22, 2008, 122 Stat. 1369, and Pub. L. 110–246, §4(a), title XI, §11016(b)(1)(C), June 18, 2008, 122 Stat. 1664, 2131; amended Pub. L. 113–79, title XII, §12106(a)(3), Feb. 7, 2014, 128 Stat. 981.)

Editorial Notes

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Amendments

2014—Pub. L. 113–79 substituted "not apply to any fish described in section 601(w)(2) of this title." for "not apply to catfish."

Statutory Notes and Related Subsidiaries

Effective Date of 2014 Amendment

Amendment by Pub. L. 113–79 effective as if enacted as part of section 11016(b) of Pub. L. 110–246, see section 12106(c) of Pub. L. 113–79, set out as a note under section 601 of this title.

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, except as otherwise provided, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.

§626. Purchase of tags, labels, stamps, and certificates

The Secretary of Agriculture is authorized to expend appropriations for meat inspection for the purchase of printed tags, labels, stamps, and certificates without regard to existing laws applicable to public printing.

(Sept. 21, 1944, ch. 412, title I, §101(f), 58 Stat. 734.)

Editorial Notes

Codification

Section was formerly classified to section 431 of Title 7, Agriculture, prior to editorial reclassification and renumbering as this section.

Section was enacted as part of the Department of Agriculture Organic Act of 1944, and not as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

Statutory Notes and Related Subsidiaries

Authorization of Appropriation

Authorization of appropriation of sums necessary for the purposes of this section, see note under section 395 of Title 7, Agriculture.

SUBCHAPTER II—MEAT PROCESSORS AND RELATED INDUSTRIES

§641. Prohibition of subchapter I inspection of articles not intended for use as human food; denaturation or other identification prior to distribution in commerce; inedible articles

Inspection shall not be provided under subchapter I of this chapter at any establishment for the slaughter of cattle, sheep, swine, goats, horses, mules, or other equines, or the preparation of any carcasses or parts or products of such animals, which are not intended for use as human food, but such articles shall, prior to their offer for sale or transportation in commerce, unless naturally inedible by humans, be denatured or otherwise identified as prescribed by regulations of the Secretary to deter their use for human food. No person, firm, or corporation shall buy, sell, transport, or offer for sale or transportation, or receive for transportation, in commerce, or import, any carcasses, parts thereof, meat or meat food products of any such animals, which are not intended for use as human food unless they are denatured or otherwise identified as required by the regulations of the Secretary or are naturally inedible by humans.

(Mar. 4, 1907, ch. 2907, title II, §201, as added Pub. L. 90–201, §14, Dec. 15, 1967, 81 Stat. 593.)

Statutory Notes and Related Subsidiaries

Effective Date

Subchapter effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as a note under section 601 of this title.

§642. Recordkeeping requirements

(a) Classes of persons bound; scope of disclosure; access to places of business; examination of records, facilities, and inventories; copies; samples

The following classes of persons, firms, and corporations shall keep such records as will fully and correctly disclose all transactions involved in their businesses; and all persons, firms, and corporations subject to such requirements shall, at all reasonable times upon notice by a duly authorized representative of the Secretary, afford such representative access to their places of business and opportunity to examine the facilities, inventory, and records thereof, to copy all such records, and to take reasonable samples of their inventory upon payment of the fair market value therefor—

(1) Any persons, firms, or corporations that engage, for commerce, in the business of slaughtering any cattle, sheep, swine, goats, horses, mules, or other equines, or preparing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any such animals, for use as human food or animal food;

(2) Any persons, firms, or corporations that engage in the business of buying or selling (as meat brokers, wholesalers or otherwise), or transporting in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any such animals;

(3) Any persons, firms, or corporations that engage in business, in or for commerce, as renderers, or engage in the business of buying, selling, or transporting, in commerce, or importing, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules, or other equines, or parts of the carcasses of any such animals that died otherwise than by slaughter.

(b) Period of maintenance

Any record required to be maintained by this section shall be maintained for such period of time as the Secretary may by regulations prescribe.

(Mar. 4, 1907, ch. 2907, title II, §202, as added Pub. L. 90–201, §14, Dec. 15, 1967, 81 Stat. 593.)

§643. Registration of business, name of person, and trade names

No person, firm, or corporation shall engage in business, in or for commerce, as a meat broker, renderer, or animal food manufacturer, or engage in business in commerce as a wholesaler of any carcasses, or parts or products of the carcasses, of any cattle, sheep, swine, goats, horses, mules, or other equines, whether intended for human food or other purposes, or engage in business as a public warehouseman storing any such articles in or for commerce, or engage in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased animals of the specified kinds, or parts of the carcasses of any such animals that died otherwise than by slaughter, unless, when required by regulations of the Secretary, he has registered with the Secretary his name, and the address of each place of business at which, and all trade names under which, he conducts such business.

(Mar. 4, 1907, ch. 2907, title II, §203, as added Pub. L. 90–201, §14, Dec. 15, 1967, 81 Stat. 594.)

§644. Regulation of transactions, transportation, or importation of 4–D animals to prevent use as human food

No person, firm, or corporation engaged in the business of buying, selling, or transporting in commerce, or importing, dead, dying, disabled, or diseased animals, or any parts of the carcasses of any animals that died otherwise than by slaughter, shall buy, sell, transport, offer for sale or transportation, or receive for transportation, in commerce, or import, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules or other equines, or parts of the carcasses of any such animals that died otherwise than by slaughter, unless such transaction, transportation or importation is made in accordance with such regulations as the Secretary may prescribe to assure that such animals, or the unwholesome parts or products thereof, will be prevented from being used for human food purposes.

(Mar. 4, 1907, ch. 2907, title II, §204, as added Pub. L. 90–201, §14, Dec. 15, 1967, 81 Stat. 594.)

§645. Federal provisions applicable to State or Territorial business transactions of a local nature and not subject to local authority

The authority conferred on the Secretary by section 642, 643, or 644 of this title with respect to persons, firms, and corporations engaged in the specified kinds of business in or for commerce may be exercised with respect to persons, firms, or corporations engaged, in any State or organized Territory, in such kinds of business but not in or for commerce, whenever the Secretary determines, after consultation with an appropriate advisory committee provided for in section 661 of this title, that the State or territory does not have at least equal authority under its laws or such authority is not exercised in a manner to effectuate the purposes of this chapter including the State providing for the Secretary or his representative being afforded access to such places of business and the facilities, inventories, and records thereof, and the taking of reasonable samples, where he determines necessary in carrying out his responsibilities under this chapter; and in such case the provisions of section 642, 643, or 644 of this title, respectively, shall apply to such persons, firms, and corporations to the same extent and in the same manner as if they were engaged in such business in or for commerce and the transactions involved were in commerce.

(Mar. 4, 1907, ch. 2907, title II, §205, as added Pub. L. 90–201, §14, Dec. 15, 1967, 81 Stat. 594.)

SUBCHAPTER III—FEDERAL AND STATE COOPERATION

§661. Federal and State cooperation

(a) Congressional statement of policy

It is the policy of the Congress to protect the consuming public from meat and meat food products that are adulterated or misbranded and to assist in efforts by State and other Government agencies to accomplish this objective. In furtherance of this policy—

(1) Development and administration of State meat inspection program equal to subchapter I ante and post mortem inspection, reinspection, and sanitation requirements

The Secretary is authorized, whenever he determines that it would effectuate the purposes of this chapter, to cooperate with the appropriate State agency in developing and administering a State meat inspection program in any State which has enacted a State meat inspection law that imposes mandatory ante mortem and post mortem inspection, reinspection and sanitation requirements that are at least equal to those under subchapter I of this chapter, with respect to all or certain classes of persons engaged in the State in slaughtering cattle, sheep, swine, goats, or equines, or preparing the carcasses, parts thereof, meat or meat food products, of any such animals for use as human food solely for distribution within such State.

(2) Development and administration of State program with authorities equal to subchapter II authorities; cooperation with Federal agencies

The Secretary is further authorized, whenever he determines that it would effectuate the purposes of this chapter, to cooperate with appropriate State agencies in developing and administering State programs under State laws containing authorities at least equal to those provided in subchapter II of this chapter; and to cooperate with other agencies of the United States in carrying out any provisions of this chapter.

(3) Scope of cooperation: advisory assistance, technical and laboratory assistance and training, and financial and other aid; limitation on amount; equitable allocation of Federal funds; adequacy of State program to obtain Federal cooperation and payments

Cooperation with State agencies under this section may include furnishing to the appropriate State agency (i) advisory assistance in planning and otherwise developing an adequate State program under the State law; and (ii) technical and laboratory assistance and training (including necessary curricular and instructional materials and equipment), and financial and other aid for administration of such a program. The amount to be contributed to any State by the Secretary under this section from Federal funds for any year shall not exceed 50 per centum of the estimated total cost of the cooperative program; and the Federal funds shall be allocated among the States desiring to cooperate on an equitable basis. Such cooperation and payment shall be contingent at all times upon the administration of the State program in a manner which the Secretary, in consultation with the appropriate advisory committee appointed under paragraph (4), deems adequate to effectuate the purposes of this section.

(4) Advisory committees

The Secretary may appoint advisory committees consisting of such representatives of appropriate State agencies as the Secretary and the State agencies may designate to consult with him concerning State and Federal programs with respect to meat inspection and other matters within the scope of this chapter, including evaluating State programs for purposes of this chapter and obtaining better coordination and more uniformity among the State programs and between the Federal and State programs and adequate protection of consumers.

(b) Single State agency; subordinate governmental unit as part of State agency

The appropriate State agency with which the Secretary may cooperate under this chapter shall be a single agency in the State which is primarily responsible for the coordination of the State programs having objectives similar to those under this chapter. When the State program includes performance of certain functions by a municipality or other subordinate governmental unit, such unit shall be deemed to be a part of the State agency for purposes of this section.

(c) State meat inspection requirements

(1) Notice to Governor of nondevelopment or nonenforcement; designation of State as subject to subchapters I and IV; delay and revocation of designation; publication in Federal Register; notice of production of adulterated meat or meat food products; designation of State

If the Secretary has reason to believe, by thirty days prior to the expiration of two years after December 15, 1967, that a State has failed to develop or is not enforcing, with respect to all establishments within its jurisdiction (except those that would be exempted from Federal inspection under subparagraph (2)) at which cattle, sheep, swine, goats, or equines are slaughtered, or their carcasses, or parts or products thereof, are prepared for use as human food, solely for distribution within such State, and the products of such establishments, requirements at least equal to those imposed under subchapter I and IV of this chapter, he shall promptly notify the Governor of the State of this fact. If the Secretary determines, after consultation with the Governor of the State, or representative selected by him, that such requirements have not been developed and activated, he shall promptly after the expiration of such two-year period designate such State as one in which the provisions of subchapters I and IV of this chapter shall apply to operations and transactions wholly within such State: Provided, That if the Secretary has reason to believe that the State will activate such requirements within one additional year, he may delay such designation for said period, and not designate the State, if he determines at the end of the year that the State then has such requirements in effective operation. The Secretary shall publish any such designation in the Federal Register and, upon the expiration of thirty days after such publication, the provisions of subchapters I and IV shall apply to operations and transactions and to persons, firms, and corporations engaged therein in the State to the same extent and in the same manner as if such operations and transactions were conducted in or for commerce. Thereafter, upon request of the Governor, the Secretary shall revoke such designation if the Secretary determines that such State has developed and will enforce requirements at least equal to those imposed under subchapter I and subchapter IV of this chapter: And provided further, That, notwithstanding any other provision of this section, if the Secretary determines that any establishment within a State is producing adulterated meat or meat food products for distribution within such State which would clearly endanger the public health he shall notify the Governor of the State and the appropriate Advisory Committee provided by section 661 of this title of such fact for effective action under State or local law. If the State does not take action to prevent such endangering of the public health within a reasonable time after such notice, as determined by the Secretary, in light of the risk to public health, the Secretary may forthwith designate any such establishment as subject to the provisions of subchapters I and IV of this chapter, and thereupon the establishment and operator thereof shall be subject to such provisions as though engaged in commerce until such time as the Secretary determines that such State has developed and will enforce requirements at least equal to those imposed under subchapter I and subchapter IV of this chapter.

(2) Exemptions of retail stores, restaurants, and similar retail-type establishments; operations conducted at a restaurant central kitchen facility

The provisions of this chapter requiring inspection of the slaughter of animals and the preparation of carcasses, parts thereof, meat and meat food products shall not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments if such establishments are subject to such inspection provisions only under this paragraph (c). For the purposes of this subparagraph, operations conducted at a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares meat or meat food products that are ready to eat when they leave such facility and are served in meals or as entrees only to customers at restaurants owned or operated by the same person, firm, or corporation owning or operating such facility: Provided, That such facility shall be subject to the provisions of section 642 of this title: Provided further, That the facility may be subject to the inspection requirements under subchapter I of this chapter for as long as the Secretary deems necessary, if the Secretary determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its meat or meat food products are rendered adulterated.

(3) Termination of designation of State upon development and enforcement of minimum requirements; redesignation; designation for nonenforcement of minimum requirements: notice and publication in Federal Register

Whenever the Secretary determines that any State designated under this paragraph (c) has developed and will enforce State meat inspection requirements at least equal to those imposed under subchapters I and IV, with respect to the operations and transactions within such State which are regulated under paragraph (1), he shall terminate the designation of such State under this paragraph (c), but this shall not preclude the subsequent redesignation of the State at any time upon thirty days notice to the Governor and publication in the Federal Register in accordance with this paragraph, and any State may be designated upon such notice and publication at any time after the period specified in this paragraph whether or not the State has theretofore been designated upon the Secretary determining that it is not effectively enforcing requirements at least equal to those imposed under subchapters I and IV.

(4) Periodic review; report to Congressional committees

The Secretary shall promptly upon December 15, 1967, and periodically thereafter, but at least annually, review the requirements, including the enforcement thereof, of the several States not designated under this paragraph (c), with respect to the slaughter, and the preparation, storage, handling and distribution of carcasses, parts thereof, meat and meat food products, of such animals, and inspection of such operations and annually report thereon to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate in the report required under section 691 ¹ of this title.

(d) "State" defined

As used in this section, the term "State" means any State (including the Commonwealth of Puerto Rico) or organized Territory.

(Mar. 4, 1907, ch. 2907, title III §301, as added Pub. L. 90–201, §15, Dec. 15, 1967, 81 Stat. 595; amended Pub. L. 98–487, §1, Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103–437, §8(2), Nov. 2, 1994, 108 Stat. 4588.)

Editorial Notes

References in Text

Section 691 of this title, referred to in subsec. (c)(4), was omitted from the Code.

Codification

In subsec. (c)(1), (4), "December 15, 1967" substituted for "enactment of the Wholesome Meat Act".

Amendments

1994—Subsec. (c)(4). Pub. L. 103–437 substituted "Agriculture, Nutrition, and Forestry" for "Agriculture and Forestry".

1984—Subsec. (c)(2). Pub. L. 98–487 inserted provisions relating to operations conducted at a restaurant central kitchen facility.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as a note under section 601 of this title.

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

¹ See References in Text note below.

SUBCHAPTER IV—AUXILIARY PROVISIONS

§671. Inspection services; refusal or withdrawal; hearing; business unfitness based upon certain convictions; other provisions for withdrawal of services unaffected; responsible connection with business; finality of Secretary's actions; judicial review; record

The Secretary may (for such period, or indefinitely, as he deems necessary to effectuate the purposes of this chapter) refuse to provide, or withdraw, inspection service under subchapter I of this chapter with respect to any establishment if he determines, after opportunity for a hearing is accorded to the applicant for, or recipient of, such service, that such applicant or recipient is unfit to engage in any business requiring inspection under subchapter I because the applicant or recipient, or anyone responsibly connected with the applicant or recipient, has been convicted, in any Federal or State court, of (1) any felony, or (2) more than one violation of any law, other than a felony, based upon the acquiring, handling, or distributing of unwholesome, mislabeled, or deceptively packaged food or upon fraud in connection with transactions in food. This section shall not affect in any way other provisions of this chapter for withdrawal of inspection services under subchapter I from establishments failing to maintain sanitary conditions or to destroy condemned carcasses, parts, meat or meat food products.

For the purpose of this section a person shall be deemed to be responsibly connected with the business if he was a partner, officer, director, holder, or owner of 10 per centum or more of its voting stock or employee in a managerial or executive capacity.

The determination and order of the Secretary with respect thereto under this section shall be final and conclusive unless the affected applicant for, or recipient of, inspection service files application for judicial review within thirty days after the effective date of such order in the appropriate court as provided in section 674 of this title. Judicial review of any such order shall be upon the record upon which the determination and order are based.

(Mar. 4, 1907, ch. 2907, title IV, §401, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 597; amended Pub. L. 99–641, title IV, §403(b), Nov. 10, 1986, 100 Stat. 3568.)

Editorial Notes

Amendments

1986—Subsec. (a). Pub. L. 99–641, §403(b)(1), (2)(B), (C), temporarily designated provisions which related to authority to refuse or withdraw inspection service as subsec. (a), struck out "any felony, or (2)" after "of (1)", and inserted "or (2) any felony" after "transactions in food". See Effective and Termination Dates of 1986 Amendment note below.

Pub. L. 99–641, §403(b)(2)(A), which directed that subsec. (a) be amended by substituting "applicant for" for "applicant, for", could not be executed because "applicant, for" does not appear.

Subsecs. (b) to (e). Pub. L. 99–641, §403(b)(6), temporarily added subsecs. (b) to (e). See Effective and Termination Dates of 1986 Amendment note below.

Subsec. (f). Pub. L. 99–641, §403(b)(3), temporarily designated provisions which related to other provisions for withdrawal of inspection services as subsec. (f). See Effective and Termination Dates of 1986 Amendment note below.

Subsec. (g). Pub. L. 99–641, §403(b)(4), temporarily designated provisions which related to responsible connection with business as subsec. (g). See Effective and Termination Dates of 1986 Amendment note below.

Subsec. (h). Pub. L. 99–641, §403(b)(5), temporarily designated provisions which related to finality of determination by Secretary and to judicial review as subsec. (h), substituted "Except as provided in subsection (e)(2) of this section, the determination" for "The determination" and "subsection (e) of this section" for "this section". See Effective and Termination Dates of 1986 Amendment note below.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1986 Amendment

Pub. L. 99–641, title IV, §403(b), Nov. 10, 1986, 100 Stat. 3568, provided that the amendment made by that section is effective only during the 6-year period beginning Nov. 10, 1986.

Effective Date

Subchapter effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as a note under section 601 of this title.

Construction and Effect of Amendments by Pub. L. 99–641

For provisions relating to construction and effect of temporary amendments by section 403 of Pub. L. 99–641, see sections 403(e) and 404 of Pub. L. 99–641, set out as notes entitled "Inspection Services for Establishments Not Participating in Total Plant Quality-Control Program" and "Savings Provision", respectively, under section 609 of this title.

§672. Administrative detention; duration; pending judicial proceedings; notification of governmental authorities; release

Whenever any carcass, part of a carcass, meat or meat food product of cattle, sheep, swine, goats, horses, mules, or other equines, or any product exempted from the definition of a meat food product, or any dead, dying, disabled, or diseased cattle, sheep, swine, goat, or equine is found by any authorized representative of the Secretary upon any premises where it is held for purposes of, or during or after distribution in, commerce or otherwise subject to subchapter I or II of this chapter, and there is reason to believe that any such article is adulterated or misbranded and is capable of use as human food, or that it has not been inspected, in violation of the provisions of subchapter I of this chapter or of any other Federal law or the laws of any State or Territory, or the District of Columbia, or that such article or animal has been or is intended to be, distributed in violation of any such provisions, it may be detained by such representative for a period not to exceed twenty days, pending action under section 673 of this title or notification of any Federal, State, or other governmental authorities having jurisdiction over such article or animal, and shall not be moved by any person, firm, or corporation from the place at which it is located when so detained, until released by such representative. All official marks may be required by such representative to be removed from such article or animal before it is released unless it appears to the satisfaction of the Secretary that the article or animal is eligible to retain such marks.

(Mar. 4, 1907, ch. 2907, title IV, §402, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 598.)

§673. Seizure and condemnation

(a) Proceedings in rem; libel of information; jurisdiction; disposal by destruction or sale; proceeds into the Treasury; sales restrictions; bond; court costs and fees, storage, and other expenses against claimants; proceedings in admiralty; jury trial; United States as plaintiff

(1) Any carcass, part of a carcass, meat or meat food product of cattle, sheep, swine, goats, horses, mules or other equines, or any dead, dying, disabled, or diseased cattle, sheep, swine, goat, or equine, that is being transported in commerce or otherwise subject to subchapter I or II of this chapter, or is held for sale in the United States after such transportation, and that (A) is or has been prepared, sold, transported, or otherwise distributed or offered or received for distribution in violation of this chapter, or (B) is capable of use as human food and is adulterated or misbranded, or (C) in any other way is in violation of this chapter, shall be liable to be proceeded against and seized and condemned, at any time, on a libel of information in any United States district court or other proper court as provided in section 674 of this title within the jurisdiction of which the article or animal is found.

(2) If the article or animal is condemned it shall, after entry of the decree, (A) be distributed in accordance with paragraph (5), or (B) be disposed of by destruction or sale as the court may direct and the proceeds, if sold, less the court costs and fees, and storage and other proper expenses, shall be paid into the Treasury of the United States, but the article or animal shall not be sold contrary to the provisions of this chapter, or the laws of the jurisdiction in which it is sold: Provided, That upon the execution and delivery of a good and sufficient bond conditioned that the article or animal shall not be sold or otherwise disposed of contrary to the provisions of this chapter, or the laws of the jurisdiction in which disposal is made, the court may direct that such article or animal be delivered to the owner thereof subject to such supervision by authorized representatives of the Secretary as is necessary to insure compliance with the applicable laws.

(3) When a decree of condemnation is entered against the article or animal and it is released under bond, or destroyed, court costs and fees, and storage and other proper expenses shall be awarded against the person, if any, intervening as claimant of the article or animal.

(4) The proceedings in such libel cases shall conform, as nearly as may be, to the proceedings in admiralty, except that either party may demand trial by jury of any issue of fact joined in any case, and all such proceedings shall be at the suit of and in the name of the United States.

(5)(A) An article that is condemned under paragraph (1) may as the court may direct, after entry of the decree, be distributed without charge to nonprofit, private entities or to Federal, State, or local government entities engaged in the distribution of food without charge to individuals, if such article—

(i) has been inspected under this chapter and found to be wholesome and not to be adulterated within the meaning of paragraphs (1) through (7) and (9) of section 601(m) of this title and a determination is made at the time of the entry of the decree that such article is wholesome and not so adulterated; and

(ii) is plainly marked "Not for Sale" on such article or its container.

(B) The United States may not be held legally responsible for any article that is distributed under subparagraph (A) to a nonprofit, private entity or to a Federal, State, or local government entity, if such article—

(i) was found after inspection under this chapter to be wholesome and not adulterated within the meaning of paragraphs (1) through (7) and (9) of section 601(m) of this title and a determination was made at the time of the entry of the decree that such article was wholesome and not so adulterated; and

(ii) was plainly marked "Not for Sale" on such article or its container.

(C) The person from whom such article was seized and condemned may not be held legally responsible for such article, if such article—

(i) was found after inspection under this chapter to be wholesome and not adulterated within the meaning of paragraphs (1) through (7) and (9) of section 601(m) of this title and a determination was made at the time of the entry of the decree that such article was wholesome and not so adulterated; and

(ii) was plainly marked "Not for Sale" on such article or its container.

(b) Condemnation or seizure under other provisions unaffected

The provisions of this section shall in no way derogate from authority for condemnation or seizure conferred by other provisions of this chapter, or other laws.

(Mar. 4, 1907, ch. 2907, title IV, §403, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 598; amended Pub. L. 101–205, §1, Dec. 7, 1989, 103 Stat. 1829.)

Editorial Notes

Amendments

1989—Subsec. (a). Pub. L. 101–205 designated first sentence as par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C), respectively, designated second sentence as par. (2) and inserted "(A) to be distributed in accordance with paragraph (5), or (B)" after "entry of the decree,", designated third and fourth sentences as pars. (3) and (4), respectively, and added par. (5).

§674. Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations of section 607(e) of this title

The United States district courts, the District Court of Guam, the District Court of the Virgin Islands, the highest court of American Samoa, and the United States courts of the other Territories, are vested with jurisdiction specifically to enforce, and to prevent and restrain violations of, this chapter, and shall have jurisdiction in all other kinds of cases arising under this chapter, except as provided in section 607(e) of this title.

(Mar. 4, 1907, ch. 2907, title IV, §404, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 599.)

§675. Assaulting, resisting, or impeding certain persons; murder; protection of such persons

Any person who forcibly assaults, resists, opposes, impedes, intimidates, or interferes with any person while engaged in or on account of the performance of his official duties under this chapter shall be fined not more than $5,000 or imprisoned not more than three years, or both. Whoever, in the commission of any such acts, uses a deadly or dangerous weapon, shall be fined not more than $10,000 or imprisoned not more than ten years, or both. Whoever kills any person while engaged in or on account of the performance of his official duties under this chapter shall be punished as provided under sections 1111 and 1114 of title 18.

(Mar. 4, 1907, ch. 2907, title IV, §405, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 599.)

§676. Violations

(a) Misdemeanors; felonies: intent to defraud and distribution of adulterated articles; good faith

Any person, firm, or corporation who violates any provision of this chapter for which no other criminal penalty is provided by this chapter shall upon conviction be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both such imprisonment and fine; but if such violation involves intent to defraud, or any distribution or attempted distribution of an article that is adulterated (except as defined in section 601(m)(8) of this title), such person, firm, or corporation shall be subject to imprisonment for not more than three years or a fine of not more than $10,000, or both: Provided, That no person, firm, or corporation, shall be subject to penalties under this section for receiving for transportation any article or animal in violation of this chapter if such receipt was made in good faith, unless such person, firm, or corporation refuses to furnish on request of a representative of the Secretary the name and address of the person from whom he received such article or animal, and copies of all documents, if any there be, pertaining to the delivery of the article or animal to him.

(b) Minor violations; written notice of warning of criminal and civil proceedings

Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice of warning.

(Mar. 4, 1907, ch. 2907, title IV, §406, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 599; amended Pub. L. 99–641, title IV, §403(c), Nov. 10, 1986, 100 Stat. 3570.)

Editorial Notes

Amendments

1986—Subsec. (b). Pub. L. 99–641, §403(c)(1), temporarily inserted provisions which related to factors required to be considered by Secretary in determining whether public interest is served by written notice of warning. See Effective and Termination Dates of 1986 Amendment note below.

Subsec. (c). Pub. L. 99–641, §403(c)(2), temporarily added subsec. (c). See Effective and Termination Dates of 1986 Amendment note below.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1986 Amendment

Pub. L. 99–641, title IV, §403(c), Nov. 10, 1986, 100 Stat. 3570, provided that the amendment made by that section is effective only during the 6-year period beginning Nov. 10, 1986.

Construction and Effect of Amendments by Pub. L. 99–641

For provisions relating to construction and effect of temporary amendments by section 403 of Pub. L. 99–641, see sections 403(e) and 404 of Pub. L. 99–641, set out as notes entitled "Inspection Services for Establishments Not Participating in Total Plant Quality-Control Program" and "Savings Provision", respectively, under section 609 of this title.

§677. Other Federal laws applicable for administration and enforcement of chapter; location of inquiries; jurisdiction of Federal courts

For the efficient administration and enforcement of this chapter, the provisions (including penalties) of sections 46, 48, 49 and 50 of title 15 (except paragraphs (c) through (h) of section 46 and the last paragraph of section 49 ¹ of title 15), and the provisions of section 409(l) ¹ of title 47; are made applicable to the jurisdiction, powers, and duties of the Secretary in administering and enforcing the provisions of this chapter and to any person, firm, or corporation with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections 49 and 50 of title 15 on the district courts of the United States may be exercised for the purposes of this chapter by any court designated in section 674 of this title.

(Mar. 4, 1907, ch. 2907, title IV, §407, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 599.)

Editorial Notes

References in Text

The last paragraph of section 49 of title 15, and the provisions of section 409(l) of title 47, referred to in text, which related to immunity of witnesses, were repealed by sections 211 and 242, respectively, of Pub. L. 91–452, Oct. 15, 1970, title II, 84 Stat. 929, 930. For provisions relating to immunity of witnesses, see section 6001 et seq. of Title 18, Crimes and Criminal Procedure.

¹ See References in Text note below.

§678. Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments with inspection services and as to marking, labeling, packaging, and ingredients; recordkeeping and related requirements; concurrent jurisdiction over distribution for human food purposes of adulterated or misbranded and imported articles; other matters

Requirements within the scope of this chapter with respect to premises, facilities and operations of any establishment at which inspection is provided under subchapter I of this chapter, which are in addition to, or different than those made under this chapter may not be imposed by any State or Territory or the District of Columbia, except that any such jurisdiction may impose recordkeeping and other requirements within the scope of section 642 of this title, if consistent therewith, with respect to any such establishment. Marking, labeling, packaging, or ingredient requirements in addition to, or different than, those made under this chapter may not be imposed by any State or Territory or the District of Columbia with respect to articles prepared at any establishment under inspection in accordance with the requirements under subchapter I of this chapter, but any State or Territory or the District of Columbia may, consistent with the requirements under this chapter, exercise concurrent jurisdiction with the Secretary over articles required to be inspected under said subchapter I, for the purpose of preventing the distribution for human food purposes of any such articles which are adulterated or misbranded and are outside of such an establishment, or, in the case of imported articles which are not at such an establishment, after their entry into the United States. This chapter shall not preclude any State or Territory or the District of Columbia from making requirement ¹ or taking other action, consistent with this chapter, with respect to any other matters regulated under this chapter.

(Mar. 4, 1907, ch. 2907, title IV, §408, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 600.)

¹ So in original. Probably should be "requirements".

§679. Application of Federal Food, Drug, and Cosmetic Act

(a) Authorities under food, drug, and cosmetic provisions unaffected

Notwithstanding any other provisions of law, including section 1002(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 392(a)), the provisions of this chapter shall not derogate from any authority conferred by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] prior to December 15, 1967.

(b) Enforcement proceedings; detainer authority of representatives of Secretary of Health and Human Services

The detainer authority conferred by section 672 of this title shall apply to any authorized representative of the Secretary of Health and Human Services for purposes of the enforcement of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with respect to any carcass, part thereof, meat, or meat food product of cattle, sheep, swine, goats, or equines that is outside any premises at which inspection is being maintained under this chapter, and for such purposes the first reference to the Secretary in section 672 of this title shall be deemed to refer to the Secretary of Health and Human Services.

(Mar. 4, 1907, ch. 2907, title IV, §409, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 600; amended Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 111–31, div. A, title I, §103(o), June 22, 2009, 123 Stat. 1838.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

2009—Subsec. (a). Pub. L. 111–31 substituted "section 1002(b)" for "section 902(b)".

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (b) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

§679a. Safe Meat and Poultry Inspection Panel

(a) Establishment

There is established in the Department of Agriculture a permanent advisory panel to be known as the "Safe Meat and Poultry Inspection Panel" (referred to in this section as the "panel").

(b) Duties

(1) Review and evaluation

The panel shall review and evaluate, as the panel considers necessary, the adequacy, necessity, safety, cost-effectiveness, and scientific merit of—

(A) inspection procedures of, and work rules and worker relations involving Federal employees employed in, plants inspected under this chapter;

(B) informal petitions or proposals for changes in inspection procedures, processes, and techniques of plants inspected under this chapter;

(C) formal changes in meat inspection regulations promulgated under this chapter, whether in notice, proposed, or final form; and

(D) such other matters as may be referred to the panel by the Secretary regarding the quality or effectiveness of a safe and cost-effective meat inspection system under this chapter.

(2) Reports

(A) In general

The panel shall submit to the Secretary a report on the results of each review and evaluation carried out under paragraph (1), including such recommendations as the panel considers appropriate.

(B) Reports on formal changes

In the case of a report concerning a formal change in meat inspection regulations, the report shall be made within the time limits prescribed for formal comments on such changes.

(C) Publication in Federal Register

Each report of the panel to the Secretary shall be published in the Federal Register.

(c) Secretarial response

Not later than 90 days after the publication of a panel report under subsection (b)(2)(C), the Secretary shall publish in the Federal Register any response required of the Secretary to the report.

(d) Composition of panel

The panel shall be composed of 7 members, not fewer than 5 of whom shall be from the food science, meat science, or poultry science profession, appointed to staggered terms not to exceed 3 years by the Secretary from nominations received from the National Institutes of Health and the Federation of American Societies of Food Animal Science and based on the professional qualifications of the nominees.

(e) Nominations

(1) Initial panel

In constituting the initial panel, the Secretary shall solicit 6 nominees from the National Institutes of Health and 6 nominees from the Federation of American Societies of Food Animal Science for membership on the panel.

(2) Vacancies

Any subsequent vacancy on the panel shall be filled by the Secretary after soliciting 2 nominees from the National Institutes of Health and 2 nominees from the Federation of American Societies of Food Animal Science.

(3) Requirements for nominees

(A) In general

Each nominee provided under paragraph (1) or (2) shall have a background in public health issues and a scientific expertise in food, meat, or poultry science or in veterinary science.

(B) Submission of information

The Secretary may require nominees to submit such information as the Secretary considers necessary prior to completing the selection process.

(4) Additional nominees

If any list of nominees provided under paragraph (1) or (2) is unsatisfactory to the Secretary, the Secretary may request the nominating entities to submit an additional list of nominees.

(f) Travel expenses

While away from the home or regular place of business of a member of the panel in the performance of services for the panel, the member shall be allowed travel expenses, including per diem in lieu of subsistence, at the same rate as a person employed intermittently in the Government service would be allowed under section 5703 of title 5.

(g) Conflicts of interest

The Secretary shall promulgate regulations regarding conflicts of interest with respect to the members of the panel.

(h) Exemption

Chapter 10 of title 5 and title XVIII of the Food and Agriculture Act of 1977 (7 U.S.C. 2281 et seq.) shall not apply to the panel.

(i) Funding

From funds available to the Secretary to carry out this chapter and the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), the Secretary shall allocate such sums as may be necessary to carry out this section.

(Mar. 4, 1907, ch. 2907, title IV, §410, as added Pub. L. 104–127, title IX, §918(a)(1)(B), Apr. 4, 1996, 110 Stat. 1188; amended Pub. L. 117–286, §4(a)(161), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

References in Text

The Food and Agriculture Act of 1977, referred to in subsec. (h), is Pub. L. 95–113, Sept. 29, 1977, 91 Stat. 913. Title XVIII of the Act is classified generally to chapter 55A (§2281 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title of 1977 Amendment note set out under section 1281 of Title 7 and Tables.

The Poultry Products Inspection Act, referred to in subsec. (i), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.

Prior Provisions

A prior section 410 of act Mar. 4, 1907, was renumbered section 411, and is classified to section 680 of this title.

Amendments

2022—Subsec. (h). Pub. L. 117–286 substituted "Chapter 10 of title 5" for "The Federal Advisory Committee Act (5 U.S.C. App.)".

Statutory Notes and Related Subsidiaries

Use of Appropriated Funds

For prohibition of use of funds appropriated by div. A of Pub. L. 113–235 or any other Act to carry out this section, see section 741 Pub. L. 113–235, set out as a note under section 471 of this title.

§679b. Pasteurization of meat and poultry

(1) In general

Effective beginning not later than 30 days after May 13, 2002, the Secretary of Agriculture shall conduct an education program regarding the availability and safety of processes and treatments that eliminate or substantially reduce the level of pathogens on meat, meat food products, poultry, and poultry products.

(2) Authorization of appropriations

There is authorized to be appropriated such sums as are necessary to carry out this section.

(Pub. L. 107–171, title X, §10808(a), May 13, 2002, 116 Stat. 530.)

Editorial Notes

Codification

Section was enacted as part of the Farm Security and Rural Investment Act of 2002, and not as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

§679c. Expansion of Food Safety Inspection Service activities

(a) In general

The Secretary of Agriculture may utilize existing authorities to give high priority to enhancing and expanding the capacity of the Food Safety Inspection Service to conduct activities to—

(1) enhance the ability of the Service to inspect and ensure the safety and wholesomeness of meat and poultry products;

(2) improve the capacity of the Service to inspect international meat and meat products, poultry and poultry products, and egg products at points of origin and at ports of entry;

(3) strengthen the ability of the Service to collaborate with relevant agencies within the Department of Agriculture and with other entities in the Federal Government, the States, and Indian tribes (as defined in section 5304(e) of title 25) through the sharing of information and technology; and

(4) otherwise expand the capacity of the Service to protect against the threat of bioterrorism.

(b) Authorization of appropriations

There is authorized to be appropriated to carry out this section, $15,000,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.

(Pub. L. 107–188, title III, §332, June 12, 2002, 116 Stat. 679.)

Editorial Notes

Codification

Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

§680. Authorization of appropriations

There are hereby authorized to be appropriated such sums as may be necessary to carry out the provisions of this chapter.

(Mar. 4, 1907, ch. 2907, title IV, §411, formerly §410, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 600; renumbered §411, Pub. L. 104–127, title IX, §918(a)(1)(A), Apr. 4, 1996, 110 Stat. 1188.)

SUBCHAPTER IV–A—INSPECTIONS BY FEDERAL AND STATE AGENCIES

§683. Interstate shipment of meat inspected by Federal and State agencies for certain small establishments

(a) Definitions

(1) Appropriate State agency

The term "appropriate State agency" means a State agency described in section 661(b) of this title.

(2) Designated personnel

The term "designated personnel" means inspection personnel of a State agency that have undergone all necessary inspection training and certification to assist the Secretary in the administration and enforcement of this chapter, including rules and regulations issued under this chapter.

(3) Eligible establishment

The term "eligible establishment" means an establishment that is in compliance with—

(A) the State inspection program of the State in which the establishment is located; and

(B) this chapter, including rules and regulations issued under this chapter.

(4) Meat item

The term "meat item" means—

(A) a portion of meat; and

(B) a meat food product.

(5) Selected establishment

The term "selected establishment" means an eligible establishment that is selected by the Secretary, in coordination with the appropriate State agency of the State in which the eligible establishment is located, under subsection (b) to ship carcasses, portions of carcasses, and meat items in interstate commerce.

(b) Authority of Secretary to allow shipments

(1) In general

Subject to paragraph (2), the Secretary, in coordination with the appropriate State agency of the State in which an establishment is located, may select the establishment to ship carcasses, portions of carcasses, and meat items in interstate commerce, and place on each carcass, portion of a carcass, and meat item shipped in interstate commerce a Federal mark, stamp, tag, or label of inspection, if—

(A) the carcass, portion of carcass, or meat item qualifies for the mark, stamp, tag, or label of inspection under the requirements of this chapter;

(B) the establishment is an eligible establishment; and

(C) inspection services for the establishment are provided by designated personnel.

(2) Prohibited establishments

In carrying out paragraph (1), the Secretary, in coordination with an appropriate State agency, shall not select an establishment that—

(A) on average, employs more than 25 employees (including supervisory and nonsupervisory employees), as defined by the Secretary;

(B) as of the date of the enactment of this section, ships in interstate commerce carcasses, portions of carcasses, or meat items that are inspected by the Secretary in accordance with this chapter;

(C)(i) is a Federal establishment;

(ii) was a Federal establishment that was reorganized on a later date under the same name or a different name or person by the person, firm, or corporation that controlled the establishment as of the date of the enactment of this section; or

(iii) was a State establishment as of the date of the enactment of this section that—

(I) as of the date of the enactment of this section, employed more than 25 employees; and

(II) was reorganized on a later date by the person, firm, or corporation that controlled the establishment as of the date of the enactment of this section;

(D) is in violation of this chapter;

(E) is located in a State that does not have a State inspection program; or

(F) is the subject of a transition carried out in accordance with a procedure developed by the Secretary under paragraph (3)(A).

(3) Establishments that employ more than 25 employees

(A) Development of procedure

The Secretary may develop a procedure to transition to a Federal establishment any establishment under this section that, on average, consistently employs more than 25 employees.

(B) Eligibility of certain establishments

(i) In general

A State establishment that employs more than 25 employees but less than 35 employees as of the date of the enactment of this section may be selected as a selected establishment under this subsection.

(ii) Procedures

A State establishment shall be subject to the procedures established under subparagraph (A) beginning on the date that is 3 years after the effective date described in subsection (j).

(c) Reimbursement of State costs

The Secretary shall reimburse a State for costs related to the inspection of selected establishments in the State in accordance with Federal requirements in an amount of not less than 60 percent of eligible State costs.

(d) Coordination between Federal and State agencies

(1) In general

The Secretary shall designate an employee of the Federal Government as State coordinator for each appropriate State agency—

(A) to provide oversight and enforcement of this subchapter; and

(B) to oversee the training and inspection activities of designated personnel of the State agency.

(2) Supervision

A State coordinator shall be under the direct supervision of the Secretary.

(3) Duties of State coordinator

(A) In general

A State coordinator shall visit selected establishments with a frequency that is appropriate to ensure that selected establishments are operating in a manner that is consistent with this chapter (including regulations and policies under this chapter).

(B) Quarterly reports

A State coordinator shall, on a quarterly basis, submit to the Secretary a report that describes the status of each selected establishment that is under the jurisdiction of the State coordinator with respect to the level of compliance of each selected establishment with the requirements of this chapter.

(C) Immediate notification requirement

If a State coordinator determines that any selected establishment that is under the jurisdiction of the State coordinator is in violation of any requirement of this chapter, the State coordinator shall—

(i) immediately notify the Secretary of the violation; and

(ii) deselect the selected establishment or suspend inspection at the selected establishment.

(4) Performance evaluations

Performance evaluations of State coordinators designated under this subsection shall be conducted by the Secretary as part of the Federal agency management control system.

(e) Audits

(1) Periodic audits conducted by Inspector General of the Department of Agriculture

Not later than 2 years after the effective date described in subsection (j), and not less often than every 3 years thereafter, the Inspector General of the Department of Agriculture shall conduct an audit of each activity taken by the Secretary under this section for the period covered by the audit to determine compliance with this section.

(2) Audit conducted by Comptroller General of the United States

Not earlier than 3 years, nor later than 5 years, after the date of the enactment of this section, the Comptroller General of the United States shall conduct an audit of the implementation of this section to determine—

(A) the effectiveness of the implementation of this section; and

(B) the number of selected establishments selected by the Secretary to ship carcasses, portions of carcasses, or meat items under this section.

(f) Technical assistance division

(1) Establishment

Not later than 180 days after the effective date described in subsection (j), the Secretary shall establish in the Food Safety and Inspection Service of the Department of Agriculture a technical assistance division to coordinate the initiatives of any other appropriate agency of the Department of Agriculture to provide—

(A) outreach, education, and training to very small or certain small establishments (as defined by the Secretary); and

(B) grants to appropriate State agencies to provide outreach, technical assistance, education, and training to very small or certain small establishments (as defined by the Secretary).

(2) Personnel

The technical assistance division shall be comprised of individuals that, as determined by the Secretary—

(A) are of a quantity sufficient to carry out the duties of the technical assistance division; and

(B) possess appropriate qualifications and expertise relating to the duties of the technical assistance division.

(g) Transition grants

The Secretary may provide grants to appropriate State agencies to assist the appropriate State agencies in helping establishments covered by subchapter III to transition to selected establishments.

(h) Violations

Any selected establishment that the Secretary determines to be in violation of any requirement of this chapter shall be transitioned to a Federal establishment in accordance with a procedure developed by the Secretary under subsection (b)(3)(A).

(i) Effect

Nothing in this section limits the jurisdiction of the Secretary with respect to the regulation of meat and meat products under this chapter.

(j) Effective date

(1) In general

This section takes effect on the date on which the Secretary, after providing a period of public comment (including through the conduct of public meetings or hearings), promulgates final regulations to carry out this section.

(2) Requirement

Not later than 18 months after the date of the enactment of this section, the Secretary shall promulgate final regulations in accordance with paragraph (1).

(Mar. 4, 1907, ch. 2907, title V, §501, as added Pub. L. 110–234, title XI, §11015(a), May 22, 2008, 122 Stat. 1362, and Pub. L. 110–246, §4(a), title XI, §11015(a), June 18, 2008, 122 Stat. 1664, 2124.)

Editorial Notes

References in Text

The date of the enactment of this section, referred to in subsecs. (b)(2)(B), (C)(ii), (iii), (3)(B)(i), (e)(2), and (j)(2), is the date of enactment of Pub. L. 110–246, which was approved June 18, 2008.

Final regulations to carry out this section, referred to in subsec. (j)(1), were published in the Federal Register on May 2, 2011, eff. July 1, 2011; see 76 F.R. 24752.

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.

SUBCHAPTER V—MISCELLANEOUS PROVISIONS

§691. Omitted

Editorial Notes

Codification

Section, Pub. L. 90–201, §17, Dec. 15, 1967, 81 Stat. 600; Pub. L. 103–437, §8(3), Nov. 2, 1994, 108 Stat. 4588, which required the Secretary of Agriculture to report annually to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate on the slaughter of animals and the processing and distribution of carcasses and products, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, page 46 of House Document No. 103–7.

§692. Inspection extended to reindeer

The provisions of the meat-inspection law may be extended to the inspection of reindeer.

(June 30, 1914, ch. 131, 38 Stat. 420.)

Editorial Notes

Codification

Section was enacted as part of the appropriation act cited as the credit to this section and not as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

Section was formerly classified to section 94 of this title.

§693. Inspection of dairy products for export

The act of March 3, 1891, as amended, for the inspection of live cattle and products thereof, shall be deemed to include dairy products intended for exportation to any foreign country, and the Secretary of Agriculture may apply, under rules and regulations to be prescribed by him, the provisions of said act for inspection and certification appropriate for ascertaining the purity and quality of such products, and may cause the same to be so marked, stamped, or labeled as to secure their identity and make known in the markets of foreign countries to which they may be sent from the United States their purity, quality, and grade; and all the provisions of said act relating to live cattle and products thereof for export shall apply to dairy products so inspected and certified.

(May 23, 1908, ch. 192, 35 Stat. 254.)

Editorial Notes

References in Text

Act of March 3, 1891, referred to in text, is act Mar. 3, 1891, ch. 555, 26 Stat. 1089, which was superseded by act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, as amended by act June 29, 1938, ch. 810, 52 Stat. 1235 (formerly classified to section 71 et seq. of this title). Act Mar. 4, 1907, ch. 2907, was generally revised by Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and is classified to this chapter.

Codification

Section was not enacted as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

Section was formerly classified to sections 94a and 132 of this title.

§694. Authorization of appropriations

Annual appropriations of the sum of $3,000,000 from the general fund of the Treasury are authorized for the expenses of the inspection of cattle, sheep, swine, and goats and the meat and meat food products thereof which enter into interstate or foreign commerce and for all expenses necessary to carry into effect the provisions of this Act relating to meat inspection, including rent and the employment of labor in Washington and elsewhere, for each year, and in addition there is authorized to be appropriated such other sums as may be necessary in the enforcement of the meat inspection laws.

(June 30, 1906, ch. 3913, 34 Stat. 679; June 26, 1934, ch. 756, §2, 48 Stat. 1225.)

Editorial Notes

References in Text

This Act, referred to in text, is act June 30, 1906, ch. 3913, 34 Stat. 669, which made appropriations for the Department of Agriculture for the fiscal year ending June 30, 1907.

Codification

Act June 26, 1934, ch. 756, §2(a), 48 Stat. 1225, which was classified to section 725a of former Title 31, Money and Finance, provided for the repeal, effective July 1, 1935, of the permanent appropriations under the appropriations titles listed in section 2(b) of such Act, and further provided that such portions of any Acts as made permanent appropriations to be expended under such accounts were amended so as to authorize, in lieu thereof, annual appropriations from the general fund of the Treasury in identical terms and in such amounts as were provided by the laws providing such permanent appropriations. The text of section 2(b)(3) of such Act provides as follows: "Meat inspection, Bureau of Animal Industry (fiscal year) (3–114)." Section 2(a) of such Act also authorized to be appropriated such other sums as necessary in the enforcement of the meat inspection laws. See 1934 Amendment note below.

Section was not enacted as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

Section was formerly classified to section 95 of this title.

Amendments

1934—Act June 26, 1934, substituted "Annual appropriations of the sum of $3,000,000 from the general fund of the Treasury are authorized" for "There is permanently appropriated, out of any money in the Treasury not otherwise appropriated, the sum of $3,000,000," and inserted before period at end ", and in addition there is authorized to be appropriated such other sums as may be necessary in the enforcement of the meat inspection laws".

Statutory Notes and Related Subsidiaries

Effective Date of 1934 Amendment

Act June 26, 1934, ch. 756, §2(a), 48 Stat. 1225, provided that the permanent appropriations under the appropriations titles listed in section 2(b) of such Act were repealed, effective July 1, 1935.

§695. Payment of cost of meat-inspection service; exception

The cost of inspection rendered on and after July 1, 1948, under the requirements of laws relating to Federal inspection of meat and meat food products shall be borne by the United States except the cost of overtime and holiday pay paid pursuant to section 2219a of title 7.

(June 5, 1948, ch. 423, 62 Stat. 344; Pub. L. 107–171, title X, §10703(c)(2), May 13, 2002, 116 Stat. 517.)

Editorial Notes

References in Text

Section 2219a of title 7, referred to in text, was in the original "section 10703 of the Farm Security and Rural Investment Act of 2002", meaning section 10703 of Pub. L. 107–171, which enacted section 2219a of Title 7, Agriculture, amended this section, section 468 of this title, and section 5549 of Title 5, Government Organization and Employees, and repealed section 394 of Title 7.

Codification

Section was formerly classified to section 98 of this title.

Section was not enacted as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

Amendments

2002—Pub. L. 107–171 substituted "overtime and holiday pay paid pursuant to section 2219a of title 7." for "overtime pursuant to section 394 of title 7."

 

CHAPTER 13—DRUG ABUSE PREVENTION AND CONTROL

SUBCHAPTER I—CONTROL AND ENFORCEMENT

Part A—Introductory Provisions

        

Part B—Authority To Control; Standards and Schedules

        

Part C—Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances

        

Part D—Offenses and Penalties

        

Part E—Administrative and Enforcement Provisions

        

Part F—General Provisions

        

SUBCHAPTER II—IMPORT AND EXPORT

        

SUBCHAPTER I—CONTROL AND ENFORCEMENT

Part A—Introductory Provisions

§801. Congressional findings and declarations: controlled substances

The Congress makes the following findings and declarations:

(1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.

(2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people.

(3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because—

(A) after manufacture, many controlled substances are transported in interstate commerce,

(B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and

(C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession.

(4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances.

(5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate.

(6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents of such traffic.

(7) The United States is a party to the Single Convention on Narcotic Drugs, 1961, and other international conventions designed to establish effective control over international and domestic traffic in controlled substances.

(Pub. L. 91–513, title II, §101, Oct. 27, 1970, 84 Stat. 1242.)

Editorial Notes

References in Text

This subchapter, referred to in par. (1), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out below and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 91–513, title II, §704, Oct. 27, 1970, 84 Stat. 1284, provided that:

"(a) Except as otherwise provided in this section, this title [see Short Title note below] shall become effective on the first day of the seventh calendar month that begins after the day immediately preceding the date of enactment [Oct. 27, 1970].

"(b) Parts A, B, E, and F of this title [Parts A, B, E, and F of this subchapter], section 702 [set out as a note under section 321 of this title], this section, and sections 705 through 709 [sections 901 to 904 of this title and note set out below], shall become effective upon enactment [Oct. 27, 1970].

"(c) Sections 305 (relating to labels and labeling) [section 825 of this title], and 306 (relating to manufacturing quotas) [section 826 of this title] shall become effective on the date specified in subsection (a) of this section, except that the Attorney General may by order published in the Federal Register postpone the effective date of either or both of these sections for such period as he may determine to be necessary for the efficient administration of this title [see Short Title note below]."

Short Title of 2022 Amendment

Pub. L. 117–215, §1(a), Dec. 2, 2022, 136 Stat. 2257, provided that: "This Act [amending sections 802, 822, 823, 824, 827, 829a, 831, 841, 843, 882, and 958 of this title and sections 290bb–36d, 290dd–3, 1395l, 1395m, 1395cc–6, and 1396b of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under this section, section 823 of this title, and sections 241 and 284 of Title 42] may be cited as the 'Medical Marijuana and Cannabidiol Research Expansion Act'."

Short Title of 2021 Amendment

Pub. L. 117–53, §1, Nov. 10, 2021, 135 Stat. 411, provided that: "This Act [amending section 822 of this title] may be cited as the 'Ensuring Compliance Against Drug Diversion Act of 2021'."

Pub. L. 117–36, §1, Aug. 6, 2021, 135 Stat. 328, provided that: "This Act [amending section 824 of this title] may be cited as the 'Debarment Enforcement of Bad Actor Registrants Act of 2021' or the 'DEBAR Act of 2021'."

Short Title of 2018 Amendment

Pub. L. 115–271, title III, §3211, Oct. 24, 2018, 132 Stat. 3947, provided that: "This chapter [chapter 2 (§§3211, 3212) of subtitle B of title III of Pub. L. 115–271, enacting provisions set out as a note under section 829 of this title] may be cited as the 'Empowering Pharmacists in the Fight Against Opioid Abuse Act'."

Pub. L. 115–271, title III, §3221, Oct. 24, 2018, 132 Stat. 3947, provided that: "This chapter [chapter 3 (§§3221–3223) of subtitle B of title III of Pub. L. 115–271, amending section 822 of this title and enacting provisions set out as notes under section 822 of this title] may be cited as the 'Safe Disposal of Unused Medication Act'."

Pub. L. 115–271, title III, §3231, Oct. 24, 2018, 132 Stat. 3949, provided that: "This chapter [chapter 4 (§§3231, 3232) of subtitle B of title III of Pub. L. 115–271, amending section 831 of this title] may be cited as the 'Special Registration for Telemedicine Clarification Act of 2018'."

Pub. L. 115–271, title III, §3271, Oct. 24, 2018, 132 Stat. 3952, provided that: "This chapter [chapter 7 (§§3271–3274) of subtitle B of title III of Pub. L. 115–271, amending sections 827, 842, and 873 of this title and enacting provisions set out as a note under section 827 of this title] may be cited as the 'Using Data To Prevent Opioid Diversion Act of 2018'."

Pub. L. 115–271, title III, §3281, Oct. 24, 2018, 132 Stat. 3954, provided that: "This chapter [chapter 8 (§§3281, 3282) of subtitle B of title III of Pub. L. 115–271, amending section 826 of this title and enacting provisions set out as a note under section 826 of this title] may be cited as the 'Opioid Quota Reform Act'."

Pub. L. 115–271, title III, §3291, Oct. 24, 2018, 132 Stat. 3956, provided that: "This chapter [chapter 9 (§§3291, 3292) of subtitle B of title III of Pub. L. 115–271, enacting section 832 of this title and amending section 802 of this title] may be cited as the 'Preventing Drug Diversion Act of 2018'."

Short Title of 2017 Amendment

Pub. L. 115–83, §1, Nov. 17, 2017, 131 Stat. 1267, provided that: "This Act [amending section 823 of this title] may be cited as the 'Protecting Patient Access to Emergency Medications Act of 2017'."

Short Title of 2016 Amendment

Pub. L. 114–145, §1, Apr. 19, 2016, 130 Stat. 354, provided that: "This Act [amending sections 823 and 824 of this title] may be cited as the 'Ensuring Patient Access and Effective Drug Enforcement Act of 2016'."

Short Title of 2014 Amendment

Pub. L. 113–260, §1, Dec. 18, 2014, 128 Stat. 2929, provided that: "This Act [amending sections 802, 811, 825, 842, and 960 of this title and enacting provisions set out as a note under section 825 of this title] may be cited as the 'Designer Anabolic Steroid Control Act of 2014'."

Pub. L. 113–143, §1, Aug. 1, 2014, 128 Stat. 1750, provided that: "This Act [amending section 822 of this title] may be cited as the 'Veterinary Medicine Mobility Act of 2014'."

Short Title of 2012 Amendment

Pub. L. 112–144, title XI, §1151, July 9, 2012, 126 Stat. 1130, provided that: "This subtitle [subtitle D (§§1151–1153) of title XI of Pub. L. 112–144, amending sections 811 and 812 of this title] may be cited as the 'Synthetic Drug Abuse Prevention Act of 2012'."

Short Title of 2010 Amendment

Pub. L. 111–273, §1, Oct. 12, 2010, 124 Stat. 2858, provided that: "This Act [amending sections 822 and 828 of this title and enacting provisions set out as a note under section 822 of this title and listed in a table relating to sentencing guidelines set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Secure and Responsible Drug Disposal Act of 2010'."

Pub. L. 111–268, §1, Oct. 12, 2010, 124 Stat. 2847, provided that: "This Act [amending sections 830 and 842 of this title and enacting provisions set out as notes under section 830 of this title] may be cited as the 'Combat Methamphetamine Enhancement Act of 2010'."

Pub. L. 111–220, §1, Aug. 3, 2010, 124 Stat. 2372, provided that: "This Act [amending sections 841, 844, and 960 of this title and enacting provisions listed in a table relating to sentencing guidelines set out under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Fair Sentencing Act of 2010'."

Short Title of 2008 Amendment

Pub. L. 110–425, §1, Oct. 15, 2008, 122 Stat. 4820, provided that: "This Act [enacting section 831 of this title, amending sections 802, 823, 827, 829, 841, 843, 882, and 960 of this title, and enacting provisions set out as notes under section 802 of this title and listed in a table relating to sentencing guidelines set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Ryan Haight Online Pharmacy Consumer Protection Act of 2008'."

Pub. L. 110–415, §1, Oct. 14, 2008, 122 Stat. 4349, provided that: "This Act [amending section 830 of this title] may be cited as the 'Methamphetamine Production Prevention Act of 2008'."

Short Title of 2006 Amendment

Pub. L. 109–177, title VII, §701, Mar. 9, 2006, 120 Stat. 256, provided that: "This title [see Tables for classification] may be cited as the 'Combat Methamphetamine Epidemic Act of 2005'."

Short Title of 2005 Amendment

Pub. L. 109–57, §1(a), Aug. 2, 2005, 119 Stat. 592, provided that: "This Act [amending section 953 of this title] may be cited as the 'Controlled Substances Export Reform Act of 2005'."

Short Title of 2004 Amendment

Pub. L. 108–358, §1, Oct. 22, 2004, 118 Stat. 1661, provided that: "This Act [enacting section 290bb–25f of Title 42, The Public Health and Welfare, amending sections 802 and 811 of this title, enacting provisions set out as notes under section 802 of this title and section 290aa–4 of Title 42 and listed in a table relating to sentencing guidelines set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure, and amending provisions set out as a note under section 802 of this title] may be cited as the 'Anabolic Steroid Control Act of 2004'."

Short Title of 2003 Amendment

Pub. L. 108–21, title VI, §608(a), Apr. 30, 2003, 117 Stat. 691, provided that: "This section [amending sections 843 and 856 of this title and enacting provisions listed in a table relating to sentencing guidelines set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Illicit Drug Anti-Proliferation Act of 2003'."

Short Title of 2000 Amendments

Pub. L. 106–310, div. B, title XXXV, §3501, Oct. 17, 2000, 114 Stat. 1222, provided that: "This title [amending sections 823 and 824 of this title] may be cited as the 'Drug Addiction Treatment Act of 2000'."

Pub. L. 106–310, div. B, title XXXVI, §3601, Oct. 17, 2000, 114 Stat. 1227, provided that: "This title [enacting section 864 of this title and sections 290aa–5b and 290bb–9 of Title 42, The Public Health and Welfare, amending sections 802, 830, 853, 856, and 863 of this title, sections 3663 and 3663A of Title 18, Crimes and Criminal Procedure, section 524 of Title 28, Judiciary and Judicial Procedure, and sections 285o–2 and 3751 of Title 42, and enacting provisions set out as notes under this section and sections 802, 872, 873, 886, and 1706 of this title, sections 524 and 994 of Title 28, and sections 201, 290aa–4, 290aa–5b and 3751 of Title 42] may be cited as the 'Methamphetamine Anti-Proliferation Act of 2000'."

Pub. L. 106–172, §1, Feb. 18, 2000, 114 Stat. 7, provided that: "This Act [amending sections 802, 827, 841 and 960 of this title and enacting provisions set out as notes under this section and section 812 of this title] may be cited as the 'Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000'."

Short Title of 1998 Amendment

Pub. L. 105–277, div. C, title VIII, §801(a), Oct. 21, 1998, 112 Stat. 2681–693, provided that: "This title [enacting section 1713 of this title and section 2291–5 of Title 22, Foreign Relations and Intercourse, amending section 956 of this title, and enacting provisions set out as notes under sections 801 and 956 of this title and section 2291 of Title 22] may be cited as the 'Western Hemisphere Drug Elimination Act'."

Pub. L. 105–277, div. C, title VIII, subtitle G (§§871, 872), §871, Oct. 21, 1998, 112 Stat. 2681–707, and Pub. L. 105–357, §1, Nov. 10, 1998, 112 Stat. 3271, provided that such subtitle and such Act, which amended section 956 of this title and enacted provisions set out as notes under section 956 of this title "may be cited as the 'Controlled Substances Trafficking Prohibition Act'."

Pub. L. 105–277, div. E, §1, Oct. 21, 1998, 112 Stat. 2681–759, provided that: "This division [amending sections 841 and 960 of this title and section 13705 of Title 42, The Public Health and Welfare] may be cited as the 'Methamphetamine Trafficking Penalty Enhancement Act of 1998'."

Short Title of 1996 Amendments

Pub. L. 104–305, §1, Oct. 13, 1996, 110 Stat. 3807, provided that: "This Act [amending sections 841, 844, 959, and 960 of this title and enacting provisions set out as notes under section 872 of this title and section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Drug-Induced Rape Prevention and Punishment Act of 1996'."

Pub. L. 104–237, §1(a), Oct. 3, 1996, 110 Stat. 3099, provided that: "This Act [enacting section 872a of this title, amending sections 802, 814, 830, 841 to 844, 853, 881, 959, and 960 of this title and section 1607 of Title 19, Customs Duties, and enacting provisions set out as notes under this section and sections 802, 872, and 971 of this title, section 994 of Title 28, Judiciary and Judicial Procedure, and section 290aa–4 of Title 42, The Public Health and Welfare] may be cited as the 'Comprehensive Methamphetamine Control Act of 1996'."

Short Title of 1994 Amendment

Pub. L. 103–322, title XVIII, §180201(a), Sept. 13, 1994, 108 Stat. 2046, provided that: "This section [enacting section 849 of this title, amending section 841 of this title, and enacting provisions set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Drug Free Truck Stop Act'."

Short Title of 1993 Amendment

Pub. L. 103–200, §1, Dec. 17, 1993, 107 Stat. 2333, provided that: "This Act [enacting section 814 of this title, amending sections 802, 821 to 824, 830, 843, 880, 957, 958, 960, and 971 of this title, and enacting provisions set out as a note under section 802 of this title] may be cited as the 'Domestic Chemical Diversion Control Act of 1993'."

Short Title of 1990 Amendment

Pub. L. 101–647, title XIX, §1901, Nov. 29, 1990, 104 Stat. 4851, provided that: "This Act [probably means title XIX of Pub. L. 101–647, which amended sections 333, 802, 812, and 844 of this title and section 290aa–6 of Title 42, The Public Health and Welfare, repealed section 333a of this title, and enacted provisions set out as notes under sections 802 and 829 of this title] may be cited as the 'Anabolic Steroids Control Act of 1990'."

Short Title of 1988 Amendment

Pub. L. 100–690, title VI, §6001, Nov. 18, 1988, 102 Stat. 4312, provided that: "This title [see Tables for classification] may be cited as the 'Anti-Drug Abuse Amendments Act of 1988'."

Pub. L. 100–690, title VI, §6051, Nov. 18, 1988, 102 Stat. 4312, provided that: "This subtitle [subtitle A (§§6051–6061) of title VI of Pub. L. 100–690, enacting section 971 of this title, amending sections 802, 830, 841 to 843, 872, 876, 881, 960, and 961 of this title, and enacting provisions set out as notes under sections 802 and 971 of this title] may be cited as the 'Chemical Diversion and Trafficking Act of 1988'."

Pub. L. 100–690, title VI, §6071, Nov. 18, 1988, 102 Stat. 4320, provided that: "This subtitle [subtitle B (§§6071–6080) of title VI of Pub. L. 100–690, enacting sections 881–1, 887, and 1509 of this title, amending section 881 of this title, section 1594 of Title 19, Customs Duties, section 524 of Title 28, Judiciary and Judicial Procedure, and section 782 of former Title 49, Transportation, and enacting provisions set out as notes under section 881 of this title] may be cited as the 'Asset Forfeiture Amendments Act of 1988'."

Short Title of 1986 Amendment

Pub. L. 99–570, §1, Oct. 27, 1986, 100 Stat. 3207, provided that: "This Act [see Tables for classification] may be cited as the 'Anti-Drug Abuse Act of 1986'."

Pub. L. 99–570, title I, §1001, Oct. 27, 1986, 100 Stat. 3207–2, provided that: "This subtitle [subtitle A (§§1001–1009) of title I of Pub. L. 99–570, amending sections 802, 841, 845, 845a, 848, 881, 960, and 962 of this title, sections 3553 and 3583 of Title 18, Crimes and Criminal Procedure, rule 35 of the Federal Rules of Criminal Procedure, Title 18, Appendix, and section 994 of Title 28, Judiciary and Judicial Procedure, and enacting provisions set out as notes under section 841 of this title, sections 3553 and 3583 of Title 18, and rule 35 of the Federal Rules of Criminal Procedure] may be cited as the 'Narcotics Penalties and Enforcement Act of 1986'."

Pub. L. 99–570, title I, §1051, Oct. 27, 1986, 100 Stat. 3207–8, provided that: "This subtitle [subtitle B (§§1051, 1052) of title I of Pub. L. 99–570, amending section 844 of this title] may be cited as the 'Drug Possession Penalty Act of 1986'."

Pub. L. 99–570, title I, §1101, Oct. 27, 1986, 100 Stat. 3207–10, provided that: "This subtitle [subtitle C (§§1101–1105) of title I of Pub. L. 99–570, enacting section 845b of this title and amending sections 841, 845, and 845a of this title] may be cited as the 'Juvenile Drug Trafficking Act of 1986'."

Pub. L. 99–570, title I, §1201, Oct. 27, 1986, 100 Stat. 3207–13, provided that: "This subtitle [subtitle E (§§1201–1204) of title I of Pub. L. 99–570, enacting section 813 of this title and amending section 802 of this title] may be cited as the 'Controlled Substance Analogue Enforcement Act of 1986'."

Pub. L. 99–570, title I, §1251, Oct. 27, 1986, 100 Stat. 3207–14, provided that: "This subtitle [subtitle F (§§1251–1253) of title I of Pub. L. 99–570, amending section 848 of this title] may be cited as the 'Continuing Drug Enterprises Act of 1986'."

Pub. L. 99–570, title I, §1301, Oct. 27, 1986, 100 Stat. 3207–15, provided that: "This subtitle [subtitle G (§§1301, 1302) of title I of Pub. L. 99–570, amending section 960 of this title] may be cited as the 'Controlled Substances Import and Export Penalties Enhancement Act of 1986'."

Pub. L. 99–570, title I, §1821, Oct. 27, 1986, 100 Stat. 3207–51, which provided that subtitle O (§§1821–1823) of title I of Pub. L. 99–570, enacting section 857 of this title and provisions set out as a note under section 857 of this title, was to be cited as the "Mail Order Drug Paraphernalia Control Act", was repealed by Pub. L. 101–647, title XXIV, §2401(d), Nov. 29, 1990, 104 Stat. 4859.

Pub. L. 99–570, title I, §1991, Oct. 27, 1986, 100 Stat. 3207–59, provided that: "This subtitle [subtitle U (§§1991, 1992) of title I of Pub. L. 99–570, amending section 881 of this title] may be cited as the 'Federal Drug Law Enforcement Agent Protection Act of 1986'."

Short Title of 1984 Amendment

Pub. L. 98–473, title II, §501, Oct. 12, 1984, 98 Stat. 2068, provided that: "This chapter [chapter V (§§501–525) of title II of Pub. L. 98–473, enacting section 845a of this title, amending sections 802, 811, 812, 822–824, 827, 841, 843, 845, 873, 881, 952, 953, 957, 958, 960, and 962 of this title, and enacting provisions set out as a note under this section] may be cited as the 'Controlled Substances Penalties Amendments Act of 1984'."

Pub. L. 98–473, title II, §506(a), Oct. 12, 1984, 98 Stat. 2070, provided that: "This part [part B of chapter V (§§506–525) of title II of Pub. L. 98–473, amending sections 802, 811, 812, 822–824, 827, 843, 873, 881, 952, 953, 957, and 958 of this title] may be cited as the 'Dangerous Drug Diversion Control Act of 1984'."

Short Title of 1978 Amendment

Pub. L. 95–633, §1, Nov. 10, 1978, 92 Stat. 3768, provided: "That this Act [enacting sections 801a, 830, and 852 of this title, amending sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and 965 of this title and section 242a of Title 42, The Public Health and Welfare, repealing section 830 of this title (effective Jan. 1, 1981), and enacting provisions set out as notes under sections 801a, 812, and 830 of this title] may be cited as the 'Psychotropic Substances Act of 1978'."

Short Title of 1974 Amendment

Pub. L. 93–281, §1, May 14, 1974, 88 Stat. 124, provided: "That this Act [amending sections 802, 823, 824, and 827 of this title] may be cited as the 'Narcotic Addict Treatment Act of 1974'."

Short Title

Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, provided: "That this Act [enacting this chapter and sections 257a, 2688l–1, 2688n–1, and 3509 of Title 42, The Public Health and Welfare, amending sections 162, 198a, 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114, 1952, and 4251 of Title 18, Crimes and Criminal Procedure, sections 1584, 2078, 2079, and 2080 of Title 19, Customs Duties, sections 4901, 4905, 6808, 7012, 7103, 7326, 7607, 7609, 7641, 7651, and 7655 of Title 26, Internal Revenue Code, section 2901 of Title 28, Judiciary and Judicial Procedure, section 304m of former Title 40, Public Buildings, Property, and Works, sections 201, 225a, 242, 242a, 246, 257, 258, 259, 260, 261, 261a, 2688k, 2688l, 2688m, 2688n, 2688o, 2688r, and 3411 of Title 42, The Public Health and Welfare, section 239a of former Title 46, Shipping, and section 787 of Title 49, Appendix, Transportation, repealing sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199, 360a, and 501 to 517 of this title, sections 1401 to 1407 and 3616 of Title 18, sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to 4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237, 7238, and 7491 of Title 26, sections 529a and 529g of former Title 31, Money and Finance, and section 1421m of Title 48, Territories and Insular Possessions, and enacting provisions set out as notes under this section and sections 171, 321, 822, 951, and 957 of this title] may be cited as the 'Comprehensive Drug Abuse Prevention and Control Act of 1970'."

Pub. L. 91–513, title II, §100, Oct. 27, 1970, 84 Stat. 1242, provided that: "This title [enacting this subchapter, repealing section 360a of this title, amending sections 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure, and section 242 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under this section and sections 321 and 822 of this title] may be cited as the 'Controlled Substances Act'."

For short title and complete classification of title III of Pub. L. 91–513, which enacted subchapter II of this chapter, as the "Controlled Substances Import and Export Act", see section 1000 of Pub. L. 91–513, set out as a note under section 951 of this title.

Severability

Pub. L. 106–310, div. B, title XXXVI, §3673, Oct. 17, 2000, 114 Stat. 1246, provided that: "Any provision of this title [see Short Title of 2000 Amendments note above] held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed as to give the maximum effect permitted by law, unless such provision is held to be utterly invalid or unenforceable, in which event such provision shall be severed from this title and shall not affect the applicability of the remainder of this title, or of such provision, to other persons not similarly situated or to other, dissimilar circumstances."

Continuation of Orders, Rules, and Regulations

Pub. L. 91–513, title II, §705, Oct. 27, 1970, 84 Stat. 1284, provided that: "Any orders, rules, and regulations which have been promulgated under any law affected by this title [see Short Title note above] and which are in effect on the day preceding enactment of this title [Oct. 27, 1970] shall continue in effect until modified, superseded, or repealed."

Doctor-Patient Relationship

Pub. L. 117–215, title III, §301, Dec. 2, 2022, 136 Stat. 2265, provided that: "It shall not be a violation of the Controlled Substances Act (21 U.S.C. 801 et seq.) for a State-licensed physician to discuss—

"(1) the currently known potential harms and benefits of marijuana derivatives, including cannabidiol, as a treatment with the legal guardian of the patient of the physician if the patient is a child; or

"(2) the currently known potential harms and benefits of marijuana and marijuana derivatives, including cannabidiol, as a treatment with the patient or the legal guardian of the patient of the physician if the patient is a legal adult."

[For definitions of "State", "marijuana", and "cannabidiol" as used in section 301 of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out below.]

Anti-Drug Messages on Federal Government Internet Sites

Pub. L. 106–391, title III, §320, Oct. 30, 2000, 114 Stat. 1597, provided that: "Not later than 90 days after the date of the enactment of this Act [Oct. 30, 2000], the Administrator [of the National Aeronautics and Space Administration], in consultation with the Director of the Office of National Drug Control Policy, shall place anti-drug messages on Internet sites controlled by the National Aeronautics and Space Administration."

Pub. L. 106–310, div. B, title XXXVI, §3671, Oct. 17, 2000, 114 Stat. 1245, provided that: "Not later than 90 days after the date of the enactment of this Act [Oct. 17, 2000], the head of each department, agency, and establishment of the Federal Government shall, in consultation with the Director of the Office of National Drug Control Policy, place antidrug messages on appropriate Internet websites controlled by such department, agency, or establishment which messages shall, where appropriate, contain an electronic hyperlink to the Internet website, if any, of the Office."

Protocols for Investigations and Prosecutions Relating to Date-Rape Drugs and Other Controlled Substances; Annual Report; National Awareness Campaign

Pub. L. 106–172, §§6, 7, Feb. 18, 2000, 114 Stat. 11, as amended by Pub. L. 111–8, div. G, title I, §1301(d), Mar. 11, 2009, 123 Stat. 829, provided that:

"SEC. 6. DEVELOPMENT OF MODEL PROTOCOLS, TRAINING MATERIALS, FORENSIC FIELD TESTS, AND COORDINATION MECHANISM FOR INVESTIGATIONS AND PROSECUTIONS RELATING TO GAMMA HYDROXYBUTYRIC ACID, OTHER CONTROLLED SUBSTANCES, AND DESIGNER DRUGS.

"(a) In General.—The Attorney General, in consultation with the Administrator of the Drug Enforcement Administration and the Director of the Federal Bureau of Investigation, shall—

"(1) develop—

"(A) model protocols for the collection of toxicology specimens and the taking of victim statements in connection with investigations into and prosecutions related to possible violations of the Controlled Substances Act [21 U.S.C. 801 et seq.] or other Federal or State laws that result in or contribute to rape, other crimes of violence, or other crimes involving abuse of gamma hydroxybutyric acid, other controlled substances, or so-called 'designer drugs'; and

"(B) model training materials for law enforcement personnel involved in such investigations; and

"(2) make such protocols and training materials available to Federal, State, and local personnel responsible for such investigations.

"(b) Grant.—

"(1) In general.—The Attorney General shall make a grant, in such amount and to such public or private person or entity as the Attorney General considers appropriate, for the development of forensic field tests to assist law enforcement officials in detecting the presence of gamma hydroxybutyric acid and related substances.

"(2) Authorization of appropriations.—There are authorized to be appropriated such sums as may be necessary to carry out this subsection.

"(c) Report.—Not later than 180 days after the date of the enactment of this Act [Feb. 18, 2000], the Attorney General shall submit to the Committees on the Judiciary of the Senate and House of Representatives a report on current mechanisms for coordinating Federal, State, and local investigations into and prosecutions related to possible violations of the Controlled Substances Act [21 U.S.C. 801 et seq.] or other Federal or State laws that result in or contribute to rape, other crimes of violence, or other crimes involving the abuse of gamma hydroxybutyric acid, other controlled substances, or so-called 'designer drugs'. The report shall also include recommendations for the improvement of such mechanisms.

"SEC. 7. ANNUAL REPORT REGARDING DATE-RAPE DRUGS; NATIONAL AWARENESS CAMPAIGN.

"(a) Annual Report.—The Secretary of Health and Human Services (in this section referred to as the 'Secretary') shall periodically submit to Congress reports each of which provides an estimate of the number of incidents of the abuse of date-rape drugs (as defined in subsection (c)) that occurred during the most recent 1-year period for which data are available. The first such report shall be submitted not later than January 15, 2000, and subsequent reports shall be submitted annually thereafter.

"(b) National Awareness Campaign.—

"(1) Development of plan; recommendations of advisory committee.—

"(A) In general.—The Secretary, in consultation with the Attorney General, shall develop a plan for carrying out a national campaign to educate individuals described in subparagraph (B) on the following:

"(i) The dangers of date-rape drugs.

"(ii) The applicability of the Controlled Substances Act [21 U.S.C. 801 et seq.] to such drugs, including penalties under such Act.

"(iii) Recognizing the symptoms that indicate an individual may be a victim of such drugs, including symptoms with respect to sexual assault.

"(iv) Appropriately responding when an individual has such symptoms.

"(B) Intended population.—The individuals referred to in subparagraph (A) are young adults, youths, law enforcement personnel, educators, school nurses, counselors of rape victims, and emergency room personnel in hospitals.

"(C) Advisory committee.—Not later than 180 days after the date of the enactment of this Act [Feb. 18, 2000], the Secretary shall establish an advisory committee to make recommendations to the Secretary regarding the plan under subparagraph (A). The committee shall be composed of individuals who collectively possess expertise on the effects of date-rape drugs and on detecting and controlling the drugs.

"(2) Implementation of plan.—Not later than 180 days after the date on which the advisory committee under paragraph (1) is established, the Secretary, in consultation with the Attorney General, shall commence carrying out the national campaign under such paragraph in accordance with the plan developed under such paragraph. The campaign may be carried out directly by the Secretary and through grants and contracts.

"(c) Definition.—For purposes of this section, the term 'date-rape drugs' means gamma hydroxybutyric acid and its salts, isomers, and salts of isomers and such other drugs or substances as the Secretary, after consultation with the Attorney General, determines to be appropriate."

Congressional Findings Regarding Methamphetamine Manufacture and Abuse

Pub. L. 104–237, §2, Oct. 3, 1996, 110 Stat. 3100, provided that: "The Congress finds the following:

"(1) Methamphetamine is a very dangerous and harmful drug. It is highly addictive and is associated with permanent brain damage in long-term users.

"(2) The abuse of methamphetamine has increased dramatically since 1990. This increased use has led to devastating effects on individuals and the community, including—

"(A) a dramatic increase in deaths associated with methamphetamine ingestion;

"(B) an increase in the number of violent crimes associated with methamphetamine ingestion; and

"(C) an increase in criminal activity associated with the illegal importation of methamphetamine and precursor compounds to support the growing appetite for this drug in the United States.

"(3) Illegal methamphetamine manufacture and abuse presents an imminent public health threat that warrants aggressive law enforcement action, increased research on methamphetamine and other substance abuse, increased coordinated efforts to prevent methamphetamine abuse, and increased monitoring of the public health threat methamphetamine presents to the communities of the United States."

Support for International Efforts To Control Methamphetamine and Precursors

Pub. L. 104–237, title I, §101, Oct. 3, 1996, 110 Stat. 3100, provided that: "The Attorney General, in consultation with the Secretary of State, shall coordinate international drug enforcement efforts to decrease the movement of methamphetamine and methamphetamine precursors into the United States."

Interagency Methamphetamine Task Force

Pub. L. 104–237, title V, §501, Oct. 3, 1996, 110 Stat. 3111, provided for the establishment of a Methamphetamine Interagency Task Force to design and implement education, prevention, and treatment strategies with respect to methamphetamine and other synthetic stimulants and for the task force to terminate 4 years after Oct. 3, 1996.

Suspicious Orders Task Force

Pub. L. 104–237, title V, §504, Oct. 3, 1996, 110 Stat. 3112, directed the Attorney General to establish a Suspicious Orders Task Force which would develop proposals to define suspicious orders of listed chemicals for registrants to use in determining if an order was a suspicious order that must be reported to DEA and would terminate upon presentation of its report to the Attorney General, or two years after Oct. 3, 1996, whichever was sooner.

Joint Federal Task Force on Illegal Drug Laboratories

Pub. L. 100–690, title II, §2405, Nov. 18, 1988, 102 Stat. 4231, provided that:

"(a) Establishment of Task Force.—There is established the Joint Federal Task Force on Illegal Drug Laboratories (hereafter in this section referred to as the 'Task Force').

"(b) Appointment and Membership of Task Force.—The members of the Task Force shall be appointed by the Administrators of the Environmental Protection Agency and the Drug Enforcement Administration (hereafter in this section referred to as the 'Administrators'). The Task Force shall consist of at least 6 and not more than 20 members. Each Administrator shall appoint one-half of the members as follows: (1) the Administrator of the Environmental Protection Agency shall appoint members from among Emergency Response Technicians and other appropriate employees of the Agency; and (2) the Administrator of the Drug Enforcement Administration shall appoint members from among Special Agents assigned to field divisions and other appropriate employees of the Administration.

"(c) Duties of Task Force.—The Task Force shall formulate, establish, and implement a program for the cleanup and disposal of hazardous waste produced by illegal drug laboratories. In formulating such program, the Task Force shall consider the following factors:

"(1) The volume of hazardous waste produced by illegal drug laboratories.

"(2) The cost of cleaning up and disposing of hazardous waste produced by illegal drug laboratories.

"(3) The effectiveness of the various methods of cleaning up and disposing of hazardous waste produced by illegal drug laboratories.

"(4) The coordination of the efforts of the Environmental Protection Agency and the Drug Enforcement Administration in cleaning up and disposing of hazardous waste produced by illegal drug laboratories.

"(5) The dissemination of information to law enforcement agencies that have responsibility for enforcement of drug laws.

"(d) Guidelines.—The Task Force shall recommend to the Administrators guidelines for cleanup of illegal drug laboratories to protect the public health and environment. Not later than 180 days after the date of the enactment of this subtitle [Nov. 18, 1988], the Administrators shall formulate and publish such guidelines.

"(e) Demonstration Projects.—

"(1) The Attorney General shall make grants to, and enter into contracts with, State and local governments for demonstration projects to clean up and safely dispose of substances associated with illegal drug laboratories which may present a danger to public health or the environment.

"(2) The Attorney General may not under this subsection make a grant or enter into a contract unless the applicant for such assistance agrees to comply with the guidelines issued pursuant to subsection (d).

"(3) The Attorney General shall, through grant or contract, provide for independent evaluations of the activities carried out pursuant to this subsection and shall recommend appropriate legislation to the Congress.

"(f) Funding.—Of the amounts made available to carry out the Controlled Substances Act [21 U.S.C. 801 et seq.] for fiscal year 1989, not less than $5,000,000 shall be made available to carry out subsections (d) and (e).

"(g) Reports.—After consultation with the Task Force, the Administrators shall—

"(1) transmit to the President and to each House of Congress not later than 270 days after the date of the enactment of this subtitle [Nov. 18, 1988] a report describing the program established by the Task Force under subsection (c) (including an analysis of the factors specified in paragraphs (1) through (5) of that subsection);

"(2) periodically transmit to the President and to each House of Congress reports describing the implementation of the program established by the Task Force under subsection (c) (including an analysis of the factors specified in paragraphs (1) through (5) of that subsection) and the progress made in the cleanup and disposal of hazardous waste produced by illegal drug laboratories; and

"(3) transmit to each House of Congress a report describing the findings made as a result of the evaluations referred to in subsection (e)(3)."

Great Lakes Drug Interdiction

Pub. L. 100–690, title VII, §7404, Nov. 18, 1988, 102 Stat. 4484, provided that:

"(a) Interagency Agreement.—The Secretary of Transportation and the Secretary of the Treasury shall enter into an agreement for the purpose of increasing the effectiveness of maritime drug interdiction activities of the Coast Guard and the Customs Service in the Great Lakes area.

"(b) Negotiations With Canada on Drug Enforcement Cooperation.—The Secretary of State is encouraged to enter into negotiations with appropriate officials of the Government of Canada for the purpose of establishing an agreement between the United States and Canada which provides for increased cooperation and sharing of information between United States and Canadian law enforcement officials with respect to law enforcement efforts conducted on the Great Lakes between the United States and Canada."

[For transfer of authorities, functions, personnel, and assets of the Coast Guard, including the authorities and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security, and for treatment of related references, see sections 468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.]

[For transfer of functions, personnel, assets, and liabilities of the United States Customs Service of the Department of the Treasury, including functions of the Secretary of the Treasury relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections 203(1), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6. For establishment of U.S. Customs and Border Protection in the Department of Homeland Security, treated as if included in Pub. L. 107–296 as of Nov. 25, 2002, see section 211 of Title 6, as amended generally by Pub. L. 114–125, and section 802(b) of Pub. L. 114–125, set out as a note under section 211 of Title 6.]

GAO Study of Capabilities of United States To Control Drug Smuggling Into United States

Pub. L. 100–180, div. A, title XII, §1241, Dec. 4, 1987, 101 Stat. 1162, directed Comptroller General of the United States to conduct a comprehensive study regarding smuggling of illegal drugs into United States and current capabilities of United States to deter such smuggling, with special consideration given to issues involving use of military and National Guard units along with Customs Service in cooperative drug smuggling interdiction efforts, and to issue, not later than Apr. 30, 1988, and Mar. 31, 1989, reports to Congress outlining results of this study.

Compliance With Budget Act

Pub. L. 99–570, §3, Oct. 27, 1986, 100 Stat. 3207–1, provided that: "Notwithstanding any other provision of this Act [see Tables for classification], any spending authority and any credit authority provided under this Act shall be effective for any fiscal year only to such extent or in such amounts as are provided in appropriation Acts. For purposes of this Act, the term 'spending authority' has the meaning provided in section 401(c)(2) of the Congressional Budget Act of 1974 [2 U.S.C. 651(c)(2)] and the term 'credit authority' has the meaning provided in section 3(10) of the Congresssional [sic] Budget Act of 1974 [2 U.S.C. 622(10)]."

Drug Interdiction

Pub. L. 99–570, title III, §§3001–3003, 3301, Oct. 27, 1986, 100 Stat. 3207–73, 3207-74, 3207-98, as amended by Pub. L. 104–66, title I, §1091(a), Dec. 21, 1995, 109 Stat. 722, provided that:

"SEC. 3001. SHORT TITLE.

"This title [enacting section 379 of Title 10, Armed Forces, sections 1590, 1628, 1629, and 2081 of Title 19, Customs Duties, and section 312a of Title 47, Telecommunications, amending section 959 of this title, sections 374 and 911 of Title 10, sections 507, 1401, 1433, 1436, 1454, 1459, 1497, 1509, 1584 to 1586, 1594 to 1595a, 1613, 1613b, 1619, and 1622 of Title 19, section 5316 of Title 31, Money and Finance, section 12109 of Title 46, Shipping, sections 1901 to 1904 of Title 46, Appendix, Shipping, and sections 1401, 1472, 1474, and 1509 of former Title 49, Transportation, repealing section 1460 of Title 19, enacting provisions set out as notes under section 801 of this title, sections 371, 374, 525, and 9441 of Title 10, sections 1613b and 1654 of Title 19, section 403 of Title 23, Highways, section 1901 of Title 46, Appendix, section 11344 of Title 49, and section 1509 of former Title 49, and repealing provisions set out as a note under section 89 of Title 14, Coast Guard] may be cited as the 'National Drug Interdiction Improvement Act of 1986'.

"SEC. 3002. FINDINGS.

"The Congress hereby finds that—

"(1) a balanced, coordinated, multifaceted strategy for combating the growing drug abuse and drug trafficking problem in the United States is essential in order to stop the flow and abuse of drugs within our borders;

"(2) a balanced, coordinated, multifaceted strategy for combating the narcotics drug abuse and trafficking in the United States should include—

"(A) increased investigations of large networks of drug smuggler organizations;

"(B) source country drug eradication;

"(C) increased emphasis on stopping narcotics traffickers in countries through which drugs are transshipped;

"(D) increased emphasis on drug education programs in the schools and workplace;

"(E) increased Federal Government assistance to State and local agencies, civic groups, school systems, and officials in their efforts to combat the drug abuse and trafficking problem at the local level; and

"(F) increased emphasis on the interdiction of drugs and drug smugglers at the borders of the United States, in the air, at sea, and on the land;

"(3) funds to support the interdiction of narcotics smugglers who threaten the transport of drugs through the air, on the sea, and across the land borders of the United States should be emphasized in the Federal Government budget process to the same extent as the other elements of a comprehensive antidrug effort are emphasized;

"(4) the Department of Defense and the use of its resources should be an integral part of a comprehensive, natonal [national] drug interdiction program;

"(5) the Federal Government civilian agencies engaged in drug interdiction, particularly the United States Customs Service and the Coast Guard, currently lack the aircraft, ships, radar, command, control, communications, and intelligence (C3I) system, and manpower resources necessary to mount a comprehensive attack on the narcotics traffickers who threaten the United States;

"(6) the civilian drug interdiction agencies of the United States are currently interdicting only a small percentage of the illegal, drug smuggler penetrations in the United States every year;

"(7) the budgets for our civilian drug interdiction agencies, primarily the United States Customs Service and the Coast Guard, have not kept pace with those of the traditional investigative law enforcement agencies of the Department of Justice; and

"(8) since the amendment of the Posse Comitatus Act (18 U.S.C. 1385) in 1981, the Department of Defense has assisted in the effort to interdict drugs, but they can do more.

"SEC. 3003. PURPOSES.

"It is the purpose of this title—

"(1) to increase the level of funding and resources available to civilian drug interdiction agencies of the Federal Government;

"(2) to increase the level of support from the Department of Defense as consistent with the Posse Comitatus Act [18 U.S.C. 1385], for interdiction of the narcotics traffickers before such traffickers penetrate the borders of the United States; and

"(3) to improve other drug interdiction programs of the Federal Government.

"SEC. 3301. ESTABLISHMENT OF A UNITED STATES-BAHAMAS DRUG INTERDICTION TASK FORCE

"(a) Authorization of Appropriations.—

"(1) Establishment of a united states-bahamas drug interdiction task force.—(A) There is authorized to be established a United States-Bahamas Drug Interdiction Task Force to be operated jointly by the United States Government and the Government of the Bahamas.

"(B) The Secretary of State, the Commandant of the Coast Guard, the Commissioner of Customs, the Attorney General, and the head of the National Narcotics Border Interdiction System (NNBIS), shall upon enactment of this Act [Oct. 27, 1986], immediately commence negotiations with the Government of the Bahamas to enter into a detailed agreement for the establishment and operation of a new drug interdiction task force, including plans for (i) the joint operation and maintenance of any drug interdiction assets authorized for the task force in this section and section 3141 [see 19 U.S.C. 2075], and (ii) any training and personnel enhancements authorized in this section and section 3141.

"(2) Amounts authorized.—There are authorized to be appropriated, in addition to any other amounts authorized to be appropriated in this title [see section 3001 of Pub. L. 99–570 set out above], $10,000,000 for the following:

"(A) $9,000,000 for 3 drug interdiction pursuit helicopters for use primarily for operations of the United States-Bahamas Drug Interdiction Task Force established under this section; and

"(B) $1,000,000 to enhance communications capabilities for the operation of a United States-Bahamas Drug Interdiction Task Force established under this section.

"(3) Coast guard-bahamas drug interdiction docking facility.—(A) There is authorized to be appropriated for acquisition, construction, and improvements for the Coast Guard for fiscal year 1987, $5,000,000, to be used for initial design engineering, and other activities for construction of a drug interdiction docking facility in the Bahamas to facilitate Coast Guard and Bahamian drug interdiction operations in and through the Bahama Islands. Of the amounts authorized to be appropriated in this subsection, such sums as may be necessary shall be available for necessary communication and air support.

"(B) The Commandant of the Coast Guard shall use such amounts appropriated pursuant to the authorization in this paragraph as may be necessary to establish a repair, maintenance, and boat lift facility to provide repair and maintenance services for both Coast Guard and Bahamian marine drug interdiction equipment, vessels, and related assets.

"(b) Concurrence by Secretary of State.—Programs authorized by this section may be carried out only with the concurrence of the Secretary of State."

Information on Drug Abuse at the Workplace

Pub. L. 99–570, title IV, §4303, Oct. 27, 1986, 100 Stat. 3207–154, directed Secretary of Labor to collect such information as is available on the incidence of drug abuse in the workplace and efforts to assist workers, including counseling, rehabilitation and employee assistance programs, to conduct such additional research as is necessary to assess the impact and extent of drug abuse and remediation efforts, and submit the findings of such collection and research to Congress no later than two years from Oct. 27, 1986.

Interagency Coordination

Pub. L. 99–570, title IV, §4304, Oct. 27, 1986, 100 Stat. 3207–154, provided that:

"(a) The Secretary of Education, the Secretary of Health and Human Services, and the Secretary of Labor shall each designate an officer or employee of the Departments of Education, Health and Human Services, and Labor, respectively, to coordinate interagency drug abuse prevention activities to prevent duplication of effort.

"(b) Within one year after enactment of this Act [Oct. 27, 1986], a report shall be jointly submitted to the Congress by such Secretaries concerning the extent to which States and localities have been able to implement non-duplicative drug abuse prevention activities."

Substance Abuse Coverage Study

Pub. L. 99–570, title VI, §6005, Oct. 27, 1986, 100 Stat. 3207–160, as amended by Pub. L. 100–690, title II, §2058(c), Nov. 18, 1988, 102 Stat. 4214, directed Secretary of Health and Human Services to contract with Institute of Medicine of National Academy of Sciences to conduct a study of extent to which cost of drug abuse treatment is covered by private insurance, public programs, and other sources of payment, and adequacy of such coverage for the rehabilitation of drug abusers, and not later than 18 months after execution of such contract to transmit to Congress a report of results of study, including recommendations of means to meet the needs identified in such study.

Health Insurance Coverage for Drug and Alcohol Treatment

Pub. L. 99–570, title VI, §6006, Oct. 27, 1986, 100 Stat. 3207–160, provided that:

"(a) Findings.—The Congress finds that—

"(1) drug and alcohol abuse are problems of grave concern and consequence in American society;

"(2) over 500,000 individuals are known heroin addicts; 5 million individuals use cocaine; and at least 7 million individuals regularly use prescription drugs, mostly addictive ones, without medical supervision;

"(3) 10 million adults and 3 million children and adolescents abuse alcohol, and an additional 30 to 40 million people are adversely affected because of close family ties to alcoholics;

"(4) the total cost of drug abuse to the Nation in 1983 was over $60,000,000,000; and

"(5) the vast majority of health benefits plans provide only limited coverage for treatment of drug and alcohol addiction, which is a fact that can discourage the abuser from seeking treatment or, if the abuser does seek treatment, can cause the abuser to face significant out of pocket expenses for the treatment.

"(b) Sense of Congress.—It is the sense of Congress that—

"(1) all employers providing health insurance policies should ensure that the policies provide adequate coverage for treatment of drug and alcohol addiction in recognition that the health consequences and costs for individuals and society can be as formidable as those resulting from other diseases and illnesses for which insurance coverage is much more adequate; and

"(2) State insurance commissioners should encourage employers providing health benefits plans to ensure that the policies provide more adequate coverage for treatment of drug and alcohol addiction."

Commission on Marihuana and Drug Abuse

Pub. L. 91–513, title II, §601, Oct. 27, 1970, 84 Stat. 1280, as amended by Pub. L. 92–13, May 14, 1971, 85 Stat. 37, provided that:

"(a) [Establishment; composition] There is established a commission to be known as the Commission on Marihuana and Drug Abuse (hereafter in this section referred to as the 'Commission'). The Commission shall be composed of—

"(1) two Members of the Senate appointed by the President of the Senate;

"(2) two Members of the House of Representatives appointed by the Speaker of the House of Representatives; and

"(3) nine members appointed by the President of the United States.

At no time shall more than one of the members appointed under paragraph (1), or more than one of the members appointed under paragraph (2), or more than five of the members appointed under paragraph (3) be members of the same political party.

"(b) [Chairman; Vice Chairman; compensation of members; meetings] (1) The President shall designate one of the members of the Commission as Chairman and one as Vice Chairman. Seven members of the Commission shall constitute a quorum, but a lesser number may conduct hearings.

"(2) Members of the Commission who are Members of Congress or full-time officers or employees of the United States shall serve without additional compensation but shall be reimbursed for travel, subsistence, and other necessary expenses incurred in the performance of the duties vested in the Commission. Members of the Commission from private life shall receive $100 per diem while engaged in the actual performance of the duties vested in the Commission, plus reimbursement for travel, subsistence, and other necessary expenses incurred in the performance of such duties.

"(3) The Commission shall meet at the call of the Chairman or at the call of a majority of the members thereof.

"(c) [Personnel; experts; information from departments and agencies] (1) The Commission shall have the power to appoint and fix the compensation of such personnel as it deems advisable, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, and the provisions of chapter 51 and subchapter III of chapter 53 of such title, relating to classification and General Schedule pay rates.

"(2) The Commission may procure, in accordance with the provisions of section 3109 of title 5, United States Code, the temporary or intermittent services of experts or consultants. Persons so employed shall receive compensation at a rate to be fixed by the Commission, but not in excess of $75 per diem, including traveltime. While away from his home or regular place of business in the performance of services for the Commission, any such person may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703(b) of title 5, United States Code, for persons in the Government service employed intermittently.

"(3) The Commission may secure directly from any department or agency of the United States information necessary to enable it to carry out its duties under this section. Upon request of the Chairman of the Commission, such department or agency shall furnish such information to the Commission.

"(d) [Marihuana study; report to the President and the Congress] (1) The Commission shall conduct a study of marihuana including, but not limited to, the following areas:

"(A) the extent of use of marihuana in the United States to include its various sources of users, number of arrests, number of convictions, amount of marihuana seized, type of user, nature of use;

"(B) an evaluation of the efficacy of existing marihuana laws;

"(C) a study of the pharmacology of marihuana and its immediate and long-term effects, both physiological and psychological;

"(D) the relationship of marihuana use to aggressive behavior and crime;

"(E) the relationship between marihuana and the use of other drugs; and

"(F) the international control of marihuana.

"(2) Within one year after the date on which funds first become available to carry out this section, the Commission shall submit to the President and the Congress a comprehensive report on its study and investigation under this subsection which shall include its recommendations and such proposals for legislation and administrative action as may be necessary to carry out its recommendations.

"(e) [Study and investigation of causes of drug abuse; report to the President and the Congress; termination of Commission] The Commission shall conduct a comprehensive study and investigation of the causes of drug abuse and their relative significance. The Commission shall submit to the President and the Congress such interim reports as it deems advisable and shall within two years after the date on which funds first become available to carry out this section submit to the President and the Congress a final report which shall contain a detailed statement of its findings and conclusions and also such recommendations for legislation and administrative actions as it deems appropriate. The Commission shall cease to exist sixty days after the final report is submitted under this subsection.

"(f) [Limitation on expenditures] Total expenditures of the Commission shall not exceed $4,000,000."

Definitions

Pub. L. 117–215, §2(a), Dec. 2, 2022, 136 Stat. 2257, provided that:

"(a) In General.—In this Act [see Short Title of 2022 Amendment note set out above]—

"(1) the term 'appropriately registered' means that an individual or entity is registered under the Controlled Substances Act (21 U.S.C. 801 et seq.) to engage in the type of activity that is carried out by the individual or entity with respect to a controlled substance on the schedule that is applicable to cannabidiol or marijuana, as applicable;

"(2) the term 'cannabidiol' means—

"(A) the substance, cannabidiol, as derived from marijuana that has a delta-9-tetrahydrocannabinol level that is greater than 0.3 percent; and

"(B) the synthetic equivalent of the substance described in subparagraph (A);

"(3) the terms 'controlled substance', 'dispense', 'distribute', 'manufacture', 'marijuana', and 'practitioner' have the meanings given such terms in section 102 of the Controlled Substances Act (21 U.S.C. 802), as amended by this Act;

"(4) the term 'covered institution of higher education' means an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) that—

"(A)(i) has highest or higher research activity, as defined by the Carnegie Classification of Institutions of Higher Education; or

"(ii) is an accredited medical school or an accredited school of osteopathic medicine; and

"(B) is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.);

"(5) the term 'drug' has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1));

"(6) the term 'medical research for drug development' means medical research that is—

"(A) a preclinical study or clinical investigation conducted in accordance with section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or otherwise permitted by the Department of Health and Human Services to determine the potential medical benefits of marijuana or cannabidiol as a drug; and

"(B) conducted by a covered institution of higher education, practitioner, or manufacturer that is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.); and

"(7) the term 'State' means any State of the United States, the District of Columbia, and any territory of the United States."

Executive Documents

Executive Order No. 11599

Ex. Ord. No. 11599, June 17, 1971, 36 F.R. 11793, which established the Special Action Office for Drug Abuse Prevention, was superseded. See Prior Provisions notes set out under section 1111 of this title.

Executive Order No. 11641

Ex. Ord. No. 11641, Jan. 28, 1972, 37 F.R. 2421, which established the Office for Drug Abuse Law Enforcement, was revoked by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out below.

Executive Order No. 11676

Ex. Ord. No. 11676, July 27, 1972, 37 F.R. 15125, which established the Office of National Narcotics Intelligence, was revoked by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out below.

Ex. Ord. No. 11727. Drug Law Enforcement

Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, provided:

Reorganization Plan No. 2 of 1973 [set out in the Appendix to Title 5, Government Organization and Employees], which becomes effective on July 1, 1973, among other things establishes a Drug Enforcement Administration in the Department of Justice. In my message to the Congress transmitting that plan, I stated that all functions of the Office for Drug Abuse Law Enforcement (established pursuant to Executive Order No. 11641 of January 28, 1972) and the Office of National Narcotics Intelligence (established pursuant to Executive Order No. 11676 of July 27, 1972) would, together with other related functions, be merged in the new Drug Enforcement Administration.

NOW, THEREFORE, by virtue of the authority vested in me by the Constitution and laws of the United States, including section 5317 of title 5 of the United States Code, as amended, it is hereby ordered as follows:

Section 1. The Attorney General, to the extent permitted by law, is authorized to coordinate all activities of executive branch departments and agencies which are directly related to the enforcement of laws respecting narcotics and dangerous drugs. Each department and agency of the Federal Government shall, upon request and to the extent permitted by law, assist the Attorney General in the performance of functions assigned to him pursuant to this order, and the Attorney General may, in carrying out those functions, utilize the services of any other agencies, Federal and State, as may be available and appropriate.

Sec. 2. Executive Order No. 11641 of January 28, 1972, is revoked and the Attorney General shall provide for the reassignment of the functions of the Office for Drug Abuse Law Enforcement and for the abolishment of that Office.

Sec. 3. Executive Order No. 11676 of July 27, 1972, is hereby revoked and the Attorney General shall provide for the reassignment of the functions of the Office of National Narcotics Intelligence and for the abolishment of that Office.

Sec. 4. Section 1 of Executive Order No. 11708 of March 23, 1973, as amended [set out as a note under section 5317 of Title 5, Government Organization and Employees], placing certain positions in level IV of the Executive Schedule is hereby further amended by deleting—

(1) "(6) Director, Office for Drug Abuse Law Enforcement, Department of Justice."; and

(2) "(7) Director, Office of National Narcotics Intelligence, Department of Justice."

Sec. 5. The Attorney General shall provide for the winding up of the affairs of the two offices and for the reassignment of their functions.

Sec. 6. This order shall be effective as of July 1, 1973.

Richard Nixon.      

Combatting the National Drug Demand and Opioid Crisis

Memorandum of President of the United States, Oct. 26, 2017, 82 F.R. 50305, provided:

Memorandum for the Heads of Executive Departments and Agencies

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby directed as follows:

Section 1. Policy. It shall be the policy of the United States to use all lawful means to combat the drug demand and opioid crisis currently afflicting our country. Individuals, families, and communities across the United States continue to be devastated by an unprecedented epidemic of drug abuse and overdose, including of prescription opioids, heroin, and illicit synthetic opioids. Last year, we lost at least 64,000 of our fellow Americans to drug overdose, primarily from opioids. This is an increase of approximately 12,000 people over the year before and more than ever recorded in United States history. Drug overdoses now kill more Americans than motor vehicle crashes or gun-related incidents, and more than 300,000 Americans have died of an opioid overdose since 2000. Further, more than 2.1 million of our fellow citizens are addicted to opioids, and in 2014 more than 1,500 people were treated each day in emergency departments for opioid-related emergencies.

This crisis has devastated our communities. It has been particularly harmful for children affected by their parents' drug abuse. The number of infants born drug-dependent increased by nearly 500 percent from 2000 to 2012. The number of children being placed into foster care due, at least in part, to parental drug abuse is increasing, and accounted for almost a third of all child removals in Fiscal Year 2015. Serious drug users are also more likely to be arrested for crimes such as burglary, robbery, and handling stolen goods. Moreover, the drug trafficking that supplies illegal drugs to our country is associated with other illegal activities, including murder and other violent crimes. All of this devastates lives and harms communities in both the United States and foreign countries involved in the illegal drug supply chain. Federal, State, and local governments; law enforcement; first responders; the medical, public health, and substance abuse treatment community; and faith-based and community organizations are working tirelessly and have even expanded their efforts to combat the drug demand and opioid crisis.

Three factors are driving the opioid aspect of this crisis in particular. First, since the 1990s, there has been a dramatic rise in opioid pain medication prescriptions. Second, heroin from Mexico has flooded the country. Third, the illicit manufacture and illegal importation of fentanyl—an extremely deadly synthetic opioid—and its analogues and related compounds have proliferated. Fentanyl is currently manufactured almost exclusively in China, and it is either shipped into the United States or smuggled across the southern border by drug traffickers. Between 2013 and 2016, the amount of fentanyl seized by Customs and Border Protection at the border increased more than 200 times over. Dealers are increasingly lacing fentanyl into other drugs and pressing it into counterfeit opioid pills. Because fentanyl is lethal in even miniscule doses, this is an extremely deadly tactic, as it too often causes users to ingest a fatal amount unknowingly.

Sec. 2. Agency Action. The Secretary of Health and Human Services shall, consistent with section 319 of the Public Health Service Act, 42 U.S.C. 247d, consider declaring that the drug demand and opioid crisis described in section 1 of this memorandum constitutes a Public Health Emergency. Additionally, the heads of executive departments and agencies, as appropriate and consistent with law, shall exercise all appropriate emergency authorities, as well as other relevant authorities, to reduce the number of deaths and minimize the devastation the drug demand and opioid crisis inflicts upon American communities.

Sec. 3. General Provisions. (a) Nothing in this memorandum shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The Secretary of Health and Human Services is hereby authorized and directed to publish this memorandum in the Federal Register.

Donald J. Trump.      

§801a. Congressional findings and declarations: psychotropic substances

The Congress makes the following findings and declarations:

(1) The Congress has long recognized the danger involved in the manufacture, distribution, and use of certain psychotropic substances for nonscientific and nonmedical purposes, and has provided strong and effective legislation to control illicit trafficking and to regulate legitimate uses of psychotropic substances in this country. Abuse of psychotropic substances has become a phenomenon common to many countries, however, and is not confined to national borders. It is, therefore, essential that the United States cooperate with other nations in establishing effective controls over international traffic in such substances.

(2) The United States has joined with other countries in executing an international treaty, entitled the Convention on Psychotropic Substances and signed at Vienna, Austria, on February 21, 1971, which is designed to establish suitable controls over the manufacture, distribution, transfer, and use of certain psychotropic substances. The Convention is not self-executing, and the obligations of the United States thereunder may only be performed pursuant to appropriate legislation. It is the intent of the Congress that the amendments made by this Act, together with existing law, will enable the United States to meet all of its obligations under the Convention and that no further legislation will be necessary for that purpose.

(3) In implementing the Convention on Psychotropic Substances, the Congress intends that, consistent with the obligations of the United States under the Convention, control of psychotropic substances in the United States should be accomplished within the framework of the procedures and criteria for classification of substances provided in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.]. This will insure that (A) the availability of psychotropic substances to manufacturers, distributors, dispensers, and researchers for useful and legitimate medical and scientific purposes will not be unduly restricted; (B) nothing in the Convention will interfere with bona fide research activities; and (C) nothing in the Convention will interfere with ethical medical practice in this country as determined by the Secretary of Health and Human Services on the basis of a consensus of the views of the American medical and scientific community.

(Pub. L. 95–633, title I, §101, Nov. 10, 1978, 92 Stat. 3768; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Editorial Notes

References in Text

This Act, referred to in par. (2), is Pub. L. 95–633, Nov. 10, 1978, 92 Stat. 2768, as amended, known as the Psychotropic Substances Act of 1978, which enacted sections 801a, 830, and 852 of this title, amended sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and 965 of this title and section 242a of Title 42, The Public Health and Welfare, repealed section 830 of this title effective Jan. 1, 1981, and enacted provisions set out as notes under sections 801, 801a, 812, and 830 of this title. For complete classification of this Act to the Code, see Short Title of 1978 Amendment note set out under section 801 of this title and Tables.

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in par. (3), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to this chapter [§801 et seq.]. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Codification

Section was enacted as a part of the Psychotropic Substances Act of 1978, and not as a part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in par. (3) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date

Pub. L. 95–633, title I, §112, Nov. 10, 1978, 92 Stat. 3774, provided that: "This title [enacting this section and section 852 of this title, amending sections 352, 802, 811, 812, 823, 827, 872, 952, and 953 of this title and section 242a of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 801 and 812 of this title] and the amendments made by this title shall take effect on the date the Convention on Psychotropic Substances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the United States." [The Convention entered into force in respect to the United States on July 15, 1980.]

§802. Definitions

As used in this subchapter:

(1) The term "addict" means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.

(2) The term "administer" refers to the direct application of a controlled substance to the body of a patient or research subject by—

(A) a practitioner (or, in his presence, by his authorized agent), or

(B) the patient or research subject at the direction and in the presence of the practitioner,

whether such application be by injection, inhalation, ingestion, or any other means.

(3) The term "agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier's or warehouseman's business.

(4) The term "Drug Enforcement Administration" means the Drug Enforcement Administration in the Department of Justice.

(5) The term "control" means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.

(6) The term "controlled substance" means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.

(7) The term "counterfeit substance" means a controlled substance which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured, distributed, or dispensed such substance and which thereby falsely purports or is represented to be the product of, or to have been distributed by, such other manufacturer, distributor, or dispenser.

(8) The terms "deliver" or "delivery" mean the actual, constructive, or attempted transfer of a controlled substance or a listed chemical, whether or not there exists an agency relationship.

(9) The term "depressant or stimulant substance" means—

(A) a drug which contains any quantity of barbituric acid or any of the salts of barbituric acid; or

(B) a drug which contains any quantity of (i) amphetamine or any of its optical isomers; (ii) any salt of amphetamine or any salt of an optical isomer of amphetamine; or (iii) any substance which the Attorney General, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or

(C) lysergic acid diethylamide; or

(D) any drug which contains any quantity of a substance which the Attorney General, after investigation, has found to have, and by regulation designated as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect.

(10) The term "dispense" means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term "dispenser" means a practitioner who so delivers a controlled substance to an ultimate user or research subject.

(11) The term "distribute" means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term "distributor" means a person who so delivers a controlled substance or a listed chemical.

(12) The term "drug" has the meaning given that term by section 321(g)(1) of this title.

(13) The term "felony" means any Federal or State offense classified by applicable Federal or State law as a felony.

(14) The term "isomer" means the optical isomer, except as used in schedule I(c) and schedule II(a)(4). As used in schedule I(c), the term "isomer" means any optical, positional, or geometric isomer. As used in schedule II(a)(4), the term "isomer" means any optical or geometric isomer.

(15) The term "manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term "manufacturer" means a person who manufactures a drug or other substance.

(16)(A) Subject to subparagraph (B), the terms "marihuana" and "marijuana" mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.

(B) The terms "marihuana" and "marijuana" do not include—

(i) hemp, as defined in section 1639o of title 7; or

(ii) the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

(17) The term "narcotic drug" means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(A) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium.

(B) Poppy straw and concentrate of poppy straw.

(C) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed.

(D) Cocaine, its salts, optical and geometric isomers, and salts of isomers.

(E) Ecgonine, its derivatives, their salts, isomers, and salts of isomers.

(F) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (E).

(18) The term "opiate" or "opioid" means any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.

(19) The term "opium poppy" means the plant of the species Papaver somniferum L., except the seed thereof.

(20) The term "poppy straw" means all parts, except the seeds, of the opium poppy, after mowing.

(21) The term "practitioner" means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.

(22) The term "production" includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance.

(23) The term "immediate precursor" means a substance—

(A) which the Attorney General has found to be and by regulation designated as being the principal compound used, or produced primarily for use, in the manufacture of a controlled substance;

(B) which is an immediate chemical intermediary used or likely to be used in the manufacture of such controlled substance; and

(C) the control of which is necessary to prevent, curtail, or limit the manufacture of such controlled substance.

(24) The term "Secretary", unless the context otherwise indicates, means the Secretary of Health and Human Services.

(25) The term "serious bodily injury" means bodily injury which involves—

(A) a substantial risk of death;

(B) protracted and obvious disfigurement; or

(C) protracted loss or impairment of the function of a bodily member, organ, or mental faculty.

(26) The term "State" means a State of the United States, the District of Columbia, and any commonwealth, territory, or possession of the United States.

(27) The term "ultimate user" means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.

(28) The term "United States", when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the United States.

(29) The term "maintenance treatment" means the dispensing, for a period in excess of twenty-one days, of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.

(30) The term "detoxification treatment" means the dispensing, for a period not in excess of one hundred and eighty days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period.

(31) The term "Convention on Psychotropic Substances" means the Convention on Psychotropic Substances signed at Vienna, Austria, on February 21, 1971; and the term "Single Convention on Narcotic Drugs" means the Single Convention on Narcotic Drugs signed at New York, New York, on March 30, 1961.

(32)(A) Except as provided in subparagraph (C), the term "controlled substance analogue" means a substance—

(i) the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or II;

(ii) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or

(iii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II.

(B) The designation of gamma butyrolactone or any other chemical as a listed chemical pursuant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph that the chemical is a controlled substance analogue.

(C) Such term does not include—

(i) a controlled substance;

(ii) any substance for which there is an approved new drug application;

(iii) with respect to a particular person any substance, if an exemption is in effect for investigational use, for that person, under section 355 of this title to the extent conduct with respect to such substance is pursuant to such exemption; or

(iv) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.

(33) The term "listed chemical" means any list I chemical or any list II chemical.

(34) The term "list I chemical" means a chemical specified by regulation of the Attorney General as a chemical that is used in manufacturing a controlled substance in violation of this subchapter and is important to the manufacture of the controlled substances, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following:

(A) Anthranilic acid, its esters, and its salts.

(B) Benzyl cyanide.

(C) Ephedrine, its salts, optical isomers, and salts of optical isomers.

(D) Ergonovine and its salts.

(E) Ergotamine and its salts.

(F) N-Acetylanthranilic acid, its esters, and its salts.

(G) Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers.

(H) Phenylacetic acid, its esters, and its salts.

(I) Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers.

(J) Piperidine and its salts.

(K) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers.

(L) 3,4-Methylenedioxyphenyl-2-propanone.

(M) Methylamine.

(N) Ethylamine.

(O) Propionic anhydride.

(P) Isosafrole.

(Q) Safrole.

(R) Piperonal.

(S) N-Methylephedrine.

(T) N-methylpseudoephedrine.

(U) Hydriodic acid.

(V) Benzaldehyde.

(W) Nitroethane.

(X) Gamma butyrolactone.

(Y) Any salt, optical isomer, or salt of an optical isomer of the chemicals listed in subparagraphs (M) through (U) of this paragraph.

(35) The term "list II chemical" means a chemical (other than a list I chemical) specified by regulation of the Attorney General as a chemical that is used in manufacturing a controlled substance in violation of this subchapter, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following chemicals:

(A) Acetic anhydride.

(B) Acetone.

(C) Benzyl chloride.

(D) Ethyl ether.

(E) Repealed. Pub. L. 101–647, title XXIII, §2301(b), Nov. 29, 1990, 104 Stat. 4858.

(F) Potassium permanganate.

(G) 2-Butanone (or Methyl Ethyl Ketone).

(H) Toluene.

(I) Iodine.

(J) Hydrochloric gas.

(36) The term "regular customer" means, with respect to a regulated person, a customer with whom the regulated person has an established business relationship that is reported to the Attorney General.

(37) The term "regular importer" means, with respect to a listed chemical, a person that has an established record as an importer of that listed chemical that is reported to the Attorney General.

(38) The term "regulated person" means a person who manufactures, distributes, imports, or exports a listed chemical, a tableting machine, or an encapsulating machine or who acts as a broker or trader for an international transaction involving a listed chemical, a tableting machine, or an encapsulating machine.

(39) The term "regulated transaction" means—

(A) a distribution, receipt, sale, importation, or exportation of, or an international transaction involving shipment of, a listed chemical, or if the Attorney General establishes a threshold amount for a specific listed chemical, a threshold amount, including a cumulative threshold amount for multiple transactions (as determined by the Attorney General, in consultation with the chemical industry and taking into consideration the quantities normally used for lawful purposes), of a listed chemical, except that such term does not include—

(i) a domestic lawful distribution in the usual course of business between agents or employees of a single regulated person;

(ii) a delivery of a listed chemical to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier, or to or by a warehouseman for storage in the lawful and usual course of the business of the warehouseman, except that if the carriage or storage is in connection with the distribution, importation, or exportation of a listed chemical to a third person, this clause does not relieve a distributor, importer, or exporter from compliance with section 830 of this title;

(iii) any category of transaction or any category of transaction for a specific listed chemical or chemicals specified by regulation of the Attorney General as excluded from this definition as unnecessary for enforcement of this subchapter or subchapter II;

(iv) any transaction in a listed chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], subject to clause (v), unless—

(I) the Attorney General has determined under section 814 of this title that the drug or group of drugs is being diverted to obtain the listed chemical for use in the illicit production of a controlled substance; and

(II) the quantity of the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical by the Attorney General;

(v) any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or a distributor required to submit reports under section 830(b)(3) of this title; or

(vi) any transaction in a chemical mixture which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical or chemicals contained in the mixture cannot be readily recovered; and

(B) a distribution, importation, or exportation of a tableting machine or encapsulating machine.

(40) The term "chemical mixture" means a combination of two or more chemical substances, at least one of which is not a list I chemical or a list II chemical, except that such term does not include any combination of a list I chemical or a list II chemical with another chemical that is present solely as an impurity.

(41)(A) The term "anabolic steroid" means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes—

(i) androstanediol—

(I) 3β,17β-dihydroxy-5α-androstane; and

(II) 3α,17β-dihydroxy-5α-androstane;

(ii) androstanedione (5α-androstan-3,17-dione);

(iii) androstenediol—

(I) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);

(II) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);

(III) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene); and

(IV) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene);

(iv) androstenedione—

(I) 1-androstenedione ([5α]-androst-1-en-3,17-dione);

(II) 4-androstenedione (androst-4-en-3,17-dione); and

(III) 5-androstenedione (androst-5-en-3,17-dione);

(v) bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);

(vi) boldenone (17β-hydroxyandrost-1,4,-diene-3-one);

(vii) calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);

(viii) clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);

(ix) dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one);

(x) Δ1-dihydrotestosterone (a.k.a. "1-testosterone") (17β-hydroxy-5α-androst-1-en-3-one);

(xi) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one);

(xii) drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one);

(xiii) ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);

(xiv) fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one);

(xv) formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one);

(xvi) furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan);

(xvii) 13β-ethyl-17β-hydroxygon-4-en-3-one;

(xviii) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one);

(xix) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one);

(xx) mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one);

(xxi) mesterolone (1α-methyl-17β-hydroxy-[5α]-androstan-3-one);

(xxii) methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one);

(xxiii) methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene);

(xxiv) methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one);

(xxv) 17α-methyl-3β, 17β-dihydroxy-5α-androstane;

(xxvi) 17α-methyl-3α,17β-dihydroxy-5α-androstane;

(xxvii) 17α-methyl-3β,17β-dihydroxyandrost-4-ene.

(xxviii) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one);

(xxix) methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);

(xxx) methyltrienolone (17α-methyl-17β-hydroxyestra-4,9-11-trien-3-one);

(xxxi) methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one);

(xxxii) mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one);

(xxxiii) 17α-methyl-Δ1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. "17-α-methyl-1-testosterone");

(xxxiv) nandrolone (17β-hydroxyestr-4-en-3-one);

(xxxv) norandrostenediol—

(I) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr-4-ene);

(II) 19-nor-4-androstenediol (3α, 17β-dihydroxyestr-4-ene);

(III) 19-nor-5-androstenediol (3β, 17β-dihydroxyestr-5-ene); and

(IV) 19-nor-5-androstenediol (3α, 17β-dihydroxyestr-5-ene);

(xxxvi) norandrostenedione—

(I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and

(II) 19-nor-5-androstenedione (estr-5-en-3,17-dione;

(xxxvii) norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one);

(xxxviii) norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);

(xxxix) norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one);

(xl) normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one);

(xli) oxandrolone (17α-methyl-17β-hydroxy-2-oxa-[5α]-androstan-3-one);

(xlii) oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one);

(xliii) oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-[5α]-androstan-3-one);

(xliv) stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);

(xlv) stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one);

(xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);

(xlvii) testosterone (17β-hydroxyandrost-4-en-3-one);

(xlviii) tetrahydrogestrinone (13β,17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one);

(xlix) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one);

(l) 5α-Androstan-3,6,17-trione;

(li) 6-bromo-androstan-3,17-dione;

(lii) 6-bromo-androsta-1,4-diene-3,17-dione;

(liii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;

(liv) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;

(lv) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;

(lvi) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;

(lvii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;

(lviii) 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one;

(lix) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;

(lx) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;

(lxi) [3,2-c]-furazan-5α-androstan-17β-ol;

(lxii) 3β-hydroxy-estra-4,9,11-trien-17-one;

(lxiii) 17α-methyl-androst-2-ene-3,17β-diol;

(lxiv) 17α-methyl-androsta-1,4-diene-3,17β-diol;

(lxv) Estra-4,9,11-triene-3,17-dione;

(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;

(lxvii) 6α-Methyl-androst-4-ene-3,17-dione;

(lxviii) 17α-Methyl-androstan-3-hydroxyimine-17β-ol;

(lxix) 17α-Methyl-5α-androstan-17β-ol;

(lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole;

(lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole;

(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol;

(lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol;

(lxxiv) [3,2-c]pyrazole-5α-androstan-17β-ol; and

(lxxv) any salt, ester, or ether of a drug or substance described in this paragraph.

The substances excluded under this subparagraph may at any time be scheduled by the Attorney General in accordance with the authority and requirements of subsections (a) through (c) of section 811 of this title.

(B)(i) Except as provided in clause (ii), such term does not include an anabolic steroid which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the Secretary of Health and Human Services for such administration.

(ii) If any person prescribes, dispenses, or distributes such steroid for human use, such person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of subparagraph (A).

(C)(i) Subject to clause (ii), a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed in subparagraph (A) and is derived from, or has a chemical structure substantially similar to, 1 or more anabolic steroids listed in subparagraph (A) shall be considered to be an anabolic steroid for purposes of this chapter if—

(I) the drug or substance has been created or manufactured with the intent of producing a drug or other substance that either—

(aa) promotes muscle growth; or

(bb) otherwise causes a pharmacological effect similar to that of testosterone; or

(II) the drug or substance has been, or is intended to be, marketed or otherwise promoted in any manner suggesting that consuming it will promote muscle growth or any other pharmacological effect similar to that of testosterone.

(ii) A substance shall not be considered to be a drug or hormonal substance for purposes of this subparagraph if it—

(I) is—

(aa) an herb or other botanical;

(bb) a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or

(cc) a combination of 2 or more substances described in item (aa) or (bb);

(II) is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and

(III) is not anabolic or androgenic.

(iii) In accordance with section 885(a) of this title, any person claiming the benefit of an exemption or exception under clause (ii) shall bear the burden of going forward with the evidence with respect to such exemption or exception.

(42) The term "international transaction" means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates.

(43) The terms "broker" and "trader" mean a person that assists in arranging an international transaction in a listed chemical by—

(A) negotiating contracts;

(B) serving as an agent or intermediary; or

(C) bringing together a buyer and seller, a buyer and transporter, or a seller and transporter.

(44) The term "felony drug offense" means an offense that is punishable by imprisonment for more than one year under any law of the United States or of a State or foreign country that prohibits or restricts conduct relating to narcotic drugs, marihuana, anabolic steroids, or depressant or stimulant substances.

(45)(A) The term "scheduled listed chemical product" means, subject to subparagraph (B), a product that—

(i) contains ephedrine, pseudoephedrine, or phenylpropanolamine; and

(ii) may be marketed or distributed lawfully in the United States under the Federal, Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] as a nonprescription drug.

Each reference in clause (i) to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.

(B) Such term does not include a product described in subparagraph (A) if the product contains a chemical specified in such subparagraph that the Attorney General has under section 811(a) of this title added to any of the schedules under section 812(c) of this title. In the absence of such scheduling by the Attorney General, a chemical specified in such subparagraph may not be considered to be a controlled substance.

(46) The term "regulated seller" means a retail distributor (including a pharmacy or a mobile retail vendor), except that such term does not include an employee or agent of such distributor.

(47) The term "mobile retail vendor" means a person or entity that makes sales at retail from a stand that is intended to be temporary, or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes).

(48) The term "at retail", with respect to the sale or purchase of a scheduled listed chemical product, means a sale or purchase for personal use, respectively.

(49)(A) The term "retail distributor" means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to ephedrine, pseudoephedrine, or phenylpropanolamine products are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales.

(B) For purposes of this paragraph, entities are defined by reference to the Standard Industrial Classification (SIC) code, as follows:

(i) A grocery store is an entity within SIC code 5411.

(ii) A general merchandise store is an entity within SIC codes 5300 through 5399 and 5499.

(iii) A drug store is an entity within SIC code 5912.

(50) The term "Internet" means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.

(51) The term "deliver, distribute, or dispense by means of the Internet" refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet.

(52) The term "online pharmacy"—

(A) means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet; and

(B) does not include—

(i) manufacturers or distributors registered under subsection (a), (b), (e), or (f) of section 823 of this title who do not dispense controlled substances to an unregistered individual or entity;

(ii) nonpharmacy practitioners who are registered under section 823(g) of this title and whose activities are authorized by that registration;

(iii) any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under section 823(g) of this title;

(iv) a health care facility owned or operated by an Indian tribe or tribal organization, only to the extent such facility is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.];

(v) any agent or employee of any hospital or facility referred to in clause (iii) or (iv), provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in clause (iv), only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such clause;

(vi) mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;

(vii) a person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States;

(viii) a pharmacy registered under section 823(g) of this title whose dispensing of controlled substances via the Internet consists solely of—

(I) refilling prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (55); or

(II) filling new prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (56); or

(ix) any other persons for whom the Attorney General and the Secretary have jointly, by regulation, found it to be consistent with effective controls against diversion and otherwise consistent with the public health and safety to exempt from the definition of an "online pharmacy".

(53) The term "homepage" means the opening or main page or screen of the website of an online pharmacy that is viewable on the Internet.

(54) The term "practice of telemedicine" means, for purposes of this subchapter, the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1395m(m) of title 42, which practice—

(A) is being conducted—

(i) while the patient is being treated by, and physically located in, a hospital or clinic registered under section 823(g) of this title; and

(ii) by a practitioner—

(I) acting in the usual course of professional practice;

(II) acting in accordance with applicable State law; and

(III) registered under section 823(g) of this title in the State in which the patient is located, unless the practitioner—

(aa) is exempted from such registration in all States under section 822(d) of this title; or

(bb) is—

(AA) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and

(BB) registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;

(B) is being conducted while the patient is being treated by, and in the physical presence of, a practitioner—

(i) acting in the usual course of professional practice;

(ii) acting in accordance with applicable State law; and

(iii) registered under section 823(g) of this title in the State in which the patient is located, unless the practitioner—

(I) is exempted from such registration in all States under section 822(d) of this title; or

(II) is—

(aa) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and

(bb) registered under section 823(g) of this title in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;

(C) is being conducted by a practitioner—

(i) who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.];

(ii) acting within the scope of the employment, contract, or compact described in clause (i); and

(iii) who is designated as an Internet Eligible Controlled Substances Provider by the Secretary under section 831(g)(2) of this title;

(D)(i) is being conducted during a public health emergency declared by the Secretary under section 247d of title 42; and

(ii) involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General, designates, provided that such designation shall not be subject to the procedures prescribed by subchapter II of chapter 5 of title 5;

(E) is being conducted by a practitioner who has obtained from the Attorney General a special registration under section 831(h) of this title;

(F) is being conducted—

(i) in a medical emergency situation—

(I) that prevents the patient from being in the physical presence of a practitioner registered under section 823(g) of this title who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;

(II) that prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;

(III) during which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and

(IV) that requires immediate intervention by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and

(ii) by a practitioner that—

(I) is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;

(II) is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title; and

(III) issues a controlled substance prescription in this emergency context that is limited to a maximum of a 5-day supply which may not be extended or refilled; or

(G) is being conducted under any other circumstances that the Attorney General and the Secretary have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.

(55) The term "refilling prescriptions for controlled substances in schedule III, IV, or V"—

(A) means the dispensing of a controlled substance in schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of section 829 of this title, as appropriate; and

(B) does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.

(56) The term "filling new prescriptions for controlled substances in schedule III, IV, or V" means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if—

(A) the pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of subsections (b) and (c) of section 829 of this title (in this paragraph referred to as the "original prescription");

(B) the pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in subparagraph (A); and

(C) the practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.

(57) ¹ The term "suspicious order" may include, but is not limited to—

(A) an order of a controlled substance of unusual size;

(B) an order of a controlled substance deviating substantially from a normal pattern; and

(C) orders of controlled substances of unusual frequency.

(57) ¹ The term "serious drug felony" means an offense described in section 924(e)(2) of title 18 for which—

(A) the offender served a term of imprisonment of more than 12 months; and

(B) the offender's release from any term of imprisonment was within 15 years of the commencement of the instant offense.

(58) The term "serious violent felony" means—

(A) an offense described in section 3559(c)(2) of title 18 for which the offender served a term of imprisonment of more than 12 months; and

(B) any offense that would be a felony violation of section 113 of title 18, if the offense were committed in the special maritime and territorial jurisdiction of the United States, for which the offender served a term of imprisonment of more than 12 months.

(Pub. L. 91–513, title II, §102, Oct. 27, 1970, 84 Stat. 1242; Pub. L. 93–281, §2, May 14, 1974, 88 Stat. 124; Pub. L. 95–633, title I, §102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96–132, §16(a), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 98–473, title II, §507(a), (b), Oct. 12, 1984, 98 Stat. 2071; Pub. L. 98–509, title III, §301(a), Oct. 19, 1984, 98 Stat. 2364; Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 99–570, title I, §§1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207–6, 3207-13, 3207-56; Pub. L. 99–646, §83, Nov. 10, 1986, 100 Stat. 3619; Pub. L. 100–690, title VI, §6054, Nov. 18, 1988, 102 Stat. 4316; Pub. L. 101–647, title XIX, §1902(b), title XXIII, §2301, title XXXV, §3599I, Nov. 29, 1990, 104 Stat. 4852, 4858, 4932; Pub. L. 103–200, §§2(a), 7–9(a), Dec. 17, 1993, 107 Stat. 2333, 2340; Pub. L. 103–322, title IX, §90105(d), title XXXIII, §330024(a), (b), (d)(1), Sept. 13, 1994, 108 Stat. 1988, 2150; Pub. L. 104–237, title II, §§204(a), 209, title IV, §401(a), (b), Oct. 3, 1996, 110 Stat. 3102, 3104, 3106, 3107; Pub. L. 104–294, title VI, §§604(b)(4), 607(j), Oct. 11, 1996, 110 Stat. 3506, 3512; Pub. L. 105–115, title I, §126(c)(3), Nov. 21, 1997, 111 Stat. 2328; Pub. L. 106–172, §§3(c), 5(a), Feb. 18, 2000, 114 Stat. 9, 10; Pub. L. 106–310, div. B, title XXXVI, §3622(a), Oct. 17, 2000, 114 Stat. 1231; Pub. L. 107–273, div. B, title IV, §4002(c)(1), Nov. 2, 2002, 116 Stat. 1808; Pub. L. 108–358, §2(a), Oct. 22, 2004, 118 Stat. 1661; Pub. L. 109–162, title XI, §1180, Jan. 5, 2006, 119 Stat. 3126; Pub. L. 109–177, title VII, §§711(a)(1), (2)(A), 712(a)(1), Mar. 9, 2006, 120 Stat. 256, 257, 263; Pub. L. 110–425, §3(a), Oct. 15, 2008, 122 Stat. 4821; Pub. L. 113–260, §2(a), Dec. 18, 2014, 128 Stat. 2929; Pub. L. 114–198, title III, §303(a)(2), July 22, 2016, 130 Stat. 722; Pub. L. 115–271, title III, §§3202(c), 3292(a), Oct. 24, 2018, 132 Stat. 3945, 3956; Pub. L. 115–334, title XII, §12619(a), Dec. 20, 2018, 132 Stat. 5018; Pub. L. 115–391, title IV, §401(a)(1), Dec. 21, 2018, 132 Stat. 5220; Pub. L. 117–215, §2(b), title I, §103(b)(1)(A), Dec. 2, 2022, 136 Stat. 2258, 2262.)

Editorial Notes

References in Text

Schedules I, II, III, IV, and V, referred to in pars. (6), (14), (32)(A), (52)(B)(viii), (55), and (56), are set out in section 812(c) of this title.

This subchapter, referred to in introductory provisions and in pars. (34), (35), (39)(A)(iii), (vi), and (54), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Subchapter II, referred to in par. (39)(A)(iii), (vi), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in pars. (39)(A)(iv), (41)(C)(ii)(II), and (45)(A)(ii), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This chapter, referred to in par. (41)(C)(i), was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Indian Self-Determination and Education Assistance Act, referred to in pars. (52)(B)(iv) and (54)(C)(i), is Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

Amendments

2022—Par. (16)(A). Pub. L. 117–215, §2(b)(1), substituted "the terms 'marihuana' and 'marijuana' mean" for "the term 'marihuana' means".

Par. (16)(B). Pub. L. 117–215, §2(b)(2), substituted "The terms 'marihuana' and 'marijuana' do not" for "The term 'marihuana' does not" in introductory provisions.

Par. (52)(B). Pub. L. 117–215, §103(b)(1)(A)(i)(I), substituted "823(g)" for "823(f)" wherever appearing.

Par. (52)(B)(i). Pub. L. 117–215, §103(b)(1)(A)(i)(II), substituted "(e), or (f)" for "(d), or (e)".

Par. (54). Pub. L. 117–215, §103(b)(1)(A)(ii), substituted "823(g)" for "823(f)" wherever appearing.

2018—Par. (16). Pub. L. 115–334 designated first sentence as subpar. (A), substituted "Subject to subparagraph (B), the" for "The", inserted subpar. (B) designation, introductory provisions, and cl. (i), designated second sentence as cl. (ii) of subpar. (B), and substituted "the" for "Such term does not include the" in cl. (ii).

Par. (24). Pub. L. 115–271, §3202(c), substituted "Health and Human Services" for "Health, Education, and Welfare".

Par. (57). Pub. L. 115–391, §401(a)(1), added par. (57) defining the term "serious drug felony".

Pub. L. 115–271, §3292(a), added par. (57) defining the term "suspicious order".

Par. (58). Pub. L. 115–391, §401(a)(1), added par. (58).

2016—Par. (18). Pub. L. 114–198 inserted "or 'opioid' " after "The term 'opiate' ".

2014—Par. (41)(A)(l) to (lxxv). Pub. L. 113–260, §2(a)(1), added cls. (l) to (lxxiv) and redesignated former cl. (xlx) as (lxxv).

Par. (41)(C). Pub. L. 113–260, §2(a)(2), added subpar. (C).

2008—Pars. (50) to (56). Pub. L. 110–425 added pars. (50) to (56).

2006—Par. (39)(A)(iv). Pub. L. 109–177, §712(a)(1)(A)(i), amended cl. (iv) generally. Prior to amendment, cl. (iv) related to transactions involving drugs containing ephedrine, pseudoephedrine, or phenylpropanolamine.

Par. (39)(A)(v), (vi). Pub. L. 109–177, §712(a)(1)(A)(ii), (iii), added cl. (v) and redesignated former cl. (v) as (vi).

Par. (41)(A)(xvii). Pub. L. 109–162, §1180(1), substituted "13β-ethyl-17β-hydroxygon-4-en-3-one;" for "13β-ethyl-17α-hydroxygon-4-en-3-one;".

Par. (41)(A)(xliv). Pub. L. 109–162, §1180(2), substituted "(17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);" for "(17α-methyl-17α-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);".

Par. (45). Pub. L. 109–177, §§711(a)(1)(B), 712(a)(1)(B), added par. (45) and struck out former par. (45) which defined "ordinary over-the-counter pseudoephedrine or phenylpropanolamine product".

Pars. (46) to (48). Pub. L. 109–177, §§711(a)(1)(B), added pars. (46) to (48). Former par. (46) redesignated (49).

Par. (49). Pub. L. 109–177, §711(a)(1)(A), (2)(A), redesignated par. (46) as (49), substituted "ephedrine, pseudoephedrine, or" for "pseudoephedrine or" in subpar. (A), redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: "For purposes of this paragraph, sale for personal use means the sale of below-threshold quantities in a single transaction to an individual for legitimate medical use."

2004—Par. (41). Pub. L. 108–358, §2(a)(1), realigned margins, added subpar. (A), and struck out former subpar. (A) which defined "anabolic steroid".

Par. (44). Pub. L. 108–358, §2(a)(2), inserted "anabolic steroids," after "marihuana,".

2002—Pars. (43), (44). Pub. L. 107–273 repealed Pub. L. 104–294, §§604(b)(4), 607(j)(2). See 1996 Amendment note below.

2000—Par. (32)(A). Pub. L. 106–172, §5(a)(1), substituted "subparagraph (C)" for "subparagraph (B)" in introductory provisions.

Par. (32)(B), (C). Pub. L. 106–172, §5(a)(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).

Par. (34)(X), (Y). Pub. L. 106–172, §3(c), added subpar. (X) and redesignated former subpar. (X) as (Y).

Par. (39)(A)(iv)(II). Pub. L. 106–310 substituted "9 grams" for "24 grams" in two places and inserted before semicolon at end "and sold in package sizes of not more than 3 grams of pseudoephedrine base or 3 grams of phenylpropanolamine base".

1997—Par. (9)(A). Pub. L. 105–115 redesignated cl. (i) as subpar. (A) and struck out cl. (ii) which read as follows: "any derivative of barbituric acid which has been designated by the Secretary as habit forming under section 352(d) of this title; or".

1996—Par. (26). Pub. L. 104–294, §607(j)(1), amended par. (26) generally. Prior to amendment, par. (26) read as follows: "The term 'State' means any State, territory, or possession of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Trust Territory of the Pacific Islands, and the Canal Zone."

Par. (34)(P), (S), (U). Pub. L. 104–237, §209(1), substituted "Isosafrole" for "Insosafrole" in subpar. (P), "N-Methylephedrine" for "N-Methylepherdrine" in subpar. (S), and "Hydriodic acid" for "Hydriotic acid" in subpar. (U).

Par. (35)(G). Pub. L. 104–237, §209(2), amended subpar. (G) generally, inserting "(or Methyl Ethyl Ketone)" before period at end.

Par. (35)(I), (J). Pub. L. 104–237, §204(a), added subpars. (I) and (J).

Par. (39)(A)(iv)(I)(aa). Pub. L. 104–237, §401(a)(1), (b)(1), substituted ", pseudoephedrine or its salts, optical isomers, or salts of optical isomers, or phenylpropanolamine or its salts, optical isomers, or salts of optical isomers unless otherwise provided by regulation of the Attorney General issued pursuant to section 814(e) of this title, except that any sale of ordinary over-the-counter pseudoephedrine or phenylpropanolamine products by retail distributors shall not be a regulated transaction (except as provided in section 401(d) of the Comprehensive Methamphetamine Control Act of 1996);" for "as the only active medicinal ingredient or contains ephedrine or its salts, optical isomers, or salts of optical isomers and therapeutically insignificant quantities of another active medicinal ingredient;".

Par. (39)(A)(iv)(II). Pub. L. 104–237, §401(a)(2), (b)(2), inserted ", pseudoephedrine, phenylpropanolamine," after "ephedrine" and inserted before semicolon ", except that the threshold for any sale of products containing pseudoephedrine or phenylpropanolamine products by retail distributors or by distributors required to submit reports by section 830(b)(3) of this title shall be 24 grams of pseudoephedrine or 24 grams of phenylpropanolamine in a single transaction".

Pars. (43), (44). Pub. L. 104–294, §§604(b)(4), 607(j)(2), which provided for amendment to section identical to Pub. L. 104–237, §401(b)(3), below, were repealed by Pub. L. 107–273, §4002(c)(1).

Pub. L. 104–237, §401(b)(3), redesignated par. (43), relating to felony drug offense, as (44).

Pars. (45), (46). Pub. L. 104–237, §401(b)(4), added pars. (45) and (46).

1994—Par. (34)(V), (W). Pub. L. 103–322, §330024(b), realigned margins and capitalized first letter.

Par. (35). Pub. L. 103–322, §330024(d)(1), made technical correction to directory language of Pub. L. 103–200, §2(a)(4)(B). See 1993 Amendment note below.

Par. (39)(A)(iv)(II). Pub. L. 103–322, §330024(a), substituted "; or" for period at end.

Par. (43). Pub. L. 103–322, §90105(d), added par. (43) defining "felony drug offense".

1993—Par. (33). Pub. L. 103–200, §2(a)(1), substituted "any list I chemical or any list II chemical" for "any listed precursor chemical or listed essential chemical".

Par. (34). Pub. L. 103–200, §2(a)(2), substituted "list I chemical" for "listed precursor chemical" and "important to the manufacture" for "critical to the creation" in introductory provisions.

Par. (34)(A), (F), (H). Pub. L. 103–200, §2(a)(3), inserted ", its esters," before "and".

Par. (34)(O). Pub. L. 103–200, §8(1), (2), redesignated subpar. (P) as (O) and struck out former subpar. (O) which read as follows: "D-lysergic acid."

Par. (34)(P) to (S). Pub. L. 103–200, §8(2), redesignated subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P) redesignated (O).

Par. (34)(T). Pub. L. 103–200, §8(2), redesignated subpar. (V) as (T). Former subpar. (T) redesignated (S).

Par. (34)(U). Pub. L. 103–200, §8(1), (2), redesignated subpar. (X) as (U) and struck out former subpar. (U) which read as follows: "N-ethylephedrine."

Par. (34)(V). Pub. L. 103–200, §8(2), (4), added subpar. (V) and redesignated former subpar. (V) as (T).

Par. (34)(W). Pub. L. 103–200, §8(1), (4), added subpar. (W) and struck out former subpar. (W) which read as follows: "N-ethylpseudoephedrine."

Par. (34)(X). Pub. L. 103–200, §8(2), (3), redesignated subpar. (Y) as (X) and substituted "through (U)" for "through (X)".

Par. (34)(Y). Pub. L. 103–200, §8(2), redesignated subpar. (Y) as (X).

Par. (35). Pub. L. 103–200, §2(a)(4)(A), (C), substituted "list II chemical" for "listed essential chemical" and struck out "as a solvent, reagent, or catalyst" before "in manufacturing".

Pub. L. 103–200, §2(a)(4)(B), as amended by Pub. L. 103–322, §330024(d)(1), inserted "(other than a list I chemical)" before "specified" the first time appearing.

Par. (37). Pub. L. 103–200, §9(a), amended par. (37) generally. Prior to amendment, par. (37) read as follows: "The term 'regular supplier' means, with respect to a regulated person, a supplier with whom the regulated person has an established business relationship that is reported to the Attorney General."

Par. (38). Pub. L. 103–200, §2(a)(5), inserted before period at end "or who acts as a broker or trader for an international transaction involving a listed chemical, a tableting machine, or an encapsulating machine".

Par. (39)(A). Pub. L. 103–200, §§2(a)(6)(A), 7, in introductory provisions, substituted "importation, or exportation of, or an international transaction involving shipment of," for "importation or exportation of" and inserted "a listed chemical, or if the Attorney General establishes a threshold amount for a specific listed chemical," before "a threshold amount,".

Par. (39)(A)(iii). Pub. L. 103–200, §2(a)(6)(B), inserted "or any category of transaction for a specific listed chemical or chemicals" after "transaction".

Par. (39)(A)(iv). Pub. L. 103–200, §2(a)(6)(C), amended cl. (iv) generally. Prior to amendment, cl. (iv) read as follows: "any transaction in a listed chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act; or".

Par. (39)(A)(v). Pub. L. 103–200, §2(a)(6)(D), inserted before semicolon at end "which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical or chemicals contained in the mixture cannot be readily recovered".

Par. (40). Pub. L. 103–200, §2(a)(7), substituted "list I chemical or a list II chemical" for "listed precursor chemical or a listed essential chemical" in two places.

Pars. (42), (43). Pub. L. 103–200, §2(a)(8), added pars. (42) and (43).

1990—Par. (32)(A). Pub. L. 101–647, §3599I, substituted "the stimulant" for "the stimulent" in cl. (ii) and "a stimulant" for "a stimulent" in cl. (iii).

Par. (34)(M) to (Y). Pub. L. 101–647, §2301(a), added subpars. (M) to (Y).

Par. (35)(E). Pub. L. 101–647, §2301(b), struck out subpar. (E) "Hydriodic acid."

Par. (41). Pub. L. 101–647, §1902(b), added par. (41).

1988—Par. (8). Pub. L. 100–690, §6054(1), inserted "or a listed chemical" after "a controlled substance".

Par. (11). Pub. L. 100–690, §6054(2), inserted "or a listed chemical" after "a controlled substance" in two places.

Pars. (33) to (40). Pub. L. 100–690, §6054(3), added pars. (33) to (40).

1986—Par. (6). Pub. L. 99–514 substituted "Internal Revenue Code of 1986" for "Internal Revenue Code of 1954".

Par. (14). Pub. L. 99–570, §1870, and Pub. L. 99–646 amended par. (14) identically, substituting "any optical" for "the optical" in second and third sentences.

Par. (25). Pub. L. 99–570, §1003(b)(1), added par. (25). Former par. (25) redesignated (26).

Pars. (26) to (31). Pub. L. 99–570, §1003(b)(2), redesignated pars. (25) to (30) as (26) to (31), respectively.

Par. (32). Pub. L. 99–570, §1203, added par. (32).

1984—Pars. (14) to (16). Pub. L. 98–473, §507(a), added par. (14) and redesignated former pars. (14) to (16) as (15) to (17), respectively.

Par. (17). Pub. L. 98–473, §507, redesignated former par. (16) as (17), and expanded and revised definition of "narcotic drug", including within term poppy straw, cocaine, and ecgonine. Former par. (17) redesignated (18).

Pars. (18) to (28). Pub. L. 98–473, §507(a), redesignated former pars. (17) to (27) as (18) to (28), respectively.

Par. (29). Pub. L. 98–509 which directed the substitution of "one hundred and eighty" for "twenty-one" in par. (28), was executed to par. (29) in view of the redesignation of par. (28) as par. (29) by Pub. L. 98–473.

Pub. L. 98–473, §507(a), redesignated former par. (28) as (29). Former par. (29) redesignated (30).

Par. (30). Pub. L. 98–473, §507(a), redesignated former par. (29) as (30).

1979—Par. (4). Pub. L. 96–132 substituted provisions defining "Drug Enforcement Administration" for provisions defining "Bureau of Narcotics and Dangerous Drugs".

1978—Par. (29). Pub. L. 95–633 added par. (29).

1974—Pars. (27), (28). Pub. L. 93–281 added pars. (27) and (28).

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Pub. L. 115–391, title IV, §401(c), Dec. 21, 2018, 132 Stat. 5221, provided that: "This section [amending this section and sections 841 and 960 of this title], and the amendments made by this section, shall apply to any offense that was committed before the date of enactment of this Act [Dec. 21, 2018], if a sentence for the offense has not been imposed as of such date of enactment."

Effective Date of 2008 Amendment

Pub. L. 110–425, §3(j), Oct. 15, 2008, 122 Stat. 4832, provided that:

"(1) In general.—Except as provided in paragraph (2), the amendments made by this Act [enacting section 831 of this title and amending this section and sections 823, 827, 829, 841, 843, 882 and 960 of this title] shall take effect 180 days after the date of enactment of this Act [Oct. 15, 2008].

"(2) Definition of practice of telemedicine.—

"(A) In general.—Until the earlier of 3 months after the date on which regulations are promulgated to carry out section 311(h) of the Controlled Substances Act [21 U.S.C. 831(h)], as amended by this Act, or 15 months after the date of enactment of this Act—

"(i) the definition of the term 'practice of telemedicine' in subparagraph (B) of this paragraph shall apply for purposes of the Controlled Substances Act [21 U.S.C. 801 et seq.]; and

"(ii) the definition of the term 'practice of telemedicine' in section 102(54) of the Controlled Substances Act [21 U.S.C. 802(54)], as amended by this Act, shall not apply.

"(B) Temporary phase-in of telemedicine regulation.—During the period specified in subparagraph (A), the term 'practice of telemedicine' means the practice of medicine in accordance with applicable Federal and State laws by a practitioner (as that term is defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if the practitioner is using an interactive telecommunications system that satisfies the requirements of section 410.78(a)(3) of title 42, Code of Federal Regulations.

"(C) Rule of construction.—Nothing in this subsection may be construed to create a precedent that any specific course of conduct constitutes the 'practice of telemedicine' (as that term is defined in section 102(54) of the Controlled Substances Act, as amended by this Act) after the end of the period specified in subparagraph (A)."

Effective Date of 2004 Amendment

Pub. L. 108–358, §2(d), Oct. 22, 2004, 118 Stat. 1664, provided that: "The amendments made by this section [amending this section, section 811 of this title, and provisions set out as a note under this section] shall take effect 90 days after the date of enactment of this Act [Oct. 22, 2004]."

Effective Date of 2002 Amendment

Pub. L. 107–273, div. B, title IV, §4002(c)(1), Nov. 2, 2002, 116 Stat. 1808, provided that the amendment made by section 4002(c)(1) is effective Oct. 11, 1996.

Effective Date of 2000 Amendment

Pub. L. 106–310, div. B, title XXXVI, §3622(b), Oct. 17, 2000, 114 Stat. 1231, provided that: "The amendments made by subsection (a) [amending this section] shall take effect 1 year after the date of the enactment of this Act [Oct. 17, 2000]."

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1996 Amendments

Amendment by section 604(b)(4) of Pub. L. 104–294 effective Sept. 13, 1994, see section 604(d) of Pub. L. 104–294, set out as a note under section 13 of Title 18, Crimes and Criminal Procedure.

Pub. L. 104–237, title IV, §401(g), Oct. 3, 1996, 110 Stat. 3110, provided that: "Notwithstanding any other provision of this Act [see section 1(a) of Pub. L. 104–237, set out as a Short Title of 1996 Amendments note under section 801 of this title], this section [amending this section and section 814 of this title and enacting provisions set out as a note below] shall not apply to the sale of any pseudoephedrine or phenylpropanolamine product prior to 12 months after the date of enactment of this Act [Oct. 3, 1996], except that, on application of a manufacturer of a particular pseudoephedrine or phenylpropanolamine drug product, the Attorney General may, in her sole discretion, extend such effective date up to an additional six months. Notwithstanding any other provision of law, the decision of the Attorney General on such an application shall not be subject to judicial review."

Effective Date of 1994 Amendment

Pub. L. 103–322, title XXXIII, §330024(f), Sept. 13, 1994, 108 Stat. 2151, provided that: "The amendments made by this section [amending this section and sections 824, 960, and 971 of this title] shall take effect as of the date that is 120 days after the date of enactment of the Domestic Chemical Diversion Control Act of 1993 [Dec. 17, 1993]."

Effective Date of 1993 Amendment

Pub. L. 103–200, §11, Dec. 17, 1993, 107 Stat. 2341, provided that: "This Act [enacting section 814 of this title, amending this section and sections 821 to 824, 830, 843, 880, 957, 958, 960, and 971 of this title, and enacting provisions set out as a note under section 801 of this title] and the amendments made by this Act shall take effect on the date that is 120 days after the date of enactment of this Act [Dec. 17, 1993]."

Effective Date of 1990 Amendment

Pub. L. 101–647, title XIX, §1902(d), Nov. 29, 1990, 104 Stat. 4852, provided that: "This section [amending this section and section 812 of this title and enacting provisions set out as a note under section 829 of this title] and the amendment made by this section shall take effect 90 days after the date of enactment of this Act [Nov. 29, 1990]."

Effective Date of 1988 Amendment

Pub. L. 100–690, title VI, §6061, Nov. 18, 1988, 102 Stat. 4320, provided that: "Except as otherwise provided in this subtitle, this subtitle [subtitle A (§§6051–6061) of title VI of Pub. L. 100–690, enacting section 971 of this title, amending this section and sections 830, 841 to 843, 872, 876, 881, 960, and 961 of this title, and enacting provisions set out as notes under this section and section 971 of this title] shall take effect 120 days after the enactment of this Act [Nov. 18, 1988]."

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Regulations

Pub. L. 110–425, §3(k)(1), Oct. 15, 2008, 122 Stat. 4833, provided that: "The Attorney General may promulgate and enforce any rules, regulations, and procedures which may be necessary and appropriate for the efficient execution of functions under this Act [see Short Title of 2008 Amendment note set out under section 801 of this title] or the amendments made by this Act, and, with the concurrence of the Secretary of Health and Human Services where this Act or the amendments made by this Act so provide, promulgate any interim rules necessary for the implementation of this Act or the amendments made by this Act, prior to its effective date [see Effective Date of 2008 Amendment note above]."

Pub. L. 98–509, title III, §301(b), Oct. 19, 1984, 98 Stat. 2364, provided that: "The Secretary of Health and Human Services shall, within ninety days of the date of the enactment of this Act [Oct. 19, 1984], promulgate regulations for the administration of section 102(28) of the Controlled Substances Act [21 U.S.C. 802(29)] as amended by subsection (a) and shall include in the first report submitted under section 505(b) [503(b)] of the Public Health Service Act [former 42 U.S.C. 290aa–2(b)] after the expiration of such ninety days the findings of the Secretary with respect to the effect of the amendment made by subsection (a)."

Construction of 2008 Amendment

Pub. L. 110–425, §4, Oct. 15, 2008, 122 Stat. 4834, provided that: "Nothing in this Act [see Short Title of 2008 Amendment note set out under section 801 of this title] or the amendments made by this Act shall be construed as authorizing, prohibiting, or limiting the use of electronic prescriptions for controlled substances."

Preservation of State Authority To Regulate Scheduled Listed Chemicals

Pub. L. 109–177, title VII, §711(g), Mar. 9, 2006, 120 Stat. 263, provided that: "This section [amending this section and sections 830, 841, 842, and 844 of this title and enacting provisions set out as notes under sections 830 and 844 of this title] and the amendments made by this section may not be construed as having any legal effect on section 708 of the Controlled Substances Act [21 U.S.C. 903] as applied to the regulation of scheduled listed chemicals (as defined in section 102(45) of such Act [21 U.S.C. 802(45)])."

Report on Diversion of Ordinary, Over-the-Counter Pseudoephedrine and Phenylpropanolamine Products

Pub. L. 106–310, div. B, title XXXVI, §3642, Oct. 17, 2000, 114 Stat. 1237, provided that:

"(a) Study.—The Attorney General shall conduct a study of the use of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products in the clandestine production of illicit drugs. Sources of data for the study shall include the following:

"(1) Information from Federal, State, and local clandestine laboratory seizures and related investigations identifying the source, type, or brand of drug products being utilized and how they were obtained for the illicit production of methamphetamine and amphetamine.

"(2) Information submitted voluntarily from the pharmaceutical and retail industries involved in the manufacture, distribution, and sale of drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine, including information on changes in the pattern, volume, or both, of sales of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products.

"(b) Report.—

"(1) Requirement.—Not later than 1 year after the date of the enactment of this Act [Oct. 17, 2000], the Attorney General shall submit to Congress a report on the study conducted under subsection (a).

"(2) Elements.—The report shall include—

"(A) the findings of the Attorney General as a result of the study; and

"(B) such recommendations on the need to establish additional measures to prevent diversion of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine (such as a threshold on ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products) as the Attorney General considers appropriate.

"(3) Matters considered.—In preparing the report, the Attorney General shall consider the comments and recommendations including the comments on the Attorney General's proposed findings and recommendations, of State and local law enforcement and regulatory officials and of representatives of the industry described in subsection (a)(2).

"(c) Regulation of Retail Sales.—

"(1) In general.—Notwithstanding section 401(d) of the Comprehensive Methamphetamine Control Act of 1996 [Pub. L. 104–237] (21 U.S.C. 802 note) and subject to paragraph (2), the Attorney General shall establish by regulation a single-transaction limit of not less than 24 grams of ordinary, over-the-counter pseudoephedrine or phenylpropanolamine (as the case may be) for retail distributors, if the Attorney General finds, in the report under subsection (b), that—

"(A) there is a significant number of instances (as set forth in paragraph (3)(A) of such section 401(d) for purposes of such section) where ordinary, over-the-counter pseudoephedrine products, phenylpropanolamine products, or both such products that were purchased from retail distributors were widely used in the clandestine production of illicit drugs; and

"(B) the best practical method of preventing such use is the establishment of single-transaction limits for retail distributors of either or both of such products.

"(2) Due process.—The Attorney General shall establish the single-transaction limit under paragraph (1) only after notice, comment, and an informal hearing."

Regulation of Retail Sales of Certain Precursor Chemicals; Effect on Thresholds; Combination Ephedrine Products

Pub. L. 104–237, title IV, §401(d)–(f), Oct. 3, 1996, 110 Stat. 3108, which authorized the Attorney General to establish a single-transaction limit of 24 grams for pseudoephedrine, phenylpropanolamine, and combination ephedrine products for retail distributors, was repealed by Pub. L. 109–177, title VII, §712(b), Mar. 9, 2006, 120 Stat. 264.

Exemption for Substances in Paragraph (41)

Pub. L. 101–647, title XIX, §1903, Nov. 29, 1990, 104 Stat. 4853, as amended by Pub. L. 108–358, §2(c), Oct. 22, 2004, 118 Stat. 1663, provided that:

"(a) Drugs for Treatment of Rare Diseases.—If the Attorney General finds that a drug listed in paragraph (41) of section 102 of the Controlled Substances Act (as added by section 2 [1902] of this Act) is—

"(1) approved by the Food and Drug Administration as an accepted treatment for a rare disease or condition, as defined in section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and

"(2) does not have a significant potential for abuse, the Attorney General may exempt such drug from any production regulations otherwise issued under the Controlled Substances Act as may be necessary to ensure adequate supplies of such drug for medical purposes.

"(b) Date of Issuance of Regulations.—The Attorney General shall issue regulations implementing this section not later than 45 days after the date of enactment of this Act [Nov. 29, 1990], except that the regulations required under section 3(a) [former 1903(a)] shall be issued not later than 180 days after the date of enactment of this Act."

¹ So in original. Two pars. (57) have been enacted.

§803. Repealed. Pub. L. 95–137, §1(b), Oct. 18, 1977, 91 Stat. 1169

Section, Pub. L. 91–513, title II, §103, Oct. 27, 1970, 84 Stat. 1245, authorized Bureau of Narcotics and Dangerous Drugs to add, during fiscal year 1971, 300 agents, together with necessary supporting personnel, and provided for appropriations of $6,000,000 to carry out such addition.

Part B—Authority To Control; Standards and Schedules

§811. Authority and criteria for classification of substances

(a) Rules and regulations of Attorney General; hearing

The Attorney General shall apply the provisions of this subchapter to the controlled substances listed in the schedules established by section 812 of this title and to any other drug or other substance added to such schedules under this subchapter. Except as provided in subsections (d) and (e), the Attorney General may by rule—

(1) add to such a schedule or transfer between such schedules any drug or other substance if he—

(A) finds that such drug or other substance has a potential for abuse, and

(B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed; or

(2) remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.

Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of title 5. Proceedings for the issuance, amendment, or repeal of such rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary, or (3) on the petition of any interested party.

(b) Evaluation of drugs and other substances

The Attorney General shall, before initiating proceedings under subsection (a) to control a drug or other substance or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance. In making such evaluation and recommendations, the Secretary shall consider the factors listed in paragraphs (2), (3), (6), (7), and (8) of subsection (c) and any scientific or medical considerations involved in paragraphs (1), (4), and (5) of such subsection. The recommendations of the Secretary shall include recommendations with respect to the appropriate schedule, if any, under which such drug or other substance should be listed. The evaluation and the recommendations of the Secretary shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the Secretary to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance. If the Attorney General determines that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or substantial evidence that the drug or other substance should be removed entirely from the schedules, he shall initiate proceedings for control or removal, as the case may be, under subsection (a).

(c) Factors determinative of control or removal from schedules

In making any finding under subsection (a) of this section or under subsection (b) of section 812 of this title, the Attorney General shall consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the schedules:

(1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if known.

(3) The state of current scientific knowledge regarding the drug or other substance.

(4) Its history and current pattern of abuse.

(5) The scope, duration, and significance of abuse.

(6) What, if any, risk there is to the public health.

(7) Its psychic or physiological dependence liability.

(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

(d) International treaties, conventions, and protocols requiring control; procedures respecting changes in drug schedules of Convention on Psychotropic Substances

(1) If control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by subsection (a) of this section or section 812(b) of this title and without regard to the procedures prescribed by subsections (a) and (b) of this section.

(2)(A) Whenever the Secretary of State receives notification from the Secretary-General of the United Nations that information has been transmitted by or to the World Health Organization, pursuant to article 2 of the Convention on Psychotropic Substances, which may justify adding a drug or other substance to one of the schedules of the Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State shall immediately transmit the notice to the Secretary of Health and Human Services who shall publish it in the Federal Register and provide opportunity to interested persons to submit to him comments respecting the scientific and medical evaluations which he is to prepare respecting such drug or substance. The Secretary of Health and Human Services shall prepare for transmission through the Secretary of State to the World Health Organization such medical and scientific evaluations as may be appropriate regarding the possible action that could be proposed by the World Health Organization respecting the drug or substance with respect to which a notice was transmitted under this subparagraph.

(B) Whenever the Secretary of State receives information that the Commission on Narcotic Drugs of the United Nations proposes to decide whether to add a drug or other substance to one of the schedules of the Convention, transfer a drug or substance from one schedule to another, or delete it from the schedules, the Secretary of State shall transmit timely notice to the Secretary of Health and Human Services of such information who shall publish a summary of such information in the Federal Register and provide opportunity to interested persons to submit to him comments respecting the recommendation which he is to furnish, pursuant to this subparagraph, respecting such proposal. The Secretary of Health and Human Services shall evaluate the proposal and furnish a recommendation to the Secretary of State which shall be binding on the representative of the United States in discussions and negotiations relating to the proposal.

(3) When the United States receives notification of a scheduling decision pursuant to article 2 of the Convention on Psychotropic Substances that a drug or other substance has been added or transferred to a schedule specified in the notification or receives notification (referred to in this subsection as a "schedule notice") that existing legal controls applicable under this subchapter to a drug or substance and the controls required by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] do not meet the requirements of the schedule of the Convention in which such drug or substance has been placed, the Secretary of Health and Human Services after consultation with the Attorney General, shall first determine whether existing legal controls under this subchapter applicable to the drug or substance and the controls required by the Federal Food, Drug, and Cosmetic Act, meet the requirements of the schedule specified in the notification or schedule notice and shall take the following action:

(A) If such requirements are met by such existing controls but the Secretary of Health and Human Services nonetheless believes that more stringent controls should be applied to the drug or substance, the Secretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance, pursuant to subsections (a) and (b) of this section, to apply to such controls.

(B) If such requirements are not met by such existing controls and the Secretary of Health and Human Services concurs in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance under the appropriate schedule pursuant to subsections (a) and (b) of this section.

(C) If such requirements are not met by such existing controls and the Secretary of Health and Human Services does not concur in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall—

(i) if he deems that additional controls are necessary to protect the public health and safety, recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance pursuant to subsections (a) and (b) of this section, to apply such additional controls;

(ii) request the Secretary of State to transmit a notice of qualified acceptance, within the period specified in the Convention, pursuant to paragraph 7 of article 2 of the Convention, to the Secretary-General of the United Nations;

(iii) request the Secretary of State to transmit a notice of qualified acceptance as prescribed in clause (ii) and request the Secretary of State to ask for a review by the Economic and Social Council of the United Nations, in accordance with paragraph 8 of article 2 of the Convention, of the scheduling decision; or

(iv) in the case of a schedule notice, request the Secretary of State to take appropriate action under the Convention to initiate proceedings to remove the drug or substance from the schedules under the Convention or to transfer the drug or substance to a schedule under the Convention different from the one specified in the schedule notice.

(4)(A) If the Attorney General determines, after consultation with the Secretary of Health and Human Services, that proceedings initiated under recommendations made under paragraph ¹ (B) or (C)(i) of paragraph (3) will not be completed within the time period required by paragraph 7 of article 2 of the Convention, the Attorney General, after consultation with the Secretary and after providing interested persons opportunity to submit comments respecting the requirements of the temporary order to be issued under this sentence, shall issue a temporary order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drug or substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the United States obligations under paragraph 7 of article 2 of the Convention. In the case of proceedings initiated under subparagraph (B) of paragraph (3), the Attorney General, concurrently with the issuance of such order, shall request the Secretary of State to transmit a notice of qualified acceptance to the Secretary-General of the United Nations pursuant to paragraph 7 of article 2 of the Convention. A temporary order issued under this subparagraph controlling a drug or other substance subject to proceedings initiated under subsections (a) and (b) of this section shall expire upon the effective date of the application to the drug or substance of the controls resulting from such proceedings.

(B) After a notice of qualified acceptance of a scheduling decision with respect to a drug or other substance is transmitted to the Secretary-General of the United Nations in accordance with clause (ii) or (iii) of paragraph (3)(C) or after a request has been made under clause (iv) of such paragraph with respect to a drug or substance described in a schedule notice, the Attorney General, after consultation with the Secretary of Health and Human Services and after providing interested persons opportunity to submit comments respecting the requirements of the order to be issued under this sentence, shall issue an order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention in the case of a drug or substance for which a notice of qualified acceptance was transmitted or whichever the Attorney General determines is appropriate in the case of a drug or substance described in a schedule notice. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drug or substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the United States obligations under paragraph 7 of article 2 of the Convention. If, as a result of a review under paragraph 8 of article 2 of the Convention of the scheduling decision with respect to which a notice of qualified acceptance was transmitted in accordance with clause (ii) or (iii) of paragraph (3)(C)—

(i) the decision is reversed, and

(ii) the drug or substance subject to such decision is not required to be controlled under schedule IV or V to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention,

the order issued under this subparagraph with respect to such drug or substance shall expire upon receipt by the United States of the review decision. If, as a result of action taken pursuant to action initiated under a request transmitted under clause (iv) of paragraph (3)(C), the drug or substance with respect to which such action was taken is not required to be controlled under schedule IV or V, the order issued under this paragraph with respect to such drug or substance shall expire upon receipt by the United States of a notice of the action taken with respect to such drug or substance under the Convention.

(C) An order issued under subparagraph (A) or (B) may be issued without regard to the findings required by subsection (a) of this section or by section 812(b) of this title and without regard to the procedures prescribed by subsection (a) or (b) of this section.

(5) Nothing in the amendments made by the Psychotropic Substances Act of 1978 or the regulations or orders promulgated thereunder shall be construed to preclude requests by the Secretary of Health and Human Services or the Attorney General through the Secretary of State, pursuant to article 2 or other applicable provisions of the Convention, for review of scheduling decisions under such Convention, based on new or additional information.

(e) Immediate precursors

The Attorney General may, without regard to the findings required by subsection (a) of this section or section 812(b) of this title and without regard to the procedures prescribed by subsections (a) and (b) of this section, place an immediate precursor in the same schedule in which the controlled substance of which it is an immediate precursor is placed or in any other schedule with a higher numerical designation. If the Attorney General designates a substance as an immediate precursor and places it in a schedule, other substances shall not be placed in a schedule solely because they are its precursors.

(f) Abuse potential

If, at the time a new-drug application is submitted to the Secretary for any drug having a stimulant, depressant, or hallucinogenic effect on the central nervous system, it appears that such drug has an abuse potential, such information shall be forwarded by the Secretary to the Attorney General.

(g) Exclusion of non-narcotic substances sold over the counter without a prescription; dextromethorphan; exemption of substances lacking abuse potential

(1) The Attorney General shall by regulation exclude any non-narcotic drug which contains a controlled substance from the application of this subchapter and subchapter II of this chapter if such drug may, under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], be lawfully sold over the counter without a prescription.

(2) Dextromethorphan shall not be deemed to be included in any schedule by reason of enactment of this subchapter unless controlled after October 27, 1970 pursuant to the foregoing provisions of this section.

(3) The Attorney General may, by regulation, exempt any compound, mixture, or preparation containing a controlled substance from the application of all or any part of this subchapter if he finds such compound, mixture, or preparation meets the requirements of one of the following categories:

(A) A mixture, or preparation containing a nonnarcotic controlled substance, which mixture or preparation is approved for prescription use, and which contains one or more other active ingredients which are not listed in any schedule and which are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse.

(B) A compound, mixture, or preparation which contains any controlled substance, which is not for administration to a human being or animal, and which is packaged in such form or concentration, or with adulterants or denaturants, so that as packaged it does not present any significant potential for abuse.

(C) Upon the recommendation of the Secretary of Health and Human Services, a compound, mixture, or preparation which contains any anabolic steroid, which is intended for administration to a human being or an animal, and which, because of its concentration, preparation, formulation or delivery system, does not present any significant potential for abuse.

(h) Temporary scheduling to avoid imminent hazards to public safety

(1) If the Attorney General finds that the scheduling of a substance in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, he may, by order and without regard to the requirements of subsection (b) relating to the Secretary of Health and Human Services, schedule such substance in schedule I if the substance is not listed in any other schedule in section 812 of this title or if no exemption or approval is in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355]. Such an order may not be issued before the expiration of thirty days from—

(A) the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and

(B) the date the Attorney General has transmitted the notice required by paragraph (4).

(2) The scheduling of a substance under this subsection shall expire at the end of 2 years from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings under subsection (a)(1) with respect to the substance, extend the temporary scheduling for up to 1 year.

(3) When issuing an order under paragraph (1), the Attorney General shall be required to consider, with respect to the finding of an imminent hazard to the public safety, only those factors set forth in paragraphs (4), (5), and (6) of subsection (c), including actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution.

(4) The Attorney General shall transmit notice of an order proposed to be issued under paragraph (1) to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary in response to a notice transmitted pursuant to this paragraph.

(5) An order issued under paragraph (1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under subsection (a) with respect to such substance.

(6) An order issued under paragraph (1) is not subject to judicial review.

(i) Temporary and permanent scheduling of recently emerged anabolic steroids

(1) The Attorney General may issue a temporary order adding a drug or other substance to the definition of anabolic steroids if the Attorney General finds that—

(A) the drug or other substance satisfies the criteria for being considered an anabolic steroid under section 802(41) of this title but is not listed in that section or by regulation of the Attorney General as being an anabolic steroid; and

(B) adding such drug or other substance to the definition of anabolic steroids will assist in preventing abuse or misuse of the drug or other substance.

(2) An order issued under paragraph (1) shall not take effect until 30 days after the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued. The order shall expire not later than 24 months after the date it becomes effective, except that the Attorney General may, during the pendency of proceedings under paragraph (6), extend the temporary scheduling order for up to 6 months.

(3) The Attorney General shall transmit notice of an order proposed to be issued under paragraph (1) to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary in response to a notice transmitted pursuant to this paragraph.

(4) A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent scheduling order under paragraph (6).

(5) An order issued under paragraph (1) is not subject to judicial review.

(6) The Attorney General may, by rule, issue a permanent order adding a drug or other substance to the definition of anabolic steroids if such drug or other substance satisfies the criteria for being considered an anabolic steroid under section 802(41) of this title. Such rulemaking may be commenced simultaneously with the issuance of the temporary order issued under paragraph (1).

(j) Interim final rule; date of issuance; procedure for final rule

(1) With respect to a drug referred to in subsection (f), if the Secretary of Health and Human Services recommends that the Attorney General control the drug in schedule II, III, IV, or V pursuant to subsections (a) and (b), the Attorney General shall, not later than 90 days after the date described in paragraph (2), issue an interim final rule controlling the drug in accordance with such subsections and section 812(b) of this title using the procedures described in paragraph (3).

(2) The date described in this paragraph shall be the later of—

(A) the date on which the Attorney General receives the scientific and medical evaluation and the scheduling recommendation from the Secretary of Health and Human Services in accordance with subsection (b); or

(B) the date on which the Attorney General receives notification from the Secretary of Health and Human Services that the Secretary has approved an application under section 505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c), 360b, 360ccc] or section 262(a) of title 42, or indexed a drug under section 572 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ccc–1], with respect to the drug described in paragraph (1).

(3) A rule issued by the Attorney General under paragraph (1) shall become immediately effective as an interim final rule without requiring the Attorney General to demonstrate good cause therefor. The interim final rule shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General shall issue a final rule in accordance with the scheduling criteria of subsections (b), (c), and (d) of this section and section 812(b) of this title.

(Pub. L. 91–513, title II, §201, Oct. 27, 1970, 84 Stat. 1245; Pub. L. 95–633, title I, §102(a), Nov. 10, 1978, 92 Stat. 3769; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 98–473, title II, §§508, 509(a), Oct. 12, 1984, 98 Stat. 2071, 2072; Pub. L. 108–358, §2(b), Oct. 22, 2004, 118 Stat. 1663; Pub. L. 112–144, title XI, §1153, July 9, 2012, 126 Stat. 1132; Pub. L. 113–260, §2(b), Dec. 18, 2014, 128 Stat. 2930; Pub. L. 114–89, §2(b), Nov. 25, 2015, 129 Stat. 700.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a), (c)(8), (d)(3), (4)(A), (B), and (g)(2), (3), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (d)(3) and (g)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Schedules I, II, III, IV, and V, referred to in subsecs. (d)(4)(A), (B), (h)(1), and (j)(1), are set out in section 812(c) of this title.

The Psychotropic Substances Act of 1978, referred to in subsec. (d)(5), is Pub. L. 95–633, Nov. 10, 1978, 92 Stat. 3768, which enacted sections 801a, 830, and 852 of this title, amended sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and 965 of this title and section 242a of Title 42, The Public Health and Welfare, repealed section 830 of this title effective Jan. 1, 1981, and enacted provisions set out as notes under sections 801, 801a, 812, and 830 of this title. For complete classification of this Act to the Code, see Short Title of 1978 Amendment note set out under section 801 of this title and Tables.

This subchapter and subchapter II of this chapter, referred to in subsec. (g)(1), was in the original "titles II and III of the Comprehensive Drug Abuse Prevention and Control Act", which was translated as meaning titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, 1285, to reflect the probable intent of Congress. Title II is classified principally to this subchapter and part A of title III comprises subchapter II of this chapter. For complete classification of this Act to the Code, see Short Title notes set out under section 801 of this title and Tables.

Amendments

2015—Subsec. (j). Pub. L. 114–89 added subsec. (j).

2014—Subsec. (i). Pub. L. 113–260 added subsec. (i).

2012—Subsec. (h)(2). Pub. L. 112–144 substituted "2 years" for "one year" and "1 year" for "six months".

2004—Subsec. (g)(1). Pub. L. 108–358, §2(b)(1), substituted "drug which contains a controlled substance from the application of this subchapter and subchapter II of this chapter if such drug" for "substance from a schedule if such substance".

Subsec. (g)(3)(C). Pub. L. 108–358, §2(b)(2), added subpar. (C).

1984—Subsec. (g)(3). Pub. L. 98–473, §509(a), added par. (3).

Subsec. (h). Pub. L. 98–473, §508, added subsec. (h).

1978—Subsec. (d). Pub. L. 95–633 designated existing provisions as par. (1) and added pars. (2) to (5).

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (d)(2), (3), (4)(A), (B), (5) pursuant to section 509(b) of Pub. L. 96–88 which is classified to section 3508(b) of Title 20, Education.

Effective Date of 2004 Amendment

Amendment by Pub. L. 108–358 effective 90 days after Oct. 22, 2004, see section 2(d) of Pub. L. 108–358, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

¹ So in original. Probably should be "subparagraph".

§812. Schedules of controlled substances

(a) Establishment

There are established five schedules of controlled substances, to be known as schedules I, II, III, IV, and V. Such schedules shall initially consist of the substances listed in this section. The schedules established by this section shall be updated and republished on a semiannual basis during the two-year period beginning one year after October 27, 1970, and shall be updated and republished on an annual basis thereafter.¹

(b) Placement on schedules; findings required

Except where control is required by United States obligations under an international treaty, convention, or protocol, in effect on October 27, 1970, and except in the case of an immediate precursor, a drug or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance. The findings required for each of the schedules are as follows:

(1) Schedule I.—

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has no currently accepted medical use in treatment in the United States.

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

(2) Schedule II.—

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.

(C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.

(3) Schedule III.—

(A) The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.

(B) The drug or other substance has a currently accepted medical use in treatment in the United States.

(C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.

(4) Schedule IV.—

(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.

(B) The drug or other substance has a currently accepted medical use in treatment in the United States.

(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.

(5) Schedule V.—

(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.

(B) The drug or other substance has a currently accepted medical use in treatment in the United States.

(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.

(c) Initial schedules of controlled substances

Schedules I, II, III, IV, and V shall, unless and until amended pursuant to section 811 of this title, consist of the following drugs or other substances,¹ by whatever official name, common or usual name, chemical name, or brand name designated:

Schedule I

(a) Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

(1) Acetylmethadol.

(2) Allylprodine.

(3) Alphacetylmathadol.²

(4) Alphameprodine.

(5) Alphamethadol.

(6) Benzethidine.

(7) Betacetylmethadol.

(8) Betameprodine.

(9) Betamethadol.

(10) Betaprodine.

(11) Clonitazene.

(12) Dextromoramide.

(13) Dextrorphan.

(14) Diampromide.

(15) Diethylthiambutene.

(16) Dimenoxadol.

(17) Dimepheptanol.

(18) Dimethylthiambutene.

(19) Dioxaphetyl butyrate.

(20) Dipipanone.

(21) Ethylmethylthiambutene.

(22) Etonitazene.

(23) Etoxeridine.

(24) Furethidine.

(25) Hydroxypethidine.

(26) Ketobemidone.

(27) Levomoramide.

(28) Levophenacylmorphan.

(29) Morpheridine.

(30) Noracymethadol.

(31) Norlevorphanol.

(32) Normethadone.

(33) Norpipanone.

(34) Phenadoxone.

(35) Phenampromide.

(36) Phenomorphan.

(37) Phenoperidine.

(38) Piritramide.

(39) Proheptazine.

(40) Properidine.

(41) Racemoramide.

(42) Trimeperidine.

(b) Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Acetorphine.

(2) Acetyldihydrocodeine.

(3) Benzylmorphine.

(4) Codeine methylbromide.

(5) Codeine-N-Oxide.

(6) Cyprenorphine.

(7) Desomorphine.

(8) Dihydromorphine.

(9) Etorphine.

(10) Heroin.

(11) Hydromorphinol.

(12) Methyldesorphine.

(13) Methylhydromorphine.

(14) Morphine methylbromide.

(15) Morphine methylsulfonate.

(16) Morphine-N-Oxide.

(17) Myrophine.

(18) Nicocodeine.

(19) Nicomorphine.

(20) Normorphine.

(21) Pholcodine.

(22) Thebacon.

(c) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) 3,4-methylenedioxy amphetamine.

(2) 5-methoxy-3,4-methylenedioxy amphetamine.

(3) 3,4,5-trimethoxy amphetamine.

(4) Bufotenine.

(5) Diethyltryptamine.

(6) Dimethyltryptamine.

(7) 4-methyl-2,5-dimethoxyamphetamine.

(8) Ibogaine.

(9) Lysergic acid diethylamide.

(10) Marihuana.

(11) Mescaline.

(12) Peyote.

(13) N-ethyl-3-piperidyl benzilate.

(14) N-methyl-3-piperidyl benzilate.

(15) Psilocybin.

(16) Psilocyn.

(17) Tetrahydrocannabinols, except for tetrahydrocannabinols in hemp (as defined under section 1639o of title 7).

(18) 4-methylmethcathinone (Mephedrone).

(19) 3,4-methylenedioxypyrovalerone (MDPV).

(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E).

(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D).

(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C).

(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I).

(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2).

(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4).

(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H).

(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N).

(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–P).

(d)(1) Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of cannabimimetic agents, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

(2) In paragraph (1):

(A) The term "cannabimimetic agents" means any substance that is a cannabinoid receptor type 1 (CB1 receptor) agonist as demonstrated by binding studies and functional assays within any of the following structural classes:

(i) 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-position of the phenolic ring by alkyl or alkenyl, whether or not substituted on the cyclohexyl ring to any extent.

(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not substituted on the naphthoyl or naphthyl ring to any extent.

(iii) 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted in the pyrrole ring to any extent, whether or not substituted on the naphthoyl ring to any extent.

(iv) 1-(1-naphthylmethylene)indene by substitution of the 3-position of the indene ring, whether or not further substituted in the indene ring to any extent, whether or not substituted on the naphthyl ring to any extent.

(v) 3-phenylacetylindole or 3-benzoylindole by substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent, whether or not substituted on the phenyl ring to any extent.

(B) Such term includes—

(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP–47,497);

(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog);

(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678);

(iv) 1-butyl-3-(1-naphthoyl)indole (JWH–073);

(v) 1-hexyl-3-(1-naphthoyl)indole (JWH–019);

(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200);

(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250);

(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081);

(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122);

(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398);

(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);

(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);

(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19 and RCS–4);

(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8); and

(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH–203).

Schedule II

(a) Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate.

(2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (1), except that these substances shall not include the isoquinoline alkaloids of opium.

(3) Opium poppy and poppy straw.

(4) coca ³ leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed; cocaine, its salts, optical and geometric isomers, and salts of isomers; ecgonine, its derivatives, their salts, isomers, and salts of isomers; or any compound, mixture, or preparation which contains any quantity of any of the substances referred to in this paragraph.

(b) Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

(1) Alphaprodine.

(2) Anileridine.

(3) Bezitramide.

(4) Dihydrocodeine.

(5) Diphenoxylate.

(6) Fentanyl.

(7) Isomethadone.

(8) Levomethorphan.

(9) Levorphanol.

(10) Metazocine.

(11) Methadone.

(12) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane.

(13) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid.

(14) Pethidine.

(15) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine.

(16) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate.

(17) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid.

(18) Phenazocine.

(19) Piminodine.

(20) Racemethorphan.

(21) Racemorphan.

(c) Unless specifically excepted or unless listed in another schedule, any injectable liquid which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers.

Schedule III

(a) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system:

(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers.

(2) Phenmetrazine and its salts.

(3) Any substance (except an injectable liquid) which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers.

(4) Methylphenidate.

(b) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system:

(1) Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid.

(2) Chorhexadol. ⁴

(3) Glutethimide.

(4) Lysergic acid.

(5) Lysergic acid amide.

(6) Methyprylon.

(7) Phencyclidine.

(8) Sulfondiethylmethane.

(9) Sulfonethylmethane.

(10) Sulfonmethane.

(c) Nalorphine.

(d) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof:

(1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.

(2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts.

(3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.

(4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.

(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.

(6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.

(7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.

(8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.

(e) Anabolic steroids.

Schedule IV

(1) Barbital.

(2) Chloral betaine.

(3) Chloral hydrate.

(4) Ethchlorvynol.

(5) Ethinamate.

(6) Methohexital.

(7) Meprobamate.

(8) Methylphenobarbital.

(9) Paraldehyde.

(10) Petrichloral.

(11) Phenobarbital.

Schedule V

Any compound, mixture, or preparation containing any of the following limited quantities of narcotic drugs, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the narcotic drug alone:

(1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.

(2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.

(3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.

(4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.

(5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.

(Pub. L. 91–513, title II, §202, Oct. 27, 1970, 84 Stat. 1247; Pub. L. 95–633, title I, §103, Nov. 10, 1978, 92 Stat. 3772; Pub. L. 98–473, title II, §§507(c), 509(b), Oct. 12, 1984, 98 Stat. 2071, 2072; Pub. L. 99–570, title I, §1867, Oct. 27, 1986, 100 Stat. 3207–55; Pub. L. 99–646, §84, Nov. 10, 1986, 100 Stat. 3619; Pub. L. 101–647, title XIX, §1902(a), Nov. 29, 1990, 104 Stat. 4851; Pub. L. 112–144, title XI, §1152, July 9, 2012, 126 Stat. 1130; Pub. L. 115–334, title XII, §12619(b), Dec. 20, 2018, 132 Stat. 5018.)

Editorial Notes

Amendments

2018—Subsec. (c). Pub. L. 115–334 inserted ", except for tetrahydrocannabinols in hemp (as defined under section 1639o of title 7)" after "Tetrahydrocannabinols" in schedule I(c)(17).

2012—Subsec. (c). Pub. L. 112–144, §1152(b), added schedule I(c)(18) to (28).

Pub. L. 112–144, §1152(a), added schedule I(d).

1990—Subsec. (c). Pub. L. 101–647 added item (e) at end of schedule III.

1986—Subsec. (c). Pub. L. 99–646 amended schedule II(a)(4) generally. Prior to amendment, schedule II(a)(4) read as follows: "Coca leaves (except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed); cocaine, its salts, optical and geometric isomers, and salts of isomers; and ecgonine, its derivatives, their salts, isomers, and salts of isomers."

Pub. L. 99–570 amended schedule II(a)(4) generally. Prior to amendment, schedule II(a)(4) read as follows: "Coca leaves and any salt, compound, derivative, or preparation of coca leaves (including cocaine and ecgonine and their salts, isomers, derivatives, and salts of isomers and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine."

1984—Subsec. (c). Pub. L. 98–473, §507(c), in schedule II(a)(4) added applicability to cocaine and ecgonine and their salts, isomers, etc.

Subsec. (d). Pub. L. 98–473, §509(b), struck out subsec. (d) which related to authority of Attorney General to except stimulants or depressants containing active medicinal ingredients.

1978—Subsec. (d)(3). Pub. L. 95–633 added cl. (3).

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

Amendment by Pub. L. 101–647 effective 90 days after Nov. 29, 1990, see section 1902(d) of Pub. L. 101–647, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Amendment of Schedules of Controlled Substances

For updated and republished schedules of controlled substances established by this section, see Code of Federal Regulations, Part 1308 of Title 21, Food and Drugs.

Congressional Finding; Emergency Scheduling of GHB in Controlled Substances Act

Pub. L. 106–172, §§2, 3(a), Feb. 18, 2000, 114 Stat. 7, 8, provided that:

"SEC. 2. FINDINGS.

"Congress finds as follows:

"(1) Gamma hydroxybutyric acid (also called G, Liquid X, Liquid Ecstasy, Grievous Bodily Harm, Georgia Home Boy, Scoop) has become a significant and growing problem in law enforcement. At least 20 States have scheduled such drug in their drug laws and law enforcement officials have been experiencing an increased presence of the drug in driving under the influence, sexual assault, and overdose cases especially at night clubs and parties.

"(2) A behavioral depressant and a hypnotic, gamma hydroxybutyric acid ('GHB') is being used in conjunction with alcohol and other drugs with detrimental effects in an increasing number of cases. It is difficult to isolate the impact of such drug's ingestion since it is so typically taken with an ever-changing array of other drugs and especially alcohol which potentiates its impact.

"(3) GHB takes the same path as alcohol, processes via alcohol dehydrogenase, and its symptoms at high levels of intake and as impact builds are comparable to alcohol ingestion/intoxication. Thus, aggression and violence can be expected in some individuals who use such drug.

"(4) If taken for human consumption, common industrial chemicals such as gamma butyrolactone and 1.4-butanediol are swiftly converted by the body into GHB. Illicit use of these and other GHB analogues and precursor chemicals is a significant and growing law enforcement problem.

"(5) A human pharmaceutical formulation of gamma hydroxybutyric acid is being developed as a treatment for cataplexy, a serious and debilitating disease. Cataplexy, which causes sudden and total loss of muscle control, affects about 65 percent of the estimated 180,000 Americans with narcolepsy, a sleep disorder. People with cataplexy often are unable to work, drive a car, hold their children or live a normal life.

"(6) Abuse of illicit GHB is an imminent hazard to public safety that requires immediate regulatory action under the Controlled Substances Act (21 U.S.C. 801 et seq.).

"SEC. 3. EMERGENCY SCHEDULING OF GAMMA HYDROXYBUTYRIC ACID AND LISTING OF GAMMA BUTYROLACTONE AS LIST I CHEMICAL.

"(a) Emergency Scheduling of GHB.—

"(1) In general.—The Congress finds that the abuse of illicit gamma hydroxybutyric acid is an imminent hazard to the public safety. Accordingly, the Attorney General, notwithstanding sections 201(a), 201(b), 201(c), and 202 of the Controlled Substances Act [21 U.S.C. 811(a)–(c), 812], shall issue, not later than 60 days after the date of the enactment of this Act [Feb. 18, 2000], a final order that schedules such drug (together with its salts, isomers, and salts of isomers) in the same schedule under section 202(c) of the Controlled Substances Act as would apply to a scheduling of a substance by the Attorney General under section 201(h)(1) of such Act (relating to imminent hazards to the public safety), except as follows:

"(A) For purposes of any requirements that relate to the physical security of registered manufacturers and registered distributors, the final order shall treat such drug, when the drug is manufactured, distributed, or possessed in accordance with an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i)] (whether the exemption involved is authorized before, on, or after the date of the enactment of this Act [Feb. 18, 2000]), as being in the same schedule as that recommended by the Secretary of Health and Human Services for the drug when the drug is the subject of an authorized investigational new drug application (relating to such section 505(i)). The recommendation referred to in the preceding sentence is contained in the first paragraph of the letter transmitted on May 19, 1999, by such Secretary (acting through the Assistant Secretary for Health) to the Attorney General (acting through the Deputy Administrator of the Drug Enforcement Administration), which letter was in response to the letter transmitted by the Attorney General (acting through such Deputy Administrator) on September 16, 1997. In publishing the final order in the Federal Register, the Attorney General shall publish a copy of the letter that was transmitted by the Secretary of Health and Human Services.

"(B) In the case of gamma hydroxybutyric acid that is contained in a drug product for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (whether the application involved is approved before, on, or after the date of the enactment of this Act [Feb. 18, 2000]), the final order shall schedule such drug in the same schedule as that recommended by the Secretary of Health and Human Services for authorized formulations of the drug. The recommendation referred to in the preceding sentence is contained in the last sentence of the fourth paragraph of the letter referred to in subparagraph (A) with respect to May 19, 1999.

"(2) Failure to issue order.—If the final order is not issued within the period specified in paragraph (1), gamma hydroxybutyric acid (together with its salts, isomers, and salts of isomers) is deemed to be scheduled under section 202(c) of the Controlled Substances Act [21 U.S.C. 812(c)] in accordance with the policies described in paragraph (1), as if the Attorney General had issued a final order in accordance with such paragraph."

Placement of Pipradrol and SPA in Schedule IV To Carry Out Obligation Under Convention on Psychotropic Substances

Pub. L. 95–633, title I, §102(c), Nov. 10, 1978, 92 Stat. 3772, provided that: "For the purpose of carrying out the minimum United States obligations under paragraph 7 of article 2 of the Convention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, with respect to pipradrol and SPA (also known as (-)-1-dimethylamino-1,2-diphenylethane), the Attorney General shall by order, made without regard to sections 201 and 202 of the Controlled Substances Act [this section and section 811 of this title], place such drugs in schedule IV of such Act [see subsec. (c) of this section]."

Provision of section 102(c) of Pub. L. 95–633, set out above, effective on the date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

¹ See Amendment of Schedules of Controlled Substances note below.

² So in original. Probably should be "Alphacetylmethadol."

³ So in original. Probably should be capitalized.

⁴ So in original. Probably should be "Chlorhexadol."

§813. Treatment of controlled substance analogues

(a) In general

A controlled substance analogue shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I.

(b) Determination

In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors:

(1) The marketing, advertising, and labeling of the substance.

(2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose.

(3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold.

(4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance.

(5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means.

(6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws.

(c) Limitation

For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption.

(Pub. L. 91–513, title II, §203, as added Pub. L. 99–570, title I, §1202, Oct. 27, 1986, 100 Stat. 3207–13; amended Pub. L. 100–690, title VI, §6470(c), Nov. 18, 1988, 102 Stat. 4378; Pub. L. 115–271, title III, §3241, Oct. 24, 2018, 132 Stat. 3950.)

Editorial Notes

References in Text

Schedule I, referred to in subsec. (a), is set out in section 812(c) of this title.

Amendments

2018—Pub. L. 115–271 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).

1988—Pub. L. 100–690 substituted "any Federal law" for "this subchapter and subchapter II of this chapter".

§814. Removal of exemption of certain drugs

(a) Removal of exemption

The Attorney General shall by regulation remove from exemption under section 802(39)(A)(iv) of this title a drug or group of drugs that the Attorney General finds is being diverted to obtain a listed chemical for use in the illicit production of a controlled substance.

(b) Factors to be considered

In removing a drug or group of drugs from exemption under subsection (a), the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption—

(1) the scope, duration, and significance of the diversion;

(2) whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and

(3) whether the listed chemical can be readily recovered from the drug or group of drugs.

(c) Specificity of designation

The Attorney General shall limit the designation of a drug or a group of drugs removed from exemption under subsection (a) to the most particularly identifiable type of drug or group of drugs for which evidence of diversion exists unless there is evidence, based on the pattern of diversion and other relevant factors, that the diversion will not be limited to that particular drug or group of drugs.

(d) Reinstatement of exemption with respect to particular drug products

(1) Reinstatement

On application by a manufacturer of a particular drug product that has been removed from exemption under subsection (a), the Attorney General shall by regulation reinstate the exemption with respect to that particular drug product if the Attorney General determines that the particular drug product is manufactured and distributed in a manner that prevents diversion.

(2) Factors to be considered

In deciding whether to reinstate the exemption with respect to a particular drug product under paragraph (1), the Attorney General shall consider—

(A) the package sizes and manner of packaging of the drug product;

(B) the manner of distribution and advertising of the drug product;

(C) evidence of diversion of the drug product;

(D) any actions taken by the manufacturer to prevent diversion of the drug product; and

(E) such other factors as are relevant to and consistent with the public health and safety, including the factors described in subsection (b) as applied to the drug product.

(3) Status pending application for reinstatement

A transaction involving a particular drug product that is the subject of a bona fide pending application for reinstatement of exemption filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to subsection (a) shall not be considered to be a regulated transaction if the transaction occurs during the pendency of the application and, if the Attorney General denies the application, during the period of 60 days following the date on which the Attorney General denies the application, unless—

(A) the Attorney General has evidence that, applying the factors described in subsection (b) to the drug product, the drug product is being diverted; and

(B) the Attorney General so notifies the applicant.

(4) Amendment and modification

A regulation reinstating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a finding that—

(A) applying the factors described in subsection (b) to the drug product, the drug product is being diverted; or

(B) there is a significant change in the data that led to the issuance of the regulation.

(Pub. L. 91–513, title II, §204, as added Pub. L. 103–200, §2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104–237, title IV, §401(c), Oct. 3, 1996, 110 Stat. 3108; Pub. L. 109–177, title VII, §712(a)(2), Mar. 9, 2006, 120 Stat. 263.)

Editorial Notes

Amendments

2006—Subsec. (e). Pub. L. 109–177 struck out subsec. (e). Text read as follows: "Pursuant to subsection (d)(1) of this section, the Attorney General shall by regulation reinstate the exemption with respect to a particular ephedrine, pseudoephedrine, or phenylpropanolamine drug product if the Attorney General determines that the drug product is manufactured and distributed in a manner that prevents diversion. In making this determination the Attorney General shall consider the factors listed in subsection (d)(2) of this section. Any regulation issued pursuant to this subsection may be amended or revoked based on the factors listed in subsection (d)(4) of this section."

1996—Subsec. (e). Pub. L. 104–237 added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1996 Amendment

Amendment by Pub. L. 104–237 not applicable to sale of any pseudoephedrine or phenylpropanolamine product prior to 12 months after Oct. 3, 1996, except that, on application of manufacturer of particular drug product, Attorney General may exercise sole and judicially unreviewable discretion to extend such effective date up to additional 6 months, see section 401(g) of Pub. L. 104–237, set out as a note under section 802 of this title.

Effective Date

Section effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as an Effective Date of 1993 Amendment note under section 802 of this title.

Part C—Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances

§821. Rules and regulations

The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals.

(Pub. L. 91–513, title II, §301, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 103–200, §3(a), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 108–447, div. B, title VI, §633(b), Dec. 8, 2004, 118 Stat. 2922.)

Editorial Notes

Amendments

2004—Pub. L. 108–447 substituted "listed chemicals" for "the registration and control of regulated persons and of regulated transactions".

1993—Pub. L. 103–200 inserted before period at end "and to the registration and control of regulated persons and of regulated transactions".

Statutory Notes and Related Subsidiaries

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

§822. Persons required to register

(a) Period of registration

(1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.

(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.

(3)(A) Except as provided in subparagraph (C), the registration of any registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals terminates if and when such registrant—

(i) dies;

(ii) ceases legal existence;

(iii) discontinues business or professional practice; or

(iv) surrenders such registration.

(B) In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact.

(C) No registration under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals, and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture, distribute, or dispense controlled substances or list I chemicals pursuant to such registration until the Attorney General receives such written consent.

(D) In the case of a registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals desiring to discontinue business or professional practice altogether or with respect to controlled substances and list I chemicals (without assigning or transferring such business or professional practice to another entity), such registrant shall return to the Attorney General for cancellation—

(i) the registrant's certificate of registration;

(ii) any unexecuted order forms in the registrant's possession; and

(iii) any other documentation that the Attorney General may require.

(b) Authorized activities

Persons registered by the Attorney General under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their registration and in conformity with the other provisions of this subchapter.

(c) Exceptions

The following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this subchapter:

(1) An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance or list I chemical if such agent or employee is acting in the usual course of his business or employment.

(2) A common or contract carrier or warehouseman, or an employee thereof, whose possession of the controlled substance or list I chemical is in the usual course of his business or employment.

(3) An ultimate user who possesses such substance for a purpose specified in section 802(25) ¹ of this title.

(d) Waiver

The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.

(e) Separate registration

(1) A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals.

(2) Notwithstanding paragraph (1), a registrant who is a veterinarian shall not be required to have a separate registration in order to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registrant's registered principal place of business or professional practice, so long as the site of transporting and dispensing is located in a State where the veterinarian is licensed to practice veterinary medicine and is not a principal place of business or professional practice.

(3) Notwithstanding paragraph (1), a registrant that is dispensing pursuant to section 823(g) ¹ of this title narcotic drugs to individuals for maintenance treatment or detoxification treatment shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant's practice to dispense such narcotics at locations other than the registrant's principal place of business or professional practice described in paragraph (1), so long as the registrant meets such standards for operation of a mobile medication unit as the Attorney General may establish.

(f) Inspection

The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.

(g) Delivery of controlled substances by ultimate users for disposal

(1) An ultimate user who has lawfully obtained a controlled substance in accordance with this subchapter may, without being registered, deliver the controlled substance to another person for the purpose of disposal of the controlled substance if—

(A) the person receiving the controlled substance is authorized under this subchapter to engage in such activity; and

(B) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.

(2) In developing regulations under this subsection, the Attorney General shall take into consideration the public health and safety, as well as the ease and cost of program implementation and participation by various communities. Such regulations may not require any entity to establish or operate a delivery or disposal program.

(3) The Attorney General may, by regulation, authorize long-term care facilities, as defined by the Attorney General by regulation, to dispose of controlled substances on behalf of ultimate users who reside, or have resided, at such long-term care facilities in a manner that the Attorney General determines will provide effective controls against diversion and be consistent with the public health and safety.

(4) If a person dies while lawfully in possession of a controlled substance for personal use, any person lawfully entitled to dispose of the decedent's property may deliver the controlled substance to another person for the purpose of disposal under the same conditions as provided in paragraph (1) for an ultimate user.

(5)(A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law and—

(i) the disposal occurs after the death of a person receiving hospice care;

(ii) the controlled substance is expired; or

(iii)(I) the employee is—

(aa) the physician of the person receiving hospice care; and

(bb) registered under section 823(g) of this title; and

(II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified.

(B) For the purposes of this paragraph:

(i) The terms "hospice care" and "hospice program" have the meanings given to those terms in section 1395x(dd) of title 42.

(ii) The term "employee of a qualified hospice program" means a physician, physician assistant, nurse, or other person who—

(I) is employed by, or pursuant to arrangements made by, a qualified hospice program;

(II)(aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and

(bb) is acting within the scope of such employment in accordance with applicable State law; and

(III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion.

(iii) The term "qualified hospice program" means a hospice program that—

(I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person's death;

(II) at the time when the controlled substances are first ordered—

(aa) provides a copy of the written policies and procedures to the patient or patient representative and family;

(bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and

(cc) documents in the patient's clinical record that the written policies and procedures were provided and discussed; and

(III) at the time following the disposal of the controlled substances—

(aa) documents in the patient's clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and

(bb) the time, date, and manner in which that disposal occurred.

(Pub. L. 91–513, title II, §302, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 98–473, title II, §510, Oct. 12, 1984, 98 Stat. 2072; Pub. L. 103–200, §3(b), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 111–273, §3(a), Oct. 12, 2010, 124 Stat. 2859; Pub. L. 113–143, §2, Aug. 1, 2014, 128 Stat. 1750; Pub. L. 115–271, title III, §3222(a), Oct. 24, 2018, 132 Stat. 3948; Pub. L. 117–53, §2, Nov. 10, 2021, 135 Stat. 411; Pub. L. 117–215, title I, §103(b)(1)(B), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §1252(a), Dec. 29, 2022, 136 Stat. 5681.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a)(3), (b), (c), and (g)(1), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Section 802(25) of this title, referred to in subsec. (c)(3), was redesignated section 802(26) of this title by Pub. L. 98–473, title II, §507(a), Oct. 12, 1984, 98 Stat. 2071, and was further redesignated section 802(27) of this title by Pub. L. 99–570, title I, §1003(b)(2), Oct. 27, 1986, 100 Stat. 3207–6.

Section 823(g) of this title, referred to in subsec. (e)(3), was redesignated section 823(h) of this title by Pub. L. 117–215, title I, §103(a)(1), Dec. 2, 2022, 136 Stat. 2261.

Amendments

2022—Subsec. (e)(3). Pub. L. 117–328, §1252(a), added par. (3).

Subsec. (g)(5)(A)(iii)(I)(bb). Pub. L. 117–215 substituted "823(g)" for "823(f)".

2021—Subsec. (a)(3). Pub. L. 117–53 added par. (3).

2018—Subsec. (g)(5). Pub. L. 115–271 added par. (5).

2014—Subsec. (e). Pub. L. 113–143 designated existing provisions as par. (1) and added par. (2).

2010—Subsec. (g). Pub. L. 111–273 added subsec. (g).

1993—Subsec. (a)(1). Pub. L. 103–200, §3(b)(1), inserted "or list I chemical" after "controlled substance" in two places.

Subsec. (b). Pub. L. 103–200, §3(b)(2), inserted "or list I chemicals" after "controlled substances" and "or chemicals" after "such substances".

Subsec. (c). Pub. L. 103–200, §3(b)(3), inserted "or list I chemical" after "controlled substance" wherever appearing.

Subsec. (e). Pub. L. 103–200, §3(b)(4), inserted "or list I chemicals" after "controlled substances".

1984—Subsec. (a). Pub. L. 98–473 designated existing provisions as par. (1), struck out provisions relating to dispensing controlled substances, and added par. (2).

Statutory Notes and Related Subsidiaries

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Rule of Construction Relating to State and Local Law

Pub. L. 115–271, title III, §3222(c), Oct. 24, 2018, 132 Stat. 3949, provided that: "Nothing in this section [amending this section and enacting provisions set out as a note below] or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs."

Guidance

Pub. L. 115–271, title III, §3222(b), Oct. 24, 2018, 132 Stat. 3949, provided that: "The Attorney General may issue guidance to hospice programs (as defined in paragraph (5) of section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)), as added by subsection (a)) to assist the programs in satisfying the requirements under such paragraph (5)."

Findings

Pub. L. 111–273, §2, Oct. 12, 2010, 124 Stat. 2858, provided that: "Congress finds the following:

"(1) The nonmedical use of prescription drugs is a growing problem in the United States, particularly among teenagers.

"(2) According to the Department of Justice's 2009 National Prescription Drug Threat Assessment—

"(A) the number of deaths and treatment admissions for controlled prescription drugs (CPDs) has increased significantly in recent years;

"(B) unintentional overdose deaths involving prescription opioids, for example, increased 114 percent from 2001 to 2005, and the number of treatment admissions for prescription opioids increased 74 percent from 2002 to 2006; and

"(C) violent crime and property crime associated with abuse and diversion of CPDs has increased in all regions of the United States over the past 5 years.

"(3) According to the Office of National Drug Control Policy's 2008 Report 'Prescription for Danger', prescription drug abuse is especially on the rise for teens—

"(A) one-third of all new abusers of prescription drugs in 2006 were 12- to 17-year-olds;

"(B) teens abuse prescription drugs more than any illicit drug except marijuana—more than cocaine, heroin, and methamphetamine combined; and

"(C) responsible adults are in a unique position to reduce teen access to prescription drugs because the drugs often are found in the home.

"(4)(A) Many State and local law enforcement agencies have established drug disposal programs (often called 'take-back' programs) to facilitate the collection and destruction of unused, unwanted, or expired medications. These programs help get outdated or unused medications off household shelves and out of the reach of children and teenagers.

"(B) However, take-back programs often cannot dispose of the most dangerous pharmaceutical drugs—controlled substance medications—because Federal law does not permit take-back programs to accept controlled substances unless they get specific permission from the Drug Enforcement Administration and arrange for full-time law enforcement officers to receive the controlled substances directly from the member of the public who seeks to dispose of them.

"(C) Individuals seeking to reduce the amount of unwanted controlled substances in their household consequently have few disposal options beyond discarding or flushing the substances, which may not be appropriate means of disposing of the substances. Drug take-back programs are also a convenient and effective means for individuals in various communities to reduce the introduction of some potentially harmful substances into the environment, particularly into water.

"(D) Long-term care facilities face a distinct set of obstacles to the safe disposal of controlled substances due to the increased volume of controlled substances they handle.

"(5) This Act [see Short Title of 2010 Amendment note set out under section 801 of this title] gives the Attorney General authority to promulgate new regulations, within the framework of the Controlled Substances Act [21 U.S.C. 801 et seq.], that will allow patients to deliver unused pharmaceutical controlled substances to appropriate entities for disposal in a safe and effective manner consistent with effective controls against diversion.

"(6) The goal of this Act is to encourage the Attorney General to set controlled substance diversion prevention parameters that will allow public and private entities to develop a variety of methods of collection and disposal of controlled substances, including some pharmaceuticals, in a secure, convenient, and responsible manner. This will also serve to reduce instances of diversion and introduction of some potentially harmful substances into the environment."

Provisional Registration

Pub. L. 91–513, title II, §703, Oct. 27, 1970, 84 Stat. 1283, as amended by Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095, provided that:

"(a)(1) Any person who—

"(A) is engaged in manufacturing, distributing, or dispensing any controlled substance on the day before the effective date of section 302 [this section], and

"(B) is registered on such day under section 510 of the Federal Food, Drug, and Cosmetic Act [section 360 of this title] or under section 4722 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722 of Title 26],

shall, with respect to each establishment for which such registration is in effect under any such section, be deemed to have a provisional registration under section 303 [section 823 of this title] for the manufacture, distribution, or dispensing (as the case may be) of controlled substances.

"(2) During the period his provisional registration is in effect under this section, the registration number assigned such person under such section 510 [section 360 of this title] or under such section 4722 [section 4722 of Title 26] (as the case may be) shall be his registration number for purposes of section 303 of this title [section 823 of this title].

"(b) The provisions of section 304 [section 824 of this title], relating to suspension and revocation of registration, shall apply to a provisional registration under this section.

"(c) Unless sooner suspended or revoked under subsection (b), a provisional registration of a person under subsection (a)(1) of this section shall be in effect until—

"(1) the date on which such person has registered with the Attorney General under section 303 [section 823 of this title] or has had his registration denied under such section, or

"(2) such date as may be prescribed by the Attorney General for registration of manufacturers, distributors, or dispensers, as the case may be,

whichever occurs first."

¹ See References in Text note below.

§822a. Prescription drug take back expansion

(a) Definition of covered entity

In this section, the term "covered entity" means—

(1) a State, local, or tribal law enforcement agency;

(2) a manufacturer, distributor, or reverse distributor of prescription medications;

(3) a retail pharmacy;

(4) a registered narcotic treatment program;

(5) a hospital or clinic with an onsite pharmacy;

(6) an eligible long-term care facility; or

(7) any other entity authorized by the Drug Enforcement Administration to dispose of prescription medications.

(b) Program authorized

The Attorney General, in coordination with the Administrator of the Drug Enforcement Administration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, shall coordinate with covered entities in expanding or making available disposal sites for unwanted prescription medications.

(Pub. L. 114–198, title II, §203, July 22, 2016, 130 Stat. 717.)

Editorial Notes

Codification

Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Access to Increased Drug Disposal

Pub. L. 115–271, title III, subtitle B, ch. 6, Oct. 24, 2018, 132 Stat. 3950, provided that:

"SEC. 3251. SHORT TITLE.

"This chapter may be cited as the 'Access to Increased Drug Disposal Act of 2018'.

"SEC. 3252. DEFINITIONS.

"In this chapter—

"(1) the term 'Attorney General' means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs;

"(2) the term 'authorized collector' means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation);

"(3) the term 'covered grant' means a grant awarded under section 3003 [probably means section 3253; no section 3003 of Pub. L. 115–271 has been enacted]; and

"(4) the term 'eligible collector' means a person who is eligible to be an authorized collector.

"SEC. 3253. AUTHORITY TO MAKE GRANTS.

"The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors.

"SEC. 3254. APPLICATION.

"A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum—

"(1) identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant;

"(2) details a plan to increase participation rates of eligible collectors as authorized collectors; and

"(3) describes how the State will select eligible collectors to be served under the grant.

"SEC. 3255. USE OF GRANT FUNDS.

"A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors.

"SEC. 3256. ELIGIBILITY FOR GRANT.

"The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General.

"SEC. 3257. DURATION OF GRANTS.

"The Attorney General shall determine the period of years for which a covered grant is made to a State.

"SEC. 3258. ACCOUNTABILITY AND OVERSIGHT.

"A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that—

"(1) lists the ultimate recipients of the grant amounts;

"(2) describes the activities undertaken by the State using the grant amounts; and

"(3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors.

"SEC. 3259. DURATION OF PROGRAM.

"The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act [Oct. 24, 2018].

"SEC. 3260. AUTHORIZATION OF APPROPRIATIONS.

"There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this chapter."

§823. Registration requirements

(a) Manufacturers of controlled substances in schedule I or II

The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered:

(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;

(2) compliance with applicable State and local law;

(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;

(4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;

(5) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and

(6) such other factors as may be relevant to and consistent with the public health and safety.

(b) Distributors of controlled substances in schedule I or II

The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

(1) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;

(2) compliance with applicable State and local law;

(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;

(4) past experience in the distribution of controlled substances; and

(5) such other factors as may be relevant to and consistent with the public health and safety.

(c) Manufacturers of marijuana for research purposes

(1)(A) As it relates to applications to manufacture marijuana for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities registered under this chapter to manufacture marijuana to supply appropriately registered researchers in the United States, the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application—

(i) approve the application; or

(ii) request supplemental information.

(B) For purposes of subparagraph (A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following:

(i) The requirements designated in the notice in the Federal Register are satisfied.

(ii) The requirements under this chapter are satisfied.

(iii) The applicant will limit the transfer and sale of any marijuana manufactured under this subsection—

(I) to researchers who are registered under this chapter to conduct research with controlled substances in schedule I; and

(II) for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 355(i) ¹ of this title.

(iv) The applicant will transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General.

(v) The applicant has completed the application and review process under subsection (a) for the bulk manufacture of controlled substances in schedule I.

(vi) The applicant has established and begun operation of a process for storage and handling of controlled substances in schedule I, including for inventory control and monitoring security in accordance with section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act.

(vii) The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture marijuana, if that State requires such a license.

(C) Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) with respect to an application, the Attorney General shall approve or deny the application.

(2) If an application described in this subsection is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant.

(d) Limits of authorized activities

Registration granted under subsections (a) and (b) of this section shall not entitle a registrant to (1) manufacture or distribute controlled substances in schedule I or II other than those specified in the registration, or (2) manufacture any quantity of those controlled substances in excess of the quota assigned pursuant to section 826 of this title.

(e) Manufacturers of controlled substances in schedule III, IV, or V

The Attorney General shall register an applicant to manufacture controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific, or industrial channels;

(2) compliance with applicable State and local law;

(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;

(4) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;

(5) past experience in the manufacture, distribution, and dispensing of controlled substances, and the existence in the establishment of effective controls against diversion; and

(6) such other factors as may be relevant to and consistent with the public health and safety.

(f) Distributors of controlled substances in schedule III, IV, or V

The Attorney General shall register an applicant to distribute controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

(1) maintenance of effective controls against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;

(2) compliance with applicable State and local law;

(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;

(4) past experience in the distribution of controlled substances; and

(5) such other factors as may be relevant to and consistent with the public health and safety.

(g) Research by practitioners; pharmacies; research applications; construction of Article 7 of the Convention on Psychotropic Substances

(1) The Attorney General shall register practitioners (including pharmacies, as distinguished from pharmacists) to dispense, or conduct research with, controlled substances in schedule II, III, IV, or V and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet, if the applicant is authorized to dispense, or conduct research with respect to, controlled substances under the laws of the State in which he practices. The Attorney General may deny an application for such registration or such modification of registration if the Attorney General determines that the issuance of such registration or modification would be inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

(A) The recommendation of the appropriate State licensing board or professional disciplinary authority.

(B) The applicant's experience in dispensing, or conducting research with respect to controlled substances.

(C) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.

(E) Such other conduct which may threaten the public health and safety.

Separate registration under this part for practitioners engaging in research with controlled substances in schedule II, III, IV, or V, who are already registered under this part in another capacity, shall not be required.

(2)(A) Registration applications by practitioners wishing to conduct research with controlled substances in schedule I shall be referred to the Secretary, who shall determine the qualifications and competency of each practitioner requesting registration, as well as the merits of the research protocol. The Secretary, in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such controlled substances from legitimate medical or scientific use. Registration for the purpose of bona fide research with controlled substances in schedule I by a practitioner deemed qualified by the Secretary may be denied by the Attorney General only on a ground specified in section 824(a) of this title.

(B)(i) The Attorney General shall register a practitioner to conduct research with marijuana (including any derivative, extract, preparation, and compound thereof) if—

(I) the applicant's research protocol has been reviewed and allowed—

(aa) by the Secretary of Health and Human Services under section 355(i) of this title;

(bb) by the National Institutes of Health or another Federal agency that funds scientific research; or

(cc) pursuant to sections 1301.18 and 1301.32 of title 21, Code of Federal Regulations, or any successors thereto; and

(II) the applicant has demonstrated to the Attorney General that there are effective procedures in place to adequately safeguard against diversion of the controlled substance for legitimate medical or scientific use pursuant to section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act, including demonstrating that the security measures are adequate for storing the quantity of marijuana the applicant would be authorized to possess.

(ii) The Attorney General may deny an application for registration under this subparagraph only if the Attorney General determines that the issuance of the registration would be inconsistent with the public interest. In determining the public interest, the Attorney General shall consider the factors listed in—

(I) subparagraphs (B) through (E) of paragraph (1); and

(II) subparagraph (A) of paragraph (1), if the applicable State requires practitioners conducting research to register with a board or authority described in such subparagraph (A).

(iii)(I) Not later than 60 days after the date on which the Attorney General receives a complete application for registration under this subparagraph, the Attorney General shall—

(aa) approve the application; or

(bb) request supplemental information.

(II) For purposes of subclause (I), an application shall be deemed complete when the applicant has submitted documentation showing that the requirements under clause (i) are satisfied.

(iv) Not later than 30 days after the date on which the Attorney General receives supplemental information as described in clause (iii)(I)(bb) in connection with an application described in this subparagraph, the Attorney General shall approve or deny the application.

(v) If an application described in this subparagraph is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant.

(vi)(I) If the Attorney General grants an application for registration under clause (i), the registrant may amend or supplement the research protocol without notification to, or review by, the Drug Enforcement Administration if the registrant does not change—

(aa) the quantity or type of marijuana or cannabidiol (including any derivative, extract, preparation, and compound thereof);

(bb) the source of such marijuana or cannabidiol; or

(cc) the conditions under which such marijuana or cannabidiol is stored, tracked, or administered.

(II)(aa) If a registrant under clause (i) seeks to change the type of marijuana or cannabidiol (including any derivative, extract, preparation, and compound thereof), the source of such marijuana or cannabidiol, or the conditions under which such marijuana or cannabidiol is stored, tracked, or administered, the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol.

(bb) A registrant may proceed with an amended or supplemental research protocol described in item (aa) if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (aa).

(cc) The Attorney General may only object to an amended or supplemental research protocol under this subclause if additional security measures are needed to safeguard against diversion or abuse.

(dd) If a registrant under clause (i) seeks to address additional security measures identified by the Attorney General under item (cc), the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol.

(ee) A registrant may proceed with an amended or supplemental research protocol described in item (dd) if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (dd).

(III)(aa) If a registrant under clause (i) seeks to change the quantity of marijuana needed for research and the change in quantity does not impact the factors described in item (bb) or (cc) of subclause (I) of this clause, the registrant shall notify the Attorney General via registered mail or using an electronic means permitted by the Attorney General.

(bb) A notification under item (aa) shall include—

(AA) the Drug Enforcement Administration registration number of the registrant;

(BB) the quantity of marijuana or cannabidiol already obtained;

(CC) the quantity of additional marijuana or cannabidiol needed to complete the research; and

(DD) an attestation that the change in quantity does not impact the source of the marijuana or cannabidiol or the conditions under which the marijuana or cannabidiol is stored, tracked, or administered.

(cc) The Attorney General shall ensure that—

(AA) any registered mail return receipt with respect to a notification under item (aa) is submitted for delivery to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General; and

(BB) notice of receipt of a notification using an electronic means permitted under item (aa) is provided to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General.

(dd)(AA) On and after the date described in subitem (BB), a registrant that submits a notification in accordance with item (aa) may proceed with the research as if the change in quantity has been approved on such date, unless the Attorney General notifies the registrant of an objection described in item (ee).

(BB) The date described in this subitem is the date on which a registrant submitting a notification under item (aa) receives the registered mail return receipt with respect to the notification or the date on which the registrant receives notice that the notification using an electronic means permitted under item (aa) was received by the Attorney General, as the case may be.

(ee) A notification submitted under item (aa) shall be deemed to be approved unless the Attorney General, not later than 10 days after receiving the notification, explicitly objects based on a finding that the change in quantity—

(AA) does impact the source of the marijuana or cannabidiol or the conditions under which the marijuana or cannabidiol is stored, tracked, or administered; or

(BB) necessitates that the registrant implement additional security measures to safeguard against diversion or abuse.

(IV) Nothing in this clause shall limit the authority of the Secretary of Health and Human Services over requirements related to research protocols, including changes in—

(aa) the method of administration of marijuana or cannabidiol;

(bb) the dosing of marijuana or cannabidiol; and

(cc) the number of individuals or patients involved in research.

(3) Article 7 of the Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions upon, research involving drugs or other substances scheduled under the convention which is conducted in conformity with this subsection and other applicable provisions of this subchapter.

(h) Practitioners dispensing narcotic drugs for narcotic treatment; annual registration; separate registration; qualifications

Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment shall obtain annually a separate registration for that purpose. The Attorney General shall register an applicant to dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment (or both)—

(1) if the applicant is a practitioner who is determined by the Secretary to be qualified (under standards established by the Secretary) to engage in the treatment with respect to which registration is sought;

(2) if the Attorney General determines that the applicant will comply with standards established by the Attorney General respecting (A) security of stocks of narcotic drugs for such treatment, and (B) the maintenance of records (in accordance with section 827 of this title) on such drugs; and

(3) if the Secretary determines that the applicant will comply with standards established by the Secretary (after consultation with the Attorney General) respecting the quantities of narcotic drugs which may be provided for unsupervised use by individuals in such treatment.

(i) Applicants for distribution of list I chemicals

The Attorney General shall register an applicant to distribute a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection shall not be required for the distribution of a drug product that is exempted under clause (iv) or (v) of section 802(39)(A) of this title. In determining the public interest for the purposes of this subsection, the Attorney General shall consider—

(1) maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels;

(2) compliance by the applicant with applicable Federal, State, and local law;

(3) any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;

(4) any past experience of the applicant in the manufacture and distribution of chemicals; and

(5) such other factors as are relevant to and consistent with the public health and safety.

(j) Registration to manufacture certain controlled substances for use only in a clinical trial

(1) For purposes of registration to manufacture a controlled substance under subsection (e) for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 824(c) of this title, not later than 180 days after the date on which the application is accepted for filing.

(2) For purposes of registration to manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 824(c) of this title, unless the Attorney General has granted a hearing on the application under section 958(i) of this title.

(k) Emergency medical services that administer controlled substances

(1) Registration

For the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services in accordance with the requirements of this subsection, the Attorney General—

(A) shall register an emergency medical services agency if the agency submits an application demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices; and

(B) may deny an application for such registration if the Attorney General determines that the issuance of such registration would be inconsistent with the requirements of this subsection or the public interest based on the factors listed in subsection (g).

(2) Option for single registration

In registering an emergency medical services agency pursuant to paragraph (1), the Attorney General shall allow such agency the option of a single registration in each State where the agency administers controlled substances in lieu of requiring a separate registration for each location of the emergency medical services agency.

(3) Hospital-based agency

If a hospital-based emergency medical services agency is registered under subsection (g), the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection.

(4) Administration outside physical presence of medical director or authorizing medical professional

Emergency medical services professionals of a registered emergency medical services agency may administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services if the administration is—

(A) authorized by the law of the State in which it occurs; and

(B) pursuant to—

(i) a standing order that is issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State authority; or

(ii) a verbal order that is—

(I) issued in accordance with a policy of the agency; and

(II) provided by a medical director or authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient—

(aa) in the case of a mass casualty incident; or

(bb) to ensure the proper care and treatment of a specific patient.

(5) Delivery

A registered emergency medical services agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency—

(A) designates the unregistered location for such delivery; and

(B) notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location.

(6) Storage

A registered emergency medical services agency may store controlled substances—

(A) at a registered location of the agency;

(B) at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency; or

(C) in an emergency medical services vehicle used by the agency that is—

(i) traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency; or

(ii) otherwise actively in use by the agency under circumstances that provide for security of the controlled substances consistent with the requirements established by regulations of the Attorney General.

(7) No treatment as distribution

The delivery of controlled substances by a registered emergency medical services agency pursuant to this subsection shall not be treated as distribution for purposes of section 828 of this title.

(8) Restocking of emergency medical services vehicles at a hospital

Notwithstanding paragraph (13)(J), a registered emergency medical services agency may receive controlled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency response, and without being subject to the requirements of section 828 of this title, provided all of the following conditions are satisfied:

(A) The registered or designated location of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with paragraph (9).

(B) The hospital maintains a record of such delivery to the agency in accordance with section 827 of this title.

(C) If the vehicle is primarily situated at a designated location, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the controlled substances.

(9) Maintenance of records

(A) In general

A registered emergency medical services agency shall maintain records in accordance with subsections (a) and (b) of section 827 of this title of all controlled substances that are received, administered, or otherwise disposed of pursuant to the agency's registration, without regard to subsection 827(c)(1)(B) of this title.

(B) Requirements

Such records—

(i) shall include records of deliveries of controlled substances between all locations of the agency; and

(ii) shall be maintained, whether electronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of.

(10) Other requirements

A registered emergency medical services agency, under the supervision of a medical director, shall be responsible for ensuring that—

(A) all emergency medical services professionals who administer controlled substances using the agency's registration act in accordance with the requirements of this subsection;

(B) the recordkeeping requirements of paragraph (9) are met with respect to a registered location and each designated location of the agency;

(C) the applicable physical security requirements established by regulation of the Attorney General are complied with wherever controlled substances are stored by the agency in accordance with paragraph (6); and

(D) the agency maintains, at a registered location of the agency, a record of the standing orders issued or adopted in accordance with paragraph (9).

(11) Regulations

The Attorney General may issue regulations—

(A) specifying, with regard to delivery of controlled substances under paragraph (5)—

(i) the types of locations that may be designated under such paragraph; and

(ii) the manner in which a notification under paragraph (5)(B) must be made;

(B) specifying, with regard to the storage of controlled substances under paragraph (6), the manner in which such substances must be stored at registered and designated locations, including in emergency medical service vehicles; and

(C) addressing the ability of hospitals, emergency medical services agencies, registered locations, and designated locations to deliver controlled substances to each other in the event of—

(i) shortages of such substances;

(ii) a public health emergency; or

(iii) a mass casualty event.

(12) Rule of construction

Nothing in this subsection shall be construed—

(A) to limit the authority vested in the Attorney General by other provisions of this subchapter to take measures to prevent diversion of controlled substances; or

(B) to override the authority of any State to regulate the provision of emergency medical services consistent with this subsection.

(13) Definitions

In this section:

(A) The term "authorizing medical professional" means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant)—

(i) who is registered under this chapter;

(ii) who is acting within the scope of the registration; and

(iii) whose scope of practice under a State license or certification includes the ability to provide verbal orders.

(B) The term "designated location" means a location designated by an emergency medical services agency under paragraph (5).

(C) The term "emergency medical services" means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility.

(D) The term "emergency medical services agency" means an organization providing emergency medical services, including such an organization that—

(i) is governmental (including fire-based and hospital-based agencies), nongovernmental (including hospital-based agencies), private, or volunteer-based;

(ii) provides emergency medical services by ground, air, or otherwise; and

(iii) is authorized by the State in which the organization is providing such services to provide emergency medical care, including the administering of controlled substances, to members of the general public on an emergency basis.

(E) The term "emergency medical services professional" means a health care professional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional's State license or certification.

(F) The term "emergency medical services vehicle" means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations.

(G) The term "hospital-based" means, with respect to an agency, owned or operated by a hospital.

(H) The term "medical director" means a physician who is registered under subsection (g) and provides medical oversight for an emergency medical services agency.

(I) The term "medical oversight" means supervision of the provision of medical care by an emergency medical services agency.

(J) The term "registered emergency medical services agency" means—

(i) an emergency medical services agency that is registered pursuant to this subsection; or

(ii) a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection (g).

(K) The term "registered location" means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection (g), which shall be where the agency receives controlled substances from distributors.

(L) The term "specific State authority" means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emergency medical services in the geographic jurisdiction of such agency or authority within the State that may be adopted by medical directors.

(M) The term "standing order" means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services.

(N) The term "verbal order" means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.

(l) ² "Factors as may be relevant to and consistent with the public health and safety" defined

In this section, the phrase "factors as may be relevant to and consistent with the public health and safety" means factors that are relevant to and consistent with the findings contained in section 801 of this title.

(l) ² Required training for prescribers

(1) Training required

As a condition on registration under this section to dispense controlled substances in schedule II, III, IV, or V, the Attorney General shall require any qualified practitioner, beginning with the first applicable registration for the practitioner, to meet the following:

(A) If the practitioner is a physician (as defined under section 1395x(r) of title 42) and the practitioner meets one or more of the following conditions:

(i) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.

(ii) The physician holds a board certification from the American Board of Addiction Medicine.

(iii) The physician holds a board certification in addiction medicine from the American Osteopathic Association.

(iv) The physician has, with respect to the treatment and management of patients with opioid or other substance use disorders, or the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid or other substance use disorders, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by—

(I) the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Dental Association, the American Association of Oral and Maxillofacial Surgeons, the American Psychiatric Association, or any other organization accredited by the Accreditation Council for Continuing Medical Education (ACCME) or the Commission for Continuing Education Provider Recognition (CCEPR);

(II) any organization accredited by a State medical society accreditor that is recognized by the ACCME or the CCEPR;

(III) any organization accredited by the American Osteopathic Association to provide continuing medical education; or

(IV) any organization approved by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR.

(v) The physician graduated in good standing from an accredited school of allopathic medicine, osteopathic medicine, dental surgery, or dental medicine in the United States during the 5-year period immediately preceding the date on which the physician first registers or renews under this section and has successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency or dental surgery or dental medicine curriculum that included not less than 8 hours of training on—

(I) treating and managing patients with opioid or other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder; or

(II) the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid and other substance use disorders.

(B) If the practitioner is not a physician (as defined under section 1395x(r) of title 42), the practitioner is legally authorized by the State to dispense controlled substances under schedule II, III, IV, or V and is dispensing such substances within such State in accordance with all applicable State laws, and the practitioner meets one or more of the following conditions:

(i) The practitioner has completed not fewer than 8 hours of training with respect to the treatment and management of patients with opioid or other substance use disorders (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Associates, or any other organization approved or accredited by the Assistant Secretary for Mental Health and Substance Use or the Accreditation Council for Continuing Medical Education.

(ii) The practitioner has graduated in good standing from an accredited physician assistant school or accredited school of advanced practice nursing in the United States during the 5-year period immediately preceding the date on which the practitioner first registers or renews under this section and has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that included not fewer than 8 hours of training on treating and managing patients with opioid and other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder.

(2) One-time training

(A) In general

The Attorney General shall not require any qualified practitioner to complete the training described in clause (iv) or (v) of paragraph (1)(A) or clause (i) or (ii) of paragraph (1)(B) more than once.

(B) Notification

Not later than 90 days after December 29, 2022, the Attorney General shall provide to qualified practitioners a single written, electronic notification of the training described in clauses (iv) and (v) of paragraph (1)(A) or clauses (i) and (ii) of paragraph (1)(B).

(3) Rule of construction

Nothing in this subsection shall be construed—

(A) to preclude the use, by a qualified practitioner, of training received pursuant to this subsection to satisfy registration requirements of a State or for some other lawful purpose; or

(B) to preempt any additional requirements by a State related to the dispensing of controlled substances under schedule II, III, IV, or V.

(4) Definitions

In this section:

(A) First applicable registration

The term "first applicable registration" means the first registration or renewal of registration by a qualified practitioner under this section that occurs on or after the date that is 180 days after December 29, 2022.

(B) Qualified practitioner

In this subsection, the term "qualified practitioner" means a practitioner who—

(i) is licensed under State law to prescribe controlled substances; and

(ii) is not solely a veterinarian.

(Pub. L. 91–513, title II, §303, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 93–281, §3, May 14, 1974, 88 Stat. 124; Pub. L. 95–633, title I, §109, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 98–473, title II, §511, Oct. 12, 1984, 98 Stat. 2073; Pub. L. 103–200, §3(c), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 106–310, div. B, title XXXV, §3502(a), Oct. 17, 2000, 114 Stat. 1222; Pub. L. 107–273, div. B, title II, §2501, Nov. 2, 2002, 116 Stat. 1803; Pub. L. 109–56, §1(a), (b), Aug. 2, 2005, 119 Stat. 591; Pub. L. 109–177, title VII, §712(a)(3), Mar. 9, 2006, 120 Stat. 263; Pub. L. 109–469, title XI, §1102, Dec. 29, 2006, 120 Stat. 3540; Pub. L. 110–425, §3(b), Oct. 15, 2008, 122 Stat. 4824; Pub. L. 114–89, §3, Nov. 25, 2015, 129 Stat. 701; Pub. L. 114–145, §2(a)(1), Apr. 19, 2016, 130 Stat. 354; Pub. L. 114–198, title III, §303(a)(1), (b), July 22, 2016, 130 Stat. 720, 723; Pub. L. 115–83, §2, Nov. 17, 2017, 131 Stat. 1267; Pub. L. 115–271, title III, §§3201(a)–(d), 3202(a), Oct. 24, 2018, 132 Stat. 3943, 3944; Pub. L. 117–215, title I, §§101, 102(a), 103(a), Dec. 2, 2022, 136 Stat. 2258, 2260, 2261; Pub. L. 117–328, div. FF, title I, §§1262(a), 1263(a), Dec. 29, 2022, 136 Stat. 5681, 5683.)

Editorial Notes

References in Text

Schedules I, II, III, IV, and V, referred to in subsecs. (a) to (g)(2), (k)(1), (4), and (l)(1), (3)(B), are set out in section 812(c) of this title.

This chapter, referred to in subsecs. (c)(1)(A), (B) and (k)(13)(A)(i), was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act, referred to in subsecs. (c)(1)(B)(vi) and (g)(2)(B)(i)(II), is section 105 of Pub. L. 117–215, which is set out as a note below.

This subchapter, referred to in subsecs. (g)(3) and (k)(12)(A), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Amendments

2022—Subsecs. (c) to (e). Pub. L. 117–215, §103(a)(1), (2), added subsec. (c) and redesignated former subsecs. (c) and (d) as (d) and (e), respectively. Former subsec. (e) redesignated (f).

Subsec. (f). Pub. L. 117–215, §103(a)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g).

Pub. L. 117–215, §101, designated introductory provisions through first sentence of concluding provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), designated second to fourth sentences of concluding provisions as subpar. (A) of par. (2), added subpar. (B) of par. (2), and designated last sentence of concluding provisions as par. (3).

Subsec. (f)(2)(B)(vi). Pub. L. 117–215, §102(a), added cl. (vi).

Subsec. (g). Pub. L. 117–215, §103(a)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h).

Subsec. (h). Pub. L. 117–328, §1262(a), which directed amendment of subsec. (g) by substituting "Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment" for "(1) Except as provided in paragraph (2), practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment", redesignating subpars. (A) to (C) of former par. (1) as pars. (1) to (3), respectively, redesignating cls. (i) and (ii) of par. (2) as subpars. (A) and (B), respectively, and striking former par. (2) which related to waiver of registration requirements, was executed to subsec. (h) to reflect the probable intent of Congress and the redesignation of subsec. (g) as (h) by Pub. L. 117–215, §103(a)(1). See Amendment note below.

Pub. L. 117–215, §103(a)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i).

Subsec. (h)(2). Pub. L. 117–215, §103(a)(3), substituted "subsection (g)" for "subsection (f)" wherever appearing.

Subsec. (i). Pub. L. 117–215, §103(a)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j).

Subsec. (j). Pub. L. 117–215, §103(a)(1), redesignated subsec. (i) as (j). Former subsec. (j) redesignated (k).

Subsec. (j)(1). Pub. L. 117–215, §103(a)(4), substituted "subsection (e)" for "subsection (d)".

Subsec. (k). Pub. L. 117–215, §103(a)(1), (5), redesignated subsec. (j) as (k) and substituted "subsection (g)" for "subsection (f)" wherever appearing. Former subsec. (k) redesignated (l).

Subsec. (l). Pub. L. 117–328, §1263(a), added subsec. (l) relating to required training for prescribers.

Pub. L. 117–215, §103(a)(1), redesignated subsec. (k) as (l).

2018—Subsec. (g)(2)(B)(iii)(II). Pub. L. 115–271, §3201(a), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: "The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients."

Subsec. (g)(2)(G)(ii)(VIII). Pub. L. 115–271, §3202(a), added subcl. (VIII).

Subsec. (g)(2)(G)(iii)(II). Pub. L. 115–271, §3201(b), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: "during the period beginning on July 22, 2016, and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv)."

Subsec. (g)(2)(G)(iii)(III). Pub. L. 115–271, §3201(b)(1), (c), added subcl. (III).

Subsec. (g)(2)(G)(iv). Pub. L. 115–271, §3201(d), substituted "nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant" for "nurse practitioner or physician assistant" wherever appearing.

2017—Subsecs. (j), (k). Pub. L. 115–83 added subsec. (j) and redesignated former subsec. (j) as (k).

2016—Subsec. (g)(2)(B). Pub. L. 114–198, §303(a)(1)(A), added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows:

"(i) The practitioner is a qualifying physician (as defined in subparagraph (G)).

"(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to refer the patients for appropriate counseling and other appropriate ancillary services.

"(iii) The total number of such patients of the practitioner at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The Secretary may by regulation change such total number."

Subsec. (g)(2)(D)(ii). Pub. L. 114–198, §303(a)(1)(B)(i), substituted "Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B)" for "Upon receiving a notification under subparagraph (B)".

Subsec. (g)(2)(D)(iii). Pub. L. 114–198, §303(a)(1)(B)(ii), inserted "and shall forward such determination to the Attorney General" after "a waiver under subparagraph (B)" and substituted "assign the practitioner" for "assign the physician".

Subsec. (g)(2)(G)(ii)(I). Pub. L. 114–198, §303(a)(1)(C)(i), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: "The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties."

Subsec. (g)(2)(G)(ii)(II). Pub. L. 114–198, §303(a)(1)(C)(ii), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: "The physician holds an addiction certification from the American Society of Addiction Medicine."

Subsec. (g)(2)(G)(ii)(III). Pub. L. 114–198, §303(a)(1)(C)(iii), struck out "subspecialty" before "board certification".

Subsec. (g)(2)(G)(ii)(IV). Pub. L. 114–198, §303(a)(1)(C)(iv), amended subcl. (IV) generally. Prior to amendment, subcl. (IV) read as follows: "The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause."

Subsec. (g)(2)(G)(iii), (iv). Pub. L. 114–198, §303(a)(1)(C)(v), added cls. (iii) and (iv).

Subsec. (g)(2)(H)(i)(III). Pub. L. 114–198, §303(a)(1)(D)(i), added subcl. (III).

Subsec. (g)(2)(H)(ii). Pub. L. 114–198, §303(a)(1)(D)(ii), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: "Not later than 120 days after October 17, 2000, the Secretary shall issue a treatment improvement protocol containing best practice guidelines for the treatment and maintenance of opiate-dependent patients. The Secretary shall develop the protocol in consultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration and other substance abuse disorder professionals. The protocol shall be guided by science."

Subsec. (g)(2)(I), (J). Pub. L. 114–198, §303(b), added subpar. (I) and struck out former subpars. (I) and (J) which limited a State's ability to preclude a practitioner from dispensing or prescribing certain approved drugs and provided the effective date of the paragraph and authorized the Secretary and the Attorney General to make certain determinations.

Subsec. (j). Pub. L. 114–145 added subsec. (j).

2015—Subsec. (i). Pub. L. 114–89 added subsec. (i).

2008—Subsec. (f). Pub. L. 110–425, in introductory provisions, inserted "and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet" after "schedule II, III, IV, or V" and substituted "or such modification of registration if the Attorney General determines that the issuance of such registration or modification" for "if he determines that the issuance of such registration".

2006—Subsec. (g)(2)(B)(iii). Pub. L. 109–469, §1102(1), substituted "unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The" for "except that the".

Subsec. (g)(2)(J)(i). Pub. L. 109–469, §1102(2)(A), substituted "thereafter." for "thereafter except as provided in clause (iii) (relating to a decision by the Secretary or the Attorney General that this paragraph should not remain in effect)."

Subsec. (g)(2)(J)(ii). Pub. L. 109–469, §1102(2)(B), substituted "December 29, 2006" for "October 17, 2000" in introductory provisions.

Subsec. (g)(2)(J)(iii). Pub. L. 109–469, §1102(2)(C), substituted "subparagraph (B)(iii) should be applied by limiting the total number of patients a practitioner may treat to 30, then the provisions in such subparagraph (B)(iii) permitting more than 30 patients shall not apply, effective" for "this paragraph should not remain in effect, this paragraph ceases to be in effect".

Subsec. (h). Pub. L. 109–177 substituted "clause (iv) or (v) of section 802(39)(A) of this title" for "section 802(39)(A)(iv) of this title" in introductory provisions.

2005—Subsec. (g)(2)(B)(iii). Pub. L. 109–56, §1(b), substituted "The total" for "In any case in which the practitioner is not in a group practice, the total".

Subsec. (g)(2)(B)(iv). Pub. L. 109–56, §1(a), struck out cl. (iv) which read as follows: "In any case in which the practitioner is in a group practice, the total number of such patients of the group practice at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total number, and the Secretary for such purposes may by regulation establish different categories on the basis of the number of practitioners in a group practice and establish for the various categories different numerical limitations on the number of such patients that the group practice may have."

2002—Subsec. (g)(2)(I). Pub. L. 107–273, §2501(1), which directed the substitution of "on the date of approval by the Food and Drug Administration of a drug in schedule III, IV, or V, a State may not preclude a practitioner from dispensing or prescribing such drug, or combination of such drugs," for "on October 17, 2000, a State may not preclude a practitioner from dispensing or prescribing drugs in schedule III, IV, or V, or combinations of such drugs,", was executed by making the substitution for the phrase which in the original began with "on the date of the enactment of the Drug Addiction Treatment Act of 2000," rather than the editorial translation "on October 17, 2000," to reflect the probable intent of Congress.

Subsec. (g)(2)(J)(i). Pub. L. 107–273, §2501(2), which directed the substitution of "the date referred to in subparagraph (I)," for "October 17, 2000," was executed by making the substitution for text which in the original read "the date of the enactment of the Drug Addiction Treatment Act of 2000," rather than the editorial translation "October 17, 2000," to reflect the probable intent of Congress.

2000—Subsec. (g). Pub. L. 106–310 designated existing provisions as par. (1), substituted "Except as provided in paragraph (2), practitioners who dispense" for "Practitioners who dispense", redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1) and redesignated former subpars. (A) and (B) of former par. (2) as cls. (i) and (ii), respectively, of subpar. (B) of par. (1), and added par. (2).

1993—Subsec. (h). Pub. L. 103–200 added subsec. (h).

1984—Subsec. (f). Pub. L. 98–473 amended subsec. (f) generally, substituting provisions relating to registration authority of Attorney General respecting dispensation or conduct of research with controlled research, and separate authority of Secretary respecting registration, for provisions relating to general registration requirements respecting dispensation or conduct of research with controlled or nonnarcotic controlled substances.

1978—Subsec. (f). Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances.

1974—Subsec. (g). Pub. L. 93–281 added subsec. (g).

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

Effective Date of 2005 Amendment

Pub. L. 109–56, §1(c), Aug. 2, 2005, 119 Stat. 591, provided that: "This section [amending this section] shall take effect on the date of enactment of this Act [Aug. 2, 2005]."

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Regulations

Pub. L. 117–215, title I, §102(b), Dec. 2, 2022, 136 Stat. 2261, provided that: "Not later than 1 year after the date of enactment of this Act [Dec. 2, 2022], the Attorney General shall promulgate regulations to carry out the amendment made by this section [amending this section]."

Update Regulations

Pub. L. 117–328, div. FF, title I, §1252(b), Dec. 29, 2022, 136 Stat. 5681, provided that: "Not later than 18 months after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services shall revise section 8.12(e)(1) of title 42, Code of Federal Regulations (or successor regulations), to eliminate the requirement that an opioid treatment program only admit an individual for treatment under the program if the individual has been addicted to opioids for at least 1 year before being so admitted for treatment."

Pub. L. 114–198, title III, §303(c), July 22, 2016, 130 Stat. 723, provided that: "Not later than 18 months after the date of enactment of this Act [July 22, 2016], the Attorney General and the Secretary of Health and Human Services, as appropriate, shall update regulations regarding practitioners described in subsection (a)(3)(B)(vii) (as amended by this section) [probably means subsec. (a)(3)(B)(vii) "of this section", set out as a note below] to include nurse practitioners and physician assistants to ensure the quality of patient care and prevent diversion."

Adequate and Uninterrupted Supply

Pub. L. 117–215, title I, §104, Dec. 2, 2022, 136 Stat. 2263, provided that:

"(a) In General.—On an annual basis, the Attorney General, in consultation with the Secretary of Health and Human Services, shall assess whether there is an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.

"(b) Report to Congress.—If the Attorney General, in consultation with the Secretary of Health and Human Services, determines there is an inadequate or interrupted supply of marijuana, including of specific strains for research purposes, the Attorney General shall report to Congress within 60 days of the determination on at least—

"(1) the factors contributing to the inadequate or interrupted supply of marijuana;

"(2) expected impacts of the inadequate or interrupted supply on ongoing research protocols; and

"(3) specific steps the Attorney General will take to restore an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes."

[For definition of "marijuana" as used in section 104 of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out as a note under section 801 of this title.]

Security Requirements

Pub. L. 117–215, title I, §105, Dec. 2, 2022, 136 Stat. 2264, provided that:

"(a) In General.—An individual or entity engaged in researching marijuana or its components shall store it in a securely locked, substantially constructed cabinet.

"(b) Requirements for Other Measures.—Any other security measures required by the Attorney General to safeguard against diversion shall be consistent with those required for practitioners conducting research on other controlled substances in schedules I and II in section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) that have a similar risk of diversion and abuse."

[For definitions of "marijuana", "controlled substances", and "practitioners" as used in section 105 of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out as a note under section 801 of this title.]

Development of Food and Drug Administration-Approved Drugs Using Cannabidiol and Marijuana

Pub. L. 117–215, title II, Dec. 2, 2022, 136 Stat. 2264, provided that:

"SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL.

"Notwithstanding any provision of the Controlled Substances Act (21 U.S.C. 801 et seq.), the Safe and Drug-Free Schools and Communities Act (20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code, or any other Federal law, an appropriately registered covered institution of higher education, practitioner, or manufacturer may manufacture, distribute, dispense, or possess marijuana or cannabidiol if the marijuana or cannabidiol is manufactured, distributed, dispensed, or possessed, respectively, for purposes of medical research for drug development or subsequent commercial production in accordance with section 202.

"SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUCTION AND DISTRIBUTION OF FOOD AND DRUG ADMINISTRATION-APPROVED DRUGS.

"The Attorney General shall register an applicant to manufacture or distribute cannabidiol or marijuana for the purpose of commercial production of a drug containing or derived from marijuana that is approved by the Secretary of Health and Human Services under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in accordance with the applicable requirements under subsection (a) or (b) of section 303 of the Controlled Substances Act (21 U.S.C. 823)."

[For definitions of terms used in title II of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out as a note under section 801 of this title.]

Treatment for Children

Pub. L. 115–271, title III, §3202(b), Oct. 24, 2018, 132 Stat. 3945, provided that: "The Secretary of Health and Human Services shall consider ways to ensure that an adequate number of qualified practitioners, as defined in [former] subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], who have a specialty in pediatrics or the treatment of children or adolescents, are granted a waiver under such section 303(g)(2) to treat children and adolescents with substance use disorders."

Grants To Enhance Access to Substance Use Disorder Treatment

Pub. L. 115–271, title III, §3203, Oct. 24, 2018, 132 Stat. 3945, provided that:

"(a) In General.—The Secretary of Health and Human Services shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under [former] subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act [former 21 U.S.C. 823(h)(2)(G)(ii)], as added by section 3202(a) of this Act.

"(b) Authorization of Appropriations.—There is authorized to be appropriated, for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023."

Reports to Congress

Pub. L. 114–198, title III, §303(a)(3), July 22, 2016, 130 Stat. 722, provided that:

"(A) In general.—Not later than 3 years after the date of enactment of this Act [July 22, 2016] and not later than 3 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use disorder research and treatment, shall—

"(i) perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and nonspecialty settings; and

"(ii) submit a report to the Congress on the findings and conclusions of such review.

"(B) Contents.—Each report under subparagraph (A) shall include an assessment of—

"(i) compliance with the requirements of [former] section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], as amended by this section;

"(ii) the measures taken by the Secretary of Health and Human Services to ensure such compliance;

"(iii) whether there is further need to increase or decrease the number of patients a practitioner, pursuant to a waiver under [former] section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], is permitted to treat;

"(iv) the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings;

"(v) access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services;

"(vi) changes in State or local policies and legislation relating to opioid use disorder treatment;

"(vii) the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver described in clause (iii);

"(viii) the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in clause (vii); and

"(ix) the effectiveness of cross-agency collaboration between [the] Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment."

Provisional Registration

For provisional registration of persons engaged in manufacturing, distributing, or dispensing of controlled substances on the day before the effective date of section 822 of this title who are registered on such date under section 360 of this title or section 4722 of Title 26, Internal Revenue Code, see section 703 of Pub. L. 91–513, set out as a note under section 822 of this title.

¹ So in original. Probably should be preceded by "section".

² So in original. Two subsecs. (l) have been enacted.

§824. Denial, revocation, or suspension of registration

(a) Grounds

A registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant—

(1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II;

(2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a list I chemical;

(3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority;

(4) has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section; or

(5) has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a–7(a) of title 42.

A registration pursuant to section 823(h)(1) ¹ of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section 823(h)(1) ¹ of this title.

(b) Limits of revocation or suspension

The Attorney General may limit revocation or suspension of a registration to the particular controlled substance or list I chemical with respect to which grounds for revocation or suspension exist.

(c) Service of show cause order; proceedings

(1) Before taking action pursuant to this section, or pursuant to a denial of registration under section 823 of this title, the Attorney General shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended.

(2) An order to show cause under paragraph (1) shall—

(A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant;

(B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and

(C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance.

(3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan.

(4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States.

(5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d).

(d) Suspension of registration in cases of imminent danger

(1) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety. A failure to comply with a standard referred to in section 823(h)(1) ¹ of this title may be treated under this subsection as grounds for immediate suspension of a registration granted under such section. A suspension under this subsection shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.

(2) In this subsection, the phrase "imminent danger to the public health or safety" means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this subchapter or subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.

(e) Suspension and revocation of quotas

The suspension or revocation of a registration under this section shall operate to suspend or revoke any quota applicable under section 826 of this title.

(f) Disposition of controlled substances or list I chemicals

In the event the Attorney General suspends or revokes a registration granted under section 823 of this title, all controlled substances or list I chemicals owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be placed under seal. No disposition may be made of any controlled substances or list I chemicals under seal until the time for taking an appeal has elapsed or until all appeals have been concluded except that a court, upon application therefor, may at any time order the sale of perishable controlled substances or list I chemicals. Any such order shall require the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled substances or list I chemicals (or proceeds of sale deposited in court) shall be forfeited to the United States; and the Attorney General shall dispose of such controlled substances or list I chemicals in accordance with section 881(e) of this title. All right, title, and interest in such controlled substances or list I chemicals shall vest in the United States upon a revocation order becoming final.

(g) Seizure or placement under seal of controlled substances or list I chemicals

The Attorney General may, in his discretion, seize or place under seal any controlled substances or list I chemicals owned or possessed by a registrant whose registration has expired or who has ceased to practice or do business in the manner contemplated by his registration. Such controlled substances or list I chemicals shall be held for the benefit of the registrant, or his successor in interest. The Attorney General shall notify a registrant, or his successor in interest, who has any controlled substance or list I chemical seized or placed under seal of the procedures to be followed to secure the return of the controlled substance or list I chemical and the conditions under which it will be returned. The Attorney General may not dispose of any controlled substance or list I chemical seized or placed under seal under this subsection until the expiration of one hundred and eighty days from the date such substance or chemical was seized or placed under seal.

(h) Order to prohibit registration based on prior history

The Attorney General may issue an order to prohibit, conditionally or unconditionally, and permanently or for such period as the Attorney General may determine, any person from being registered under this subchapter to manufacture, distribute, or dispense a controlled substance or a list I chemical, if the Attorney General finds that—

(1) such person meets or has met any of the conditions for suspension or revocation of registration under subsection (a); and

(2) such person has a history of prior suspensions or revocations of registration.

(Pub. L. 91–513, title II, §304, Oct. 27, 1970, 84 Stat. 1255; Pub. L. 93–281, §4, May 14, 1974, 88 Stat. 125; Pub. L. 98–473, title II, §§304, 512, 513, Oct. 12, 1984, 98 Stat. 2050, 2073; Pub. L. 100–93, §8(j), Aug. 18, 1987, 101 Stat. 695; Pub. L. 103–200, §3(d), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 103–322, title XXXIII, §330024(e), Sept. 13, 1994, 108 Stat. 2151; Pub. L. 106–310, div. B, title XXXV, §3502(b), Oct. 17, 2000, 114 Stat. 1227; Pub. L. 114–145, §2(a)(2), (b), Apr. 19, 2016, 130 Stat. 354; Pub. L. 117–36, §2, Aug. 6, 2021, 135 Stat. 328; Pub. L. 117–215, title I, §103(b)(1)(C), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §1262(b)(1), Dec. 29, 2022, 136 Stat. 5682.)

Editorial Notes

References in Text

Section 823(h) of this title, referred to in subsecs. (a) and (d)(1), originally consisted of pars. (1) and (2). Par. (1) was redesignated as the entire subsec. (h), with its subpars. (A) to (C) redesignated pars. (1) to (3), and former par. (2) was struck out by Pub. L. 117–328, div. FF, title I, §1262(a), Dec. 29, 2022, 136 Stat. 5681.

This subchapter, referred to in subsecs. (a)(1), (2), (c)(4), (d)(2), and (h), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Subchapter II, referred to in subsecs. (a)(1), (2) and (d)(2), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Amendments

2022—Subsec. (a). Pub. L. 117–328, §1262(b)(1), which directed substitution of "823(g)" for "823(g)(1)" in two places in concluding provisions, could not be executed because of the intervening amendment by Pub. L. 117–215, §103(b)(1)(C). See Amendment note below.

Pub. L. 117–215, in concluding provisions, substituted "823(h)(1)" for "823(g)(1)" in two places.

Subsec. (d)(1). Pub. L. 117–328, §1262(b)(1), which directed substitution of "823(g)" for "823(g)(1)", could not be executed because of the intervening amendment by Pub. L. 117–215, §103(b)(1)(C). See Amendment note below.

Pub. L. 117–215 substituted "823(h)(1)" for "823(g)(1)".

2021—Subsec. (h). Pub. L. 117–36 added subsec. (h).

2016—Subsec. (c). Pub. L. 114–145, §2(b), struck out "The order to show cause shall contain a statement of the basis thereof and shall call upon the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but in no event less than thirty days after the date of receipt of the order. Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States." after "denied, revoked, or suspended.", designated existing provisions as par. (1), and added pars. (2) to (5).

Subsec. (d). Pub. L. 114–145, §2(a)(2), designated existing provisions as par. (1) and added par. (2).

2000—Subsec. (a). Pub. L. 106–310, §3502(b)(1), substituted "section 823(g)(1) of this title" for "section 823(g) of this title" in two places in concluding provisions.

Subsec. (d). Pub. L. 106–310, §3502(b)(2), substituted "section 823(g)(1) of this title" for "section 823(g) of this title".

1994—Subsec. (g). Pub. L. 103–322 inserted "or chemical" after "such substance" in last sentence.

1993—Subsec. (a). Pub. L. 103–200, §3(d)(1), inserted "or a list I chemical" after "controlled substance" in introductory provisions and par. (2) and inserted "or list I chemicals" after "controlled substances" in par. (3).

Subsec. (b). Pub. L. 103–200, §3(d)(2), inserted "or list I chemical" after "controlled substance".

Subsec. (f). Pub. L. 103–200, §3(d)(3), inserted "or list I chemicals" after "controlled substances" wherever appearing.

Subsec. (g). Pub. L. 103–200, §3(d)(4), inserted "or list I chemicals" after "controlled substances" in two places and "or list I chemical" after "controlled substance" wherever appearing.

1987—Subsec. (a)(5). Pub. L. 100–93 added par. (5).

1984—Subsec. (a)(3). Pub. L. 98–473, §512(1), inserted provisions relating to suspension, etc., recommended by competent State authority.

Subsec. (a)(4). Pub. L. 98–473, §512(2), added par. (4).

Subsec. (f). Pub. L. 98–473, §304, inserted provisions relating to vesting of right, title, and interest in the United States.

Subsec. (g). Pub. L. 98–473, §513, added subsec. (g).

1974—Subsec. (a). Pub. L. 93–281, §4(a), provided for revocation or suspension of a registration pursuant to section 823(g) of this title for failure of a registrant to comply with standards referred to in such section 823(g).

Subsec. (d). Pub. L. 93–281, §4(b), substituted "A suspension under this subsection" for "Such suspension" in third sentence.

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title.

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1987 Amendment

Amendment by Pub. L. 100–93 effective at end of fourteen-day period beginning Aug. 18, 1987, and inapplicable to administrative proceedings commenced before end of such period, see section 15(a) of Pub. L. 100–93, set out as a note under section 1320a–7 of Title 42, The Public Health and Welfare.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Provisional Registration

Applicability of this section to provisional registrations, see section 703 of Pub. L. 91–513, set out as a note under section 822 of this title.

¹ See References in Text note below.

§825. Labeling and packaging

(a) Symbol

It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in section 321(k) of this title) containing an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of controlled substances.

(b) Unlawful distribution without identifying symbol

It shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling (as defined in section 321(m) of this title) of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under subsection (a).

(c) Warning on label

The Secretary shall prescribe regulations under section 353(b) of this title which shall provide that the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient.

(d) Containers to be securely sealed

It shall be unlawful to distribute controlled substances in schedule I or II, and narcotic drugs in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General.

(e) False labeling of anabolic steroids

(1) It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, an anabolic steroid or product containing an anabolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC).

(2)(A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(B) A product is described in this subparagraph if the product—

(i) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b), (j)]; or

(ii) is exempt from the provisions of section 505 of such Act relating to new drugs because—

(I) it is intended solely for investigational use as described in section 505(i) of such Act; and

(II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.

(Pub. L. 91–513, title II, §305, Oct. 27, 1970, 84 Stat. 1256; Pub. L. 113–260, §3(a), Dec. 18, 2014, 128 Stat. 2931.)

Editorial Notes

References in Text

Schedules I, II, III, and IV, referred to in subsecs. (c) and (d), are set out in section 812(c) of this title.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(2)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

2014—Subsec. (e). Pub. L. 113–260 added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see section 704(c) of Pub. L. 91–513, set out as a note under section 801 of this title.

Identification and Publication of List of Products Containing Anabolic Steroids

Pub. L. 113–260, §4, Dec. 18, 2014, 128 Stat. 2932, provided that:

"(a) In General.—The Attorney General may, in the Attorney General's discretion, collect data and analyze products to determine whether they contain anabolic steroids and are properly labeled in accordance with this Act [see section 1 of Pub. L. 113–260, set out as a Short Title of 2014 Amendment note under section 801 of this title] and the amendments made by this Act. The Attorney General may publish in the Federal Register or on the website of the Drug Enforcement Administration a list of products which the Attorney General has determined, based on substantial evidence, contain an anabolic steroid and are not labeled in accordance with this Act and the amendments made by this Act.

"(b) Absence From List.—The absence of a product from the list referred to in subsection (a) shall not constitute evidence that the product does not contain an anabolic steroid."

§826. Production quotas for controlled substances

(a) Establishment of total annual needs

(1) The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. Except as provided in paragraph (2), production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.

(2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance.

(b) Individual manufacturing quotas; revised quotas

The Attorney General shall limit or reduce individual manufacturing quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under subsection (a). The quota of each registered manufacturer for each basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas. However, if any registrant, before the issuance of a limitation or reduction in quota, has manufactured in excess of his revised quota, the amount of the excess shall be subtracted from his quota for the following year.

(c) Manufacturing quotas for registered manufacturers

On or before December 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine that the manufacturer seeks to produce. The quota shall be subject to the provisions of subsections (a) and (b) of this section. In fixing such quotas, the Attorney General shall determine the manufacturer's estimated disposal, inventory, and other requirements for the calendar year; and, in making his determination, the Attorney General shall consider the manufacturer's current rate of disposal, the trend of the national disposal rate during the preceding calendar year, the manufacturer's production cycle and inventory position, the economic availability of raw materials, yield and stability problems, emergencies such as strikes and fires, and other factors.

(d) Quotas for registrants who have not manufactured controlled substance during one or more preceding years

The Attorney General shall, upon application and subject to the provisions of subsections (a) and (b) of this section, fix a quota for a basic class of controlled substance in schedule I or II for any registrant who has not manufactured that basic class of controlled substance or ephedrine, pseudoephedrine, or phenylpropanolamine during one or more preceding calendar years. In fixing such quota, the Attorney General shall take into account the registrant's reasonably anticipated requirements for the current year; and, in making his determination of such requirements, he shall consider such factors specified in subsection (c) of this section as may be relevant.

(e) Quota increases

At any time during the year any registrant who has applied for or received a manufacturing quota for a basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine may apply for an increase in that quota to meet his estimated disposal, inventory, and other requirements during the remainder of that year. In passing upon the application the Attorney General shall take into consideration any occurrences since the filing of the registrant's initial quota application that may require an increased manufacturing rate by the registrant during the balance of the year. In passing upon the application the Attorney General may also take into account the amount, if any, by which the determination of the Attorney General under subsection (a) of this section exceeds the aggregate of the quotas of all registrants under this section.

(f) Incidental production exception

Notwithstanding any other provisions of this subchapter, no registration or quota may be required for the manufacture of such quantities of controlled substances in schedules I and II or ephedrine, pseudoephedrine, or phenylpropanolamine as incidentally and necessarily result from the manufacturing process used for the manufacture of a controlled substance or of ephedrine, pseudoephedrine, or phenylpropanolamine with respect to which its manufacturer is duly registered under this subchapter. The Attorney General may, by regulation, prescribe restrictions on the retention and disposal of such incidentally produced substances or chemicals.

(g) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine

Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.

(h) Quotas applicable to drugs in shortage

(1) Not later than 30 days after the receipt of a request described in paragraph (2), the Attorney General shall—

(A) complete review of such request; and

(B)(i) as necessary to address a shortage of a controlled substance, increase the aggregate and individual production quotas under this section applicable to such controlled substance and any ingredient therein to the level requested; or

(ii) if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide a written response detailing the basis for the Attorney General's determination.

The Secretary shall make the written response provided under subparagraph (B)(ii) available to the public on the Internet Web site of the Food and Drug Administration.

(2) A request is described in this paragraph if—

(A) the request pertains to a controlled substance on the list of drugs in shortage maintained under section 356e of this title;

(B) the request is submitted by the manufacturer of the controlled substance; and

(C) the controlled substance is in schedule II.

(i) Strengthening considerations for DEA opioid quotas

(1)(A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a "covered controlled substance"), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States.

(B) In estimating diversion under this paragraph, the Attorney General—

(i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and

(ii) may take into consideration whatever other sources of information the Attorney General determines reliable.

(C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered.

(2)(A) For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States.

(B) Not later than 1 year after October 24, 2018, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance:

(i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance.

(ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year.

(3) Not later than 1 year after October 24, 2018, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will—

(A) take into consideration changes in the accepted medical use of the covered controlled substances; and

(B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events.

(Pub. L. 91–513, title II, §306, Oct. 27, 1970, 84 Stat. 1257; Pub. L. 94–273, §3(16), Apr. 21, 1976, 90 Stat. 377; Pub. L. 109–177, title VII, §713, Mar. 9, 2006, 120 Stat. 264; Pub. L. 112–144, title X, §1005, July 9, 2012, 126 Stat. 1105; Pub. L. 115–271, title III, §3282(a), Oct. 24, 2018, 132 Stat. 3954.)

Editorial Notes

References in Text

Schedules I and II, referred to in text, are set out in section 812(c) of this title.

Amendments

2018—Subsec. (a). Pub. L. 115–271, §3282(a)(1), designated existing provisions as par. (1), substituted "Except as provided in paragraph (2), production" for "Production" in second sentence, and added par. (2).

Subsec. (b). Pub. L. 115–271, §3282(a)(2), substituted "reduce individual manufacturing" for "reduce individual production".

Subsec. (c). Pub. L. 115–271, §3282(a)(3), substituted "December" for "October".

Subsec. (i). Pub. L. 115–271, §3282(a)(4), added subsec. (i).

2012—Subsec. (h). Pub. L. 112–144 added subsec. (h).

2006—Subsec. (a). Pub. L. 109–177, §713(1), inserted "and for ephedrine, pseudoephedrine, and phenylpropanolamine" after "for each basic class of controlled substance in schedules I and II".

Subsec. (b). Pub. L. 109–177, §713(2), inserted "or for ephedrine, pseudoephedrine, or phenylpropanolamine" after "for each basic class of controlled substance in schedule I or II".

Subsec. (c). Pub. L. 109–177, §713(3), inserted "and for ephedrine, pseudoephedrine, and phenylpropanolamine" after "for the basic classes of controlled substances in schedules I and II".

Subsec. (d). Pub. L. 109–177, §713(4), inserted "or ephedrine, pseudoephedrine, or phenylpropanolamine" after "that basic class of controlled substance".

Subsec. (e). Pub. L. 109–177, §713(5), inserted "or for ephedrine, pseudoephedrine, or phenylpropanolamine" after "for a basic class of controlled substance in schedule I or II".

Subsec. (f). Pub. L. 109–177, §713(6), inserted "or ephedrine, pseudoephedrine, or phenylpropanolamine" after "controlled substances in schedules I and II", "or of ephedrine, pseudoephedrine, or phenylpropanolamine" after "the manufacture of a controlled substance", and "or chemicals" after "such incidentally produced substances".

Subsec. (g). Pub. L. 109–177, §713(7), added subsec. (g).

1976—Subsec. (c). Pub. L. 94–273 substituted "October" for "July".

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see section 704(c) of Pub. L. 91–513, set out as a note under section 801 of this title.

Change to Editorial Heading in United States Code

Pub. L. 115–271, title III, §3282(b), Oct. 24, 2018, 132 Stat. 3955, provided that: "The Law Revision Counsel is directed to amend the heading for subsection (b) of section 826 of title 21, United States Code, by striking 'Production' and inserting 'Manufacturing'."

Coordination With United States Trade Representative

Pub. L. 109–177, title VII, §718, Mar. 9, 2006, 120 Stat. 267, provided that: "In implementing sections 713 through 717 and section 721 of this title [amending this section and sections 830, 842, 952, 960, and 971 of this title], the Attorney General shall consult with the United States Trade Representative to ensure implementation complies with all applicable international treaties and obligations of the United States."

§826a. Attorney General report on drug shortages

Not later than 6 months after July 9, 2012, and annually thereafter, the Attorney General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on the Judiciary of the Senate a report on drug shortages that—

(1) identifies the number of requests received under section 826(h) of this title (as added by section 1005 of this Act), the average review time for such requests, the number of requests granted and denied under such section, and, for each of the requests denied under such section, the basis for such denial;

(2) describes the coordination between the Drug Enforcement Administration and Food and Drug Administration on efforts to prevent or alleviate drug shortages; and

(3) identifies drugs containing a controlled substance subject to section 826 of this title when such a drug is determined by the Secretary to be in shortage.

(Pub. L. 112–144, title X, §1006, July 9, 2012, 126 Stat. 1105.)

Editorial Notes

References in Text

Section 1005 of this Act, referred to in par. (1), means section 1005 of Pub. L. 112–144, which amended section 826 of this title.

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Definition of "Secretary"

The term "Secretary" as meaning the Secretary of Health and Human Services, see section 1001(b) of Pub. L. 112–144, set out as an Effect of Notification note under section 356c of this title.

§827. Records and reports of registrants

(a) Inventory

Except as provided in subsection (c)—

(1) every registrant under this subchapter shall, on May 1, 1971, or as soon thereafter as such registrant first engages in the manufacture, distribution, or dispensing of controlled substances, and every second year thereafter, make a complete and accurate record of all stocks thereof on hand, except that the regulations prescribed under this section shall permit each such biennial inventory (following the initial inventory required by this paragraph) to be prepared on such registrant's regular general physical inventory date (if any) which is nearest to and does not vary by more than six months from the biennial date that would otherwise apply;

(2) on the effective date of each regulation of the Attorney General controlling a substance that immediately prior to such date was not a controlled substance, each registrant under this subchapter manufacturing, distributing, or dispensing such substance shall make a complete and accurate record of all stocks thereof on hand; and

(3) on and after May 1, 1971, every registrant under this subchapter manufacturing, distributing, or dispensing a controlled substance or substances shall maintain, on a current basis, a complete and accurate record of each such substance manufactured, received, sold, delivered, or otherwise disposed of by him, except that this paragraph shall not require the maintenance of a perpetual inventory.

(b) Availability of records

Every inventory or other record required under this section (1) shall be in accordance with, and contain such relevant information as may be required by, regulations of the Attorney General, (2) shall (A) be maintained separately from all other records of the registrant, or (B) alternatively, in the case of nonnarcotic controlled substances, be in such form that information required by the Attorney General is readily retrievable from the ordinary business records of the registrant, and (3) shall be kept and be available, for at least two years, for inspection and copying by officers or employees of the United States authorized by the Attorney General.

(c) Nonapplicability

The foregoing provisions of this section shall not apply—

(1)(A) to the prescribing of controlled substances in schedule II, III, IV, or V by practitioners acting in the lawful course of their professional practice unless such substance is prescribed in the course of maintenance or detoxification treatment of an individual; or

(B) to the administering of a controlled substance in schedule II, III, IV, or V unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges his patients, either separately or together with charges for other professional services, for substances so dispensed or administered or unless such substance is administered in the course of maintenance treatment or detoxification treatment of an individual;

(2)(A) to the use of controlled substances, at establishments registered under this subchapter which keep records with respect to such substances, in research conducted in conformity with an exemption granted under section 355(i) or 360b(j) of this title;

(B) to the use of controlled substances, at establishments registered under this subchapter which keep records with respect to such substances, in preclinical research or in teaching; or

(3) to the extent of any exemption granted to any person, with respect to all or part of such provisions, by the Attorney General by or pursuant to regulation on the basis of a finding that the application of such provisions (or part thereof) to such person is not necessary for carrying out the purposes of this subchapter.

Nothing in the Convention on Psychotropic Substances shall be construed as superseding or otherwise affecting the provisions of paragraph (1)(B), (2), or (3) of this subsection.

(d) Periodic reports to Attorney General

(1) Every manufacturer registered under section 823 of this title shall, at such time or times and in such form as the Attorney General may require, make periodic reports to the Attorney General of every sale, delivery or other disposal by him of any controlled substance, and each distributor shall make such reports with respect to narcotic controlled substances, identifying by the registration number assigned under this subchapter the person or establishment (unless exempt from registration under section 822(d) of this title) to whom such sale, delivery, or other disposal was made.

(2) Each pharmacy with a modified registration under section 823(g) of this title that authorizes the dispensing of controlled substances by means of the Internet shall report to the Attorney General the controlled substances it dispenses, in the amount specified, and in such time and manner as the Attorney General by regulation shall require, except that the Attorney General, under this paragraph, may not require any pharmacy to report any information other than the total quantity of each controlled substance that the pharmacy has dispensed each month. For purposes of this paragraph, no reporting shall be required unless the pharmacy has met 1 of the following thresholds in the month for which the reporting is required:

(A) 100 or more prescriptions dispensed.

(B) 5,000 or more dosage units of all controlled substances combined.

(e) Reporting and recordkeeping requirements of drug conventions

In addition to the reporting and recordkeeping requirements under any other provision of this subchapter, each manufacturer registered under section 823 of this title shall, with respect to narcotic and nonnarcotic controlled substances manufactured by it, make such reports to the Attorney General, and maintain such records, as the Attorney General may require to enable the United States to meet its obligations under articles 19 and 20 of the Single Convention on Narcotic Drugs and article 16 of the Convention on Psychotropic Substances. The Attorney General shall administer the requirements of this subsection in such a manner as to avoid the unnecessary imposition of duplicative requirements under this subchapter on manufacturers subject to the requirements of this subsection.

(f) Records and reports of registrants

(1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances:

(A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant.

(B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A).

(2) The information required to be made available under paragraph (1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates.

(3)(A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection.

(B) In determining whether to initiate proceedings under this subchapter against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this subchapter or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant.

(g) Investigational uses of drugs; procedures

Regulations under sections 355(i) and 360(j) of this title, relating to investigational use of drugs, shall include such procedures as the Secretary, after consultation with the Attorney General, determines are necessary to insure the security and accountability of controlled substances used in research to which such regulations apply.

(h) Change of address

Every registrant under this subchapter shall be required to report any change of professional or business address in such manner as the Attorney General shall by regulation require.

(i) Reporting requirements for GHB

In the case of a drug product containing gamma hydroxybutyric acid for which an application has been approved under section 355 of this title, the Attorney General may, in addition to any other requirements that apply under this section with respect to such a drug product, establish any of the following as reporting requirements:

(1) That every person who is registered as a manufacturer of bulk or dosage form, as a packager, repackager, labeler, relabeler, or distributor shall report acquisition and distribution transactions quarterly, not later than the 15th day of the month succeeding the quarter for which the report is submitted, and annually report end-of-year inventories.

(2) That all annual inventory reports shall be filed no later than January 15 of the year following that for which the report is submitted and include data on the stocks of the drug product, drug substance, bulk drug, and dosage forms on hand as of the close of business December 31, indicating whether materials reported are in storage or in process of manufacturing.

(3) That every person who is registered as a manufacturer of bulk or dosage form shall report all manufacturing transactions both inventory increases, including purchases, transfers, and returns, and reductions from inventory, including sales, transfers, theft, destruction, and seizure, and shall provide data on material manufactured, manufactured from other material, use in manufacturing other material, and use in manufacturing dosage forms.

(4) That all reports under this section must include the registered person's registration number as well as the registration numbers, names, and other identifying information of vendors, suppliers, and customers, sufficient to allow the Attorney General to track the receipt and distribution of the drug.

(5) That each dispensing practitioner shall maintain for each prescription the name of the prescribing practitioner, the prescribing practitioner's Federal and State registration numbers, with the expiration dates of these registrations, verification that the prescribing practitioner possesses the appropriate registration to prescribe this controlled substance, the patient's name and address, the name of the patient's insurance provider and documentation by a medical practitioner licensed and registered to prescribe the drug of the patient's medical need for the drug. Such information shall be available for inspection and copying by the Attorney General.

(6) That section 830(b)(3) of this title (relating to mail order reporting) applies with respect to gamma hydroxybutyric acid to the same extent and in the same manner as such section applies with respect to the chemicals and drug products specified in subparagraph (A)(i) of such section.

(j) Electronic reporting format

All of the reports required under this section shall be provided in an electronic format.

(Pub. L. 91–513, title II, §307, Oct. 27, 1970, 84 Stat. 1258; Pub. L. 93–281, §5, May 14, 1974, 88 Stat. 125; Pub. L. 95–633, title I, §§104, 110, Nov. 10, 1978, 92 Stat. 3772, 3773; Pub. L. 98–473, title II, §§514, 515, Oct. 12, 1984, 98 Stat. 2074; Pub. L. 106–172, §4, Feb. 18, 2000, 114 Stat. 9; Pub. L. 110–425, §3(c), Oct. 15, 2008, 122 Stat. 4824; Pub. L. 115–271, title III, §3273(a), Oct. 24, 2018, 132 Stat. 3952; Pub. L. 117–215, title I, §103(b)(1)(D), Dec. 2, 2022, 136 Stat. 2263.)

Editorial Notes

References in Text

Schedules II, III, IV, and V, referred to in subsec. (c), are set out in section 812(c) of this title.

Amendments

2022—Subsec. (d)(2). Pub. L. 117–215 substituted "823(g)" for "823(f)" in introductory provisions.

2018—Subsecs. (f) to (i). Pub. L. 115–271, §3273(a)(1), (2), added subsec. (f) and redesignated former subsecs. (f) to (h) as (g) to (i), respectively.

Subsec. (j). Pub. L. 115–271, §3273(a)(3), added subsec. (j).

2008—Subsec. (d). Pub. L. 110–425 designated existing provisions as par. (1) and added par. (2).

2000—Subsec. (h). Pub. L. 106–172 added subsec. (h).

1984—Subsec. (c)(1)(A). Pub. L. 98–473, §514(a), substituted "to the prescribing of controlled substances in schedule II, III, IV, or V by practitioners acting in the lawful course of their professional practice unless such substance is prescribed in the course of maintenance or detoxification treatment of an individual" for "with respect to any narcotic controlled substance in schedule II, III, IV, or V, to the prescribing or administering of such substance by a practitioner in the lawful course of his professional practice unless such substance was prescribed or administered in the course of maintenance treatment or detoxification treatment of an individual".

Subsec. (c)(1)(B). Pub. L. 98–473, §514(b), substituted "to the administering of a controlled substance in schedule II, III, IV, or V unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges his patients, either separately or together with charges for other professional services, for substances so dispensed or administered or unless such substance is administered in the course of maintenance treatment or detoxification treatment of an individual" for "with respect to nonnarcotic controlled substances in schedule II, III, IV, or V, to any practitioner who dispenses such substances to his patients, unless the practitioner is regularly engaged in charging his patients, either separately or together with charges for other professional services, for substances so dispensed".

Subsec. (g). Pub. L. 98–473, §515, added subsec. (g).

1978—Subsec. (c). Pub. L. 95–633, §110, inserted provision following par. (3) relating to the construction of the Convention on Psychotropic Substances.

Subsecs. (e), (f). Pub. L. 95–633 added subsec. (e) and redesignated former subsec. (e) as (f).

1974—Subsec. (c)(1)(A). Pub. L. 93–281 substituted "any narcotic controlled substance" for "narcotic controlled substances" and made section applicable to any narcotic controlled substance prescribed or administered in the course of maintenance treatment or detoxification treatment of an individual.

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Purpose

Pub. L. 115–271, title III, §3272, Oct. 24, 2018, 132 Stat. 3952, provided that:

"(a) In General.—The purpose of this chapter [see section 3271 of Pub. L. 115–271, set out as a Short Title of 2018 Amendment note under section 801 of this title] is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates.

"(b) Rule of Construction.—Nothing in this chapter should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to—

"(1) identify, stop, and report suspicious orders; or

"(2) maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (21 U.S.C. 823) or any successor law or associated regulation."

§828. Order forms

(a) Unlawful distribution of controlled substances

It shall be unlawful for any person to distribute a controlled substance in schedule I or II to another except in pursuance of a written order of the person to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with subsection (d) and regulations prescribed by him pursuant to this section.

(b) Nonapplicability of provisions

Nothing in subsection (a) shall apply to—

(1) the exportation of such substances from the United States in conformity with subchapter II;

(2) the delivery of such a substance to or by a common or contract carrier for carriage in the lawful and usual course of its business, or to or by a warehouseman for storage in the lawful and usual course of its business; but where such carriage or storage is in connection with the distribution by the owner of the substance to a third person, this paragraph shall not relieve the distributor from compliance with subsection (a); or

(3) the delivery of such a substance for the purpose of disposal by an ultimate user, long-term care facility, or other person acting in accordance with section 822(g) of this title.

(c) Preservation and availability

(1) Every person who in pursuance of an order required under subsection (a) distributes a controlled substance shall preserve such order for a period of two years, and shall make such order available for inspection and copying by officers and employees of the United States duly authorized for that purpose by the Attorney General, and by officers or employees of States or their political subdivisions who are charged with the enforcement of State or local laws regulating the production, or regulating the distribution or dispensing, of controlled substances and who are authorized under such laws to inspect such orders.

(2) Every person who gives an order required under subsection (a) shall, at or before the time of giving such order, make or cause to be made a duplicate thereof on a form to be issued by the Attorney General in blank in accordance with subsection (d) and regulations prescribed by him pursuant to this section, and shall, if such order is accepted, preserve such duplicate for a period of two years and make it available for inspection and copying by the officers and employees mentioned in paragraph (1) of this subsection.

(d) Issuance

(1) The Attorney General shall issue forms pursuant to subsections (a) and (c)(2) only to persons validly registered under section 823 of this title (or exempted from registration under section 822(d) of this title). Whenever any such form is issued to a person, the Attorney General shall, before delivery thereof, insert therein the name of such person, and it shall be unlawful for any other person (A) to use such form for the purpose of obtaining controlled substances or (B) to furnish such form to any person with intent thereby to procure the distribution of such substances.

(2) The Attorney General may charge reasonable fees for the issuance of such forms in such amounts as he may prescribe for the purpose of covering the cost to the United States of issuing such forms, and other necessary activities in connection therewith.

(e) Unlawful acts

It shall be unlawful for any person to obtain by means of order forms issued under this section controlled substances for any purpose other than their use, distribution, dispensing, or administration in the conduct of a lawful business in such substances or in the course of his professional practice or research.

(Pub. L. 91–513, title II, §308, Oct. 27, 1970, 84 Stat. 1259; Pub. L. 111–273, §3(b), Oct. 12, 2010, 124 Stat. 2860.)

Editorial Notes

References in Text

Schedules I and II, referred to in subsec. (a), are set out in section 812(c) of this title.

Amendments

2010—Subsec. (b)(3). Pub. L. 111–273 added par. (3).

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

§829. Prescriptions

(a) Schedule II substances

Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act [21 U.S.C. 353(b)]. Prescriptions shall be retained in conformity with the requirements of section 827 of this title. No prescription for a controlled substance in schedule II may be refilled.

(b) Schedule III and IV substances

Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [21 U.S.C. 353(b)]. Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.

(c) Schedule V substances

No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose.

(d) Non-prescription drugs with abuse potential

Whenever it appears to the Attorney General that a drug not considered to be a prescription drug under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] should be so considered because of its abuse potential, he shall so advise the Secretary and furnish to him all available data relevant thereto.

(e) Controlled substances dispensed by means of the Internet

(1) No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.

(2) As used in this subsection:

(A) The term "valid prescription" means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—

(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or

(ii) a covering practitioner.

(B)(i) The term "in-person medical evaluation" means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.

(ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.

(C) The term "covering practitioner" means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who—

(i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and

(ii) is temporarily unavailable to conduct the evaluation of the patient.

(3) Nothing in this subsection shall apply to—

(A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; or

(B) the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion.

(f) Partial fills of schedule II controlled substances

(1) Partial fills

A prescription for a controlled substance in schedule II may be partially filled if—

(A) it is not prohibited by State law;

(B) the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and State law;

(C) the partial fill is requested by the patient or the practitioner that wrote the prescription; and

(D) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.

(2) Remaining portions

(A) In general

Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—

(i) may be filled; and

(ii) shall be filled not later than 30 days after the date on which the prescription is written.

(B) Emergency situations

In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II—

(i) may be filled; and

(ii) shall be filled not later than 72 hours after the prescription is issued.

(3) Currently lawful partial fills

Notwithstanding paragraph (1) or (2), in any circumstance in which, as of the day before July 22, 2016, a prescription for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled.

(Pub. L. 91–513, title II, §309, Oct. 27, 1970, 84 Stat. 1260; Pub. L. 110–425, §2, Oct. 15, 2008, 122 Stat. 4820; Pub. L. 114–198, title VII, §702(a), July 22, 2016, 130 Stat. 740.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a), (b), (d), and (e)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Schedules II, III, IV, and V, referred to in subsecs. (a) to (c), are set out in section 812(c) of this title.

Amendments

2016—Subsec. (f). Pub. L. 114–198 added subsec. (f).

2008—Subsec. (e). Pub. L. 110–425 added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Construction of 2016 Amendment

Pub. L. 114–198, title VII, §702(b), July 22, 2016, 130 Stat. 741, provided that: "Nothing in this section [amending this section] shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to be partially filled."

Dispensation of Narcotic Drugs for the Purpose of Relieving Acute Withdrawal Symptoms From Opioid Use Disorder

Pub. L. 116–215, div. B, title III, §1302, Dec. 11, 2020, 134 Stat. 1046, provided that: "Not later than 180 days after the date of enactment of this Act [Dec. 11, 2020], the Attorney General shall revise section 1306.07(b) of title 21, Code of Federal Regulations, so that practitioners, in accordance with applicable State, Federal, or local laws relating to controlled substances, are allowed to dispense not more than a three-day supply of narcotic drugs to one person or for one person's use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both)."

Programs and Materials for Training on Certain Circumstances Under Which a Pharmacist May Decline To Fill a Prescription

Pub. L. 115–271, title III, §3212, Oct. 24, 2018, 132 Stat. 3947, as amended by Pub. L. 117–328, div. FF, title I, §1271(a), Dec. 29, 2022, 136 Stat. 5685, provided that:

"(a) In General.—The Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate not later than 1 year after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022 [Dec. 29, 2022], and update periodically thereafter, as appropriate, materials for pharmacists, health care providers, and patients on—

"(1) circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act (21 U.S.C. 829) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and

"(2) other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances.

"(b) Materials Included.—In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for—

"(1) pharmacists on how to verify the identity of the patient;

"(2) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and

"(3) other health care practitioners and the public on a pharmacist's ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)).

"(c) Stakeholder Input.—In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain.

"(d) Materials for Training on Verification of Identity.—Not later than 1 year after the date of enactment of this subsection [Dec. 29, 2022], the Secretary of Health and Human Services, after seeking stakeholder input in accordance with subsection (c), shall—

"(1) update the materials developed under subsection (a) to include information for pharmacists on how to verify the identity of the patient; and

"(2) disseminate, as appropriate, the updated materials."

Effect of Scheduling on Prescriptions

Pub. L. 101–647, title XIX, §1902(c), Nov. 29, 1990, 104 Stat. 4852, provided that any prescription for anabolic steroids subject to refill on or after Nov. 29, 1990, could be refilled without restriction under subsec. (a) of this section.

§829a. Delivery of a controlled substance by a pharmacy to an administering practitioner

(a) In general

Notwithstanding section 802(10) of this title, a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this subchapter and the regulations issued by the Attorney General under this subchapter, for the purpose of administering the controlled substance by the practitioner if—

(1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner's certificate of registration issued under this subchapter;

(2) the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;

(3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place;

(4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;

(5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 45 days after the date of receipt of the controlled substance by the practitioner; and

(6) notwithstanding any exceptions under section 827 of this title, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General.

(b) Modification of number of days before which controlled substance shall be administered

(1) Initial 2-year period

During the 2-year period beginning on October 24, 2018, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will—

(A) reduce the risk of diversion; or

(B) protect the public health.

(2) Modifications after submission of report

After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5).

(3) Minimum number of days

Any modification under this subsection shall be for a period of not less than 7 days.

(Pub. L. 91–513, title II, §309A, as added Pub. L. 115–271, title III, §3204(a), Oct. 24, 2018, 132 Stat. 3945; amended Pub. L. 117–215, title I, §103(b)(1)(E), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §§1262(b)(2), 1264, Dec. 29, 2022, 136 Stat. 5682, 5685.)

Editorial Notes

References in Text

Section 3204(b) of the SUPPORT for Patients and Communities Act, referred to in subsec. (b)(2), is section 3204(b) of Pub. L. 115–271, title III, Oct. 24, 2018, 132 Stat. 3946, which is not classified to the Code.

Amendments

2022—Subsec. (a)(2). Pub. L. 117–328, §1262(b)(2), which directed substitution of "the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;" for "the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 823(g)(2) and—"

"(A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and

"(B) the controlled substance is to be administered by injection or implantation;"

was executed by making the substitution for "the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 823(h)(2) and—" and subpars. (A) and (B), to reflect the probable intent of Congress and the intervening amendment by Pub. L. 117–215. See Amendment note below.

Pub. L. 117–215 substituted "823(h)(2)" for "823(g)(2)" in introductory provisions.

Subsec. (a)(5). Pub. L. 117–328, §1264, substituted "45 days" for "14 days".

§830. Regulation of listed chemicals and certain machines

(a) Record of regulated transactions

(1) Each regulated person who engages in a regulated transaction involving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction.

(2) A record under this subsection shall be retrievable and shall include the date of the regulated transaction, the identity of each party to the regulated transaction, a statement of the quantity and form of the listed chemical, a description of the tableting machine or encapsulating machine, and a description of the method of transfer. Such record shall be available for inspection and copying by the Attorney General.

(3) It is the duty of each regulated person who engages in a regulated transaction to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph.

(b) Reports to Attorney General

(1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation—

(A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this subchapter;

(B) any proposed regulated transaction with a person whose description or other identifying characteristic the Attorney General furnishes in advance to the regulated person;

(C) any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person; and

(D) any regulated transaction in a tableting machine or an encapsulating machine.

Each report under subparagraph (A) shall be made at the earliest practicable opportunity after the regulated person becomes aware of the circumstance involved. A regulated person may not complete a transaction with a person whose description or identifying characteristic is furnished to the regulated person under subparagraph (B) unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guidance documents describing transactions and circumstances for which reports are required under subparagraph (A) and subparagraph (C).

(2) A regulated person that manufactures a listed chemical shall report annually to the Attorney General, in such form and manner and containing such specific data as the Attorney General shall prescribe by regulation, information concerning listed chemicals manufactured by the person. The requirement of the preceding sentence shall not apply to the manufacture of a drug product that is exempted under section 802(39)(A)(iv) of this title.

(3) Mail order reporting.—(A) As used in this paragraph:

(i) The term "drug product" means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act ¹ [21 U.S.C. 301 et seq.] for distribution in the United States.

(ii) The term "valid prescription" means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner's professional practice.

(B) Each regulated person who engages in a transaction with a nonregulated person or who engages in an export transaction which—

(i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and

(ii) uses or attempts to use the Postal Service or any private or commercial carrier;

shall, on a monthly basis, submit a report of each such transaction conducted during the previous month to the Attorney General in such form, containing such data, and at such times as the Attorney General shall establish by regulation.

(C) The data required for such reports shall include—

(i) the name of the purchaser;

(ii) the quantity and form of the ephedrine, pseudoephedrine, or phenylpropanolamine purchased; and

(iii) the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent.

(D) Except as provided in subparagraph (E), the following distributions to a nonregulated person, and the following export transactions, shall not be subject to the reporting requirement in subparagraph (B):

(i) Distributions of sample packages of drug products when such packages contain not more than two solid dosage units or the equivalent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30-day period.

(ii) Distributions of drug products by retail distributors that may not include face-to-face transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as specified in section 802(49) of this title, except that this clause does not apply to sales of scheduled listed chemical products at retail.

(iii) Distributions of drug products to a resident of a long term care facility (as that term is defined in regulations prescribed by the Attorney General) or distributions of drug products to a long term care facility for dispensing to or for use by a resident of that facility.

(iv) Distributions of drug products pursuant to a valid prescription.

(v) Exports which have been reported to the Attorney General pursuant to section 954 or 971 of this title or which are subject to a waiver granted under section 971(f)(2) of this title.

(vi) Any quantity, method, or type of distribution or any quantity, method, or type of distribution of a specific listed chemical (including specific formulations or drug products) or of a group of listed chemicals (including specific formulations or drug products) which the Attorney General has excluded by regulation from such reporting requirement on the basis that such reporting is not necessary for the enforcement of this subchapter or subchapter II.

(E) The Attorney General may revoke any or all of the exemptions listed in subparagraph (D) for an individual regulated person if he finds that drug products distributed by the regulated person are being used in violation of this subchapter or subchapter II. The regulated person shall be notified of the revocation, which will be effective upon receipt by the person of such notice, as provided in section 971(c)(1) of this title, and shall have the right to an expedited hearing as provided in section 971(c)(2) of this title.

(c) Confidentiality of information obtained by Attorney General; non-disclosure; exceptions

(1) Except as provided in paragraph (2), any information obtained by the Attorney General under this section which is exempt from disclosure under section 552(a) of title 5, by reason of section 552(b)(4) of such title, is confidential and may not be disclosed to any person.

(2) Information referred to in paragraph (1) may be disclosed only—

(A) to an officer or employee of the United States engaged in carrying out this subchapter, subchapter II, or the customs laws;

(B) when relevant in any investigation or proceeding for the enforcement of this subchapter, subchapter II, or the customs laws;

(C) when necessary to comply with an obligation of the United States under a treaty or other international agreement; or

(D) to a State or local official or employee in conjunction with the enforcement of controlled substances laws or chemical control laws.

(3) The Attorney General shall—

(A) take such action as may be necessary to prevent unauthorized disclosure of information by any person to whom such information is disclosed under paragraph (2); and

(B) issue guidelines that limit, to the maximum extent feasible, the disclosure of proprietary business information, including the names or identities of United States exporters of listed chemicals, to any person to whom such information is disclosed under paragraph (2).

(4) Any person who is aggrieved by a disclosure of information in violation of this section may bring a civil action against the violator for appropriate relief.

(5) Notwithstanding paragraph (4), a civil action may not be brought under such paragraph against investigative or law enforcement personnel of the Drug Enforcement Administration.

(d) Scheduled listed chemicals; restrictions on sales quantity; requirements regarding nonliquid forms

With respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product—

(1) the quantity of such base sold at retail in such a product by a regulated seller, or a distributor required to submit reports by subsection (b)(3) may not, for any purchaser, exceed a daily amount of 3.6 grams, without regard to the number of transactions; and

(2) such a seller or distributor may not sell such a product in nonliquid form (including gel caps) at retail unless the product is packaged in blister packs, each blister containing not more than 2 dosage units, or where the use of blister packs is technically infeasible, the product is packaged in unit dose packets or pouches.

(e) Scheduled listed chemicals; behind-the-counter access; logbook requirement; training of sales personnel; privacy protections

(1) Requirements regarding retail transactions

(A) In general

Each regulated seller shall ensure that, subject to subparagraph (F), sales by such seller of a scheduled listed chemical product at retail are made in accordance with the following:

(i) In offering the product for sale, the seller places the product such that customers do not have direct access to the product before the sale is made (in this paragraph referred to as "behind-the-counter" placement). For purposes of this paragraph, a behind-the-counter placement of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the facility involved to which customers do have direct access.

(ii) The seller delivers the product directly into the custody of the purchaser.

(iii) The seller maintains, in accordance with criteria issued by the Attorney General, a written or electronic list of such sales that identifies the products by name, the quantity sold, the names and addresses of purchasers, and the dates and times of the sales (which list is referred to in this subsection as the "logbook"), except that such requirement does not apply to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine.

(iv) In the case of a sale to which the requirement of clause (iii) applies, the seller does not sell such a product unless the sale is made in accordance with the following:

(I) The prospective purchaser—

(aa) presents an identification card that provides a photograph and is issued by a State or the Federal Government, or a document that, with respect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (as in effect on or after March 9, 2006); and

(bb) signs the written logbook and enters in the logbook his or her name, address, and the date and time of the sale, or for transactions involving an electronic logbook, the purchaser provides a signature using one of the following means:

(AA) Signing a device presented by the seller that captures signatures in an electronic format. Such device shall display the notice described in clause (v). Any device used shall preserve each signature in a manner that clearly links that signature to the other electronically-captured logbook information relating to the prospective purchaser providing that signature.

(BB) Signing a bound paper book. Such bound paper book shall include, for such purchaser, either (aaa) a printed sticker affixed to the bound paper book at the time of sale which either displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale, or a unique identifier which can be linked to that electronic information, or (bbb) a unique identifier which can be linked to that information and which is written into the book by the seller at the time of sale. The purchaser shall sign adjacent to the printed sticker or written unique identifier related to that sale. Such bound paper book shall display the notice described in clause (v).

(CC) Signing a printed document that includes, for such purchaser, the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale. Such document shall be printed by the seller at the time of the sale. Such document shall contain a clearly identified signature line for a purchaser to sign. Such printed document shall display the notice described in clause (v). Each signed document shall be inserted into a binder or other secure means of document storage immediately after the purchaser signs the document.

(II) The seller enters in the logbook the name of the product and the quantity sold. Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.

(III) The logbook maintained by the seller includes the prospective purchaser's name, address, and the date and time of the sale, as follows:

(aa) If the purchaser enters the information, the seller must determine that the name entered in the logbook corresponds to the name provided on such identification and that the date and time entered are correct.

(bb) If the seller enters the information, the prospective purchaser must verify that the information is correct.

(cc) Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.

(v) The written or electronic logbook includes, in accordance with criteria of the Attorney General, a notice to purchasers that entering false statements or misrepresentations in the logbook, or supplying false information or identification that results in the entry of false statements or misrepresentations, may subject the purchasers to criminal penalties under section 1001 of title 18, which notice specifies the maximum fine and term of imprisonment under such section.

(vi) Regardless of whether the logbook entry is written or electronic, the seller maintains each entry in the logbook for not fewer than 2 years after the date on which the entry is made.

(vii) In the case of individuals who are responsible for delivering such products into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products, the seller has submitted to the Attorney General a self-certification that all such individuals have, in accordance with criteria under subparagraph (B)(ii), undergone training provided by the seller to ensure that the individuals understand the requirements that apply under this subsection and subsection (d).

(viii) The seller maintains a copy of such certification and records demonstrating that individuals referred to in clause (vii) have undergone the training.

(ix) If the seller is a mobile retail vendor:

(I) The seller complies with clause (i) by placing the product in a locked cabinet.

(II) The seller does not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.

(B) Additional provisions regarding certifications and training

(i) In general

A regulated seller may not sell any scheduled listed chemical product at retail unless the seller has submitted to the Attorney General the self-certification referred to in subparagraph (A)(vii). The certification is not effective for purposes of the preceding sentence unless, in addition to provisions regarding the training of individuals referred to in such subparagraph, the certification includes a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements.

(ii) Issuance of criteria; self-certification

The Attorney General shall by regulation establish criteria for certifications under this paragraph. The criteria shall—

(I) provide that the certifications are self-certifications provided through the program under clause (iii);

(II) provide that a separate certification is required for each place of business at which a regulated seller sells scheduled listed chemical products at retail; and

(III) include criteria for training under subparagraph (A)(vii).

(iii) Program for regulated sellers

The Attorney General shall establish a program regarding such certifications and training in accordance with the following:

(I) The program shall be carried out through an Internet site of the Department of Justice and such other means as the Attorney General determines to be appropriate.

(II) The program shall inform regulated sellers that section 1001 of title 18 applies to such certifications.

(III) The program shall make available to such sellers an explanation of the criteria under clause (ii).

(IV) The program shall be designed to permit the submission of the certifications through such Internet site.

(V) The program shall be designed to automatically provide the explanation referred to in subclause (III), and an acknowledgement that the Department has received a certification, without requiring direct interactions of regulated sellers with staff of the Department (other than the provision of technical assistance, as appropriate).

(iv) Availability of certification to State and local officials

Promptly after receiving a certification under subparagraph (A)(vii), the Attorney General shall make available a copy of the certification to the appropriate State and local officials.

(v) Publication of list of self-certified persons

The Attorney General shall develop and make available a list of all persons who are currently self-certified in accordance with this section. This list shall be made publicly available on the website of the Drug Enforcement Administration in an electronically downloadable format.

(C) Privacy protections

In order to protect the privacy of individuals who purchase scheduled listed chemical products, the Attorney General shall by regulation establish restrictions on disclosure of information in logbooks under subparagraph (A)(iii). Such regulations shall—

(i) provide for the disclosure of the information as appropriate to the Attorney General and to State and local law enforcement agencies; and

(ii) prohibit accessing, using, or sharing information in the logbooks for any purpose other than to ensure compliance with this subchapter or to facilitate a product recall to protect public health and safety.

(D) False statements or misrepresentations by purchasers

For purposes of section 1001 of title 18, entering information in the logbook under subparagraph (A)(iii) shall be considered a matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States.

(E) Good faith protection

A regulated seller who in good faith releases information in a logbook under subparagraph (A)(iii) to Federal, State, or local law enforcement authorities is immune from civil liability for such release unless the release constitutes gross negligence or intentional, wanton, or willful misconduct.

(F) Inapplicability of requirements to certain sales

Subparagraph (A) does not apply to the sale at retail of a scheduled listed chemical product if a report on the sales transaction is required to be submitted to the Attorney General under subsection (b)(3).

(G) Certain measures regarding theft and diversion

A regulated seller may take reasonable measures to guard against employing individuals who may present a risk with respect to the theft and diversion of scheduled listed chemical products, which may include, notwithstanding State law, asking applicants for employment whether they have been convicted of any crime involving or related to such products or controlled substances.

(2) Mail-order reporting; verification of identity of purchaser; 30-day restriction on quantities for individual purchasers

Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General is subject to the following:

(A) The person shall, prior to shipping the product, confirm the identity of the purchaser in accordance with procedures established by the Attorney General. The Attorney General shall by regulation establish such procedures.

(B) The person may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.

(C) Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General may not sell any scheduled listed chemical product at retail unless such regulated person has submitted to the Attorney General a self-certification including a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements. The Attorney General shall by regulation establish criteria for certifications of mail-order distributors that are consistent with the criteria established for the certifications of regulated sellers under paragraph (1)(B).

(3) Exemptions for certain products

Upon the application of a manufacturer of a scheduled listed chemical product, the Attorney General may by regulation provide that the product is exempt from the provisions of subsection (d) and paragraphs (1) and (2) of this subsection if the Attorney General determines that the product cannot be used in the illicit manufacture of methamphetamine.

(Pub. L. 91–513, title II, §310, as added Pub. L. 95–633, title II, §202(a), Nov. 10, 1978, 92 Stat. 3774; amended Pub. L. 100–690, title VI, §6052(a), Nov. 18, 1988, 102 Stat. 4312; Pub. L. 103–200, §§2(c), 10, Dec. 17, 1993, 107 Stat. 2336, 2341; Pub. L. 104–237, title II, §208, title IV, §402, Oct. 3, 1996, 110 Stat. 3104, 3111; Pub. L. 106–310, div. B, title XXXVI, §3652, Oct. 17, 2000, 114 Stat. 1239; Pub. L. 109–177, title VII, §§711(a)(2)(B), (b)(1), (c)(1), (2), (d), 716(b)(2), Mar. 9, 2006, 120 Stat. 257, 261, 267; Pub. L. 110–415, §2, Oct. 14, 2008, 122 Stat. 4349; Pub. L. 111–268, §§2, 3, Oct. 12, 2010, 124 Stat. 2847.)

Editorial Notes

References in Text

The Food, Drug, and Cosmetic Act, referred to in subsec. (b)(3)(A)(i), probably means the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This subchapter, referred to in subsecs. (b)(3)(D)(vi), (E) and (e)(1)(C)(ii), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Subchapter II, referred to in subsecs. (b)(3)(D)(iv), (E) and (c)(2)(A), (B), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Amendments

2010—Subsec. (e)(1)(B)(v). Pub. L. 111–268, §3, added cl. (v).

Subsec. (e)(2)(C). Pub. L. 111–268, §2, added subpar. (C).

2008—Subsec. (e)(1)(A)(iv) to (vi). Pub. L. 110–415 added cls. (iv) to (vi) and struck out former cls. (iv) to (vi) which related to procedures for sales subject to the logbook requirement.

2006—Subsec. (b)(3)(D)(ii). Pub. L. 109–177, §711(c)(2), inserted ", except that this clause does not apply to sales of scheduled listed chemical products at retail" before period at end.

Pub. L. 109–177, §711(a)(2)(B), substituted "section 802(49)" for "section 802(46)".

Subsec. (b)(3)(D)(v). Pub. L. 109–177, §716(b)(2), substituted "section 971(f)(2)" for "section 971(e)(2)".

Subsec. (d). Pub. L. 109–177, §711(b)(1), added subsec. (d).

Subsec. (e)(1). Pub. L. 109–177, §711(b)(1), added subsec. heading and par. (1).

Subsec. (e)(2). Pub. L. 109–177, §711(c)(1), added par. (2).

Subsec. (e)(3). Pub. L. 109–177, §711(d), added par. (3).

2000—Subsec. (b)(3). Pub. L. 106–310 added subpars. (A), (D), and (E), redesignated former subpars. (A) and (B) as (B) and (C), respectively, and inserted "or who engages in an export transaction" after "nonregulated person" in introductory provisions of subpar. (B).

1996—Subsec. (a)(1). Pub. L. 104–237, §208, substituted "for two years after the date of the transaction." for the dash after "record of the transaction" and struck out subpars. (A) and (B) which read as follows:

"(A) for 4 years after the date of the transaction, if the listed chemical is a list I chemical or if the transaction involves a tableting machine or an encapsulating machine; and

"(B) for 2 years after the date of the transaction, if the listed chemical is a list II chemical."

Subsec. (b)(3). Pub. L. 104–237, §402, added par. (3).

1993—Subsec. (a)(1). Pub. L. 103–200, §2(c)(1), substituted "list I chemical" for "precursor chemical" in subpar. (A) and "a list II chemical" for "an essential chemical" in subpar. (B).

Subsec. (b). Pub. L. 103–200, §10, designated existing provisions as par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, in concluding provisions, substituted "subparagraph (A)" for "paragraph (1)" in two places, "subparagraph (B)" for "paragraph (2)", and "subparagraph (C)" for "paragraph (3)", and added par. (2).

Subsec. (c)(2)(D). Pub. L. 103–200, §2(c)(2), substituted "chemical control laws" for "precursor chemical laws".

1988—Pub. L. 100–690 amended section generally, substituting provisions relating to regulation of listed chemicals and certain machines for provisions relating to reporting by any person who distributes, sells, or imports any piperidine.

Statutory Notes and Related Subsidiaries

Effective Date of 2010 Amendment

Pub. L. 111–268, §6(a), Oct. 12, 2010, 124 Stat. 2848, provided that: "This Act [amending this section and section 842 of this title and enacting provisions set out as notes under this section and section 801 of this title] and the amendments made by this Act shall take effect 180 days after the date of enactment of this Act [Oct. 12, 2010]."

Effective Date of 2006 Amendment

Pub. L. 109–177, title VII, §711(b)(2), Mar. 9, 2006, 120 Stat. 261, provided that: "With respect to subsections (d) and (e)(1) of section 310 of the Controlled Substances Act [21 U.S.C. 830(d), (e)(1)], as added by paragraph (1) of this subsection:

"(A) Such subsection (d) applies on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006].

"(B) Such subsection (e)(1) applies on and after September 30, 2006."

Pub. L. 109–177, title VII, §711(c)(3), Mar. 9, 2006, 120 Stat. 261, provided that: "The amendments made by paragraphs (1) and (2) [amending this section] apply on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006]."

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date; Time To Submit Piperidine Report; Required Information

Pub. L. 95–633, title II, §203(a), Nov. 10, 1978, 92 Stat. 3776, provided that:

"(1) Except as provided under paragraph (2), the amendments made by this title [enacting this section and amending sections 841 to 843 of this title] shall take effect on the date of the enactment of this Act [Nov. 10, 1978].

"(2) Any person required to submit a report under section 310(a)(1) of the Controlled Substances Act [subsec. (a)(1) of this section] respecting a distribution, sale, or importation of piperidine during the 90 days after the date of the enactment of this Act [Nov. 10, 1978] may submit such report any time up to 97 days after such date of enactment.

"(3) Until otherwise provided by the Attorney General by regulation, the information required to be reported by a person under section 310(a)(1) of the Controlled Substances Act (as added by section 202(a)(2) of this title) [subsec. (a)(1) of this section] with respect to the person's distribution, sale, or importation of piperidine shall—

"(A) be the information described in subparagraphs (A) and (B) of such section, and

"(B) except as provided in paragraph (2) of this subsection, be reported not later than seven days after the date of such distribution, sale, or importation."

Repeals

Pub. L. 96–359, §8(b), Sept. 26, 1980, 94 Stat. 1194, repealed section 203(d) of Pub. L. 95–633, which had provided for the repeal of this section effective Jan. 1, 1981.

Regulations

Pub. L. 111–268, §6(b), Oct. 12, 2010, 124 Stat. 2848, provided that: "In promulgating the regulations authorized by section 2 [amending this section], the Attorney General may issue regulations on an interim basis as necessary to ensure the implementation of this Act by the effective date [see Effective Date of 2010 Amendment note above]."

Pub. L. 95–633, title II, §203(b), Nov. 10, 1978, 92 Stat. 3777, required the Attorney General to publish proposed interim regulations for piperidine reporting under section 830(a) of this title not later than 30 days after enactment, and final interim regulations not later than 75 days after enactment, such final interim regulations to be effective on and after the ninety-first day after enactment.

Report to President and Congress on Effectiveness of Title II of Pub. L. 95–633

Pub. L. 95–633, title II, §203(c), Nov. 10, 1978, 92 Stat. 3777, required the Attorney General to analyze and evaluate the impact and effectiveness of the amendments made by title II of Pub. L. 95–633, and report to the President and Congress not later than Mar. 1, 1980.

¹ See References in Text note below.

§831. Additional requirements relating to online pharmacies and telemedicine

(a) In general

An online pharmacy shall display in a visible and clear manner on its homepage a statement that it complies with the requirements of this section with respect to the delivery or sale or offer for sale of controlled substances and shall at all times display on the homepage of its Internet site a declaration of compliance in accordance with this section.

(b) Licensure

Each online pharmacy shall comply with the requirements of State law concerning the licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses or offers to deliver, distribute, or dispense controlled substances by means of the Internet, pursuant to applicable licensure requirements, as determined by each such State.

(c) Internet pharmacy site disclosure information

Each online pharmacy shall post in a visible and clear manner on the homepage of each Internet site it operates, or on a page directly linked thereto in which the hyperlink is also visible and clear on the homepage, the following information for each pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on behalf of, that website:

(1) The name and address of the pharmacy as it appears on the pharmacy's Drug Enforcement Administration certificate of registration.

(2) The pharmacy's telephone number and email address.

(3) The name, professional degree, and States of licensure of the pharmacist-in-charge, and a telephone number at which the pharmacist-in-charge can be contacted.

(4) A list of the States in which the pharmacy is licensed to dispense controlled substances.

(5) A certification that the pharmacy is registered under this part to deliver, distribute, or dispense by means of the Internet controlled substances.

(6) The name, address, telephone number, professional degree, and States of licensure of any practitioner who has a contractual relationship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the website or at the request of the owner or operator of the website, or any employee or agent thereof.

(7) The following statement, unless revised by the Attorney General by regulation: "This online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation or medical evaluation via telemedicine in accordance with applicable requirements of section 309.".

(d) Notification

(1) In general

Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing, the online pharmacy shall notify the Attorney General, in such form and manner as the Attorney General shall determine, and the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances.

(2) Contents

The notification required under paragraph (1) shall include—

(A) the information required to be posted on the online pharmacy's Internet site under subsection (c) and shall notify the Attorney General and the applicable State boards of pharmacy, under penalty of perjury, that the information disclosed on its Internet site under subsection (c) is true and accurate;

(B) the online pharmacy's Internet site address and a certification that the online pharmacy shall notify the Attorney General of any change in the address at least 30 days in advance; and

(C) the Drug Enforcement Administration registration numbers of any pharmacies and practitioners referred to in subsection (c), as applicable.

(3) Existing online pharmacies

An online pharmacy that is already operational as of the effective date of this section, shall notify the Attorney General and applicable State boards of pharmacy in accordance with this subsection not later than 30 days after such date.

(e) Declaration of compliance

On and after the date on which it makes the notification under subsection (d), each online pharmacy shall display on the homepage of its Internet site, in such form as the Attorney General shall by regulation require, a declaration that it has made such notification to the Attorney General.

(f) Reports

Any statement, declaration, notification, or disclosure required under this section shall be considered a report required to be kept under this part.

(g) Notice and designations concerning Indian tribes

(1) In general

For purposes of sections 802(52) and 882(c)(6)(B) of this title, the Secretary shall notify the Attorney General, at such times and in such manner as the Secretary and the Attorney General determine appropriate, of the Indian tribes or tribal organizations with which the Secretary has contracted or compacted under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.] for the tribes or tribal organizations to provide pharmacy services.

(2) Designations

(A) In general

The Secretary may designate a practitioner described in subparagraph (B) as an Internet Eligible Controlled Substances Provider. Such designations shall be made only in cases where the Secretary has found that there is a legitimate need for the practitioner to be so designated because the population served by the practitioner is in a sufficiently remote location that access to medical services is limited.

(B) Practitioners

A practitioner described in this subparagraph is a practitioner who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.] with the Indian Health Service.

(h) Special registration for telemedicine

(1) In general

The Attorney General may issue to a practitioner a special registration to engage in the practice of telemedicine for purposes of section 802(54)(E) of this title if the practitioner, upon application for such special registration—

(A) demonstrates a legitimate need for the special registration; and

(B) is registered under section 823(g) of this title in the State in which the patient will be located when receiving the telemedicine treatment, unless the practitioner—

(i) is exempted from such registration in all States under section 822(d) of this title; or

(ii) is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract and is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title.

(2) Regulations

Not later than 1 year after October 24, 2018, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying—

(A) the limited circumstances in which a special registration under this subsection may be issued; and

(B) the procedure for obtaining a special registration under this subsection.

(3) Denials

Proceedings to deny an application for registration under this subsection shall be conducted in accordance with section 824(c) of this title.

(i) Reporting of telemedicine by VHA during medical emergency situations

(1) In general

Any practitioner issuing a prescription for a controlled substance under the authorization to conduct telemedicine during a medical emergency situation described in section 802(54)(F) of this title shall report to the Secretary of Veterans Affairs the authorization of that emergency prescription, in accordance with such requirements as the Secretary of Veterans Affairs shall, by regulation, establish.

(2) To Attorney General

Not later than 30 days after the date that a prescription described in subparagraph (A) is issued, the Secretary of Veterans Affairs shall report to the Attorney General the authorization of that emergency prescription.

(j) Clarification concerning prescription transfers

Any transfer between pharmacies of information relating to a prescription for a controlled substance shall meet the applicable requirements under regulations promulgated by the Attorney General under this chapter.

(Pub. L. 91–513, title II, §311, as added Pub. L. 110–425, §3(d)(1), Oct. 15, 2008, 122 Stat. 4825; amended Pub. L. 115–271, title III, §3232, Oct. 24, 2018, 132 Stat. 3950; Pub. L. 117–215, title I, §103(b)(1)(F), Dec. 2, 2022, 136 Stat. 2263.)

Editorial Notes

References in Text

Section 309, referred to in subsec. (c)(7), is section 309 of Pub. L. 91–513, which is classified to section 829 of this title.

For effective date of this section, referred to in subsec. (d)(3), see Effective Date note below.

The Indian Self-Determination and Education Assistance Act, referred to in subsec. (g)(1), (2)(B), is Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

This chapter, referred to in subsec. (j), was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Amendments

2022—Subsec. (h)(1)(B). Pub. L. 117–215 substituted "823(g)" for "823(f)" wherever appearing.

2018—Subsec. (h)(2). Pub. L. 115–271 amended par. (2) generally. Prior to amendment, text read as follows: "The Attorney General shall, with the concurrence of the Secretary, promulgate regulations specifying the limited circumstances in which a special registration under this subsection may be issued and the procedures for obtaining such a special registration."

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as an Effective Date of 2008 Amendment note under section 802 of this title.

§832. Suspicious orders

(a) Reporting

Each registrant shall—

(1) design and operate a system to identify suspicious orders for the registrant;

(2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and

(3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.

(b) Suspicious order database

(1) In general

Not later than 1 year after October 24, 2018, the Attorney General shall establish a centralized database for collecting reports of suspicious orders.

(2) Satisfaction of reporting requirements

If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.

(c) Sharing information with the States

(1) In general

The Attorney General shall prepare and make available information regarding suspicious orders in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State.

(2) Timing

The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information.

(3) Coordination

In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law.

(Pub. L. 91–513, title II, §312, as added Pub. L. 115–271, title III, §3292(b), Oct. 24, 2018, 132 Stat. 3956.)

Part D—Offenses and Penalties

§841. Prohibited acts A

(a) Unlawful acts

Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally—

(1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or

(2) to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.

(b) Penalties

Except as otherwise provided in section 849, 859, 860, or 861 of this title, any person who violates subsection (a) of this section shall be sentenced as follows:

(1)(A) In the case of a violation of subsection (a) of this section involving—

(i) 1 kilogram or more of a mixture or substance containing a detectable amount of heroin;

(ii) 5 kilograms or more of a mixture or substance containing a detectable amount of—

(I) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;

(II) cocaine, its salts, optical and geometric isomers, and salts of isomers;

(III) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or

(IV) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subclauses (I) through (III);

(iii) 280 grams or more of a mixture or substance described in clause (ii) which contains cocaine base;

(iv) 100 grams or more of phencyclidine (PCP) or 1 kilogram or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);

(v) 10 grams or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);

(vi) 400 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-piperidinyl ] propanamide or 100 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;

(vii) 1000 kilograms or more of a mixture or substance containing a detectable amount of marihuana, or 1,000 or more marihuana plants regardless of weight; or

(viii) 50 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 500 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers;

such person shall be sentenced to a term of imprisonment which may not be less than 10 years or more than life and if death or serious bodily injury results from the use of such substance shall be not less than 20 years or more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $10,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 15 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $20,000,000 if the defendant is an individual or $75,000,000 if the defendant is other than an individual, or both. If any person commits a violation of this subparagraph or of section 849, 859, 860, or 861 of this title after 2 or more prior convictions for a serious drug felony or serious violent felony have become final, such person shall be sentenced to a term of imprisonment of not less than 25 years and fined in accordance with the preceding sentence. Notwithstanding section 3583 of title 18, any sentence under this subparagraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 5 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 10 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under this subparagraph. No person sentenced under this subparagraph shall be eligible for parole during the term of imprisonment imposed therein.

(B) In the case of a violation of subsection (a) of this section involving—

(i) 100 grams or more of a mixture or substance containing a detectable amount of heroin;

(ii) 500 grams or more of a mixture or substance containing a detectable amount of—

(I) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;

(II) cocaine, its salts, optical and geometric isomers, and salts of isomers;

(III) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or

(IV) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subclauses (I) through (III);

(iii) 28 grams or more of a mixture or substance described in clause (ii) which contains cocaine base;

(iv) 10 grams or more of phencyclidine (PCP) or 100 grams or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);

(v) 1 gram or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);

(vi) 40 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-piperidinyl ] propanamide or 10 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;

(vii) 100 kilograms or more of a mixture or substance containing a detectable amount of marihuana, or 100 or more marihuana plants regardless of weight; or

(viii) 5 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 50 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers;

such person shall be sentenced to a term of imprisonment which may not be less than 5 years and not more than 40 years and if death or serious bodily injury results from the use of such substance shall be not less than 20 years or more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $5,000,000 if the defendant is an individual or $25,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment which may not be less than 10 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $8,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence imposed under this subparagraph shall, in the absence of such a prior conviction, include a term of supervised release of at least 4 years in addition to such term of imprisonment and shall, if there was such a prior conviction, include a term of supervised release of at least 8 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under this subparagraph. No person sentenced under this subparagraph shall be eligible for parole during the term of imprisonment imposed therein.

(C) In the case of a controlled substance in schedule I or II, gamma hydroxybutyric acid (including when scheduled as an approved drug product for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000), or 1 gram of flunitrazepam, except as provided in subparagraphs (A), (B), and (D), such person shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years or more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $2,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 6 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this subparagraph which provide for a mandatory term of imprisonment if death or serious bodily injury results, nor shall a person so sentenced be eligible for parole during the term of such a sentence.

(D) In the case of less than 50 kilograms of marihuana, except in the case of 50 or more marihuana plants regardless of weight, 10 kilograms of hashish, or one kilogram of hashish oil, such person shall, except as provided in paragraphs (4) and (5) of this subsection, be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 10 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 2 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 4 years in addition to such term of imprisonment.

(E)(i) Except as provided in subparagraphs (C) and (D), in the case of any controlled substance in schedule III, such person shall be sentenced to a term of imprisonment of not more than 10 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than 15 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $500,000 if the defendant is an individual or $2,500,000 if the defendant is other than an individual, or both.

(ii) If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than 30 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both.

(iii) Any sentence imposing a term of imprisonment under this subparagraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 2 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 4 years in addition to such term of imprisonment.

(2) In the case of a controlled substance in schedule IV, such person shall be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 10 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual, or both. Any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least one year in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 2 years in addition to such term of imprisonment.

(3) In the case of a controlled substance in schedule V, such person shall be sentenced to a term of imprisonment of not more than one year, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $100,000 if the defendant is an individual or $250,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 4 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $200,000 if the defendant is an individual or $500,000 if the defendant is other than an individual, or both. Any sentence imposing a term of imprisonment under this paragraph may, if there was a prior conviction, impose a term of supervised release of not more than 1 year, in addition to such term of imprisonment.

(4) Notwithstanding paragraph (1)(D) of this subsection, any person who violates subsection (a) of this section by distributing a small amount of marihuana for no remuneration shall be treated as provided in section 844 of this title and section 3607 of title 18.

(5) Any person who violates subsection (a) of this section by cultivating or manufacturing a controlled substance on Federal property shall be imprisoned as provided in this subsection and shall be fined any amount not to exceed—

(A) the amount authorized in accordance with this section;

(B) the amount authorized in accordance with the provisions of title 18;

(C) $500,000 if the defendant is an individual; or

(D) $1,000,000 if the defendant is other than an individual;

or both.

(6) Any person who violates subsection (a), or attempts to do so, and knowingly or intentionally uses a poison, chemical, or other hazardous substance on Federal land, and, by such use—

(A) creates a serious hazard to humans, wildlife, or domestic animals,

(B) degrades or harms the environment or natural resources, or

(C) pollutes an aquifer, spring, stream, river, or body of water,

shall be fined in accordance with title 18 or imprisoned not more than five years, or both.

(7) Penalties for distribution.—

(A) In general.—Whoever, with intent to commit a crime of violence, as defined in section 16 of title 18 (including rape), against an individual, violates subsection (a) by distributing a controlled substance or controlled substance analogue to that individual without that individual's knowledge, shall be imprisoned not more than 20 years and fined in accordance with title 18.

(B) Definition.—For purposes of this paragraph, the term "without that individual's knowledge" means that the individual is unaware that a substance with the ability to alter that individual's ability to appraise conduct or to decline participation in or communicate unwillingness to participate in conduct is administered to the individual.

(c) Offenses involving listed chemicals

Any person who knowingly or intentionally—

(1) possesses a listed chemical with intent to manufacture a controlled substance except as authorized by this subchapter;

(2) possesses or distributes a listed chemical knowing, or having reasonable cause to believe, that the listed chemical will be used to manufacture a controlled substance except as authorized by this subchapter; or

(3) with the intent of causing the evasion of the recordkeeping or reporting requirements of section 830 of this title, or the regulations issued under that section, receives or distributes a reportable amount of any listed chemical in units small enough so that the making of records or filing of reports under that section is not required;

shall be fined in accordance with title 18 or imprisoned not more than 20 years in the case of a violation of paragraph (1) or (2) involving a list I chemical or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph (1) or (2) involving a list I chemical, or both.

(d) Boobytraps on Federal property; penalties; "boobytrap" defined

(1) Any person who assembles, maintains, places, or causes to be placed a boobytrap on Federal property where a controlled substance is being manufactured, distributed, or dispensed shall be sentenced to a term of imprisonment for not more than 10 years or fined under title 18, or both.

(2) If any person commits such a violation after 1 or more prior convictions for an offense punishable under this subsection, such person shall be sentenced to a term of imprisonment of not more than 20 years or fined under title 18, or both.

(3) For the purposes of this subsection, the term "boobytrap" means any concealed or camouflaged device designed to cause bodily injury when triggered by any action of any unsuspecting person making contact with the device. Such term includes guns, ammunition, or explosive devices attached to trip wires or other triggering mechanisms, sharpened stakes, and lines or wires with hooks attached.

(e) Ten-year injunction as additional penalty

In addition to any other applicable penalty, any person convicted of a felony violation of this section relating to the receipt, distribution, manufacture, exportation, or importation of a listed chemical may be enjoined from engaging in any transaction involving a listed chemical for not more than ten years.

(f) Wrongful distribution or possession of listed chemicals

(1) Whoever knowingly distributes a listed chemical in violation of this subchapter (other than in violation of a recordkeeping or reporting requirement of section 830 of this title) shall, except to the extent that paragraph (12), (13), or (14) of section 842(a) of this title applies, be fined under title 18 or imprisoned not more than 5 years, or both.

(2) Whoever possesses any listed chemical, with knowledge that the recordkeeping or reporting requirements of section 830 of this title have not been adhered to, if, after such knowledge is acquired, such person does not take immediate steps to remedy the violation shall be fined under title 18 or imprisoned not more than one year, or both.

(g) Internet sales of date rape drugs

(1) Whoever knowingly uses the Internet to distribute a date rape drug to any person, knowing or with reasonable cause to believe that—

(A) the drug would be used in the commission of criminal sexual conduct; or

(B) the person is not an authorized purchaser;

shall be fined under this subchapter or imprisoned not more than 20 years, or both.

(2) As used in this subsection:

(A) The term "date rape drug" means—

(i) gamma hydroxybutyric acid (GHB) or any controlled substance analogue of GHB, including gamma butyrolactone (GBL) or 1,4–butanediol;

(ii) ketamine;

(iii) flunitrazepam; or

(iv) any substance which the Attorney General designates, pursuant to the rulemaking procedures prescribed by section 553 of title 5, to be used in committing rape or sexual assault.

The Attorney General is authorized to remove any substance from the list of date rape drugs pursuant to the same rulemaking authority.

(B) The term "authorized purchaser" means any of the following persons, provided such person has acquired the controlled substance in accordance with this chapter:

(i) A person with a valid prescription that is issued for a legitimate medical purpose in the usual course of professional practice that is based upon a qualifying medical relationship by a practitioner registered by the Attorney General. A "qualifying medical relationship" means a medical relationship that exists when the practitioner has conducted at least 1 medical evaluation with the authorized purchaser in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other heath ¹ professionals. The preceding sentence shall not be construed to imply that 1 medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.

(ii) Any practitioner or other registrant who is otherwise authorized by their registration to dispense, procure, purchase, manufacture, transfer, distribute, import, or export the substance under this chapter.

(iii) A person or entity providing documentation that establishes the name, address, and business of the person or entity and which provides a legitimate purpose for using any "date rape drug" for which a prescription is not required.

(3) The Attorney General is authorized to promulgate regulations for record-keeping and reporting by persons handling 1,4–butanediol in order to implement and enforce the provisions of this section. Any record or report required by such regulations shall be considered a record or report required under this chapter.

(h) Offenses involving dispensing of controlled substances by means of the Internet

(1) In general

It shall be unlawful for any person to knowingly or intentionally—

(A) deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by this subchapter; or

(B) aid or abet (as such terms are used in section 2 of title 18) any activity described in subparagraph (A) that is not authorized by this subchapter.

(2) Examples

Examples of activities that violate paragraph (1) include, but are not limited to, knowingly or intentionally—

(A) delivering, distributing, or dispensing a controlled substance by means of the Internet by an online pharmacy that is not validly registered with a modification authorizing such activity as required by section 823(g) of this title (unless exempt from such registration);

(B) writing a prescription for a controlled substance for the purpose of delivery, distribution, or dispensation by means of the Internet in violation of section 829(e) of this title;

(C) serving as an agent, intermediary, or other entity that causes the Internet to be used to bring together a buyer and seller to engage in the dispensing of a controlled substance in a manner not authorized by sections ² 823(g) or 829(e) of this title;

(D) offering to fill a prescription for a controlled substance based solely on a consumer's completion of an online medical questionnaire; and

(E) making a material false, fictitious, or fraudulent statement or representation in a notification or declaration under subsection (d) or (e), respectively, of section 831 of this title.

(3) Inapplicability

(A) This subsection does not apply to—

(i) the delivery, distribution, or dispensation of controlled substances by nonpractitioners to the extent authorized by their registration under this subchapter;

(ii) the placement on the Internet of material that merely advocates the use of a controlled substance or includes pricing information without attempting to propose or facilitate an actual transaction involving a controlled substance; or

(iii) except as provided in subparagraph (B), any activity that is limited to—

(I) the provision of a telecommunications service, or of an Internet access service or Internet information location tool (as those terms are defined in section 231 of title 47); or

(II) the transmission, storage, retrieval, hosting, formatting, or translation (or any combination thereof) of a communication, without selection or alteration of the content of the communication, except that deletion of a particular communication or material made by another person in a manner consistent with section 230(c) of title 47 shall not constitute such selection or alteration of the content of the communication.

(B) The exceptions under subclauses (I) and (II) of subparagraph (A)(iii) shall not apply to a person acting in concert with a person who violates paragraph (1).

(4) Knowing or intentional violation

Any person who knowingly or intentionally violates this subsection shall be sentenced in accordance with subsection (b).

(Pub. L. 91–513, title II, §401, Oct. 27, 1970, 84 Stat. 1260; Pub. L. 95–633, title II, §201, Nov. 10, 1978, 92 Stat. 3774; Pub. L. 96–359, §8(c), Sept. 26, 1980, 94 Stat. 1194; Pub. L. 98–473, title II, §§224(a), 502, 503(b)(1), (2), Oct. 12, 1984, 98 Stat. 2030, 2068, 2070; Pub. L. 99–570, title I, §§1002, 1003(a), 1004(a), 1005(a), 1103, title XV, §15005, Oct. 27, 1986, 100 Stat. 3207–2, 3207-5, 3207-6, 3207-11, 3207-192; Pub. L. 100–690, title VI, §§6055, 6254(h), 6452(a), 6470(g), (h), 6479, Nov. 18, 1988, 102 Stat. 4318, 4367, 4371, 4378, 4381; Pub. L. 101–647, title X, §1002(e), title XII, §1202, title XXXV, §3599K, Nov. 29, 1990, 104 Stat. 4828, 4830, 4932; Pub. L. 103–322, title IX, §90105(a), (c), title XVIII, §180201(b)(2)(A), Sept. 13, 1994, 108 Stat. 1987, 1988, 2047; Pub. L. 104–237, title II, §206(a), title III, §302(a), Oct. 3, 1996, 110 Stat. 3103, 3105; Pub. L. 104–305, §2(a), (b)(1), Oct. 13, 1996, 110 Stat. 3807; Pub. L. 105–277, div. E, §2(a), Oct. 21, 1998, 112 Stat. 2681–759; Pub. L. 106–172, §§3(b)(1), 5(b), 9, Feb. 18, 2000, 114 Stat. 9, 10, 13; Pub. L. 107–273, div. B, title III, §3005(a), title IV, §4002(d)(2)(A), Nov. 2, 2002, 116 Stat. 1805, 1809; Pub. L. 109–177, title VII, §§711(f)(1)(B), 732, Mar. 9, 2006, 120 Stat. 262, 270; Pub. L. 109–248, title II, §201, July 27, 2006, 120 Stat. 611; Pub. L. 110–425, §3(e), (f), Oct. 15, 2008, 122 Stat. 4828, 4829; Pub. L. 111–220, §§2(a), 4(a), Aug. 3, 2010, 124 Stat. 2372; Pub. L. 115–391, title IV, §401(a)(2), Dec. 21, 2018, 132 Stat. 5220; Pub. L. 117–215, title I, §103(b)(1)(G), Dec. 2, 2022, 136 Stat. 2263.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a), (b)(1), (c)(1), (2), (f)(1), (g)(1), and (h)(1), (3)(A)(i), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Schedules I, II, III, IV, and V, referred to in subsec. (b), are set out in section 812(c) of this title.

Section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Prohibition Act of 2000, referred to in subsec. (b)(1)(C), is section 3(a)(1)(B) of Pub. L. 106–172, which is set out in a note under section 812 of this title.

This chapter, referred to in subsec. (g)(2)(B), (3), was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Amendments

2022—Subsec. (h)(2). Pub. L. 117–215 substituted "823(g)" for "823(f)" in two places.

2018—Subsec. (b)(1)(A). Pub. L. 115–391, §401(a)(2)(A), in concluding provisions, substituted "If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 15 years" for "If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment which may not be less than 20 years" and "after 2 or more prior convictions for a serious drug felony or serious violent felony have become final, such person shall be sentenced to a term of imprisonment of not less than 25 years" for "after two or more prior convictions for a felony drug offense have become final, such person shall be sentenced to a mandatory term of life imprisonment without release".

Subsec. (b)(1)(B). Pub. L. 115–391, §401(a)(2)(B), in concluding provisions, substituted "If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final" for "If any person commits such a violation after a prior conviction for a felony drug offense has become final".

2010—Subsec. (b)(1)(A). Pub. L. 111–220, §4(a)(1), in concluding provisions, substituted "$10,000,000" for "$4,000,000", "$50,000,000" for "$10,000,000", "$20,000,000" for "$8,000,000", and "$75,000,000" for "$20,000,000".

Subsec. (b)(1)(A)(iii). Pub. L. 111–220, §2(a)(1), substituted "280 grams" for "50 grams".

Subsec. (b)(1)(B). Pub. L. 111–220, §4(a)(2), in concluding provisions, substituted "$5,000,000" for "$2,000,000", "$25,000,000" for "$5,000,000", "$8,000,000" for "$4,000,000", and "$50,000,000" for "$10,000,000".

Subsec. (b)(1)(B)(iii). Pub. L. 111–220, §2(a)(2), substituted "28 grams" for "5 grams".

2008—Subsec. (b)(1)(D). Pub. L. 110–425, §3(e)(1)(A), struck out "or in the case of any controlled substance in schedule III (other than gamma hydroxybutyric acid), or 30 milligrams of flunitrazepam" after "hashish oil".

Subsec. (b)(1)(E). Pub. L. 110–425, §3(e)(1)(B), added subpar. (E).

Subsec. (b)(2). Pub. L. 110–425, §3(e)(2), substituted "5 years" for "3 years", "10 years" for "6 years", and "after a prior conviction for a felony drug offense has become final," for "after one or more prior convictions of him for an offense punishable under this paragraph, or for a felony under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final,".

Subsec. (b)(3). Pub. L. 110–425, §3(e)(3), substituted "4 years" for "2 years" and "after a prior conviction for a felony drug offense has become final," for "after one or more convictions of him for an offense punishable under this paragraph, or for a crime under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final," and inserted at end "Any sentence imposing a term of imprisonment under this paragraph may, if there was a prior conviction, impose a term of supervised release of not more than 1 year, in addition to such term of imprisonment."

Subsec. (h). Pub. L. 110–425, §3(f), added subsec. (h).

2006—Subsec. (b)(5). Pub. L. 109–177, §732, inserted "or manufacturing" after "cultivating" in introductory provisions.

Subsec. (f)(1). Pub. L. 109–177, §711(f)(1)(B), inserted ", except to the extent that paragraph (12), (13), or (14) of section 842(a) of this title applies," after "shall".

Subsec. (g). Pub. L. 109–248 added subsec. (g).

2002—Subsec. (b)(1)(A), (B). Pub. L. 107–273, §3005(a), substituted "Notwithstanding section 3583 of title 18, any sentence" for "Any sentence" in concluding provisions.

Subsec. (b)(1)(C), (D). Pub. L. 107–273, §3005(a), substituted "Notwithstanding section 3583 of title 18, any sentence" for "Any sentence".

Subsec. (d)(1). Pub. L. 107–273, §4002(d)(2)(A)(i), substituted "or fined under title 18, or both" for "and shall be fined not more than $10,000".

Subsec. (d)(2). Pub. L. 107–273, §4002(d)(2)(A)(ii), substituted "or fined under title 18, or both" for "and shall be fined not more than $20,000".

2000—Subsec. (b)(1)(C). Pub. L. 106–172, §3(b)(1)(A), inserted "gamma hydroxybutyric acid (including when scheduled as an approved drug product for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000)," after "schedule I or II," in first sentence.

Subsec. (b)(1)(D). Pub. L. 106–172, §3(b)(1)(B), substituted "(other than gamma hydroxybutyric acid), or 30" for ", or 30".

Subsec. (b)(7)(A). Pub. L. 106–172, §5(b), inserted "or controlled substance analogue" after "distributing a controlled substance".

Subsecs. (c) to (g). Pub. L. 106–172, §9, redesignated subsecs. (d) to (g) as (c) to (f), respectively.

1998—Subsec. (b)(1). Pub. L. 105–277 in subpar. (A)(viii) substituted "50 grams" and "500 grams" for "100 grams" and "1 kilogram", respectively, and in subpar. (B)(viii) substituted "5 grams" and "50 grams" for "10 grams" and "100 grams", respectively.

1996—Subsec. (b)(1)(C). Pub. L. 104–305, §2(b)(1)(A), inserted ", or 1 gram of flunitrazepam," after "schedule I or II".

Subsec. (b)(1)(D). Pub. L. 104–305, §2(b)(1)(B), inserted "or 30 milligrams of flunitrazepam," after "schedule III,".

Subsec. (b)(7). Pub. L. 104–305, §2(a), added par. (7).

Subsec. (d). Pub. L. 104–237, §302(a), in concluding provisions, substituted "not more than 20 years in the case of a violation of paragraph (1) or (2) involving a list I chemical or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph (1) or (2) involving a list I chemical," for "not more than 10 years,".

Subsec. (f). Pub. L. 104–237, §206(a), inserted "manufacture, exportation," after "distribution," and struck out "regulated" after "engaging in any".

1994—Subsec. (b). Pub. L. 103–322, §180201(b)(2)(A), inserted "849," before "859," in introductory provisions.

Subsec. (b)(1)(A). Pub. L. 103–322, §§90105(c), 180201(b)(2)(A), in concluding provisions, inserted "849," before "859," and struck out "For purposes of this subparagraph, the term 'felony drug offense' means an offense that is a felony under any provision of this subchapter or any other Federal law that prohibits or restricts conduct relating to narcotic drugs, marihuana, or depressant or stimulant substances or a felony under any law of a State or a foreign country that prohibits or restricts conduct relating to narcotic drugs, marihuana, or depressant or stimulant substances." before "Any sentence under this subparagraph".

Subsec. (b)(1)(B). Pub. L. 103–322, §90105(a), in sentence in concluding provisions beginning "If any person commits", substituted "a prior conviction for a felony drug offense has become final" for "one or more prior convictions for an offense punishable under this paragraph, or for a felony under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final".

Subsec. (b)(1)(C). Pub. L. 103–322, §90105(a), in sentence beginning "If any person commits", substituted "a prior conviction for a felony drug offense has become final" for "one or more prior convictions for an offense punishable under this paragraph, or for a felony under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final".

Subsec. (b)(1)(D). Pub. L. 103–322, §90105(a), in sentence beginning "If any person commits", substituted "a prior conviction for a felony drug offense has become final" for "one or more prior convictions of him for an offense punishable under this paragraph, or for a felony under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final".

1990—Subsec. (b). Pub. L. 101–647, §1002(e)(1), substituted "section 859, 860, or 861" for "section 845, 845a, or 845b" in introductory provisions.

Subsec. (b)(1)(A). Pub. L. 101–647, §1002(e)(1), substituted "section 859, 860, or 861" for "section 845, 845a, or 845b" in concluding provisions.

Subsec. (b)(1)(A)(ii)(IV). Pub. L. 101–647, §3599K, substituted "any of the substances" for "any of the substance".

Subsec. (b)(1)(A)(viii). Pub. L. 101–647, §1202, substituted "or 1 kilogram or more of a mixture or substance containing a detectable amount of methamphetamine" for "or 100 grams or more of a mixture or substance containing a detectable amount of methamphetamine".

Subsec. (b)(1)(B)(ii)(IV). Pub. L. 101–647, §3599K, substituted "any of the substances" for "any of the substance".

Subsec. (c). Pub. L. 101–647, §1002(e)(2), directed amendment of subsec. (c) by substituting "section 859, 860, or 861 of this title" for "section 845, 845a, or 845b of this title". Subsec. (c) was previously repealed by Pub. L. 98–473, §224(a)(2), as renumbered by Pub. L. 99–570, §1005(a), effective Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such amendment. See 1984 Amendment note and Effective Date of 1984 Amendment note below.

1988—Subsec. (b)(1)(A). Pub. L. 100–690, §§6452(a), 6470(g), 6479(1), inserted ", or 1,000 or more marihuana plants regardless of weight" in cl. (vii), added cl. (viii), substituted "a prior conviction for a felony drug offense has become final" for "one or more prior convictions for an offense punishable under this paragraph, or for a felony under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final" in second sentence, and added provisions relating to sentencing for a person who violates this subpar. or section 485, 485a, or 485b of this title after two or more prior convictions for a felony drug offense have become final and defining "felony drug offense".

Subsec. (b)(1)(B). Pub. L. 100–690, §§6470(h), 6479(2), inserted ", or 100 or more marihuana plants regardless of weight" in cl. (vii) and added cl. (viii).

Subsec. (b)(1)(D). Pub. L. 100–690, §6479(3), substituted "50 or more marihuana plants" for "100 or more marihuana plants".

Subsec. (b)(6). Pub. L. 100–690, §6254(h), added par. (6).

Subsec. (d). Pub. L. 100–690, §6055(a), amended subsec. (d) generally. Prior to amendment, subsec. (d) read as follows: "Any person who knowingly or intentionally—

"(1) possesses any piperidine with intent to manufacture phencyclidine except as authorized by this subchapter, or

"(2) possesses any piperidine knowing, or having reasonable cause to believe, that the piperidine will be used to manufacture phencyclidine except as authorized by this subchapter,

shall be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both."

Subsecs. (f), (g). Pub. L. 100–690, §6055(b), added subsecs. (f) and (g).

1986—Pub. L. 99–570, §1005(a), amended Pub. L. 98–473, §224(a). See 1984 Amendment note below.

Subsec. (b). Pub. L. 99–570, §1103(a), substituted ", 845a, or 845b" for "or 845a" in introductory provisions.

Subsec. (b)(1)(A). Pub. L. 99–570, §1002(2), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "In the case of a violation of subsection (a) of this section involving—

"(i) 100 grams or more of a controlled substance in schedule I or II which is a mixture or substance containing a detectable amount of a narcotic drug other than a narcotic drug consisting of—

"(I) coca leaves;

"(II) a compound, manufacture, salt, derivative, or preparation of coca leaves; or

"(III) a substance chemically identical thereto;

"(ii) a kilogram or more of any other controlled substance in schedule I or II which is a narcotic drug;

"(iii) 500 grams or more of phencyclidine (PCP); or

"(iv) 5 grams or more of lysergic acid diethylamide (LSD);

such person shall be sentenced to a term of imprisonment of not more than 20 years, a fine of not more than $250,000, or both. If any person commits such a violation after one or more prior convictions of him for an offense punishable under this paragraph, or for a felony under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final, such person shall be sentenced to a term of imprisonment of not more than 40 years, a fine of not more than $500,000, or both".

Subsec. (b)(1)(B). Pub. L. 99–570, §1002(2), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "In the case of a controlled substance in schedule I or II except as provided in subparagraphs (A) and (C),, such person shall be sentenced to a term of imprisonment of not more than 15 years, a fine of not more than $125,000, or both. If any person commits such a violation after one or more prior convictions of him for an offense punishable under this paragraph, or for a felony under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final, such person shall be sentenced to a term of imprisonment of not more than 30 years, a fine of not more than $250,000, or both. Any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a special parole term of at least 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a special parole term of at least 6 years in addition to such term of imprisonment."

Subsec. (b)(1)(C). Pub. L. 99–570, §1002(2), added subpar. (C). Former subpar. (C) redesignated (D).

Subsec. (b)(1)(D). Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term" in two places.

Pub. L. 99–570, §§1002(1), 1003(a)(1), redesignated former subpar. (C) as (D), substituted "a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual" for "a fine of not more than $50,000" and "a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual" for "a fine of not more than $100,000", and inserted "except in the case of 100 or more marihuana plants regardless of weight,".

Subsec. (b)(2). Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term" in two places.

Pub. L. 99–570, §1003(a)(2), substituted "a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual" for "a fine of not more than $25,000" and "a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual" for "a fine of not more than $50,000".

Subsec. (b)(3). Pub. L. 99–570, §1003(a)(3), substituted "a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $100,000 if the defendant is an individual or $250,000 if the defendant is other than an individual" for "a fine of not more than $10,000" and "a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $200,000 if the defendant is an individual or $500,000 if the defendant is other than an individual" for "a fine of not more than $20,000".

Subsec. (b)(4). Pub. L. 99–570, §1003(a)(4), which directed the substitution of "1(D)" for "1(C)" was executed by substituting "(1)(D)" for "(1)(C)" as the probable intent of Congress.

Subsec. (b)(5). Pub. L. 99–570, §1003(a)(5), amended par. (5) generally. Prior to amendment, par. (5) read as follows: "Notwithstanding paragraph (1), any person who violates subsection (a) of this section by cultivating a controlled substance on Federal property shall be fined not more than—

"(A) $500,000 if such person is an individual; and

"(B) $1,000,000 if such person is not an individual."

Subsec. (c). Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term" wherever appearing, effective Nov. 1, 1987, the effective date of the repeal of subsec. (c) by Pub. L. 98–473, §224(a)(2). See 1984 Amendment note below.

Pub. L. 99–570, §1103(b), substituted ", 845a, or 845b" for "845a" in two places.

Subsec. (d). Pub. L. 99–570, §1003(a)(6), substituted "a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual" for "a fine of not more than $15,000".

Subsec. (e). Pub. L. 99–570, §15005, added subsec. (e).

1984—Subsec. (b). Pub. L. 98–473, §503(b)(1), inserted reference to section 845a of this title in provisions preceding par. (1)(A).

Pub. L. 98–473, §224(a)(1)–(3), (5), which directed amendment of this subsection effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L. 98–473 set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure) was repealed by Pub. L. 99–570, §1005(a), and the remaining pars. (4) and (6) of Pub. L. 98–473, §224(a), were redesignated as pars. (1) and (2), respectively.

Subsec. (b)(1)(A). Pub. L. 98–473, §502(1)(A), added subpar. (A). Former subpar. (A) redesignated (B).

Subsec. (b)(1)(B). Pub. L. 98–473, §502(1)(A), (B), redesignated former subpar. (A) as (B), substituted "except as provided in subparagraphs (A) and (C)," for "which is a narcotic drug", "$125,000" for "$25,000", and "$250,000" for "$50,000", and inserted references to laws of a State and a foreign country. Former subpar. (B) redesignated (C).

Subsec. (b)(1)(C). Pub. L. 98–473, §502(1)(A), (C), redesignated former subpar. (B) as (C), substituted "less than 50 kilograms of marihuana, 10 kilograms of hashish, or one kilogram of hashish oil" for "a controlled substance in schedule I or II which is not a narcotic drug", "and (5)" for ", (5), and (6)", "$50,000" for "$15,000", and "$100,000" for "$30,000", and inserted references to laws of a State and a foreign country.

Subsec. (b)(2). Pub. L. 98–473, §502(2), substituted "$25,000" for "$10,000" and "$50,000" for "$20,000", and inserted references to laws of a State or of a foreign country.

Subsec. (b)(3). Pub. L. 98–473, §502(3), substituted "$10,000" for "$5,000" and "$20,000" for "$10,000", and inserted references to laws of a State or of a foreign country.

Subsec. (b)(4). Pub. L. 98–473, §502(4), substituted "(1)(C)" for "(1)(B)".

Pub. L. 98–473, §224(a)(1), as renumbered by Pub. L. 99–570, §1005(a), substituted "in section 844 of this title and section 3607 of title 18" for "in subsections (a) and (b) of section 844 of this title".

Subsec. (b)(5). Pub. L. 98–473, §502(5), (6), added par. (5) and struck out former par. (5) which related to penalties for manufacturing, etc., phencyclidine.

Subsec. (b)(6). Pub. L. 98–473, §502(5), struck out par. (6) which related to penalties for violations involving a quantity of marihuana exceeding 1,000 pounds.

Subsec. (c). Pub. L. 98–473, §224(a)(2), as renumbered by Pub. L. 99–570, §1005(a), struck out subsec. (c) which read as follows: "A special parole term imposed under this section or section 845, 845a, or 845b of this title may be revoked if its terms and conditions are violated. In such circumstances the original term of imprisonment shall be increased by the period of the special parole term and the resulting new term of imprisonment shall not be diminished by the time which was spent on special parole. A person whose special parole term has been revoked may be required to serve all or part of the remainder of the new term of imprisonment. A special parole term provided for in this section or section 845, 845a, or 845b of this title shall be in addition to, and not in lieu of, any other parole provided for by law."

Pub. L. 98–473, §503(b)(2), inserted reference to section 845a of this title in two places.

1980—Subsec. (b)(1)(B). Pub. L. 96–359, §8(c)(1), inserted reference to par. (6) of this subsection.

Subsec. (b)(6). Pub. L. 96–359, §8(c)(2), added par. (6).

1978—Subsec. (b)(1)(B). Pub. L. 95–633, §201(1), inserted ", except as provided in paragraphs (4) and (5) of this subsection," after "such person shall".

Subsec. (b)(5). Pub. L. 95–633, §201(2), added par. (5).

Subsec. (d). Pub. L. 95–633, §201(3), added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Amendment by Pub. L. 115–391 applicable to any offense that was committed before Dec. 21, 2018, if a sentence for the offense has not been imposed as of Dec. 21, 2018, see section 401(c) of Pub. L. 115–391, set out as a note under section 802 of this title.

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

Effective Date of 1988 Amendment

Amendment by section 6055 of Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date of 1986 Amendment

Pub. L. 99–570, title I, §1004(b), Oct. 27, 1986, 100 Stat. 3207–6, provided that: "The amendments made by this section [amending this section and sections 845, 845a, 960, and 962 of this title] shall take effect on the date of the taking effect of section 3583 of title 18, United States Code [Nov. 1, 1987]."

Effective Date of 1984 Amendment

Amendment by section 224(a) of Pub. L. 98–473 effective Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such amendment, see section 235(a)(1) of Pub. L. 98–473, set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective Nov. 10, 1978, see section 203(a) of Pub. L. 95–633 set out as an Effective Date note under section 830 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Repeals

Pub. L. 96–359, §8(b), Sept. 26, 1980, 94 Stat. 1194, repealed section 203(d) of Pub. L. 95–633, which had provided for the repeal of subsec. (d) of this section effective Jan. 1, 1981.

Application of Fair Sentencing Act

Pub. L. 115–391, title IV, §404, Dec. 21, 2018, 132 Stat. 5222, provided that:

"(a) Definition of Covered Offense.—In this section, the term 'covered offense' means a violation of a Federal criminal statute, the statutory penalties for which were modified by section 2 or 3 of the Fair Sentencing Act of 2010 (Public Law 111–220; 124 Stat. 2372) [amending this section and sections 844 and 960 of this title], that was committed before August 3, 2010.

"(b) Defendants Previously Sentenced.—A court that imposed a sentence for a covered offense may, on motion of the defendant, the Director of the Bureau of Prisons, the attorney for the Government, or the court, impose a reduced sentence as if sections 2 and 3 of the Fair Sentencing Act of 2010 (Public Law 111–220; 124 Stat. 2372) were in effect at the time the covered offense was committed.

"(c) Limitations.—No court shall entertain a motion made under this section to reduce a sentence if the sentence was previously imposed or previously reduced in accordance with the amendments made by sections 2 and 3 of the Fair Sentencing Act of 2010 (Public Law 111–220; 124 Stat. 2372) or if a previous motion made under this section to reduce the sentence was, after the date of enactment of this Act [Dec. 21, 2018], denied after a complete review of the motion on the merits. Nothing in this section shall be construed to require a court to reduce any sentence pursuant to this section."

¹ So in original. Probably should be "health".

² So in original. Probably should be "section".

§842. Prohibited acts B

(a) Unlawful acts

It shall be unlawful for any person—

(1) who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of section 829 of this title;

(2) who is a registrant to distribute or dispense a controlled substance not authorized by his registration to another registrant or other authorized person or to manufacture a controlled substance not authorized by his registration;

(3) who is a registrant to distribute a controlled substance in violation of section 825 of this title;

(4) to remove, alter, or obliterate a symbol or label required by section 825 of this title;

(5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II;

(6) to refuse any entry into any premises or inspection authorized by this subchapter or subchapter II;

(7) to remove, break, injure, or deface a seal placed upon controlled substances pursuant to section 824(f) or 881 of this title or to remove or dispose of substances so placed under seal;

(8) to use, to his own advantage, or to reveal, other than to duly authorized officers or employees of the United States, or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection authorized by this subchapter concerning any method or process which as a trade secret is entitled to protection, or to use to his own advantage or reveal (other than as authorized by section 830 of this title) any information that is confidential under such section;

(9) who is a regulated person to engage in a regulated transaction without obtaining the identification required by 830(a)(3) of this title.¹

(10) negligently to fail to keep a record or make a report under section 830 of this title or negligently to fail to self-certify as required under section 830 of this title;

(11) to distribute a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, in violation of this subchapter or subchapter II, with reckless disregard for the illegal uses to which such a laboratory supply will be put;

(12) who is a regulated seller, or a distributor required to submit reports under subsection (b)(3) of section 830 of this title—

(A) to sell at retail a scheduled listed chemical product in violation of paragraph (1) of subsection (d) of such section, knowing at the time of the transaction involved (independent of consulting the logbook under subsection (e)(1)(A)(iii) of such section) that the transaction is a violation; or

(B) to knowingly or recklessly sell at retail such a product in violation of paragraph (2) of such subsection (d);

(13) who is a regulated seller to knowingly or recklessly sell at retail a scheduled listed chemical product in violation of subsection (e) of such section;

(14) who is a regulated seller or an employee or agent of such seller to disclose, in violation of regulations under subparagraph (C) of section 830(e)(1) of this title, information in logbooks under subparagraph (A)(iii) of such section, or to refuse to provide such a logbook to Federal, State, or local law enforcement authorities;

(15) to distribute a scheduled listed chemical product to a regulated seller, or to a regulated person referred to in section 830(b)(3)(B) of this title, unless such regulated seller or regulated person is, at the time of such distribution, currently registered with the Drug Enforcement Administration, or on the list of persons referred to under section 830(e)(1)(B)(v) of this title;

(16) to violate subsection (e) of section 825 of this title; ² or

(17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 827(f) of this title.

As used in paragraph (11), the term "laboratory supply" means a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. For purposes of paragraph (11), there is a rebuttable presumption of reckless disregard at trial if the Attorney General notifies a firm in writing that a laboratory supply sold by the firm, or any other person or firm, has been used by a customer of the notified firm, or distributed further by that customer, for the unlawful production of controlled substances or listed chemicals a firm distributes and 2 weeks or more after the notification the notified firm distributes a laboratory supply to the customer. For purposes of paragraph (15), if the distributor is temporarily unable to access the list of persons referred to under section 830(e)(1)(B)(v) of this title, the distributor may rely on a written, faxed, or electronic copy of a certificate of self-certification submitted by the regulated seller or regulated person, provided the distributor confirms within 7 business days of the distribution that such regulated seller or regulated person is on the list referred to under section 830(e)(1)(B)(v) of this title.

(b) Manufacture

It shall be unlawful for any person who is a registrant to manufacture a controlled substance in schedule I or II, or ephedrine, pseudoephedrine, or phenylpropanolamine or any of the salts, optical isomers, or salts of optical isomers of such chemical, which is—

(1) not expressly authorized by his registration and by a quota assigned to him pursuant to section 826 of this title; or

(2) in excess of a quota assigned to him pursuant to section 826 of this title.

(c) Penalties

(1)(A) Except as provided in subparagraph (B), (C), or (D) of this paragraph and paragraph (2), any person who violates this section shall, with respect to any such violation, be subject to a civil penalty of not more than $25,000. The district courts of the United States (or, where there is no such court in the case of any territory or possession of the United States, then the court in such territory or possession having the jurisdiction of a district court of the United States in cases arising under the Constitution and laws of the United States) shall have jurisdiction in accordance with section 1355 of title 28 to enforce this paragraph.

(B)(i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the civil penalty shall not exceed $10,000.

(ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 827(f) of this title, the penalty shall not exceed $100,000.

(C) In the case of a violation of paragraph (16) of subsection (a) of this section by an importer, exporter, manufacturer, or distributor (other than as provided in subparagraph (D)), up to $500,000 per violation. For purposes of this subparagraph, a violation is defined as each instance of importation, exportation, manufacturing, distribution, or possession with intent to manufacture or distribute, in violation of paragraph (16) of subsection (a).

(D) In the case of a distribution, dispensing, or possession with intent to distribute or dispense in violation of paragraph (16) of subsection (a) of this section at the retail level, up to $1000 per violation. For purposes of this paragraph, the term "at the retail level" refers to products sold, or held for sale, directly to the consumer for personal use. Each package, container or other separate unit containing an anabolic steroid that is distributed, dispensed, or possessed with intent to distribute or dispense at the retail level in violation of such paragraph (16) of subsection (a) shall be considered a separate violation.

(2)(A) If a violation of this section is prosecuted by an information or indictment which alleges that the violation was committed knowingly and the trier of fact specifically finds that the violation was so committed, such person shall, except as otherwise provided in subparagraph (B) or (D) of this paragraph, be sentenced to imprisonment of not more than one year or a fine under title 18, or both.

(B) If a violation referred to in subparagraph (A) was committed after one or more prior convictions of the offender for an offense punishable under this paragraph (2), or for a crime under any other provision of this subchapter or subchapter II or other law of the United States relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final, such person shall be sentenced to a term of imprisonment of not more than 2 years, a fine under title 18, or both.

(C) In addition to the penalties set forth elsewhere in this subchapter or subchapter II, any business that violates paragraph (11) of subsection (a) shall, with respect to the first such violation, be subject to a civil penalty of not more than $250,000, but shall not be subject to criminal penalties under this section, and shall, for any succeeding violation, be subject to a civil fine of not more than $250,000 or double the last previously imposed penalty, whichever is greater.

(D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 827(f) of this title, the criminal fine under title 18 shall not exceed $500,000.

(3) Except under the conditions specified in paragraph (2) of this subsection, a violation of this section does not constitute a crime, and a judgment for the United States and imposition of a civil penalty pursuant to paragraph (1) shall not give rise to any disability or legal disadvantage based on conviction for a criminal offense.

(4)(A) If a regulated seller, or a distributor required to submit reports under section 830(b)(3) of this title, violates paragraph (12) of subsection (a) of this section, or if a regulated seller violates paragraph (13) of such subsection, the Attorney General may by order prohibit such seller or distributor (as the case may be) from selling any scheduled listed chemical product. Any sale of such a product in violation of such an order is subject to the same penalties as apply under paragraph (2).

(B) An order under subparagraph (A) may be imposed only through the same procedures as apply under section 824(c) of this title for an order to show cause.

(Pub. L. 91–513, title II, §402, Oct. 27, 1970, 84 Stat. 1262; Pub. L. 95–633, title II, §202(b)(1), (2), Nov. 10, 1978, 92 Stat. 3776; Pub. L. 100–690, title VI, §6056, Nov. 18, 1988, 102 Stat. 4318; Pub. L. 104–237, title II, §205, Oct. 3, 1996, 110 Stat. 3103; Pub. L. 105–277, div. A, §101(b) [title I, §117], Oct. 21, 1998, 112 Stat. 2681–50, 2681-68; Pub. L. 107–273, div. B, title IV, §4002(b)(16), (d)(2)(B), Nov. 2, 2002, 116 Stat. 1808, 1809; Pub. L. 109–177, title VII, §§711(f)(1)(A), (2), 714, Mar. 9, 2006, 120 Stat. 262–264; Pub. L. 111–268, §§4, 5, Oct. 12, 2010, 124 Stat. 2847, 2848; Pub. L. 113–260, §3(c), Dec. 18, 2014, 128 Stat. 2931; Pub. L. 115–271, title III, §3273(c), Oct. 24, 2018, 132 Stat. 3953.)

Editorial Notes

References in Text

Section 825 of this title, referred to in subsec. (a)(16), was so in the original, but probably should have been a reference to section 305 of Pub. L. 91–513, which is classified to section 825 of this title.

Schedules I and II, referred to in subsec. (b), are set out in section 812(c) of this title.

Amendments

2018—Subsec. (a)(17). Pub. L. 115–271, §3273(c)(1), added par. (17).

Subsec. (c)(1)(B). Pub. L. 115–271, §3273(c)(2)(A), added subpar. (B) and struck out former subpar. (B) which read as follows: "In the case of a violation of paragraph (5) or (10) of subsection (a), the civil penalty shall not exceed $10,000."

Subsec. (c)(2)(A). Pub. L. 115–271, §3273(c)(2)(B)(i), inserted "or (D)" after "subparagraph (B)".

Subsec. (c)(2)(D). Pub. L. 115–271, §3273(c)(2)(B)(ii), added subpar. (D).

2014—Subsec. (a)(16). Pub. L. 113–260, §3(c)(1), added par. (16).

Subsec. (c)(1)(A). Pub. L. 113–260, §3(c)(2)(A), inserted ", (C), or (D)" after "subparagraph (B)".

Subsec. (c)(1)(C), (D). Pub. L. 113–260, §3(c)(2)(B), added subpars. (C) and (D).

2010—Subsec. (a). Pub. L. 111–268, §4(4), inserted "For purposes of paragraph (15), if the distributor is temporarily unable to access the list of persons referred to under section 830(e)(1)(B)(v) of this title, the distributor may rely on a written, faxed, or electronic copy of a certificate of self-certification submitted by the regulated seller or regulated person, provided the distributor confirms within 7 business days of the distribution that such regulated seller or regulated person is on the list referred to under section 830(e)(1)(B)(v) of this title." at end of concluding provisions.

Subsec. (a)(10). Pub. L. 111–268, §5, inserted "or negligently to fail to self-certify as required under section 830 of this title" before semicolon.

Subsec. (a)(15). Pub. L. 111–268, §4(1)–(3), added par. (15).

2006—Subsec. (a)(12) to (14). Pub. L. 109–177, §711(f)(1)(A), added pars. (12) to (14).

Subsec. (b). Pub. L. 109–177, §714, inserted ", or ephedrine, pseudoephedrine, or phenylpropanolamine or any of the salts, optical isomers, or salts of optical isomers of such chemical," after "manufacture a controlled substance in schedule I or II" in introductory provisions.

Subsec. (c)(4). Pub. L. 109–177, §711(f)(2), added par. (4).

2002—Subsec. (c)(2)(A). Pub. L. 107–273, §4002(d)(2)(B)(i), substituted "under title 18" for "of not more than $25,000".

Subsec. (c)(2)(B). Pub. L. 107–273, §4002(d)(2)(B)(ii), substituted "under title 18" for "of $50,000".

Subsec. (c)(2)(C). Pub. L. 107–273, §4002(b)(16), realigned margins.

1998—Subsec. (a)(5). Pub. L. 105–277, §101(b) [title I, §117(1)], inserted "negligently" before "fail".

Subsec. (a)(10). Pub. L. 105–277, §101(b) [title I, §117(2)], inserted "negligently" before "to fail".

Subsec. (c)(1). Pub. L. 105–277, §101(b) [title I, §117(3)], designated existing provisions as subpar. (A), inserted "subparagraph (B) of this paragraph and" before "paragraph (2)", and added subpar. (B).

1996—Subsec. (a). Pub. L. 104–237, §205(a), added par. (11) and closing provisions.

Subsec. (c)(2)(C). Pub. L. 104–237, §205(b), added subpar. (C).

1988—Subsec. (a)(8). Pub. L. 100–690, §6056(a), inserted ", or to use to his own advantage or reveal (other than as authorized by section 830 of this title) any information that is confidential under such section" after "protection".

Subsec. (a)(9). Pub. L. 100–690, §6056(b), amended par. (9) generally. Prior to amendment, par. (9) read as follows: "to distribute or sell piperidine in violation of regulations established under section 830(a)(2) of this title, respecting presentation of identification."

Subsec. (a)(10). Pub. L. 100–690, §6056(d), added par. (10).

Subsec. (c)(2)(C). Pub. L. 100–690, §6056(c), struck out subpar. (C) which read as follows: "Subparagraphs (A) and (B) shall not apply to a violation of subsection (a)(5) of this section with respect to a refusal or failure to make a report required under section 830(a) of this title (relating to piperidine reporting)."

1978—Subsec. (a)(9). Pub. L. 95–633, §202(b)(1), added par. (9).

Subsec. (c)(2)(C). Pub. L. 95–633, §202(b)(2), added subpar. (C).

Statutory Notes and Related Subsidiaries

Effective Date of 2010 Amendment

Amendment by Pub. L. 111–268 effective 180 days after Oct. 12, 2010, see section 6(a) of Pub. L. 111–268, set out as a note under section 830 of this title.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective Nov. 10, 1978, see section 203(a) of Pub. L. 95–633 set out as an Effective Date note under section 830 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Repeals

Pub. L. 96–359, §8(b), Sept. 26, 1980, 94 Stat. 1194, repealed section 203(d) of Pub. L. 95–633, which had provided for the repeal of subsecs. (a)(9) and (c)(2)(C) of this section effective Jan. 1, 1981.

¹ So in original. Probably should be "section 830(a)(3) of this title;".

² See References in Text note below.

§843. Prohibited acts C

(a) Unlawful acts

It shall be unlawful for any person knowingly or intentionally—

(1) who is a registrant to distribute a controlled substance classified in schedule I or II, in the course of his legitimate business, except pursuant to an order or an order form as required by section 828 of this title;

(2) to use in the course of the manufacture, distribution, or dispensing of a controlled substance, or to use for the purpose of acquiring or obtaining a controlled substance, a registration number which is fictitious, revoked, suspended, expired, or issued to another person;

(3) to acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge;

(4)(A) to furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made, kept, or filed under this subchapter or subchapter II, or (B) to present false or fraudulent identification where the person is receiving or purchasing a listed chemical and the person is required to present identification under section 830(a) of this title;

(5) to make, distribute, or possess any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit substance;

(6) to possess any three-neck round-bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to manufacture a controlled substance or listed chemical, knowing, intending, or having reasonable cause to believe, that it will be used to manufacture a controlled substance or listed chemical in violation of this subchapter or subchapter II;

(7) to manufacture, distribute, export, or import any three-neck round-bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to manufacture a controlled substance or listed chemical, knowing, intending, or having reasonable cause to believe, that it will be used to manufacture a controlled substance or listed chemical in violation of this subchapter or subchapter II or, in the case of an exportation, in violation of this subchapter or subchapter II or of the laws of the country to which it is exported;

(8) to create a chemical mixture for the purpose of evading a requirement of section 830 of this title or to receive a chemical mixture created for that purpose; or

(9) to distribute, import, or export a list I chemical without the registration required by this subchapter or subchapter II.

(b) Communication facility

It shall be unlawful for any person knowingly or intentionally to use any communication facility in committing or in causing or facilitating the commission of any act or acts constituting a felony under any provision of this subchapter or subchapter II. Each separate use of a communication facility shall be a separate offense under this subsection. For purposes of this subsection, the term "communication facility" means any and all public and private instrumentalities used or useful in the transmission of writing, signs, signals, pictures, or sounds of all kinds and includes mail, telephone, wire, radio, and all other means of communication.

(c) Advertisement

(1) It shall be unlawful for any person to place in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule ¹ I controlled substance. As used in this section the term "advertisement" includes, in addition to its ordinary meaning, such advertisements as those for a catalog of Schedule ¹ I controlled substances and any similar written advertisement that has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule ¹ I controlled substance. The term "advertisement" does not include material which merely advocates the use of a similar material, which advocates a position or practice, and does not attempt to propose or facilitate an actual transaction in a Schedule ¹ I controlled substance.

(2)(A) It shall be unlawful for any person to knowingly or intentionally use the Internet, or cause the Internet to be used, to advertise the sale of, or to offer to sell, distribute, or dispense, a controlled substance where such sale, distribution, or dispensing is not authorized by this subchapter or by the Controlled Substances Import and Export Act [21 U.S.C. 951 et seq.].

(B) Examples of activities that violate subparagraph (A) include, but are not limited to, knowingly or intentionally causing the placement on the Internet of an advertisement that refers to or directs prospective buyers to Internet sellers of controlled substances who are not registered with a modification under section 823(g) of this title.

(C) Subparagraph (A) does not apply to material that either—

(i) merely advertises the distribution of controlled substances by nonpractitioners to the extent authorized by their registration under this subchapter; or

(ii) merely advocates the use of a controlled substance or includes pricing information without attempting to facilitate an actual transaction involving a controlled substance.

(d) Penalties

(1) Except as provided in paragraph (2), any person who violates this section shall be sentenced to a term of imprisonment of not more than 4 years, a fine under title 18, or both; except that if any person commits such a violation after one or more prior convictions of him for violation of this section, or for a felony under any other provision of this subchapter or subchapter II or other law of the United States relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final, such person shall be sentenced to a term of imprisonment of not more than 8 years, a fine under title 18, or both.

(2) Any person who, with the intent to manufacture or to facilitate the manufacture of methamphetamine, violates paragraph (6) or (7) of subsection (a), shall be sentenced to a term of imprisonment of not more than 10 years, a fine under title 18, or both; except that if any person commits such a violation after one or more prior convictions of that person—

(A) for a violation of paragraph (6) or (7) of subsection (a);

(B) for a felony under any other provision of this subchapter or subchapter II of this chapter; ² or

(C) under any other law of the United States or any State relating to controlled substances or listed chemicals,

has become final, such person shall be sentenced to a term of imprisonment of not more than 20 years, a fine under title 18, or both.

(e) Additional penalties

In addition to any other applicable penalty, any person convicted of a felony violation of this section relating to the receipt, distribution, manufacture, exportation, or importation of a listed chemical may be enjoined from engaging in any transaction involving a listed chemical for not more than ten years.

(f) Injunctions

(1) In addition to any penalty provided in this section, the Attorney General is authorized to commence a civil action for appropriate declaratory or injunctive relief relating to violations of this section, section 842 of this title, or 856 ³ of this title.

(2) Any action under this subsection may be brought in the district court of the United States for the district in which the defendant is located or resides or is doing business.

(3) Any order or judgment issued by the court pursuant to this subsection shall be tailored to restrain violations of this section or section 842 of this title.

(4) The court shall proceed as soon as practicable to the hearing and determination of such an action. An action under this subsection is governed by the Federal Rules of Civil Procedure except that, if an indictment has been returned against the respondent, discovery is governed by the Federal Rules of Criminal Procedure.

(Pub. L. 91–513, title II, §403, Oct. 27, 1970, 84 Stat. 1263; Pub. L. 95–633, title II, §202(b)(3), Nov. 10, 1978, 92 Stat. 3776; Pub. L. 98–473, title II, §516, Oct. 12, 1984, 98 Stat. 2074; Pub. L. 99–570, title I, §1866(a), Oct. 27, 1986, 100 Stat. 3207–54; Pub. L. 100–690, title VI, §6057, Nov. 18, 1988, 102 Stat. 4319; Pub. L. 103–200, §3(g), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 103–322, title IX, §90106, Sept. 13, 1994, 108 Stat. 1988; Pub. L. 104–237, title II, §§203(a), 206(b), Oct. 3, 1996, 110 Stat. 3102, 3103; Pub. L. 107–273, div. B, title IV, §4002(d)(2)(C), Nov. 2, 2002, 116 Stat. 1810; Pub. L. 108–21, title VI, §608(d), Apr. 30, 2003, 117 Stat. 691; Pub. L. 110–425, §3(g), Oct. 15, 2008, 122 Stat. 4830; Pub. L. 117–215, title I, §103(b)(1)(H), Dec. 2, 2022, 136 Stat. 2263.)

Editorial Notes

References in Text

Schedules I and II, referred to in subsecs. (a)(1) and (c)(1), are set out in section 812(c) of this title.

This subchapter, referred to in subsec. (c)(2)(A), (C)(i), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

The Controlled Substances Import and Export Act, referred to in subsec. (c)(2)(A), is title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285, which is classified principally to subchapter II (§951 et seq.) of this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 951 of this title and Tables.

This subchapter or subchapter II of this chapter, referred to in subsec. (d)(2)(B), was in the original a reference to "this subchapter or subchapter II of this chapter" but probably should be a reference to "this title or title III of this Act", meaning titles II and III, respectively, of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, 1285.

The Federal Rules of Civil Procedure, referred to in subsec. (f)(4), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

The Federal Rules of Criminal Procedure, referred to in subsec. (f)(4), are set out in the Appendix to Title 18, Crimes and Criminal Procedure.

Amendments

2022—Subsec. (c)(2)(B). Pub. L. 117–215 substituted "823(g)" for "823(f)".

2008—Subsec. (c). Pub. L. 110–425 designated existing provisions as par. (1) and added par. (2).

2003—Subsec. (f)(1). Pub. L. 108–21 substituted "this section, section 842 of this title, or 856 of this title" for "this section or section 842 of this title".

2002—Subsec. (d). Pub. L. 107–273 substituted "under title 18, or both;" for "of not more than $30,000, or both;" in two places and "under title 18, or both." for "of not more than $60,000, or both." in two places.

1996—Subsec. (d). Pub. L. 104–237, §203(a), inserted par. (1) designation, substituted "Except as provided in paragraph (2), any person" for "Any person", and added par. (2).

Subsec. (e). Pub. L. 104–237, §206(b)(1), inserted "manufacture, exportation," after "distribution," and struck out "regulated" after "engaging in any".

Subsec. (f). Pub. L. 104–237, §206(b)(2), added subsec. (f).

1994—Subsecs. (c) to (e). Pub. L. 103–322 added subsec. (c) and redesignated former subsecs. (c) and (d) as (d) and (e), respectively.

1993—Subsec. (a)(6), (7). Pub. L. 103–200, §3(g)(1), amended pars. (6) and (7) generally. Prior to amendment, pars. (6) and (7) read as follows:

"(6) to possess any three-neck round-bottom flask, tableting machine, encapsulating machine, gelatin capsule, or equipment specially designed or modified to manufacture a controlled substance, with intent to manufacture a controlled substance except as authorized by this subchapter;

"(7) to manufacture, distribute, or import any three-neck round-bottom flask, tableting machine, encapsulating machine, gelatin capsule, or equipment specially designed or modified to manufacture a controlled substance, knowing that it will be used to manufacture a controlled substance except as authorized by this subchapter; or".

Subsec. (a)(9). Pub. L. 103–200, §3(g)(2), (3), added par. (9).

1988—Subsec. (a)(4)(B). Pub. L. 100–690, §6057(a)(1), substituted "a listed chemical" for "piperidine".

Subsec. (a)(6) to (8). Pub. L. 100–690, §6057(a)(2)–(4), added pars. (6) to (8).

Subsec. (d). Pub. L. 100–690, §6057(b), added subsec. (d).

1986—Subsec. (a)(2). Pub. L. 99–570 substituted a semicolon for the period at end.

1984—Subsec. (a)(2). Pub. L. 98–473 added applicability to dispensing, acquiring, or obtaining a controlled substance, and applicability to an expired number.

1978—Subsec. (a)(4). Pub. L. 95–633, §202(b)(3), designated existing provisions as subpar. (A) and added subpar. (B).

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective Nov. 10, 1978, except as otherwise provided, see section 203(a) of Pub. L. 95–633, set out as an Effective Date note under section 830 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Repeals

Pub. L. 96–359, §8(b), Sept. 26, 1980, 94 Stat. 1194, repealed section 203(d) of Pub. L. 95–633, which had provided for the repeal of subsec. (a)(4)(B) of this section effective Jan. 1, 1981.

¹ So in original. Probably should not be capitalized.

² See References in Text note below.

³ So in original. Probably should be preceded by "section".

§844. Penalties for simple possession

(a) Unlawful acts; penalties

It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this subchapter or subchapter II. It shall be unlawful for any person knowingly or intentionally to possess any list I chemical obtained pursuant to or under authority of a registration issued to that person under section 823 of this title or section 958 of this title if that registration has been revoked or suspended, if that registration has expired, or if the registrant has ceased to do business in the manner contemplated by his registration. It shall be unlawful for any person to knowingly or intentionally purchase at retail during a 30 day period more than 9 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product, except that, of such 9 grams, not more than 7.5 grams may be imported by means of shipping through any private or commercial carrier or the Postal Service. Any person who violates this subsection may be sentenced to a term of imprisonment of not more than 1 year, and shall be fined a minimum of $1,000, or both, except that if he commits such offense after a prior conviction under this subchapter or subchapter II, or a prior conviction for any drug, narcotic, or chemical offense chargeable under the law of any State, has become final, he shall be sentenced to a term of imprisonment for not less than 15 days but not more than 2 years, and shall be fined a minimum of $2,500, except, further, that if he commits such offense after two or more prior convictions under this subchapter or subchapter II, or two or more prior convictions for any drug, narcotic, or chemical offense chargeable under the law of any State, or a combination of two or more such offenses have become final, he shall be sentenced to a term of imprisonment for not less than 90 days but not more than 3 years, and shall be fined a minimum of $5,000. Notwithstanding any penalty provided in this subsection, any person convicted under this subsection for the possession of flunitrazepam shall be imprisoned for not more than 3 years, shall be fined as otherwise provided in this section, or both. The imposition or execution of a minimum sentence required to be imposed under this subsection shall not be suspended or deferred. Further, upon conviction, a person who violates this subsection shall be fined the reasonable costs of the investigation and prosecution of the offense, including the costs of prosecution of an offense as defined in sections 1918 and 1920 of title 28, except that this sentence shall not apply and a fine under this section need not be imposed if the court determines under the provision of title 18 that the defendant lacks the ability to pay.

(b) Repealed. Pub. L. 98–473, title II, §219(a), Oct. 12, 1984, 98 Stat. 2027

(c) "Drug, narcotic, or chemical offense" defined

As used in this section, the term "drug, narcotic, or chemical offense" means any offense which proscribes the possession, distribution, manufacture, cultivation, sale, transfer, or the attempt or conspiracy to possess, distribute, manufacture, cultivate, sell or transfer any substance the possession of which is prohibited under this subchapter.

(Pub. L. 91–513, title II, §404, Oct. 27, 1970, 84 Stat. 1264; Pub. L. 98–473, title II, §219, Oct. 12, 1984, 98 Stat. 2027; Pub. L. 99–570, title I, §1052, Oct. 27, 1986, 100 Stat. 3207–8; Pub. L. 100–690, title VI, §§6371, 6480, Nov. 18, 1988, 102 Stat. 4370, 4382; Pub. L. 101–647, title XII, §1201, title XIX, §1907, Nov. 29, 1990, 104 Stat. 4829, 4854; Pub. L. 104–237, title II, §201(a), Oct. 3, 1996, 110 Stat. 3101; Pub. L. 104–305, §2(c), Oct. 13, 1996, 110 Stat. 3808; Pub. L. 109–177, title VII, §711(e)(1), Mar. 9, 2006, 120 Stat. 262; Pub. L. 111–220, §3, Aug. 3, 2010, 124 Stat. 2372.)

Editorial Notes

Amendments

2010—Subsec. (a). Pub. L. 111–220 struck out "Notwithstanding the preceding sentence, a person convicted under this subsection for the possession of a mixture or substance which contains cocaine base shall be imprisoned not less than 5 years and not more than 20 years, and fined a minimum of $1,000, if the conviction is a first conviction under this subsection and the amount of the mixture or substance exceeds 5 grams, if the conviction is after a prior conviction for the possession of such a mixture or substance under this subsection becomes final and the amount of the mixture or substance exceeds 3 grams, or if the conviction is after 2 or more prior convictions for the possession of such a mixture or substance under this subsection become final and the amount of the mixture or substance exceeds 1 gram." after "$5,000."

2006—Subsec. (a). Pub. L. 109–177 inserted after second sentence "It shall be unlawful for any person to knowingly or intentionally purchase at retail during a 30 day period more than 9 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product, except that, of such 9 grams, not more than 7.5 grams may be imported by means of shipping through any private or commercial carrier or the Postal Service."

1996—Subsec. (a). Pub. L. 104–305 inserted "Notwithstanding any penalty provided in this subsection, any person convicted under this subsection for the possession of flunitrazepam shall be imprisoned for not more than 3 years, shall be fined as otherwise provided in this section, or both." after "mixture or substance exceeds 1 gram."

Pub. L. 104–237, §201(a)(1), inserted after first sentence "It shall be unlawful for any person knowingly or intentionally to possess any list I chemical obtained pursuant to or under authority of a registration issued to that person under section 823 of this title or section 958 of this title if that registration has been revoked or suspended, if that registration has expired, or if the registrant has ceased to do business in the manner contemplated by his registration." and substituted "drug, narcotic, or chemical" for "drug or narcotic" in two places.

Subsec. (c). Pub. L. 104–237, §201(a)(2), substituted "drug, narcotic, or chemical" for "drug or narcotic".

1990—Subsec. (a). Pub. L. 101–647, §1907, inserted subsec. (a) designation.

Pub. L. 101–647, §1201, substituted "shall be imprisoned not less than 5 years and not more than 20 years, and fined a minimum of $1,000" for "shall be fined under title 18 or imprisoned not less than 5 years and not more than 20 years, or both".

1988—Subsec. (a). Pub. L. 100–690, §6480(1)(A)–(C), struck out "but not more than $5,000" after "$1,000", "but not more than $10,000" after "$2,500", and "but not more than $25,000" after "$5,000" in second sentence.

Pub. L. 100–690, §6371, inserted provisions relating to increased penalties in cases of certain serious crack possession offenses, making offenders subject to fines under title 18 or imprisonment to terms not less than 5 years nor more than 20 years, or both.

1986—Subsec. (a). Pub. L. 99–570 amended subsec. (a) generally. Prior to amendment, subsec. (a) read as follows: "It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this subchapter or subchapter II of this chapter. Any person who violates this subsection shall be sentenced to a term of imprisonment of not more than one year, a fine of not more than $5,000, or both, except that if he commits such offense after a prior conviction or convictions under this subsection have become final, he shall be sentenced to a term of imprisonment of not more than 2 years, a fine of not more than $10,000 or both."

Subsec. (b). Pub. L. 99–570, in amending subsec. (b) generally, substituted "Upon the discharge of such person and dismissal of the proceedings" for "Upon the dismissal of such person and discharge of the proceedings" in par. (2).

Subsec. (c). Pub. L. 99–570, in amending section generally, added subsec. (c).

1984—Pub. L. 98–473 struck out subsec. (a) designation and struck out subsec. (b) which related to probation before judgment and expunging of records for first offense.

Statutory Notes and Related Subsidiaries

Effective Date of 2006 Amendment

Pub. L. 109–177, title VII, §711(e)(2), Mar. 9, 2006, 120 Stat. 262, provided that: "The amendment made by paragraph (1) [amending this section] applies on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006]."

Effective Date of 1984 Amendment

Amendment by Pub. L. 98–473 effective Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such amendment, see section 235(a)(1) of Pub. L. 98–473, set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Executive Documents

Proc. No. 10467. Granting Pardon for the Offense of Simple Possession of Marijuana

Proc. No. 10467, Oct. 6, 2022, 87 F.R. 61441, provided:

Acting pursuant to the grant of authority in Article II, Section 2, of the Constitution of the United States, I, Joseph R. Biden Jr., do hereby grant a full, complete, and unconditional pardon to (1) all current United States citizens and lawful permanent residents who committed the offense of simple possession of marijuana in violation of the Controlled Substances Act, as currently codified at 21 U.S.C. 844 and as previously codified elsewhere in the United States Code, or in violation of D.C. Code 48–904.01(d)(1), on or before the date of this proclamation [Oct. 6, 2022], regardless of whether they have been charged with or prosecuted for this offense on or before the date of this proclamation; and (2) all current United States citizens and lawful permanent residents who have been convicted of the offense of simple possession of marijuana in violation of the Controlled Substances Act, as currently codified at 21 U.S.C. 844 and as previously codified elsewhere in the United States Code, or in violation of D.C. Code 48–904.01(d)(1); which pardon shall restore to them full political, civil, and other rights.

My intent by this proclamation is to pardon only the offense of simple possession of marijuana in violation of Federal law or in violation of D.C. Code 48–904.01(d)(1), and not any other offenses related to marijuana or other controlled substances. No language herein shall be construed to pardon any person for any other offense, including possession of other controlled substances, whether committed prior, subsequent, or contemporaneous to the pardoned offense of simple possession of marijuana. This pardon does not apply to individuals who were non-citizens not lawfully present in the United States at the time of their offense.

Pursuant to this proclamation, the Attorney General, acting through the Pardon Attorney, shall administer and effectuate the issuance of certificates of pardon to eligible applicants who have been charged or convicted for the offense of simple possession of marijuana in violation of the Controlled Substances Act, as currently codified at 21 U.S.C. 844 and as previously codified elsewhere in the United States Code, or in violation of D.C. Code 48–904.01(d)(1). The Attorney General, acting through the Pardon Attorney, is directed to develop and announce application procedures for certificates of pardon and to begin accepting applications in accordance with such procedures as soon as reasonably practicable. The Attorney General, acting through the Pardon Attorney, shall review all properly submitted applications and shall issue certificates of pardon to eligible applicants in due course.

IN WITNESS WHEREOF, I have hereunto set my hand this sixth day of October, in the year of our Lord two thousand twenty-two, and of the Independence of the United States of America the two hundred and forty-seventh.

J.R. Biden, Jr.      

Proc. No. 10688. Granting Pardon for the Offense of Simple Possession of Marijuana, Attempted Simple Possession of Marijuana, or Use of Marijuana

Proc. No. 10688, Dec. 22, 2023, 88 F.R. 90083, provided:

In Proclamation 10467 of October 6, 2022 (Granting Pardon for the Offense of Simple Possession of Marijuana) [set out above], I exercised my authority under the Constitution to pardon individuals who committed or were convicted of the offense of simple possession of marijuana in violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] and section 48–904.01(d)(1) of the Code of the District of Columbia (D.C. Code). As I have said before, convictions for simple possession of marijuana have imposed needless barriers to employment, housing, and educational opportunities. Through this proclamation, consistent with the grant of Proclamation 10467, I am pardoning additional individuals who may continue to experience the unnecessary collateral consequences of a conviction for simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana. Therefore, acting pursuant to the grant of authority in Article II, Section 2, of the Constitution of the United States, I, Joseph R. Biden Jr., do hereby grant a full, complete, and unconditional pardon to all current United States citizens and lawful permanent residents who, on or before the date of this proclamation [Dec. 22, 2023], committed or were convicted of the offense of simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana, regardless of whether they have been charged with or prosecuted for these offenses on or before the date of this proclamation, in violation of:

(1) section 844 of title 21, United States Code, section 846 of title 21, United States Code, and previous provisions in the United States Code that prohibited simple possession of marijuana or attempted simple possession of marijuana;

(2) section 48–904.01(d)(1) of the D.C. Code and previous provisions in the D.C. Code that prohibited simple possession of marijuana;

(3) section 48–904.09 of the D.C. Code and previous provisions in the D.C. Code that prohibited attempted simple possession of marijuana; and

(4) provisions in the Code of Federal Regulations, including as enforced under the United States Code, that prohibit only the simple possession or use of marijuana on Federal properties or installations, or in other locales, as currently or previously codified, including but not limited to 25 C.F.R. 11.452(a); 32 C.F.R. 1903.12(b)(2); 36 C.F.R. 2.35(b)(2); 36 C.F.R. 1002.35(b)(2); 36 C.F.R. 1280.16(a)(1); 36 C.F.R. 702.6(b); 41 C.F.R. 102–74.400(a); 43 C.F.R. 8365.1–4(b)(2); and 50 C.F.R. 27.82(b)(2).

My intent by this proclamation is to pardon only the offenses of simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana in violation of the Federal and D.C. laws set forth in paragraphs (1) through (3) of this proclamation, as well as the provisions in the Code of Federal Regulations consistent with paragraph (4) of this proclamation, and not any other offenses involving other controlled substances or activity beyond simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana, such as possession of marijuana with intent to distribute or driving offenses committed while under the influence of marijuana. This pardon does not apply to individuals who were non-citizens not lawfully present in the United States at the time of their offense.

Pursuant to the procedures in Proclamation 10467, the Attorney General, acting through the Pardon Attorney, shall review all properly submitted applications for certificates of pardon and shall issue such certificates of pardon to eligible applicants in due course.

IN WITNESS WHEREOF, I have hereunto set my hand this twenty-second day of December, in the year of our Lord two thousand twenty-three, and of the Independence of the United States of America the two hundred and forty-eighth.

J.R. Biden, Jr.      

§844a. Civil penalty for possession of small amounts of certain controlled substances

(a) In general

Any individual who knowingly possesses a controlled substance that is listed in section 841(b)(1)(A) of this title in violation of section 844 of this title in an amount that, as specified by regulation of the Attorney General, is a personal use amount shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each such violation.

(b) Income and net assets

The income and net assets of an individual shall not be relevant to the determination whether to assess a civil penalty under this section or to prosecute the individual criminally. However, in determining the amount of a penalty under this section, the income and net assets of an individual shall be considered.

(c) Prior conviction

A civil penalty may not be assessed under this section if the individual previously was convicted of a Federal or State offense relating to a controlled substance.

(d) Limitation on number of assessments

A civil penalty may not be assessed on an individual under this section on more than two separate occasions.

(e) Assessment

A civil penalty under this section may be assessed by the Attorney General only by an order made on the record after opportunity for a hearing in accordance with section 554 of title 5. The Attorney General shall provide written notice to the individual who is the subject of the proposed order informing the individual of the opportunity to receive such a hearing with respect to the proposed order. The hearing may be held only if the individual makes a request for the hearing before the expiration of the 30-day period beginning on the date such notice is issued.

(f) Compromise

The Attorney General may compromise, modify, or remit, with or without conditions, any civil penalty imposed under this section.

(g) Judicial review

If the Attorney General issues an order pursuant to subsection (e) after a hearing described in such subsection, the individual who is the subject of the order may, before the expiration of the 30-day period beginning on the date the order is issued, bring a civil action in the appropriate district court of the United States. In such action, the law and the facts of the violation and the assessment of the civil penalty shall be determined de novo, and shall include the right of a trial by jury, the right to counsel, and the right to confront witnesses. The facts of the violation shall be proved beyond a reasonable doubt.

(h) Civil action

If an individual does not request a hearing pursuant to subsection (e) and the Attorney General issues an order pursuant to such subsection, or if an individual does not under subsection (g) seek judicial review of such an order, the Attorney General may commence a civil action in any appropriate district court of the United States for the purpose of recovering the amount assessed and an amount representing interest at a rate computed in accordance with section 1961 of title 28. Such interest shall accrue from the expiration of the 30-day period described in subsection (g). In such an action, the decision of the Attorney General to issue the order, and the amount of the penalty assessed by the Attorney General, shall not be subject to review.

(i) Limitation

The Attorney General may not under this subsection ¹ commence proceeding against an individual after the expiration of the 5-year period beginning on the date on which the individual allegedly violated subsection (a).

(j) Expungement procedures

The Attorney General shall dismiss the proceedings under this section against an individual upon application of such individual at any time after the expiration of 3 years if—

(1) the individual has not previously been assessed a civil penalty under this section;

(2) the individual has paid the assessment;

(3) the individual has complied with any conditions imposed by the Attorney General;

(4) the individual has not been convicted of a Federal or State offense relating to a controlled substance; and

(5) the individual agrees to submit to a drug test, and such test shows the individual to be drug free.

A nonpublic record of a disposition under this subsection shall be retained by the Department of Justice solely for the purpose of determining in any subsequent proceeding whether the person qualified for a civil penalty or expungement under this section. If a record is expunged under this subsection, an individual concerning whom such an expungement has been made shall not be held thereafter under any provision of law to be guilty of perjury, false swearing, or making a false statement by reason of his failure to recite or acknowledge a proceeding under this section or the results thereof in response to an inquiry made of him for any purpose.

(Pub. L. 91–513, title II, §405, formerly Pub. L. 100–690, title VI, §6486, Nov. 18, 1988, 102 Stat. 4384, renumbered §405 of Pub. L. 91–513, and amended Pub. L. 101–647, title X, §1002(g)(1), (2), Nov. 29, 1990, 104 Stat. 4828.)

Editorial Notes

Prior Provisions

A prior section 405 of Pub. L. 91–513 was renumbered section 418 and is classified to section 859 of this title.

Amendments

1990—Subsec. (a). Pub. L. 101–647, §1002(g)(2)(A), made technical amendments to references to sections 841(b)(1)(A) and 844 of this title to correct references to corresponding provisions of original act.

Subsecs. (c), (j)(4). Pub. L. 101–647, §1002(g)(2)(B), (C), struck out "as defined in section 802 of this title" after "controlled substance".

¹ So in original. Probably should be "section".

§§845 to 845b. Transferred

Editorial Notes

Codification

Section 845, Pub. L. 91–513, title II, §405, Oct. 27, 1970, 84 Stat. 1265, as amended, which related to distribution of controlled substances to persons under age twenty-one, was renumbered §418 of Pub. L. 91–513 by Pub. L. 101–647, title X, §1002(a)(1), Nov. 29, 1990, 104 Stat. 4827, and transferred to section 859 of this title.

Section 845a, Pub. L. 91–513, title II, §405A, as added Pub. L. 98–473, title II, §503(a), Oct. 12, 1984, 98 Stat. 2069, and amended, which related to distribution or manufacturing of controlled substances in or near schools and colleges, was renumbered §419 of Pub. L. 91–513 by Pub. L. 101–647, title X, §1002(b), Nov. 29, 1990, 104 Stat. 4827, and transferred to section 860 of this title.

Section 845b, Pub. L. 91–513, title II, §405B, as added Pub. L. 99–570, title I, §1102, Oct. 27, 1986, 100 Stat. 3207–10, and amended, which related to employment or use of persons under 18 years of age in drug operations, was renumbered §420 of Pub. L. 91–513 by Pub. L. 101–647, title X, §1002(c), Nov. 29, 1990, 104 Stat. 4827, and transferred to section 861 of this title.

§846. Attempt and conspiracy

Any person who attempts or conspires to commit any offense defined in this subchapter shall be subject to the same penalties as those prescribed for the offense, the commission of which was the object of the attempt or conspiracy.

(Pub. L. 91–513, title II, §406, Oct. 27, 1970, 84 Stat. 1265; Pub. L. 100–690, title VI, §6470(a), Nov. 18, 1988, 102 Stat. 4377.)

Editorial Notes

Amendments

1988—Pub. L. 100–690 substituted "shall be subject to the same penalties as those prescribed for the offense" for "is punishable by imprisonment or fine or both which may not exceed the maximum punishment prescribed for the offense".

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

§847. Additional penalties

Any penalty imposed for violation of this subchapter shall be in addition to, and not in lieu of, any civil or administrative penalty or sanction authorized by law.

(Pub. L. 91–513, title II, §407, Oct. 27, 1970, 84 Stat. 1265.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

§848. Continuing criminal enterprise

(a) Penalties; forfeitures

Any person who engages in a continuing criminal enterprise shall be sentenced to a term of imprisonment which may not be less than 20 years and which may be up to life imprisonment, to a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $2,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, and to the forfeiture prescribed in section 853 of this title; except that if any person engages in such activity after one or more prior convictions of him under this section have become final, he shall be sentenced to a term of imprisonment which may not be less than 30 years and which may be up to life imprisonment, to a fine not to exceed the greater of twice the amount authorized in accordance with the provisions of title 18 or $4,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, and to the forfeiture prescribed in section 853 of this title.

(b) Life imprisonment for engaging in continuing criminal enterprise

Any person who engages in a continuing criminal enterprise shall be imprisoned for life and fined in accordance with subsection (a), if—

(1) such person is the principal administrator, organizer, or leader of the enterprise or is one of several such principal administrators, organizers, or leaders; and

(2)(A) the violation referred to in subsection (c)(1) involved at least 300 times the quantity of a substance described in subsection 841(b)(1)(B) of this title, or

(B) the enterprise, or any other enterprise in which the defendant was the principal or one of several principal administrators, organizers, or leaders, received $10 million dollars in gross receipts during any twelve-month period of its existence for the manufacture, importation, or distribution of a substance described in section 841(b)(1)(B) of this title.

(c) "Continuing criminal enterprise" defined

For purposes of subsection (a), a person is engaged in a continuing criminal enterprise if—

(1) he violates any provision of this subchapter or subchapter II the punishment for which is a felony, and

(2) such violation is a part of a continuing series of violations of this subchapter or subchapter II—

(A) which are undertaken by such person in concert with five or more other persons with respect to whom such person occupies a position of organizer, a supervisory position, or any other position of management, and

(B) from which such person obtains substantial income or resources.

(d) Suspension of sentence and probation prohibited

In the case of any sentence imposed under this section, imposition or execution of such sentence shall not be suspended, probation shall not be granted, and the Act of July 15, 1932 (D.C. Code, secs. 24–203—24–207), shall not apply.

(e) Death penalty

(1) In addition to the other penalties set forth in this section—

(A) any person engaging in or working in furtherance of a continuing criminal enterprise, or any person engaging in an offense punishable under section 841(b)(1)(A) ¹ of this title or section 960(b)(1) ¹ of this title who intentionally kills or counsels, commands, induces, procures, or causes the intentional killing of an individual and such killing results, shall be sentenced to any term of imprisonment, which shall not be less than 20 years, and which may be up to life imprisonment, or may be sentenced to death; and

(B) any person, during the commission of, in furtherance of, or while attempting to avoid apprehension, prosecution or service of a prison sentence for, a felony violation of this subchapter or subchapter II who intentionally kills or counsels, commands, induces, procures, or causes the intentional killing of any Federal, State, or local law enforcement officer engaged in, or on account of, the performance of such officer's official duties and such killing results, shall be sentenced to any term of imprisonment, which shall not be less than 20 years, and which may be up to life imprisonment, or may be sentenced to death.

(2) As used in paragraph (1)(B), the term "law enforcement officer" means a public servant authorized by law or by a Government agency or Congress to conduct or engage in the prevention, investigation, prosecution or adjudication of an offense, and includes those engaged in corrections, probation, or parole functions.

(g) ² to (p) Repealed. Pub. L. 109–177, title II, §221(2), Mar. 9, 2006, 120 Stat. 231

(q) Repealed. Pub. L. 109–177, title II, §§221(4), 222(c), Mar. 9, 2006, 120 Stat. 231, 232

(r) Repealed. Pub. L. 109–177, title II, §221(3), Mar. 9, 2006, 120 Stat. 231

(s) Special provision for methamphetamine

For the purposes of subsection (b), in the case of continuing criminal enterprise involving methamphetamine or its salts, isomers, or salts of isomers, paragraph (2)(A) shall be applied by substituting "200" for "300", and paragraph (2)(B) shall be applied by substituting "$5,000,000" for "$10 million dollars".

(Pub. L. 91–513, title II, §408, Oct. 27, 1970, 84 Stat. 1265; Pub. L. 98–473, title II, §§224(b), formerly §224(c), 305, Oct. 12, 1984, 98 Stat. 2030, 2050; Pub. L. 99–570, title I, §§1005(b)(2), 1252, 1253, Oct. 27, 1986, 100 Stat. 3207–6, 3207-14; Pub. L. 100–690, title VI, §6481, title VII, §7001, Nov. 18, 1988, 102 Stat. 4382, 4387; Pub. L. 103–322, title XXXIII, §§330003(e), 330009(d), 330014, Sept. 13, 1994, 108 Stat. 2141, 2143, 2146; Pub. L. 104–132, title I, §108, title IX, §903(b), Apr. 24, 1996, 110 Stat. 1226, 1318; Pub. L. 109–177, title II, §§221, 222(c), title VII, §733, Mar. 9, 2006, 120 Stat. 231, 232, 270.)

Editorial Notes

References in Text

Section 841(b)(1)(A), referred to in subsec. (e)(1)(A), was in the original a reference to "section 841(b)(1)(A)" but probably should be a reference to "section 401(b)(1)(A)", meaning section 401(b)(1)(A) of Pub. L. 91–513, title II, Oct. 27, 1970, 84 Stat. 1260.

Section 960(b)(1), referred to in subsec. (e)(1)(A), was in the original a reference to "section 960(b)(1)" but probably should be a reference to "section 1010(b)(1)", meaning section 1010(b)(1) of Pub. L. 91–513, title III, Oct. 27, 1970, 84 Stat. 1290.

Act of July 15, 1932 (D.C. Code, secs. 24–203—24–207), referred to in subsec. (d), is act July 15, 1932, ch. 492, 47 Stat. 696, which is not classified to the Code.

Amendments

2006—Subsec. (e)(2). Pub. L. 109–177, §221(1), substituted "(1)(B)" for "(1)(b)".

Subsecs. (g) to (p). Pub. L. 109–177, §221(2), struck out subsecs. (g) to (p) which related to hearing and sentencing procedures in death penalty cases and sentencing in capital cases in which the death penalty is not sought or imposed.

Subsec. (q). Pub. L. 109–177, §§221(4), 222(c), struck out subsec. (q) which related to appeal in capital cases and counsel for financially unable defendants.

Subsec. (r). Pub. L. 109–177, §221(3), struck out subsec. (r) which provided for refusal by State and Federal correctional employees to participate in executions.

Subsec. (s). Pub. L. 109–177, §733, added subsec. (s).

1996—Subsec. (q)(9). Pub. L. 104–132, §108, amended par. (9) generally. Prior to amendment, par. (9) read as follows: "Upon a finding in ex parte proceedings that investigative, expert or other services are reasonably necessary for the representation of the defendant, whether in connection with issues relating to guilt or sentence, the court shall authorize the defendant's attorneys to obtain such services on behalf of the defendant and shall order the payment of fees and expenses therefore, under paragraph (10). Upon a finding that timely procurement of such services could not practicably await prior authorization, the court may authorize the provision of and payment for such services nunc pro tunc."

Subsec. (q)(10). Pub. L. 104–132, §903(b), amended par. (10) generally. Prior to amendment, par. (10) read as follows: "Notwithstanding the rates and maximum limits generally applicable to criminal cases and any other provision of law to the contrary, the court shall fix the compensation to be paid to attorneys appointed under this subsection and the fees and expenses to be paid for investigative, expert, and other reasonably necessary services authorized under paragraph (9), at such rates or amounts as the court determines to be reasonably necessary to carry out the requirements of paragraphs (4) through (9)."

1994—Subsec. (b)(2)(A). Pub. L. 103–322, §330003(e), substituted "subsection (c)(1)" for "subsection (d)(1)".

Subsec. (n)(11). Pub. L. 103–322, §330014, made technical amendment to reference to section 859 of this title to correct reference to corresponding section of original act.

Subsec. (q)(8). Pub. L. 103–322, §330009(d), substituted "applications for writ" for "applications, for writ".

1988—Subsec. (a). Pub. L. 100–690, §6481(a), increased minimum term of imprisonment for first violations to 20 from 10 years and for subsequent violations to 30 from 20 years.

Subsecs. (c), (d). Pub. L. 100–690, §6481(b), redesignated subsecs. (d) and (e) as (c) and (d), respectively.

Subsec. (e). Pub. L. 100–690, §7001(a)(2), added subsec. (e). Former subsec. (e) redesignated (d).

Pub. L. 100–690, §7001(a)(1), which directed redesignation of former subsec. (e) as (f), could not be executed because of prior redesignation of former subsec. (e) as (d) by Pub. L. 100–690, §6481(b), which resulted in there not being a subsec. (f).

Subsecs. (g) to (r). Pub. L. 100–690, §7001(b), added subsecs. (g) to (r).

1986—Subsec. (a). Pub. L. 99–570, §1252, substituted "to a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $2,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual," for "to a fine of not more than $100,000," and "to a fine not to exceed the greater of twice the amount authorized in accordance with the provisions of title 18 or $4,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual," for "to a fine of not more than $200,000,".

Subsecs. (b) to (e). Pub. L. 99–570, §1253, added subsec. (b) and redesignated former subsecs. (b) and (c) as (d) and (e), respectively, which resulted in there not being a subsec. (c).

1984—Subsec. (a). Pub. L. 98–473, §305, struck out par. (1) designation, substituted references to section 853 of this title for references to paragraph (2) in two places, and struck out par. (2) which related to forfeitures to the United States by any person convicted under par. (1).

Subsec. (d). Pub. L. 98–473, §305(b), struck out subsec. (d) relating to jurisdiction of courts of the United States.

Subsec. (e). Pub. L. 98–473, §224(b), as renumbered by Pub. L. 99–570, §1005(b)(2), which directed the amendment of subsec. (c) of this section by striking out "and section 4202 of title 18 of the United States Code", was executed by striking out that language in subsec. (e) to reflect the probable intent of Congress and the intervening amendment by Pub. L. 99–570, §1253, which redesignated subsec. (c) as (e). See 1986 Amendment note above.

Statutory Notes and Related Subsidiaries

Effective Date of 1996 Amendment

Amendment by section 903(b) of Pub. L. 104–132 effective as to cases commenced or appeals perfected on or after Apr. 24, 1996, see section 903(c) of Pub. L. 104–132, set out as a note under section 3006A of Title 18, Crimes and Criminal Procedure.

Effective Date of 1984 Amendment

Amendment by section 224(b) of Pub. L. 98–473 effective Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such amendment, see section 235(a)(1) of Pub. L. 98–473, set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

GAO Study of Cost of Executions

Pub. L. 100–690, title VII, §7002, Nov. 18, 1988, 102 Stat. 4395, directed Comptroller General to conduct a study of cost of executions and report to Congress, prior to repeal by Pub. L. 104–66, title I, §1091(d), Dec. 21, 1995, 109 Stat. 722.

¹ See References in Text note below.

² So in original. Section does not contain a subsec. (f), see 1988 Amendment note below.

§849. Transportation safety offenses

(a) Definitions

In this section—

"safety rest area" means a roadside facility with parking facilities for the rest or other needs of motorists.

"truck stop" means a facility (including any parking lot appurtenant thereto) that—

(A) has the capacity to provide fuel or service, or both, to any commercial motor vehicle (as defined in section 31301 of title 49), operating in commerce (as defined in that section); and

(B) is located within 2,500 feet of the National System of Interstate and Defense Highways or the Federal-Aid Primary System.

(b) First offense

A person who violates section 841(a)(1) of this title or section 856 of this title by distributing or possessing with intent to distribute a controlled substance in or on, or within 1,000 feet of, a truck stop or safety rest area is (except as provided in subsection (b)) ¹ subject to—

(1) twice the maximum punishment authorized by section 841(b) of this title; and

(2) twice any term of supervised release authorized by section 841(b) of this title for a first offense.

(c) Subsequent offense

A person who violates section 841(a)(1) of this title or section 856 of this title by distributing or possessing with intent to distribute a controlled substance in or on, or within 1,000 feet of, a truck stop or a safety rest area after a prior conviction or convictions under subsection (a) ² have become final is subject to—

(1) 3 times the maximum punishment authorized by section 841(b) of this title; and

(2) 3 times any term of supervised release authorized by section 841(b) of this title for a first offense.

(Pub. L. 91–513, title II, §409, as added Pub. L. 103–322, title XVIII, §180201(b)(1), Sept. 13, 1994, 108 Stat. 2046.)

Editorial Notes

Prior Provisions

A prior section 849, Pub. L. 91–513, title II, §409, Oct. 27, 1970, 84 Stat. 1266; Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095, related to dangerous special drug offender sentencing, prior to repeal by Pub. L. 98–473, title II, §§219(a), 235(a)(1), Oct. 12, 1984, 98 Stat. 2027, 2031, eff. Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such repeal.

¹ So in original. Probably should refer to subsection (c).

² So in original. Probably should refer to subsection (b).

§850. Information for sentencing

Except as otherwise provided in this subchapter or section 242a(a) ¹ of title 42, no limitation shall be placed on the information concerning the background, character, and conduct of a person convicted of an offense which a court of the United States may receive and consider for the purpose of imposing an appropriate sentence under this subchapter or subchapter II.

(Pub. L. 91–513, title II, §410, Oct. 27, 1970, 84 Stat. 1269.)

Editorial Notes

References in Text

Section 242a of title 42, referred to in text, was repealed by Pub. L. 106–310, div. B, title XXXII, §3201(b)(1), Oct. 17, 2000, 114 Stat. 1190.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

¹ See References in Text note below.

§851. Proceedings to establish prior convictions

(a) Information filed by United States Attorney

(1) No person who stands convicted of an offense under this part shall be sentenced to increased punishment by reason of one or more prior convictions, unless before trial, or before entry of a plea of guilty, the United States attorney files an information with the court (and serves a copy of such information on the person or counsel for the person) stating in writing the previous convictions to be relied upon. Upon a showing by the United States attorney that facts regarding prior convictions could not with due diligence be obtained prior to trial or before entry of a plea of guilty, the court may postpone the trial or the taking of the plea of guilty for a reasonable period for the purpose of obtaining such facts. Clerical mistakes in the information may be amended at any time prior to the pronouncement of sentence.

(2) An information may not be filed under this section if the increased punishment which may be imposed is imprisonment for a term in excess of three years unless the person either waived or was afforded prosecution by indictment for the offense for which such increased punishment may be imposed.

(b) Affirmation or denial of previous conviction

If the United States attorney files an information under this section, the court shall after conviction but before pronouncement of sentence inquire of the person with respect to whom the information was filed whether he affirms or denies that he has been previously convicted as alleged in the information, and shall inform him that any challenge to a prior conviction which is not made before sentence is imposed may not thereafter be raised to attack the sentence.

(c) Denial; written response; hearing

(1) If the person denies any allegation of the information of prior conviction, or claims that any conviction alleged is invalid, he shall file a written response to the information. A copy of the response shall be served upon the United States attorney. The court shall hold a hearing to determine any issues raised by the response which would except the person from increased punishment. The failure of the United States attorney to include in the information the complete criminal record of the person or any facts in addition to the convictions to be relied upon shall not constitute grounds for invalidating the notice given in the information required by subsection (a)(1). The hearing shall be before the court without a jury and either party may introduce evidence. Except as otherwise provided in paragraph (2) of this subsection, the United States attorney shall have the burden of proof beyond a reasonable doubt on any issue of fact. At the request of either party, the court shall enter findings of fact and conclusions of law.

(2) A person claiming that a conviction alleged in the information was obtained in violation of the Constitution of the United States shall set forth his claim, and the factual basis therefor, with particularity in his response to the information. The person shall have the burden of proof by a preponderance of the evidence on any issue of fact raised by the response. Any challenge to a prior conviction, not raised by response to the information before an increased sentence is imposed in reliance thereon, shall be waived unless good cause be shown for failure to make a timely challenge.

(d) Imposition of sentence

(1) If the person files no response to the information, or if the court determines, after hearing, that the person is subject to increased punishment by reason of prior convictions, the court shall proceed to impose sentence upon him as provided by this part.

(2) If the court determines that the person has not been convicted as alleged in the information, that a conviction alleged in the information is invalid, or that the person is otherwise not subject to an increased sentence as a matter of law, the court shall, at the request of the United States attorney, postpone sentence to allow an appeal from that determination. If no such request is made, the court shall impose sentence as provided by this part. The person may appeal from an order postponing sentence as if sentence had been pronounced and a final judgment of conviction entered.

(e) Statute of limitations

No person who stands convicted of an offense under this part may challenge the validity of any prior conviction alleged under this section which occurred more than five years before the date of the information alleging such prior conviction.

(Pub. L. 91–513, title II, §411, Oct. 27, 1970, 84 Stat. 1269.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

§852. Application of treaties and other international agreements

Nothing in the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, or other treaties or international agreements shall be construed to limit the provision of treatment, education, or rehabilitation as alternatives to conviction or criminal penalty for offenses involving any drug or other substance subject to control under any such treaty or agreement.

(Pub. L. 91–513, title II, §412, as added Pub. L. 95–633, title I, §107(a), Nov. 10, 1978, 92 Stat. 3773.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as a note under section 801a of this title.

§853. Criminal forfeitures

(a) Property subject to criminal forfeiture

Any person convicted of a violation of this subchapter or subchapter II punishable by imprisonment for more than one year shall forfeit to the United States, irrespective of any provision of State law—

(1) any property constituting, or derived from, any proceeds the person obtained, directly or indirectly, as the result of such violation;

(2) any of the person's property used, or intended to be used, in any manner or part, to commit, or to facilitate the commission of, such violation; and

(3) in the case of a person convicted of engaging in a continuing criminal enterprise in violation of section 848 of this title, the person shall forfeit, in addition to any property described in paragraph (1) or (2), any of his interest in, claims against, and property or contractual rights affording a source of control over, the continuing criminal enterprise.

The court, in imposing sentence on such person, shall order, in addition to any other sentence imposed pursuant to this subchapter or subchapter II, that the person forfeit to the United States all property described in this subsection. In lieu of a fine otherwise authorized by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds.

(b) Meaning of term "property"

Property subject to criminal forfeiture under this section includes—

(1) real property, including things growing on, affixed to, and found in land; and

(2) tangible and intangible personal property, including rights, privileges, interests, claims, and securities.

(c) Third party transfers

All right, title, and interest in property described in subsection (a) vests in the United States upon the commission of the act giving rise to forfeiture under this section. Any such property that is subsequently transferred to a person other than the defendant may be the subject of a special verdict of forfeiture and thereafter shall be ordered forfeited to the United States, unless the transferee establishes in a hearing pursuant to subsection (n) that he is a bona fide purchaser for value of such property who at the time of purchase was reasonably without cause to believe that the property was subject to forfeiture under this section.

(d) Rebuttable presumption

There is a rebuttable presumption at trial that any property of a person convicted of a felony under this subchapter or subchapter II is subject to forfeiture under this section if the United States establishes by a preponderance of the evidence that—

(1) such property was acquired by such person during the period of the violation of this subchapter or subchapter II or within a reasonable time after such period; and

(2) there was no likely source for such property other than the violation of this subchapter or subchapter II.

(e) Protective orders

(1) Upon application of the United States, the court may enter a restraining order or injunction, require the execution of a satisfactory performance bond, or take any other action to preserve the availability of property described in subsection (a) for forfeiture under this section—

(A) upon the filing of an indictment or information charging a violation of this subchapter or subchapter II for which criminal forfeiture may be ordered under this section and alleging that the property with respect to which the order is sought would, in the event of conviction, be subject to forfeiture under this section; or

(B) prior to the filing of such an indictment or information, if, after notice to persons appearing to have an interest in the property and opportunity for a hearing, the court determines that—

(i) there is a substantial probability that the United States will prevail on the issue of forfeiture and that failure to enter the order will result in the property being destroyed, removed from the jurisdiction of the court, or otherwise made unavailable for forfeiture; and

(ii) the need to preserve the availability of the property through the entry of the requested order outweighs the hardship on any party against whom the order is to be entered:

Provided, however, That an order entered pursuant to subparagraph (B) shall be effective for not more than ninety days, unless extended by the court for good cause shown or unless an indictment or information described in subparagraph (A) has been filed.

(2) A temporary restraining order under this subsection may be entered upon application of the United States without notice or opportunity for a hearing when an information or indictment has not yet been filed with respect to the property, if the United States demonstrates that there is probable cause to believe that the property with respect to which the order is sought would, in the event of conviction, be subject to forfeiture under this section and that provision of notice will jeopardize the availability of the property for forfeiture. Such a temporary order shall expire not more than fourteen days after the date on which it is entered, unless extended for good cause shown or unless the party against whom it is entered consents to an extension for a longer period. A hearing requested concerning an order entered under this paragraph shall be held at the earliest possible time and prior to the expiration of the temporary order.

(3) The court may receive and consider, at a hearing held pursuant to this subsection, evidence and information that would be inadmissible under the Federal Rules of Evidence.

(4) Order to repatriate and deposit.—

(A) In general.—Pursuant to its authority to enter a pretrial restraining order under this section, the court may order a defendant to repatriate any property that may be seized and forfeited, and to deposit that property pending trial in the registry of the court, or with the United States Marshals Service or the Secretary of the Treasury, in an interest-bearing account, if appropriate.

(B) Failure to comply.—Failure to comply with an order under this subsection, or an order to repatriate property under subsection (p), shall be punishable as a civil or criminal contempt of court, and may also result in an enhancement of the sentence of the defendant under the obstruction of justice provision of the Federal Sentencing Guidelines.

(f) Warrant of seizure

The Government may request the issuance of a warrant authorizing the seizure of property subject to forfeiture under this section in the same manner as provided for a search warrant. If the court determines that there is probable cause to believe that the property to be seized would, in the event of conviction, be subject to forfeiture and that an order under subsection (e) may not be sufficient to assure the availability of the property for forfeiture, the court shall issue a warrant authorizing the seizure of such property.

(g) Execution

Upon entry of an order of forfeiture under this section, the court shall authorize the Attorney General to seize all property ordered forfeited upon such terms and conditions as the court shall deem proper. Following entry of an order declaring the property forfeited, the court may, upon application of the United States, enter such appropriate restraining orders or injunctions, require the execution of satisfactory performance bonds, appoint receivers, conservators, appraisers, accountants, or trustees, or take any other action to protect the interest of the United States in the property ordered forfeited. Any income accruing to or derived from property ordered forfeited under this section may be used to offset ordinary and necessary expenses to the property which are required by law, or which are necessary to protect the interests of the United States or third parties.

(h) Disposition of property

Following the seizure of property ordered forfeited under this section, the Attorney General shall direct the disposition of the property by sale or any other commercially feasible means, making due provision for the rights of any innocent persons. Any property right or interest not exercisable by, or transferable for value to, the United States shall expire and shall not revert to the defendant, nor shall the defendant or any person acting in concert with him or on his behalf be eligible to purchase forfeited property at any sale held by the United States. Upon application of a person, other than the defendant or a person acting in concert with him or on his behalf, the court may restrain or stay the sale or disposition of the property pending the conclusion of any appeal of the criminal case giving rise to the forfeiture, if the applicant demonstrates that proceeding with the sale or disposition of the property will result in irreparable injury, harm, or loss to him.

(i) Authority of the Attorney General

With respect to property ordered forfeited under this section, the Attorney General is authorized to—

(1) grant petitions for mitigation or remission of forfeiture, restore forfeited property to victims of a violation of this subchapter, or take any other action to protect the rights of innocent persons which is in the interest of justice and which is not inconsistent with the provisions of this section;

(2) compromise claims arising under this section;

(3) award compensation to persons providing information resulting in a forfeiture under this section;

(4) direct the disposition by the United States, in accordance with the provisions of section 881(e) of this title, of all property ordered forfeited under this section by public sale or any other commercially feasible means, making due provision for the rights of innocent persons; and

(5) take appropriate measures necessary to safeguard and maintain property ordered forfeited under this section pending its disposition.

(j) Applicability of civil forfeiture provisions

Except to the extent that they are inconsistent with the provisions of this section, the provisions of section 881(d) of this title shall apply to a criminal forfeiture under this section.

(k) Bar on intervention

Except as provided in subsection (n), no party claiming an interest in property subject to forfeiture under this section may—

(1) intervene in a trial or appeal of a criminal case involving the forfeiture of such property under this section; or

(2) commence an action at law or equity against the United States concerning the validity of his alleged interest in the property subsequent to the filing of an indictment or information alleging that the property is subject to forfeiture under this section.

(l) Jurisdiction to enter orders

The district courts of the United States shall have jurisdiction to enter orders as provided in this section without regard to the location of any property which may be subject to forfeiture under this section or which has been ordered forfeited under this section.

(m) Depositions

In order to facilitate the identification and location of property declared forfeited and to facilitate the disposition of petitions for remission or mitigation of forfeiture, after the entry of an order declaring property forfeited to the United States, the court may, upon application of the United States, order that the testimony of any witness relating to the property forfeited be taken by deposition and that any designated book, paper, document, record, recording, or other material not privileged be produced at the same time and place, in the same manner as provided for the taking of depositions under Rule 15 of the Federal Rules of Criminal Procedure.

(n) Third party interests

(1) Following the entry of an order of forfeiture under this section, the United States shall publish notice of the order and of its intent to dispose of the property in such manner as the Attorney General may direct. The Government may also, to the extent practicable, provide direct written notice to any person known to have alleged an interest in the property that is the subject of the order of forfeiture as a substitute for published notice as to those persons so notified.

(2) Any person, other than the defendant, asserting a legal interest in property which has been ordered forfeited to the United States pursuant to this section may, within thirty days of the final publication of notice or his receipt of notice under paragraph (1), whichever is earlier, petition the court for a hearing to adjudicate the validity of his alleged interest in the property. The hearing shall be held before the court alone, without a jury.

(3) The petition shall be signed by the petitioner under penalty of perjury and shall set forth the nature and extent of the petitioner's right, title, or interest in the property, the time and circumstances of the petitioner's acquisition of the right, title, or interest in the property, any additional facts supporting the petitioner's claim, and the relief sought.

(4) The hearing on the petition shall, to the extent practicable and consistent with the interests of justice, be held within thirty days of the filing of the petition. The court may consolidate the hearing on the petition with a hearing on any other petition filed by a person other than the defendant under this subsection.

(5) At the hearing, the petitioner may testify and present evidence and witnesses on his own behalf, and cross-examine witnesses who appear at the hearing. The United States may present evidence and witnesses in rebuttal and in defense of its claim to the property and cross-examine witnesses who appear at the hearing. In addition to testimony and evidence presented at the hearing, the court shall consider the relevant portions of the record of the criminal case which resulted in the order of forfeiture.

(6) If, after the hearing, the court determines that the petitioner has established by a preponderance of the evidence that—

(A) the petitioner has a legal right, title, or interest in the property, and such right, title, or interest renders the order of forfeiture invalid in whole or in part because the right, title, or interest was vested in the petitioner rather than the defendant or was superior to any right, title, or interest of the defendant at the time of the commission of the acts which gave rise to the forfeiture of the property under this section; or

(B) the petitioner is a bona fide purchaser for value of the right, title, or interest in the property and was at the time of purchase reasonably without cause to believe that the property was subject to forfeiture under this section;

the court shall amend the order of forfeiture in accordance with its determination.

(7) Following the court's disposition of all petitions filed under this subsection, or if no such petitions are filed following the expiration of the period provided in paragraph (2) for the filing of such petitions, the United States shall have clear title to property that is the subject of the order of forfeiture and may warrant good title to any subsequent purchaser or transferee.

(o) Construction

The provisions of this section shall be liberally construed to effectuate its remedial purposes.

(p) Forfeiture of substitute property

(1) In general

Paragraph (2) of this subsection shall apply, if any property described in subsection (a), as a result of any act or omission of the defendant—

(A) cannot be located upon the exercise of due diligence;

(B) has been transferred or sold to, or deposited with, a third party;

(C) has been placed beyond the jurisdiction of the court;

(D) has been substantially diminished in value; or

(E) has been commingled with other property which cannot be divided without difficulty.

(2) Substitute property

In any case described in any of subparagraphs (A) through (E) of paragraph (1), the court shall order the forfeiture of any other property of the defendant, up to the value of any property described in subparagraphs (A) through (E) of paragraph (1), as applicable.

(3) Return of property to jurisdiction

In the case of property described in paragraph (1)(C), the court may, in addition to any other action authorized by this subsection, order the defendant to return the property to the jurisdiction of the court so that the property may be seized and forfeited.

(q) Restitution for cleanup of clandestine laboratory sites

The court, when sentencing a defendant convicted of an offense under this subchapter or subchapter II involving the manufacture, the possession, or the possession with intent to distribute, of amphetamine or methamphetamine, shall—

(1) order restitution as provided in sections 3612 and 3664 of title 18;

(2) order the defendant to reimburse the United States, the State or local government concerned, or both the United States and the State or local government concerned for the costs incurred by the United States or the State or local government concerned, as the case may be, for the cleanup associated with the manufacture of amphetamine or methamphetamine by the defendant, or on premises or in property that the defendant owns, resides, or does business in; and

(3) order restitution to any person injured as a result of the offense as provided in section 3663A of title 18.

(Pub. L. 91–513, title II, §413, as added and amended Pub. L. 98–473, title II, §§303, 2301(d)–(f), Oct. 12, 1984, 98 Stat. 2044, 2192, 2193; Pub. L. 99–570, title I, §§1153(b), 1864, Oct. 27, 1986, 100 Stat. 3207–13, 3207-54; Pub. L. 104–237, title II, §207, Oct. 3, 1996, 110 Stat. 3104; Pub. L. 106–310, div. B, title XXXVI, §3613(a), Oct. 17, 2000, 114 Stat. 1229; Pub. L. 107–56, title III, §319(d), Oct. 26, 2001, 115 Stat. 314; Pub. L. 109–177, title VII, §743(a), Mar. 9, 2006, 120 Stat. 272; Pub. L. 111–16, §5, May 7, 2009, 123 Stat. 1608.)

Editorial Notes

References in Text

The Federal Rules of Evidence, referred to in subsec. (e)(3), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

The Federal Rules of Criminal Procedure, referred to in subsec. (m), are set out in the Appendix to Title 18, Crimes and Criminal Procedure.

Amendments

2009—Subsec. (e)(2). Pub. L. 111–16 substituted "fourteen days" for "ten days".

2006—Subsec. (q). Pub. L. 109–177, §743(a)(1), inserted ", the possession, or the possession with intent to distribute," after "manufacture" in introductory provisions.

Subsec. (q)(2). Pub. L. 109–177, §743(a)(2), inserted ", or on premises or in property that the defendant owns, resides, or does business in" after "by the defendant".

2001—Subsec. (e)(4). Pub. L. 107–56, §319(d)(2), added par. (4).

Subsec. (p). Pub. L. 107–56, §319(d)(1), inserted heading and amended text of subsec. (p) generally. Prior to amendment, text read as follows: "If any of the property described in subsection (a) of this section, as a result of any act or omission of the defendant—

"(1) cannot be located upon the exercise of due diligence;

"(2) has been transferred or sold to, or deposited with, a third party;

"(3) has been placed beyond the jurisdiction of the court;

"(4) has been substantially diminished in value; or

"(5) has been commingled with other property which cannot be divided without difficulty;

the court shall order the forfeiture of any other property of the defendant up to the value of any property described in paragraphs (1) through (5)."

2000—Subsec. (q). Pub. L. 106–310, §3613(a)(1), (2), in introductory provisions, inserted "amphetamine or" before "methamphetamine" and substituted "shall" for "may".

Subsec. (q)(2). Pub. L. 106–310, §3613(a)(2), (3), inserted ", the State or local government concerned, or both the United States and the State or local government concerned" after "to reimburse the United States", "or the State or local government concerned, as the case may be," after "costs incurred by the United States", and "amphetamine or" before "methamphetamine".

Subsec. (q)(3). Pub. L. 106–310, §3613(a)(4), substituted "section 3663A of title 18" for "section 3663 of title 18".

1996—Subsec. (q). Pub. L. 104–237 added subsec. (q).

1986—Subsec. (c). Pub. L. 99–570, §1864(1), substituted "subsection (n)" for "subsection (o)".

Subsec. (f). Pub. L. 99–570, §1864(2), substituted "subsection (e)" for "subsection (f)".

Subsec. (i)(1). Pub. L. 99–570, §1864(3), substituted "this subchapter" for "this chapter".

Subsec. (k). Pub. L. 99–570, §1864(1), (4), which directed the substitution of "subsection (n)" for "subsection (o)" in "the second subsection (h)", and directed the redesignation of "the second subsection (h)" as subsection (k), were executed to this subsection because the "second subsection (h)" had been editorially redesignated subsec. (k) to reflect the probable intent of Congress. See 1984 Amendment note below.

Subsec. (p). Pub. L. 99–570, §1153(b), which directed that "section 413 of title II of the Comprehensive Drug Abuse Prevention and Control Act of 1975" be amended "by redesignating subsection '(p)' as subsection '(q)' " and adding subsec. (p) was executed to this section, which is section 413 of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as the probable intent of Congress, by adding a subsec. (p) in view of the prior redesignation of subsec. (p) as (o) by Pub. L. 98–473, §2301(e)(2). See 1984 Amendment note below.

1984—Subsec. (a). Pub. L. 98–473, §2301(d), inserted "In lieu of a fine otherwise authorized by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds."

Subsec. (d). Pub. L. 98–473, §2301(e), struck out subsec. (d) which related to forfeiture of property other than that described in subsec. (a) and the conditions therefor, and redesignated former subsec. (e) as (d).

Subsecs. (e) to (p). Pub. L. 98–473, §2301(e)(2), which directed that this section be amended by redesignating subsecs. (e), (f), (g), (h), (i), (l), (m), (n), (o), and (p) as subsecs. (d), (e), (f), (g), (h), (i), (j), (h), (l), (m), (n), and (o), respectively, was executed by redesignating subsecs. (e) to (p) as (d) to (o), respectively, to give effect to the probable intent of Congress.

Subsec. (n)(1). Pub. L. 98–473, §2301(f), struck out "for at least seven successive court days" after "to dispose of the property".

Statutory Notes and Related Subsidiaries

Effective Date of 2009 Amendment

Amendment by Pub. L. 111–16 effective Dec. 1, 2009, see section 7 of Pub. L. 111–16, set out as a note under section 109 of Title 11, Bankruptcy.

Savings Clause

Pub. L. 109–177, title VII, §743(b), Mar. 9, 2006, 120 Stat. 273, provided that: "Nothing in this section [amending this section] shall be interpreted or construed to amend, alter, or otherwise affect the obligations, liabilities and other responsibilities of any person under any Federal or State environmental laws."

§853a. Transferred

Editorial Notes

Codification

Section, Pub. L. 100–690, title V, §5301, Nov. 18, 1988, 102 Stat. 4310, which related to denial of Federal benefits to drug traffickers and possessors, was renumbered section 421 of the Controlled Substances Act by Pub. L. 101–647, title X, §1002(d)(1), Nov. 29, 1990, 104 Stat. 4827, and is classified to section 862 of this title.

§854. Investment of illicit drug profits

(a) Prohibition

It shall be unlawful for any person who has received any income derived, directly or indirectly, from a violation of this subchapter or subchapter II punishable by imprisonment for more than one year in which such person has participated as a principal within the meaning of section 2 of title 18, to use or invest, directly or indirectly, any part of such income, or the proceeds of such income, in acquisition of any interest in, or the establishment or operation of, any enterprise which is engaged in, or the activities of which affect interstate or foreign commerce. A purchase of securities on the open market for purposes of investment, and without the intention of controlling or participating in the control of the issuer, or of assisting another to do so, shall not be unlawful under this section if the securities of the issuer held by the purchaser, the members of his immediate family, and his or their accomplices in any violation of this subchapter or subchapter II after such purchase do not amount in the aggregate to 1 per centum of the outstanding securities of any one class, and do not confer, either in law or in fact, the power to elect one or more directors of the issuer.

(b) Penalty

Whoever violates this section shall be fined not more than $50,000 or imprisoned not more than ten years, or both.

(c) "Enterprise" defined

As used in this section, the term "enterprise" includes any individual, partnership, corporation, association, or other legal entity, and any union or group of individuals associated in fact although not a legal entity.

(d) Construction

The provisions of this section shall be liberally construed to effectuate its remedial purposes.

(Pub. L. 91–513, title II, §414, as added Pub. L. 98–473, title II, §303, Oct. 12, 1984, 98 Stat. 2049.)

§855. Alternative fine

In lieu of a fine otherwise authorized by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds.

(Pub. L. 91–513, title II, §415, as added Pub. L. 98–473, title II, §2302, Oct. 12, 1984, 98 Stat. 2193.)

§856. Maintaining drug-involved premises

(a) Unlawful acts

Except as authorized by this subchapter, it shall be unlawful to—

(1) knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance;

(2) manage or control any place, whether permanently or temporarily, either as an owner, lessee, agent, employee, occupant, or mortgagee, and knowingly and intentionally rent, lease, profit from, or make available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance.

(b) Criminal penalties

Any person who violates subsection (a) of this section shall be sentenced to a term of imprisonment of not more than 20 years or a fine of not more than $500,000, or both, or a fine of $2,000,000 for a person other than an individual.

(c) Violation as offense against property

A violation of subsection (a) shall be considered an offense against property for purposes of section 3663A(c)(1)(A)(ii) of title 18.

(d) Civil penalties

(1) Any person who violates subsection (a) shall be subject to a civil penalty of not more than the greater of—

(A) $250,000; or

(B) 2 times the gross receipts, either known or estimated, that were derived from each violation that is attributable to the person.

(2) If a civil penalty is calculated under paragraph (1)(B), and there is more than 1 defendant, the court may apportion the penalty between multiple violators, but each violator shall be jointly and severally liable for the civil penalty under this subsection.

(e) Declaratory and injunctive remedies

Any person who violates subsection (a) shall be subject to declaratory and injunctive remedies as set forth in section 843(f) of this title.

(Pub. L. 91–513, title II, §416, as added Pub. L. 99–570, title I, §1841(a), Oct. 27, 1986, 100 Stat. 3207–52; amended Pub. L. 106–310, div. B, title XXXVI, §3613(e), Oct. 17, 2000, 114 Stat. 1230; Pub. L. 108–21, title VI, §608(b)(1), (2), (c), Apr. 30, 2003, 117 Stat. 691.)

Editorial Notes

Amendments

2003—Pub. L. 108–21, §608(b)(2), substituted "Maintaining drug-involved premises" for "Establishment of manufacturing operations" in section catchline.

Subsec. (a)(1). Pub. L. 108–21, §608(b)(1)(A), substituted "open, lease, rent, use, or maintain any place, whether permanently or temporarily," for "open or maintain any place".

Subsec. (a)(2). Pub. L. 108–21, §608(b)(1)(B), added par. (2) and struck out former par. (2) which read as follows: "manage or control any building, room, or enclosure, either as an owner, lessee, agent, employee, or mortgagee, and knowingly and intentionally rent, lease, or make available for use, with or without compensation, the building, room, or enclosure for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance."

Subsecs. (d), (e). Pub. L. 108–21, §608(c), added subsecs. (d) and (e).

2000—Subsec. (c). Pub. L. 106–310 added subsec. (c).

§857. Repealed. Pub. L. 101–647, title XXIV, §2401(d), Nov. 29, 1990, 104 Stat. 4859

Section, Pub. L. 99–570, title I, §1822, Oct. 27, 1986, 100 Stat. 3207–51; Pub. L. 100–690, title VI, §6485, Nov. 18, 1988, 102 Stat. 4384; Pub. L. 101–647, title XXIV, §2401(b), Nov. 29, 1990, 104 Stat. 4859, related to interstate and foreign sale and transportation of drug paraphernalia.

Subsec. (a), which related to unlawful acts, was repealed.

Subsecs. (b) to (f) were redesignated as subsecs. (b) to (f) of section 422 of the Controlled Substances Act by section 2401(b) of Pub. L. 101–647 and transferred to section 863(b) to (f) of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 99–570, title I, §1823, Oct. 27, 1986, 100 Stat. 3207–52, which provided that subtitle O (§§1821–1823) of title I of Pub. L. 99–570, enacting this section and provisions set out as a note under section 801 of this title, was to become effective 90 days after Oct. 27, 1986, was repealed by Pub. L. 101–647, title XXIV, §2401(d), Nov. 29, 1990, 104 Stat. 4859.

§858. Endangering human life while illegally manufacturing controlled substance

Whoever, while manufacturing a controlled substance in violation of this subchapter, or attempting to do so, or transporting or causing to be transported materials, including chemicals, to do so, creates a substantial risk of harm to human life shall be fined in accordance with title 18 or imprisoned not more than 10 years, or both.

(Pub. L. 91–513, title II, §417, as added Pub. L. 100–690, title VI, §6301(a), Nov. 18, 1988, 102 Stat. 4370.)

§859. Distribution to persons under age twenty-one

(a) First offense

Except as provided in section 860 of this title, any person at least eighteen years of age who violates section 841(a)(1) of this title by distributing a controlled substance to a person under twenty-one years of age is (except as provided in subsection (b)) subject to (1) twice the maximum punishment authorized by section 841(b) of this title, and (2) at least twice any term of supervised release authorized by section 841(b) of this title, for a first offense involving the same controlled substance and schedule. Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a term of imprisonment under this subsection shall be not less than one year. The mandatory minimum sentencing provisions of this subsection shall not apply to offenses involving 5 grams or less of marihuana.

(b) Second offense

Except as provided in section 860 of this title, any person at least eighteen years of age who violates section 841(a)(1) of this title by distributing a controlled substance to a person under twenty-one years of age after a prior conviction under subsection (a) of this section (or under section 333(b) of this title as in effect prior to May 1, 1971) has become final, is subject to (1) three times the maximum punishment authorized by section 841(b) of this title, and (2) at least three times any term of supervised release authorized by section 841(b) of this title, for a second or subsequent offense involving the same controlled substance and schedule. Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a term of imprisonment under this subsection shall be not less than one year. Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title.

(Pub. L. 91–513, title II, §418, formerly §405, Oct. 27, 1970, 84 Stat. 1265; Pub. L. 98–473, title II, §§224(b), 503(b)(3), Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99–570, title I, §§1004(a), 1005(b)(1), 1105(a), (b), Oct. 27, 1986, 100 Stat. 3207–6, 3207-11; Pub. L. 100–690, title VI, §§6452(b), 6455, 6456, Nov. 18, 1988, 102 Stat. 4371, 4372; renumbered §418 and amended Pub. L. 101–647, title X, §§1002(a), 1003(a), title XXXV, §3599L, Nov. 29, 1990, 104 Stat. 4827, 4828, 4932.)

Editorial Notes

Codification

Section was classified to section 845 of this title prior to renumbering by Pub. L. 101–647.

Amendments

1990—Subsec. (a). Pub. L. 101–647, §1003(a)(1), substituted "subject to (1) twice the maximum punishment authorized by section 841(b) of this title" for "punishable by (1) a term of imprisonment, or a fine, or both, up to twice that authorized by section 841(b) of this title".

Pub. L. 101–647, §1002(a)(2)(A), substituted "section 860" for "section 845a".

Subsec. (b). Pub. L. 101–647, §3599L, substituted "has become final" for "have become final".

Pub. L. 101–647, §1003(a)(2), substituted "subject to (1) three times the maximum punishment authorized by section 841(b) of this title" for "punishable by (1) a term of imprisonment, or a fine, or both, up to three times that authorized by section 841(b) of this title".

Pub. L. 101–647, §1002(a)(2)(B), substituted "section 860" for "section 845a".

1988—Subsec. (a). Pub. L. 100–690, §6455, inserted at end "The mandatory minimum sentencing provisions of this subsection shall not apply to offenses involving 5 grams or less of marihuana."

Subsec. (b). Pub. L. 100–690, §6452(b), struck out "or subsequent" after "Second" in heading, and in text struck out "or convictions" after "a prior conviction", and inserted at end "Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title."

Pub. L. 100–690, §6456, struck out "The mandatory minimum sentencing provisions of this paragraph shall not apply to offenses involving 5 grams or less of marihuana."

1986—Subsec. (a). Pub. L. 99–570, §1105(a), inserted "Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a term of imprisonment under this subsection shall be not less than one year."

Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term".

Subsec. (b). Pub. L. 99–570, §1105(b), inserted "Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a term of imprisonment under this subsection shall be not less than one year. The mandatory minimum sentencing provisions of this paragraph shall not apply to offenses involving 5 grams or less of marihuana."

Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term".

1984—Subsecs. (a), (b). Pub. L. 98–473, §503(b)(3), substituted "Except as provided in section 845a of this title, any" for "Any".

Pub. L. 98–473, §224(b), which directed amendment of this section effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L. 98–473 set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure) was repealed by Pub. L. 99–570, §1005(b)(1).

Statutory Notes and Related Subsidiaries

Effective Date of 1986 Amendment

Amendment by section 1004(a) of Pub. L. 99–570 effective on date of taking effect of section 3583 of Title 18, Crimes and Criminal Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99–570 set out as a note under section 841 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

§860. Distribution or manufacturing in or near schools and colleges

(a) Penalty

Any person who violates section 841(a)(1) of this title or section 856 of this title by distributing, possessing with intent to distribute, or manufacturing a controlled substance in or on, or within one thousand feet of, the real property comprising a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university, or a playground, or housing facility owned by a public housing authority, or within 100 feet of a public or private youth center, public swimming pool, or video arcade facility, is (except as provided in subsection (b)) subject to (1) twice the maximum punishment authorized by section 841(b) of this title; and (2) at least twice any term of supervised release authorized by section 841(b) of this title for a first offense. A fine up to twice that authorized by section 841(b) of this title may be imposed in addition to any term of imprisonment authorized by this subsection. Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a person shall be sentenced under this subsection to a term of imprisonment of not less than one year. The mandatory minimum sentencing provisions of this paragraph shall not apply to offenses involving 5 grams or less of marihuana.

(b) Second offenders

Any person who violates section 841(a)(1) of this title or section 856 of this title by distributing, possessing with intent to distribute, or manufacturing a controlled substance in or on, or within one thousand feet of, the real property comprising a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university, or a playground, or housing facility owned by a public housing authority, or within 100 feet of a public or private youth center, public swimming pool, or video arcade facility, after a prior conviction under subsection (a) has become final is punishable (1) by the greater of (A) a term of imprisonment of not less than three years and not more than life imprisonment or (B) three times the maximum punishment authorized by section 841(b) of this title for a first offense, and (2) at least three times any term of supervised release authorized by section 841(b) of this title for a first offense. A fine up to three times that authorized by section 841(b) of this title may be imposed in addition to any term of imprisonment authorized by this subsection. Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a person shall be sentenced under this subsection to a term of imprisonment of not less than three years. Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title.

(c) Employing children to distribute drugs near schools or playgrounds

Notwithstanding any other law, any person at least 21 years of age who knowingly and intentionally—

(1) employs, hires, uses, persuades, induces, entices, or coerces a person under 18 years of age to violate this section; or

(2) employs, hires, uses, persuades, induces, entices, or coerces a person under 18 years of age to assist in avoiding detection or apprehension for any offense under this section by any Federal, State, or local law enforcement official,

is punishable by a term of imprisonment, a fine, or both, up to triple those authorized by section 841 of this title.

(d) Suspension of sentence; probation; parole

In the case of any mandatory minimum sentence imposed under this section, imposition or execution of such sentence shall not be suspended and probation shall not be granted. An individual convicted under this section shall not be eligible for parole until the individual has served the mandatory minimum term of imprisonment as provided by this section.

(e) Definitions

For the purposes of this section—

(1) The term "playground" means any outdoor facility (including any parking lot appurtenant thereto) intended for recreation, open to the public, and with any portion thereof containing three or more separate apparatus intended for the recreation of children including, but not limited to, sliding boards, swingsets, and teeterboards.

(2) The term "youth center" means any recreational facility and/or gymnasium (including any parking lot appurtenant thereto), intended primarily for use by persons under 18 years of age, which regularly provides athletic, civic, or cultural activities.

(3) The term "video arcade facility" means any facility, legally accessible to persons under 18 years of age, intended primarily for the use of pinball and video machines for amusement containing a minimum of ten pinball and/or video machines.

(4) The term "swimming pool" includes any parking lot appurtenant thereto.

(Pub. L. 91–513, title II, §419, formerly §405A, as added Pub. L. 98–473, title II, §503(a), Oct. 12, 1984, 98 Stat. 2069; amended Pub. L. 99–570, title I, §§1004(a), 1104, 1105(c), 1841(b), 1866(b), (c), Oct. 27, 1986, 100 Stat. 3207–6, 3207-11, 3207-52, 3207-55; Pub. L. 99–646, §28, Nov. 10, 1986, 100 Stat. 3598; Pub. L. 100–690, title VI, §§6452(b)(1), 6457, 6458, Nov. 18, 1988, 102 Stat. 4371, 4373; renumbered §419 and amended Pub. L. 101–647, title X, §§1002(b), 1003(b), title XII, §1214, title XV, §1502, title XXXV, §3599L, Nov. 29, 1990, 104 Stat. 4827, 4829, 4833, 4836, 4932; Pub. L. 103–322, title XIV, §140006, title XXXII, §320107, title XXXIII, §330009(a), Sept. 13, 1994, 108 Stat. 2032, 2111, 2143.)

Editorial Notes

Codification

Section was classified to section 845a of this title prior to renumbering by Pub. L. 101–647.

Amendments

1994—Subsec. (a). Pub. L. 103–322, §320107, substituted "playground, or housing facility owned by a public housing authority, or within" for "playground, or within".

Subsec. (b). Pub. L. 103–322, §§320107, 330009(a), substituted "playground, or housing facility owned by a public housing authority, or within" for "playground, or within" and inserted a period at end of penultimate sentence.

Subsecs. (c) to (e). Pub. L. 103–322, §140006, added subsec. (c) and redesignated former subsecs. (c) and (d) as (d) and (e), respectively.

1990—Subsec. (a). Pub. L. 101–647, §1502(1), inserted "or a playground," after "university," and struck out "playground," after "within 100 feet of a".

Pub. L. 101–647, §1214(1)(C), substituted "a person shall be sentenced under this subsection to a term of imprisonment of not less than one year" for "a term of imprisonment under this subsection shall be not less than one year".

Pub. L. 101–647, §1214(1)(B), inserted "A fine up to twice that authorized by section 841(b) of this title may be imposed in addition to any term of imprisonment authorized by this subsection."

Pub. L. 101–647, §1214(1)(A), which directed the amendment of par. (1) by striking out ", or a fine, or both," could not be executed because those words did not appear. See note below.

Pub. L. 101–647, §1003(b)(1), which directed the substitution of "subject to (1) twice the maximum punishment authorized by section 841(b) of this title" for "punishable (1) by a term of imprisonment, or a fine, or both, up to twice that authorized by section 841(b) of this title", was executed by making the substitution for "punishable (1) by a term of imprisonment, or fine, or both, up to twice that authorized by section 841(b) of this title" to reflect the probable intent of Congress.

Subsec. (b). Pub. L. 101–647, §3599L, substituted "has become final" for "have become final".

Pub. L. 101–647, §1502(2), inserted "or a playground," after "university," and struck out "playground," after "within 100 feet of a".

Pub. L. 101–647, §1214(2)(B), inserted after first sentence "A fine up to three times that authorized by section 841(b) of this title may be imposed in addition to any term of imprisonment authorized by this subsection. Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a person shall be sentenced under this subsection to a term of imprisonment of not less than three years".

Subsec. (b)(1)(B). Pub. L. 101–647, §1214(2)(A), which directed the amendment of subpar. (B) by striking ", or a fine up to three times that" through "or both", could not be executed because the language did not appear after execution of the intervening amendment by Pub. L. 101–647, §1003(b)(2). See below.

Pub. L. 101–647, §1003(b)(2), substituted "three times the maximum punishment authorized by section 841(b) of this title for a first offense" for "a term of imprisonment of up to three times that authorized by section 841(b) of this title for a first offense, or a fine up to three times that authorized by section 841(b) of this title for a first offense, or both".

Subsec. (c). Pub. L. 101–647, §1214(3), inserted "mandatory minimum" after "In the case of any", struck out "subsection (b)" after "imposed under", struck out "of" before "this section" in a reference to "of this section" which was editorially added before ", imposition or", and substituted "An individual convicted under this section shall not be eligible for parole until the individual has served the mandatory minimum term of imprisonment as provided by this section" for "An individual convicted under subsection (b) of this section shall not be eligible for parole under chapter 311 of title 18 until the individual has served the minimum sentence required by such subsection".

1988—Subsec. (a). Pub. L. 100–690, §§6457, 6458(a), inserted ", possessing with intent to distribute," after "distributing" and ", or within 100 feet of a playground, public or private youth center, public swimming pool, or video arcade facility," after "university".

Subsec. (b). Pub. L. 100–690, §§6452(b)(1), 6457, 6458(a), inserted ", possessing with intent to distribute," after "distributing", and ", or within 100 feet of a playground, public or private youth center, public swimming pool, or video arcade facility," after "university", substituted "a prior conviction" for "a prior conviction or convictions", and inserted at end "Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title."

Subsec. (d). Pub. L. 100–690, §6458(b), added subsec. (d).

1986—Subsec. (a). Pub. L. 99–570, §§1104(a), (b), 1105(c), 1841(b)(1), inserted "or section 856 of this title" and "or manufacturing", substituted "a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university" for "a public or private elementary or secondary school", struck out "involving the same controlled substance and schedule" after "for a first offense", and inserted "Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a term of imprisonment under this subsection shall be not less than one year. The mandatory minimum sentencing provisions of this paragraph shall not apply to offenses involving 5 grams or less of marihuana."

Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term".

Subsec. (b). Pub. L. 99–646 which directed that "parole" be inserted after "(2) at least three times any special" could not be executed in view of prior amendment by Pub. L. 99–570, §1104(c) below.

Pub. L. 99–570, §1866(b), which directed that "term of supervised release" be substituted for "special term" could not be executed in view of prior amendment by Pub. L. 99–570, §1104(c) below.

Pub. L. 99–570, §§1104(a), 1841(b)(2), inserted reference to section 856 of this title, inserted "or manufacturing" after "distributing" and substituted "a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university" for "a public or private elementary or secondary school".

Pub. L. 99–570, §1104(c), amended cls. (1) and (2) generally. Prior to amendment, cls. (1) and (2) read as follows: "(1) by a term of imprisonment of not less than three years and not more than life imprisonment and (2) at least three times any special term authorized by section 841(b) of this title for a second or subsequent offense involving the same controlled substance and schedule."

Subsec. (c). Pub. L. 99–570, §1866(c), substituted reference to chapter 311 of title 18 for reference to section 4202 of that title.

Statutory Notes and Related Subsidiaries

Effective Date of 1986 Amendment

Amendment by section 1004(a) of Pub. L. 99–570 effective on date of taking effect of section 3583 of Title 18, Crimes and Criminal Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99–570 set out as a note under section 841 of this title.

§860a. Consecutive sentence for manufacturing or distributing, or possessing with intent to manufacture or distribute, methamphetamine on premises where children are present or reside

Whoever violates section 841(a)(1) of this title by manufacturing or distributing, or possessing with intent to manufacture or distribute, methamphetamine or its salts, isomers or salts of isomers on premises in which an individual who is under the age of 18 years is present or resides, shall, in addition to any other sentence imposed, be imprisoned for a period of any term of years but not more than 20 years, subject to a fine, or both.

(Pub. L. 91–513, title II, §419a, as added Pub. L. 109–177, title VII, §734(a), Mar. 9, 2006, 120 Stat. 270.)

§861. Employment or use of persons under 18 years of age in drug operations

(a) Unlawful acts

It shall be unlawful for any person at least eighteen years of age to knowingly and intentionally—

(1) employ, hire, use, persuade, induce, entice, or coerce, a person under eighteen years of age to violate any provision of this subchapter or subchapter II;

(2) employ, hire, use, persuade, induce, entice, or coerce, a person under eighteen years of age to assist in avoiding detection or apprehension for any offense of this subchapter or subchapter II by any Federal, State, or local law enforcement official; or

(3) receive a controlled substance from a person under 18 years of age, other than an immediate family member, in violation of this subchapter or subchapter II.

(b) Penalty for first offense

Any person who violates subsection (a) is subject to twice the maximum punishment otherwise authorized and at least twice any term of supervised release otherwise authorized for a first offense. Except to the extent a greater minimum sentence is otherwise provided, a term of imprisonment under this subsection shall not be less than one year.

(c) Penalty for subsequent offenses

Any person who violates subsection (a) after a prior conviction under subsection (a) of this section has become final, is subject to three times the maximum punishment otherwise authorized and at least three times any term of supervised release otherwise authorized for a first offense. Except to the extent a greater minimum sentence is otherwise provided, a term of imprisonment under this subsection shall not be less than one year. Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title.

(d) Penalty for providing or distributing controlled substance to underage person

Any person who violates subsection (a)(1) or (2) ¹

(1) by knowingly providing or distributing a controlled substance or a controlled substance analogue to any person under eighteen years of age; or

(2) if the person employed, hired, or used is fourteen years of age or younger,

shall be subject to a term of imprisonment for not more than five years or a fine of not more than $50,000, or both, in addition to any other punishment authorized by this section.

(e) Suspension of sentence; probation; parole

In any case of any sentence imposed under this section, imposition or execution of such sentence shall not be suspended and probation shall not be granted. An individual convicted under this section of an offense for which a mandatory minimum term of imprisonment is applicable shall not be eligible for parole under section 4202 of title 18 ² until the individual has served the mandatory term of imprisonment as enhanced by this section.

(f) Distribution of controlled substance to pregnant individual

Except as authorized by this subchapter, it shall be unlawful for any person to knowingly or intentionally provide or distribute any controlled substance to a pregnant individual in violation of any provision of this subchapter. Any person who violates this subsection shall be subject to the provisions of subsections (b), (c), and (e).

(Pub. L. 91–513, title II, §420, formerly §405B, as added Pub. L. 99–570, title I, §1102, Oct. 27, 1986, 100 Stat. 3207–10; amended Pub. L. 100–690, title VI, §§6452(b)(1), 6459, 6470(d), Nov. 18, 1988, 102 Stat. 4371, 4373, 4378; renumbered §420 and amended Pub. L. 101–647, title X, §§1002(c), 1003(c), title XXXV, §3599L, Nov. 29, 1990, 104 Stat. 4827, 4829, 4932.)

Editorial Notes

References in Text

Section 4202 of title 18, referred to in subsec. (e), which, as originally enacted in Title 18, Crimes and Criminal Procedure, related to eligibility of prisoners for parole, was repealed and a new section 4202 enacted as part of the repeal and enactment of a new chapter 311 (§4201 et seq.) of Title 18, by Pub. L. 94–233, §2, Mar. 15, 1976, 90 Stat. 219. For provisions relating to the eligibility of prisoners for parole, see section 4205 of Title 18. Pub. L. 98–473, title II, §§218(a)(5), 235(a)(1), (b)(1), Oct. 12, 1984, 98 Stat. 2027, 2031, 2032, as amended, provided that, effective on the first day of the first calendar month beginning 36 months after Oct. 12, 1984 (Nov. 1, 1987), chapter 311 of Title 18 is repealed, subject to remaining effective for five years after Nov. 1, 1987, in certain circumstances. See Effective Date note set out under section 3551 of Title 18.

Codification

Section was classified to section 845b of this title prior to renumbering by Pub. L. 101–647.

Amendments

1990—Subsec. (b). Pub. L. 101–647, §1003(c)(1), which directed the substitution of "is subject to twice the maximum punishment otherwise authorized" for "is punishable by a term of imprisonment up to twice that authorized, or up to twice the fine authorized, or both," was executed by making the substitution for "is punishable by a term of imprisonment up to twice that otherwise authorized, or up to twice the fine otherwise authorized, or both," to reflect the probable intent of Congress.

Subsec. (c). Pub. L. 101–647, §3599L, substituted "has become final" for "have become final".

Pub. L. 101–647, §1003(c)(2), which directed the substitution of "is subject to three times the maximum punishment otherwise authorized" for "is punishable by a term of imprisonment up to three times that authorized, or up to three times the fine authorized, or both," was executed by making the substitution for "is punishable by a term of imprisonment up to three times that otherwise authorized, or up to three times the fine otherwise authorized, or both," to reflect the probable intent of Congress.

1988—Subsec. (a)(3). Pub. L. 100–690, §6459, added par. (3).

Subsec. (c). Pub. L. 100–690, §6452(b)(1), struck out "or convictions" after "a prior conviction" and inserted at end "Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title."

Subsec. (e). Pub. L. 100–690, §6470(d), struck out "required by section 841(b) of this title" after "mandatory term of imprisonment".

¹ So in original. Probably should be followed by a dash.

² See References in Text note below.

§862. Denial of Federal benefits to drug traffickers and possessors

(a) Drug traffickers

(1) Any individual who is convicted of any Federal or State offense consisting of the distribution of controlled substances shall—

(A) at the discretion of the court, upon the first conviction for such an offense be ineligible for any or all Federal benefits for up to 5 years after such conviction;

(B) at the discretion of the court, upon a second conviction for such an offense be ineligible for any or all Federal benefits for up to 10 years after such conviction; and

(C) upon a third or subsequent conviction for such an offense be permanently ineligible for all Federal benefits.

(2) The benefits which are denied under this subsection shall not include benefits relating to long-term drug treatment programs for addiction for any person who, if there is a reasonable body of evidence to substantiate such declaration, declares himself to be an addict and submits himself to a long-term treatment program for addiction, or is deemed to be rehabilitated pursuant to rules established by the Secretary of Health and Human Services.

(b) Drug possessors

(1) Any individual who is convicted of any Federal or State offense involving the possession of a controlled substance (as such term is defined for purposes of this subchapter) shall—

(A) upon the first conviction for such an offense and at the discretion of the court—

(i) be ineligible for any or all Federal benefits for up to one year;

(ii) be required to successfully complete an approved drug treatment program which includes periodic testing to insure that the individual remains drug free;

(iii) be required to perform appropriate community service; or

(iv) any combination of clause (i), (ii), or (iii); and

(B) upon a second or subsequent conviction for such an offense be ineligible for all Federal benefits for up to 5 years after such conviction as determined by the court. The court shall continue to have the discretion in subparagraph (A) above. In imposing penalties and conditions under subparagraph (A), the court may require that the completion of the conditions imposed by clause (ii) or (iii) be a requirement for the reinstatement of benefits under clause (i).

(2) The penalties and conditions which may be imposed under this subsection shall be waived in the case of a person who, if there is a reasonable body of evidence to substantiate such declaration, declares himself to be an addict and submits himself to a long-term treatment program for addiction, or is deemed to be rehabilitated pursuant to rules established by the Secretary of Health and Human Services.

(c) Suspension of period of ineligibility

The period of ineligibility referred to in subsections (a) and (b) shall be suspended if the individual—

(A) completes a supervised drug rehabilitation program after becoming ineligible under this section;

(B) has otherwise been rehabilitated; or

(C) has made a good faith effort to gain admission to a supervised drug rehabilitation program, but is unable to do so because of inaccessibility or unavailability of such a program, or the inability of the individual to pay for such a program.

(d) Definitions

As used in this section—

(1) the term "Federal benefit"—

(A) means the issuance of any grant, contract, loan, professional license, or commercial license provided by an agency of the United States or by appropriated funds of the United States; and

(B) does not include any retirement, welfare, Social Security, health, disability, veterans benefit, public housing, or other similar benefit, or any other benefit for which payments or services are required for eligibility; and

(2) the term "veterans benefit" means all benefits provided to veterans, their families, or survivors by virtue of the service of a veteran in the Armed Forces of the United States.

(e) Inapplicability of this section to Government witnesses

The penalties provided by this section shall not apply to any individual who cooperates or testifies with the Government in the prosecution of a Federal or State offense or who is in a Government witness protection program.

(f) Indian provision

Nothing in this section shall be construed to affect the obligation of the United States to any Indian or Indian tribe arising out of any treaty, statute, Executive order, or the trust responsibility of the United States owing to such Indian or Indian tribe. Nothing in this subsection shall exempt any individual Indian from the sanctions provided for in this section, provided that no individual Indian shall be denied any benefit under Federal Indian programs comparable to those described in subsection (d)(1)(B) or (d)(2).

(g) Presidential report

(1) On or before May 1, 1989, the President shall transmit to the Congress a report—

(A) delineating the role of State courts in implementing this section;

(B) describing the manner in which Federal agencies will implement and enforce the requirements of this section;

(C) detailing the means by which Federal and State agencies, courts, and law enforcement agencies will exchange and share the data and information necessary to implement and enforce the withholding of Federal benefits; and

(D) recommending any modifications to improve the administration of this section or otherwise achieve the goal of discouraging the trafficking and possession of controlled substances.

(2) No later than September 1, 1989, the Congress shall consider the report of the President and enact such changes as it deems appropriate to further the goals of this section.

(h) Effective date

The denial of Federal benefits set forth in this section shall take effect for convictions occurring after September 1, 1989.

(Pub. L. 91–513, title II, §421, formerly Pub. L. 100–690, title V, §5301, Nov. 18, 1988, 102 Stat. 4310; renumbered §421 of Pub. L. 91–513 and amended Pub. L. 101–647, title X, §1002(d), Nov. 29, 1990, 104 Stat. 4827.)

Editorial Notes

Codification

Section was classified to section 853a of this title prior to renumbering by Pub. L. 101–647.

Amendments

1990—Pub. L. 101–647, §1002(d)(1), renumbered section 853a of this title as this section.

Subsec. (a)(1). Pub. L. 101–647, §1002(d)(2), struck out "(as such terms are defined for purposes of the Controlled Substances Act)" after "controlled substances" in introductory provisions.

§862a. Denial of assistance and benefits for certain drug-related convictions

(a) In general

An individual convicted (under Federal or State law) of any offense which is classified as a felony by the law of the jurisdiction involved and which has as an element the possession, use, or distribution of a controlled substance (as defined in section 802(6) of this title) shall not be eligible for—

(1) assistance under any State program funded under part A of title IV of the Social Security Act [42 U.S.C. 601 et seq.], or

(2) benefits under the supplemental nutrition assistance program (as defined in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C. 2012)) or any State program carried out under that Act [7 U.S.C. 2011 et seq.].

(b) Effects on assistance and benefits for others

(1) Program of temporary assistance for needy families

The amount of assistance otherwise required to be provided under a State program funded under part A of title IV of the Social Security Act [42 U.S.C. 601 et seq.] to the family members of an individual to whom subsection (a) applies shall be reduced by the amount which would have otherwise been made available to the individual under such part.

(2) Benefits under the Food and Nutrition Act of 2008

The amount of benefits otherwise required to be provided to a household under the supplemental nutrition assistance program (as defined in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C. 2012)), or any State program carried out under that Act [7 U.S.C. 2011 et seq.], shall be determined by considering the individual to whom subsection (a) applies not to be a member of such household, except that the income and resources of the individual shall be considered to be income and resources of the household.

(c) Enforcement

A State that has not exercised its authority under subsection (d)(1)(A) shall require each individual applying for assistance or benefits referred to in subsection (a), during the application process, to state, in writing, whether the individual, or any member of the household of the individual, has been convicted of a crime described in subsection (a).

(d) Limitations

(1) State elections

(A) Opt out

A State may, by specific reference in a law enacted after August 22, 1996, exempt any or all individuals domiciled in the State from the application of subsection (a).

(B) Limit period of prohibition

A State may, by law enacted after August 22, 1996, limit the period for which subsection (a) shall apply to any or all individuals domiciled in the State.

(2) Inapplicability to convictions occurring on or before August 22, 1996

Subsection (a) shall not apply to a conviction if the conviction is for conduct occurring on or before August 22, 1996.

(e) "State" defined

For purposes of this section, the term "State" has the meaning given it—

(1) in section 419(5) of the Social Security Act [42 U.S.C. 619(5)], when referring to assistance provided under a State program funded under part A of title IV of the Social Security Act [42 U.S.C. 601 et seq.], and

(2) in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C. 2012), when referring to the supplemental nutrition assistance program (as defined in that section) or any State program carried out under that Act [7 U.S.C. 2011 et seq.].

(f) Rule of interpretation

Nothing in this section shall be construed to deny the following Federal benefits:

(1) Emergency medical services under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.].

(2) Short-term, noncash, in-kind emergency disaster relief.

(3)(A) Public health assistance for immunizations.

(B) Public health assistance for testing and treatment of communicable diseases if the Secretary of Health and Human Services determines that it is necessary to prevent the spread of such disease.

(4) Prenatal care.

(5) Job training programs.

(6) Drug treatment programs.

(Pub. L. 104–193, title I, §115, Aug. 22, 1996, 110 Stat. 2180; Pub. L. 105–33, title V, §5516(a), Aug. 5, 1997, 111 Stat. 620; Pub. L. 110–234, title IV, §4115(c)(2)(C), May 22, 2008, 122 Stat. 1109; Pub. L. 110–246, §4(a), title IV, §4115(c)(2)(C), June 18, 2008, 122 Stat. 1664, 1871; Pub. L. 113–79, title IV, §4030(n), Feb. 7, 2014, 128 Stat. 814.)

Editorial Notes

References in Text

The Social Security Act, referred to in subsecs. (a)(1), (b)(1), (e)(1), and (f)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Part A of title IV of the Act is classified generally to part A (§601 et seq.) of subchapter IV of chapter 7 of Title 42, The Public Health and Welfare. Title XIX of the Act is classified generally to subchapter XIX (§1396 et seq.) of chapter 7 of Title 42. For complete classification of this Act to the Code, see section 1305 of Title 42 and Tables.

The Food and Nutrition Act of 2008, referred to in subsecs. (a)(2), (b)(2), and (e)(2), is Pub. L. 88–525, Aug. 31, 1964, 78 Stat. 703, which is classified generally to chapter 51 (§2011 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 2011 of Title 7 and Tables.

Codification

Pub. L. 110–234 and Pub. L. 110–246 made identical amendments to this section. The amendments by Pub. L. 110–234 were repealed by section 4(a) of Pub. L. 110–246.

Section was enacted as part of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, and not as part of the Controlled Substances Act which comprises this subchapter.

Amendments

2014—Subsec. (a)(2). Pub. L. 113–79, §4030(n)(1), substituted "supplemental nutrition assistance program (as defined in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C. 2012)) or any State program carried out under that Act" for "food stamp program (as defined in section 3(l) of the Food Stamp Act of 1977) or any State program carried out under the Food Stamp Act of 1977".

Subsec. (b)(2). Pub. L. 113–79, §4030(n)(2), substituted "supplemental nutrition assistance program (as defined in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C. 2012)), or any State program carried out under that Act" for "food stamp program (as defined in section 3(l) of the Food Stamp Act of 1977), or any State program carried out under the Food Stamp Act of 1977".

Subsec. (e)(2). Pub. L. 113–79, §4030(n)(3), substituted "section 3 of the Food and Nutrition Act of 2008 (7 U.S.C. 2012), when referring to the supplemental nutrition assistance program (as defined in that section) or any State program carried out under that Act" for "section 3(s) of the Food Stamp Act of 1977, when referring to the food stamp program (as defined in section 3(l) of the Food Stamp Act of 1977) or any State program carried out under the Food Stamp Act of 1977".

2008—Subsecs. (a)(2), (b)(2). Pub. L. 110–246, §4115(c)(2)(C)(i), substituted "section 3(l)" for "section 3(h)".

Subsec. (e)(2). Pub. L. 110–246, §4115(c)(2)(C), substituted "section 3(s)" for "section 3(m)" and "section 3(l)" for "section 3(h)".

1997—Subsec. (d)(2). Pub. L. 105–33 substituted "a conviction if the conviction is for conduct" for "convictions".

Statutory Notes and Related Subsidiaries

Change of Name

References to the food stamp program established under the Food Stamp Act of 1977, now known as the Food and Nutrition Act of 2008, considered to refer to the supplemental nutrition assistance program established under that Act, see section 4002(c) of Pub. L. 110–246, set out as a note under section 2012 of Title 7, Agriculture.

Effective Date of 2008 Amendment

Amendment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, except as otherwise provided, see section 4 of Pub. L. 110–246, set out as an Effective Date note under section 8701 of Title 7, Agriculture.

Amendment by section 4115(c)(2)(C) of Pub. L. 110–246 effective Oct. 1, 2008, see section 4407 of Pub. L. 110–246, set out as a note under section 1161 of Title 2, The Congress.

Effective Date of 1997 Amendment

Pub. L. 105–33, title V, §5518(d), Aug. 5, 1997, 111 Stat. 621, provided that: "The amendments made by this chapter to a provision of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 [Pub. L. 104–193] that have not become part of another statute [chapter 1 (§§5501–5518) of subtitle F of title V of Pub. L. 105–33, amending this section, sections 601 to 603, 604 to 608, 609 to 611, and 612 to 617 of Title 42, The Public Health and Welfare, and provisions set out as notes under section 612c of Title 7, Agriculture, and sections 601 and 613 of Title 42] shall take effect as if the amendments had been included in the provision at the time the provision became law."

Effective Date

Section effective July 1, 1997, with transition rules relating to State options to accelerate such date, rules relating to claims, actions, and proceedings commenced before such date, rules relating to closing out of accounts for terminated or substantially modified programs and continuance in office of Assistant Secretary for Family Support, and provisions relating to termination of entitlement under AFDC program, see section 116 of Pub. L. 104–193, as amended, set out as an Effective Date note under section 601 of Title 42, The Public Health and Welfare.

§862b. Sanctioning for testing positive for controlled substances

Notwithstanding any other provision of law, States shall not be prohibited by the Federal Government from testing welfare recipients for use of controlled substances nor from sanctioning welfare recipients who test positive for use of controlled substances.

(Pub. L. 104–193, title IX, §902, Aug. 22, 1996, 110 Stat. 2347.)

Editorial Notes

Codification

Section was enacted as part of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, and not as part of the Controlled Substances Act which comprises this subchapter.

§863. Drug paraphernalia

(a) In general

It is unlawful for any person—

(1) to sell or offer for sale drug paraphernalia;

(2) to use the mails or any other facility of interstate commerce to transport drug paraphernalia; or

(3) to import or export drug paraphernalia.

(b) Penalties

Anyone convicted of an offense under subsection (a) of this section shall be imprisoned for not more than three years and fined under title 18.

(c) Seizure and forfeiture

Any drug paraphernalia involved in any violation of subsection (a) of this section shall be subject to seizure and forfeiture upon the conviction of a person for such violation. Any such paraphernalia shall be delivered to the Administrator of General Services, General Services Administration, who may order such paraphernalia destroyed or may authorize its use for law enforcement or educational purposes by Federal, State, or local authorities.

(d) "Drug paraphernalia" defined

The term "drug paraphernalia" means any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under this subchapter. It includes items primarily intended or designed for use in ingesting, inhaling, or otherwise introducing marijuana,¹ cocaine, hashish, hashish oil, PCP, methamphetamine, or amphetamines into the human body, such as—

(1) metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls;

(2) water pipes;

(3) carburetion tubes and devices;

(4) smoking and carburetion masks;

(5) roach clips: meaning objects used to hold burning material, such as a marihuana cigarette, that has become too small or too short to be held in the hand;

(6) miniature spoons with level capacities of one-tenth cubic centimeter or less;

(7) chamber pipes;

(8) carburetor pipes;

(9) electric pipes;

(10) air-driven pipes;

(11) chillums;

(12) bongs;

(13) ice pipes or chillers;

(14) wired cigarette papers; or

(15) cocaine freebase kits.

(e) Matters considered in determination of what constitutes drug paraphernalia

In determining whether an item constitutes drug paraphernalia, in addition to all other logically relevant factors, the following may be considered:

(1) instructions, oral or written, provided with the item concerning its use;

(2) descriptive materials accompanying the item which explain or depict its use;

(3) national and local advertising concerning its use;

(4) the manner in which the item is displayed for sale;

(5) whether the owner, or anyone in control of the item, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products;

(6) direct or circumstantial evidence of the ratio of sales of the item(s) to the total sales of the business enterprise;

(7) the existence and scope of legitimate uses of the item in the community; and

(8) expert testimony concerning its use.

(f) Exemptions

This section shall not apply to—

(1) any person authorized by local, State, or Federal law to manufacture, possess, or distribute such items; or

(2) any item that, in the normal lawful course of business, is imported, exported, transported, or sold through the mail or by any other means, and traditionally intended for use with tobacco products, including any pipe, paper, or accessory.

(Pub. L. 91–513, title II, §422, as added and amended Pub. L. 101–647, title XXIV, §2401(a)–(c), Nov. 29, 1990, 104 Stat. 4858, 4859; Pub. L. 106–310, div. B, title XXXVI, §3614, Oct. 17, 2000, 114 Stat. 1230.)

Editorial Notes

Codification

The text of section 857(b) to (f) of this title, which was transferred to subsecs. (b) to (f) of this section by Pub. L. 101–647, §2401(b), was based on Pub. L. 99–570, title I, §1822(b)–(f), Oct. 27, 1986, 100 Stat. 3207–51; Pub. L. 100–690, title VI, §6485, Nov. 18, 1988, 102 Stat. 4384.

Amendments

2000—Subsec. (d). Pub. L. 106–310 inserted "methamphetamine," after "PCP," in introductory provisions.

1990—Subsec. (b). Pub. L. 101–647, §2401(c)(1), substituted "fined under title 18" for "fined not more than $100,000".

Pub. L. 101–647, §2401(b), redesignated subsec. (b) of section 857 of this title as subsec. (b) of this section. See Codification note above.

Subsecs. (c) to (e). Pub. L. 101–647, §2401(b), redesignated subsecs. (c) to (e) of section 857 of this title as subsecs. (c) to (e) of this section. See Codification note above.

Subsec. (f). Pub. L. 101–647, §2401(c)(2), made technical amendment to reference to "This section" to correct reference to corresponding provision of original act.

Pub. L. 101–647, §2401(b), redesignated subsec. (f) of section 857 of this title as subsec. (f) of this section. See Codification note above.

¹ So in original. Probably should be "marihuana,".

§864. Anhydrous ammonia

(a) It is unlawful for any person—

(1) to steal anhydrous ammonia, or

(2) to transport stolen anhydrous ammonia across State lines,

knowing, intending, or having reasonable cause to believe that such anhydrous ammonia will be used to manufacture a controlled substance in violation of this part.

(b) Any person who violates subsection (a) shall be imprisoned or fined, or both, in accordance with section 843(d) of this title as if such violation were a violation of a provision of section 843 of this title.

(Pub. L. 91–513, title II, §423, as added Pub. L. 106–310, div. B, title XXXVI, §3653(a), Oct. 17, 2000, 114 Stat. 1240.)

§864a. Grants to reduce production of methamphetamines from anhydrous ammonia

(a) Definitions

In this section:

(1) Eligible entity

The term "eligible entity" means—

(A) a producer of agricultural commodities;

(B) a cooperative association, a majority of the members of which produce or process agricultural commodities; or

(C) a person in the trade or business of—

(i) selling an agricultural product (including an agricultural chemical) at retail, predominantly to farmers and ranchers; or

(ii) aerial and ground application of an agricultural chemical.

(2) Nurse tank

The term "nurse tank" shall be considered to be a cargo tank (within the meaning of section 173.315(m) of title 49, Code of Federal Regulations, as in effect as of the date of the enactment of this Act).

(b) Grant authority

The Secretary may make a grant to an eligible entity to enable the eligible entity to obtain and add to an anhydrous ammonia fertilizer nurse tank a physical lock or a substance to reduce the amount of methamphetamine that can be produced from any anhydrous ammonia removed from the nurse tank.

(c) Grant amount

The amount of a grant made under this section to an eligible entity shall be the product obtained by multiplying—

(1) an amount not less than $40 and not more than $60, as determined by the Secretary; and

(2) the number of fertilizer nurse tanks of the eligible entity.

(d) Authorization of appropriations

There is authorized to be appropriated to the Secretary to make grants under this section $15,000,000 for the period of fiscal years 2008 through 2012.

(Pub. L. 110–234, title XIV, §14203, May 22, 2008, 122 Stat. 1458; Pub. L. 110–246, §4(a), title XIV, §14203, June 18, 2008, 122 Stat. 1664, 2220.)

Editorial Notes

References in Text

The date of the enactment of this Act, referred to in subsec. (a)(2), is the date of enactment of Pub. L. 110–246, which was approved June 18, 2008.

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Section was enacted as part of the Food, Conservation, and Energy Act of 2008, and not as part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.

Definition of "Secretary"

"Secretary" as meaning the Secretary of Agriculture, see section 8701 of Title 7, Agriculture.

§865. Smuggling methamphetamine or methamphetamine precursor chemicals into the United States while using facilitated entry programs

(a) Enhanced prison sentence

The sentence of imprisonment imposed on a person convicted of an offense under the Controlled Substances Act (21 U.S.C. 801 et seq.) or the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), involving methamphetamine or any listed chemical that is defined in section 102(33) of the Controlled Substances Act (21 U.S.C. 802(33),¹ shall, if the offense is committed under the circumstance described in subsection (b), be increased by a consecutive term of imprisonment of not more than 15 years.

(b) Circumstances

For purposes of subsection (a), the circumstance described in this subsection is that the offense described in subsection (a) was committed by a person who—

(1) was enrolled in, or who was acting on behalf of any person or entity enrolled in, any dedicated commuter lane, alternative or accelerated inspection system, or other facilitated entry program administered or approved by the Federal Government for use in entering the United States; and

(2) committed the offense while entering the United States, using such lane, system, or program.

(c) Permanent ineligibility

Any person whose term of imprisonment is increased under subsection (a) shall be permanently and irrevocably barred from being eligible for or using any lane, system, or program described in subsection (b)(1).

(Pub. L. 109–177, title VII, §731, Mar. 9, 2006, 120 Stat. 270.)

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (a), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to this subchapter. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Controlled Substances Import and Export Act, referred to in subsec. (a), is title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285, which is classified principally to subchapter II (§951 et seq.) of this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 951 of this title and Tables.

Codification

Section was enacted as part of the USA PATRIOT Improvement and Reauthorization Act of 2005 and also as part of the Combat Methamphetamine Epidemic Act of 2005, and not as part of the Controlled Substances Act which comprises this subchapter.

¹ So in original. A second closing parenthesis probably should precede the comma.

Part E—Administrative and Enforcement Provisions

§871. Attorney General

(a) Delegation of functions

The Attorney General may delegate any of his functions under this subchapter to any officer or employee of the Department of Justice.

(b) Rules and regulations

The Attorney General may promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter.

(c) Acceptance of devises, bequests, gifts, and donations

The Attorney General may accept in the name of the Department of Justice any form of devise, bequest, gift, or donation where the donor intends to donate property for the purpose of preventing or controlling the abuse of controlled substances. He may take all appropriate steps to secure possession of such property and may sell, assign, transfer, or convey any such property other than moneys.

(Pub. L. 91–513, title II, §501, Oct. 27, 1970, 84 Stat. 1270.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a) and (b), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

§871a. Semiannual reports to Congress

(a) In general

The Attorney General shall, on a semiannual basis, submit to the congressional committees and organizations specified in subsection (b) reports that—

(1) describe the allocation of the resources of the Drug Enforcement Administration and the Federal Bureau of Investigation for the investigation and prosecution of alleged violations of the Controlled Substances Act [21 U.S.C. 801 et seq.] involving methamphetamine; and

(2) the measures being taken to give priority in the allocation of such resources to such violations involving—

(A) persons alleged to have imported into the United States substantial quantities of methamphetamine or scheduled listed chemicals (as defined pursuant to the amendment made by section 711(a)(1)); ¹

(B) persons alleged to have manufactured methamphetamine; and

(C) circumstances in which the violations have endangered children.

(b) Congressional committees

The congressional committees and organizations referred to in subsection (a) are—

(1) in the House of Representatives, the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Government Reform; and

(2) in the Senate, the Committee on the Judiciary, the Committee on Commerce, Science, and Transportation, and the Caucus on International Narcotics Control.

(Pub. L. 109–177, title VII, §736, Mar. 9, 2006, 120 Stat. 271.)

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (a)(1), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to this subchapter. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Section 711(a)(1), referred to in subsec. (a)(2)(A), is section 711(a)(1) of Pub. L. 109–177, which amended section 802 of this title.

Codification

Section was enacted as part of the USA PATRIOT Improvement and Reauthorization Act of 2005 and also as part of the Combat Methamphetamine Epidemic Act of 2005, and not as part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Government Reform of House of Representatives changed to Committee on Oversight and Government Reform of House of Representatives by House Resolution No. 6, One Hundred Tenth Congress, Jan. 5, 2007. Committee on Oversight and Government Reform of House of Representatives changed to Committee on Oversight and Reform of House of Representatives by House Resolution No. 6, One Hundred Sixteenth Congress, Jan. 9, 2019. Committee on Oversight and Reform of House of Representatives changed to Committee on Oversight and Accountability of House of Representatives by House Resolution No. 5, One Hundred Eighteenth Congress, Jan. 9, 2023.

¹ See References in Text note below.

§872. Education and research programs of Attorney General

(a) Authorization

The Attorney General is authorized to carry out educational and research programs directly related to enforcement of the laws under his jurisdiction concerning drugs or other substances which are or may be subject to control under this subchapter. Such programs may include—

(1) educational and training programs on drug abuse and controlled substances law enforcement for local, State, tribal, and Federal personnel;

(2) studies or special projects designed to compare the deterrent effects of various enforcement strategies on drug use and abuse;

(3) studies or special projects designed to assess and detect accurately the presence in the human body of drugs or other substances which are or may be subject to control under this subchapter, including the development of rapid field identification methods which would enable agents to detect microquantities of such drugs or other substances;

(4) studies or special projects designed to evaluate the nature and sources of the supply of illegal drugs throughout the country;

(5) studies or special projects to develop more effective methods to prevent diversion of controlled substances into illegal channels; and

(6) studies or special projects to develop information necessary to carry out his functions under section 811 of this title.

(b) Contracts

The Attorney General may enter into contracts for such educational and research activities without performance bonds and without regard to section 6101 of title 41.

(c) Identification of research populations; authorization to withhold

The Attorney General may authorize persons engaged in research to withhold the names and other identifying characteristics of persons who are the subjects of such research. Persons who obtain this authorization may not be compelled in any Federal, State, tribal, or local civil, criminal, administrative, legislative, or other proceeding to identify the subjects of research for which such authorization was obtained.

(d) Affect of treaties and other international agreements on confidentiality

Nothing in the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, or other treaties or international agreements shall be construed to limit, modify, or prevent the protection of the confidentiality of patient records or of the names and other identifying characteristics of research subjects as provided by any Federal, State, or local law or regulation.

(e) Use of controlled substances in research

The Attorney General, on his own motion or at the request of the Secretary, may authorize the possession, distribution, and dispensing of controlled substances by persons engaged in research. Persons who obtain this authorization shall be exempt from State or Federal prosecution for possession, distribution, and dispensing of controlled substances to the extent authorized by the Attorney General.

(f) Program to curtail diversion of precursor and essential chemicals

The Attorney General shall maintain an active program, both domestic and international, to curtail the diversion of precursor chemicals and essential chemicals used in the illicit manufacture of controlled substances.

(Pub. L. 91–513, title II, §502, Oct. 27, 1970, 84 Stat. 1271; Pub. L. 95–633, title I, §108(a), Nov. 10, 1978, 92 Stat. 3773; Pub. L. 100–690, title VI, §6060, Nov. 18, 1988, 102 Stat. 4320; Pub. L. 111–211, title II, §232(a), July 29, 2010, 124 Stat. 2278.)

Editorial Notes

Codification

In subsec. (b), "section 6101 of title 41" substituted for "section 3709 of the Revised Statutes (41 U.S.C. 5)" on authority of Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

2010—Subsecs. (a)(1), (c). Pub. L. 111–211 inserted "tribal," after "State,".

1988—Subsec. (f). Pub. L. 100–690 added subsec. (f).

1978—Subsecs. (d), (e). Pub. L. 95–633 added subsec. (d) and redesignated former subsec. (d) as (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Effect of Grants

Pub. L. 111–211, title II, §232(e), July 29, 2010, 124 Stat. 2279, provided that: "Nothing in this section [amending this section and sections 872a, 873, and 878 of this title] or any amendment made by this section—

"(1) allows the grant to be made to, or used by, an entity for law enforcement activities that the entity lacks jurisdiction to perform; or

"(2) has any effect other than to authorize, award, or deny a grant of funds to a federally recognized Indian tribe for the purposes described in the relevant grant program."

[For definition of "Indian tribe" as used in section 232(e) of Pub. L. 111–211, set out above, see section 203(a) of Pub. L. 111–211, set out as a note under section 2801 of Title 25, Indians.]

Training for Drug Enforcement Administration and State and Local Law Enforcement Personnel Relating to Clandestine Laboratories

Pub. L. 106–310, div. B, title XXXVI, §3623, Oct. 17, 2000, 114 Stat. 1231, provided that:

"(a) In General.—

"(1) Requirement.—The Administrator of the Drug Enforcement Administration shall carry out the programs described in subsection (b) with respect to the law enforcement personnel of States and localities determined by the Administrator to have significant levels of methamphetamine-related or amphetamine-related crime or projected by the Administrator to have the potential for such levels of crime in the future.

"(2) Duration.—The duration of any program under that subsection may not exceed 3 years.

"(b) Covered Programs.—The programs described in this subsection are as follows:

"(1) Advanced mobile clandestine laboratory training teams.—A program of advanced mobile clandestine laboratory training teams, which shall provide information and training to State and local law enforcement personnel in techniques utilized in conducting undercover investigations and conspiracy cases, and other information designed to assist in the investigation of the illegal manufacturing and trafficking of amphetamine and methamphetamine.

"(2) Basic clandestine laboratory certification training.—A program of basic clandestine laboratory certification training, which shall provide information and training—

"(A) to Drug Enforcement Administration personnel and State and local law enforcement personnel for purposes of enabling such personnel to meet any certification requirements under law with respect to the handling of wastes created by illegal amphetamine and methamphetamine laboratories; and

"(B) to State and local law enforcement personnel for purposes of enabling such personnel to provide the information and training covered by subparagraph (A) to other State and local law enforcement personnel.

"(3) Clandestine laboratory recertification and awareness training.—A program of clandestine laboratory recertification and awareness training, which shall provide information and training to State and local law enforcement personnel for purposes of enabling such personnel to provide recertification and awareness training relating to clandestine laboratories to additional State and local law enforcement personnel.

"(c) Authorization of Appropriations.—There are authorized to be appropriated for each of fiscal years 2000, 2001, and 2002 amounts as follows:

"(1) $1,500,000 to carry out the program described in subsection (b)(1).

"(2) $3,000,000 to carry out the program described in subsection (b)(2).

"(3) $1,000,000 to carry out the program described in subsection (b)(3)."

Educational Program for Police Departments

Pub. L. 104–305, §4, Oct. 13, 1996, 110 Stat. 3809, provided that: "The Attorney General may—

"(1) create educational materials regarding the use of controlled substances (as that term is defined in section 102 of the Controlled Substances Act [21 U.S.C. 802]) in the furtherance of rapes and sexual assaults; and

"(2) disseminate those materials to police departments throughout the United States."

Study and Report on Measures To Prevent Sales of Agents Used in Methamphetamine Production

Pub. L. 104–237, title II, §202, Oct. 3, 1996, 110 Stat. 3101, required the Attorney General of the United States to conduct a study on measures to effectively prevent the diversion of red phosphorous, iodine, hydrochloric gas, and other agents for use in the production of methamphetamine, and to submit to Congress no later than Jan. 1, 1998, a report of the findings pursuant to the study on the need for and advisability of preventive measures.

§872a. Public-private education program

(a) Advisory panel

The Attorney General shall establish an advisory panel consisting of an appropriate number of representatives from Federal, State, tribal, and local law enforcement and regulatory agencies with experience in investigating and prosecuting illegal transactions of precursor chemicals. The Attorney General shall convene the panel as often as necessary to develop and coordinate educational programs for wholesale and retail distributors of precursor chemicals and supplies.

(b) Continuation of current efforts

The Attorney General shall continue to—

(1) maintain an active program of seminars and training to educate wholesale and retail distributors of precursor chemicals and supplies regarding the identification of suspicious transactions and their responsibility to report such transactions; and

(2) provide assistance to State, tribal, and local law enforcement and regulatory agencies to facilitate the establishment and maintenance of educational programs for distributors of precursor chemicals and supplies.

(Pub. L. 104–237, title V, §503, Oct. 3, 1996, 110 Stat. 3112; Pub. L. 111–211, title II, §232(b), July 29, 2010, 124 Stat. 2278.)

Editorial Notes

Codification

Section was enacted as part of the Comprehensive Methamphetamine Control Act of 1996, and not as part of the Controlled Substances Act which comprises this subchapter.

Amendments

2010—Subsec. (a). Pub. L. 111–211, §232(b)(1), inserted "tribal," after "State,".

Subsec. (b)(2). Pub. L. 111–211, §232(b)(2), inserted ", tribal," after "State".

§873. Cooperative arrangements

(a) Cooperation of Attorney General with local, State, tribal, and Federal agencies

The Attorney General shall cooperate with local, State, tribal, and Federal agencies concerning traffic in controlled substances and in suppressing the abuse of controlled substances. To this end, he is authorized to—

(1) arrange for the exchange of information between governmental officials concerning the use and abuse of controlled substances;

(2) cooperate in the institution and prosecution of cases in the courts of the United States and before the licensing boards and courts of the several States;

(3) conduct training programs on controlled substance law enforcement for local, State, tribal, and Federal personnel;

(4) maintain in the Department of Justice a unit which will accept, catalog, file, and otherwise utilize all information and statistics, including records of controlled substance abusers and other controlled substance law offenders, which may be received from Federal, State, tribal, and local agencies, and make such information available for Federal, State, tribal, and local law enforcement purposes;

(5) conduct programs of eradication aimed at destroying wild or illicit growth of plant species from which controlled substances may be extracted;

(6) assist State, tribal, and local governments in suppressing the diversion of controlled substances from legitimate medical, scientific, and commercial channels by—

(A) making periodic assessments of the capabilities of State, tribal, and local governments to adequately control the diversion of controlled substances;

(B) providing advice and counsel to State, tribal, and local governments on the methods by which such governments may strengthen their controls against diversion; and

(C) establishing cooperative investigative efforts to control diversion; and

(7) notwithstanding any other provision of law, enter into contractual agreements with State, tribal, and local law enforcement agencies to provide for cooperative enforcement and regulatory activities under this chapter.¹

(b) Requests by Attorney General for assistance from Federal agencies or instrumentalities

When requested by the Attorney General, it shall be the duty of any agency or instrumentality of the Federal Government to furnish assistance, including technical advice, to him for carrying out his functions under this subchapter; except that no such agency or instrumentality shall be required to furnish the name of, or other identifying information about, a patient or research subject whose identity it has undertaken to keep confidential.

(c) Descriptive and analytic reports; limitation on court challenges

(1) The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of States a standardized report containing descriptive and analytic information on the actual distribution patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to section 827 of this title and which includes detailed amounts, outliers, and trends of distributor and pharmacy registrants, in such States for the controlled substances contained in schedule II, which, in the discretion of the Attorney General, are determined to have the highest abuse.

(2) If the Attorney General publishes the report described in paragraph (1) once every 6 months as required under paragraph (1), nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the Attorney General to produce any documents or reports referred to in this subsection.

(d) Grants by Attorney General

(1) The Attorney General may make grants, in accordance with paragraph (2), to State, tribal, and local governments to assist in meeting the costs of—

(A) collecting and analyzing data on the diversion of controlled substances,

(B) conducting investigations and prosecutions of such diversions,

(C) improving regulatory controls and other authorities to control such diversions,

(D) programs to prevent such diversions,

(E) preventing and detecting forged prescriptions, and

(F) training law enforcement and regulatory personnel to improve the control of such diversions.

(2) No grant may be made under paragraph (1) unless an application therefor is submitted to the Attorney General in such form and manner as the Attorney General may prescribe. No grant may exceed 80 per centum of the costs for which the grant is made, and no grant may be made unless the recipient of the grant provides assurances satisfactory to the Attorney General that it will obligate funds to meet the remaining 20 per centum of such costs. The Attorney General shall review the activities carried out with grants under paragraph (1) and shall report annually to Congress on such activities.

(3) To carry out this subsection there is authorized to be appropriated $6,000,000 for fiscal year 1985 and $6,000,000 for fiscal year 1986.

(Pub. L. 91–513, title II, §503, Oct. 27, 1970, 84 Stat. 1271; Pub. L. 96–359, §8(a) Sept. 26, 1980, 94 Stat. 1194; Pub. L. 98–473, title II, §517, Oct. 12, 1984, 98 Stat. 2074; Pub. L. 99–570, title I, §1868, Oct. 27, 1986, 100 Stat. 3207–55; Pub. L. 99–646, §85, Nov. 10, 1986, 100 Stat. 3620; Pub. L. 111–211, title II, §232(c), July 29, 2010, 124 Stat. 2278; Pub. L. 115–271, title III, §3273(b), Oct. 24, 2018, 132 Stat. 3953.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a)(7), was in the original as added by Pub. L. 99–646 "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. In the subsec. (a)(7) added by Pub. L. 99–570, the reference was "this title", meaning title II of Pub. L. 91–513 which is popularly known as the "Controlled Substances Act" and is classified principally to this subchapter. For complete classification of this Act and title II to the Code, see Short Title note set out under section 801 of this title and Tables.

Schedule II, referred to in subsec. (c), is set out in section 812(c) of this title.

Amendments

2018—Subsec. (c). Pub. L. 115–271 added subsec. (c) and struck out former subsec. (c). Prior to amendment, text read as follows: "The Attorney General shall annually (1) select the controlled substance (or controlled substances) contained in schedule II which, in the Attorney General's discretion, is determined to have the highest rate of abuse, and (2) prepare and make available to regulatory, licensing, and law enforcement agencies of States descriptive and analytic reports on the actual distribution patterns in such States of each such controlled substance."

2010—Subsec. (a). Pub. L. 111–211, §232(c)(1)(A), inserted "tribal," after "State," wherever appearing in introductory provisions and pars. (3) and (4).

Subsec. (a)(6), (7). Pub. L. 111–211, §232(c)(1)(B), inserted ", tribal," after "State" wherever appearing.

Subsec. (d)(1). Pub. L. 111–211, §232(c)(2), inserted ", tribal," after "State" in introductory provisions.

1986—Subsec. (a)(7). Pub. L. 99–570 and Pub. L. 99–646 made substantially identical amendment, adding par. (7).

1984—Subsec. (a)(6). Pub. L. 98–473, §517(a), added par. (6).

Subsec. (d). Pub. L. 98–473, §517(b), added subsec. (d).

1980—Subsec. (c). Pub. L. 96–359 added subsec. (c).

Statutory Notes and Related Subsidiaries

Annual Report on Counterdrug Intelligence Matters

Pub. L. 107–306, title VIII, §826, Nov. 27, 2002, 116 Stat. 2429, which required the Counterdrug Intelligence Coordinating Group to submit to certain committees of Congress an annual report on counterdrug intelligence matters, was repealed by Pub. L. 111–259, title III, §347(g), Oct. 7, 2010, 124 Stat. 2699.

Combating Amphetamine and Methamphetamine Manufacturing and Trafficking

Pub. L. 106–310, div. B, title XXXVI, §3625, Oct. 17, 2000, 114 Stat. 1233, provided that:

"(a) Activities.—In order to combat the illegal manufacturing and trafficking in amphetamine and methamphetamine, the Administrator of the Drug Enforcement Administration may—

"(1) assist State and local law enforcement in small and mid-sized communities in all phases of investigations related to such manufacturing and trafficking, including assistance with foreign-language interpretation;

"(2) staff additional regional enforcement and mobile enforcement teams related to such manufacturing and trafficking;

"(3) establish additional resident offices and posts of duty to assist State and local law enforcement in rural areas in combating such manufacturing and trafficking;

"(4) provide the Special Operations Division of the Administration with additional agents and staff to collect, evaluate, interpret, and disseminate critical intelligence targeting the command and control operations of major amphetamine and methamphetamine manufacturing and trafficking organizations;

"(5) enhance the investigative and related functions of the Chemical Control Program of the Administration to implement more fully the provisions of the Comprehensive Methamphetamine Control Act of 1996 (Public Law 104–237) [see Short Title of 1996 Amendments note set out under section 801 of this title];

"(6) design an effective means of requiring an accurate accounting of the import and export of list I chemicals, and coordinate investigations relating to the diversion of such chemicals;

"(7) develop a computer infrastructure sufficient to receive, process, analyze, and redistribute time-sensitive enforcement information from suspicious order reporting to field offices of the Administration and other law enforcement and regulatory agencies, including the continuing development of the Suspicious Order Reporting and Tracking System (SORTS) and the Chemical Transaction Database (CTRANS) of the Administration;

"(8) establish an education, training, and communication process in order to alert the industry to current trends and emerging patterns in the illegal manufacturing of amphetamine and methamphetamine; and

"(9) carry out such other activities as the Administrator considers appropriate.

"(b) Additional Positions and Personnel.—

"(1) In general.—In carrying out activities under subsection (a), the Administrator may establish in the Administration not more than 50 full-time positions, including not more than 31 special-agent positions, and may appoint personnel to such positions.

"(2) Particular positions.—In carrying out activities under paragraphs (5) through (8) of subsection (a), the Administrator may establish in the Administration not more than 15 full-time positions, including not more than 10 diversion investigator positions, and may appoint personnel to such positions. Any positions established under this paragraph are in addition to any positions established under paragraph (1).

"(c) Authorization of Appropriations.—There are authorized to be appropriated for the Drug Enforcement Administration for each fiscal year after fiscal year 1999, $9,500,000 for purposes of carrying out the activities authorized by subsection (a) and employing personnel in positions established under subsection (b), of which $3,000,000 shall be available for activities under paragraphs (5) through (8) of subsection (a) and for employing personnel in positions established under subsection (b)(2)."

National Drug Intelligence Center

Pub. L. 108–487, title I, §104(e), Dec. 23, 2004, 118 Stat. 3942, provided that:

"(1) In general.—Of the amount authorized to be appropriated in subsection (a) [118 Stat. 3941], $42,322,000 shall be available for the National Drug Intelligence Center. Within such amount, funds provided for research, development, testing, and evaluation purposes shall remain available until September 30, 2006, and funds provided for procurement purposes shall remain available until September 30, 2007.

"(2) Transfer of funds.—The Director of National Intelligence shall transfer to the Attorney General funds available for the National Drug Intelligence Center under paragraph (1). The Attorney General shall utilize funds so transferred for the activities of the National Drug Intelligence Center.

"(3) Limitation.—Amounts available for the National Drug Intelligence Center may not be used in contravention of the provisions of section 103(d)(1) of the National Security Act of 1947 (50 U.S.C. 403–3(d)(1)) [now 50 U.S.C. 3025(d)(1)].

"(4) Authority.—Notwithstanding any other provision of law, the Attorney General shall retain full authority over the operations of the National Drug Intelligence Center."

Similar provisions were contained in the following prior authorization acts:

Pub. L. 108–177, title I, §104(e), Dec. 13, 2003, 117 Stat. 2602.

Pub. L. 107–306, title I, §104(e), Nov. 27, 2002, 116 Stat. 2387.

Pub. L. 107–108, title I, §104(e), Dec. 28, 2001, 115 Stat. 1396.

Pub. L. 106–567, title I, §104(e), Dec. 27, 2000, 114 Stat. 2834.

Pub. L. 106–120, title I, §104(e), Dec. 3, 1999, 113 Stat. 1609.

Pub. L. 105–272, title I, §104(e), Oct. 20, 1998, 112 Stat. 2398.

Pub. L. 105–107, title I, §104(e), Nov. 20, 1997, 111 Stat. 2250.

Pub. L. 104–293, title I, §104(d), Oct. 11, 1996, 110 Stat. 3464.

Pub. L. 103–139, title VIII, §8056, Nov. 11, 1993, 107 Stat. 1452, provided that: "During the current fiscal year and thereafter, there is established, under the direction and control of the Attorney General, the National Drug Intelligence Center, whose mission it shall be to coordinate and consolidate drug intelligence from all national security and law enforcement agencies, and produce information regarding the structure, membership, finances, communications, and activities of drug trafficking organizations: Provided, That funding for the operation of the National Drug Intelligence Center, including personnel costs associated therewith, shall be provided from the funds appropriated to the Department of Defense."

Similar provisions were contained in the following prior appropriation act:

Pub. L. 102–396, title IX, §9078, Oct. 6, 1992, 106 Stat. 1919.

¹ See References in Text note below.

§874. Advisory committees

The Attorney General may from time to time appoint committees to advise him with respect to preventing and controlling the abuse of controlled substances. Members of the committees may be entitled to receive compensation at the rate of $100 for each day (including traveltime) during which they are engaged in the actual performance of duties. While traveling on official business in the performance of duties for the committees, members of the committees shall be allowed expenses of travel, including per diem instead of subsistence, in accordance with subchapter I of chapter 57 of title 5.

(Pub. L. 91–513, title II, §504, Oct. 27, 1970, 84 Stat. 1272.)

Statutory Notes and Related Subsidiaries

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

§875. Administrative hearings

(a) Power of Attorney General

In carrying out his functions under this subchapter, the Attorney General may hold hearings, sign and issue subpenas, administer oaths, examine witnesses, and receive evidence at any place in the United States.

(b) Procedures applicable

Except as otherwise provided in this subchapter, notice shall be given and hearings shall be conducted under appropriate procedures of subchapter II of chapter 5 of title 5.

(Pub. L. 91–513, title II, §505, Oct. 27, 1970, 84 Stat. 1272.)

§876. Subpenas

(a) Authorization of use by Attorney General

In any investigation relating to his functions under this subchapter with respect to controlled substances, listed chemicals, tableting machines, or encapsulating machines, the Attorney General may subpena witnesses, compel the attendance and testimony of witnesses, and require the production of any records (including books, papers, documents, and other tangible things which constitute or contain evidence) which the Attorney General finds relevant or material to the investigation. The attendance of witnesses and the production of records may be required from any place in any State or in any territory or other place subject to the jurisdiction of the United States at any designated place of hearing; except that a witness shall not be required to appear at any hearing more than 500 miles distant from the place where he was served with a subpena. Witnesses summoned under this section shall be paid the same fees and mileage that are paid witnesses in the courts of the United States.

(b) Service

A subpena issued under this section may be served by any person designated in the subpena to serve it. Service upon a natural person may be made by personal delivery of the subpena to him. Service may be made upon a domestic or foreign corporation or upon a partnership or other unincorporated association which is subject to suit under a common name, by delivering the subpena to an officer, to a managing or general agent, or to any other agent authorized by appointment or by law to receive service of process. The affidavit of the person serving the subpena entered on a true copy thereof by the person serving it shall be proof of service.

(c) Enforcement

In the case of contumacy by or refusal to obey a subpena issued to any person, the Attorney General may invoke the aid of any court of the United States within the jurisdiction of which the investigation is carried on or of which the subpenaed person is an inhabitant, or in which he carries on business or may be found, to compel compliance with the subpena. The court may issue an order requiring the subpenaed person to appear before the Attorney General to produce records, if so ordered, or to give testimony touching the matter under investigation. Any failure to obey the order of the court may be punished by the court as a contempt thereof. All process in any such case may be served in any judicial district in which such person may be found.

(Pub. L. 91–513, title II, §506, Oct. 27, 1970, 84 Stat. 1272; Pub. L. 100–690, title VI, §6058, Nov. 18, 1988, 102 Stat. 4319.)

Editorial Notes

Amendments

1988—Subsec. (a). Pub. L. 100–690 inserted "listed chemicals, tableting machines, or encapsulating machines," after "with respect to controlled substances,".

Statutory Notes and Related Subsidiaries

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

§877. Judicial review

All final determinations, findings, and conclusions of the Attorney General under this subchapter shall be final and conclusive decisions of the matters involved, except that any person aggrieved by a final decision of the Attorney General may obtain review of the decision in the United States Court of Appeals for the District of Columbia or for the circuit in which his principal place of business is located upon petition filed with the court and delivered to the Attorney General within thirty days after notice of the decision. Findings of fact by the Attorney General, if supported by substantial evidence, shall be conclusive.

(Pub. L. 91–513, title II, §507, Oct. 27, 1970, 84 Stat. 1273.)

§878. Powers of enforcement personnel

(a) Any officer or employee of the Drug Enforcement Administration or any State, tribal, or local law enforcement officer designated by the Attorney General may—

(1) carry firearms;

(2) execute and serve search warrants, arrest warrants, administrative inspection warrants, subpenas, and summonses issued under the authority of the United States;

(3) make arrests without warrant (A) for any offense against the United States committed in his presence, or (B) for any felony, cognizable under the laws of the United States, if he has probable cause to believe that the person to be arrested has committed or is committing a felony;

(4) make seizures of property pursuant to the provisions of this subchapter; and

(5) perform such other law enforcement duties as the Attorney General may designate.

(b) State and local law enforcement officers performing functions under this section shall not be deemed Federal employees and shall not be subject to provisions of law relating to Federal employees, except that such officers shall be subject to section 3374(c) of title 5.

(Pub. L. 91–513, title II, §508, Oct. 27, 1970, 84 Stat. 1273; Pub. L. 96–132, §16(b), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 99–570, title I, §1869, Oct. 27, 1986, 100 Stat. 3207–55; Pub. L. 99–646, §86, Nov. 10, 1986, 100 Stat. 3620; Pub. L. 111–211, title II, §232(d), July 29, 2010, 124 Stat. 2278.)

Editorial Notes

Amendments

2010—Subsec. (a). Pub. L. 111–211 inserted ", tribal," after "State" in introductory provisions.

1986—Pub. L. 99–570 and Pub. L. 99–646 amended section substantially identically designating existing provisions as subsec. (a) and adding subsec. (b), with the exception of the amendment of subsec. (a) for which Pub. L. 99–570 directed the insertion of "or (with respect to offenses under this subchapter or subchapter II of this chapter) any State or local law enforcement officer" and Pub. L. 99–646 directed the insertion of "or any State or local law enforcement officer", the latter of which was executed to reflect the probable intent of Congress.

1979—Pub. L. 96–132 substituted "Drug Enforcement Administration" for "Bureau of Narcotics and Dangerous Drugs".

§879. Search warrants

A search warrant relating to offenses involving controlled substances may be served at any time of the day or night if the judge or United States magistrate judge issuing the warrant is satisfied that there is probable cause to believe that grounds exist for the warrant and for its service at such time.

(Pub. L. 91–513, title II, §509, Oct. 27, 1970, 84 Stat. 1274; Pub. L. 93–481, §3, Oct. 26, 1974, 88 Stat. 1455; Pub. L. 101–650, title III, §321, Dec. 1, 1990, 104 Stat. 5117.)

Editorial Notes

Amendments

1974—Pub. L. 93–481 struck out designation "(a)" before "A search warrant", and struck out subsec. (b) which permitted officers authorized to execute search warrants to break open and enter premises under certain circumstances and which required that such officers identify themselves and give reasons and authority for their entry after such entry.

Statutory Notes and Related Subsidiaries

Change of Name

"United States magistrate judge" substituted in text for "United States magistrate" pursuant to section 321 of Pub. L. 101–650, set out as a note under section 631 of Title 28, Judiciary and Judicial Procedure.

§880. Administrative inspections and warrants

(a) "Controlled premises" defined

As used in this section, the term "controlled premises" means—

(1) places where original or other records or documents required under this subchapter are kept or required to be kept, and

(2) places, including factories, warehouses, and other establishments, and conveyances, where persons registered under section 823 of this title (or exempt from registration under section 822(d) of this title or by regulation of the Attorney General) or regulated persons may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances or listed chemicals or where records relating to those activities are maintained.

(b) Grant of authority; scope of inspections

(1) For the purpose of inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under this subchapter and otherwise facilitating the carrying out of his functions under this subchapter, the Attorney General is authorized, in accordance with this section, to enter controlled premises and to conduct administrative inspections thereof, and of the things specified in this section, relevant to those functions.

(2) Such entries and inspections shall be carried out through officers or employees (hereinafter referred to as "inspectors") designated by the Attorney General. Any such inspector, upon stating his purpose and presenting to the owner, operator, or agent in charge of such premises (A) appropriate credentials and (B) a written notice of his inspection authority (which notice in the case of an inspection requiring, or in fact supported by, an administrative inspection warrant shall consist of such warrant), shall have the right to enter such premises and conduct such inspection at reasonable times.

(3) Except as may otherwise be indicated in an applicable inspection warrant, the inspector shall have the right—

(A) to inspect and copy records, reports, and other documents required to be kept or made under this subchapter;

(B) to inspect, within reasonable limits and in a reasonable manner, controlled premises and all pertinent equipment, finished and unfinished drugs, listed chemicals, and other substances or materials, containers, and labeling found therein, and, except as provided in paragraph (4) of this subsection, all other things therein (including records, files, papers, processes, controls, and facilities) appropriate for verification of the records, reports, and documents referred to in clause (A) or otherwise bearing on the provisions of this subchapter; and

(C) to inventory any stock of any controlled substance or listed chemical therein and obtain samples of any such substance or chemical.

(4) Except when the owner, operator, or agent in charge of the controlled premises so consents in writing, no inspection authorized by this section shall extend to—

(A) financial data;

(B) sales data other than shipment data; or

(C) pricing data.

(c) Situations not requiring warrants

A warrant under this section shall not be required for the inspection of books and records pursuant to an administrative subpena issued in accordance with section 876 of this title, nor for entries and administrative inspections (including seizures of property)—

(1) with the consent of the owner, operator, or agent in charge of the controlled premises;

(2) in situations presenting imminent danger to health or safety;

(3) in situations involving inspection of conveyances where there is reasonable cause to believe that the mobility of the conveyance makes it impracticable to obtain a warrant;

(4) in any other exceptional or emergency circumstance where time or opportunity to apply for a warrant is lacking; or

(5) in any other situations where a warrant is not constitutionally required.

(d) Administrative inspection warrants; issuance; execution; probable cause

Issuance and execution of administrative inspection warrants shall be as follows:

(1) Any judge of the United States or of a State court of record, or any United States magistrate judge, may, within his territorial jurisdiction, and upon proper oath or affirmation showing probable cause, issue warrants for the purpose of conducting administrative inspections authorized by this subchapter or regulations thereunder, and seizures of property appropriate to such inspections. For the purposes of this section, the term "probable cause" means a valid public interest in the effective enforcement of this subchapter or regulations thereunder sufficient to justify administrative inspections of the area, premises, building, or conveyance, or contents thereof, in the circumstances specified in the application for the warrant.

(2) A warrant shall issue only upon an affidavit of an officer or employee having knowledge of the facts alleged, sworn to before the judge or magistrate judge and establishing the grounds for issuing the warrant. If the judge or magistrate judge is satisfied that grounds for the application exist or that there is probable cause to believe they exist, he shall issue a warrant identifying the area, premises, building, or conveyance to be inspected, the purpose of such inspection, and, where appropriate, the type of property to be inspected, if any. The warrant shall identify the items or types of property to be seized, if any. The warrant shall be directed to a person authorized under subsection (b)(2) to execute it. The warrant shall state the grounds for its issuance and the name of the person or persons whose affidavit has been taken in support thereof. It shall command the person to whom it is directed to inspect the area, premises, building, or conveyance identified for the purpose specified, and, where appropriate, shall direct the seizure of the property specified. The warrant shall direct that it be served during normal business hours. It shall designate the judge or magistrate judge to whom it shall be returned.

(3) A warrant issued pursuant to this section must be executed and returned within ten days of its date unless, upon a showing by the United States of a need therefor, the judge or magistrate judge allows additional time in the warrant. If property is seized pursuant to a warrant, the person executing the warrant shall give to the person from whom or from whose premises the property was taken a copy of the warrant and a receipt for the property taken or shall leave the copy and receipt at the place from which the property was taken. The return of the warrant shall be made promptly and shall be accompanied by a written inventory of any property taken. The inventory shall be made in the presence of the person executing the warrant and of the person from whose possession or premises the property was taken, if they are present, or in the presence of at least one credible person other than the person making such inventory, and shall be verified by the person executing the warrant. The judge or magistrate judge, upon request, shall deliver a copy of the inventory to the person from whom or from whose premises the property was taken and to the applicant for the warrant.

(4) The judge or magistrate judge who has issued a warrant under this section shall attach to the warrant a copy of the return and all papers filed in connection therewith and shall file them with the clerk of the district court of the United States for the judicial district in which the inspection was made.

(Pub. L. 91–513, title II, §510, Oct. 27, 1970, 84 Stat. 1274; Pub. L. 101–647, title XXXV, §3599M, Nov. 29, 1990, 104 Stat. 4932; Pub. L. 101–650, title III, §321, Dec. 1, 1990, 104 Stat. 5117; Pub. L. 103–200, §6, Dec. 17, 1993, 107 Stat. 2339.)

Editorial Notes

Amendments

1993—Subsec. (a)(2). Pub. L. 103–200, §6(1), amended par. (2) generally. Prior to amendment, par. (2) read as follows: "places, including factories, warehouses, or other establishments, and conveyances, where persons registered under section 823 of this title (or exempted from registration under section 822(d) of this title) may lawfully hold, manufacture, or distribute, dispense, administer, or otherwise dispose of controlled substances."

Subsec. (b)(3)(B). Pub. L. 103–200, §6(2)(A), inserted ", listed chemicals," after "unfinished drugs".

Subsec. (b)(3)(C). Pub. L. 103–200, §6(2)(B), inserted "or listed chemical" after "controlled substance" and "or chemical" after "such substance".

1990—Subsec. (b)(3)(B). Pub. L. 101–647 substituted "paragraph (4)" for "paragraph (5)".

Statutory Notes and Related Subsidiaries

Change of Name

"United States magistrate judge" and "magistrate judge" substituted for "United States magistrate" and "magistrate", respectively, wherever appearing in subsec. (d) pursuant to section 321 of Pub. L. 101–650, set out as a note under section 631 of Title 28, Judiciary and Judicial Procedure.

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

§881. Forfeitures

(a) Subject property

The following shall be subject to forfeiture to the United States and no property right shall exist in them:

(1) All controlled substances which have been manufactured, distributed, dispensed, or acquired in violation of this subchapter.

(2) All raw materials, products, and equipment of any kind which are used, or intended for use, in manufacturing, compounding, processing, delivering, importing, or exporting any controlled substance or listed chemical in violation of this subchapter.

(3) All property which is used, or intended for use, as a container for property described in paragraph (1), (2), or (9).

(4) All conveyances, including aircraft, vehicles, or vessels, which are used, or are intended for use, to transport, or in any manner to facilitate the transportation, sale, receipt, possession, or concealment of property described in paragraph (1), (2), or (9).

(5) All books, records, and research, including formulas, microfilm, tapes, and data which are used, or intended for use, in violation of this subchapter.

(6) All moneys, negotiable instruments, securities, or other things of value furnished or intended to be furnished by any person in exchange for a controlled substance or listed chemical in violation of this subchapter, all proceeds traceable to such an exchange, and all moneys, negotiable instruments, and securities used or intended to be used to facilitate any violation of this subchapter.

(7) All real property, including any right, title, and interest (including any leasehold interest) in the whole of any lot or tract of land and any appurtenances or improvements, which is used, or intended to be used, in any manner or part, to commit, or to facilitate the commission of, a violation of this subchapter punishable by more than one year's imprisonment.

(8) All controlled substances which have been possessed in violation of this subchapter.

(9) All listed chemicals, all drug manufacturing equipment, all tableting machines, all encapsulating machines, and all gelatin capsules, which have been imported, exported, manufactured, possessed, distributed, dispensed, acquired, or intended to be distributed, dispensed, acquired, imported, or exported, in violation of this subchapter or subchapter II.

(10) Any drug paraphernalia (as defined in section 863 of this title).

(11) Any firearm (as defined in section 921 of title 18) used or intended to be used to facilitate the transportation, sale, receipt, possession, or concealment of property described in paragraph (1) or (2) and any proceeds traceable to such property.

(b) Seizure procedures

Any property subject to forfeiture to the United States under this section may be seized by the Attorney General in the manner set forth in section 981(b) of title 18.

(c) Custody of Attorney General

Property taken or detained under this section shall not be repleviable, but shall be deemed to be in the custody of the Attorney General, subject only to the orders and decrees of the court or the official having jurisdiction thereof. Whenever property is seized under any of the provisions of this subchapter, the Attorney General may—

(1) place the property under seal;

(2) remove the property to a place designated by him; or

(3) require that the General Services Administration take custody of the property and remove it, if practicable, to an appropriate location for disposition in accordance with law.

(d) Other laws and proceedings applicable

The provisions of law relating to the seizure, summary and judicial forfeiture, and condemnation of property for violation of the customs laws; the disposition of such property or the proceeds from the sale thereof; the remission or mitigation of such forfeitures; and the compromise of claims shall apply to seizures and forfeitures incurred, or alleged to have been incurred, under any of the provisions of this subchapter, insofar as applicable and not inconsistent with the provisions hereof; except that such duties as are imposed upon the customs officer or any other person with respect to the seizure and forfeiture of property under the customs laws shall be performed with respect to seizures and forfeitures of property under this subchapter by such officers, agents, or other persons as may be authorized or designated for that purpose by the Attorney General, except to the extent that such duties arise from seizures and forfeitures effected by any customs officer.

(e) Disposition of forfeited property

(1) Whenever property is civilly or criminally forfeited under this subchapter the Attorney General may—

(A) retain the property for official use or, in the manner provided with respect to transfers under section 1616a of title 19, transfer the property to any Federal agency or to any State or local law enforcement agency which participated directly in the seizure or forfeiture of the property;

(B) except as provided in paragraph (4), sell, by public sale or any other commercially feasible means, any forfeited property which is not required to be destroyed by law and which is not harmful to the public;

(C) require that the General Services Administration take custody of the property and dispose of it in accordance with law;

(D) forward it to the Bureau of Narcotics and Dangerous Drugs for disposition (including delivery for medical or scientific use to any Federal or State agency under regulations of the Attorney General); or

(E) transfer the forfeited personal property or the proceeds of the sale of any forfeited personal or real property to any foreign country which participated directly or indirectly in the seizure or forfeiture of the property, if such a transfer—

(i) has been agreed to by the Secretary of State;

(ii) is authorized in an international agreement between the United States and the foreign country; and

(iii) is made to a country which, if applicable, has been certified under section 2291j(b) of title 22.

(2)(A) The proceeds from any sale under subparagraph (B) of paragraph (1) and any moneys forfeited under this subchapter shall be used to pay—

(i) all property expenses of the proceedings for forfeiture and sale including expenses of seizure, maintenance of custody, advertising, and court costs; and

(ii) awards of up to $100,000 to any individual who provides original information which leads to the arrest and conviction of a person who kills or kidnaps a Federal drug law enforcement agent.

Any award paid for information concerning the killing or kidnapping of a Federal drug law enforcement agent, as provided in clause (ii), shall be paid at the discretion of the Attorney General.

(B) The Attorney General shall forward to the Treasurer of the United States for deposit in accordance with section 524(c) of title 28, any amounts of such moneys and proceeds remaining after payment of the expenses provided in subparagraph (A), except that, with respect to forfeitures conducted by the Postal Service, the Postal Service shall deposit in the Postal Service Fund, under section 2003(b)(7) of title 39, such moneys and proceeds.

(3) The Attorney General shall assure that any property transferred to a State or local law enforcement agency under paragraph (1)(A)—

(A) has a value that bears a reasonable relationship to the degree of direct participation of the State or local agency in the law enforcement effort resulting in the forfeiture, taking into account the total value of all property forfeited and the total law enforcement effort with respect to the violation of law on which the forfeiture is based; and

(B) will serve to encourage further cooperation between the recipient State or local agency and Federal law enforcement agencies.

(4)(A) With respect to real property described in subparagraph (B), if the chief executive officer of the State involved submits to the Attorney General a request for purposes of such subparagraph, the authority established in such subparagraph is in lieu of the authority established in paragraph (1)(B).

(B) In the case of property described in paragraph (1)(B) that is civilly or criminally forfeited under this subchapter, if the property is real property that is appropriate for use as a public area reserved for recreational or historic purposes or for the preservation of natural conditions, the Attorney General, upon the request of the chief executive officer of the State in which the property is located, may transfer title to the property to the State, either without charge or for a nominal charge, through a legal instrument providing that—

(i) such use will be the principal use of the property; and

(ii) title to the property reverts to the United States in the event that the property is used otherwise.

(f) Forfeiture and destruction of schedule I and II substances

(1) All controlled substances in schedule I or II that are possessed, transferred, sold, or offered for sale in violation of the provisions of this subchapter; all dangerous, toxic, or hazardous raw materials or products subject to forfeiture under subsection (a)(2) of this section; and any equipment or container subject to forfeiture under subsection (a)(2) or (3) which cannot be separated safely from such raw materials or products shall be deemed contraband and seized and summarily forfeited to the United States. Similarly, all substances in schedule I or II, which are seized or come into the possession of the United States, the owners of which are unknown, shall be deemed contraband and summarily forfeited to the United States.

(2) The Attorney General may direct the destruction of all controlled substances in schedule I or II seized for violation of this subchapter; all dangerous, toxic, or hazardous raw materials or products subject to forfeiture under subsection (a)(2) of this section; and any equipment or container subject to forfeiture under subsection (a)(2) or (3) which cannot be separated safely from such raw materials or products under such circumstances as the Attorney General may deem necessary.

(g) Plants

(1) All species of plants from which controlled substances in schedules I and II may be derived which have been planted or cultivated in violation of this subchapter, or of which the owners or cultivators are unknown, or which are wild growths, may be seized and summarily forfeited to the United States.

(2) The failure, upon demand by the Attorney General or his duly authorized agent, of the person in occupancy or in control of land or premises upon which such species of plants are growing or being stored, to produce an appropriate registration, or proof that he is the holder thereof, shall constitute authority for the seizure and forfeiture.

(3) The Attorney General, or his duly authorized agent, shall have authority to enter upon any lands, or into any dwelling pursuant to a search warrant, to cut, harvest, carry off, or destroy such plants.

(h) Vesting of title in United States

All right, title, and interest in property described in subsection (a) shall vest in the United States upon commission of the act giving rise to forfeiture under this section.

(i) Stay of civil forfeiture proceedings

The provisions of section 981(g) of title 18 regarding the stay of a civil forfeiture proceeding shall apply to forfeitures under this section.

(j) Venue

In addition to the venue provided for in section 1395 of title 28 or any other provision of law, in the case of property of a defendant charged with a violation that is the basis for forfeiture of the property under this section, a proceeding for forfeiture under this section may be brought in the judicial district in which the defendant owning such property is found or in the judicial district in which the criminal prosecution is brought.

(l) ¹ Agreement between Attorney General and Postal Service for performance of functions

The functions of the Attorney General under this section shall be carried out by the Postal Service pursuant to such agreement as may be entered into between the Attorney General and the Postal Service.

(Pub. L. 91–513, title II, §511, Oct. 27, 1970, 84 Stat. 1276; Pub. L. 95–633, title III, §301(a), Nov. 10, 1978, 92 Stat. 3777; Pub. L. 96–132, §14, Nov. 30, 1979, 93 Stat. 1048; Pub. L. 98–473, title II, §§306, 309, 518, Oct. 12, 1984, 98 Stat. 2050, 2051, 2075; Pub. L. 99–570, title I, §§1006(c), 1865, 1992, Oct. 27, 1986, 100 Stat. 3207–7, 3207-54, 3207-59; Pub. L. 99–646, §74, Nov. 10, 1986, 100 Stat. 3618; Pub. L. 100–690, title V, §5105, title VI, §§6059, 6074, 6075, 6077(a), (b), 6253, Nov. 18, 1988, 102 Stat. 4301, 4319, 4323-4325, 4363; Pub. L. 101–189, div. A, title XII, §1215(a), Nov. 29, 1989, 103 Stat. 1569; Pub. L. 101–647, title XX, §§2003, 2004, 2007, 2008, Nov. 29, 1990, 104 Stat. 4855, 4856; Pub. L. 102–239, §2, Dec. 17, 1991, 105 Stat. 1912; Pub. L. 103–447, title I, §102(d), Nov. 2, 1994, 108 Stat. 4693; Pub. L. 104–237, title II, §201(b), Oct. 3, 1996, 110 Stat. 3101; Pub. L. 106–185, §§2(c)(2), 5(b), 8(b), Apr. 25, 2000, 114 Stat. 210, 214, 216; Pub. L. 107–273, div. B, title IV, §4002(e)(3), Nov. 2, 2002, 116 Stat. 1810.)

Editorial Notes

References in Text

Subchapter II, referred to in subsec. (a)(9), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Schedules I and II, referred to in subsecs. (f) and (g), are set out in section 812(c) of this title.

Amendments

2002—Subsec. (a)(10). Pub. L. 107–273 substituted "section 863 of this title" for "section 1822 of the Mail Order Drug Paraphernalia Control Act".

2000—Subsec. (a)(4). Pub. L. 106–185, §2(c)(2), struck out before period at end ", except that—

"(A) no conveyance used by any person as a common carrier in the transaction of business as a common carrier shall be forfeited under the provisions of this section unless it shall appear that the owner or other person in charge of such conveyance was a consenting party or privy to a violation of this subchapter or subchapter II of this chapter;

"(B) no conveyance shall be forfeited under the provisions of this section by reason of any act or omission established by the owner thereof to have been committed or omitted by any person other than such owner while such conveyance was unlawfully in the possession of a person other than the owner in violation of the criminal laws of the United States, or of any State; and

"(C) no conveyance shall be forfeited under this paragraph to the extent of an interest of an owner, by reason of any act or omission established by that owner to have been committed or omitted without the knowledge, consent, or willful blindness of the owner".

Subsec. (a)(6). Pub. L. 106–185, §2(c)(2), struck out before period at end ", except that no property shall be forfeited under this paragraph, to the extent of the interest of an owner, by reason of any act or omission established by that owner to have been committed or omitted without the knowledge or consent of that owner".

Subsec. (a)(7). Pub. L. 106–185, §2(c)(2), struck out before period at end ", except that no property shall be forfeited under this paragraph, to the extent of an interest of an owner, by reason of any act or omission established by that owner to have been committed or omitted without the knowledge or consent of that owner".

Subsec. (b). Pub. L. 106–185, §5(b), inserted heading and amended text of subsec. (b) generally. Prior to amendment, subsec. (b) authorized the Attorney General to seize property under this subchapter upon process issued pursuant to the Supplemental Rules for Certain Admirality and Maritime claims and to seize it without process in certain described circumstances.

Subsec. (i). Pub. L. 106–185, §8(b), inserted heading and amended text of subsec. (i) generally. Prior to amendment, text read as follows: "The filing of an indictment or information alleging a violation of this subchapter or subchapter II of this chapter, or a violation of State or local law that could have been charged under this subchapter or subchapter II of this chapter, which is also related to a civil forfeiture proceeding under this section shall, upon motion of the United States and for good cause shown, stay the civil forfeiture proceeding."

1996—Subsec. (a)(2), (6). Pub. L. 104–237, §201(b)(1), inserted "or listed chemical" after "controlled substance".

Subsec. (a)(9). Pub. L. 104–237, §201(b)(2), substituted "possessed, distributed, dispensed, acquired, or intended to be distributed, dispensed, acquired," for "possessed, distributed, or intended to be distributed," and struck out "a felony provision of" after "in violation of".

1994—Subsec. (e)(1)(E)(iii). Pub. L. 103–447 substituted "section 2291j(b) of title 22" for "section 2291(h) of title 22".

1991—Subsec. (e)(1)(B). Pub. L. 102–239, §2(1), substituted "except as provided in paragraph (4), sell" for "sell".

Subsec. (e)(4). Pub. L. 102–239, §2(2), added par. (4).

1990—Subsec. (a)(10). Pub. L. 101–647, §2007, added par. (10).

Subsec. (a)(11). Pub. L. 101–647, §2008, added par. (11).

Subsec. (e)(1)(B). Pub. L. 101–647, §2003, inserted ", by public sale or any other commercially feasible means," after "sell".

Subsec. (f). Pub. L. 101–647, §2004, inserted "; all dangerous, toxic, or hazardous raw materials or products subject to forfeiture under subsection (a)(2) of this section; and any equipment or container subject to forfeiture under subsection (a)(2) or (3) which cannot be separated safely from such raw materials or products" after "this subchapter" in pars. (1) and (2).

1989—Subsec. (e)(3)(B). Pub. L. 101–189 amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "is not so transferred to circumvent any requirement of State law that prohibits forfeiture or limits use or disposition of property forfeited to State or local agencies."

1988—Subsec. (a)(3). Pub. L. 100–690, §6059(b), inserted reference to par. (9).

Subsec. (a)(4). Pub. L. 100–690, §§6059(b), 6075, inserted in introductory provisions reference to par. (9) and added subpar. (C).

Subsec. (a)(7). Pub. L. 100–690, §5105, inserted "(including any leasehold interest)" after "interest".

Subsec. (a)(9). Pub. L. 100–690, §6059(a), added par. (9).

Subsec. (e)(1)(A). Pub. L. 100–690, §6077(b), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "retain the property for official use or transfer the custody or ownership of any forfeited property to any Federal, State, or local agency pursuant to section 1616a of title 19;".

Subsec. (e)(1)(E). Pub. L. 100–690, §6074, added subpar. (E).

Subsec. (e)(2)(B). Pub. L. 100–690, §6253(b), provided for deposit of moneys and proceeds in Postal Service Fund in cases of forfeitures conducted by Postal Service.

Subsec. (e)(3). Pub. L. 100–690, §6077(a), added par. (3).

Subsec. (l). Pub. L. 100–690, §6253(a), added subsec. (l).

1986—Subsec. (b). Pub. L. 99–570, §1865(1)–(3), and Pub. L. 99–646, §74(1)–(3), in making identical amendments in introductory provision and par. (4), struck out "or criminal" after "subject to civil" and inserted paragraph permitting the Government to request issuance of a warrant authorizing seizure of property subject to forfeiture under this section in the same manner as provided for a search warrant under the Federal Rules of Criminal Procedure.

Subsec. (e). Pub. L. 99–570, §1992, designated existing provisions as par. (1) and former pars. (1) to (4) as subpars. (A) to (D), respectively, and added par. (2) in lieu of former concluding provisions which read as follows: "The Attorney General shall ensure the equitable transfer pursuant to paragraph (1) of any forfeited property to the appropriate State or local law enforcement agency so as to reflect generally the contribution of any such agency participating directly in any of the acts which led to the seizure or forfeiture of such property. A decision by the Attorney General pursuant to paragraph (1) shall not be subject to review. The proceeds from any sale under paragraph (2) and any moneys forfeited under this subchapter shall be used to pay all proper expenses of the proceedings for forfeiture and sale including expenses of seizure, maintenance of custody, advertising, and court costs. The Attorney General shall forward to the Treasurer of the United States for deposit in accordance with section 524(c) of title 28 any amounts of such moneys and proceeds remaining after payment of such expenses."

Subsec. (f). Pub. L. 99–570, §1006(c), which directed the amendment of section 511 of the "Comprehensive Drug Abuse Prevention Act of 1978" was executed to this section which is section 511 of the Comprehensive Drug Abuse Prevention Act of 1970, as the probable intent of Congress, by designating existing provisions as par. (1), inserting "or II" in two places, and adding par. (2).

Subsec. (i). Pub. L. 99–570, §1865(b) and Pub. L. 99–646, §74(b), made identical amendments, inserting ", or a violation of State or local law that could have been charged under this subchapter or subchapter II of this chapter,".

1984—Subsec. (a)(7). Pub. L. 98–473, §306(a), added par. (7).

Subsec. (a)(8). Pub. L. 98–473, §518, added par. (8).

Subsec. (b). Pub. L. 98–473, §306(b)(1), inserted "civil or criminal" after "property subject to".

Subsec. (b)(4). Pub. L. 98–473, §306(b)(2), substituted "is subject to civil or criminal forfeiture under" for "has been used or is intended to be used in violation of".

Subsec. (c). Pub. L. 98–473, §306(c)(1), in provisions preceding par. (1), inserted "any of" after "seized under".

Subsec. (c)(3). Pub. L. 98–473, §306(c)(2), inserted ", if practicable," after "remove it".

Subsec. (d). Pub. L. 98–473, §306(d), inserted "any of" after "incurred, under".

Subsec. (e). Pub. L. 98–473, §§306(e), 309, inserted "civilly or criminally" after "Whenever property is" and in provisions preceding par. (1), inserted provisions relating to transfer of custody or ownership of forfeited property in par. (1), substituted "and dispose of it" for "and remove it for disposition" in par. (3), and, in provisions following par. (4), inserted sentence requiring the Attorney General to ensure equitable transfer of any forfeited property, and substituted "accordance with section 524(c) of title 28" for "the general fund of the United States Treasury".

Subsecs. (h) to (j). Pub. L. 98–473, §306(f), added subsecs. (h) to (j).

1979—Subsec. (d). Pub. L. 96–132 substituted "The provisions" for "All provisions" and struck out "and the award of compensation to informers in respect of such forfeitures" after "compromise of claims".

1978—Subsec. (a)(6). Pub. L. 95–633, §301(1), added par. (6).

Subsec. (e). Pub. L. 95–633, §301(a)(2), (3), struck out of cl. (2) provisions relating to use of proceeds of sale and inserted last sentence relating to the forwarding by the Attorney General of money and proceeds remaining after payment of expenses.

Statutory Notes and Related Subsidiaries

Effective Date of 2000 Amendment

Amendment by Pub. L. 106–185 applicable to any forfeiture proceeding commenced on or after the date that is 120 days after Apr. 25, 2000, see section 21 of Pub. L. 106–185, set out as a note under section 1324 of Title 8, Aliens and Nationality.

Effective Date of 1989 Amendment

Pub. L. 101–189, div. A, title XII, §1215(b), Nov. 29, 1989, 103 Stat. 1569, provided that: "The amendment made by subsection (a) [amending this section] shall take effect as of October 1, 1989."

Effective Date of 1988 Amendment

Amendment by section 6059 of Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Pub. L. 100–690, title VI, §6077(c), Nov. 18, 1988, 102 Stat. 4325, as amended by Pub. L. 101–162, title II, §208, Nov. 21, 1989, 103 Stat. 1005, provided that: "Section 551(e)(3)(B) of the Controlled Substances Act [probably means section 511(e)(3)(B) of the Controlled Substances Act, 21 U.S.C. 881(e)(3)(B)], as enacted by subsection (a), shall apply with respect to fiscal years beginning after September 30, 1991."

Constructive Seizure Procedures

Pub. L. 101–225, title II, §210, Dec. 12, 1989, 103 Stat. 1913, provided that: "Not later than 6 months after the date of enactment of this Act [Dec. 12, 1989], the Secretary of Transportation and the Secretary of the Treasury, in order to avoid the devastating economic effects on innocent owners of seizures of their vessels, shall develop a procedure for constructive seizure of vessels of the United States engaged in commercial service as defined in section 2101 of title 46, United States Code, that are suspected of being used for committing violations of law involving personal use quantities of controlled substances."

Regulations for Expedited Administrative Forfeiture Procedures

Pub. L. 100–690, title VI, §6079, Nov. 18, 1988, 102 Stat. 4325, provided that:

"(a) In General.—Not later than 90 days after the date of enactment of this Act [Nov. 18, 1988], the Attorney General and the Secretary of the Treasury shall consult, and after providing a 30-day public comment period, shall prescribe regulations for expedited administrative procedures for seizures under section 511(a)(4), (6), and (7) of the Controlled Substances Act (21 U.S.C. 881(a)(4), (6), and (7)); section 596 of the Tariff Act of 1930 (19 U.S.C. 1595a(a)); and section 2 of the Act of August 9, 1939 (53 Stat. 1291; 49 U.S.C. App. 782 [now 49 U.S.C. 80303]) for violations involving the possession of personal use quantities of a controlled substance.

"(b) Specifications.—The regulations prescribed pursuant to subsection (a) shall—

"(1) minimize the adverse impact caused by prolonged detention, and

"(2) provide for a final administrative determination of the case within 21 days of seizure, or provide a procedure by which the defendant can obtain release of the property pending a final determination of the case. Such regulations shall provide that the appropriate agency official rendering a final determination shall immediately return the property if the following conditions are established:

"(A) the owner or interested party did not know of or consent to the violation;

"(B) the owner establishes a valid, good faith interest in the seized property as owner or otherwise; and

"(C)(1) the owner establishes that the owner at no time had any knowledge or reason to believe that the property in which the owner claims an interest was being or would be used in a violation of the law; and

"(2) if the owner at any time had, or should have had, knowledge or reason to believe that the property in which the owner claims an interest was being or would be used in a violation of the law, that the owner did what reasonably could be expected to prevent the violation.

An owner shall not have the seized property returned under this subsection if the owner had not acted in a normal and customary manner to ascertain how the property would be used.

"(c) Notice.—At the time of seizure or upon issuance of a summons to appear under subsection (d), the officer making the seizure shall furnish to any person in possession of the conveyance a written notice specifying the procedures under this section. At the earliest practicable opportunity after determining ownership of the seized conveyance, the head of the department or agency that seizes the conveyance shall furnish a written notice to the owner and other interested parties (including lienholders) of the legal and factual basis of the seizure.

"(d) Summons in Lieu of Seizure of Commercial Fishing Industry Vessels.—Not later than 90 days after the enactment of this Act [Nov. 18, 1988], the Attorney General, the Secretary of the Treasury, and the Secretary of Transportation shall prescribe joint regulations, after a public comment period of at least 30 days, providing for issuance of a summons to appear in lieu of seizure of a commercial fishing industry vessel as defined in section 2101(11a), (11b), and (11c) [now 2101(12), (13), and (14)] of title 46, United States Code, for violations involving the possession of personal use quantities of a controlled substance. These regulations shall apply when the violation is committed on a commercial fishing industry vessel that is proceeding to or from a fishing area or intermediate port of call, or is actively engaged in fishing operations. The authority provided under this section shall not affect existing authority to arrest an individual for drug-related offenses or to release that individual into the custody of the vessel's master. Upon answering a summons to appear, the procedures set forth in subsections (a), (b), and (c) of this section shall apply. The jurisdiction of the district court for any forfeiture incurred shall not be affected by the use of a summons under this section.

"(e) Personal Use Quantities of a Controlled Substance.—For the purposes of this section, personal use quantities of a controlled substance shall not include sweepings or other evidence of non-personal use amounts."

Executive Documents

Transfer of Functions

Bureau of Narcotics and Dangerous Drugs, including office of Director thereof, in Department of Justice abolished by Reorg. Plan No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, set out in the Appendix to Title 5, Government Organization and Employees. Reorg. Plan No. 2 of 1973 also created in Department of Justice a single, comprehensive agency for enforcement of drug laws to be known as Drug Enforcement Administration, empowered Attorney General to authorize performance by officers, employees, and agencies of Department of functions transferred to him, and directed Attorney General to coordinate all drug law enforcement functions to assure maximum cooperation between Drug Enforcement Administration, Federal Bureau of Investigation, and other units of Department of Justice involved in drug law enforcement.

¹ So in original. No subsec. (k) has been enacted.

§§881–1, 881a. Transferred

Editorial Notes

Codification

Section 881–1, Pub. L. 91–513, title II, §511A, as added Pub. L. 100–690, title VI, §6080(a), Nov. 18, 1988, 102 Stat. 4326, which related to expedited procedures for seized conveyances, was renumbered §518 of Pub. L. 91–513 by Pub. L. 101–647, title X, §1002(h)(1), Nov. 29, 1990, 104 Stat. 4828, transferred to section 888 of this title and subsequently repealed.

Section 881a, Pub. L. 99–198, title XVII, §1764, Dec. 23, 1985, 99 Stat. 1652, which related to production control of controlled substances, was renumbered section 519 of the Controlled Substances Act by Pub. L. 101–647, title X, §1002(h)(2), Nov. 29, 1990, 104 Stat. 4828, and is classified to section 889 of this title.

§882. Injunctions

(a) Jurisdiction

The district courts of the United States and all courts exercising general jurisdiction in the territories and possessions of the United States shall have jurisdiction in proceedings in accordance with the Federal Rules of Civil Procedure to enjoin violations of this subchapter.

(b) Jury trial

In case of an alleged violation of an injunction or restraining order issued under this section, trial shall, upon demand of the accused, be by a jury in accordance with the Federal Rules of Civil Procedure.

(c) State cause of action pertaining to online pharmacies

(1) In general

In any case in which the State has reason to believe that an interest of the residents of that State has been or is being threatened or adversely affected by the action of a person, entity, or Internet site that violates the provisions of section 823(g), 829(e), or 831 of this title, the State may bring a civil action on behalf of such residents in a district court of the United States with appropriate jurisdiction—

(A) to enjoin the conduct which violates this section;

(B) to enforce compliance with this section;

(C) to obtain damages, restitution, or other compensation, including civil penalties under section 842(b) of this title; and

(D) to obtain such other legal or equitable relief as the court may find appropriate.

(2) Service; intervention

(A) Prior to filing a complaint under paragraph (1), the State shall serve a copy of the complaint upon the Attorney General and upon the United States Attorney for the judicial district in which the complaint is to be filed. In any case where such prior service is not feasible, the State shall serve the complaint on the Attorney General and the appropriate United States Attorney on the same day that the State's complaint is filed in Federal district court of the United States. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or any other proceedings under this subchapter or any other laws of the United States.

(B) Upon receiving notice respecting a civil action pursuant to this section, the United States shall have the right to intervene in such action and, upon so intervening, to be heard on all matters arising therein, and to file petitions for appeal.

(C) Service of a State's complaint on the United States as required in this paragraph shall be made in accord with the requirements of rule 4(i)(1) of the Federal Rule ¹ of Civil Procedure.

(3) Powers conferred by State law

For purposes of bringing any civil action under paragraph (1), nothing in this chapter shall prevent an attorney general of a State from exercising the powers conferred on the attorney general of a State by the laws of such State to conduct investigations or to administer oaths or affirmations or to compel the attendance of witnesses of or the production of documentary or other evidence.

(4) Venue

Any civil action brought under paragraph (1) in a district court of the United States may be brought in the district in which the defendant is found, is an inhabitant, or transacts business or wherever venue is proper under section 1391 of title 28. Process in such action may be served in any district in which the defendant is an inhabitant or in which the defendant may be found.

(5) No private right of action

No private right of action is created under this subsection.

(6) Limitation

No civil action may be brought under paragraph (1) against—

(A) the United States;

(B) an Indian Tribe or tribal organization, to the extent such tribe or tribal organization is lawfully carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.]; or

(C) any employee of the United States or such Indian tribe or tribal organization, provided such agent or employee is acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee therewith.

(Pub. L. 91–513, title II, §512, Oct. 27, 1970, 84 Stat. 1278; Pub. L. 110–425, §3(h), Oct. 15, 2008, 122 Stat. 4830; Pub. L. 117–215, title I, §103(b)(1)(I), Dec. 2, 2022, 136 Stat. 2263.)

Editorial Notes

References in Text

The Federal Rules of Civil Procedure, referred to in subsecs. (a), (b), and (c)(2)(C), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

This subchapter, referred to in subsecs. (a) and (c)(2)(A), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

This chapter, referred to in subsec. (c)(3), was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Indian Self-Determination and Education Assistance Act, referred to in subsec. (c)(6)(B), is Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

Amendments

2022—Subsec. (c)(1). Pub. L. 117–215 substituted "823(g)" for "823(f)" in introductory provisions.

2008—Subsec. (c). Pub. L. 110–425 added subsec. (c).

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

¹ So in original. Probably should be "Rules".

§883. Enforcement proceedings

Before any violation of this subchapter is reported by the Administrator of the Drug Enforcement Administration to any United States attorney for institution of a criminal proceeding, the Administrator may require that the person against whom such proceeding is contemplated is given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding.

(Pub. L. 91–513, title II, §513, Oct. 27, 1970, 84 Stat. 1278; Pub. L. 96–132, §16(c), Nov. 30, 1979, 93 Stat. 1049.)

Editorial Notes

Amendments

1979—Pub. L. 96–132 substituted "Administrator of the Drug Enforcement Administration" for "Director of the Bureau of Narcotics and Dangerous Drugs" and "Administrator may" for "Director may".

§884. Immunity and privilege

(a) Refusal to testify

Whenever a witness refuses, on the basis of his privilege against self-incrimination, to testify or provide other information in a proceeding before a court or grand jury of the United States, involving a violation of this subchapter, and the person presiding over the proceeding communicates to the witness an order issued under this section, the witness may not refuse to comply with the order on the basis of his privilege against self-incrimination. But no testimony or other information compelled under the order issued under subsection (b) of this section or any information obtained by the exploitation of such testimony or other information, may be used against the witness in any criminal case, including any criminal case brought in a court of a State, except a prosecution for perjury, giving a false statement, or otherwise failing to comply with the order.

(b) Order of United States district court

In the case of any individual who has been or may be called to testify or provide other information at any proceeding before a court or grand jury of the United States, the United States district court for the judicial district in which the proceeding is or may be held shall issue, upon the request of the United States attorney for such district, an order requiring such individual to give any testimony or provide any other information which he refuses to give or provide on the basis of his privilege against self-incrimination.

(c) Request by United States attorney

A United States attorney may, with the approval of the Attorney General or the Deputy Attorney General, the Associate Attorney General, or any Assistant Attorney General designated by the Attorney General, request an order under subsection (b) when in his judgment—

(1) the testimony or other information from such individual may be necessary to the public interest; and

(2) such individual has refused or is likely to refuse to testify or provide other information on the basis of his privilege against self-incrimination.

(Pub. L. 91–513, title II, §514, Oct. 27, 1970, 84 Stat. 1278; Pub. L. 100–690, title VII, §7020(f), Nov. 18, 1988, 102 Stat. 4396.)

Editorial Notes

Amendments

1988—Subsec. (c). Pub. L. 100–690 inserted reference to Associate Attorney General.

§885. Burden of proof; liabilities

(a) Exemptions and exceptions; presumption in simple possession offenses

(1) It shall not be necessary for the United States to negative any exemption or exception set forth in this subchapter in any complaint, information, indictment, or other pleading or in any trial, hearing, or other proceeding under this subchapter, and the burden of going forward with the evidence with respect to any such exemption or exception shall be upon the person claiming its benefit.

(2) In the case of a person charged under section 844(a) of this title with the possession of a controlled substance, any label identifying such substance for purposes of section 353(b)(2) of this title shall be admissible in evidence and shall be prima facie evidence that such substance was obtained pursuant to a valid prescription from a practitioner while acting in the course of his professional practice.

(b) Registration and order forms

In the absence of proof that a person is the duly authorized holder of an appropriate registration or order form issued under this subchapter, he shall be presumed not to be the holder of such registration or form, and the burden of going forward with the evidence with respect to such registration or form shall be upon him.

(c) Use of vehicles, vessels, and aircraft

The burden of going forward with the evidence to establish that a vehicle, vessel, or aircraft used in connection with controlled substances in schedule I was used in accordance with the provisions of this subchapter shall be on the persons engaged in such use.

(d) Immunity of Federal, State, local and other officials

Except as provided in sections 2234 and 2235 of title 18, no civil or criminal liability shall be imposed by virtue of this subchapter upon any duly authorized Federal officer lawfully engaged in the enforcement of this subchapter, or upon any duly authorized officer of any State, territory, political subdivision thereof, the District of Columbia, or any possession of the United States, who shall be lawfully engaged in the enforcement of any law or municipal ordinance relating to controlled substances.

(Pub. L. 91–513, title II, §515, Oct. 27, 1970, 84 Stat. 1279.)

Editorial Notes

References in Text

Schedule I, referred to in subsec. (c), is set out in section 812(c) of this title.

§886. Payments and advances

(a) Payment to informers

The Attorney General is authorized to pay any person, from funds appropriated for the Drug Enforcement Administration, for information concerning a violation of this subchapter, such sum or sums of money as he may deem appropriate, without reference to any moieties or rewards to which such person may otherwise be entitled by law.

(b) Reimbursement for purchase of controlled substances

Moneys expended from appropriations of the Drug Enforcement Administration for purchase of controlled substances and subsequently recovered shall be reimbursed to the current appropriation for the Administration.¹

(c) Advance of funds for enforcement purposes

The Attorney General is authorized to direct the advance of funds by the Treasury Department in connection with the enforcement of this subchapter.

(d) Drug Pollution Fund

(1) There is established in the Treasury a trust fund to be known as the "Drug Pollution Fund" (hereinafter referred to in this subsection as the "Fund"), consisting of amounts appropriated or credited to such Fund under section 841(b)(6) of this title.

(2) There are hereby appropriated to the Fund amounts equivalent to the fines imposed under section 841(b)(6) of this title.

(3) Amounts in the Fund shall be available, as provided in appropriations Acts, for the purpose of making payments in accordance with paragraph (4) for the clean up of certain pollution resulting from the actions referred to in section 841(b)(6) of this title.

(4)(A) The Secretary of the Treasury, after consultation with the Attorney General, shall make payments under paragraph (3), in such amounts as the Secretary determines appropriate, to the heads of executive agencies or departments that meet the requirements of subparagraph (B).

(B) In order to receive a payment under paragraph (3), the head of an executive agency or department shall submit an application in such form and containing such information as the Secretary of the Treasury shall by regulation require. Such application shall contain a description of the fine imposed under section 841(b)(6) of this title, the circumstances surrounding the imposition of such fine, and the type and severity of pollution that resulted from the actions to which such fine applies.

(5) For purposes of subchapter B of chapter 98 of title 26, the Fund established under this paragraph shall be treated in the same manner as a trust fund established under subchapter A of such chapter.

(Pub. L. 91–513, title II, §516, Oct. 27, 1970, 84 Stat. 1279; Pub. L. 96–132, §16(b), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 100–690, title VI, §6254(i), Nov. 18, 1988, 102 Stat. 4367.)

Editorial Notes

Codification

In subsec. (b), "Administration" substituted for "Bureau" as the probable intent of Congress in view of amendment by Pub. L. 96–132, which substituted references to the Drug Enforcement Administration for references to the Bureau of Narcotics and Dangerous Drugs wherever appearing in text.

Amendments

1988—Subsec. (d). Pub. L. 100–690 added subsec. (d).

1979—Subsecs. (a), (b). Pub. L. 96–132 substituted "Drug Enforcement Administration" for "Bureau of Narcotics and Dangerous Drugs".

Statutory Notes and Related Subsidiaries

Reimbursement by Drug Enforcement Administration of Expenses Incurred To Remediate Methamphetamine Laboratories

Pub. L. 106–310, div. B, title XXXVI, §3672, Oct. 17, 2000, 114 Stat. 1246, provided that:

"(a) Reimbursement Authorized.—The Attorney General, acting through the Administrator of the Drug Enforcement Administration, may reimburse States, units of local government, Indian tribal governments, other public entities, and multi-jurisdictional or regional consortia thereof for expenses incurred to clean up and safely dispose of substances associated with clandestine methamphetamine laboratories which may present a danger to public health or the environment.

"(b) Additional DEA Personnel.—From amounts appropriated or otherwise made available to carry out this section, the Attorney General may hire not more than five additional Drug Enforcement Administration personnel to administer this section.

"(c) Authorization of Appropriations.—There is authorized to be appropriated to the Attorney General to carry out this section $20,000,000 for fiscal year 2001."

¹ See Codification note below.

§886a. Diversion Control Fee Account

(1) In general

There is established in the general fund of the Treasury a separate account which shall be known as the Diversion Control Fee Account. For fiscal year 1993 and thereafter:

(A) There shall be deposited as offsetting receipts into that account all fees collected by the Drug Enforcement Administration, in excess of $15,000,000, for the operation of its diversion control program.

(B) Such amounts as are deposited into the Diversion Control Fee Account shall remain available until expended and shall be refunded out of that account by the Secretary of the Treasury, at least on a quarterly basis, to reimburse the Drug Enforcement Administration for expenses incurred in the operation of the diversion control program. Such reimbursements shall be made without distinguishing between expenses related to controlled substance activities and expenses related to chemical activities.

(C) Fees charged by the Drug Enforcement Administration under its diversion control program shall be set at a level that ensures the recovery of the full costs of operating the various aspects of that program.

(D) The amount required to be refunded from the Diversion Control Fee Account for fiscal year 1994 and thereafter shall be refunded in accordance with estimates made in the budget request of the Attorney General for those fiscal years. Any proposed changes in the amounts designated in said budget requests shall only be made after notification to the Committees on Appropriations of the House of Representatives and the Senate fifteen days in advance.

(2) Definitions

In this section:

(A) Diversion control program

The term "diversion control program" means the controlled substance and chemical diversion control activities of the Drug Enforcement Administration.

(B) Controlled substance and chemical diversion control activities

The term "controlled substance and chemical diversion control activities" means those activities related to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals.

(Pub. L. 102–395, title I, §111(b), Oct. 6, 1992, 106 Stat. 1843; Pub. L. 105–362, title X, §1001(b), Nov. 10, 1998, 112 Stat. 3291; Pub. L. 108–447, div. B, title VI, §633(a), Dec. 8, 2004, 118 Stat. 2921.)

Editorial Notes

Codification

Section was enacted as part of the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1993, and not as part of the Controlled Substances Act which comprises this subchapter.

Amendments

2004—Pub. L. 108–447, §633(a)(2) to (4), designated existing provisions as par. (1) and inserted heading, substituted "program. Such reimbursements shall be made without distinguishing between expenses related to controlled substance activities and expenses related to chemical activities" for "program" in par. (1)(B), and added par. (2).

Pub. L. 108–447, §633(a)(1), which directed redesignation of pars. (1) to (5) as subpars. (A) to (E) and adjustment of margins, was executed by redesignating pars. (1) to (4) as (A) to (D), respectively, to reflect the probable intent of Congress, because Pub. L. 105–362 struck out par. (5). See 1998 Amendment note below.

1998—Par. (5). Pub. L. 105–362 struck out par. (5) which read as follows: "The Attorney General shall prepare and submit annually to the Congress, statements of financial condition of the account, including the beginning balance, receipts, refunds to appropriations, transfers to the general fund, and the ending balance."

§887. Coordination and consolidation of post-seizure administration

The Attorney General and the Secretary of the Treasury shall take such action as may be necessary to develop and maintain a joint plan to coordinate and consolidate post-seizure administration of property seized under this subchapter, subchapter II, or provisions of the customs laws relating to controlled substances.

(Pub. L. 91–513, title II, §517, as added Pub. L. 100–690, title VI, §6078(a), Nov. 18, 1988, 102 Stat. 4325.)

§888. Repealed. Pub. L. 106–185, §2(c)(3), Apr. 25, 2000, 114 Stat. 210

Section, Pub. L. 91–513, title II, §518, formerly §511A, as added Pub. L. 100–690, title VI, §6080(a), Nov. 18, 1988, 102 Stat. 4326; renumbered §518, Pub. L. 101–647, title X, §1002(h)(1), Nov. 29, 1990, 104 Stat. 4828, related to expedited procedures for seized conveyances.

Section was classified to section 881–1 of this title prior to renumbering by Pub. L. 101–647.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal applicable to any forfeiture proceeding commenced on or after the date that is 120 days after Apr. 25, 2000, see section 21 of Pub. L. 106–185, set out as an Effective Date of 2000 Amendment note under section 1324 of Title 8, Aliens and Nationality.

§889. Production control of controlled substances

(a) Definitions

As used in this section:

(1) The term "controlled substance" has the same meaning given such term in section 802(6) of this title.

(2) The term "Secretary" means the Secretary of Agriculture.

(3) The term "State" means each of the fifty States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands of the United States, American Samoa, the Commonwealth of the Northern Mariana Islands, or the Trust Territory of the Pacific Islands.

(b) Persons ineligible for Federal agricultural program benefits

Notwithstanding any other provision of law, following December 23, 1985, any person who is convicted under Federal or State law of planting, cultivation, growing, producing, harvesting, or storing a controlled substance in any crop year shall be ineligible for—

(1) as to any commodity produced during that crop year, and the four succeeding crop years, by such person—

(A) any price support or payment made available under the Agricultural Act of 1949 (7 U.S.C. 1421 et seq.), the Commodity Credit Corporation Charter Act (15 U.S.C. 714 et seq.), or any other Act;

(B) a farm storage facility loan made under section 4(h) of the Commodity Credit Corporation Charter Act (15 U.S.C. 714b(h));

(C) crop insurance under the Federal Crop Insurance Act (7 U.S.C. 1501 et seq.);

(D) a disaster payment made under the Agricultural Act of 1949 (7 U.S.C. 1421 et seq.); or

(E) a loan made, insured or guaranteed under the Consolidated Farm and Rural Development Act (7 U.S.C. 1921 et seq.) or any other provision of law administered by the Farmers Home Administration; or

(2) a payment made under section 4 or 5 of the Commodity Credit Corporation Charter Act (15 U.S.C. 714b or 714c) for the storage of an agricultural commodity that is—

(A) produced during that crop year, or any of the four succeeding crop years, by such person; and

(B) acquired by the Commodity Credit Corporation.

(c) Regulations

Not later than 180 days after December 23, 1985, the Secretary shall issue such regulations as the Secretary determines are necessary to carry out this section, including regulations that—

(1) define the term "person";

(2) govern the determination of persons who shall be ineligible for program benefits under this section; and

(3) protect the interests of tenants and sharecroppers.

(Pub. L. 91–513, title II, §519, formerly Pub. L. 99–198, title XVII, §1764, Dec. 23, 1985, 99 Stat. 1652; renumbered §519 of Pub. L. 91–513, Pub. L. 101–647, title X, §1002(h)(2), Nov. 29, 1990, 104 Stat. 4828.)

Editorial Notes

References in Text

The Agricultural Act of 1949, referred to in subsec. (b)(1)(A), (D), is act Oct. 31, 1949, ch. 792, 63 Stat. 1051, which is classified principally to chapter 35A (§1421 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 1421 of Title 7 and Tables.

The Commodity Credit Corporation Charter Act, referred to in subsec. (b)(1)(A), is act June 29, 1948, ch. 704, 62 Stat. 1070, and is classified generally to subchapter II (§714 et seq.) of chapter 15 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 714 of Title 15 and Tables.

The Federal Crop Insurance Act, referred to in subsec. (b)(1)(C), is subtitle A of title V of act Feb. 16, 1938, ch. 30, 52 Stat. 72, which is classified generally to subchapter I (§1501 et seq.) of chapter 36 of Title 7, Agriculture. For complete classification of this Act to the Code, see section 1501 of Title 7 and Tables.

The Consolidated Farm and Rural Development Act, referred to in subsec. (b)(1)(E), is title III of Pub. L. 87–128, Aug. 8, 1961, 75 Stat. 307, which is classified principally to chapter 50 (§1921 et seq.) of Title 7. For complete classification of this Act to the Code, see Short Title note set out under section 1921 of Title 7 and Tables.

Codification

Section was classified to section 881a of this title prior to renumbering by Pub. L. 101–647.

Amendments

1990—Pub. L. 101–647 renumbered section 881a of this title as this section.

Executive Documents

Termination of Trust Territory of the Pacific Islands

For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title 48, Territories and Insular Possessions.

§890. Review of Federal sales of chemicals usable to manufacture controlled substances

A Federal department or agency may not sell from the stocks of the department or agency any chemical which, as determined by the Administrator of the Drug Enforcement Administration, could be used in the manufacture of a controlled substance unless the Administrator certifies in writing to the head of the department or agency that there is no reasonable cause to believe that the sale of the chemical would result in the illegal manufacture of a controlled substance.

(Pub. L. 91–513, title II, §520, as added Pub. L. 104–201, div. A, title X, §1034(a), Sept. 23, 1996, 110 Stat. 2640.)

Part F—General Provisions

Editorial Notes

Codification

The letter designation for this Part F was, in the original, Part G. The original Part F of title II of Pub. L. 91–513, consisting of section 601 thereof, is set out as a note under section 801 of this title. The original Part G of title II of Pub. L. 91–513 consisted of sections 701 to 709. Sections 701 to 705 amended and repealed sections in this title and in Title 18, Crimes and Criminal Procedure, and Title 42, The Public Health and Welfare, and enacted provisions set out as notes under sections 321, 801, and 822 of this title. See Tables for classifications of said sections 701 to 705. Sections 706 to 709 of Pub. L. 91–513 are set out as sections 901 to 904 of this title and, for purposes of codification, comprise this Part F.

§901. Severability

If a provision of this chapter is held invalid, all valid provisions that are severable shall remain in effect. If a provision of this chapter is held invalid in one or more of its applications, the provision shall remain in effect in all its valid applications that are severable.

(Pub. L. 91–513, title II, §706, Oct. 27, 1970, 84 Stat. 1284.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

§902. Savings provisions

Nothing in this chapter, except this part and, to the extent of any inconsistency, sections 827(e) and 829 of this title, shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §301 et seq.].

(Pub. L. 91–513, title II, §707, Oct. 27, 1970, 84 Stat. 1284.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

§903. Application of State law

No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.

(Pub. L. 91–513, title II, §708, Oct. 27, 1970, 84 Stat. 1284.)

Editorial Notes

References in Text

This subchapter, referred to in text, was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

§904. Payment of tort claims

Notwithstanding section 2680(k) of title 28, the Attorney General, in carrying out the functions of the Department of Justice under this subchapter, is authorized to pay tort claims in the manner authorized by section 2672 of title 28, when such claims arise in a foreign country in connection with the operations of the Drug Enforcement Administration abroad.

(Pub. L. 91–513, title II, §709, Oct. 27, 1970, 84 Stat. 1284; Pub. L. 93–481, §1, Oct. 26, 1974, 88 Stat. 1455; Pub. L. 95–137, §1(a), Oct. 18, 1977, 91 Stat. 1169; Pub. L. 96–132, §§13, 15, Nov. 30, 1979, 93 Stat. 1048; Pub. L. 97–414, §9(g)(1), Jan. 4, 1983, 96 Stat. 2064.)

Editorial Notes

Amendments

1983—Pub. L. 97–414 struck out subsecs. (a) and (b) which had provided, respectively, that (a) there were authorized to be appropriated $105,000,000 for the fiscal year ending June 30, 1975, $175,000,000 for the fiscal year ending June 30, 1976, $200,000,000 for the fiscal year ending September 30, 1977, $188,000,000 for the fiscal year ending September 30, 1978, $215,000,000 for the fiscal year ending September 30, 1979, and $198,336,000 for the fiscal year ending September 30, 1980, for the expenses of the Department of Justice in carrying out its functions under this subchapter, and that (b) no funds appropriated under any other provision of this chapter could be used for the expenses of the Department of Justice for which funds were authorized to be appropriated by former subsection (a) of this section, and removed the subsection designator (c) before "Notwithstanding".

1979—Subsec. (a). Pub. L. 96–132, §15, inserted provisions authorizing appropriations of $198,336,000 for the fiscal year ending Sept. 30, 1980.

Subsec. (c). Pub. L. 96–132, §13, added subsec. (c).

1977—Subsec. (a). Pub. L. 95–137 substituted "September 30, 1977, $188,000,000 for the fiscal year ending September 30, 1978, and $215,000,000 for the fiscal year ending September 30, 1979," for "June 30, 1977," and struck out "(other than its expenses incurred in connection with carrying out section 803(a) of this title)".

1974—Pub. L. 93–481 designated existing provisions as subsec. (a), substituted authorization of appropriations for fiscal years ending June 30, 1975, June 30, 1976, and June 30, 1977, for authorization of appropriations for fiscal years ending June 30, 1972, June 30, 1973, and June 30, 1974, and added subsec. (b).

SUBCHAPTER II—IMPORT AND EXPORT

Editorial Notes

Codification

This subchapter is comprised of Part A of title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part B of title III contains amendatory, repealing, and transitional provisions generally classified elsewhere.

§951. Definitions

(a) For purposes of this subchapter—

(1) The term "import" means, with respect to any article, any bringing in or introduction of such article into any area (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).

(2) The term "customs territory of the United States" has the meaning assigned to such term by general note 2 of the Harmonized Tariff Schedule of the United States.

(b) Each term defined in section 802 of this title shall have the same meaning for purposes of this subchapter as such term has for purposes of subchapter I.

(Pub. L. 91–513, title III, §1001, Oct. 27, 1970, 84 Stat. 1285; Pub. L. 100–418, title I, §1214(m), Aug. 23, 1988, 102 Stat. 1158.)

Editorial Notes

References in Text

The Harmonized Tariff Schedule of the United States, referred to in subsec. (a)(2), is not set out in the Code. See Publication of Harmonized Tariff Schedule note set out under section 1202 of Title 19, Customs Duties.

This subchapter, referred to in subsecs. (a) and (b), was in the original "this title", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises this subchapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Amendments

1988—Subsec. (a)(2). Pub. L. 100–418 substituted "general note 2 of the Harmonized Tariff Schedule of the United States" for "general headnote 2 to the Tariff Schedules of the United States".

Statutory Notes and Related Subsidiaries

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–418 effective Jan. 1, 1989, and applicable with respect to articles entered on or after such date, see section 1217(b)(1) of Pub. L. 100–418, set out as an Effective Date note under section 3001 of Title 19, Customs Duties.

Effective Date

Pub. L. 91–513, title III, §1105(a)–(c), Oct. 27, 1970, 84 Stat. 1295, as amended by Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095, provided that:

"(a) Except as otherwise provided in this section, this title [see Short Title note below] shall become effective on the first day of the seventh calendar month that begins after the day immediately preceding the date of enactment [Oct. 27, 1970].

"(b) Sections 1000, 1001, 1006, 1015, 1016, 1103, 1104 [see Short Title note below and sections 171 note, 951, 956, 957 note, 965, and 966 of this title], and this section shall become effective upon enactment [Oct. 27, 1970].

"(c)(1) If the Attorney General, pursuant to the authority of section 704(c) of title II [set out as a note under section 801 of this title], postpones the effective date of section 306 (relating to manufacturing quotas) [section 826 of this title] for any period beyond the date specified in section 704(a) [set out as a note under section 801 of this title], and such postponement applies to narcotic drugs, the repeal of the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title] by paragraph (10) of section 1101(a) of this title is hereby postponed for the same period, except that the postponement made by this paragraph shall not apply to the repeal of sections 4, 5, 13, 15, and 16 of that Act [which were classified to sections 182, 503, 511, and 513 of this title and sections 4702, 4731, and 4731 note of Title 26, Internal Revenue Code].

"(2) Effective for any period of postponement, by paragraph (1) of this subsection, of the repeal of provisions of the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title], that Act shall be applied subject to the following modifications:

"(A) The term 'narcotic drug' shall mean a narcotic drug as defined in section 102(16) of title II [section 802(16) of this title], and all references, in the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title], to a narcotic drug as defined by section 4731 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4731 of Title 26] are amended to refer to a narcotic drug as defined by such section 102(16) [section 802(16) of this title].

"(B) On and after the date prescribed by the Attorney General pursuant to clause (2) of section 703(c) of title II, [set out as a note under section 822 of this title], the requirements of a manufacturer's license with respect to a basic class of narcotic drug under the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title], and of a registration under section 4722 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722 of Title 26] as a prerequisite to issuance of such a license, shall be superseded by a requirement of actual registration (as distinguished from provisional registration) as a manufacturer of that class of drug under section 303(a) of title II [section 823(a) of this title].

"(C) On and after the effective date of the repeal of such section 4722 [section 4722 of title 26] by section 1101(b)(3) of this title, but prior to the date specified in subparagraph (B) of this paragraph, the requirement of registration under such section 4722 [section 4722 of title 26] as a prerequisite of a manufacturer's license under the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title] shall be superseded by a requirement of either (i) actual registration as a manufacturer under section 303 of title II [section 823 of this title] or (ii) provisional registration (by virtue of a preexisting registration under such section 4722) under section 703 of title II [set out as a note under section 822 of this title]."

Short Title

Pub. L. 91–513, title III, §1000, Oct. 27, 1970, 84 Stat. 1285, provided that: "This title [enacting this subchapter, amending sections 162 and 967 of this title, section 4251 of Title 18, Crimes and Criminal Procedure, section 1584 of Title 19, Customs Duties, sections 4901, 4905, 6808, 7012, 7103, 7326, 7607, 7609, 7641, 7651, and 7655 of Title 26, Internal Revenue Code, section 2901 of Title 28, Judiciary and Judicial Procedure, sections 529d, 529e, and 529f of former Title 31, Money and Finance, section 304m of former Title 40, Public Buildings, Property, and Works, section 3411 of Title 42, The Public Health and Welfare, section 239a of former Title 46, Shipping, and section 787 of former Title 49, Transportation, repealing sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199, and 501 to 517 of this title, sections 1401 to 1407, and 3616 of Title 18, sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to 4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237, 7238, and 7491 of Title 26, sections 529a and 529g of former Title 31, section 1421m of Title 48, Territories and Insular Possessions, and enacting provisions set out as notes under this section and sections 171 and 957 of this title] may be cited as the 'Controlled Substances Import and Export Act'."

Rules and Regulations

Pub. L. 91–513, title III, §1105(d), Oct. 27, 1970, 84 Stat. 1296, provided: "Any orders, rules and regulations which have been promulgated under any law affected by this title [see Short Title note above] and which are in effect on the day preceding enactment of this title [Oct. 27, 1970] shall continue in effect until modified, superseded, or repealed."

§952. Importation of controlled substances

(a) Controlled substances in schedule I or II and narcotic drugs in schedule III, IV, or V; exceptions

It shall be unlawful to import into the customs territory of the United States from any place outside thereof (but within the United States), or to import into the United States from any place outside thereof, any controlled substance in schedule I or II of subchapter I, or any narcotic drug in schedule III, IV, or V of subchapter I, or ephedrine, pseudoephedrine, or phenylpropanolamine, except that—

(1) such amounts of crude opium, poppy straw, concentrate of poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and phenylpropanolamine, as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes, and

(2) such amounts of any controlled substance in schedule I or II or any narcotic drug in schedule III, IV, or V that the Attorney General finds to be necessary to provide for the medical, scientific, or other legitimate needs of the United States—

(A) during an emergency in which domestic supplies of such substance or drug are found by the Attorney General to be inadequate,

(B) in any case in which the Attorney General finds that competition among domestic manufacturers of the controlled substance is inadequate and will not be rendered adequate by the registration of additional manufacturers under section 823 of this title, or

(C) in any case in which the Attorney General finds that such controlled substance is in limited quantities exclusively for scientific, analytical, or research uses,

may be so imported under such regulations as the Attorney General shall prescribe. No crude opium may be so imported for the purpose of manufacturing heroin or smoking opium.

(b) Nonnarcotic controlled substances in schedule III, IV, or V

It shall be unlawful to import into the customs territory of the United States from any place outside thereof (but within the United States), or to import into the United States from  any  place  outside  thereof,  any  nonnarcotic controlled substance in schedule III, IV, or V, unless such nonnarcotic controlled substance—

(1) is imported for medical, scientific, or other legitimate uses, and

(2) is imported pursuant to such notification, or declaration, or in the case of any nonnarcotic controlled substance in schedule III, such import permit, notification, or declaration, as the Attorney General may by regulation prescribe, except that if a nonnarcotic controlled substance in schedule IV or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention.

(c) Coca leaves

In addition to the amount of coca leaves authorized to be imported into the United States under subsection (a), the Attorney General may permit the importation of additional amounts of coca leaves. All cocaine and ecgonine (and all salts, derivatives, and preparations from which cocaine or ecgonine may be synthesized or made) contained in such additional amounts of coca leaves imported under this subsection shall be destroyed under the supervision of an authorized representative of the Attorney General.

(d) Application for increased importation of ephedrine, pseudoephedrine, or phenylpropanolamine

(1) With respect to a registrant under section 958 of this title who is authorized under subsection (a)(1) to import ephedrine, pseudoephedrine, or phenylpropanolamine, at any time during the year the registrant may apply for an increase in the amount of such chemical that the registrant is authorized to import, and the Attorney General may approve the application if the Attorney General determines that the approval is necessary to provide for medical, scientific, or other legitimate purposes regarding the chemical.

(2) With respect to the application under paragraph (1):

(A) Not later than 60 days after receiving the application, the Attorney General shall approve or deny the application.

(B) In approving the application, the Attorney General shall specify the period of time for which the approval is in effect, or shall provide that the approval is effective until the registrant involved is notified in writing by the Attorney General that the approval is terminated.

(C) If the Attorney General does not approve or deny the application before the expiration of the 60-day period under subparagraph (A), the application is deemed to be approved, and such approval remains in effect until the Attorney General notifies the registrant in writing that the approval is terminated.

(e) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine

Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.

(Pub. L. 91–513, title III, §1002, Oct. 27, 1970, 84 Stat. 1285; Pub. L. 95–633, title I, §105, Nov. 10, 1978, 92 Stat. 3772; Pub. L. 98–473, title II, §§519–521, Oct. 12, 1984, 98 Stat. 2075; Pub. L. 109–177, title VII, §715, Mar. 9, 2006, 120 Stat. 264.)

Editorial Notes

References in Text

Schedules I, II, III, IV, and V, referred to in subsecs. (a) and (b), are set out in section 812(c) of this title.

Amendments

2006—Subsec. (a). Pub. L. 109–177, §715(1)(A), inserted "or ephedrine, pseudoephedrine, or phenylpropanolamine," after "schedule III, IV, or V of subchapter I," in introductory provisions.

Subsec. (a)(1). Pub. L. 109–177, §715(1)(B), inserted ", and of ephedrine, pseudoephedrine, and phenylpropanolamine," after "coca leaves".

Subsecs. (d), (e). Pub. L. 109–177, §715(2), added subsecs. (d) and (e).

1984—Subsec. (a)(1). Pub. L. 98–473, §519, amended par. (1) generally, inserting references to poppy straw and concentrate of poppy straw.

Subsec. (a)(2)(C). Pub. L. 98–473, §520, added subpar. (C).

Subsec. (b)(2). Pub. L. 98–473, §521, substituted "is imported pursuant to such notification, or declaration, or in the case of any nonnarcotic controlled substance in schedule III, such import permit, notification, or declaration, as the Attorney General may by regulation prescribe, except that if a nonnarcotic controlled substance in schedule IV or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention" for "is imported pursuant to such notification or declaration requirements as the Attorney General may by regulation prescribe, except that if a nonnarcotic controlled substance in schedule III, IV, or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention".

1978—Subsec. (b)(2). Pub. L. 95–633 inserted provision relating to exception for nonnarcotic controlled substances listed in schedule I or II of the Convention on Psychotropic Substances.

Statutory Notes and Related Subsidiaries

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§953. Exportation of controlled substances

(a) Narcotic drugs in schedule I, II, III, or IV

It shall be unlawful to export from the United States any narcotic drug in schedule I, II, III, or IV unless—

(1) it is exported to a country which is a party to—

(A) the International Opium Convention of 1912 for the Suppression of the Abuses of Opium, Morphine, Cocaine, and Derivative Drugs, or to the International Opium Convention signed at Geneva on February 19, 1925; or

(B) the Convention for Limiting the Manufacture and Regulating the Distribution of Narcotic Drugs concluded at Geneva, July 13, 1931, as amended by the protocol signed at Lake Success on December 11, 1946, and the protocol bringing under international control drugs outside the scope of the convention of July 13, 1931, for limiting the manufacture and regulating the distribution of narcotic drugs (as amended by the protocol signed at Lake Success on December 11, 1946), signed at Paris, November 19, 1948; or

(C) the Single Convention on Narcotic Drugs, 1961, signed at New York, March 30, 1961;

(2) such country has instituted and maintains, in conformity with the conventions to which it is a party, a system for the control of imports of narcotic drugs which the Attorney General deems adequate;

(3) the narcotic drug is consigned to a holder of such permits or licenses as may be required under the laws of the country of import, and a permit or license to import such drug has been issued by the country of import;

(4) substantial evidence is furnished to the Attorney General by the exporter that (A) the narcotic drug is to be applied exclusively to medical or scientific uses within the country of import, and (B) there is an actual need for the narcotic drug for medical or scientific uses within such country; and

(5) a permit to export the narcotic drug in each instance has been issued by the Attorney General.

(b) Exception for exportation for special scientific purposes

Notwithstanding subsection (a), the Attorney General may authorize any narcotic drug (including crude opium and coca leaves) in schedule I, II, III, or IV to be exported from the United States to a country which is a party to any of the international instruments mentioned in subsection (a) if the particular drug is to be applied to a special scientific purpose in the country of destination and the authorities of such country will permit the importation of the particular drug for such purpose.

(c) Nonnarcotic controlled substances in schedule I or II

It shall be unlawful to export from the United States any nonnarcotic controlled substance in schedule I or II unless—

(1) it is exported to a country which has instituted and maintains a system which the Attorney General deems adequate for the control of imports of such substances;

(2) the controlled substance is consigned to a holder of such permits or licenses as may be required under the laws of the country of import;

(3) substantial evidence is furnished to the Attorney General that (A) the controlled substance is to be applied exclusively to medical, scientific, or other legitimate uses within the country to which exported, (B) it will not be exported from such country, and (C) there is an actual need for the controlled substance for medical, scientific, or other legitimate uses within the country; and

(4) a permit to export the controlled substance in each instance has been issued by the Attorney General.

(d) Exception for exportation for special scientific purposes

Notwithstanding subsection (c), the Attorney General may authorize any nonnarcotic controlled substance in schedule I or II to be exported from the United States if the particular substance is to be applied to a special scientific purpose in the country of destination and the authorities of such country will permit the importation of the particular drug for such purpose.

(e) Nonnarcotic controlled substances in schedule III or IV; controlled substances in schedule V

It shall be unlawful to export from the United States to any other country any nonnarcotic controlled substance in schedule III or IV or any controlled substances in schedule V unless—

(1) there is furnished (before export) to the Attorney General documentary proof that importation is not contrary to the laws or regulations of the country of destination for consumption for medical, scientific, or other legitimate purposes;

(2) it is exported pursuant to such notification or declaration, or in the case of any nonnarcotic controlled substance in schedule III, such export permit, notification, or declaration as the Attorney General may by regulation prescribe; and

(3) in the case of a nonnarcotic controlled substance in schedule IV or V which is also listed in schedule I or II of the Convention on Psychotropic Substances, it is exported pursuant to such export permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention.

(f) Exception for exportation for subsequent export

Notwithstanding subsections (a)(4) and (c)(3), the Attorney General may authorize any controlled substance that is in schedule I or II, or is a narcotic drug in schedule III or IV, to be exported from the United States to a country for subsequent export from that country to another country, if each of the following conditions is met:

(1) Both the country to which the controlled substance is exported from the United States (referred to in this subsection as the "first country") and the country to which the controlled substance is exported from the first country (referred to in this subsection as the "second country") are parties to the Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971.

(2) The first country and the second country have each instituted and maintain, in conformity with such Conventions, a system of controls of imports of controlled substances which the Attorney General deems adequate.

(3) With respect to the first country, the controlled substance is consigned to a holder of such permits or licenses as may be required under the laws of such country, and a permit or license to import the controlled substance has been issued by the country.

(4) With respect to the second country, substantial evidence is furnished to the Attorney General by the person who will export the controlled substance from the United States that—

(A) the controlled substance is to be consigned to a holder of such permits or licenses as may be required under the laws of such country, and a permit or license to import the controlled substance is to be issued by the country; and

(B) the controlled substance is to be applied exclusively to medical, scientific, or other legitimate uses within the country.

(5)(A) The controlled substance will not be exported from the second country, except that the controlled substance may be exported from a second country that is a member of the European Economic Area to another country that is a member of the European Economic Area, provided that the first country is also a member of the European Economic Area.

(B) Subsequent to any re-exportation described in subparagraph (A), a controlled substance may continue to be exported from any country that is a member of the European Economic Area to any other such country, if—

(i) the conditions applicable with respect to the first country under paragraphs (1), (2), (3), (4), (6), and (7) are met by each subsequent country from which the controlled substance is exported pursuant to this paragraph; and

(ii) the conditions applicable with respect to the second country under paragraphs (1), (2), (3), (4), (6), and (7) are met by each subsequent country to which the controlled substance is exported pursuant to this paragraph.

(6)(A) Within 30 days after the controlled substance is exported from the first country to the second country, the person who exported the controlled substance from the United States delivers to the Attorney General documentation certifying that such export from the first country has occurred.

(B) In the case of re-exportation among members of the European Economic Area, within 30 days after each re-exportation, the person who exported the controlled substance from the United States delivers to the Attorney General—

(i) documentation certifying that such re-exportation has occurred; and

(ii) information concerning the consignee, country, and product.

(7) A permit to export the controlled substance from the United States has been issued by the Attorney General.

(g) Limitation

Subject to paragraphs (5) and (6) of subsection (f) in the case of any controlled substance in schedule I or II or any narcotic drug in schedule III or IV, the Attorney General shall not promulgate nor enforce any regulation, subregulatory guidance, or enforcement policy which impedes re-exportation of any controlled substance among European Economic Area countries, including by promulgating or enforcing any requirement that—

(1) re-exportation from the first country to the second country or re-exportation from the second country to another country occur within a specified period of time; or

(2) information concerning the consignee, country, and product be provided prior to exportation of the controlled substance from the United States or prior to each re-exportation among members of the European Economic Area.

(Pub. L. 91–513, title III, §1003, Oct. 27, 1970, 84 Stat. 1286; Pub. L. 95–633, title I, §106, Nov. 10, 1978, 92 Stat. 3772; Pub. L. 98–473, title II, §522, Oct. 12, 1984, 98 Stat. 2076; Pub. L. 109–57, §1(b), Aug. 2, 2005, 119 Stat. 592; Pub. L. 114–89, §4, Nov. 25, 2015, 129 Stat. 701.)

Editorial Notes

References in Text

Schedules I, II, III, IV and V, referred to in text, are set out in section 812(c) of this title.

Amendments

2015—Subsec. (f)(5). Pub. L. 114–89, §4(1)(A), designated existing provisions as subpar. (A), inserted ", except that the controlled substance may be exported from a second country that is a member of the European Economic Area to another country that is a member of the European Economic Area, provided that the first country is also a member of the European Economic Area" before period at end, and added subpar. (B).

Subsec. (f)(6). Pub. L. 114–89, §4(1)(B), designated existing provisions as subpar. (A) and added subpar. (B).

Subsec. (g). Pub. L. 114–89, §4(2), added subsec. (g).

2005—Subsec. (f). Pub. L. 109–57 added subsec. (f).

1984—Subsec. (e). Pub. L. 98–473 in cl. (1) inserted provisions for consumption for medical, etc., purposes, added cls. (2) and (3), and struck out former cls. (2) to (4), respectively, relating to a special controlled substance invoice, two additional copies of the invoice, and exportation of a nonnarcotic controlled substance in schedule III, IV, or V, also listed in schedule I or II of the Convention.

1978—Subsec. (e)(4). Pub. L. 95–633 added par. (4).

Statutory Notes and Related Subsidiaries

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§954. Transshipment and in-transit shipment of controlled substances

Notwithstanding sections 952, 953, and 957 of this title—

(1) A controlled substance in schedule I may—

(A) be imported into the United States for transshipment to another country, or

(B) be transferred or transshipped from one vessel, vehicle, or aircraft to another vessel, vehicle, or aircraft within the United States for immediate exportation,

if and only if it is so imported, transferred, or transshipped (i) for scientific, medical, or other legitimate purposes in the country of destination, and (ii) with the prior written approval of the Attorney General (which shall be granted or denied within 21 days of the request).

(2) A controlled substance in schedule II, III, or IV may be so imported, transferred, or transshipped if and only if advance notice is given to the Attorney General in accordance with regulations of the Attorney General.

(Pub. L. 91–513, title III, §1004, Oct. 27, 1970, 84 Stat. 1287.)

Editorial Notes

References in Text

Schedules I, II, III, and IV, referred to in text, are set out in section 812(c) of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§955. Possession on board vessels, etc., arriving in or departing from United States

It shall be unlawful for any person to bring or possess on board any vessel or aircraft, or on board any vehicle of a carrier, arriving in or departing from the United States or the customs territory of the United States, a controlled substance in schedule I or II or a narcotic drug in schedule III or IV, unless such substance or drug is a part of the cargo entered in the manifest or part of the official supplies of the vessel, aircraft, or vehicle.

(Pub. L. 91–513, title III, §1005, Oct. 27, 1970, 84 Stat. 1287.)

Editorial Notes

References in Text

Schedules I, II, III, and IV, referred to in text, are set out in section 812(c) of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§§955a to 955d. Transferred

Editorial Notes

Codification

Sections, Pub. L. 96–350, §§1–4, Sept. 15, 1980, 94 Stat. 1159, 1160, relating to maritime drug law enforcement, were transferred to sections 1901 to 1904 of the former Appendix to Title 46, Shipping. Sections 1901 to 1904 of the former Appendix to Title 46 were repealed and restated in chapter 705 of Title 46, Shipping, by Pub. L. 109–304, §§10(2), 19, Oct. 6, 2006, 120 Stat. 1683, 1710. For disposition of sections of the former Appendix to Title 46, see Disposition Table preceding section 101 of Title 46.

§956. Exemption authority

(a) Individual possessing controlled substance

(1) Subject to paragraph (2), the Attorney General may by regulation exempt from sections 952(a) and (b), 953, 954, and 955 of this title any individual who has a controlled substance (except a substance in schedule I) in his possession for his personal medical use, or for administration to an animal accompanying him, if he lawfully obtained such substance and he makes such declaration (or gives such other notification) as the Attorney General may by regulation require.

(2) Notwithstanding any exemption under paragraph (1), a United States resident who enters the United States through an international land border with a controlled substance (except a substance in schedule I) for which the individual does not possess a valid prescription issued by a practitioner (as defined in section 802 of this title) in accordance with applicable Federal and State law (or documentation that verifies the issuance of such a prescription to that individual) may not import the controlled substance into the United States in an amount that exceeds 50 dosage units of the controlled substance.

(b) Compound, mixture, or preparation

The Attorney General may by regulation except any compound, mixture, or preparation containing any depressant or stimulant substance listed in paragraph (a) or (b) of schedule III or in schedule IV or V from the application of all or any part of this subchapter if (1) the compound, mixture, or preparation contains one or more active medicinal ingredients not having a depressant or stimulant effect on the central nervous system, and (2) such ingredients are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse of the substances which do have a depressant or stimulant effect on the central nervous system.

(Pub. L. 91–513, title III, §1006, Oct. 27, 1970, 84 Stat. 1288; Pub. L. 105–277, div. C, title VIII, §872(a), Oct. 21, 1998, 112 Stat. 2681–707; Pub. L. 105–357, §2(a), Nov. 10, 1998, 112 Stat. 3271.)

Editorial Notes

References in Text

Schedules I, III, IV, and V, referred to in text, are set out in section 812(c) of this title.

Amendments

1998—Subsec. (a). Pub. L. 105–277 and Pub. L. 105–357 amended subsec. (a) identically, designating existing provisions as par. (1), substituting "Subject to paragraph (2), the Attorney General" for "The Attorney General", and adding par. (2).

Statutory Notes and Related Subsidiaries

Federal Minimum Requirement

Pub. L. 105–357, §2(b), Nov. 10, 1998, 112 Stat. 3271, provided that: "Section 1006(a)(2) of the Controlled Substances Import and Export Act [21 U.S.C. 956(a)(2)], as added by this section, is a minimum Federal requirement and shall not be construed to limit a State from imposing any additional requirement."

Pub. L. 105–277, div. C, title VIII, §872(b), Oct. 21, 1998, 112 Stat. 2681–707, enacted a provision substantially identical to that enacted by Pub. L. 105–357, §2(b), set out above.

Jurisdiction of Secretary of Health and Human Services

Pub. L. 105–277, div. C, title VIII, §872(c), Oct. 21, 1998, 112 Stat. 2681–707, and Pub. L. 105–357, §2(c), Nov. 10, 1998, 112 Stat. 3271, provided that: "The amendment made by subsection (a) [amending this section] shall not be construed to affect the jurisdiction of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.)."

§957. Persons required to register

(a) Coverage

No person may—

(1) import into the customs territory of the United States from any place outside thereof (but within the United States), or import into the United States from any place outside thereof, any controlled substance or list I chemical, or

(2) export from the United States any controlled substance or list I chemical,

unless there is in effect with respect to such person a registration issued by the Attorney General under section 958 of this title, or unless such person is exempt from registration under subsection (b).

(b) Exemptions

(1) The following persons shall not be required to register under the provisions of this section and may lawfully possess a controlled substance or list I chemical:

(A) An agent or an employee of any importer or exporter registered under section 958 of this title if such agent or employee is acting in the usual course of his business or employment.

(B) A common or contract carrier or warehouseman, or an employee thereof, whose possession of any controlled substance or list I chemical is in the usual course of his business or employment.

(C) An ultimate user who possesses such substance for a purpose specified in section 802(25) ¹ of this title and in conformity with an exemption granted under section 956(a) of this title.

(2) The Attorney General may, by regulation, waive the requirement for registration of certain importers and exporters if he finds it consistent with the public health and safety; and may authorize any such importer or exporter to possess controlled substances or list I chemicals for purposes of importation and exportation.

(Pub. L. 91–513, title III, §1007, Oct. 27, 1970, 84 Stat. 1288; Pub. L. 98–473, title II, §523, Oct. 12, 1984, 98 Stat. 2076; Pub. L. 103–200, §3(e), Dec. 17, 1993, 107 Stat. 2337.)

Editorial Notes

References in Text

Section 802(25) of this title, referred to in subsec. (b)(1)(C), was redesignated section 802(26) of this title by Pub. L. 98–473, title II, §507(a), Oct. 12, 1984, 98 Stat. 2071, and was further redesignated section 802(27) of this title by Pub. L. 99–570, title I, §1003(b)(2), Oct. 27, 1986, 100 Stat. 3207–6.

Amendments

1993—Subsec. (a)(1). Pub. L. 103–200, §3(e)(1)(A), inserted "or list I chemical" after "controlled substance".

Subsec. (a)(2). Pub. L. 103–200, §3(e)(1)(B), substituted "or list I chemical," for "in schedule I, II, III, IV, or V,".

Subsec. (b)(1). Pub. L. 103–200, §3(e)(2)(A), inserted "or list I chemical" after "controlled substance" in introductory provisions and subpar. (B).

Subsec. (b)(2). Pub. L. 103–200, §3(e)(2)(B), inserted "or list I chemicals" after "controlled substances".

1984—Subsec. (a)(2). Pub. L. 98–473 inserted reference to schedule V.

Statutory Notes and Related Subsidiaries

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

Provisional Registration

Pub. L. 91–513, title III, §1104, Oct. 27, 1970, 84 Stat. 1294, as amended by Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095, provided that:

"(a)(1) Any person—

"(A) who is engaged in importing or exporting any controlled substance on the day before the effective date of section 1007 [May 1, 1971],

"(B) who notifies the Attorney General that he is so engaged, and

"(C) who is registered on such day under section 510 of the Federal Food, Drug, and Cosmetic Act [section 360 of this title] or under section 4722 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722 of title 26],

shall, with respect to each establishment for which such registration is in effect under any such section, be deemed to have a provisional registration under section 1008 [section 958 of this title] for the import or export (as the case may be) of controlled substances.

"(2) During the period his provisional registration is in effect under this section, the registration number assigned such person under such section 510 or under such section 4722 (as the case may be) shall be his registration number for purposes of part A of this title [this subchapter].

"(b) The provisions of section 304 [section 824 of this title], relating to suspension and revocation of registration, shall apply to a provisional registration under this section.

"(c) Unless sooner suspended or revoked under subsection (b), a provisional registration of a person under subsection (a)(1) of this section shall be in effect until—

"(1) the date on which such person has registered with the Attorney General under section 1008 [section 958 of this title] or has had his registration denied under such section, or

"(2) such date as may be prescribed by the Attorney General for registration of importers or exporters, as the case may be,

whichever occurs first."

¹ See References in Text note below.

§958. Registration requirements

(a) Applicants to import or export controlled substances in schedule I or II

The Attorney General shall register an applicant to import or export a controlled substance in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the factors enumerated in paragraph (1) through (6) of section 823(a) of this title shall be considered.

(b) Activity limited to specified substances

Registration granted under this section shall not entitle a registrant to import or export controlled substances other than specified in the registration.

(c) Applicants to import controlled substances in schedule III, IV, or V or to export controlled substances in schedule III or IV; applicants to import or export list I chemicals

(1) The Attorney General shall register an applicant to import a controlled substance in schedule III, IV, or V or to export a controlled substance in schedule III or IV, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the factors enumerated in paragraphs (1) through (6) of section 823(e) of this title shall be considered.

(2)(A) The Attorney General shall register an applicant to import or export a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection shall not be required for the import or export of a drug product that is exempted under section 802(39)(A)(iv) of this title.

(B) In determining the public interest for the purposes of subparagraph (A), the Attorney General shall consider the factors specified in section 823(i) of this title.

(d) Denial of application

(1) The Attorney General may deny an application for registration under subsection (a) if he is unable to determine that such registration is consistent with the public interest (as defined in subsection (a)) and with the United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971.

(2) The Attorney General may deny an application for registration under subsection (c), or revoke or suspend a registration under subsection (a) or (c), if he determines that such registration is inconsistent with the public interest (as defined in subsection (a) or (c)) or with the United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971.

(3) The Attorney General may limit the revocation or suspension of a registration to the particular controlled substance, or substances, or list I chemical or chemicals, with respect to which grounds for revocation or suspension exist.

(4) Before taking action pursuant to this subsection, the Attorney General shall serve upon the applicant or registrant an order to show cause as to why the registration should not be denied, revoked, or suspended. The order to show cause shall contain a statement of the basis thereof and shall call upon the applicant or registrant to appear before the Attorney General, or his designee, at a time and place stated in the order, but in no event less than thirty days after the date of receipt of the order. Proceedings to deny, revoke, or suspend shall be conducted pursuant to this subsection in accordance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States.

(5) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this subsection, in cases where he finds that there is an imminent danger to the public health and safety. Such suspension shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.

(6) In the event that the Attorney General suspends or revokes a registration granted under this section, all controlled substances or list I chemicals owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be seized or placed under seal. No disposition may be made of any controlled substances or list I chemicals under seal until the time for taking an appeal has elapsed or until all appeals have been concluded, except that a court, upon application therefor, may at any time order the sale of perishable controlled substances or list I chemicals. Any such order shall require the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled substances or list I chemicals (or proceeds of the sale thereof which have been deposited with the court) shall be forfeited to the United States; and the Attorney General shall dispose of such controlled substances or list I chemicals in accordance with section 881(e) of this title.

(e) Registration period

No registration shall be issued under this subchapter for a period in excess of one year. Unless the regulations of the Attorney General otherwise provide, sections 822(f), 825, 827, and 830 of this title shall apply to persons registered under this section to the same extent such sections apply to persons registered under section 823 of this title.

(f) Rules and regulations

The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of importers and exporters of controlled substances or listed chemicals.

(g) Scope of authorized activity

Persons registered by the Attorney General under this section to import or export controlled substances or list I chemicals may import or export (and for the purpose of so importing or exporting, may possess) such substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter and subchapter I.

(h) Separate registrations for each principal place of business

A separate registration shall be required at each principal place of business where the applicant imports or exports controlled substances or list I chemicals.

(i) Emergency situations

Except in emergency situations as described in section 952(a)(2)(A) of this title, prior to issuing a registration under this section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under section 952(a) of this title authorizing the importation of such a substance, the Attorney General shall give manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing.

(Pub. L. 91–513, title III, §1008, Oct. 27, 1970, 84 Stat. 1289; Pub. L. 98–473, title II, §§524, 525, Oct. 12, 1984, 98 Stat. 2076; Pub. L. 99–570, title I, §1866(d), Oct. 27, 1986, 100 Stat. 3207–55; Pub. L. 103–200, §3(f), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 108–447, div. B, title VI, §633(c), Dec. 8, 2004, 118 Stat. 2922; Pub. L. 117–215, title I, §103(b)(2), Dec. 2, 2022, 136 Stat. 2263.)

Editorial Notes

References in Text

Schedules I, II, III, IV, and V, referred to in subsecs. (a), (c), and (i), are set out in section 812(c) of this title.

This subchapter, referred to in subsecs. (d)(4) and (g), was in the original "this title", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises this subchapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Codification

In subsecs. (a) and (d), "May 1, 1971" substituted for "the effective date of this section" and "the effective date of this part", respectively.

Amendments

2022—Subsec. (c)(1). Pub. L. 117–215, §103(b)(2)(A), substituted "823(e)" for "823(d)".

Subsec. (c)(2)(B). Pub. L. 117–215, §103(b)(2)(B), substituted "823(i)" for "823(h)".

2004—Subsec. (f). Pub. L. 108–447, which directed amendment of subsec. (f) of section 1088 of the Controlled Substances Import and Export Act by inserting "and control" after "the registration" and substituting "listed chemicals" for "list I chemicals under this section", was executed to subsec. (f) of this section, which is section 1008 of the Controlled Substances Import and Export Act, to reflect the probable intent of Congress.

1993—Subsec. (c). Pub. L. 103–200, §3(f)(1), designated existing provisions as par. (1) and added par. (2).

Subsec. (d)(3). Pub. L. 103–200, §3(f)(2)(A), inserted "or list I chemical or chemicals," after "substances,".

Subsec. (d)(6). Pub. L. 103–200, §3(f)(2)(B), inserted "or list I chemicals" after "controlled substances" wherever appearing.

Subsec. (e). Pub. L. 103–200, §3(f)(3), inserted reference to section 830 of this title.

Subsecs. (f) to (h). Pub. L. 103–200, §3(f)(4), inserted "or list I chemicals" after "controlled substances".

1986—Subsec. (e). Pub. L. 99–570 substituted "sections" for first reference to "section".

1984—Subsec. (b). Pub. L. 98–473, §524, substituted "Registration granted under this section shall not entitle a registrant to import or export controlled substances other than specified in the registration" for "Registration granted under subsection (a) of this section shall not entitle a registrant to import or export controlled substances in schedule I or II other than those specified in the registration".

Subsecs. (d) to (i). Pub. L. 98–473, §525, added subsec. (d), redesignated former subsec. (d) as (e) and struck out reference to section 824 of this title, and redesignated former subsecs. (e) to (h) as (f) to (i), respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§959. Possession, manufacture, or distribution of controlled substance

(a) Manufacture or distribution for purpose of unlawful importation

It shall be unlawful for any person to manufacture or distribute a controlled substance in schedule I or II or flunitrazepam or a listed chemical intending, knowing, or having reasonable cause to believe that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States.

(b) Manufacture or distribution of listed chemical for purpose of manufacture or unlawful importation of controlled substance

It shall be unlawful for any person to manufacture or distribute a listed chemical—

(1) intending or knowing that the listed chemical will be used to manufacture a controlled substance; and

(2) intending, knowing, or having reasonable cause to believe that the controlled substance will be unlawfully imported into the United States.

(c) Possession, manufacture, or distribution by person on board aircraft

It shall be unlawful for any United States citizen on board any aircraft, or any person on board an aircraft owned by a United States citizen or registered in the United States, to—

(1) manufacture or distribute a controlled substance or listed chemical; or

(2) possess a controlled substance or listed chemical with intent to distribute.

(d) Acts committed outside territorial jurisdiction of United States

This section is intended to reach acts of manufacture or distribution committed outside the territorial jurisdiction of the United States.

(Pub. L. 91–513, title III, §1009, Oct. 27, 1970, 84 Stat. 1289; Pub. L. 99–570, title III, §3161(a), Oct. 27, 1986, 100 Stat. 3207–94; Pub. L. 104–237, title I, §102(a), (b), Oct. 3, 1996, 110 Stat. 3100; Pub. L. 104–305, §2(b)(2)(A), Oct. 13, 1996, 110 Stat. 3807; Pub. L. 114–154, §2, May 16, 2016, 130 Stat. 387; Pub. L. 115–91, div. A, title X, §1012(b), Dec. 12, 2017, 131 Stat. 1546.)

Editorial Notes

References in Text

Schedules I and II, referred to in subsec. (a), are set out in section 812(c) of this title.

Amendments

2017—Subsec. (d). Pub. L. 115–91 struck out "; venue" after "United States" in heading and "Any person who violates this section shall be tried in the United States district court at the point of entry where such person enters the United States, or in the United States District Court for the District of Columbia." after "United States." in text.

2016—Subsec. (a). Pub. L. 114–154, §2(2), substituted "It shall be unlawful for any person to manufacture or distribute a controlled substance in schedule I or II or flunitrazepam or a listed chemical intending, knowing, or having reasonable cause to believe that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States." for "It shall be unlawful for any person to manufacture or distribute a controlled substance in schedule I or II or flunitrazepam or listed chemical—

"(1) intending that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States; or

"(2) knowing that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States."

Subsecs. (b) to (d). Pub. L. 114–154 added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively.

1996—Subsec. (a). Pub. L. 104–305 inserted "or flunitrazepam" after "schedule I or II" in introductory provisions.

Pub. L. 104–237, §102(a), inserted "or listed chemical" after "schedule I or II" in introductory provisions and "or chemical" after "substance" in pars. (1) and (2).

Subsec. (b). Pub. L. 104–237, §102(b), inserted "or listed chemical" after "controlled substance" in pars. (1) and (2).

1986—Pub. L. 99–570 designated first sentence as subsec. (a) and inserted "or into waters within a distance of 12 miles of the coast of the United States" in pars. (1) and (2), added subsec. (b), and designated last two sentences as subsec. (c).

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§960. Prohibited acts A

(a) Unlawful acts

Any person who—

(1) contrary to section 825, 952, 953, or 957 of this title, knowingly or intentionally imports or exports a controlled substance,

(2) contrary to section 955 of this title, knowingly or intentionally brings or possesses on board a vessel, aircraft, or vehicle a controlled substance, or

(3) contrary to section 959 of this title, manufactures, possesses with intent to distribute, or distributes a controlled substance,

shall be punished as provided in subsection (b).

(b) Penalties

(1) In the case of a violation of subsection (a) of this section involving—

(A) 1 kilogram or more of a mixture or substance containing a detectable amount of heroin;

(B) 5 kilograms or more of a mixture or substance containing a detectable amount of—

(i) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;

(ii) cocaine, its salts, optical and geometric isomers, and salts or isomers;

(iii) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or

(iv) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in clauses (i) through (iii);

(C) 280 grams or more of a mixture or substance described in subparagraph (B) which contains cocaine base;

(D) 100 grams or more of phencyclidine (PCP) or 1 kilogram or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);

(E) 10 grams or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);

(F) 400 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-piperidinyl] propanamide or 100 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;

(G) 1000 kilograms or more of a mixture or substance containing a detectable amount of marihuana; or

(H) 50 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 500 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers.¹

the person committing such violation shall be sentenced to a term of imprisonment of not less than 10 years and not more than life and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than 20 years and not more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $10,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 15 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $20,000,000 if the defendant is an individual or $75,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 5 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 10 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under this paragraph. No person sentenced under this paragraph shall be eligible for parole during the term of imprisonment imposed therein.

(2) In the case of a violation of subsection (a) of this section involving—

(A) 100 grams or more of a mixture or substance containing a detectable amount of heroin;

(B) 500 grams or more of a mixture or substance containing a detectable amount of—

(i) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;

(ii) cocaine, its salts, optical and geometric isomers, and salts or isomers;

(iii) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or

(iv) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in clauses (i) through (iii);

(C) 28 grams or more of a mixture or substance described in subparagraph (B) which contains cocaine base;

(D) 10 grams or more of phencyclidine (PCP) or 100 grams or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);

(E) 1 gram or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);

(F) 40 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-piperidinyl] propanamide or 10 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;

(G) 100 kilograms or more of a mixture or substance containing a detectable amount of marihuana; or

(H) 5 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 50 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers.¹

the person committing such violation shall be sentenced to a term of imprisonment of not less than 5 years and not more than 40 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years and not more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $5,000,000 if the defendant is an individual or $25,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 10 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $8,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence imposed under this paragraph shall, in the absence of such a prior conviction, include a term of supervised release of at least 4 years in addition to such term of imprisonment and shall, if there was such a prior conviction, include a term of supervised release of at least 8 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under this paragraph. No person sentenced under this paragraph shall be eligible for parole during the term of imprisonment imposed therein.

(3) In the case of a violation under subsection (a) of this section involving a controlled substance in schedule I or II, gamma hydroxybutyric acid (including when scheduled as an approved drug product for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000), or flunitrazepam, the person committing such violation shall, except as provided in paragraphs (1), (2), and (4), be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years and not more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $2,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 6 years in addition to such term of imprisonment. Notwithstanding the prior sentence, and notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results.

(4) In the case of a violation under subsection (a) with respect to less than 50 kilograms of marihuana, except in the case of 100 or more marihuana plants regardless of weight, less than 10 kilograms of hashish, or less than one kilogram of hashish oil, the person committing such violation shall be sentenced in accordance with section 841(b)(1)(D) of this title.

(5) In the case of a violation of subsection (a) involving a controlled substance in schedule III, such person shall be sentenced in accordance with section 841(b)(1) of this title.

(6) In the case of a violation of subsection (a) involving a controlled substance in schedule IV, such person shall be sentenced in accordance with section 841(b)(2) of this title.

(7) In the case of a violation of subsection (a) involving a controlled substance in schedule V, such person shall be sentenced in accordance with section 841(b)(3) of this title.

(c) Repealed. Pub. L. 98–473, title II, §225, formerly §225(a), Oct. 12, 1984, 98 Stat. 2030, as amended by Pub. L. 99–570, title I, §1005(c), Oct. 27, 1986, 100 Stat. 3207–6

(d) Penalty for importation or exportation

A person who knowingly or intentionally—

(1) imports or exports a listed chemical with intent to manufacture a controlled substance in violation of this subchapter or subchapter I;

(2) exports a listed chemical in violation of the laws of the country to which the chemical is exported or serves as a broker or trader for an international transaction involving a listed chemical, if the transaction is in violation of the laws of the country to which the chemical is exported;

(3) imports or exports a listed chemical knowing, or having reasonable cause to believe, that the chemical will be used to manufacture a controlled substance in violation of this subchapter or subchapter I;

(4) exports a listed chemical, or serves as a broker or trader for an international transaction involving a listed chemical, knowing, or having reasonable cause to believe, that the chemical will be used to manufacture a controlled substance in violation of the laws of the country to which the chemical is exported;

(5) imports or exports a listed chemical, with the intent to evade the reporting or recordkeeping requirements of section 971 of this title applicable to such importation or exportation by falsely representing to the Attorney General that the importation or exportation qualifies for a waiver of the 15-day notification requirement granted pursuant to paragraph (2) or (3) of section 971(f) of this title by misrepresenting the actual country of final destination of the listed chemical or the actual listed chemical being imported or exported;

(6) imports a listed chemical in violation of section 952 of this title, imports or exports such a chemical in violation of section 957 or 971 of this title, or transfers such a chemical in violation of section 971(d) of this title; or

(7) manufactures, possesses with intent to distribute, or distributes a listed chemical in violation of section 959 of this title.²

shall be fined in accordance with title 18, imprisoned not more than 20 years in the case of a violation of paragraph (1) or (3) involving a list I chemical or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph (1) or (3) involving a list I chemical, or both.

(Pub. L. 91–513, title III, §1010, Oct. 27, 1970, 84 Stat. 1290; Pub. L. 98–473, title II, §§225, formerly §225(a), 504, Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99–570, title I, §§1004(a), 1005(c), 1302, 1866(e), Oct. 27, 1986, 100 Stat. 3207–6, 3207-15, 3207-55; Pub. L. 100–690, title VI, §§6053(c), 6475, Nov. 18, 1988, 102 Stat. 4315, 4380; Pub. L. 101–647, title XII, §1204, title XXXV, §3599J, Nov. 29, 1990, 104 Stat. 4830, 4932; Pub. L. 103–200, §§4(b), 5(b), Dec. 17, 1993, 107 Stat. 2338, 2339; Pub. L. 103–322, title IX, §90105(a), title XXXIII, §330024(d)(2), Sept. 13, 1994, 108 Stat. 1987, 2151; Pub. L. 104–237, title I, §102(c), title III, §302(b), Oct. 3, 1996, 110 Stat. 3100, 3105; Pub. L. 104–305, §2(b)(2)(B), (C), Oct. 13, 1996, 110 Stat. 3807; Pub. L. 105–277, div. E, §2(b), Oct. 21, 1998, 112 Stat. 2681–759; Pub. L. 106–172, §3(b)(2), Feb. 18, 2000, 114 Stat. 9; Pub. L. 107–273, div. B, title III, §3005(b), Nov. 2, 2002, 116 Stat. 1806; Pub. L. 109–177, title VII, §§716(b)(1)(A), 717, Mar. 9, 2006, 120 Stat. 267; Pub. L. 110–425, §3(i), Oct. 15, 2008, 122 Stat. 4832; Pub. L. 111–220, §§2(b), 4(b), Aug. 3, 2010, 124 Stat. 2372; Pub. L. 113–260, §3(b), Dec. 18, 2014, 128 Stat. 2931; Pub. L. 115–391, title IV, §401(b), Dec. 21, 2018, 132 Stat. 5221.)

Editorial Notes

References in Text

Schedules I, II, III, IV, and V, referred to in subsec. (b), are set out in section 812(c) of this title.

Section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Prohibition Act of 2000, referred to in subsec. (b)(3), is section 3(a)(1)(B) of Pub. L. 106–172, which is set out in a note under section 812 of this title.

Amendments

2018—Subsec. (b)(1). Pub. L. 115–391, §401(b)(1), in concluding provisions, substituted "If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 15 years" for "If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not less than 20 years".

Subsec. (b)(2). Pub. L. 115–391, §401(b)(2), substituted "serious drug felony or serious violent felony" for "felony drug offense" in concluding provisions.

2014—Subsec. (a)(1). Pub. L. 113–260 inserted "825," before "952".

2010—Subsec. (b)(1). Pub. L. 111–220, §4(b)(1), in concluding provisions, substituted "$10,000,000" for "$4,000,000", "$50,000,000" for "$10,000,000", "$20,000,000" for "$8,000,000", and "$75,000,000" for "$20,000,000".

Subsec. (b)(1)(C). Pub. L. 111–220, §2(b)(1), substituted "280 grams" for "50 grams".

Subsec. (b)(2). Pub. L. 111–220, §4(b)(2), in concluding provisions, substituted "$5,000,000" for "$2,000,000", "$25,000,000" for "$5,000,000", "$8,000,000" for "$4,000,000", and "$50,000,000" for "$10,000,000".

Subsec. (b)(2)(C). Pub. L. 111–220, §2(b)(2), substituted "28 grams" for "5 grams".

2008—Subsec. (b)(3). Pub. L. 110–425, §3(i)(3), struck out before period at end ", nor shall a person so sentenced be eligible for parole during the term of such a sentence".

Subsec. (b)(4). Pub. L. 110–425, §3(i)(1), inserted "or" after "hashish,", struck out "or any quantity of a controlled substance in schedule III, IV, or V, (except a violation involving flunitrazepam and except a violation involving gamma hydroxybutyric acid)" after "hashish oil,", and substituted "sentenced in accordance with section 841(b)(1)(D) of this title" for "imprisoned not more than five years, or be fined not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If a sentence under this paragraph provides for imprisonment, the sentence shall, notwithstanding section 3583 of title 18, in addition to such term of imprisonment, include (A) a term of supervised release of not less than two years if such controlled substance is in schedule I, II, III, or (B) a term of supervised release of not less than one year if such controlled substance is in schedule IV".

Subsec. (b)(5) to (7). Pub. L. 110–425, §3(i)(2), added pars. (5) to (7).

2006—Subsec. (d)(5). Pub. L. 109–177, §716(b)(1)(A), substituted "paragraph (2) or (3) of section 971(f) of this title" for "section 971(e)(2) or (3) of this title".

Subsec. (d)(6). Pub. L. 109–177, §717, amended par. (6) generally. Prior to amendment, par. (6) read as follows: "imports or exports a listed chemical in violation of section 957 or 971 of this title; or".

2002—Subsec. (b)(1), (2). Pub. L. 107–273, §3005(b)(1), substituted "Notwithstanding section 3583 of title 18, any sentence" for "Any sentence" in concluding provisions.

Subsec. (b)(3). Pub. L. 107–273, §3005(b)(1), substituted "Notwithstanding section 3583 of title 18, any sentence" for "Any sentence".

Subsec. (b)(4). Pub. L. 107–273, §3005(b)(2), inserted "notwithstanding section 3583 of title 18," before "in addition to such term of imprisonment".

2000—Subsec. (b)(3). Pub. L. 106–172, §3(b)(2)(A), inserted "gamma hydroxybutyric acid (including when scheduled as an approved drug product for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000)," after "schedule I or II," in first sentence.

Subsec. (b)(4). Pub. L. 106–172, §3(b)(2)(B), substituted "flunitrazepam and except a violation involving gamma hydroxybutyric acid)" for "flunitrazepam)".

1998—Subsec. (b)(1)(H). Pub. L. 105–277, §2(b)(1), substituted "50 grams" and "500 grams" for "100 grams" and "1 kilogram", respectively.

Subsec. (b)(2)(H). Pub. L. 105–277, §2(b)(2), substituted "5 grams" and "50 grams" for "10 grams" and "100 grams", respectively.

1996—Subsec. (b)(3). Pub. L. 104–305, §2(b)(2)(B), inserted "or flunitrazepam," after "schedule I or II,".

Subsec. (b)(4). Pub. L. 104–305, §2(b)(2)(C), inserted "(except a violation involving flunitrazepam)" after "schedule III, IV, or V,".

Subsec. (d). Pub. L. 104–237, §302(b), in closing provisions, substituted "not more than 20 years in the case of a violation of paragraph (1) or (3) involving a list I chemical or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph (1) or (3) involving a list I chemical," for "not more than 10 years,".

Subsec. (d)(7). Pub. L. 104–237, §102(c), added par. (7).

1994—Subsec. (b)(1), (2). Pub. L. 103–322, §90105(a), in sentence in concluding provisions beginning "If any person commits", substituted "a prior conviction for a felony drug offense has become final" for "one or more prior convictions for an offense punishable under this subsection, or for a felony under any other provision of this subchapter or subchapter I of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final".

Subsec. (b)(3). Pub. L. 103–322, §90105(a), in sentence beginning "If any person commits", substituted "a prior conviction for a felony drug offense has become final" for "one or more prior convictions for an offense punishable under this subsection, or for a felony under any other provision of this subchapter or subchapter I of this chapter or other law of a State, the United States or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final".

Subsec. (d)(5), (6). Pub. L. 103–322, §330024(d)(2), amended directory language of Pub. L. 103–200, §5(b)(3). See 1993 Amendment note below.

1993—Subsec. (d). Pub. L. 103–200, §5(b), as amended by Pub. L. 103–322, §330024(d)(2), added pars. (5) and (6).

Pub. L. 103–200, §4(b), amended subsec. (d) generally. Prior to amendment, subsec. (d) read as follows: "Any person who knowingly or intentionally—

"(1) imports or exports a listed chemical with intent to manufacture a controlled substance in violation of this subchapter or, in the case of an exportation, in violation of the law of the country to which the chemical is exported; or

"(2) imports or exports a listed chemical knowing, or having reasonable cause to believe, that the listed chemical will be used to manufacture a controlled substance in violation of this subchapter or, in the case of an exportation, in violation of the law of the country to which the chemical is exported;

shall be fined in accordance with title 18, or imprisoned not more than 10 years, or both."

1990—Subsec. (b)(1)(H). Pub. L. 101–647, §1204(a), added subpar. (H).

Subsec. (b)(2). Pub. L. 101–647, §3599J, substituted "supervised" for "suspervised" in two places in concluding provisions.

Subsec. (b)(2)(H). Pub. L. 101–647, §1204(b), added subpar. (H).

1988—Subsec. (a)(3). Pub. L. 100–690, §6475, substituted "manufactures, possesses with intent to distribute, or distributes a controlled substance" for "manufactures or distributes a controlled substance".

Subsec. (d). Pub. L. 100–690, §6053(c), added subsec. (d).

1986—Pub. L. 99–570, §1005(c), amended Pub. L. 98–473, §225. See 1984 Amendment note below.

Subsec. (b)(1), (2). Pub. L. 99–570, §1302(a)(2), added pars. (1) and (2) and struck out former pars. (1) and (2) which read as follows:

"(1) In the case of a violation under subsection (a) of this section involving—

"(A) 100 grams or more of a mixture or substance containing a detectable amount of a narcotic drug in schedule I or II other than a narcotic drug consisting of—

"(i) coca leaves;

"(ii) a compound, manufacture, salt, derivative, or preparation of coca leaves; or

"(iii) a substance chemically identical thereto;

"(B) a kilogram or more of any other narcotic drug in schedule I or II;

"(C) 500 grams or more of phencyclidine (PCP);

"(D) 5 grams or more of lysergic acid diethylamide (LSD);

the person committing such violation shall be imprisoned for not more than twenty years, or fined not more than $250,000, or both.

"(2) In the case of a violation under subsection (a) of this section with respect to a controlled substance in schedule I or II, the person committing such violation shall, except as provided in paragraphs (1) and (3), be imprisoned not more than fifteen years, or fined not more than $125,000, or both. If a sentence under this paragraph provides for imprisonment, the sentence shall include a special parole term of not less than three years in addition to such term of imprisonment."

Subsec. (b)(3). Pub. L. 99–570, §1302(a)(2), added par. (3). Former par. (3) redesignated (4).

Subsec. (b)(4). Pub. L. 99–570, §1302(a)(1), (3), (b)(2), (3), redesignated former par. (3) as (4), inserted "except in the case of 100 or more marihuana plants regardless of weight," and substituted "fined not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual" for "fined not more than $50,000".

Pub. L. 99–570, §§1302(b)(1), 1866(e), made identical amendment striking out ", except as provided in paragraph (4)" after "such violation shall".

Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term" in two places.

Subsec. (c). Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term" wherever appearing, effective Nov. 1, 1987, the effective date of the repeal of subsec. (c) by Pub. L. 98–473, §225. See 1984 Amendment note below.

1984—Subsec. (b). Pub. L. 98–473, §225(a), which directed amendment of this subsection effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L. 98–473 set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure) was omitted in the general amendment of section 225 of Pub. L. 98–473 by Pub. L. 99–570, §1005(c).

Subsec. (b)(1). Pub. L. 98–473, §504(1), added par. (1). Former par. (1) redesignated (2).

Subsec. (b)(2). Pub. L. 98–473, §504(1), (2), redesignated former par. (1) as (2), inserted provisions excepting pars. (1) and (3), and substituted reference to controlled substance for reference to narcotic drug, and "$125,000" for "$25,000". Former par. (2) redesignated (3).

Subsec. (b)(3). Pub. L. 98–473, §504(1), (3), redesignated former par. (2) as (3) and substituted "less than 50 kilograms of marihuana, less than 10 kilograms of hashish, less than one kilogram of hashish oil, or any quantity of a controlled substance in schedule III, IV, or V, the person committing such violation shall, except as provided in paragraph (4)" for "a controlled substance other than a narcotic drug in schedule I or II, the person committing such violation shall", and "$50,000" for "$15,000".

Subsec. (c). Pub. L. 98–473, §225, as amended by Pub. L. 99–570, §1005(c), struck out subsec. (c) which related to special parole terms imposed under this section or section 962 of this title. Notwithstanding directory language that the amendment be made to "Section 1515 of the Controlled Substances Import and Export Act (21 U.S.C. 960)", the amendment was executed to this section as the probable intent of Congress.

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Amendment by Pub. L. 115–391 applicable to any offense that was committed before Dec. 21, 2018, if a sentence for the offense has not been imposed as of Dec. 21, 2018, see section 401(c) of Pub. L. 115–391, set out as a note under section 802 of this title.

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

Effective Date of 1994 Amendment

Amendment by section 330024(d)(2) of Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title.

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1988 Amendment

Amendment by section 6053(c) of Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date of 1986 Amendment

Amendment by section 1004(a) of Pub. L. 99–570 effective on date of taking effect of section 3583 of Title 18, Crimes and Criminal Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99–570 set out as a note under section 841 of this title.

Effective Date of 1984 Amendment

Amendment by section 225 of Pub. L. 98–473 effective Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such amendment, see section 235(a)(1) of Pub. L. 98–473, set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

¹ So in original. The period probably should be a semicolon.

² So in original. The period probably should be a comma.

§960a. Foreign terrorist organizations, terrorist persons and groups

(a) Prohibited acts

Whoever engages in conduct that would be punishable under section 841(a) ¹ of this title if committed within the jurisdiction of the United States, or attempts or conspires to do so, knowing or intending to provide, directly or indirectly, anything of pecuniary value to any person or organization that has engaged or engages in terrorist activity (as defined in section 1182(a)(3)(B) of title 8) or terrorism (as defined in section 2656f(d)(2) of title 22), shall be sentenced to a term of imprisonment of not less than twice the minimum punishment under section 841(b)(1),¹ and not more than life, a fine in accordance with the provisions of title 18, or both. Notwithstanding section 3583 of title 18, any sentence imposed under this subsection shall include a term of supervised release of at least 5 years in addition to such term of imprisonment.

(b) Jurisdiction

There is jurisdiction over an offense under this section if—

(1) the prohibited drug activity or the terrorist offense is in violation of the criminal laws of the United States;

(2) the offense, the prohibited drug activity, or the terrorist offense occurs in or affects interstate or foreign commerce;

(3) an offender provides anything of pecuniary value for a terrorist offense that causes or is designed to cause death or serious bodily injury to a national of the United States while that national is outside the United States, or substantial damage to the property of a legal entity organized under the laws of the United States (including any of its States, districts, commonwealths, territories, or possessions) while that property is outside of the United States;

(4) the offense or the prohibited drug activity occurs in whole or in part outside of the United States (including on the high seas), and a perpetrator of the offense or the prohibited drug activity is a national of the United States or a legal entity organized under the laws of the United States (including any of its States, districts, commonwealths, territories, or possessions); or

(5) after the conduct required for the offense occurs an offender is brought into or found in the United States, even if the conduct required for the offense occurs outside the United States.

(c) Proof requirements

To violate subsection (a), a person must have knowledge that the person or organization has engaged or engages in terrorist activity (as defined in section 1182(a)(3)(B) of title 8) or terrorism (as defined in section 2656f(d)(2) of title 22).

(d) Definition

As used in this section, the term "anything of pecuniary value" has the meaning given the term in section 1958(b)(1) of title 18.

(Pub. L. 91–513, title III, §1010A, as added Pub. L. 109–177, title I, §122, Mar. 9, 2006, 120 Stat. 225.)

Editorial Notes

References in Text

Section 841, referred to in the original in subsec. (a), probably should have been a reference to section 401 of Pub. L. 91–513, which is classified to section 841 of this title. Pub. L. 91–513 does not contain a section 841.

¹ See References in Text note below.

§961. Prohibited acts B

Any person who violates section 954 of this title or fails to notify the Attorney General of an importation or exportation under section 971 of this title shall be subject to the following penalties:

(1) Except as provided in paragraph (2), any such person shall, with respect to any such violation, be subject to a civil penalty of not more than $25,000. Sections 842(c)(1) and (c)(3) of this title shall apply to any civil penalty assessed under this paragraph.

(2) If such a violation is prosecuted by an information or indictment which alleges that the violation was committed knowingly or intentionally and the trier of fact specifically finds that the violation was so committed, such person shall be sentenced to imprisonment for not more than one year or a fine of not more than $25,000 or both.

(Pub. L. 91–513, title III, §1011, Oct. 27, 1970, 84 Stat. 1290; Pub. L. 100–690, title VI, §6053(d), Nov. 18, 1988, 102 Stat. 4316.)

Editorial Notes

Amendments

1988—Pub. L. 100–690 inserted "or fails to notify the Attorney General of an importation or exportation under section 971 of this title".

Statutory Notes and Related Subsidiaries

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§962. Second or subsequent offenses

(a) Term of imprisonment and fine

Any person convicted of any offense under this subchapter is, if the offense is a second or subsequent offense, punishable by a term of imprisonment twice that otherwise authorized, by twice the fine otherwise authorized, or by both. If the conviction is for an offense punishable under section 960(b) of this title, and if it is the offender's second or subsequent offense, the court shall impose, in addition to any term of imprisonment and fine, twice the term of supervised release otherwise authorized.

(b) Determination of status

For purposes of this section, a person shall be considered convicted of a second or subsequent offense if, prior to the commission of such offense, one or more prior convictions of such person for a felony drug offense have become final.

(c) Procedures applicable

Section 851 of this title shall apply with respect to any proceeding to sentence a person under this section.

(Pub. L. 91–513, title III, §1012, Oct. 27, 1970, 84 Stat. 1290; Pub. L. 98–473, title II, §§225(b), 505, Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99–570, title I, §§1004(a), 1005(c), Oct. 27, 1986, 100 Stat. 3207–6; Pub. L. 103–322, title IX, §90105(b), Sept. 13, 1994, 108 Stat. 1988.)

Editorial Notes

Amendments

1994—Subsec. (b). Pub. L. 103–322 substituted "one or more prior convictions of such person for a felony drug offense have become final" for "one or more prior convictions of him for a felony under any provision of this subchapter or subchapter I of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant drugs, have become final".

1986—Subsec. (a). Pub. L. 99–570, §1005(c), amended Pub. L. 98–473, §225. See 1984 Amendment note below.

Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term".

1984—Subsec. (a). Pub. L. 98–473, §225(b), which directed amendment of this section effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L. 98–473 set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure) was omitted in the general amendment of section 225 of Pub. L. 98–473 by Pub. L. 99–570, §1005(c).

Subsec. (b). Pub. L. 98–473, §505, inserted references to laws of a State or of a foreign country.

Statutory Notes and Related Subsidiaries

Effective Date of 1986 Amendment

Amendment by section 1004(a) of Pub. L. 99–570 effective on date of taking effect of section 3583 of Title 18, Crimes and Criminal Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99–570 set out as a note under section 841 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§963. Attempt and conspiracy

Any person who attempts or conspires to commit any offense defined in this subchapter shall be subject to the same penalties as those prescribed for the offense, the commission of which was the object of the attempt or conspiracy.

(Pub. L. 91–513, title III, §1013, Oct. 27, 1970, 84 Stat. 1291; Pub. L. 100–690, title VI, §6470(a), Nov. 18, 1988, 102 Stat. 4377.)

Editorial Notes

Amendments

1988—Pub. L. 100–690 substituted "shall be subject to the same penalties as those prescribed for the offense" for "is punishable by imprisonment or fine or both which may not exceed the maximum punishment prescribed for the offense".

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§964. Additional penalties

Any penalty imposed for violation of this subchapter shall be in addition to, and not in lieu of, any civil or administrative penalty or sanction authorized by law.

(Pub. L. 91–513, title III, §1014, Oct. 27, 1970, 84 Stat. 1291.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

§965. Applicability of part E of subchapter I

Part E of subchapter I shall apply with respect to functions of the Attorney General (and of officers and employees of the Bureau of Narcotics and Dangerous Drugs) under this subchapter, to administrative and judicial proceedings under this subchapter, and to violations of this subchapter, to the same extent that such part applies to functions of the Attorney General (and such officers and employees) under subchapter I, to such proceedings under subchapter I, and to violations of subchapter I. For purposes of the application of this section to section 880 or 881 of this title, any reference in such section 880 or 881 of this title to "this subchapter" shall be deemed to be a reference to this subchapter, any reference to section 823 of this title shall be deemed to be a reference to section 958 of this title, and any reference to section 822(d) of this title shall be deemed to be a reference to section 957(b)(2) of this title.

(Pub. L. 91–513, title III, §1015, Oct. 27, 1970, 84 Stat. 1291; Pub. L. 95–633, title III, §301(b), Nov. 10, 1978, 92 Stat. 3778.)

Editorial Notes

Amendments

1978—Pub. L. 95–633 inserted "or 881" after "880" wherever appearing.

Executive Documents

Transfer of Functions

For abolition of Bureau of Narcotics and Dangerous Drugs, including Office of Director thereof, and creation of a single comprehensive agency for enforcement of drug laws by Reorg. Plan No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, see note set out under section 881 of this title.

§966. Authority of Secretary of the Treasury

Nothing in this chapter shall derogate from the authority of the Secretary of the Treasury under the customs and related laws.

(Pub. L. 91–513, title III, §1016, Oct. 27, 1970, 84 Stat. 1291.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

§967. Smuggling of controlled substances; investigations; oaths; subpenas; witnesses; evidence; production of records; territorial limits; fees and mileage of witnesses

For the purpose of any investigation which, in the opinion of the Secretary of the Treasury, is necessary and proper to the enforcement of section 545 of title 18 (relating to smuggling goods into the United States) with respect to any controlled substance (as defined in section 802 of this title), the Secretary of the Treasury may administer oaths and affirmations, subpena witnesses, compel their attendance, take evidence, and require the production of records (including books, papers, documents and tangible things which constitute or contain evidence) relevant or material to the investigation. The attendance of witnesses and the production of records may be required from any place within the customs territory of the United States, except that a witness shall not be required to appear at any hearing distant more than 100 miles from the place where he was served with subpena. Witnesses summoned by the Secretary shall be paid the same fees and mileage that are paid witnesses in the courts of the United States. Oaths and affirmations may be made at any place subject to the jurisdiction of the United States.

(Aug. 11, 1955, ch. 800, §1, 69 Stat. 684; Pub. L. 91–513, title III, §1102(t), Oct. 27, 1970, 84 Stat. 1294.)

Editorial Notes

Codification

Section was not enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970 which comprises this chapter.

Section was formerly classified to section 1034 of Title 31 prior to the general revision and enactment of Title 31, Money and Finance, by Pub. L. 97–258, §1, Sept. 13, 1982, 96 Stat. 877.

Section was also formerly classified to section 198a of this title.

Amendments

1970—Pub. L. 91–513 substituted "section 545 of title 18 (relating to smuggling goods into the United States) with respect to any controlled substance (as defined in section 802 of this title)" for "the laws of the United States relating to narcotic drugs and marihuana" and substituted the customs territory of the United States for any State or any territory or other place subject to the jurisdiction of the United States is the defined area from within which the attendance of witnesses and the production of records may be required, and struck out provisions making the discretion of the Secretary of the Treasury the determinative factor as to what is relevant or material to the investigation.

Statutory Notes and Related Subsidiaries

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of amendment of this section by section 1102 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title.

§968. Service of subpena; proof of service

A subpena of the Secretary of the Treasury may be served by any person designated in the subpena to serve it. Service upon a natural person may be made by personal delivery of the subpena to him. Service may be made upon a domestic or foreign corporation or upon a partnership or other unincorporated association which is subject to suit under a common name, by delivering the subpena to an officer, a managing or general agent, or to any other agent authorized by appointment or by law to receive service of process. The affidavit of the person serving the subpena entered on a true copy thereof by the person serving it shall be proof of service.

(Aug. 11, 1955, ch. 800, §2, 69 Stat. 685.)

Editorial Notes

Codification

Section was not enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970 which comprises this chapter.

Section was formerly classified to section 1035 of Title 31 prior to the general revision and enactment of Title 31, Money and Finance, by Pub. L. 97–258, §1, Sept. 13, 1982, 96 Stat. 877.

Section was also formerly classified to section 198b of this title.

§969. Contempt proceedings

In case of contumacy by, or refusal to obey a subpena issued to, any person, the Secretary of the Treasury may invoke the aid of any court of the United States within the jurisdiction of which the investigation is carried on or of which the subpenaed person is an inhabitant, carries on business or may be found, to compel compliance with the subpena of the Secretary of the Treasury. The court may issue an order requiring the subpenaed person to appear before the Secretary of the Treasury there to produce records, if so ordered, or to give testimony touching the matter under investigation. Any failure to obey the order of the court may be punished by the court as a contempt thereof. All process in any such case may be served in the judicial district whereof the subpenaed person is an inhabitant or wherever he may be found.

(Aug. 11, 1955, ch. 800, §3, 69 Stat. 685.)

Editorial Notes

Codification

Section was not enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970 which comprises this chapter.

Section was formerly classified to section 1036 of Title 31 prior to the general revision and enactment of Title 31, Money and Finance, by Pub. L. 97–258, §1, Sept. 13, 1982, 96 Stat. 877.

Section was also formerly classified to section 198c of this title.

§970. Criminal forfeitures

Section 853 of this title, relating to criminal forfeitures, shall apply in every respect to a violation of this subchapter punishable by imprisonment for more than one year.

(Pub. L. 91–513, title III, §1017, as added Pub. L. 98–473, title II, §307, Oct. 12, 1984, 98 Stat. 2051.)

§971. Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals

(a) Notification prior to transaction

Each regulated person who imports or exports a listed chemical shall notify the Attorney General of the importation or exportation not later than 15 days before the transaction is to take place.

(b) Regular customers or importers

(1) The Attorney General shall provide by regulation for circumstances in which the requirement of subsection (a) does not apply to a transaction between a regulated person and a regular customer or to a transaction that is an importation by a regular importer. At the time of any importation or exportation constituting a transaction referred to in the preceding sentence, the regulated person shall notify the Attorney General of the transaction.

(2) The regulations under this subsection shall provide that the initial notification under subsection (a) with respect to a customer of a regulated person or to an importer shall, upon the expiration of the 15-day period, qualify the customer as a regular customer or the importer as a regular importer, unless the Attorney General otherwise notifies the regulated person in writing.

(c) Suspension of importation or exportation; disqualification of regular customers or importers; hearing

(1) The Attorney General may order the suspension of any importation or exportation of a listed chemical (other than a regulated transaction to which the requirement of subsection (a) does not apply by reason of subsection (b)) or may disqualify any regular customer or regular importer on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance (without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred). From and after the time when the Attorney General provides written notice of the order (including a statement of the legal and factual basis for the order) to the regulated person, the regulated person may not carry out the transaction.

(2) Upon written request to the Attorney General, a regulated person to whom an order applies under paragraph (1) is entitled to an agency hearing on the record in accordance with subchapter II of chapter 5 of title 5. The hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time, if so requested by the regulated person.

(d) Information required in notice; updated notice for change in circumstances

(1)(A) Information provided in a notice under subsection (a) or (b) shall include the name of the person to whom the importer or exporter involved intends to transfer the listed chemical involved, and the quantity of such chemical to be transferred.

(B) In the case of a notice under subsection (b) submitted by a regular importer, if the transferee identified in the notice is not a regular customer, such importer may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the notice is submitted to the Attorney General.

(C) After a notice under subsection (a) or (b) is submitted to the Attorney General, if circumstances change and the importer or exporter will not be transferring the listed chemical to the transferee identified in the notice, or will be transferring a greater quantity of the chemical than specified in the notice, the importer or exporter shall update the notice to identify the most recent prospective transferee or the most recent quantity or both (as the case may be) and may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the update is submitted to the Attorney General, except that such 15-day restriction does not apply if the prospective transferee identified in the update is a regular customer. The preceding sentence applies with respect to changing circumstances regarding a transferee or quantity identified in an update to the same extent and in the same manner as such sentence applies with respect to changing circumstances regarding a transferee or quantity identified in the original notice under subsection (a) or (b).

(D) In the case of a transfer of a listed chemical that is subject to a 15-day restriction under subparagraph (B) or (C), the transferee involved shall, upon the expiration of the 15-day period, be considered to qualify as a regular customer, unless the Attorney General otherwise notifies the importer or exporter involved in writing.

(2) With respect to a transfer of a listed chemical with which a notice or update referred to in paragraph (1) is concerned:

(A) The Attorney General, in accordance with the same procedures as apply under subsection (c)(2)—

(i) may order the suspension of the transfer of the listed chemical by the importer or exporter involved, except for a transfer to a regular customer, on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance (without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred), subject to the Attorney General ordering such suspension before the expiration of the 15-day period referred to in paragraph (1) with respect to the importation or exportation (in any case in which such a period applies); and

(ii) may, for purposes of clause (i) and paragraph (1), disqualify a regular customer on such ground.

(B) From and after the time when the Attorney General provides written notice of the order under subparagraph (A) (including a statement of the legal and factual basis for the order) to the importer or exporter, the importer or exporter may not carry out the transfer.

(3) For purposes of this subsection:

(A) The terms "importer" and "exporter" mean a regulated person who imports or exports a listed chemical, respectively.

(B) The term "transfer", with respect to a listed chemical, includes the sale of the chemical.

(C) The term "transferee" means a person to whom an importer or exporter transfers a listed chemical.

(e) Broker or trader for international transaction in listed chemical

A person located in the United States who is a broker or trader for an international transaction in a listed chemical that is a regulated transaction solely because of that person's involvement as a broker or trader shall, with respect to that transaction, be subject to all of the notification, reporting, recordkeeping, and other requirements placed upon exporters of listed chemicals by this subchapter and subchapter I.

(f) Application of notification requirement to exports of listed chemical; waiver

(1) The Attorney General may by regulation require that the 15-day notification requirement of subsection (a) apply to all exports of a listed chemical to a specified country, regardless of the status of certain customers in such country as regular customers, if the Attorney General finds that such notification is necessary to support effective chemical diversion control programs or is required by treaty or other international agreement to which the United States is a party.

(2) The Attorney General may by regulation waive the 15-day notification requirement for exports of a listed chemical to a specified country if the Attorney General determines that such notification is not required for effective chemical diversion control. If the notification requirement is waived, exporters of the listed chemical shall be required to submit to the Attorney General reports of individual exportations or periodic reports of such exportation of the listed chemical, at such time or times and containing such information as the Attorney General shall establish by regulation.

(3) The Attorney General may by regulation waive the 15-day notification requirement for the importation of a listed chemical if the Attorney General determines that such notification is not necessary for effective chemical diversion control. If the notification requirement is waived, importers of the listed chemical shall be required to submit to the Attorney General reports of individual importations or periodic reports of the importation of the listed chemical, at such time or times and containing such information as the Attorney General shall establish by regulation.

(g) Return declaration

Within 30 days after a transaction covered by this section is completed, the importer or exporter shall send the Attorney General a return declaration containing particulars of the transaction, including the date, quantity, chemical, container, name of transferees, and such other information as the Attorney General may specify in regulations. For importers, a single return declaration may include the particulars of both the importation and distribution. If the importer has not distributed all chemicals imported by the end of the initial 30-day period, the importer shall file supplemental return declarations no later than 30 days from the date of any further distribution, until the distribution or other disposition of all chemicals imported pursuant to the import notification or any update are accounted for.

(h) Importation and distribution of ephedrine, pseudoephedrine, or phenylpropanolamine

(1) With respect to a regulated person importing ephedrine, pseudoephedrine, or phenylpropanolamine (referred to in this section as an "importer"), a notice of importation under subsection (a) or (b) shall include all information known to the importer on the chain of distribution of such chemical from the manufacturer to the importer.

(2) For the purpose of preventing or responding to the diversion of ephedrine, pseudoephedrine, or phenylpropanolamine for use in the illicit production of methamphetamine, the Attorney General may, in the case of any person who is a manufacturer or distributor of such chemical in the chain of distribution referred to in paragraph (1) (which person is referred to in this subsection as a "foreign-chain distributor"), request that such distributor provide to the Attorney General information known to the distributor on the distribution of the chemical, including sales.

(3) If the Attorney General determines that a foreign-chain distributor is refusing to cooperate with the Attorney General in obtaining the information referred to in paragraph (2), the Attorney General may, in accordance with procedures that apply under subsection (c), issue an order prohibiting the importation of ephedrine, pseudoephedrine, or phenylpropanolamine in any case in which such distributor is part of the chain of distribution for such chemical. Not later than 60 days prior to issuing the order, the Attorney General shall publish in the Federal Register a notice of intent to issue the order. During such 60-day period, imports of the chemical with respect to such distributor may not be restricted under this paragraph.

(Pub. L. 91–513, title III, §1018, as added Pub. L. 100–690, title VI, §6053(a), Nov. 18, 1988, 102 Stat. 4314; amended Pub. L. 103–200, §§4(a), 5(a), 9(b), Dec. 17, 1993, 107 Stat. 2338–2340; Pub. L. 103–322, title XXXIII, §330024(c), Sept. 13, 1994, 108 Stat. 2150; Pub. L. 109–177, title VII, §§716(a), (b)(1)(B), 721, Mar. 9, 2006, 120 Stat. 265, 267.)

Editorial Notes

Amendments

2006—Subsec. (b)(1). Pub. L. 109–177, §716(a)(1), substituted "or to a transaction that is an importation by a regular importer" for "or to an importation by a regular importer".

Subsec. (c)(1). Pub. L. 109–177, §716(b)(1)(B), inserted "(without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred)" after "manufacture of a controlled substance".

Subsecs. (d) to (f). Pub. L. 109–177, §716(a)(2), (3), added subsec. (d) and redesignated former subsecs. (d) and (e) as (e) and (f), respectively.

Subsec. (g). Pub. L. 109–177, §716(a)(4), added subsec. (g).

Subsec. (h). Pub. L. 109–177, §721, added subsec. (h).

1994—Subsecs. (b)(1), (2), (c)(1). Pub. L. 103–322, §330024(c)(2), made technical amendment to directory language of Pub. L. 103–200, §9(b). See 1993 Amendment notes below.

Subsec. (e). Pub. L. 103–322, §330024(c)(1), made technical amendment to directory language of Pub. L. 103–200, §5(a). See 1993 Amendment note below.

1993—Subsec. (b)(1). Pub. L. 103–200, §9(b)(1)(A), as amended by Pub. L. 103–322, §330024(c)(2), substituted "to an importation by a regular importer" for "regular supplier of the regulated person".

Subsec. (b)(2). Pub. L. 103–200, §9(b)(1)(B), as amended by Pub. L. 103–322, §330024(c)(2), substituted "a customer of a regulated person or to an importer" for "a customer or supplier of a regulated person" and "the importer as a regular importer" for "regular supplier".

Subsec. (c)(1). Pub. L. 103–200, §9(b)(2), as amended by Pub. L. 103–322, §330024(c)(2), substituted "regular importer" for "regular supplier".

Subsec. (d). Pub. L. 103–200, §4(a), added subsec. (d).

Subsec. (e). Pub. L. 103–200, §5(a), as amended by Pub. L. 103–322, §330024(c)(1), added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title.

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date

Pub. L. 100–690, title VI, §6053(b), Nov. 18, 1988, 102 Stat. 4315, provided that:

"(1) Not later than 45 days after the date of the enactment of this Act [Nov. 18, 1988], the Attorney General shall forward to the Director of the Office of Management and Budget proposed regulations required by the amendment made by subsection (a) [enacting this section].

"(2) Not later than 55 days after the date of the enactment of this Act, the Director of the Office of Management and Budget shall—

"(A) review such proposed regulations of the Attorney General; and

"(B) forward any comments and recommendations for modifications to the Attorney General.

"(3) Not later than 60 days after the date of the enactment of this Act, the Attorney General shall publish the proposed final regulations required by the amendment made by subsection (a).

"(4) Not later than 120 days after the date of the enactment of this Act, the Attorney General shall promulgate final regulations required by the amendment made by subsection (a).

"(5) Subsection (a) of section 1018 of the Controlled Substances Import and Export Act [subsection (a) of this section], as added by subsection (a) of this section, shall take effect 90 days after the promulgation of the final regulations under paragraph (4).

"(6) Each regulated person shall provide to the Attorney General the identity of any regular customer or regular supplier of the regulated person not later than 30 days after the promulgation of the final regulations under paragraph (4). Not later than 60 days after the end of such 30-day period, each regular customer and regular supplier so identified shall be a regular customer or regular supplier for purposes of any applicable exception from the requirement of subsection (a) of such section 1018, unless the the [sic] Attorney General otherwise notifies the regulated person in writing."

Section effective 120 days after Nov. 18, 1988 [except subsec. (a), see above], see section 6061 of Pub. L. 100–690, set out as an Effective Date of 1988 Amendment note under section 802 of this title.

Exception for Iodine to Importation and Exportation Requirements for Listed Chemicals

Pub. L. 104–237, title II, §204(b), Oct. 3, 1996, 110 Stat. 3102, provided that:

"(1) Iodine shall not be subject to the requirements for listed chemicals provided in section 1018 of the Controlled Substances Import and Export Act (21 U.S.C. 971).

"(2) Effect of Exception.—The exception made by paragraph (1) shall not limit the authority of the Attorney General to impose the requirements for listed chemicals provided in section 1018 of the Controlled Substances Import and Export Act (21 U.S.C. 971)."

CHAPTER 14—ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND ACTIVITIES

§§1001 to 1007. Repealed. Pub. L. 97–35, title V, §587(a)(3), Aug. 13, 1981, 95 Stat. 480

Section 1001, Pub. L. 91–527, §2, Dec. 3, 1970, 84 Stat. 1385; Pub. L. 93–422, §2(b), Sept. 21, 1974, 88 Stat. 1154; Pub. L. 95–336, §2, Aug. 4, 1978, 92 Stat. 451, set forth Congressional declaration of purpose for Alcohol and Drug Abuse Education Act.

Section 1002, Pub. L. 91–527, §3, Dec. 3, 1970, 84 Stat. 1386; Pub. L. 93–422, §2(c), Sept. 21, 1974, 88 Stat. 1155; Pub. L. 95–336, §§3, 4, Aug. 4, 1978, 92 Stat. 451, 452; S. Res. 30, Mar. 7, 1979; Pub. L. 96–88, title III, §301(a)(1), (2)(Q), (b)(1), title V, §507, Oct. 17, 1979, 93 Stat. 677, 678, 692, set forth grant and contract authority, etc., for projects and programs.

Section 1003, Pub. L. 91–527, §4, Dec. 3, 1970, 84 Stat. 1387; Pub. L. 93–422, §2(d), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 96–88, title III, §301(a)(1), title V, §507, Oct. 17, 1979, 93 Stat. 677, 692, related to recordkeeping requirements, and access to and inspection of records.

Section 1004, Pub. L. 91–527, §5, Dec. 3, 1970, 84 Stat. 1388; Pub. L. 93–422, §2(e), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 96–88, title V, §508(i), Oct. 17, 1979, 93 Stat. 693, related to technical assistance to local agencies, etc.

Section 1005, Pub. L. 91–527, §6, Dec. 3, 1970, 84 Stat. 1388, related to nature of payments.

Section 1006, Pub. L. 91–527, §7, Dec. 3, 1970, 84 Stat. 1388, related to utilization of services and facilities of Federal agencies and public and private agencies and institutions.

Section 1007, Pub. L. 91–527, §8, Dec. 3, 1970, 84 Stat. 1388; Pub. L. 93–422, §2(f), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 95–336, §5, Aug. 4, 1978, 92 Stat. 453; Pub. L. 96–88, title III, §301(a)(1), (2)(Q), title V, §507, Oct. 17, 1979, 93 Stat. 677, 678, 692, defined "Secretary" and "State".

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Oct. 1, 1982, see section 587(a) of Pub. L. 97–35, set out as section 3863(a) of Title 20, Education.

CHAPTER 15—EGG PRODUCTS INSPECTION

        

§1031. Congressional statement of findings

Eggs and egg products are an important source of the Nation's total supply of food, and are used in food in various forms. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential, in the public interest, that the health and welfare of consumers be protected by the adoption of measures prescribed herein for assuring that eggs and egg products distributed to them and used in products consumed by them are wholesome, otherwise not adulterated, and properly labeled and packaged. Lack of effective regulation for the handling or disposition of unwholesome, otherwise adulterated, or improperly labeled or packaged egg products and certain qualities of eggs is injurious to the public welfare and destroys markets for wholesome, not adulterated, and properly labeled and packaged eggs and egg products and results in sundry losses to producers and processors, as well as injury to consumers. Unwholesome, otherwise adulterated, or improperly labeled or packaged products can be sold at lower prices and compete unfairly with the wholesome, not adulterated, and properly labeled and packaged products, to the detriment of consumers and the public generally. It is hereby found that all egg products and the qualities of eggs which are regulated under this chapter are either in interstate or foreign commerce, or substantially affect such commerce, and that regulation by the Secretary of Agriculture and the Secretary of Health and Human Services, and cooperation by the States and other jurisdictions, as contemplated by this chapter, are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.

(Pub. L. 91–597, §2, Dec. 29, 1970, 84 Stat. 1620; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out below and Tables.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in text pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date

Pub. L. 91–597, §29, Dec. 29, 1970, 84 Stat. 1635, provided that: "The provisions of this Act [enacting this chapter, amending sections 633 and 636 of Title 15, Commerce and Trade, and enacting provisions set out as notes under this section] with respect to egg products shall take effect six months after enactment [Dec. 29, 1970]. Otherwise, this Act shall take effect eighteen months after enactment."

Short Title

Pub. L. 91–597, §1, Dec. 29, 1970, 84 Stat. 1620, provided: "That this Act [enacting this chapter, amending sections 633 and 636 of Title 15, Commerce and Trade, and enacting provisions set as notes under this section] may be cited as the 'Egg Products Inspection Act'."

Maintenance of Eggs at Proper Temperature

Pub. L. 102–237, title X, §1012(a), Dec. 13, 1991, 105 Stat. 1899, provided that:

"(1) Findings.—Congress finds that—

"(A) food borne illness is a serious health problem;

"(B) its incidence can be reduced through proper handling of food; and

"(C) eggs are perishable and therefore are particularly susceptible to supporting microbial growth if proper temperature controls are not maintained.

"(2) Purposes.—It is the purpose of this section [amending sections 1034, 1037, 1041, 1042, 1046, and 1052 of this title and enacting provisions set out as a note under section 1034 of this title] to prescribe the temperature at which eggs are maintained in order to reduce the potential for harmful microbial growth to protect the health and welfare of consumers."

§1032. Congressional declaration of policy

It is hereby declared to be the policy of the Congress to provide for the inspection of certain egg products, restrictions upon the disposition of certain qualities of eggs, and uniformity of standards for eggs, and otherwise regulate the processing and distribution of eggs and egg products as hereinafter prescribed to prevent the movement or sale for human food, of eggs and egg products which are adulterated or misbranded or otherwise in violation of this chapter.

(Pub. L. 91–597, §3, Dec. 29, 1970, 84 Stat. 1621.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1033. Definitions

For purposes of this chapter—

(a) The term "adulterated" applies to any egg or egg product under one or more of the following circumstances—

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;

(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food;

(B) if it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 346a of this title;

(C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title;

(D) if it bears or contains any color additive which is unsafe within the meaning of section 379e of this title: Provided, That an article which is not otherwise deemed adulterated under clause (B), (C), or (D) shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive, in or on such article, is prohibited by regulations of the Secretary in official plants;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for human food;

(4) if it has been prepared, packaged, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

(5) if it is an egg which has been subjected to incubation or the product of any egg which has been subjected to incubation;

(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title; or

(8) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

(b) The term "capable of use as human food" shall apply to any egg or egg product, unless it is denatured, or otherwise identified, as required by regulations prescribed by the Secretary to deter its use as human food.

(c) The term "commerce" means interstate, foreign, or intrastate commerce.

(d) The term "container" or "package" includes any box, can, tin, plastic, or other receptacle, wrapper, or cover.

(1) The term "immediate container" means any consumer package; or any other container in which egg products, not consumer packaged, are packed.

(2) The term "shipping container" means any container used in packaging a product packed in an immediate container.

(e) The term "egg handler" means any person who engages in any business in commerce which involves buying or selling any eggs (as a poultry producer or otherwise), or processing any egg products, or otherwise using any eggs in the preparation of human food.

(f) The term "egg product" means any dried, frozen, or liquid eggs, with or without added ingredients, excepting products which contain eggs only in a relatively small proportion or historically have not been, in the judgment of the Secretary, considered by consumers as products of the egg food industry, and which may be exempted by the Secretary under such conditions as he may prescribe to assure that the egg ingredients are not adulterated and such products are not represented as egg products.

(g) The term "egg" means the shell egg of the domesticated chicken, turkey, duck, goose, or guinea.

(1) The term "check" means an egg that has a broken shell or crack in the shell but has its shell membranes intact and contents not leaking.

(2) The term "clean and sound shell egg" means any egg whose shell is free of adhering dirt or foreign material and is not cracked or broken.

(3) The term "dirty egg" means an egg that has a shell that is unbroken and has adhering dirt or foreign material.

(4) The term "incubator reject" means an egg that has been subjected to incubation and has been removed from incubation during the hatching operations as infertile or otherwise unhatchable.

(5) The term "inedible" means eggs of the following descriptions: black rots, yellow rots, white rots, mixed rots (addled eggs), sour eggs, eggs with green whites, eggs with stuck yolks, moldy eggs, musty eggs, eggs showing blood rings, and eggs containing embryo chicks (at or beyond the blood ring stage).

(6) The term "leaker" means an egg that has a crack or break in the shell and shell membranes to the extent that the egg contents are exposed or are exuding or free to exude through the shell.

(7) The term "loss" means an egg that is unfit for human food because it is smashed or broken so that its contents are leaking; or overheated, frozen, or contaminated; or an incubator reject; or because it contains a bloody white, large meat spots, a large quantity of blood, or other foreign material.

(8) The term "restricted egg" means any check, dirty egg, incubator reject, inedible, leaker, or loss.

(h) The term "Fair Packaging and Labeling Act" [15 U.S.C. 1451 et seq.] means the Act so entitled, approved November 3, 1966 (80 Stat. 1296), and Acts amendatory thereof or supplementary thereto.

(i) The term "Federal Food, Drug, and Cosmetic Act" [21 U.S.C. 301 et seq.] means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto.

(j) The term "inspection" means the application of such inspection methods and techniques as are deemed necessary by the responsible Secretary to carry out the provisions of this chapter.

(k) The term "inspector" means:

(1) any employee or official of the United States Government authorized to inspect eggs or egg products under the authority of this chapter; or

(2) any employee or official of the government of any State or local jurisdiction authorized by the Secretary to inspect eggs or egg products under the authority of this chapter, under an agreement entered into between the Secretary and the appropriate State or other agency.

(l) The term "misbranded" shall apply to egg products which are not labeled and packaged in accordance with the requirements prescribed by regulations of the Secretary under section 1036 of this title.

(m) The term "official certificate" means any certificate prescribed by regulations of the Secretary for issuance by an inspector or other person performing official functions under this chapter.

(n) The term "official device" means any device prescribed or authorized by the Secretary for use in applying any official mark.

(o) The term "official inspection legend" means any symbol prescribed by regulations of the Secretary showing that egg products were inspected in accordance with this chapter.

(p) The term "official mark" means the official inspection legend or any other symbol prescribed by regulations of the Secretary to identify the status of any article under this chapter.

(q) The term "official plant" means any plant, as determined by the Secretary, at which inspection of the processing of egg products is maintained by the Department of Agriculture under the authority of this chapter.

(r) The term "official standards" means the standards of quality, grades, and weight classes for eggs, in effect upon the effective date of this chapter, or as thereafter amended, under the Agricultural Marketing Act of 1946 (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq.).

(s) The term "pasteurize" means the subjecting of each particle of egg products to heat or other treatments to destroy harmful viable micro-organisms by such processes as may be prescribed by regulations of the Secretary.

(t) The term "person" means any individual, partnership, corporation, association, or other business unit.

(u) The terms "pesticide chemical," "food additive," "color additive," and "raw agricultural commodity" shall have the same meaning for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(v) The term "plant" means any place of business where egg products are processed.

(w) The term "processing" means manufacturing egg products, including breaking eggs or filtering, mixing, blending, pasteurizing, stabilizing, cooling, freezing, drying, or packaging egg products.

(x) The term "Secretary" means the Secretary of Agriculture or his delegate.

(y) The term "State" means any State of the United States, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, and the District of Columbia.

(z) The term "United States" means the States.

(Pub. L. 91–597, §4, Dec. 29, 1970, 84 Stat. 1621; Pub. L. 102–571, title I, §107(15), Oct. 29, 1992, 106 Stat. 4499.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (h), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (i) and (u), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

The effective date of this chapter, referred to in subsec. (r), means the effective date of Pub. L. 91–597. For such effective date, see Effective Date note set out under section 1031 of this title.

The Agricultural Marketing Act of 1946, referred to in subsec. (r), is title II of act Aug. 14, 1946, ch. 966, 60 Stat. 1087, which is classified generally to chapter 38 (§1621 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 1621 of Title 7 and Tables.

Amendments

1992—Subsec. (a)(2)(D). Pub. L. 102–571 substituted "379e" for "376".

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1034. Inspection of egg products

(a) Processing operations and establishments subject to coverage; rules and regulations

For the purpose of preventing the entry into or flow or movement in commerce of, or the burdening of commerce by, any egg product which is capable of use as human food and is misbranded or adulterated, the Secretary shall, whenever processing operations are being conducted, cause continuous inspection to be made, in accordance with the regulations promulgated under this chapter, of the processing of egg products, in each plant processing egg products for commerce, unless exempted under section 1044 of this title. Without restricting the application of the preceding sentence to other kinds of establishments within its provisions, any food manufacturing establishment, institution, or restaurant which uses any eggs that do not meet the requirements of section 1044(a)(1) of this title in the preparation of any articles for human food shall be deemed to be a plant processing egg products, with respect to such operations.

(b) Authority of Secretary to retain, segregate, and reinspect eggs and egg products

The Secretary, at any time, shall cause such retention, segregation, and reinspection as he deems necessary of eggs and egg products capable of use as human food in each official plant.

(c) Condemnation of adulterated products; destruction or reprocessing; procedure upon appeal from determination of adulteration

Eggs and egg products found to be adulterated at official plants shall be condemned and, if no appeal be taken from such determination of condemnation, such articles shall be destroyed for human food purposes under the supervision of an inspector: Provided, That articles which may by reprocessing be made not adulterated need not be condemned and destroyed if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated. If an appeal be taken from such determination, the eggs or egg products shall be appropriately marked and segregated pending completion of an appeal inspection, which appeal shall be at the cost of the appellant if the Secretary determines that the appeal is frivolous. If the determination of condemnation is sustained, the eggs or egg products shall be destroyed for human food purposes under the supervision of an inspector.

(d) Inspection of business premises, facilities, inventory, operations, and records of egg handlers; inspection of records and inventory of others required to keep records; authority of Secretary of Health and Human Services to inspect food manufacturing establishments, institutions, and restaurants; access to places of business

The Secretary shall cause such other inspections to be made of the business premises, facilities, inventory, operations, and records of egg handlers, and the records and inventory of other persons required to keep records under section 1040 of this title, as he deems appropriate (and in the case of shell egg packers, packing eggs for the ultimate consumer, at least once each calendar quarter) to assure that only eggs fit for human food are used for such purpose, and otherwise to assure compliance by egg handlers and other persons with the requirements of section 1037 of this title, except that the Secretary of Health and Human Services shall cause such inspections to be made as he deems appropriate to assure compliance with such requirements at food manufacturing establishments, institutions, and restaurants, other than plants processing egg products. Representatives of said Secretaries shall be afforded access to all such places of business for purposes of making the inspections provided for in this chapter.

(e) Refrigeration and labeling requirements

(1) Subject to paragraphs (2), (3), and (4), the Secretary shall make such inspections as the Secretary considers appropriate of a facility of an egg handler (including a transport vehicle) to determine if shell eggs destined for the ultimate consumer—

(A) are being held under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit after packing; and

(B) contain labeling that indicates that refrigeration is required.

(2) In the case of a shell egg packer packing eggs for the ultimate consumer, the Secretary shall make an inspection in accordance with paragraph (1) at least once each calendar quarter.

(3) The Secretary of Health and Human Services shall cause such inspections to be made as the Secretary considers appropriate to ensure compliance with the requirements of paragraph (1) at food manufacturing establishments, institutions, and restaurants, other than plants packing eggs.

(4) The Secretary shall not make an inspection as provided in paragraph (1) on any egg handler with a flock of not more than 3,000 layers.

(5) A representative of the Secretary and the Secretary of Health and Human Services shall be afforded access to a place of business referred to in this subsection, including a transport vehicle, for purposes of making an inspection required under this subsection.

(Pub. L. 91–597, §5, Dec. 29, 1970, 84 Stat. 1624; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, §1012(b), Dec. 13, 1991, 105 Stat. 1899.)

Editorial Notes

References in Text

This chapter, referred to in subsecs. (a) and (d), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Subsec. (e). Pub. L. 102–237 added subsec. (e).

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (d) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1991 Amendment

Pub. L. 102–237, title X, §1012(h), Dec. 13, 1991, 105 Stat. 1901, provided that: "This section and the amendments made by this section [amending this section and sections 1037, 1041, 1042, 1046, and 1052 of this title and enacting provisions set out as a note under section 1031 of this title] shall become effective 12 months after the Secretary of Agriculture promulgates final regulations implementing this section and the amendments." [Final regulations were promulgated Aug. 20, 1998, effective Aug. 27, 1999. See 63 F.R. 45663.]

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1035. Sanitary operating practices in official plants

(a) Premises, facilities, and equipment

Each official plant shall be operated in accordance with such sanitary practices and shall have such premises, facilities, and equipment as are required by regulations promulgated by the Secretary to effectuate the purposes of this chapter, including requirements for segregation and disposition of restricted eggs.

(b) Refusal by Secretary to inspect nonconforming plants

The Secretary shall refuse to render inspection to any plant whose premises, facilities, or equipment, or the operation thereof, fail to meet the requirements of this section.

(Pub. L. 91–597, §6, Dec. 29, 1970, 84 Stat. 1625.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1036. Pasteurization and labeling of egg products at official plants

(a) Contents of label

Egg products inspected at any official plant under the authority of this chapter and found to be not adulterated shall be pasteurized before they leave the official plant, except as otherwise permitted by regulations of the Secretary, and shall at the time they leave the official plant, bear in distinctly legible form on their shipping containers or immediate containers, or both, when required by regulations of the Secretary, the official inspection legend and official plant number, of the plant where the products were processed, and such other information as the Secretary may require by regulations to describe the products adequately and to assure that they will not have false or misleading labeling.

(b) False or misleading or use of nonapproved labeling or containers; determination by Secretary; procedures applicable; appeal

No labeling or container shall be used for egg products at official plants if it is false or misleading or has not been approved as required by the regulations of the Secretary. If the Secretary has reason to believe that any labeling or the size or form of any container in use or proposed for use with respect to egg products at any official plant is false or misleading in any particular, he may direct that such use be withheld unless the labeling or container is modified in such manner as he may prescribe so that it will not be false or misleading. If the person using or proposing to use the labeling or container does not accept the determination of the Secretary, such person may request a hearing, but the use of the labeling or container shall, if the Secretary so directs, be withheld pending hearing and final determination by the Secretary. Any such determination by the Secretary shall be conclusive unless, within thirty days after receipt of notice of such final determination, the person adversely affected thereby appeals to the United States court of appeals for the circuit in which such person has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. The provisions of section 194 of title 7,¹ shall be applicable to appeals taken under this section.

(Pub. L. 91–597, §7, Dec. 29, 1970, 84 Stat. 1625.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

¹ So in original. The comma probably should not appear.

§1037. Prohibited acts

(a)(1) No person shall buy, sell, or transport, or offer to buy or sell, or offer or receive for transportation, in any business in commerce any restricted eggs, capable of use as human food, except as authorized by regulations of the Secretary under such conditions as he may prescribe to assure that only eggs fit for human food are used for such purpose.

(2) No egg handler shall possess with intent to use, or use, any restricted eggs in the preparation of human food for commerce except that such eggs may be so possessed and used when authorized by regulations of the Secretary under such conditions as he may prescribe to assure that only eggs fit for human food are used for such purpose.

(b)(1) No person shall process any egg products for commerce at any plant except in compliance with the requirements of this chapter.

(2) No person shall buy, sell, or transport, or offer to buy or sell, or offer or receive for transportation, in commerce any egg products required to be inspected under this chapter unless they have been so inspected and are labeled and packaged in accordance with the requirements of section 1036 of this title.

(3) No operator of any official plant shall fail to comply with any requirements of section 1035(a) of this title or the regulations thereunder.

(4) No operator of any official plant shall allow any egg products to be moved from such plant if they are adulterated or misbranded and capable of use as human food.

(c) No egg handler shall possess any eggs after the eggs have been packed into a container that is destined for the ultimate consumer unless the eggs are stored and transported under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit, as prescribed by rules and regulations promulgated by the Secretary.

(d) No person shall violate any provision of section 1039, 1040 or 1046 of this title.

(e) No person shall—

(1) manufacture, cast, print, lithograph, or otherwise make any device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, or any form of official certificate or simulation thereof, except as authorized by the Secretary;

(2) forge or alter any official device, mark, or certificate;

(3) without authorization from the Secretary, use any official device, mark, or certificate, or simulation thereof, or detach, deface, or destroy any official device or mark; or use any labeling or container ordered to be withheld from use under section 1036 of this title after final judicial affirmance of such order or expiration of the time for appeal if no appeal is taken under said section;

(4) contrary to the regulations prescribed by the Secretary, fail to use, or to detach, deface, or destroy any official device, mark, or certificate;

(5) knowingly possess, without promptly notifying the Secretary or his representative, any official device or any counterfeit, simulated, forged, or improperly altered official certificate or any device or label, or any eggs or egg products bearing any counterfeit, simulated, forged, or improperly altered official mark;

(6) knowingly make any false statement in any shipper's certificate or other nonofficial or official certificate provided for in the regulations prescribed by the Secretary;

(7) knowingly represent that any article has been inspected or exempted, under this chapter, when, in fact, it has, respectively, not been so inspected or exempted; and

(8) refuse access, at any reasonable time, to any representative of the Secretary of Agriculture or the Secretary of Health and Human Services, to any plant or other place of business subject to inspection under any provisions of this chapter.

(f) No person, while an official or employee of the United States Government or any State or local governmental agency, or thereafter, shall use to his own advantage, or reveal other than to the authorized representatives of the United States Government or any State or other government in their official capacity, or as ordered by a court in a judicial proceeding, any information acquired under the authority of this chapter concerning any matter which is entitled to protection as a trade secret.

(Pub. L. 91–597, §8, Dec. 29, 1970, 84 Stat. 1626; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, §1012(c), Dec. 13, 1991, 105 Stat. 1899.)

Editorial Notes

References in Text

This chapter, referred to in subsecs. (b)(1), (2), (e)(7), (8), and (f), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Subsecs. (c) to (f). Pub. L. 102–237 added subsec. (c) and redesignated former subsecs. (c) to (e) as (d) to (f), respectively.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (e)(8) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1038. Cooperation with appropriate State and other governmental agencies; utilization of employees; reimbursement

The Secretary shall, whenever he determines that it would effectuate the purposes of this chapter, cooperate with appropriate State and other governmental agencies, in carrying out any provisions of this chapter. In carrying out the provisions of this chapter, the Secretary may conduct such examinations, investigations, and inspections as he determines practicable through any officer or employee of any such agency commissioned by him for such purpose. The Secretary shall reimburse the States and other agencies for the costs incurred by them in such cooperative programs.

(Pub. L. 91–597, §9, Dec. 29, 1970, 84 Stat. 1627.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1039. Eggs and egg products not intended for use as human food; inspection; denaturing or otherwise identifying

Inspection shall not be provided under this chapter at any plant for the processing of any egg products which are not intended for use as human food, but such articles, prior to their offer for sale or transportation in commerce, shall be denatured or otherwise identified as prescribed by regulations of the Secretary to deter their use for human food. No person shall buy, sell, or transport or offer to buy or sell, or offer or receive for transportation, in commerce, any restricted eggs or egg products which are not intended for use as human food unless they are denatured or otherwise identified as required by the regulations of the Secretary.

(Pub. L. 91–597, §10, Dec. 29, 1970, 84 Stat. 1627.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1040. Recordkeeping requirements; persons required to maintain records; scope of disclosure; access to records

For the purpose of enforcing the provisions of this chapter and the regulations promulgated thereunder, all persons engaged in the business of transporting, shipping, or receiving any eggs or egg products in commerce or holding such articles so received, and all egg handlers, shall maintain such records showing, for such time and in such form and manner, as the Secretary of Agriculture or the Secretary of Health and Human Services may prescribe, to the extent that they are concerned therewith, the receipt, delivery, sale, movement, and disposition of all eggs and egg products handled by them, and shall, upon the request of a duly authorized representative of either of said Secretaries, permit him at reasonable times to have access to and to copy all such records.

(Pub. L. 91–597, §11, Dec. 29, 1970, 84 Stat. 1627; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1041. Enforcement provisions

(a) Violations of section 1037; term of imprisonment and fine

Any person who commits any offense prohibited by section 1037 of this title shall upon conviction be subject to imprisonment for not more than one year, or a fine of not more than $5,000, or both such imprisonment and fine, but if such violation involves intent to defraud, or any distribution or attempted distribution of any article that is known to be adulterated (except as defined in section 1033(a)(8) of this title), such person shall be subject to imprisonment for not more than three years or a fine of not more than $10,000, or both.

(b) Persons preventing enforcement of chapter; term of imprisonment and fine

Any person who forcibly assaults, resists, opposes, impedes, intimidates, or interferes with any person while engaged in or on account of the performance of his official duties under this chapter shall be fined not more than $5,000 or imprisoned not more than three years or both. Whoever, in the commission of any such act, uses a deadly or dangerous weapon, shall be fined not more than $10,000 or imprisoned not more than ten years, or both. Whoever kills any person while engaged in or on account of the performance of his official duties under this chapter shall be punished as provided under sections 1111 and 1112 of title 18.

(c) Civil penalty

(1)(A) Except as otherwise provided in this subsection, any person who violates any provision of this chapter or any regulation issued under this chapter, other than a violation for which a criminal penalty has been imposed under this chapter, may be assessed a civil penalty by the Secretary of not more than $5,000 for each such violation. Each violation to which this subparagraph applies shall be considered a separate offense.

(B) No penalty shall be assessed against any person under this subsection unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5.

(C) The amount of the civil penalty imposed under this subsection—

(i) shall be assessed by the Secretary, by written order, taking into account the gravity of the violation, degree of culpability, and history of prior offenses; and

(ii) may be reviewed only as provided in paragraph (2).

(2)(A) The determination and order of the Secretary under this subsection shall be final and conclusive unless the person against whom such a violation is found under paragraph (1) files an application for judicial review within 30 days after service of the order in the United States court of appeals for the circuit in which the person has its principal place of business or in the United States Court of Appeals for the District of Columbia Circuit.

(B) Judicial review of any such order shall be based on the record on which the determination and order are based.

(C) If the court determines that additional evidence needs to be taken, the court shall order the hearing to be reopened for this purpose in such manner and on such terms and conditions as the court considers proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, on the basis of the additional evidence so taken.

(3) If any person fails to pay an assessment of a civil penalty after the penalty has become a final and unappealable order, or after the appropriate court of appeals has entered a final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General. The Attorney General shall institute a civil action to recover the amount assessed in an appropriate district court of the United States. In the collection action, the validity and appropriateness of the Secretary's order imposing the civil penalty shall not be subject to review.

(4) All penalties collected under this subsection shall be paid into the Treasury of the United States.

(5) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty assessed under this subsection.

(6) Paragraph (1) shall not apply to an official plant.

(d) Scope of liability for violations of section 1037

When construing or enforcing the provisions of section 1037 of this title, the act, omission, or failure of any person acting for or employed by any individual, partnership, corporation, or association within the scope of his employment or office shall in every case be deemed the act, omission, or failure of such individual, partnership, corporation, or association, as well as of such person.

(e) Penalties applicable to carriers or warehousemen

No carrier or warehouseman shall be subject to the penalties of this chapter, other than the penalties for violation of section 1040 of this title or paragraph (c) ¹ of this section, by reason of his receipt, carriage, holding, or delivery, in the usual course of business, as a carrier or warehouseman of eggs or egg products owned by another person unless the carrier or warehouseman has knowledge, or is in possession of facts which would cause a reasonable person to believe that such eggs or egg products were not eligible for transportation under, or were otherwise in violation of, this chapter, or unless the carrier or warehouseman refuses to furnish on request of a representative of the Secretary the name and address of the person from whom he received such eggs or egg products and copies of all documents, if there be any, pertaining to the delivery of the eggs or egg products to, or by, such carrier or warehouseman.

(Pub. L. 91–597, §12, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 102–237, title X, §1012(d), Dec. 13, 1991, 105 Stat. 1899.)

Editorial Notes

References in Text

This chapter, referred to in subsecs. (b), (c)(1)(A), and (e), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Subsec. (a). Pub. L. 102–237, §1012(d)(1), (2), substituted "$5,000" for "$1,000" in first sentence, and redesignated last sentence, relating to scope of liability for violations of section 1037 of this title, as subsec. (d).

Subsec. (b). Pub. L. 102–237, §1012(d)(4), redesignated subsec. (c) as (b). Former subsec. (b) redesignated (e).

Subsec. (c). Pub. L. 102–237, §1012(d)(5), added subsec. (c). Former subsec. (c) redesignated (b).

Subsec. (d). Pub. L. 102–237, §1012(d)(2), designated last sentence of subsec. (a), relating to scope of liability for violations of section 1037 of this title, as subsec. (d).

Subsec. (e). Pub. L. 102–237, §1012(d)(3), redesignated subsec. (b) as (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

¹ So in original. Probably should be "subsection (c)".

§1042. Reporting of violation to United States attorney for institution of criminal proceedings; procedure; presentation of views

Before any violation of this chapter is reported by the Secretary of Agriculture or Secretary of Health and Human Services to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given reasonable notice of the alleged violation and opportunity to present his views orally or in writing with regard to such contemplated proceeding. Nothing in this chapter shall be construed as requiring the Secretary of Agriculture or Secretary of Health and Human Services to report for criminal prosecution violations of this chapter whenever he believes that the public interest will be adequately served and compliance with this chapter obtained by a suitable written notice of warning or an action to assess civil penalties.

(Pub. L. 91–597, §13, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, §1012(e), Dec. 13, 1991, 105 Stat. 1900.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Pub. L. 102–237 inserted "or an action to assess civil penalties" before period at end.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1043. Rules and regulations; administration and enforcement

The Secretary shall promulgate such rules and regulations as he deems necessary to carry out the purposes or provisions of this chapter, and shall be responsible for the administration and enforcement of this chapter except as otherwise provided in section 1034(d) of this title.

(Pub. L. 91–597, §14, Dec. 29, 1970, 84 Stat. 1629.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1044. Exemption of certain activities

(a) Regulation for exemptions

The Secretary may, by regulation and under such conditions and procedures as he may prescribe, exempt from specific provisions of this chapter—

(1) the sale, transportation, possession, or use of eggs which contain no more restricted eggs than are allowed by the tolerance in the official standards of United States consumer grades for shell eggs;

(2) the processing of egg products at any plant where the facilities and operating procedures meet such sanitary standards as may be prescribed by the Secretary, and where the eggs received or used in the manufacture of egg products contain no more restricted eggs than are allowed by the official standards of United States consumer grades for shell eggs, and the egg products processed at such plant;

(3) the sale of eggs by any poultry producer from his own flocks directly to a household consumer exclusively for use by such consumer and members of his household and his nonpaying guests and employees, and the transportation, possession, and use of such eggs in accordance with this paragraph;

(4) the processing of egg products by any poultry producer from eggs of his own flocks' production for sale of such products directly to a household consumer exclusively for use by such consumer and members of his household and his nonpaying guests and employees, and the egg products so processed when handled in accordance with this paragraph;

(5) the sale of eggs by shell egg packers on his own premises directly to household consumers for use by such consumer and members of his household and his nonpaying guests and employees, and the transportation, possession, and use of such eggs in accordance with this paragraph;

(6) for such period of time (not to exceed two years) during the initiation of operations under this chapter as the Secretary determines that it is impracticable to provide inspection, the processing of egg products at any class of plants and the egg products processed at such plants; and

(7) the sale of eggs by any egg producer with an annual egg production from a flock of three thousand or less hens.

(b) Plants located in noncontiguous areas of United States

The Secretary shall, by regulation and under such procedures as he may prescribe, exempt any plant located within noncontiguous areas of the United States from specific provisions of this chapter, where, despite good faith efforts by the owner of such plant, such owner has not been able to bring his plant into full compliance with this chapter: Provided, That in order to provide at least minimum standards for the protection of the public health, whenever processing operations are being conducted at any such plant, continuous inspection shall be maintained to assure that it is operated in a sanitary manner. No exemption under this subsection shall be granted for a period extending beyond December 31, 1971.

(c) Suspension or termination of exemptions

The Secretary may immediately suspend or terminate any exemption under paragraph (a)(2) or (6) ¹ of this section at any time with respect to any person, if the conditions of exemption prescribed by this section or the regulations of the Secretary are not being met. The Secretary may modify or revoke any regulation granting exemption under this chapter whenever he deems such action appropriate to effectuate the purposes of this chapter.

(Pub. L. 91–597, §15, Dec. 29, 1970, 84 Stat. 1629; Pub. L. 92–67, Aug. 6, 1971, 85 Stat. 173.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1971—Subsecs. (b), (c). Pub. L. 92–67 added subsec. (b) and redesignated former subsec. (b) as (c).

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

¹ So in original. Probably should be "subsection (a)(2) or (6)".

§1045. Limitation on entry of eggs and egg products and other materials into official plants

The Secretary may limit the entry of eggs and egg products and other materials into official plants under such conditions as he may prescribe to assure that allowing the entry of such articles into such plants will be consistent with the purposes of this chapter.

(Pub. L. 91–597, §16, Dec. 29, 1970, 84 Stat. 1630.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1046. Imports

(a) Authorization for importation of restricted eggs; prerequisites for importation of egg products; treatment as domestic articles subject to this chapter; marking and labeling exemption for personal consumption

(1) No restricted eggs capable of use as human food shall be imported into the United States except as authorized by regulations of the Secretary.

(2) No egg products capable of use as human food shall be imported into the United States unless they were processed under an approved continuous inspection system of the government of the foreign country of origin or subdivision thereof and are labeled and packaged in accordance with, and otherwise comply with the standards of this chapter and regulations issued thereunder applicable to such articles within the United States.

(3) No eggs packed into a container that is destined for the ultimate consumer shall be imported into the United States unless the eggs are accompanied by a certification that the eggs have at all times after packaging been stored and transported under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit, as required by sections 1034(e) and 1037(c) of this title.

(4) All such imported articles shall upon entry into the United States be deemed and treated as domestic articles subject to the other provisions of this chapter: Provided, That they shall be labeled as required by such regulations for imported articles: Provided further, That nothing in this section shall apply to eggs or egg products purchased outside the United States by any individual for consumption by him and members of his household and his nonpaying guests and employees.

(b) Terms and conditions for destruction

The Secretary may prescribe the terms and conditions for the destruction of all such articles which are imported contrary to this section, unless (1) they are exported by the consignee within the time fixed therefor by the Secretary or (2) in the case of articles which are not in compliance solely because of misbranding, such articles are brought into compliance with this chapter under supervision of authorized representatives of the Secretary.

(c) Payment of storage, cartage, and labor charges by owner or consignee; liens

All charges for storage, cartage, and labor with respect to any article which is imported contrary to this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against such article and any other article thereafter imported under this chapter by or for such owner or consignee.

(d) Prohibition

The importation of any article contrary to this section is prohibited.

(Pub. L. 91–597, §17, Dec. 29, 1970, 84 Stat. 1630; Pub. L. 102–237, title X, §1012(f), Dec. 13, 1991, 105 Stat. 1901.)

Editorial Notes

References in Text

This chapter, referred to in subsecs. (a) to (c), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Subsec. (a). Pub. L. 102–237 designated first sentence as par. (1) and second sentence as par. (2), added par. (3), and designated third sentence as par. (4).

Statutory Notes and Related Subsidiaries

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1047. Refusal or withdrawal of inspection services; hearing; grounds; person deemed to have responsible connection with business; finality of order of Secretary; judicial review; other provisions for refusal of services unaffected

The Secretary (for such period, or indefinitely, as he deems necessary to effectuate the purposes of this chapter) may refuse to provide or may withdraw inspection service under this chapter with respect to any plant if he determines, after opportunity for a hearing is accorded to the applicant for, or recipient of, such service, that such applicant or recipient is unfit to engage in any business requiring inspection under this chapter because the applicant or recipient or anyone responsibly connected with the applicant or recipient has been convicted in any Federal or State court, within the previous ten years, of (1) any felony or more than one misdemeanor under any law based upon the acquiring, handling, or distributing of adulterated, mislabeled, or deceptively packaged food or fraud in connection with transactions in food, or (2) any felony, involving fraud, bribery, extortion, or any other act or circumstances indicating a lack of the integrity needed for the conduct of operations affecting the public health.

For the purpose of this section, a person shall be deemed to be responsibly connected with the business if he is a partner, officer, director, holder, or owner of 10 per centum or more of its voting stock, or employee in a managerial or executive capacity.

The determination and order of the Secretary with respect thereto under this section shall be final and conclusive unless the affected applicant for, or recipient of, inspection service files application for judicial review within thirty days after the effective date of such order in the United States court of appeals for the circuit in which such applicant or recipient has its principal place of business or in the United States Court of Appeals for the District of Columbia Circuit. Judicial review of any such order shall be upon the record upon which the determination and order are based. The provisions of section 194 of title 7 shall be applicable to appeals taken under this section.

This section shall not affect in any way other provisions of this chapter for refusal of inspection services.

(Pub. L. 91–597, §18, Dec. 29, 1970, 84 Stat. 1630.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1048. Administrative detention of violative articles; duration; release; removal of official marks

Whenever any eggs or egg products subject to this chapter, are found by any authorized representative of the Secretary upon any premises and there is reason to believe that they are or have been processed, bought, sold, possessed, used, transported, or offered or received for sale or transportation in violation of this chapter or that they are in any other way in violation of this chapter, or whenever any restricted eggs capable of use as human food are found by such a representative in the possession of any person not authorized to acquire such eggs under the regulations of the Secretary, such articles may be detained by such representative for a reasonable period but not to exceed twenty days, pending action under section 1049 of this title or notification of any Federal, State, or other governmental authorities having jurisdiction over such articles and shall not be moved by any person from the place at which they are located when so detained until released by such representative. All official marks may be required by such representative to be removed from such articles before they are released unless it appears to the satisfaction of the Secretary that the articles are eligible to retain such marks.

(Pub. L. 91–597, §19, Dec. 29, 1970, 84 Stat. 1631.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1049. Seizure and condemnation proceedings

(a) Jurisdiction; disposal of condemned articles; court costs and fees; conformity to supplemental rules for admiralty and maritime claims; jury trial; United States as plaintiff

Any eggs or egg products that are or have been processed, bought, sold, possessed, used, transported, or offered or received for sale or transportation, in violation of this chapter, or in any other way are in violation of this chapter; and any restricted eggs, capable of use as human food, in the possession of any person not authorized to acquire such eggs under the regulations of the Secretary shall be liable to be proceeded against and seized and condemned, at any time, on a complaint in any United States district court or other proper court as provided in section 1050 of this title within the jurisdiction of which the articles are found. If the articles are condemned they shall, after entry of the decree, be disposed of by destruction or sale as the court may direct and the proceeds, if sold, less the court costs and fees, and storage and other proper expenses, shall be paid into the Treasury of the United States, but the articles shall not be sold contrary to the provision of this chapter, the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or the Fair Packaging and Labeling Act [15 U.S.C. 1451 et seq.], or the laws of the jurisdiction in which they are sold: Provided, That upon the execution and delivery of a good and sufficient bond conditioned that the articles shall not be sold or otherwise disposed of contrary to the provisions of this chapter, the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, or the laws of the jurisdiction in which disposal is made, the court may direct that they be delivered to the owner thereof subject to such supervision by authorized representatives of the Secretary as is necessary to insure compliance with the applicable laws. When a decree of condemnation is entered against the articles and they are released under bond, or destroyed, court costs and fees, and storage and other proper expenses shall be awarded against the person, if any, intervening as claimant thereof. The proceedings in such cases shall conform, as nearly as may be, to the supplemental rules for certain admiralty and maritime claims, except that either party may demand trial by jury of any issue of fact joined in any case, and all such proceedings shall be at the suit of and in the name of the United States.

(b) Condemnation or seizure under other provisions unaffected

The provisions of this section shall in no way derogate from authority for condemnation or seizure conferred by other provisions of this chapter, or other laws.

(Pub. L. 91–597, §20, Dec. 29, 1970, 84 Stat. 1631.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (a), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables.

The supplemental rules for certain admiralty and maritime claims, referred to in subsec. (a), were renamed the Supplemental Rules for Admiralty or Maritime Claims and Asset Forfeiture Actions and are set out as part of the Federal Rules of Civil Procedure in the Appendix to Title 28, Judiciary and Judicial Procedure.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1050. Jurisdiction of district courts; United States as plaintiff in enforcement and restraining proceedings; subpenas for witnesses

The United States district courts and the District Court of the Virgin Islands are vested with jurisdiction specifically to enforce, and to prevent and restrain violations of, this chapter, and shall have jurisdiction in all other cases, arising under this chapter, except as provided in section 1047 of this title. All proceedings for the enforcement or to restrain violations of this chapter shall be by and in the name of the United States. Subpenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any such proceeding.

(Pub. L. 91–597, §21, Dec. 29, 1970, 84 Stat. 1632.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1051. Other Federal laws applicable for administration and enforcement of chapter; prosecution of inquiries; exercise of jurisdiction

For the efficient administration and enforcement of this chapter, the provisions (including penalties) of sections 46, 48, 49, and 50 of title 15 (except paragraphs (c) through (h) of section 46 and the last paragraph of section 49 ¹ of title 15), and the provisions of section 409(l) ¹ of title 47, are made applicable to the jurisdiction, powers, and duties of the Secretary in administering and enforcing the provisions of this chapter and to any person with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections 49 and 50 of title 15, on the district courts of the United States may be exercised for the purposes of this chapter by any court designated in section 1050 of this title.

(Pub. L. 91–597, §22, Dec. 29, 1970, 84 Stat. 1632.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The last paragraph of section 49 of title 15, and the provisions of section 409(l) of title 47, referred to in text, which related to immunity of witnesses, were repealed by sections 211 and 242, respectively, of Pub. L. 91–452, Oct. 15, 1970, title II, 84 Stat. 929, 930. For provisions relating to immunity of witnesses, see section 6001 et seq. of Title 18, Crimes and Criminal Procedure.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

¹ See References in Text note below.

§1052. State or local regulation

(a) Prohibition against additional or different requirements than Federal requirements relating to premises, facilities, and operations at official plants; authority to impose recordkeeping and related requirements consistent with Federal requirements

Requirements within the scope of this chapter with respect to premises, facilities, and operations of any official plant which are in addition to or different than those made under this chapter may not be imposed by any State or local jurisdiction except that any such jurisdiction may impose recordkeeping and other requirements within the scope of section 1040 of this title, if consistent therewith, with respect to any such plant.

(b) Prohibition against additional or different standards than Federal standards of quality, etc., or requiring labeling to show area of production or origin; authority to require name, address, and license number of processor or packer on containers; prohibition against additional or different requirements than Federal requirements relating to labeling, packaging or ingredients; authority to prevent distribution of violative articles; validity of nonconflicting laws

For eggs which have moved or are moving in interstate or foreign commerce, (1) no State or local jurisdiction may require the use of standards of quality, condition, weight, quantity, or grade which are in addition to or different from the official Federal standards, (2) with respect to egg handlers specified in paragraphs (1) and (2) of section 1034(e) of this title, no State or local jurisdiction may impose temperature requirements pertaining to eggs packaged for the ultimate consumer which are in addition to, or different from, Federal requirements, and (3) no State or local jurisdiction other than those in noncontiguous areas of the United States may require labeling to show the State or other geographical area of production or origin: Provided, however, That this shall not preclude a State from requiring that the name, address, and license number of the person processing or packaging eggs, be shown on each container. Labeling, packaging, or ingredient requirements, in addition to or different than those made under this chapter, the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and the Fair Packaging and Labeling Act [15 U.S.C. 1451 et seq.], may not be imposed by any State or local jurisdiction, with respect to egg products processed at any official plant in accordance with the requirements under this chapter and such Acts. However, any State or local jurisdiction may exercise jurisdiction with respect to eggs and egg products for the purpose of preventing the distribution for human food purposes of any such articles which are outside of such a plant and are in violation of any of said Federal Acts or any State or local law consistent therewith. Otherwise the provisions of this chapter shall not invalidate any law or other provisions of any State or other jurisdiction in the absence of a conflict with this chapter.

(c) Applicability of other Federal laws and authority of other Federal officials relating to eggs, egg products, or other food products unaffected; authority of Secretary of Agriculture to regulate official plants processing egg products

The provisions of this chapter shall not affect the applicability of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or the Fair Packaging and Labeling Act [15 U.S.C. 1451 et seq.] or other Federal laws to eggs, egg products, or other food products or diminish any authority conferred on the Secretary of Health and Human Services or other Federal officials by such other laws, except that the Secretary of Agriculture shall have exclusive jurisdiction to regulate official plants processing egg products and operations thereof as to all matters within the scope of this chapter.

(d) Detainer authority

The detainer authority conferred on representatives of the Secretary of Agriculture by section 1048 of this title shall also apply to any authorized representative of the Secretary of Health and Human Services for the purposes of section 1034(d) of this title, with respect to any eggs or egg products that are outside any plant processing egg products.

(Pub. L. 91–597, §23, Dec. 29, 1970, 84 Stat. 1632; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, §1012(g), Dec. 13, 1991, 105 Stat. 1901.)

Editorial Notes

References in Text

This chapter, referred to in subsecs. (a) to (c), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (b) and (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

The Fair Packaging and Labeling Act, referred to in subsecs. (b) and (c), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables.

Amendments

1991—Subsec. (b). Pub. L. 102–237 substituted "(2) with respect to egg handlers specified in paragraphs (1) and (2) of section 1034(e) of this title, no State or local jurisdiction may impose temperature requirements pertaining to eggs packaged for the ultimate consumer which are in addition to, or different from, Federal requirements, and (3)" for "and (2)".

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsecs. (c) and (d) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1053. Inspection and administration costs

(a) Overtime and holiday work costs; availability of funds

The cost of inspection rendered under the requirements of this chapter, and other costs of administration of this chapter, shall be borne by the United States, except that the cost of overtime and holiday work performed in official plants subject to the provisions of this chapter at such rates as the Secretary may determine shall be borne by such official plants. Sums received by the Secretary from official plants under this section shall be available without fiscal year limitation to carry out the purposes of this chapter.

(b) "Holiday" defined

The term "holiday" for the purposes of assessment or reimbursement of the cost of inspection performed under this chapter, the Wholesome Poultry Products Act [21 U.S.C. 467a et seq.] and the Wholesome Meat Act [21 U.S.C. 601 et seq.] shall mean the legal public holidays specified by the Congress in section 6103(a) of title 5.

(Pub. L. 91–597, §24, Dec. 29, 1970, 84 Stat. 1633.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The Wholesome Poultry Products Act, referred to in subsec. (b), is Pub. L. 90–492, Aug. 18, 1968, 82 Stat. 791, which enacted sections 467a to 467f and 470 of this title, amended sections 451 to 461, 463 to 465, and 467 of this title, and enacted provisions set out as notes under section 451 of this title. For complete classification of this Act to the Code, see Short Title of 1968 Amendment note set out under section 451 of this title and Tables.

The Wholesome Meat Act, referred to in subsec. (b), is Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, which enacted sections 601, 602, 624, 641 to 645, 661, 671 to 680, and 691 of this title, amended sections 603 to 623 of this title, repealed section 96 of this title and section 1306(b) of Title 19, Customs Duties, and enacted provisions set out as notes under section 601 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1054. Annual report to Congressional committees

(a) ¹ Not later than March 1 of each year following December 29, 1970, the Secretary shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a comprehensive and detailed written report with respect to—

(1) the processing, storage, handling, and distribution of eggs and egg products subject to the provisions of this chapter; the inspection of establishments operated in connection therewith; the effectiveness of the operation of the inspection, including the effectiveness of the operations of State egg inspection programs; and recommendations for legislation to improve such program; and

(2) the administration of section 1046 of this title (relating to imports) during the immediately preceding calendar year, including but not limited to—

(A) a certification by the Secretary that foreign plants exporting eggs or egg products to the United States have complied with requirements of this chapter and regulations issued thereunder;

(B) the names and locations of plants authorized or permitted to export eggs or egg products to the United States;

(C) the number of inspectors employed by the Department of Agriculture in the calendar year concerned who were assigned to inspect plants referred to in paragraph (B) hereof and the frequency with which each such plant was inspected by such inspectors;

(D) the number of inspectors that were licensed by each country from which any imports were received and that were assigned, during the calendar year concerned, to inspect such imports and the facilities in which such imports were handled; and the frequency and effectiveness of such inspections;

(E) the total volume of eggs and egg products which was imported into the United States during the calendar year concerned from each country, including a separate itemization of the volume of each major category of such imports from each country during such year, and a detailed report of rejections of plants and products because of failure to meet appropriate standards prescribed by this chapter; and

(F) recommendations for legislation to improve such program.

(Pub. L. 91–597, §26, Dec. 29, 1970, 84 Stat. 1634; Pub. L. 103–437, §8(4), Nov. 2, 1994, 108 Stat. 4588.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a)(1), (2)(A), (E), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1994—Pub. L. 103–437 substituted "Agriculture, Nutrition, and Forestry" for "Agriculture and Forestry" in introductory provisions.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

¹ So in original. No subsec. (b) has been enacted.

§1055. Authorization of appropriations

Such sums as are necessary to carry out the provisions of this chapter are hereby authorized to be appropriated.

(Pub. L. 91–597, §27, Dec. 29, 1970, 84 Stat. 1635.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

§1056. Separability

If any provision of this chapter or the application thereof to any person or circumstances is held invalid, the validity of the remainder of the chapter and of the application of such provision to other persons and circumstances shall not be affected thereby.

(Pub. L. 91–597, §28, Dec. 29, 1970, 84 Stat. 1635.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

CHAPTER 16—DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION

SUBCHAPTER I—GENERAL PROVISIONS

        

SUBCHAPTER II—DRUG ABUSE POLICY COORDINATION

        

SUBCHAPTER III—NATIONAL DRUG ABUSE STRATEGY

        

SUBCHAPTER IV—OTHER FEDERAL PROGRAMS

        

SUBCHAPTER V—NATIONAL INSTITUTE ON DRUG ABUSE

        

SUBCHAPTER I—GENERAL PROVISIONS

§1101. Congressional findings

The Congress makes the following findings:

(1) Drug abuse is rapidly increasing in the United States and now afflicts urban, suburban, and rural areas of the Nation.

(2) Drug abuse seriously impairs individual, as well as societal, health and well-being.

(3) Drug abuse, especially heroin addiction, substantially contributes to crime.

(4) The adverse impact of drug abuse inflicts increasing pain and hardship on individuals, families, and communities and undermines our institutions.

(5) Too little is known about drug abuse, especially the causes, and ways to treat and prevent drug abuse.

(6) The success of Federal drug abuse programs and activities requires a recognition that education, treatment, rehabilitation, research, training, and law enforcement efforts are interrelated.

(7) The effectiveness of efforts by State and local governments and by the Federal Government to control and treat drug abuse in the United States has been hampered by a lack of coordination among the States, between States and localities, among the Federal Government, States and localities, and throughout the Federal establishment.

(8) Control of drug abuse requires the development of a comprehensive, coordinated long-term Federal strategy that encompasses both effective law enforcement against illegal drug traffic and effective health programs to rehabilitate victims of drug abuse.

(9) The increasing rate of drug abuse constitutes a serious and continuing threat to national health and welfare, requiring an immediate and effective response on the part of the Federal Government.

(10) Although the Congress observed a significant apparent reduction in the rate of increase of drug abuse during the three-year period subsequent to March 21, 1972, and in certain areas of the country apparent temporary reductions in its incidence, the increase and spread of heroin consumption since 1974, and the continuing abuse of other dangerous drugs, clearly indicate the need for effective, ongoing, and highly visible Federal leadership in the formation and execution of a comprehensive, coordinated drug abuse policy.

(11) Shifts in the usage of various drugs and in the Nation's demographic composition require a Federal strategy to adjust the focus of drug abuse programs to meet new needs and priorities on a cost-effective basis.

(12) The growing extent of drug abuse indicates an urgent need for prevention and intervention programs designed to reach the general population and members of high risk populations such as youth, women, and the elderly.

(13) Effective control of drug abuse requires high-level coordination of Federal international and domestic activities relating to both supply of, and demand for, commonly abused drugs.

(14) Local governments with high concentrations of drug abuse should be actively involved in the planning and coordination of efforts to combat drug abuse.

(Pub. L. 92–255, title I, §101, Mar. 21, 1972, 86 Stat. 66; Pub. L. 94–237, §1, Mar. 19, 1976, 90 Stat. 241; Pub. L. 96–181, §2, Jan. 2, 1980, 93 Stat. 1309.)

Editorial Notes

Amendments

1980—Pars. (11) to (14). Pub. L. 96–181 added pars. (11) to (14).

1976—Par. (10). Pub. L. 94–237 added par. (10).

Statutory Notes and Related Subsidiaries

Short Title of 1980 Amendment

Pub. L. 96–181, §1(a), Jan. 2, 1980, 93 Stat. 1309, provided that: "This Act [enacting sections 1111 to 1117 and 1181 of this title, amending this section, sections 1102, 1162, 1164, 1176, 1177, 1180, and 1191 to 1193 of this title, and sections 218, 300l–2, 300m–3, and 3733 of Title 42, The Public Health and Welfare, omitting sections 1118 to 1120 and 1131 to 1133 of this title, enacting provisions set out as notes under this section and section 1193 of this title, and amending provisions set out as a note below] may be cited as the 'Drug Abuse Prevention, Treatment, and Rehabilitation Amendments of 1979'."

Short Title of 1978 Amendment

Pub. L. 95–461, §1, Oct. 14, 1978, 92 Stat. 1268, provided that: "This Act [enacting section 1194 of this title, amending sections 1172, 1176, 1177, 1192, and 1193 of this title, enacting a provision set out as a note under section 1172 of this title and amending a provision set out as a note under section 242 of Title 42, The Public Health and Welfare] may be cited as the 'Drug Abuse Prevention and Treatment Amendments of 1978'."

Short Title

Pub. L. 92–255, §1, Mar. 21, 1972, 86 Stat. 65, as amended by Pub. L. 96–181, §15(a), Jan. 2, 1980, 93 Stat. 1316, provided that: "This Act [enacting this chapter, and amending sections 5313, 5315, and 5316 of Title 5, Government Organization and Employees, and sections 218, 246, 257, 2684, 2688a, 2688k, 2688n–1, and 2688t of Title 42, The Public Health and Welfare] may be cited as the 'Drug Abuse Prevention, Treatment, and Rehabilitation Act'."

References to Drug Abuse Office and Treatment Act of 1972

Pub. L. 96–181, §15(b), Jan. 2, 1980, 93 Stat. 1316, provided in part that: "Whenever reference is made in any other Federal law, regulation, ruling, or order to the Drug Abuse Office and Treatment Act of 1972, the reference shall be considered to be made to the Drug Abuse Prevention, Treatment, and Rehabilitation Act."

§1102. Congressional declaration of national policy

The Congress declares that it is the policy of the United States and the purpose of this chapter to focus the comprehensive resources of the Federal Government and bring them to bear on drug abuse with the objective of significantly reducing the incidence, as well as the social and personal costs, of drug abuse in the United States, and to develop and assure the implementation of a comprehensive, coordinated long-term Federal strategy to combat drug abuse. To reach these goals, the Congress further declares that it is the policy of the United States and the purpose of this chapter to meet the problems of drug abuse through—

(1) comprehensive Federal, State, and local planning for, and effective use of, Federal assistance to States and to community-based programs to meet the urgent needs of special populations, in coordination with all other governmental and nongovernmental sources of assistance;

(2) the development and support of community-based prevention programs;

(3) the development and encouragement of effective occupational prevention and treatment programs within the Government and in cooperation with the private sector; and

(4) increased Federal commitment to research into the behavioral and biomedical etiology of, the treatment of, and the mental and physical health and social and economic consequences of, drug abuse.

(Pub. L. 92–255, title I, §102, Mar. 21, 1972, 86 Stat. 66; Pub. L. 94–237, §2, Mar. 19, 1976, 90 Stat. 241; Pub. L. 96–181, §3, Jan. 2, 1980, 93 Stat. 1309.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 92–255, Mar. 21, 1972, 86 Stat. 65, known as the Drug Abuse Prevention, Treatment, and Rehabilitation Act, which comprises this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1101 of this title and Tables.

Amendments

1980—Pub. L. 96–181 inserted additional declarations of policy prescribing methods and programs by which the goals are to be reached.

1976—Pub. L. 94–237 substituted "objective of significantly reducing the incidence, as well as the social and personal costs, of drug abuse in the United States, and to develop and assure the implementation of" for "immediate objective of significantly reducing the incidence of drug abuse in the United States within the shortest possible period of time, and to develop".

§1103. Repealed. Pub. L. 100–690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187

Section, Pub. L. 92–255, title I, §103, Mar. 21, 1972, 86 Stat. 67; Pub. L. 94–237, §§3, 4(a), Mar. 19, 1976, 90 Stat. 241, defined "drug abuse prevention function", "drug traffic prevention function", and "drug abuse function".

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100–690.

§1104. Repealed. Pub. L. 94–237, §4(c)(1), Mar. 19, 1976, 90 Stat. 244

Section, Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, provided, effective June 30, 1975, that the Special Action Office for Drug Abuse Prevention, each of the positions in the Office of Director, Deputy Director, and Assistant Director, and the National Advisory Council for Drug Abuse Prevention were abolished and former subchapter II of this chapter was repealed.

SUBCHAPTER II—DRUG ABUSE POLICY COORDINATION

§§1111 to 1114. Repealed. Pub. L. 100–690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187

Section 1111, Pub. L. 92–255, title II, §201, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310; amended Pub. L. 98–473, title II, §1306, Oct. 12, 1984, 98 Stat. 2170, related to concentration of Federal effort in drug abuse prevention.

A prior section 1111, Pub. L. 92–255, title II, §201, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for the establishment of the Office of Drug Abuse Policy, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309. Previously, the Office of Drug Abuse Policy was abolished and the functions of the Office and its Director were transferred to the President by sections 3 and 5 of Reorg. Plan No. 1 of 1977, effective Mar. 27, 1978, as provided by Ex. Ord. No. 12045, Mar. 27, 1978, 43 F.R. 13347, set out as notes preceding section 101 of Title 3, The President.

Another prior section 1111, Pub. L. 92–255, title II, §201, Mar. 21, 1972, 86 Stat. 67, which provided for the establishment of the Special Action Office for Drug Abuse Prevention, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1112, Pub. L. 92–255, title II, §202, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310, related to designation of a representative to direct activities required by this subchapter.

A prior section 1112, Pub. L. 92–255, title II, §202, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242; amended Pub. L. 95–83, title III, §311(d), Aug. 1, 1977, 91 Stat. 398, which provided for the appointment of the Director of the Office of Drug Abuse Policy, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1112, Pub. L. 92–255, title II, §202, Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of a Director of the Special Action Office for Drug Abuse Prevention, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1113, Pub. L. 92–255, title II, §203, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310, related to employment of officers and employees.

A prior section 1113, Pub. L. 92–255, title II, §203, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for the appointment and functions of Deputy Director of the Office of Drug Abuse Policy, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1113, Pub. L. 92–255, title II, §203, Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of a Deputy Director of the Special Office for Drug Abuse Prevention, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1114, Pub. L. 92–255, title II, §204, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310, related to acceptance of uncompensated services.

A prior section 1114, Pub. L. 92–255, title II, §204, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for the delegation of functions by the Director of the Office of Drug Abuse Policy, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1114, Pub. L. 92–255, title II, §204, Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of six Assistant Directors, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Provisions similar to this section were contained in section 1117 of this title prior to the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100–690.

Executive Documents

Executive Order No. 12368

Ex. Ord. No. 12368, June 24, 1982, 47 F.R. 27843, as amended by Ex. Ord. No. 12590, Mar. 26, 1987, 52 F.R. 10021, related to assignment of drug abuse policy functions.

§1115. Notice relating to the control of dangerous drugs

Whenever the Attorney General determines that there is evidence that—

(1) a drug or other substance, which is not a controlled substance (as defined in section 802(6) of this title), has a potential for abuse, or

(2) a controlled substance should be transferred or removed from a schedule under section 812 of this title,

he shall, prior to initiating any proceeding under section 811(a) of this title, give the President timely notice of such determination. Information forwarded to the Attorney General pursuant to section 811(f) of this title shall also be forwarded by the Secretary of Health and Human Services to the President.

(Pub. L. 92–255, title II, §201, formerly §205, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1311; amended Pub. L. 97–35, title IX, §973(a), Aug. 13, 1981, 95 Stat. 598; renumbered §201, Pub. L. 100–690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187.)

Editorial Notes

Prior Provisions

A prior section 201 of Pub. L. 92–255, title II, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310; amended Pub. L. 98–473, title II, §1306, Oct. 12, 1984, 98 Stat. 2170, related to concentration of Federal effort in drug abuse prevention, prior to repeal by Pub. L. 100–690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187.

A prior section 1115, Pub. L. 92–255, title II, §205, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for employment, functions, and travel expenses of employees, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1115, Pub. L. 92–255, title II, §205, Mar. 21, 1972, 86 Stat. 68, provided for the delegation of functions by the Director, prior to repeal by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Provisions similar to this section were contained in section 1118 of this title prior to the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Amendments

1981—Pub. L. 97–35 substituted "Health and Human Services" for "Health, Education, and Welfare".

§1116. Repealed. Pub. L. 100–690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187

Section, Pub. L. 92–255, title II, §206, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1311, provided that this subchapter not be construed as limiting the statutory authority of the Secretary of Defense or the Administrator of Veterans' Affairs.

A prior section 1116, Pub. L. 92–255, title II, §206, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for the employment and compensation of experts and consultants, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1116, Pub. L. 92–255, title II, §206, Mar. 21, 1972, 86 Stat. 68, which provided for the employment and prescription of functions for officers and employees by the Director, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Provisions similar to this section were contained in section 1119 of this title prior to the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100–690.

§1117. Repealed. Pub. L. 98–24, §4(b), Apr. 26, 1983, 97 Stat. 183

Section, Pub. L. 92–255, title II, §207, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1311, required the President to make annual reports to the Congress on the drug abuse prevention activities under this subchapter. See section 290aa–4 of Title 42, The Public Health and Welfare.

A prior section 1117, Pub. L. 92–255, title II, §207, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 243, which provided for acceptance of uncompensated services, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1117, Pub. L. 92–255, title II, §207, Mar. 21, 1972, 86 Stat. 68, which provided for the procurement of experts and consultants by the Director, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

§§1118 to 1120. Omitted

Editorial Notes

Codification

Section 1118, Pub. L. 92–255, title II, §208, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 243, which related to giving of notice to Director prior to initiation of a section 811(a) proceeding, was omitted in the general revision of title II of Pub. L. 92–255 by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309. See section 1115 of this title.

A prior section 1118, Pub. L. 92–255, title II, §208, Mar. 21, 1972, 86 Stat. 68, which provided for acceptance of uncompensated services by Director, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1119, Pub. L. 92–255, title II, §210, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 243, which related to effect of this subchapter on statutory requirements and authorities, was omitted in the general revision of title II of Pub. L. 92–255 by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309. See section 1116 of this title.

A prior section 1119, Pub. L. 92–255, title II, §209, Mar. 21, 1972, 86 Stat. 68, which provided for notice by Attorney General to Director with respect to control of dangerous drugs, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

A prior section 210 of Pub. L. 92–255, title II, Mar. 21, 1972, 86 Stat. 69, which provided for authority of Director to make grants and enter into contract, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1120, Pub. L. 92–255, title II, §211, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 243, which related to authorization of appropriations with regard to this subchapter, was omitted in the general revision of title II of Pub. L. 92–255 by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

A prior section 1120, Pub. L. 92–255, title II, §210, Mar. 21, 1972, 86 Stat. 69, which provided for authority of Director to make grants and enter into contracts, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

A prior section 211 of Pub. L. 92–255, title II, Mar. 21, 1972, 86 Stat. 69, which provided for appointment of an acting Director until position was initially filled, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

§§1121 to 1123. Repealed. Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67

Section 1121, Pub. L. 92–255, title II, §211, Mar. 21, 1972, 86 Stat. 69, provided for appointment of an acting Director until position was initially filled.

Section 1122, Pub. L. 92–255, title II, §213, Mar. 21, 1972, 86 Stat. 69, prohibited Director or any other Federal officer from waiving or disregarding any limitation or requirement prescribed by law with respect to any Federal program or activity.

Section 1123, Pub. L. 92–255, title II, §214, Mar. 21, 1972, 86 Stat. 70, provided for authorization of appropriations, and fiscal year availability of such appropriations.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Section 1104 of this title, prior to repeal by Pub. L. 94–237, §4(c)(1), Mar. 19, 1976, 90 Stat. 244, provided for repeal of sections effective June 30, 1975.

§§1131 to 1133. Omitted

Editorial Notes

Codification

Section 1131, Pub. L. 92–255, title II, §221, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 243, which related to functions of Director concerning planning and policies, was omitted in the general revision of title II of Pub. L. 92–255 by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309. See section 1111 of this title.

A prior section 1131, Pub. L. 92–255, title II, §221, Mar. 21, 1972, 86 Stat. 70, which provided for establishment of overall planning and policy and the criteria to achieve objectives and priorities for all Federal drug abuse prevention functions, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1132, Pub. L. 92–255, title II, §222, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 243, which authorized President to designate Director to represent United States in negotiations concerning drug abuse functions, was omitted in the general revision of title II of Pub. L. 92–255 by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309. See section 1112 of this title.

A prior section 1132, Pub. L. 92–255, title II, §222, Mar. 21, 1972, 86 Stat. 71, which provided for review and modification of implementation plans and budget requests, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1133, Pub. L. 92–255, title II, §223, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 244, which related to an annual report to President and Congress on activities of Office of Drug Abuse Policy, was omitted in the general revision of title II of Pub. L. 92–255 by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309. See section 1117 of this title.

A prior section 1133, Pub. L. 92–255, title II, §223, Mar. 21, 1972, 86 Stat. 71, which provided for establishment and the objectives of a Special Fund, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

§§1134 to 1143. Repealed. Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67

Section 1134, Pub. L. 92–255, title II, §224, Mar. 21, 1972, 86 Stat. 71, provided for establishment of research and development programs by Director.

Section 1135, Pub. L. 92–255, title II, §225, Mar. 21, 1972, 86 Stat. 72, provided for establishment of a single non-Federal share requirement.

Section 1136, Pub. L. 92–255, title II, §226, Mar. 21, 1972, 86 Stat. 72, provided for Director to make drug prevention function recommendations to President and to consult with responsible agencies with respect to drug prevention functions.

Section 1137, Pub. L. 92–255, title II, §227, Mar. 21, 1972, 86 Stat. 72, provided for resolution of agency conflicts with regard to drug prevention functions.

Section 1138, Pub. L. 92–255, title II, §228, Mar. 21, 1972, 86 Stat. 72, provided for communications and liaison with respect to drug prevention functions by one of Assistant Directors.

Section 1139, Pub. L. 92–255, title II, §229, Mar. 21, 1972, 86 Stat. 72, provided, with respect to drug prevention functions, coordination of State and local governments, availability of information and other services and activities.

Section 1140, Pub. L. 92–255, title II, §230, Mar. 21, 1972, 86 Stat. 73, provided for a management oversight review by a Federal officer.

Section 1141, Pub. L. 92–255, title II, §231, Mar. 21, 1972, 86 Stat. 73, provided for convening of a council of officials of Federal agencies responsible for drug prevention functions by Director.

Section 1142, Pub. L. 92–255, title II, §232, Mar. 21, 1972, 86 Stat. 73, provided for designation of the Director to represent Government in international negotiations related to drug prevention functions.

Section 1143, Pub. L. 92–255, title II, §233, Mar. 21, 1972, 86 Stat. 73, provided for an annual written report to the President by the Director.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Section 1104 of this title, prior to repeal by Pub. L. 94–237, §4(c)(1), Mar. 19, 1976, 90 Stat. 244, provided for repeal of sections effective June 30, 1975.

§§1151 to 1155. Repealed. Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67

Section 1151, Pub. L. 92–255, title II, §251, Mar. 21, 1972, 86 Stat. 74, provided for establishment of a National Advisory Council for Drug Abuse Prevention.

Section 1152, Pub. L. 92–255, title II, §252, Mar. 21, 1972, 86 Stat. 74, provided for membership of National Advisory Council for Drug Abuse Prevention.

Section 1153, Pub. L. 92–255, title II, §253, Mar. 21, 1972, 86 Stat. 74, provided for designation of chairman of National Advisory Council for Drug Abuse Prevention.

Section 1154, Pub. L. 92–255, title II, §254, Mar. 21, 1972, 86 Stat. 74, provided for compensation and expenses for members of National Advisory Council for Drug Abuse Prevention.

Section 1155, Pub. L. 92–255, title II, §255, Mar. 21, 1972, 86 Stat. 74, set forth functions of National Advisory Council for Drug Abuse Prevention.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Section 1104 of this title, prior to repeal by Pub. L. 94–237, §4(c)(1), Mar. 19, 1976, 90 Stat. 244, provided for repeal of sections effective June 30, 1975.

SUBCHAPTER III—NATIONAL DRUG ABUSE STRATEGY

§§1161 to 1165. Repealed. Pub. L. 98–509, title III, §301(d), Oct. 19, 1984, 98 Stat. 2364

Section 1161, Pub. L. 92–255, title III, §301, Mar. 21, 1972, 86 Stat. 74, related to development, and initial promulgation no later than nine months after Mar. 21, 1972, by the President, of a national drug abuse strategy.

Section 1162, Pub. L. 92–255, title III, §302, Mar. 21, 1972, 86 Stat. 75; Pub. L. 94–237, §4(c)(2), (3), (5)(A), Mar. 19, 1976, 90 Stat. 244; Pub. L. 96–181, §5(a), (b), Jan. 2, 1980, 93 Stat. 1311; Pub. L. 97–35, title IX, §973(b), Aug. 13, 1981, 95 Stat. 598, related to establishment and membership of a Strategy Council, interim provision of services by the Director, and review and commentary on the national drug abuse strategy by those Federal officials participating in its preparation.

Section 1163, Pub. L. 92–255, title III, §303, Mar. 21, 1972, 86 Stat. 75, related to contents of the national drug abuse strategy.

Section 1164, Pub. L. 92–255, title III, §304, Mar. 21, 1972, 86 Stat. 75; Pub. L. 94–237, §4(c)(4), Mar. 19, 1976, 90 Stat. 244; Pub. L. 96–181, §5(c), Jan. 2, 1980, 93 Stat. 1311, related to preparation of the national drug abuse strategy.

Section 1165, Pub. L. 92–255, title III, §305, Mar. 21, 1972, 86 Stat. 75; Pub. L. 94–237, §5, Mar. 19, 1976, 90 Stat. 244; Pub. L. 98–24, §4(a), Apr. 26, 1983, 97 Stat. 183, related to submission by the President to the Congress, on or before Aug. 1, 1984, and every two years thereafter, of a written report describing the national drug abuse strategy, and prescribed the contents of the report.

SUBCHAPTER IV—OTHER FEDERAL PROGRAMS

§1171. Drug abuse prevention function appropriations

Any request for appropriations by a department or agency of the Government submitted after March 21, 1972, shall specify (1) on a line item basis, that part of the appropriations which the department or agency is requesting to carry out its drug abuse prevention functions, and (2) the authorization of the appropriations requested to carry out each of its drug abuse prevention functions.

(Pub. L. 92–255, title IV, §404, Mar. 21, 1972, 86 Stat. 77.)

§1172. Repealed. Pub. L. 98–24, §2(c)(2), Apr. 26, 1983, 97 Stat. 182

Section, Pub. L. 92–255, title IV, §405, Mar. 21, 1972, 86 Stat. 77; Pub. L. 95–461, §3(b), Oct. 14, 1978, 92 Stat. 1268; Pub. L. 97–35, title IX, §973(c)(1), Aug. 13, 1981, 95 Stat. 598, required that the Secretary of Health and Human Services make periodic reports to the Congress and to the President on drug abuse in the United States. See section 290aa–4 of Title 42, The Public Health and Welfare.

§1173. Transferred and Omitted

Editorial Notes

Codification

Section, Pub. L. 92–255, title IV, §406, Mar. 21, 1972, 86 Stat. 78; Pub. L. 97–35, title IX, §968(a), Aug. 13, 1981, 95 Stat. 595, established additional drug abuse prevention functions of the Secretary of Health and Human Services.

Subsec. (a) was redesignated as section 503(e) of the Public Health Service Act by Pub. L. 98–24, §2(b)(5), Apr. 26, 1983, 97 Stat. 177, and was classified to former section 290aa–2(e) of Title 42, The Public Health and Welfare, prior to repeal by Pub. L. 102–321, title I, §101(b), July 10, 1992, 106 Stat. 331.

Subsec. (b), which directed that the Secretary carry out his functions under subsec. (a) of this section through the National Institute on Drug Abuse, was omitted.

§§1174, 1175. Transferred

Editorial Notes

Codification

Section 1174, Pub. L. 92–255, title IV, §407, Mar. 21, 1972, 86 Stat. 78; Pub. L. 94–237, §6(a), Mar. 19, 1976, 90 Stat. 244; Pub. L. 94–581, title I, §111(c)(2), Oct. 21, 1976, 90 Stat. 2852, which prohibited discrimination against drug abusers by general hospitals, was redesignated section 526 of the Public Health Service Act by Pub. L. 98–24, §2(b)(16)(B), Apr. 26, 1983, 97 Stat. 182, and is classified to section 290ee–2 of Title 42, The Public Health and Welfare.

Section 1175, Pub. L. 92–255, title IV, §408, Mar. 21, 1972, 86 Stat. 79; Pub. L. 93–282, title III, §303(a), (b), May 14, 1974, 88 Stat. 137, 138; Pub. L. 94–237, §4(c)(5)(A), (B), Mar. 19, 1976, 90 Stat. 244; Pub. L. 94–581, title I, §111(c)(3), Oct. 21, 1976, 90 Stat. 2852; Pub. L. 97–35, title IX, §973(d), Aug. 13, 1981, 95 Stat. 598, which related to confidentiality of patients' records, was redesignated section 527 of the Public Health Service Act by Pub. L. 98–24, §2(b)(16)(B), Apr. 26, 1983, 97 Stat. 182, and is classified to section 290ee–3 of Title 42.

§1176. Repealed. Pub. L. 97–35, title IX, §969(a), Aug. 13, 1981, 95 Stat. 595

Section, Pub. L. 92–255, title IV, §409, Mar. 21, 1972, 86 Stat. 80; Pub. L. 94–237, §§7, 8(a), 9(a)(1), (b)(1), Mar. 19, 1976, 90 Stat. 245–247; Pub. L. 94–371, §10(a)(1), (b)(1), July 26, 1976, 90 Stat. 1040; Pub. L. 95–83, title III, §311(a)(3), Aug. 1, 1977, 91 Stat. 397; Pub. L. 95–461, §§2(a), 4, Oct. 14, 1978, 92 Stat. 1268, 1269; Pub. L. 96–79, title I, §115(j)(2), Oct. 4, 1979, 93 Stat. 610; Pub. L. 96–181, §6, Jan. 2, 1980, 93 Stat. 1311, provided for creation and funding through the fiscal year ending Sept. 30, 1981, of a program of formula grants to States to operate State plans for the establishment, conduct, and coordination of projects for the development of more effective drug abuse prevention functions in the States and for the evaluation of such programs.

§1177. Special project grants and contracts

(a) Scope of programs; priority

The Secretary ¹ acting through the National Institute on Drug Abuse, may make grants to and enter into contracts with individuals and public and private nonprofit entities—

(1) to provide training seminars, educational programs, and technical assistance for the development, demonstration, and evaluation of drug abuse prevention, treatment, and rehabilitation programs; and

(2) to conduct demonstration and evaluation projects, with a high priority on prevention and early intervention projects and on identifying new and more effective drug abuse prevention, treatment, and rehabilitation programs.

In the implementation of his authority under this section, the Secretary shall accord a high priority to applications for grants or contracts for primary prevention programs. For purposes of the preceding sentence, primary prevention programs include programs designed to discourage persons from beginning drug abuse. To the extent that appropriations authorized under this section are used to fund treatment services, the Secretary shall not limit such funding to treatment for opiate abuse, but shall also provide support for treatment for non-opiate drug abuse including polydrug abuse. Furthermore, nothing shall prevent the use of funds provided under this section for programs and projects aimed at the prevention, treatment, and rehabilitation of alcohol abuse and alcoholism as well as drug abuse.

(b) Authorization of appropriations

There are authorized to be appropriated $25,000,000 for the fiscal year ending June 30, 1972; $65,000,000 for the fiscal year ending June 30, 1973; $100,000,000 for the fiscal year ending June 30, 1974; $160,000,000 for each of the fiscal years ending June 30, 1975 and June 30, 1976; $40,000,000 for the period July 1, 1976, through September 30, 1976; and $160,000,000 for each of the fiscal years ending September 30, 1977, and September 30, 1978, to carry out this section. For the fiscal year ending September 30, 1979, there is authorized to be appropriated (1) $153,000,000 for grants and contracts under paragraphs (3) and (6) of subsection (a) for drug abuse treatment programs, and (2) $24,000,000 for grants and contracts under such subsection for other programs and activities. For grants and contracts under paragraphs (3) and (6) of subsection (a) for drug abuse treatment programs there is authorized to be appropriated $149,000,000 for the fiscal year ending September 30, 1980, and $155,000,000 for the fiscal year ending September 30, 1981; and for grants and contracts under such subsection for other programs and activities there is authorized to be appropriated $20,000,000 for the fiscal year ending September 30, 1980, and $30,000,000 for the fiscal year ending September 30, 1981. Of the funds appropriated under the preceding sentence for the fiscal year ending September 30, 1980, at least 7 percent of the funds shall be obligated for grants and contracts for primary prevention and intervention programs designed to discourage individuals, particularly those in high risk populations, from abusing drugs; and of the funds appropriated under the preceding sentence for the next fiscal year, at least 10 percent of the funds shall be obligated for such grants and contracts. For carrying out the purposes of this section, there are authorized to be appropriated $15,000,000 for the fiscal year ending September 30, 1982. Of the funds appropriated under the preceding sentence, at least 25 per centum of the funds shall be obligated for grants and contracts for primary prevention and intervention programs designed to discourage individuals, particularly individuals in high risk populations, from abusing drugs.

(c) Coordination of applications for programs in a State; precedence restriction; project evaluation; application approval; criteria; proposed performance standards or research protocol

(1) In carrying out this section, the Secretary shall require coordination of all applications for programs in a State and shall not give precedence to public agencies over private agencies, institutions, and organizations, or to State agencies over local agencies.

(2) Each applicant within a State, upon filing its application with the Secretary for a grant or contract under this section, shall submit a copy of its application for review by the State agency (if any) responsible for the administration of drug abuse prevention activities. Such State agency shall be given not more than thirty days from the date of receipt of the application to submit to the Secretary, in writing, an evaluation of the project set forth in the application. Such evaluation shall include comments on the relationship of the project to other projects pending and approved and to any State comprehensive plan for treatment and prevention of drug abuse. The State shall furnish the applicant a copy of any such evaluation. A State if it so desires may, in writing, waive its rights under this paragraph.

(3) Approval of any application for a grant or contract under this section by the Secretary, including the earmarking of financial assistance for a program or project, may be granted only if the application substantially meets a set of criteria that—

(A) provide that the activities and services for which assistance under this section is sought will be substantially administered by or under the supervision of the applicant;

(B) provide for such methods of administration as are necessary for the proper and efficient operation of such programs or projects; and

(C) provide for such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and accounting for Federal funds paid to the applicant.

(4) Each applicant within a State, upon filing its application with the Secretary for a grant or contract to provide treatment or rehabilitation services shall provide a proposed performance standard or standards, to measure, or research protocol to determine, the effectiveness of such treatment or rehabilitation program or project.

(d) Programs and projects aimed at underserved groups; encouragement and special consideration given to applications

The Secretary shall encourage the submission of and give special consideration to applications under this section to programs and projects aimed at underserved populations such as racial and ethnic minorities, Native Americans (including Native Hawaiians and Native American Pacific Islanders), youth, the elderly, women, handicapped individuals, and families of drug abusers.

(e) Payments; advances; reimbursement; installments

Payment under grants or contracts under this section may be made in advance or by way of reimbursement and in such installments as the Secretary may determine.

(f) Prevention and treatment services

Projects and programs for which grants and contracts are made or entered into under this section shall, in the case of prevention and treatment services, seek to (1) be responsive to special requirements of handicapped individuals in receiving such services; (2) whenever possible, be community based, insure care of good quality in general community care facilities and under health insurance plans, and be integrated with, and provide for the active participation of, a wide range of public and nongovernmental agencies, organizations, institutions, and individuals; (3) where a substantial number of the individuals in the population served by the project or program are of limited English-speaking ability (A) utilize the services of outreach workers fluent in the language spoken by a predominant number of such individuals and develop a plan and make arrangements responsive to the needs of such population for providing services to the extent practicable in the language and cultural context most appropriate to such individuals, and (B) identify an individual who is fluent both in that language and English and whose responsibilities shall include providing guidance to the individuals of limited English-speaking ability and to appropriate staff members with respect to cultural sensitivities and bridging linguistic and cultural differences; and (4) where appropriate, utilize existing community resources (including community mental health centers).

(g) Authorization by chief executive officer of State required; maximum amount and duration of grants

(1) No grant may be made under this section to a State or to any entity within the government of a State unless the grant application has been duly authorized by the chief executive officer of such State.

(2) No grant or contract may be made under this section for a period in excess of five years.

(3)(A) The amount of any grant or contract under this section may not exceed 100 per centum of the cost of carrying out the grant or contract in the first fiscal year for which the grant or contract is made under this section, 80 per centum of such cost in the second fiscal year for which the grant or contract is made under this section, 70 per centum of such cost in the third fiscal year for which the grant or contract is made under this section, and 60 per centum of such cost in each of the fourth and fifth fiscal years for which the grant or contract is made under this section.

(B) For purposes of this paragraph, no grant or contract shall be considered to have been made under this section for a fiscal year ending before September 30, 1981.

(Pub. L. 92–255, title IV, §410, Mar. 21, 1972, 86 Stat. 82; Pub. L. 94–237, §§10, 11, Mar. 19, 1976, 90 Stat. 247; Pub. L. 94–371, §10(c)(1), July 26, 1976, 90 Stat. 1040; Pub. L. 95–461, §§2(b), 6(a), Oct. 14, 1978, 92 Stat. 1268, 1270; Pub. L. 96–181, §7, Jan. 2, 1980, 93 Stat. 1312; Pub. L. 97–35, title IX, §970(b)–(f), Aug. 13, 1981, 95 Stat. 596, 597; Pub. L. 98–24, §5(a)(3), Apr. 26, 1983, 97 Stat. 183.)

Editorial Notes

Amendments

1983—Subsec. (d). Pub. L. 98–24 substituted "Native Americans (including Native Hawaiians and Native American Pacific Islanders)" for "native Americans".

1981—Subsec. (a). Pub. L. 97–35, §970(b), substituted "The Secretary acting through the National Institute on Drug Abuse, may make grants to and enter into contracts with individuals, and public and private nonprofit entities" for "The Secretary shall" in introductory provision preceding par. (1), reduced the enumeration of authorized activities of the Secretary from six paragraphs to two paragraphs thereby eliminating provisions relating to the recruitment, training, and employment of participants in treatment programs, the establishment, conduct, and evaluation of drug abuse prevention, treatment, and rehabilitation programs, the development of methods to deal with drug abuse in particular areas, the improvement of drug maintenance techniques or programs, and the establishment, conduct, and evaluation of drug abuse prevention and treatment programs, and inserted provision that nothing shall prevent the use of funds provided under this section for programs and projects aimed at the prevention, treatment, and rehabilitation of alcohol abuse and alcoholism as well as drug abuse.

Subsec. (b). Pub. L. 97–35, §970(c), inserted provisions relating to fiscal year ending Sept. 30, 1982.

Subsec. (c)(2). Pub. L. 97–35, §970(d)(1), substituted "responsible for the administration of drug abuse prevention activities" for "designated or established under section 1176 of this title" and "any State" for "the State" and struck out reference to drug abuse under section 1176 of this title.

Subsec. (c)(3)(D). Pub. L. 97–35, §970(d)(2), struck out subpar. (D) which had provided that approval of a grant or contract could be granted only if the application provided for reasonable assurances that Federal funds made available under this section would be used to supplement and increase the level of State, local, and other non-Federal funds that would in the absence of such Federal funds be made available for the programs described in this section and would not supplant State or local funds.

Subsec. (d). Pub. L. 97–35, §970(e), inserted applicability to racial and ethnic minorities, handicapped, native Americans, and families of drug abusers.

Subsec. (g). Pub. L. 97–35, §970(f), added subsec. (g).

1980—Subsec. (a)(1). Pub. L. 96–181, §7(a)(1), substituted "development, demonstration and evaluation of drug abuse" for "development of drug abuse".

Subsec. (a)(5). Pub. L. 96–181, §7(a)(2), substituted "drug maintenance and detoxification techniques" for "drug maintenance techniques".

Subsec. (a)(6). Pub. L. 96–181, §7(a)(3), in provisions relating to evaluation of drug abuse prevention and treatment programs, inserted provision that such evaluation be with particular emphasis on replicating effective prevention and treatment programs.

Subsec. (b). Pub. L. 96–181, §7(b), inserted authorization of appropriations for grants and contracts under pars. (3) and (6) of subsec. (a) and for other programs and activities for fiscal years ending Sept. 30, 1980, and Sept. 30, 1981, and required certain percentage of appropriated funds to be obligated for grants and contracts for primary prevention and intervention programs designed to discourage individuals from abusing drugs.

Subsec. (d). Pub. L. 96–181, §7(c), inserted provisions for special consideration to applications for programs and projects for prevention and treatment of drug abuse and drug dependence by elderly.

Subsec. (f). Pub. L. 96–181, §7(d), added subsec. (f).

1978—Subsec. (a). Pub. L. 95–461, §6(a), inserted provision requiring Secretary to act through National Institute on Drug Abuse in making special project grants.

Subsec. (b). Pub. L. 95–461, §2(b), inserted provisions authorizing appropriations for fiscal year ending Sept. 30, 1979.

1976—Subsec. (a). Pub. L. 94–237, §10(a), inserted provisions which authorized Secretary to give a high priority to applications for grants and contracts for primary prevention programs, and set forth programs included within primary prevention programs and scope of Secretary's funding authority.

Subsec. (b). Pub. L. 94–237, §11, substituted "$160,000,000 for each of the fiscal years ending June 30, 1975 and June 30, 1976; $40,000,000 for the period July 1, 1976, through September 30, 1976; and $160,000,000 for each of the fiscal years ending September 30, 1977, and September 30, 1978," for "and $160,000,000 for the fiscal year ending June 30, 1975,".

Subsec. (c)(4). Pub. L. 94–237, §10(b), added par. (4).

Subsecs. (d), (e). Pub. L. 94–371 added subsec. (d) and redesignated former subsec. (d) as (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1976 Amendment

Pub. L. 94–371, §10(c)(2), July 26, 1976, 90 Stat. 1041, provided that: "The amendment made by paragraph (1) [amending this section] shall apply with respect to applications submitted for grants or contracts under section 410 of the Drug Abuse Office and Treatment Act of 1972 [this section] after June 30, 1976."

¹ So in original. Probably should be followed by a comma.

§1178. Records and audit

(a) Assistance records; contents

Each recipient of assistance under section 1177 of this title pursuant to grants or contracts entered into under other than competitive bidding procedures shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant or contract, the total cost of the project or undertaking in connection with which such grant or contract is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.

(b) Access to pertinent information for audit and examination

The Secretary and Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of such recipients that are pertinent to such grants or contracts.

(Pub. L. 92–255, title IV, §411, Mar. 21, 1972, 86 Stat. 83; Pub. L. 97–35, title IX, §971, Aug. 13, 1981, 95 Stat. 597.)

Editorial Notes

Amendments

1981—Subsec. (a). Pub. L. 97–35 struck out reference to section 1176 of this title.

§1179. National Drug Abuse Training Center

(a) Establishment; functions; general policies; transfer of supervision

The Director shall establish a National Drug Abuse Training Center (hereinafter in this section referred to as the "Center") to develop, conduct, and support a full range of training programs relating to drug abuse prevention functions. The Director shall consult with the National Advisory Council for Drug Abuse Prevention regarding the general policies of the Center. The Director may supervise the operation of the Center initially, but shall transfer the supervision of the operation of the Center to the National Institute on Drug Abuse not later than December 31, 1974.

(b) Activities and material

The Center shall conduct or arrange for training programs, seminars, meetings, conferences, and other related activities, including the furnishing of training and educational materials for use by others.

(c) Persons eligible for services and facilities

The services and facilities of the Center shall, in accordance with regulations prescribed by the Director, be available to (1) Federal, State, and local governmental officials, and their respective staffs, (2) medical and paramedical personnel, and educators, and (3) other persons, including drug dependent persons, requiring training or education in drug abuse prevention.

(d) Authorization of appropriations; fiscal year availability

(1) For the purpose of carrying out this section, there are authorized to be appropriated $1,000,000 for the fiscal year ending June 30, 1972, $3,000,000 for the fiscal year ending June 30, 1973, $5,000,000 for the fiscal year ending June 30, 1974, and $6,000,000 for the fiscal year ending June 30, 1975.

(2) Sums appropriated under this subsection shall remain available for obligation or expenditure in the fiscal year for which appropriated and in the fiscal year next following.

(Pub. L. 92–255, title IV, §412, Mar. 21, 1972, 86 Stat. 84.)

Editorial Notes

References in Text

The National Advisory Council for Drug Abuse Prevention, referred to in subsec. (a), was established by section 1151 of this title, which was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

§1180. Transferred

Editorial Notes

Codification

Section, Pub. L. 92–255, title IV, §413, Mar. 21, 1972, 86 Stat. 84; Pub. L. 96–181, §8(a), (b)(1), Jan. 2, 1980, 93 Stat. 1313, 1314; Pub. L. 97–35, title IX, §973(e), Aug. 13, 1981, 95 Stat. 598, which related to drug abuse among government and other employees, was redesignated section 525 of the Public Health Service Act by Pub. L. 98–24, §2(b)(16)(A), Apr. 26, 1983, 97 Stat. 182, and is classified to section 290ee–1 of Title 42, The Public Health and Welfare.

§1181. Contract authority

The authority of the Secretary to enter into contracts under this subchapter and subchapter V shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance by appropriation Acts.

(Pub. L. 92–255, title IV, §414, as added Pub. L. 96–181, §9(a), Jan. 2, 1980, 93 Stat. 1314.)

Editorial Notes

References in Text

Subchapter V, referred to in text, consisted of sections 501 to 504 of title V of Pub. L. 92–255, Mar. 21, 1972, 86 Stat. 85, which were classified to sections 1191 to 1194 of this title, respectively. Sections 501 to 503 were made part of the Public Health Service Act by Pub. L. 98–24, §2(b)(4), (11), (15), Apr. 26, 1983, 97 Stat. 177, 180, 181, and were transferred to former sections 290aa–2, 290ee, and 290cc, respectively, of Title 42, The Public Health and Welfare. Section 290aa–2 of Title 42 was repealed by Pub. L. 102–321, §101(b). Section 290cc of Title 42 was repealed by Pub. L. 102–321, §123(c). Section 290ee of Title 42 was omitted in the general revision of part D of subchapter III–A of chapter 6A of Title 42 by Pub. L. 102–321. Section 1194 of this title was repealed by Pub. L. 98–24, §2(c)(2).

SUBCHAPTER V—NATIONAL INSTITUTE ON DRUG ABUSE

§§1191 to 1193. Transferred

Editorial Notes

Codification

Section 1191, Pub. L. 92–255, title V, §501, Mar. 21, 1972, 86 Stat. 85; Pub. L. 93–282, title II, §204, May 14, 1974, 88 Stat. 136; Pub. L. 94–237, §12(a), Mar. 19, 1976, 90 Stat. 247; Pub. L. 96–181, §10, Jan. 2, 1980, 93 Stat. 1314; Pub. L. 97–35, title IX, §973(f), Aug. 13, 1981, 95 Stat. 598, which established the National Institute on Drug Abuse, was redesignated section 503(a)–(d) of the Public Health Service Act by Pub. L. 98–24, §2(b)(4), Apr. 26, 1983, 97 Stat. 177, transferred to section 290aa–2(a)–(d) of Title 42, The Public Health and Welfare, and subsequently repealed.

Section 1192, Pub. L. 92–255, title V, §502, as added Pub. L. 94–237, §12(b)(1), Mar. 19, 1976, 90 Stat. 247; amended Pub. L. 95–461, §5, Oct. 14, 1978, 92 Stat. 1269; Pub. L. 96–181, §11, Jan. 2, 1980, 93 Stat. 1315, which related to the coordination, information, assistance, and assignment activities and services, was redesignated section 524 of the Public Health Service Act by Pub. L. 98–24, §2(b)(15), Apr. 26, 1983, 97 Stat. 181, transferred to section 290ee of Title 42, and subsequently omitted.

Section 1193, Pub. L. 92–255, title V, §503, as added Pub. L. 94–237, §13(a), Mar. 19, 1976, 90 Stat. 248; amended Pub. L. 95–461, §2(c), Oct. 14, 1978, 92 Stat. 1268; Pub. L. 96–181, §12, Jan. 2, 1980, 93 Stat. 1315; Pub. L. 97–35, title IX, §972(a), (b), Aug. 13, 1981, 95 Stat. 597, which related to research and development functions, was redesignated section 515 of the Public Health Service Act by Pub. L. 98–24, §2(b)(11), Apr. 26, 1983, 97 Stat. 180, transferred to section 290cc of Title 42, and subsequently repealed.

Prior Provisions

A prior section 502 of Pub. L. 92–255, Mar. 21, 1972, 86 Stat. 85, amended section 217 of the Public Health Service Act by adding subsec. (e) [section 218(e) of Title 42, The Public Health and Welfare], and amended section 266 of the Community Mental Health Centers Act [former section 2688t of Title 42].

§1194. Repealed. Pub. L. 98–24, §2(c)(2), Apr. 26, 1983, 97 Stat. 182

Section, Pub. L. 92–255, title V, §504, as added Pub. L. 95–461, §6(b)(1), Oct. 14, 1978, 92 Stat. 1270, related to review by the Secretary of programs and activities. See section 290aa–5 of Title 42, The Public Health and Welfare.

CHAPTER 17—NATIONAL DRUG ENFORCEMENT POLICY

§§1201 to 1204. Repealed. Pub. L. 100–690, title I, §1007(a)(3), Nov. 18, 1988, 102 Stat. 4187

Section 1201, Pub. L. 98–473, title II, §1302, Oct. 12, 1984, 98 Stat. 2168, set forth Congressional findings and declaration of purpose relating to illegal flow of narcotics into United States.

Section 1202, Pub. L. 98–473, title II, §1303, Oct. 12, 1984, 98 Stat. 2168, established National Drug Enforcement Policy Board.

Section 1203, Pub. L. 98–473, title II, §1304, Oct. 12, 1984, 98 Stat. 2169, delineated responsibilities and functions of National Drug Enforcement Policy Board.

Section 1204, Pub. L. 98–473, title II, §1305, Oct. 12, 1984, 98 Stat. 2170, related to reports to Congress.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Pub. L. 100–690, title I, §1007(a)(3), Nov. 18, 1988, 102 Stat. 4187, provided that the repeal of this chapter is effective on 30th day after first Director of National Drug Control Policy is confirmed by the Senate.

Short Title

Pub. L. 98–473, title II, §1301, Oct. 12, 1984, 98 Stat. 2168, which provided that chapter XIII (§§1301 to 1307) of title II of Pub. L. 98–473 was to be cited as the National Narcotics Act of 1984, was repealed by Pub. L. 100–690, title I, §1007(a)(3), Nov. 18, 1988, 102 Stat. 4187.

Executive Documents

Executive Order No. 12590

Ex. Ord. No. 12590, Mar. 26, 1987, 52 F.R. 10021, as amended by Ex. Ord. No. 13284, §11, Jan. 23, 2003, 68 F.R. 4076, provided for the establishment of a National Drug Policy Board, designated its membership and functions, and authorized coordinating groups.

CHAPTER 18—PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE PREVENTION

§§1301 to 1308. Omitted

Editorial Notes

Codification

Section 1301, Pub. L. 99–570, title VIII, §8002, Oct. 27, 1986, 100 Stat. 3207–161 related to the establishment of the President's Media Commission on Alcohol and Drug Abuse Prevention.

Section 1302, Pub. L. 99–570, title VIII, §8003, Oct. 27, 1986, 100 Stat. 3207–161, related to duties of the Commission.

Section 1303, Pub. L. 99–570, title VIII, §8004, Oct. 27, 1986, 100 Stat. 3207–162, required appointment of members of the Commission within 30 days after Oct. 27, 1986.

Section 1304, Pub. L. 99–570, title VIII, §8005, Oct. 27, 1986, 100 Stat. 3207–162, related to meetings.

Section 1305, Pub. L. 99–570, title VIII, §8006, Oct. 27, 1986, 100 Stat. 3207–163, related to employment of Director and staff and the procurement of the services of experts and consultants.

Section 1306, Pub. L. 99–570, title VIII, §8007, Oct. 27, 1986, 100 Stat. 3207–163, related to the powers of the Commission.

Section 1307, Pub. L. 99–570, title VIII, §8008, Oct. 27, 1986, 100 Stat. 3207–163, related to an annual report to Congress.

Section 1308, Pub. L. 99–570, title VIII, §8009, Oct. 27, 1986, 100 Stat. 3207–163, related to termination of Commission three years after the date on which members of the Commission were first appointed unless the President extended the authority of the Commission by Executive order.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 99–570, title VIII, §8001, Oct. 27, 1986, 100 Stat. 3207–161, provided that title VIII of Pub. L. 99–570, which enacted this chapter, was to be cited as the "President's Media Commission on Alcohol and Drug Abuse Prevention Act".

CHAPTER 19—PESTICIDE MONITORING IMPROVEMENTS

        

§1401. Pesticide monitoring and enforcement information

(a) Data management systems

(1) Not later than 480 days after August 23, 1988, the Secretary of Health and Human Services shall place in effect computerized data management systems for the Food and Drug Administration under which the Administration will—

(A) record, summarize, and evaluate the results of its program for monitoring food products for pesticide residues,

(B) identify gaps in its pesticide monitoring program in the monitoring of (i) pesticides, (ii) food products, and (iii) food from specific countries and from domestic sources,

(C) detect trends in the presence of pesticide residues in food products and identify public health problems emerging from the occurrence of pesticide residues in food products,

(D) focus its testing resources for monitoring pesticide residues in food on detecting those residues which pose a public health concern,

(E) prepare summaries of the information listed in subsection (b), and

(F) provide information to assist the Environmental Protection Agency in carrying out its responsibilities under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(2) As soon as practicable, the Secretary of Health and Human Services shall develop a means to enable the computerized data management systems placed into effect under paragraph (1) to make the summary described in subsection (c).

(3)(A) Paragraph (1) does not limit the authority of the Food and Drug Administration to—

(i) use the computerized data management systems placed in effect under paragraph (1), or

(ii) develop additional data management systems,

to facilitate the regulation of any substance or product covered under the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(B) In placing into effect the computerized data management systems under paragraph (1) and in carrying out paragraph (2), the Secretary shall comply with applicable regulations governing computer system design and procurement.

(b) Information

The Food and Drug Administration shall use the computerized data management systems placed into effect under subsection (a)(1) to prepare a summary of—

(1) information on—

(A) the types of imported and domestically produced food products analyzed for compliance with the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] regarding the presence of pesticide residues,

(B) the number of samples of each such food product analyzed for such compliance by country of origin,

(C) the pesticide residues which may be detected using the testing methods employed,

(D) the pesticide residues in such food detected and the levels detected,

(E) the compliance status of each sample of such food tested and the violation rate for each country-product combination, and

(F) the action taken with respect to each sample of such food found to be in violation of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and its ultimate disposition, and

(2) information on—

(A) the country of origin of each imported food product referred to in paragraph (1)(A), and

(B) the United States district of entry for each such imported food product.

(c) Volume data

The Food and Drug Administration shall use the computerized data management systems placed into effect under subsection (a)(1) to summarize the volume of each type of food product subject to the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] which is imported into the United States and which has an entry value which exceeds an amount established by the Secretary of Health and Human Services. The summary shall be made by country of origin and district of entry. Information with respect to volumes of food products to be included in the summary shall, to the extent feasible, be obtained from data bases of other Federal agencies.

(d) Compilation

Not later than 90 days after the expiration of 1 year after the data management systems are placed into effect under subsection (a) and annually thereafter, the Secretary of Health and Human Services shall compile a summary of the information described in subsection (b) with respect to the previous year. When the Food and Drug Administration is able to make summaries under subsection (c), the Secretary shall include in the compilation under the preceding sentence a compilation of the information described in subsection (c). Compilations under this subsection shall be made available to Federal and State agencies and other interested persons.

(Pub. L. 100–418, title IV, §4702, Aug. 23, 1988, 102 Stat. 1412.)

Editorial Notes

References in Text

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsec. (a)(1)(F), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a) to (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 100–418, title IV, §4701, Aug. 23, 1988, 102 Stat. 1411, provided that: "This subtitle [subtitle G (§§4701–4704) of title IV of Pub. L. 100–418, enacting this chapter] may be cited as the 'Pesticide Monitoring Improvements Act of 1988'."

Imported Meat, Poultry Products, Eggs, and Egg Products

Pub. L. 100–418, title IV, §4506, Aug. 23, 1988, 102 Stat. 1404, required the Secretary of Agriculture, not later than 90 days after Aug. 23, 1988, to submit a report to Congress concerning the planned distribution, in fiscal years 1988 and 1989, of the resources of the Department of Agriculture available for sampling imported covered products to ensure compliance with the requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) that govern the level of residues of pesticides, drugs, and other products permitted in or on such products.

§1402. Foreign pesticide information

(a) Cooperative agreements

The Secretary of Health and Human Services shall enter into cooperative agreements with the governments of the countries which are the major sources of food imports into the United States subject to pesticide residue monitoring by the Food and Drug Administration for the purpose of improving the ability of the Food and Drug Administration to assure compliance with the pesticide tolerance requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with regard to imported food.

(b) Information activities

(1) The cooperative agreements entered into under subsection (a) with governments of foreign countries shall specify the action to be taken by the parties to the agreements to accomplish the purpose described in subsection (a), including the means by which the governments of the foreign countries will provide to the Secretary of Health and Human Services current information identifying each of the pesticides used in the production, transportation, and storage of food products imported from production regions of such countries into the United States.

(2) In the case of a foreign country with which the Secretary is unable to enter into an agreement under subsection (a) or for which the information provided under paragraph (1) is insufficient to assure an effective pesticide monitoring program, the Secretary shall, to the extent practicable, obtain the information described in paragraph (1) with respect to such country from other Federal or international agencies or private sources.

(3) The Secretary of Health and Human Services shall assure that appropriate offices of the Food and Drug Administration which are engaged in the monitoring of imported food for pesticide residues receive the information obtained under paragraph (1) or (2).

(4) The Secretary of Health and Human Services shall make available any information obtained under paragraph (1) or (2) to State agencies engaged in the monitoring of imported food for pesticide residues other than information obtained from private sources the disclosure of which to such agencies is restricted.

(c) Coordination with other agencies

The Secretary of Health and Human Services shall—

(1) notify in writing the Department of Agriculture, the Environmental Protection Agency, and the Department of State at the initiation of negotiations with a foreign country to develop a cooperative agreement under subsection (a); and

(2) coordinate the activities of the Department of Health and Human Services with the activities of those departments and agencies, as appropriate, during the course of such negotiations.

(d) Report

Not later than one year after August 23, 1988, the Secretary of Health and Human Services shall report to the Committee on Agriculture, Nutrition, and Forestry and the Committee on Labor and Human Resources of the Senate and the House of Representatives on the activities undertaken by the Secretary to implement this section. The report shall be made available to appropriate Federal and State agencies and to interested persons.

(Pub. L. 100–418, title IV, §4703, Aug. 23, 1988, 102 Stat. 1413.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

§1403. Pesticide analytical methods

The Secretary of Health and Human Services shall, in consultation with the Administrator of the Environmental Protection Agency—

(1) develop a detailed long-range plan and timetable for research that is necessary for the development of and validation of—

(A) new and improved analytical methods capable of detecting at one time the presence of multiple pesticide residues in food, and

(B) rapid pesticide analytical methods, and

(2) conduct a review to determine whether the use of rapid pesticide analytical methods by the Secretary would enable the Secretary to improve the cost-effectiveness of monitoring and enforcement activities under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], including increasing the number of pesticide residues which can be detected and the number of tests for pesticide residues which can be conducted in a cost-effective manner.

The Secretary shall report the plan developed under paragraph (1), the resources necessary to carry out the research described in such paragraph, recommendations for the implementation of such research, and the result of the review conducted under paragraph (2) not later than the expiration of 240 days after August 23, 1988, to the Committee on Agriculture, Nutrition, and Forestry and the Committee on Labor and Human Resources of the Senate and the House of Representatives.

(Pub. L. 100–418, title IV, §4704, Aug. 23, 1988, 102 Stat. 1414.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

CHAPTER 20—NATIONAL DRUG CONTROL PROGRAM

SUBCHAPTER I—OFFICE OF NATIONAL DRUG CONTROL POLICY

        

SUBCHAPTER II—DRUG-FREE COMMUNITIES

        

Part A—Drug-Free Communities Support Program

        

Part B—Advisory Commission

        

SUBCHAPTER I—OFFICE OF NATIONAL DRUG CONTROL POLICY

§§1501, 1502. Repealed. Pub. L. 100–690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234

Section 1501, Pub. L. 100–690, title I, §1002, Nov. 18, 1988, 102 Stat. 4181, established Office of National Drug Control Policy in Executive Office of President. See section 1702 of this title.

Section 1502, Pub. L. 100–690, title I, §1003, Nov. 18, 1988, 102 Stat. 4182; Pub. L. 103–322, title IX, §§90201, 90202, 90207, Sept. 13, 1994, 108 Stat. 1990, 1991, 1995, related to appointment and duties of Director, Deputy Directors, and Associate Director of Office of National Drug Control Policy. See section 1703 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100–690, as amended, which was formerly classified to section 1506 of this title.

Short Title of 1997 Amendment

Pub. L. 105–20, §1, June 27, 1997, 111 Stat. 224, provided that: "This Act [enacting subchapter II of this chapter and amending former sections 1504, 1506 to 1508 of this title, section 2291 of Title 22, Foreign Relations and Intercourse, and provisions set out as notes under this section] may be cited as the 'Drug-Free Communities Act of 1997'."

Short Title

Pub. L. 100–690, §1, Nov. 18, 1988, 102 Stat. 4181, provided that: "This Act [see Tables for classification] may be cited as the 'Anti-Drug Abuse Act of 1988'."

Pub. L. 100–690, title I, §1001, Nov. 18, 1988, 102 Stat. 4181, provided that: "This subtitle [subtitle A (§§1001–1048) of title I of Pub. L. 100–690, enacting this chapter, amending section 1115 of this title, sections 5312, 5314, and 5315 of Title 5, Government Organization and Employees, section 1105 of Title 31, Money and Finance, and section 402 of Title 50, War and National Defense, repealing sections 1103, 1111 to 1114, 1116, and 1201 to 1204 of this title, enacting provisions set out as notes under sections 1201 and 1501 of this title, and repealing provisions set out as notes under section 1201 of this title may be cited as the 'National Narcotics Leadership Act of 1988'."

References to Subtitle A of Pub. L. 100–690

Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234, provided that: "Each reference in Federal law to subtitle A of the Anti-Drug Abuse Act of 1988 [see section 1001 of Pub. L. 100–690, set out above], with the exception of section 1001 of such subtitle, in any provision of law that is in effect on the day before the date of enactment of this Act [June 27, 1997] shall be deemed to be a reference to chapter 1 of the National Narcotics Leadership Act of 1988 [chapter 1 of subtitle A (§§1002–1012) of title I of Pub. L. 100–690, see Tables for classification] (as so designated by this section)."

§1502a. Transferred

Editorial Notes

Codification

Section, Pub. L. 100–690, title I, §1003A, as added Pub. L. 101–510, div. A, title X, §1011, Nov. 5, 1990, 104 Stat. 1633, and amended, which related to the Counter-Drug Technology Assessment Center, was renumbered section 1008 of Pub. L. 100–690 by Pub. L. 103–322, title IX, §90204(c)(2), (3), Sept. 13, 1994, 108 Stat. 1994, and transferred to former section 1505 of this title.

§§1503 to 1505. Repealed. Pub. L. 100–690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234

Section 1503, Pub. L. 100–690, title I, §1004, Nov. 18, 1988, 102 Stat. 4184, related to coordination between Office of National Drug Control Policy and executive branch departments and agencies. See section 1704 of this title.

Section 1504, Pub. L. 100–690, title I, §1005, Nov. 18, 1988, 102 Stat. 4185; Pub. L. 103–322, title IX, §90203, Sept. 13, 1994, 108 Stat. 1991; Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234, related to annual development and submission of National Drug Control Strategy by President to Congress. See section 1705 of this title.

Section 1505, Pub. L. 100–690, title I, §1008, formerly §1003A, as added Pub. L. 101–510, div. A, title X, §1011, Nov. 5, 1990, 104 Stat. 1633; renumbered §1008 and amended Pub. L. 103–322, title IX, §90204(a), (b), (c)(2), (3), Sept. 13, 1994, 108 Stat. 1993, 1994, established Counter-Drug Technology Assessment Center within Office of National Drug Control Policy.

A prior section 1505, Pub. L. 100–690, title I, §1008, Nov. 18, 1988, 102 Stat. 4188, provided for an executive reorganization study and report to Congress and the President no later than Jan. 15, 1990, prior to repeal by Pub. L. 103–322, §90204(c)(1).

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100–690, as amended, which was formerly classified to section 1506 of this title.

§1505a. Annual report on development and deployment of narcotics detection technologies

(a) Report requirement

Not later than December 1st of each year, the Director of the Office of National Drug Control Policy shall submit to Congress and the President a report on the development and deployment of narcotics detection technologies by Federal agencies. Each such report shall be prepared in consultation with the Secretary of Defense, the Secretary of State, the Secretary of Homeland Security, and the Secretary of the Treasury.

(b) Matters to be included

Each report under subsection (a) shall include—

(1) a description of each project implemented by a Federal agency relating to the development or deployment of narcotics detection technology;

(2) the agency responsible for each project described in paragraph (1);

(3) the amount of funds obligated or expended to carry out each project described in paragraph (1) during the fiscal year in which the report is submitted or during any fiscal year preceding the fiscal year in which the report is submitted;

(4) the amount of funds estimated to be obligated or expended for each project described in paragraph (1) during any fiscal year after the fiscal year in which the report is submitted to Congress; and

(5) a detailed timeline for implementation of each project described in paragraph (1).

(Pub. L. 105–85, div. A, title X, §1034, Nov. 18, 1997, 111 Stat. 1884; Pub. L. 107–296, title XVII, §1704(e)(10), Nov. 25, 2002, 116 Stat. 2315.)

Editorial Notes

Codification

Section was enacted as part of the National Defense Authorization Act for Fiscal Year 1998, and not as part of the National Narcotics Leadership Act of 1988 which comprises this chapter.

Amendments

2002—Subsec. (a). Pub. L. 107–296 substituted "of Homeland Security" for "of Transportation".

Statutory Notes and Related Subsidiaries

Effective Date of 2002 Amendment

Amendment by Pub. L. 107–296 effective on the date of transfer of the Coast Guard to the Department of Homeland Security, see section 1704(g) of Pub. L. 107–296, set out as a note under section 101 of Title 10, Armed Forces.

§§1506 to 1508. Repealed. Pub. L. 100–690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234; Pub. L. 115–271, title VIII, §8203(a)(3), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(i)(III), Nov. 27, 2019, 133 Stat. 1157

Section 1506, Pub. L. 100–690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188; Pub. L. 103–322, title IX, §90208(a), Sept. 13, 1994, 108 Stat. 1995; Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234; Pub. L. 115–271, title VIII, §8203(a)(3), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(i)(III), Nov. 27, 2019, 133 Stat. 1157, repealed this subchapter, and the amendments made by this subchapter, except for section 1007, effective Sept. 30, 1997. Amendment by Pub. L. 115–271, which added another exception for sections 1021 to 1035 of Pub. L. 100–690 (21 U.S.C. 1521 to 1535), and which was not given effect because those sections had not been treated as repealed in light of Pub. L. 105–20, §2(b), was subsequently repealed by Pub. L. 116–74.

Section 1507, Pub. L. 100–690, title I, §1010, Nov. 18, 1988, 102 Stat. 4188; Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234, defined terms for purposes of this subchapter. See section 1701 of this title.

Section 1508, Pub. L. 100–690, title I, §1011, Nov. 18, 1988, 102 Stat. 4189; Pub. L. 103–322, title IX, §90206, Sept. 13, 1994, 108 Stat. 1995; Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234, authorized appropriations to carry out this subchapter. See section 1711 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

Effective Date of Repeal

Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100–690, which was formerly classified to section 1506 of this title.

§1509. Repealed. Pub. L. 109–469, title XI, §1101(b), Dec. 29, 2006, 120 Stat. 3539

Section, Pub. L. 100–690, title VI, §6073, Nov. 18, 1988, 102 Stat. 4323; Pub. L. 101–647, title XX, §2001(b), Nov. 29, 1990, 104 Stat. 4854; Pub. L. 102–393, title VI, §638(c), Oct. 6, 1992, 106 Stat. 1788; Pub. L. 103–322, title IX, §90205(a), (d), Sept. 13, 1994, 108 Stat. 1994, 1995; Pub. L. 105–277, div. C, title VII, §712, Oct. 21, 1998, 112 Stat. 2681–692, related to establishment of Special Forfeiture Fund.

SUBCHAPTER II—DRUG-FREE COMMUNITIES

Editorial Notes

Codification

This subchapter is chapter 2 of subtitle A of title I of Pub. L. 100–690. Section 1009 of Pub. L. 100–690 [former 21 U.S.C. 1506] repealed subtitle A effective Sept. 30, 1997. However, that repeal was not executed to this subchapter because of Pub. L. 105–20, §2(a)(1), (b), which not only designated subtitle A as chapter 1 of subtitle A, but also provided that any existing reference to subtitle A was to be deemed to be a reference to chapter 1 of subtitle A (see note set out under former section 1501 of this title). Based on that provision, the repeal was executed in the Code only to subchapter I of this chapter, which comprises chapter 1 of subtitle A, and not to this subchapter, which comprises chapter 2. Nevertheless, Pub. L. 115–271, title VIII, §8203(a)(1), (2), Oct. 24, 2018, 132 Stat. 4110 (set out as a note under section 1521 of this title), directed the revival and restoration of chapter 2 (this subchapter), except for subchapter II thereof (part B of this subchapter), as in effect on Sept. 29, 1997, and as amended by Pub. L. 107–82 and Pub. L. 109–469.

§1521. Findings

Congress finds the following:

(1) Substance abuse among youth has more than doubled in the 5-year period preceding 1996, with substantial increases in the use of marijuana, inhalants, cocaine, methamphetamine, LSD, and heroin.

(2) The most dramatic increases in substance abuse has occurred among 13- and 14-year-olds.

(3) Casual or periodic substance abuse by youth today will contribute to hard core or chronic substance abuse by the next generation of adults.

(4) Substance abuse is at the core of other problems, such as rising violent teenage and violent gang crime, increasing health care costs, HIV infections, teenage pregnancy, high school dropouts, and lower economic productivity.

(5) Increases in substance abuse among youth are due in large part to an erosion of understanding by youth of the high risks associated with substance abuse, and to the softening of peer norms against use.

(6)(A) Substance abuse is a preventable behavior and a treatable disease; and

(B)(i) during the 13-year period beginning with 1979, monthly use of illegal drugs among youth 12 to 17 years of age declined by over 70 percent; and

(ii) data suggests that if parents would simply talk to their children regularly about the dangers of substance abuse, use among youth could be expected to decline by as much as 30 percent.

(7) Community anti-drug coalitions throughout the United States are successfully developing and implementing comprehensive, long-term strategies to reduce substance abuse among youth on a sustained basis.

(8) Intergovernmental cooperation and coordination through national, State, and local or tribal leadership and partnerships are critical to facilitate the reduction of substance abuse among youth in communities throughout the United States.

(Pub. L. 100–690, title I, §1021, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 224.)

Statutory Notes and Related Subsidiaries

Reauthorization of the Drug-Free Communities Program and Revival of Anti-Drug Abuse Act of 1988

Pub. L. 115–271, title VIII, §8203(a)(1), (2), Oct. 24, 2018, 132 Stat. 4110, 4111, as amended by Pub. L. 116–74, §2(c)(1)(A)(i)(II), Nov. 27, 2019, 133 Stat. 1157, provided that:

"(1) In general.—Chapter 2 of subtitle A of title I of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1521 et seq.), except for subchapter II (21 U.S.C. 1541 et seq.), as in effect on September 29, 1997, and as amended by the laws described in paragraph (2), is revived and restored.

"(2) Laws described.—The laws described in this paragraph are:

"(A) Public Law 107–82 (115 Stat. 814) [amending sections 1524, 1532, 1533, and 1535 of this title and enacting provisions set out as notes below].

"(B) The Office of National Drug Control Policy Reauthorization Act of 2006 (Public Law 109–469: 120 Stat. 3502) [amending sections 1524 and 1532 of this title and provisions set out as notes under this section and section 1532 of this title], as amended by paragraph (4) [amending sections 1524 and 1532 of this title and provisions set out as a note under section 1532 of this title]."

Five-Year Extension of Drug-Free Communities Support Program

Pub. L. 107–82, §1(a), Dec. 14, 2001, 115 Stat. 814, provided that: "Congress makes the following findings:

"(1) In the next 15 years, the youth population in the United States will grow by 21 percent, adding 6,500,000 youth to the population of the United States. Even if drug use rates remain constant, there will be a huge surge in drug-related problems, such as academic failure, drug-related violence, and HIV incidence, simply due to this population increase.

"(2) According to the 1994–1996 National Household Survey, 60 percent of students age 12 to 17 who frequently cut classes and who reported delinquent behavior in the past 6 months used marijuana 52 days or more in the previous year.

"(3) The 2000 Washington Kids Count survey conducted by the University of Washington reported that students whose peers have little or no involvement with drinking and drugs have higher math and reading scores than students whose peers had low level drinking or drug use.

"(4) Substance abuse prevention works. In 1999, only 10 percent of teens saw marijuana users as popular, compared to 17 percent in 1998 and 19 percent in 1997. The rate of past-month use of any drug among 12- to 17-year-olds declined 26 percent between 1997 and 1999. Marijuana use for sixth through eighth graders is at the lowest point in 5 years, as is use of cocaine, inhalants, and hallucinogens.

"(5) Community Anti-Drug Coalitions throughout the United States are successfully developing and implementing comprehensive, long-term strategies to reduce substance abuse among youth on a sustained basis. For example:

"(A) The Boston Coalition brought college and university presidents together to create the Cooperative Agreement on Underage Drinking. This agreement represents the first coordinated effort of Boston's many institutions of higher education to address issues such as binge drinking, underage drinking, and changing the norms surrounding alcohol abuse that exist on college and university campuses.

"(B) In 2000, the Coalition for a Drug-Free Greater Cincinnati surveyed more than 47,000 local students in grades 7 through 12. The results provided evidence that the Coalition's initiatives are working. For the first time in a decade, teen drug use in Greater Cincinnati appears to be leveling off. The data collected from the survey has served as a tool to strengthen relationships between schools and communities, as well as facilitate the growth of anti-drug coalitions in communities where such coalitions had not existed.

"(C) The Miami Coalition used a three-part strategy to decrease the percentage of high school seniors who reported using marijuana at least once during the most recent 30-day period. The development of a media strategy, the creation of a network of prevention agencies, and discussions with high school students about the dangers of marijuana all contributed to a decrease in the percentage of seniors who reported using marijuana from over 22 percent in 1995 to 9 percent in 1997. The Miami Coalition was able to achieve these results while national rates of marijuana use were increasing.

"(D) The Nashville Prevention Partnership worked with elementary and middle school children in an attempt to influence them toward positive life goals and discourage them from using substances. The Partnership targeted an area in East Nashville and created after school programs, mentoring opportunities, attendance initiatives, and safe passages to and from school. Attendance and test scores increased as a result of the program.

"(E) At a youth-led town meeting sponsored by the Bering Strait Community Partnership in Nome, Alaska, youth identified a need for a safe, substance-free space. With help from a variety of community partners, the Partnership staff and youth members created the Java Hut, a substance-free coffeehouse designed for youth. The Java Hut is helping to change norms in the community by providing a fun, youth-friendly atmosphere and activities that are not centered around alcohol or marijuana.

"(F) Portland's Regional Drug Initiative (RDI) has promoted the establishment of drug-free workplaces among the city's large and small employers. Over 3,000 employers have attended an RDI training session, and of those, 92 percent have instituted drug-free workplace policies. As a result, there has been a 5.5 percent decrease in positive workplace drug tests.

"(G) San Antonio Fighting Back worked to increase the age at which youth first used illegal substances. Research suggests that the later the age of first use, the lower the risk that a young person will become a regular substance abuser. As a result, the age of first illegal drug use increased from 9.4 years in 1992 to 13.5 years in 1997.

"(H) In 1990, multiple data sources confirmed a trend of increased alcohol use by teenagers in the Troy community. Using its 'multiple strategies over multiple sectors' approach, the Troy Coalition worked with parents, physicians, students, coaches, and others to address this problem from several angles. As a result, the rate of twelfth grade students who had consumed alcohol in the past month decreased from 62.1 percent to 53.3 percent between 1991 and 1998, and the rate of eighth grade students decreased from 26.3 percent to 17.4 percent. The Troy Coalition believes that this decline represents not only a change in behavior on the part of students, but also a change in the norms of the community.

"(6) Despite these successes, drug use continues to be a serious problem facing communities across the United States. For example:

"(A) According to the Pulse Check: Trends in Drug Abuse Mid-Year 2000 report—

"(i) crack and powder cocaine remains the most serious drug problem;

"(ii) marijuana remains the most widely available illicit drug, and its potency is on the rise;

"(iii) treatment sources report an increase in admissions with marijuana as the primary drug of abuse—and adolescents outnumber other age groups entering treatment for marijuana;

"(iv) 80 percent of Pulse Check sources reported increased availability of club drugs, with ecstasy (MDMA) and ketamine the most widely cited club drugs and seven sources reporting that powder cocaine is being used as a club drug by young adults;

"(v) ecstasy abuse and trafficking is expanding, no longer confined to the 'rave' scene;

"(vi) the sale and use of club drugs has grown from nightclubs and raves to high schools, the streets, neighborhoods, open venues, and younger ages;

"(vii) ecstasy users often are unknowingly purchasing adulterated tablets or some other substance sold as MDMA; and

"(viii) along with reports of increased heroin snorting as a route of administration for initiates, there is also an increase in injecting initiates and the negative health consequences associated with injection (for example, increases in HIV/AIDS and Hepatitis C) suggesting that there is a generational forgetting of the dangers of injection of the drug.

"(B) The 2000 Parent's Resource Institute for Drug Education study reported that 23.6 percent of children in the sixth through twelfth grades used illicit drugs in the past year. The same study found that monthly usage among this group was 15.3 percent.

"(C) According to the 2000 Monitoring the Future study, the use of ecstasy among eighth graders increased from 1.7 percent in 1999 to 3.1 percent in 2000, among tenth graders from 4.4 percent to 5.4 percent, and from 5.6 percent to 8.2 percent among twelfth graders.

"(D) A 1999 Mellman Group study found that—

"(i) 56 percent of the population in the United States believed that drug use was increasing in 1999;

"(ii) 92 percent of the population viewed illegal drug use as a serious problem in the United States; and

"(iii) 73 percent of the population viewed illegal drug use as a serious problem in their communities.

"(7) According to the 2001 report of the National Center on Addiction and Substance Abuse at Columbia University entitled 'Shoveling Up: The Impact of Substance Abuse on State Budgets', using the most conservative assumption, in 1998 States spent $77,900,000,000 to shovel up the wreckage of substance abuse, only $3,000,000,000 to prevent and treat the problem and $433,000,000 for alcohol and tobacco regulation and compliance. This $77,900,000,000 burden was distributed as follows:

"(A) $30,700,000,000 in the justice system (77 percent of justice spending).

"(B) $16,500,000,000 in education costs (10 percent of education spending).

"(C) $15,200,000,000 in health costs (25 percent of health spending).

"(D) $7,700,000,000 in child and family assistance (32 percent of child and family assistance spending).

"(E) $5,900,000,000 in mental health and developmental disabilities (31 percent of mental health spending).

"(F) $1,500,000,000 in public safety (26 percent of public safety spending) and $400,000,000 for the state workforce.

"(8) Intergovernmental cooperation and coordination through national, State, and local or tribal leadership and partnerships are critical to facilitate the reduction of substance abuse among youth in communities across the United States.

"(9) Substance abuse is perceived as a much greater problem nationally than at the community level. According to a 2001 study sponsored by The Pew Charitable Trusts, between 1994 and 2000—

"(A) there was a 43 percent increase in the percentage of Americans who felt progress was being made in the war on drugs at the community level;

"(B) only 9 percent of Americans say drug abuse is a 'crisis' in their neighborhood, compared to 27 percent who say this about the nation; and

"(C) the percentage of those who felt we lost ground in the war on drugs on a community level fell by more than a quarter, from 51 percent in 1994 to 37 percent in 2000."

Authorization for National Community Antidrug Coalition Institute

Pub. L. 107–82, §4, Dec. 14, 2001, 115 Stat. 821, as amended by Pub. L. 109–469, title VIII, §805, Dec. 29, 2006, 120 Stat. 3535; Pub. L. 115–271, title VIII, §8204, Oct. 24, 2018, 132 Stat. 4112; Pub. L. 116–74, §2(e), Nov. 27, 2019, 133 Stat. 1159, provided that:

"(a) In General.—Beginning in fiscal year 2020, the Director shall make a competitive grant to provide for the continuation of the National Community Anti-drug [sic] Coalition Institute.

"(b) Eligible Organizations.—An organization eligible for the grant under subsection (a) is any national nonprofit organization that represents, provides technical assistance and training to, and has special expertise and broad, national-level experience in community antidrug coalitions under this subchapter [sic, probably means chapter 2 of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.)].

"(c) Use of Grant Amount.—The organization that receives the grant under subsection (a) shall continue a National Community Anti-Drug [sic] Coalition Institute to—

"(1) provide education, training, and technical assistance for coalition leaders and community teams, with emphasis on the development of coalitions serving economically disadvantaged areas;

"(2) develop and disseminate evaluation tools, mechanisms, and measures to better assess and document coalition performance measures and outcomes; and

"(3) bridge the gap between research and practice by translating knowledge from research into practical information.

"(d) Administration of Grant.—

"(1) Duration.—With respect to a grant made under subsection (a) in fiscal year 2020, the term of the grant shall be 4 years.

"(2) Disbursement.—To the extent amounts are provided in appropriation Acts for such grant, the Director shall disburse the amount of the grant made under subsection (a) on an annual basis."

Prohibition Against Duplication of Effort

Pub. L. 107–82, §5, Dec. 14, 2001, 115 Stat. 821, provided that: "The Director of the Office of National Drug Control Policy shall ensure that the same or similar activities are not carried out, through the use of funds for administrative costs provided under subchapter II [probably means chapter 2] of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.) or funds provided under section 4 of this Act [set out as a note above], by more than one recipient of such funds."

§1522. Purposes

The purposes of this subchapter are—

(1) to reduce substance use and misuse among youth in communities throughout the United States, and over time, to reduce substance use and misuse among adults;

(2) to strengthen collaboration among communities, the Federal Government, and State, local, and tribal governments;

(3) to enhance intergovernmental cooperation and coordination on the issue of substance use and misuse among youth;

(4) to serve as a catalyst for increased citizen participation and greater collaboration among all sectors and organizations of a community that first demonstrates a long-term commitment to reducing substance use and misuse among youth;

(5) to rechannel resources from the fiscal year 1998 Federal drug control budget to provide technical assistance, guidance, and financial support to communities that demonstrate a long-term commitment in reducing substance use and misuse among youth;

(6) to disseminate to communities timely information regarding the state-of-the-art practices and initiatives that have proven to be effective in reducing substance use and misuse among youth;

(7) to enhance, not supplant, local community initiatives for reducing substance use and misuse among youth; and

(8) to encourage the creation of and support for community anti-drug coalitions throughout the United States.

(Pub. L. 100–690, title I, §1022, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 225; amended Pub. L. 115–271, title VIII, §8203(b)(1), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

Amendments

2019—Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(1). See 2018 Amendment note below.

2018—Pub. L. 115–271, §8203(b)(1), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "substance abuse" wherever appearing.

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Pub. L. 116–74, §2(c)(2), Nov. 27, 2019, 133 Stat. 1158, provided that: "The amendments made by this subsection [amending this section, sections 1506, 1523, 1524, 1531 to 1533, 1535, 1541 to 1548, and 1705 of this title, and provisions set out as notes under sections 1521, 1524, and 1532 of this title] shall take effect as if included in the enactment of the Substance Abuse Prevention Act of 2018 (subtitle K of title VIII of Public Law 115–271) [see Tables for classification]."

§1523. Definitions

In this subchapter:

(1) Administrator

The term "Administrator" means the Administrator appointed by the Director under section 1531(c) of this title.

(2) Advisory Commission

The term "Advisory Commission" means the Advisory Commission established under section 1541 ¹ of this title.

(3) Community

The term "community" shall have the meaning provided that term by the Administrator, in consultation with the Advisory Commission.

(4) Director

The term "Director" means the Director of the Office of National Drug Control Policy.

(5) Eligible coalition

The term "eligible coalition" means a coalition that meets the applicable criteria under section 1532(a) of this title.

(6) Grant recipient

The term "grant recipient" means the recipient of a grant award under section 1532 of this title.

(7) Nonprofit organization

The term "nonprofit organization" means an organization described under section 501(c)(3) of title 26 that is exempt from taxation under section 501(a) of title 26.

(8) Program

The term "Program" means the program established under section 1531(a) of this title.

(9) Substance use and misuse

The term "substance use and misuse" means—

(A) the illegal use or misuse of drugs, including substances for which a listing is effect ² under any of schedules I through V under section 812 of this title;

(B) the misuse of inhalants or over-the-counter drugs; or

(C) the use of alcohol, tobacco, or other related product as such use is prohibited by State or local law.

(10) Youth

The term "youth" shall have the meaning provided that term by the Administrator, in consultation with the Advisory Commission.

(Pub. L. 100–690, title I, §1023, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 225; amended Pub. L. 115–271, title VIII, §8203(b)(2), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

References in Text

Section 1541 of this title, referred to in par. (2), was repealed by Pub. L. 115–271, title VIII, §8203(b)(5), Oct. 24, 2018, 132 Stat. 4112.

Amendments

2019—Par. (9). Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(2). See 2018 Amendment note below.

2018—Par. (9). Pub. L. 115–271, §8203(b)(2), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), added par. (9) and struck out former par. (9) which defined "substance abuse".

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

¹ See References in Text note below.

² So in original.

§1524. Authorization of appropriations

(a) In general

There is authorized to be appropriated to the Office of National Drug Control Policy to carry out this subchapter $99,000,000 for each of fiscal years 2018 through 2023.

(b) Administrative costs

Not more than 8 percent of the funds appropriated to carry out this subchapter may be used by the Office of National Drug Control Policy to pay administrative costs associated with the responsibilities of the Office under this subchapter.

(Pub. L. 100–690, title I, §1024, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 226; amended Pub. L. 107–82, §1(b), (c), Dec. 14, 2001, 115 Stat. 817; Pub. L. 109–469, title VIII, §801, Dec. 29, 2006, 120 Stat. 3535; Pub. L. 115–271, title VIII, §8203(a)(3)(A), (b)(3), formerly §8203(a)(4)(A), (b)(3), Oct. 24, 2018, 132 Stat. 4111, renumbered Pub. L. 116–74, §2(c)(1)(A)(i)(IV), Nov. 27, 2019, 133 Stat. 1157; Pub. L. 116–74, §2(c)(1)(A)(i)(V), (ii)(II), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

Amendments

2019—Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(3). See 2018 Amendment note below.

Pub. L. 116–74, §2(c)(1)(A)(i)(V), made technical amendment to directory language of Pub. L. 115–271, §8203(a)(3)(A). See 2018 Amendment note below.

2018—Pub. L. 115–271, §8203(b)(3), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), added subsecs. (a) and (b) and struck out former subsecs. (a) and (b), which related to authorization of appropriations and administrative costs, respectively.

Pub. L. 115–271, §8203(a)(3)(A), formerly §8203(a)(4)(A), as renumbered and amended by Pub. L. 116–74, §2(c)(1)(A)(i)(IV), (V), amended directory language of Pub. L. 109–469, §801. See 2006 Amendment notes below.

2006—Subsec. (a)(11) to (15). Pub. L. 109–469, §801(a), as amended by Pub. L. 115–271, §8203(a)(3)(A), added pars. (11) to (15).

Subsec. (b). Pub. L. 109–469, §801(b), as amended by Pub. L. 115–271, §8203(a)(3)(A), amended subsec. (b) generally. Prior to amendment, text read as follows: "Not more than the following percentages of the amounts authorized under subsection (a) of this section may be used to pay administrative costs:

"(1) 10 percent for fiscal year 1998.

"(2) 6 percent for fiscal year 1999.

"(3) 4 percent for fiscal year 2000.

"(4) 3 percent for fiscal year 2001.

"(5) 6 percent for each of fiscal years 2002 through 2007."

2001—Subsec. (a)(5) to (10). Pub. L. 107–82, §1(b), added pars. (5) to (10) and struck out former par. (5) which read as follows: "$43,500,000 for fiscal year 2002."

Subsec. (b)(5). Pub. L. 107–82, §1(c), added par. (5) and struck out former par. (5) which read as follows: "3 percent for fiscal year 2002."

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

Effective Date of 2018 Amendment

Pub. L. 115–271, title VIII, §8203(a)(3)(B), formerly §8203(a)(4)(B), Oct. 24, 2018, 132 Stat. 4111, as renumbered by Pub. L. 116–74, §2(c)(1)(A)(i)(IV), Nov. 27, 2019, 133 Stat. 1157, provided that: "The amendments made by subparagraph (A) [amending this section, section 1532 of this title, and provisions set out as a note under section 1532 of this title] shall take effect as though enacted as part of the Office of National Drug Control Policy Reauthorization Act of 2006 (Public Law 109–469; 120 Stat. 3502)."

Part A—Drug-Free Communities Support Program

§1531. Establishment of drug-free communities support program

(a) Establishment

The Director shall establish a program to support communities in the development and implementation of comprehensive, long-term plans and programs to prevent and treat substance use and misuse among youth.

(b) Program

In carrying out the Program, the Director shall—

(1) make and track grants to grant recipients;

(2) provide for technical assistance and training, data collection, and dissemination of information on state-of-the-art practices that the Director determines to be effective in reducing substance use and misuse; and

(3) provide for the general administration of the Program.

(c) Administration

Not later than 30 days after receiving recommendations from the Advisory Commission under section 1542(a)(1) ¹ of this title, the Director shall appoint an Administrator to carry out the Program.

(d) Contracting

The Director may employ any necessary staff and may enter into contracts or agreements with national drug control agencies, including interagency agreements to delegate authority for the execution of grants and for such other activities necessary to carry out this subchapter.

(Pub. L. 100–690, title I, §1031, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 226; amended Pub. L. 115–271, title VIII, §8203(b)(4)(A), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

References in Text

Section 1542(a)(1) of this title, referred to in subsec. (c), was repealed by Pub. L. 115–271, title VIII, §8203(b)(5), Oct. 24, 2018, 132 Stat. 4112.

Amendments

2019—Subsecs. (a), (b)(2). Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(4)(A). See 2018 Amendment note below.

2018—Subsecs. (a), (b)(2). Pub. L. 115–271, §8203(b)(4)(A), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "substance abuse".

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

¹ See References in Text note below.

§1532. Program authorization

(a) Grant eligibility

To be eligible to receive an initial grant or a renewal grant under this part, a coalition shall meet each of the following criteria:

(1) Application

The coalition shall submit an application to the Administrator in accordance with section 1533(a)(2) of this title.

(2) Major sector involvement

(A) In general

The coalition shall consist of 1 or more representatives of each of the following categories:

(i) Youth.

(ii) Parents.

(iii) Businesses.

(iv) The media.

(v) Schools.

(vi) Organizations serving youth.

(vii) Law enforcement.

(viii) Religious or fraternal organizations.

(ix) Civic and volunteer groups.

(x) Health care professionals.

(xi) State, local, or tribal governmental agencies with expertise in the field of substance use and misuse (including, if applicable, the State authority with primary authority for substance use and misuse).

(xii) Other organizations involved in reducing substance use and misuse.

(B) Elected officials

If feasible, in addition to representatives from the categories listed in subparagraph (A), the coalition shall have an elected official (or a representative of an elected official) from—

(i) the Federal Government; and

(ii) the government of the appropriate State and political subdivision thereof or the governing body or an Indian tribe (as that term is defined in section 5304(e) of title 25).

(C) Representation

An individual who is a member of the coalition may serve on the coalition as a representative of not more than 1 category listed under subparagraph (A).

(3) Commitment

The coalition shall demonstrate, to the satisfaction of the Administrator—

(A) that the representatives of the coalition have worked together on substance use and misuse reduction initiatives, which, at a minimum, includes initiatives that target drugs referenced in section 1523(9)(A) of this title, for a period of not less than 6 months, acting through entities such as task forces, subcommittees, or community boards; and

(B) substantial participation from volunteer leaders in the community involved (especially in cooperation with individuals involved with youth such as parents, teachers, coaches, youth workers, and members of the clergy).

(4) Mission and strategies

The coalition shall, with respect to the community involved—

(A) have as its principal mission the reduction of substance use and misuse, which, at a minimum, includes the use and abuse of drugs referenced in section 1523(9)(A) of this title, in a comprehensive and long-term manner, with a primary focus on youth in the community;

(B) describe and document the nature and extent of the substance use and misuse problem, which, at a minimum, includes the use and abuse of drugs referenced in section 1523(9)(A) of this title, in the community;

(C)(i) provide a description of substance use and misuse prevention and treatment programs and activities, which, at a minimum, includes programs and activities relating to the use and abuse of drugs referenced in section 1523(9)(A) of this title, in existence at the time of the grant application; and

(ii) identify substance use and misuse programs and service gaps, which, at a minimum, includes programs and gaps relating to the use and abuse of drugs referenced in section 1523(9)(A) of this title, in the community;

(D) develop a strategic plan to reduce substance use and misuse among youth, which, at a minimum, includes the use and abuse of drugs referenced in section 1523(9)(A) of this title, in a comprehensive and long-term fashion; and

(E) work to develop a consensus regarding the priorities of the community to combat substance use and misuse among youth, which, at a minimum, includes the use and abuse of drugs referenced in section 1523(9)(A) of this title.

(5) Sustainability

The coalition shall demonstrate that the coalition is an ongoing concern by demonstrating that the coalition—

(A) is—

(i)(I) a nonprofit organization; or

(II) an entity that the Administrator determines to be appropriate; or

(ii) part of, or is associated with, an established legal entity;

(B) receives financial support (including, in the discretion of the Administrator, in-kind contributions) from non-Federal sources; and

(C) has a strategy to solicit substantial financial support from non-Federal sources to ensure that the coalition and the programs operated by the coalition are self-sustaining.

(6) Accountability

The coalition shall—

(A) establish a system to measure and report outcomes—

(i) consistent with common indicators and evaluation protocols established by the Administrator; and

(ii) approved by the Administrator;

(B) conduct—

(i) for an initial grant under this part, an initial benchmark survey of drug use among youth (or use local surveys or performance measures available or accessible in the community at the time of the grant application); and

(ii) biennial surveys (or incorporate local surveys in existence at the time of the evaluation) to measure the progress and effectiveness of the coalition; and

(C) provide assurances that the entity conducting an evaluation under this paragraph, or from which the coalition receives information, has experience—

(i) in gathering data related to substance use and misuse among youth; or

(ii) in evaluating the effectiveness of community anti-drug coalitions.

(7) Additional criteria

The Director shall not impose any eligibility criteria on new applicants or renewal grantees not provided in this subchapter.

(b) Grant amounts

(1) In general

(A) Grants

(i) In general

Subject to clause (iv), for a fiscal year, the Administrator may grant to an eligible coalition under this paragraph, an amount not to exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year.

(ii) Suspension of grants

If such grant recipient fails to continue to meet the criteria specified in subsection (a), the Administrator may suspend the grant, after providing written notice to the grant recipient and an opportunity to appeal.

(iii) Renewal grants

Subject to clause (iv), the Administrator may award a renewal grant to a grant recipient under this subparagraph for each fiscal year following the fiscal year for which an initial grant is awarded, in an amount not to exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year, during the 4-year period following the period of the initial grant.

(iv) Limitation

The amount of a grant award under this subparagraph may not exceed $125,000 for a fiscal year.

(B) Coalition awards

(i) In general

Except as provided in clause (ii), the Administrator may, with respect to a community, make a grant to 1 eligible coalition that represents that community.

(ii) Exception

The Administrator may make a grant to more than 1 eligible coalition that represents a community if—

(I) the eligible coalitions demonstrate that the coalitions are collaborating with one another; and

(II) each of the coalitions has independently met the requirements set forth in subsection (a).

(2) Rural coalition grants

(A) In general

(i) In general

In addition to awarding grants under paragraph (1), to stimulate the development of coalitions in sparsely populated and rural areas, the Administrator, in consultation with the Advisory Commission, may award a grant in accordance with this section to a coalition that represents a county with a population that does not exceed 30,000 individuals. In awarding a grant under this paragraph, the Administrator may waive any requirement under subsection (a) if the Administrator considers that waiver to be appropriate.

(ii) Matching requirement

Subject to subparagraph (C), for a fiscal year, the Administrator may grant to an eligible coalition under this paragraph, an amount not to exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year.

(iii) Suspension of grants

If such grant recipient fails to continue to meet any criteria specified in subsection (a) that has not been waived by the Administrator pursuant to clause (i), the Administrator may suspend the grant, after providing written notice to the grant recipient and an opportunity to appeal.

(B) Renewal grants

The Administrator may award a renewal grant to an eligible coalition that is a grant recipient under this paragraph for each fiscal year following the fiscal year for which an initial grant is awarded, in an amount not to exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, during the 4-year period following the period of the initial grant.

(C) Limitations

(i) Amount

The amount of a grant award under this paragraph shall not exceed $125,000 for a fiscal year.

(ii) Awards

With respect to a county referred to in subparagraph (A), the Administrator may award a grant under this section to not more than 1 eligible coalition that represents the county.

(3) Additional grants

(A) In general

Subject to subparagraph (F), the Administrator may award an additional grant under this paragraph to an eligible coalition awarded a grant under paragraph (1) or (2) for any first fiscal year after the end of the 4-year period following the period of the initial grant under paragraph (1) or (2), as the case may be.

(B) Scope of grants

A coalition awarded a grant under paragraph (1) or (2), including a renewal grant under such paragraph, may not be awarded another grant under such paragraph, and is eligible for an additional grant under this section only under this paragraph.

(C) No priority for applications

The Administrator may not afford a higher priority in the award of an additional grant under this paragraph than the Administrator would afford the applicant for the grant if the applicant were submitting an application for an initial grant under paragraph (1) or (2) rather than an application for a grant under this paragraph.

(D) Renewal grants

Subject to clause (iv),¹ the Administrator may award a renewal grant to a grant recipient under this subparagraph ² for each fiscal year of the 4-fiscal-year period following the first fiscal year for which the initial additional grant is awarded in an amount not to exceed the following:

(i) For the first and second fiscal years of the 4-fiscal-year period, the amount of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year is not less than 125 percent of the amount awarded.

(ii) For the third and fourth fiscal years of the 4-fiscal-year period, the amount of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year is not less than 150 percent of the amount awarded.

(E) Suspension

If a grant recipient under this paragraph fails to continue to meet the criteria specified in subsection (a), the Administrator may suspend the grant, after providing written notice to the grant recipient and an opportunity to appeal.

(F) Limitation

The amount of a grant award under this paragraph may not exceed $125,000 for a fiscal year.

(4) Process for suspension

A grantee shall not be suspended or terminated under paragraph (1)(A)(ii), (2)(A)(iii), or (3)(E) unless that grantee is afforded a fair, timely, and independent appeal prior to such suspension or termination.

(c) Treatment of funds for coalitions representing certain organizations

Funds appropriated for the substance use and misuse activities of a coalition that includes a representative of the Bureau of Indian Affairs, the Indian Health Service, or a tribal government agency with expertise in the field of substance use and misuse may be counted as non-Federal funds raised by the coalition for purposes of this section.

(d) Priority in awarding grants

In awarding grants under subsection (b)(1)(A)(i), priority shall be given to a coalition serving economically disadvantaged areas.

(Pub. L. 100–690, title I, §1032, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 227; amended Pub. L. 107–82, §1(d), (g), (h), Dec. 14, 2001, 115 Stat. 818, 819; Pub. L. 109–469, title VIII, §§802(a), 803, 804, Dec. 29, 2006, 120 Stat. 3535; Pub. L. 115–271, title VIII, §8203(a)(3)(A), (b)(4), formerly §8203(a)(4)(A), (b)(4), Oct. 24, 2018, 132 Stat. 4111, renumbered Pub. L. 116–74, §2(c)(1)(A)(i)(IV), Nov. 27, 2019, 133 Stat. 1157; Pub. L. 116–74, §2(c)(1)(A)(i)(V), (ii)(II), (iii), (3), Nov. 27, 2019, 133 Stat. 1157, 1158.)

Editorial Notes

Amendments

2019—Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(4). See 2018 Amendment notes below.

Pub. L. 116–74, §2(c)(1)(A)(i)(V), made technical amendment to directory language of Pub. L. 115–271, §8203(a)(3)(A). See 2018 Amendment note below.

Subsec. (b)(1)(A)(iii). Pub. L. 116–74, §2(c)(1)(A)(ii)(II), (III), (3), amended directory language of Pub. L. 115–271, §8203(b)(4)(B). See 2018 Amendment note below.

Subsec. (b)(3)(D). Pub. L. 116–74, §2(c)(1)(A)(ii)(II), (III), (iii), amended directory language of Pub. L. 115–271, §8203(b)(4)(B). See 2018 Amendment note below.

2018—Pub. L. 115–271, §8203(b)(4)(A), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "substance abuse" wherever appearing.

Pub. L. 115–271, §8203(a)(3)(A), formerly §8203(a)(4)(A), as renumbered and amended by Pub. L. 116–74, §2(c)(1)(A)(i)(IV), (V), amended directory language of Pub. L. 109–469, §§802(a), 803, 804. See 2006 Amendment notes below.

Subsec. (b)(1)(A)(iii). Pub. L. 115–271, §8203(b)(4)(B), which originally directed striking cl. (iii) and inserting a new cl. (iii), was subsequently amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), (III), so that it no longer amended cl. (iii) but amended subsec. (b)(3)(D) instead. In addition, Pub. L. 116–74, §2(c)(3), restored the prior cl. (iii) as if the amendment made by Pub. L. 115–271, §8203(b)(4), had never been enacted. See subsec. (b)(3)(D) Amendment note below.

Subsec. (b)(3)(D). Pub. L. 115–271, §8203(b)(4)(B), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), (III), (iii), amended subpar. (D) generally. Prior to amendment, text read as follows: "Subject to subparagraph (F), the Administrator may award a renewal grant to a grant recipient under this paragraph for each of the fiscal years of the 4-fiscal-year period following the fiscal year for which the initial additional grant under subparagraph (A) is awarded in an amount not to exceed amounts as follows:

"(i) For the first and second fiscal years of that 4-fiscal-year period, the amount equal to 80 percent of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year.

"(ii) For the third and fourth fiscal years of that 4-fiscal-year period, the amount equal to 67 percent of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year."

2006—Subsec. (a)(7). Pub. L. 109–469, §804, as amended by Pub. L. 115–271, §8203(a)(3)(A), added par. (7).

Subsec. (b)(1)(A)(iv), (2)(C)(i), (3)(F). Pub. L. 109–469, §803, as amended by Pub. L. 115–271, §8203(a)(3)(A), substituted "$125,000" for "$100,000".

Subsec. (b)(4). Pub. L. 109–469, §802(a), as amended by Pub. L. 115–271, §8203(a)(3)(A), added par. (4).

2001—Subsec. (b)(3). Pub. L. 107–82, §1(d), added par. (3).

Subsec. (c). Pub. L. 107–82, §1(g), added subsec. (c).

Subsec. (d). Pub. L. 107–82, §1(h), added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

Effective Date of 2018 Amendment

Amendment by section 8203(a)(3)(A) of Pub. L. 115–271 effective as if enacted as part of Pub. L. 109–469, see section 8203(a)(3)(B) of Pub. L. 115–271, set out as a note under section 1524 of this title.

Waiver of Federal Fund Limitation for the Drug-Free Communities Support Program

Pub. L. 117–103, div. P, title I, §161, Mar. 15, 2022, 136 Stat. 801, provided that:

"(a) In General.—Subject to subsection (b), if the Administrator of the Drug-Free Communities Support Program determines that, as a result of the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, an eligible coalition is unable to raise the amount of non-Federal funds, including in-kind contributions, agreed to be raised by the coalition for fiscal year 2020, 2021, or 2022 under an agreement entered into with the Administrator pursuant to paragraph (1)(A) or (3) of section 1032(b) of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1532(b)), the Administrator may, notwithstanding such paragraphs, provide to the eligible coalition the grant or renewal grant, as applicable, for that fiscal year only in an amount—

"(1) with respect to an initial grant or renewal grant described under paragraph (1)(A) or (3)(A) of such section, that exceeds the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year;

"(2) with respect to a renewal grant described under paragraph (3)(D)(i) of such section, that exceeds 125 percent of the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year; and

"(3) with respect to a renewal grant described under paragraph (3)(D)(ii) of such section, that exceeds 150 percent of the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year.

"(b) Limitation.—The Administrator may not provide a grant or renewal grant to an eligible coalition in an amount exceeding the amount of funds initially agreed to be provided by the Administrator under the applicable agreement."

Report to Congress

Pub. L. 109–469, title VIII, §802(b), Dec. 29, 2006, 120 Stat. 3535, as amended by Pub. L. 115–271, title VIII, §8203(a)(3)(A), formerly §8203(a)(4)(A), Oct. 24, 2018, 132 Stat. 4111, as renumbered by Pub. L. 116–74, §2(c)(1)(A)(i)(IV), Nov. 27, 2019, 133 Stat. 1157; Pub. L. 116–74, §2(c)(1)(A)(i)(V), Nov. 27, 2019, 133 Stat. 1157, provided that: "Not later than 60 days after the date of enactment of this Act [Dec. 29, 2006], the Director of the Office of National Drug Control Policy shall submit to Congress a report detailing the appeals process required by section 1032(b)(4) of the Anti-Drug Abuse Act of 1988 [21 U.S.C. 1532(b)(4)], as added by subsection (a)."

¹ So in original. Probably should be "subparagraph (F),".

² So in original. Probably should be "this paragraph".

§1533. Information collection and dissemination with respect to grant recipients

(a) Coalition information

(1) General auditing authority

For the purpose of audit and examination, the Administrator—

(A) shall have access to any books, documents, papers, and records that are pertinent to any grant or grant renewal request under this subchapter; and

(B) may periodically request information from a grant recipient to ensure that the grant recipient meets the applicable criteria under section 1532(a) of this title.

(2) Application process

The Administrator shall issue a request for proposal regarding, with respect to the grants awarded under section 1532 of this title, the application process, grant renewal, and suspension or withholding of renewal grants. Each application under this paragraph shall be in writing and shall be subject to review by the Administrator.

(3) Reporting

The Administrator shall, to the maximum extent practicable and in a manner consistent with applicable law, minimize reporting requirements by a grant recipient and expedite any application for a renewal grant made under this part.

(b) Data collection and dissemination

(1) In general

The Administrator may collect data from—

(A) national substance use and misuse organizations that work with eligible coalitions, community anti-drug coalitions, departments or agencies of the Federal Government, or State or local governments and the governing bodies of Indian tribes; and

(B) any other entity or organization that carries out activities that relate to the purposes of the Program.

(2) Activities of Administrator

The Administrator may—

(A) evaluate the utility of specific initiatives relating to the purposes of the Program;

(B) conduct an evaluation of the Program; and

(C) disseminate information described in this subsection to—

(i) eligible coalitions and other substance use and misuse organizations; and

(ii) the general public.

(3) Consultation

The Administrator shall carry out activities under this subsection in consultation with the Advisory Commission and the National Community Antidrug Coalition Institute.

(4) Limitation on use of certain funds for evaluation of Program

Amounts for activities under paragraph (2)(B) may not be derived from amounts under section 1524(a) of this title except for amounts that are available under section 1524(b) of this title for administrative costs.

(Pub. L. 100–690, title I, §1033, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 230; amended Pub. L. 107–82, §1(e), (f), Dec. 14, 2001, 115 Stat. 818; Pub. L. 115–271, title VIII, §8203(b)(4)(A), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

Amendments

2019—Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(4)(A). See 2018 Amendment note below.

2018—Subsec. (b)(1)(A), (2)(C)(i). Pub. L. 115–271, §8203(b)(4)(A), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "substance abuse".

2001—Subsec. (b)(3). Pub. L. 107–82, §1(e), added par. (3).

Subsec. (b)(4). Pub. L. 107–82, §1(f), added par. (4).

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

§1534. Technical assistance and training

(a) In general

(1) Technical assistance and agreements

With respect to any grant recipient or other organization, the Administrator may—

(A) offer technical assistance and training; and

(B) enter into contracts and cooperative agreements.

(2) Coordination of programs

The Administrator may facilitate the coordination of programs between a grant recipient and other organizations and entities.

(b) Training

The Administrator may provide training to any representative designated by a grant recipient in—

(1) coalition building;

(2) task force development;

(3) mediation and facilitation, direct service, assessment and evaluation; or

(4) any other activity related to the purposes of the Program.

(Pub. L. 100–690, title I, §1034, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 231.)

§1535. Supplemental grants for coalition mentoring activities

(a) Authority to make grants

As part of the program established under section 1531 of this title, the Director may award an initial grant under this subsection, and renewal grants under subsection (f), to any coalition awarded a grant under section 1532 of this title that meets the criteria specified in subsection (d) in order to fund coalition mentoring activities by such coalition in support of the program.

(b) Treatment with other grants

(1) Supplement

A grant awarded to a coalition under this section is in addition to any grant awarded to the coalition under section 1532 of this title.

(2) Requirement for basic grant

A coalition may not be awarded a grant under this section for a fiscal year unless the coalition was awarded a grant or renewal grant under section 1532(b) of this title for that fiscal year.

(c) Application

A coalition seeking a grant under this section shall submit to the Administrator an application for the grant in such form and manner as the Administrator may require.

(d) Criteria

A coalition meets the criteria specified in this subsection if the coalition—

(1) has been in existence for at least 5 years;

(2) has achieved, by or through its own efforts, measurable results in the prevention and treatment of substance use and misuse among youth;

(3) has staff or members willing to serve as mentors for persons seeking to start or expand the activities of other coalitions in the prevention and treatment of substance use and misuse;

(4) has demonstrable support from some members of the community in which the coalition mentoring activities to be supported by the grant under this section are to be carried out; and

(5) submits to the Administrator a detailed plan for the coalition mentoring activities to be supported by the grant under this section.

(e) Use of grant funds

A coalition awarded a grant under this section shall use the grant amount for mentoring activities to support and encourage the development of new, self-supporting community coalitions that are focused on the prevention and treatment of substance use and misuse in such new coalitions' communities. The mentoring coalition shall encourage such development in accordance with the plan submitted by the mentoring coalition under subsection (d)(5).

(f) Renewal grants

The Administrator may make a renewal grant to any coalition awarded a grant under subsection (a), or a previous renewal grant under this subsection, if the coalition, at the time of application for such renewal grant—

(1) continues to meet the criteria specified in subsection (d); and

(2) has made demonstrable progress in the development of one or more new, self-supporting community coalitions that are focused on the prevention and treatment of substance use and misuse.

(g) Grant amounts

(1) In general

Subject to paragraphs (2) and (3), the total amount of grants awarded to a coalition under this section for a fiscal year may not exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year. Funds appropriated for the substance use and misuse activities of a coalition that includes a representative of the Bureau of Indian Affairs, the Indian Health Service, or a tribal government agency with expertise in the field of substance use and misuse may be counted as non-Federal funds raised by the coalition.

(2) Initial grants

The amount of the initial grant awarded to a coalition under subsection (a) may not exceed $75,000.

(3) Renewal grants

The total amount of renewal grants awarded to a coalition under subsection (f) for any fiscal year may not exceed $75,000.

(h) Fiscal year limitation on amount available for grants

The total amount available for grants under this section, including renewal grants under subsection (f), in any fiscal year may not exceed the amount equal to five percent of the amount authorized to be appropriated by section 1524(a) of this title for that fiscal year.

(i) Priority in awarding initial grants

In awarding initial grants under this section, priority shall be given to a coalition that expressly proposes to provide mentorship to a coalition or aspiring coalition serving economically disadvantaged areas.

(Pub. L. 100–690, title I, §1035, as added Pub. L. 107–82, §2, Dec. 14, 2001, 115 Stat. 819; amended Pub. L. 115–271, title VIII, §8203(b)(4)(A), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

Amendments

2019—Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(4)(A). See 2018 Amendment note below.

2018—Pub. L. 115–271, §8203(b)(4)(A), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "substance abuse" wherever appearing.

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

§1536. Community-based coalition enhancement grants to address local drug crises

(a) Definitions

In this section:

(1) Administrator

The term "Administrator" means the Administrator of the Substance Abuse and Mental Health Services Administration.

(2) Director

The term "Director" means the Director of the Office of National Drug Control Policy.

(3) Drug-Free Communities Act of 1997

The term "Drug-Free Communities Act of 1997" means chapter 2 of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.).

(4) Eligible entity

The term "eligible entity" means an organization that—

(A) on or before the date of submitting an application for a grant under this section, receives or has received a grant under the Drug-Free Communities Act of 1997; and

(B) has documented, using local data, rates of abuse of opioids or methamphetamines at levels that are—

(i) significantly higher than the national average as determined by the Secretary (including appropriate consideration of the results of the Monitoring the Future Survey published by the National Institute on Drug Abuse and the National Survey on Drug Use and Health published by the Substance Abuse and Mental Health Services Administration); or

(ii) higher than the national average, as determined by the Secretary (including appropriate consideration of the results of the surveys described in clause (i)), over a sustained period of time.

(5) Emerging drug abuse issue

The term "emerging drug abuse issue" means a substance use disorder within an area involving—

(A) a sudden increase in demand for particular drug abuse treatment services relative to previous demand; and

(B) a lack of resources in the area to address the emerging problem.

(6) Local drug crisis

The term "local drug crisis" means, with respect to the area served by an eligible entity—

(A) a sudden increase in the abuse of opioids or methamphetamines, as documented by local data;

(B) the abuse of prescription medications, specifically opioids or methamphetamines, that is significantly higher than the national average, over a sustained period of time, as documented by local data; or

(C) a sudden increase in opioid-related deaths, as documented by local data.

(7) Opioid

The term "opioid" means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.

(b) Program authorized

The Director, in coordination with the Administrator, may make grants to eligible entities to implement comprehensive community-wide strategies that address local drug crises and emerging drug abuse issues within the area served by the eligible entity.

(c) Application

(1) In general

An eligible entity seeking a grant under this section shall submit an application to the Director at such time, in such manner, and accompanied by such information as the Director may require.

(2) Criteria

As part of an application for a grant under this section, the Director shall require an eligible entity to submit a detailed, comprehensive, multisector plan for addressing the local drug crisis or emerging drug abuse issue within the area served by the eligible entity.

(d) Use of funds

An eligible entity shall use a grant received under this section—

(1) for programs designed to implement comprehensive community-wide prevention strategies to address the local drug crisis in the area served by the eligible entity, in accordance with the plan submitted under subsection (c)(2);

(2) to obtain specialized training and technical assistance from the organization funded under section 4 of Public Law 107–82 (21 U.S.C. 1521 note); and

(3) for programs designed to implement comprehensive community-wide strategies to address emerging drug abuse issues in the community.

(e) Supplement not supplant

An eligible entity shall use Federal funds received under this section only to supplement the funds that would, in the absence of those Federal funds, be made available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds.

(f) Evaluation

A grant under this section shall be subject to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on the recipient of a grant under the Drug-Free Communities Act of 1997, and may also include an evaluation of the effectiveness at reducing abuse of opioids or methamphetamines.

(g) Limitation on administrative expenses

Not more than 8 percent of the amounts made available to carry out this section for a fiscal year may be used to pay for administrative expenses.

(h) Delegation authority

The Director may enter into an interagency agreement with the Administrator to delegate authority for the execution of grants and for such other activities as may be necessary to carry out this section.

(i) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2017 through 2021.

(Pub. L. 114–198, title I, §103, July 22, 2016, 130 Stat. 699.)

Editorial Notes

References in Text

The Drug-Free Communities Act of 1997, referred to in subsec. (a)(3), is Pub. L. 105–20, June 27, 1997, 111 Stat. 224, section 2(a)(2) of which enacted chapter 2 of the National Narcotics Leadership Act of 1988, which is classified to this subchapter. For complete classification of the Drug-Free Communities Act of 1997 to the Code, see Short Title of 1997 Amendment note set out under section 1501 of this title and Tables.

Codification

Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the National Narcotics Leadership Act of 1988 which comprises this chapter.

Part B—Advisory Commission

§§1541 to 1548. Repealed. Pub. L. 115–271, title VIII, §8203(b)(5), Oct. 24, 2018, 132 Stat. 4112; Pub. L. 116–74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157

Section 1541, Pub. L. 100–690, title I, §1041, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 231, established Advisory Commission on Drug-Free Communities.

Section 1542, Pub. L. 100–690, title I, §1042, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 231, related to duties of the Commission.

Section 1543, Pub. L. 100–690, title I, §1043, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 232, related to membership of the Commission.

Section 1544, Pub. L. 100–690, title I, §1044, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 232, related to compensation.

Section 1545, Pub. L. 100–690, title I, §1045, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 233, related to terms of office.

Section 1546, Pub. L. 100–690, title I, §1046, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 233, related to Commission meetings.

Section 1547, Pub. L. 100–690, title I, §1047, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 233, related to Commission staff.

Section 1548, Pub. L. 100–690, title I, §1048, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 234; amended Pub. L. 107–82, §3, Dec. 14, 2001, 115 Stat. 820, terminated the Commission at the end of fiscal year 2007.

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out a note under section 1522 of this title.

CHAPTER 21—BIOMATERIALS ACCESS ASSURANCE

        

§1601. Findings

The Congress finds that—

(1) each year millions of citizens of the United States depend on the availability of lifesaving or life-enhancing medical devices, many of which are permanently implantable within the human body;

(2) a continued supply of raw materials and component parts is necessary for the invention, development, improvement, and maintenance of the supply of the devices;

(3) most of the medical devices are made with raw materials and component parts that—

(A) move in interstate commerce;

(B) are not designed or manufactured specifically for use in medical devices; and

(C) come in contact with internal human tissue;

(4) the raw materials and component parts also are used in a variety of nonmedical products;

(5) because small quantities of the raw materials and component parts are used for medical devices, sales of raw materials and component parts for medical devices constitute an extremely small portion of the overall market for the raw materials and component parts;

(6) under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) manufacturers of medical devices are required to demonstrate that the medical devices are safe and effective, including demonstrating that the products are properly designed and have adequate warnings or instructions;

(7) notwithstanding the fact that raw materials and component parts suppliers do not design, produce, or test a final medical device, the suppliers have been the subject of actions alleging inadequate—

(A) design and testing of medical devices manufactured with materials or parts supplied by the suppliers; or

(B) warnings related to the use of such medical devices;

(8) even though suppliers of raw materials and component parts have very rarely been held liable in such actions, such suppliers have ceased supplying certain raw materials and component parts for use in medical devices for a number of reasons, including concerns about the costs of such litigation;

(9) unless alternate sources of supply can be found, the unavailability of raw materials and component parts for medical devices will lead to unavailability of lifesaving and life-enhancing medical devices;

(10) because other suppliers of the raw materials and component parts in foreign nations are refusing to sell raw materials or component parts for use in manufacturing certain medical devices in the United States, the prospects for development of new sources of supply for the full range of threatened raw materials and component parts for medical devices are remote;

(11) it is unlikely that the small market for such raw materials and component parts in the United States could support the large investment needed to develop new suppliers of such raw materials and component parts;

(12) attempts to develop such new suppliers would raise the cost of medical devices;

(13) courts that have considered the duties of the suppliers of the raw materials and component parts have generally found that the suppliers do not have a duty—

(A) to evaluate the safety and efficacy of the use of a raw material or component part in a medical device; or

(B) to warn consumers concerning the safety and effectiveness of a medical device;

(14) because medical devices and the raw materials and component parts used in their manufacture move in interstate commerce, a shortage of such raw materials and component parts affects interstate commerce;

(15) in order to safeguard the availability of a wide variety of lifesaving and life-enhancing medical devices, immediate action is needed—

(A) to clarify the permissible bases of liability for suppliers of raw materials and component parts for medical devices; and

(B) to provide expeditious procedures to dispose of unwarranted suits against the suppliers in such manner as to minimize litigation costs;

(16) the several States and their courts are the primary architects and regulators of our tort system; Congress, however, must, in certain circumstances involving the national interest, address tort issues, and a threatened shortage of raw materials and component parts for lifesaving medical devices is one such circumstance; and

(17) the protections set forth in this chapter are needed to assure the continued supply of materials for lifesaving medical devices, although such protections do not protect negligent suppliers.

(Pub. L. 105–230, §2, Aug. 13, 1998, 112 Stat. 1519.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in par. (6), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 105–230, §8, Aug. 13, 1998, 112 Stat. 1529, provided that: "This Act [enacting this chapter] shall apply to all civil actions covered under this Act that are commenced on or after the date of enactment of this Act [Aug. 13, 1998], including any such action with respect to which the harm asserted in the action or the conduct that caused the harm occurred before the date of enactment of this Act."

Short Title

Pub. L. 105–230, §1, Aug. 13, 1998, 112 Stat. 1519, provided that: "This Act [enacting this chapter] may be cited as the 'Biomaterials Access Assurance Act of 1998'."

§1602. Definitions

As used in this chapter:

(1) Biomaterials supplier

(A) In general

The term "biomaterials supplier" means an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant.

(B) Persons included

Such term includes any person who—

(i) has submitted master files to the Secretary for purposes of premarket approval of a medical device; or

(ii) licenses a biomaterials supplier to produce component parts or raw materials.

(2) Claimant

(A) In general

The term "claimant" means any person who brings a civil action, or on whose behalf a civil action is brought, arising from harm allegedly caused directly or indirectly by an implant, including a person other than the individual into whose body, or in contact with whose blood or tissue, the implant is placed, who claims to have suffered harm as a result of the implant.

(B) Action brought on behalf of an estate

With respect to an action brought on behalf of or through the estate of a deceased individual into whose body, or in contact with whose blood or tissue the implant was placed, such term includes the decedent that is the subject of the action.

(C) Action brought on behalf of a minor or incompetent

With respect to an action brought on behalf of or through a minor or incompetent, such term includes the parent or guardian of the minor or incompetent.

(D) Exclusions

Such term does not include—

(i) a provider of professional health care services in any case in which—

(I) the sale or use of an implant is incidental to such services; and

(II) the essence of the professional health care services provided is the furnishing of judgment, skill, or services;

(ii) a person acting in the capacity of a manufacturer, seller, or biomaterials supplier; or

(iii) a person alleging harm caused by either the silicone gel or the silicone envelope utilized in a breast implant containing silicone gel, except that—

(I) neither the exclusion provided by this clause nor any other provision of this chapter may be construed as a finding that silicone gel (or any other form of silicone) may or may not cause harm; and

(II) the existence of the exclusion under this clause may not—

(aa) be disclosed to a jury in any civil action or other proceeding; and

(bb) except as necessary to establish the applicability of this chapter, otherwise be presented in any civil action or other proceeding.

(3) Component part

(A) In general

The term "component part" means a manufactured piece of an implant.

(B) Certain components

Such term includes a manufactured piece of an implant that—

(i) has significant non-implant applications; and

(ii) alone, has no implant value or purpose, but when combined with other component parts and materials, constitutes an implant.

(4) Harm

(A) In general

The term "harm" means—

(i) any injury to or damage suffered by an individual;

(ii) any illness, disease, or death of that individual resulting from that injury or damage; and

(iii) any loss to that individual or any other individual resulting from that injury or damage.

(B) Exclusion

The term does not include any commercial loss or loss of or damage to an implant.

(5) Implant

The term "implant" means—

(A) a medical device that is intended by the manufacturer of the device—

(i) to be placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days; or

(ii) to remain in contact with bodily fluids or internal human tissue through a surgically produced opening for a period of less than 30 days; and

(B) suture materials used in implant procedures.

(6) Manufacturer

The term "manufacturer" means any person who, with respect to an implant—

(A) is engaged in the manufacture, preparation, propagation, compounding, or processing (as defined in section 360(a)(1) of this title) of the implant; and

(B) is required—

(i) to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and

(ii) to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section.

(7) Medical device

The term "medical device" means a device, as defined in section 321(h) of this title, and includes any device component of any combination product as that term is used in section 353(g) of this title.

(8) Raw material

The term "raw material" means a substance or product that—

(A) has a generic use; and

(B) may be used in an application other than an implant.

(9) Secretary

The term "Secretary" means the Secretary of Health and Human Services.

(10) Seller

(A) In general

The term "seller" means a person who, in the course of a business conducted for that purpose, sells, distributes, leases, packages, labels, or otherwise places an implant in the stream of commerce.

(B) Exclusions

The term does not include—

(i) a seller or lessor of real property;

(ii) a provider of professional health care services in any case in which—

(I) the sale or use of the implant is incidental to such services; and

(II) the essence of the professional health care services provided is the furnishing of judgment, skill, or services; or

(iii) any person who acts in only a financial capacity with respect to the sale of an implant.

(Pub. L. 105–230, §3, Aug. 13, 1998, 112 Stat. 1520.)

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

§1603. General requirements; applicability; preemption

(a) General requirements

(1) In general

In any civil action covered by this chapter, a biomaterials supplier may—

(A) raise any exclusion from liability set forth in section 1604 of this title; and

(B) make a motion for dismissal or for summary judgment as set forth in section 1605 of this title.

(2) Procedures

Notwithstanding any other provision of law, a Federal or State court in which an action covered by this chapter is pending shall, in connection with a motion under section 1605 or 1606 of this title, use the procedures set forth in this chapter.

(b) Applicability

(1) In general

Except as provided in paragraph (2), this chapter applies to any civil action brought by a claimant, whether in a Federal or State court, on the basis of any legal theory, for harm allegedly caused, directly or indirectly, by an implant.

(2) Exclusion

A civil action brought by a purchaser of a medical device, purchased for use in providing professional health care services, for loss or damage to an implant or for commercial loss to the purchaser—

(A) shall not be considered an action that is subject to this chapter; and

(B) shall be governed by applicable commercial or contract law.

(c) Scope of preemption

(1) In general

This chapter supersedes any State law regarding recovery for harm caused by an implant and any rule of procedure applicable to a civil action to recover damages for such harm only to the extent that this chapter establishes a rule of law applicable to the recovery of such damages.

(2) Applicability of other laws

Any issue that arises under this chapter and that is not governed by a rule of law applicable to the recovery of damages described in paragraph (1) shall be governed by applicable Federal or State law.

(d) Statutory construction

Nothing in this chapter may be construed—

(1) to affect any defense available to a defendant under any other provisions of Federal or State law in an action alleging harm caused by an implant; or

(2) to create a cause of action or Federal court jurisdiction pursuant to section 1331 or 1337 of title 28 that otherwise would not exist under applicable Federal or State law.

(Pub. L. 105–230, §4, Aug. 13, 1998, 112 Stat. 1523.)

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

§1604. Liability of biomaterials suppliers

(a) In general

Except as provided in section 1606 of this title, a biomaterials supplier shall not be liable for harm to a claimant caused by an implant unless such supplier is liable—

(1) as a manufacturer of the implant, as provided in subsection (b);

(2) as a seller of the implant, as provided in subsection (c); or

(3) for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in subsection (d).

(b) Liability as manufacturer

(1) In general

A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable for harm to a claimant caused by an implant if the biomaterials supplier is the manufacturer of the implant.

(2) Grounds for liability

The biomaterials supplier may be considered the manufacturer of the implant that allegedly caused harm to a claimant only if the biomaterials supplier—

(A)(i) registered or was required to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and

(ii) included or was required to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section;

(B) is the subject of a declaration issued by the Secretary pursuant to paragraph (3) that states that the supplier, with respect to the implant that allegedly caused harm to the claimant, was required to—

(i) register with the Secretary under section 360 of this title, and the regulations issued under such section, but failed to do so; or

(ii) include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section, but failed to do so; or

(C) is related by common ownership or control to a person meeting all the requirements described in subparagraph (A) or (B), if the court deciding a motion to dismiss in accordance with section 1605(c)(3)(B)(i) of this title finds, on the basis of affidavits submitted in accordance with section 1605 of this title, that it is necessary to impose liability on the biomaterials supplier as a manufacturer because the related manufacturer meeting the requirements of subparagraph (A) or (B) lacks sufficient financial resources to satisfy any judgment that the court feels it is likely to enter should the claimant prevail.

(3) Administrative procedures

(A) In general

The Secretary may issue a declaration described in paragraph (2)(B) on the motion of the Secretary or on petition by any person, after providing—

(i) notice to the affected persons; and

(ii) an opportunity for an informal hearing.

(B) Docketing and final decision

Immediately upon receipt of a petition filed pursuant to this paragraph, the Secretary shall docket the petition. Not later than 120 days after the petition is filed, the Secretary shall issue a final decision on the petition.

(C) Applicability of statute of limitations

Any applicable statute of limitations shall toll during the period from the time a claimant files a petition with the Secretary under this paragraph until such time as either (i) the Secretary issues a final decision on the petition, or (ii) the petition is withdrawn.

(D) Stay pending petition for declaration

If a claimant has filed a petition for a declaration with respect to a defendant, and the Secretary has not issued a final decision on the petition, the court shall stay all proceedings with respect to that defendant until such time as the Secretary has issued a final decision on the petition.

(c) Liability as seller

A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable as a seller for harm to a claimant caused by an implant only if—

(1) the biomaterials supplier—

(A) held title to the implant and then acted as a seller of the implant after its initial sale by the manufacturer; or

(B) acted under contract as a seller to arrange for the transfer of the implant directly to the claimant after the initial sale by the manufacturer of the implant; or

(2) the biomaterials supplier is related by common ownership or control to a person meeting all the requirements described in paragraph (1), if a court deciding a motion to dismiss in accordance with section 1605(c)(3)(B)(ii) of this title finds, on the basis of affidavits submitted in accordance with section 1605 of this title, that it is necessary to impose liability on the biomaterials supplier as a seller because the related seller meeting the requirements of paragraph (1) lacks sufficient financial resources to satisfy any judgment that the court feels it is likely to enter should the claimant prevail.

(d) Liability for failure to meet applicable contractual requirements or specifications

A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable for harm to a claimant caused by an implant if the claimant in an action shows, by a preponderance of the evidence, that—

(1) the biomaterials supplier supplied raw materials or component parts for use in the implant that either—

(A) did not constitute the product described in the contract between the biomaterials supplier and the person who contracted for the supplying of the product; or

(B) failed to meet any specifications that were—

(i) accepted, pursuant to applicable law, by the biomaterials supplier;

(ii) published by the biomaterials supplier;

(iii) provided by the biomaterials supplier to the person who contracted for such product;

(iv) contained in a master file that was submitted by the biomaterials supplier to the Secretary and that is currently maintained by the biomaterials supplier for purposes of premarket approval of medical devices; or

(v) included in the submissions for purposes of premarket approval or review by the Secretary under section 360, 360c, 360e, or 360j of this title, and received clearance from the Secretary if such specifications were accepted, pursuant to applicable law, by the biomaterials supplier; and

(2) such failure to meet applicable contractual requirements or specifications was an actual and proximate cause of the harm to the claimant.

(Pub. L. 105–230, §5, Aug. 13, 1998, 112 Stat. 1524.)

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

§1605. Procedures for dismissal of civil actions against biomaterials suppliers

(a) Motion to dismiss

A defendant may, at any time during which a motion to dismiss may be filed under applicable law, move to dismiss an action against it on the grounds that the defendant is a biomaterials supplier and one or more of the following:

(1) The defendant is not liable as a manufacturer, as provided in section 1604(b) of this title.

(2) The defendant is not liable as a seller, as provided in section 1604(c) of this title.

(3) The defendant is not liable for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in section 1604(d) of this title.

(4) The claimant did not name the manufacturer as a party to the action, as provided in subsection (b).

(b) Manufacturer of implant shall be named a party

In any civil action covered by this chapter, the claimant shall be required to name the manufacturer of the implant as a party to the action, unless—

(1) the manufacturer is subject to service of process solely in a jurisdiction in which the biomaterials supplier is not domiciled or subject to a service of process; or

(2) a claim against the manufacturer is barred by applicable law or rule of practice.

(c) Proceeding on motion to dismiss

The following rules shall apply to any proceeding on a motion to dismiss filed by a defendant under this section:

(1) Effect of motion to dismiss on discovery

(A) In general

Except as provided in subparagraph (B), if a defendant files a motion to dismiss under subsection (a), no discovery shall be permitted in connection with the action that is the subject of the motion, other than discovery necessary to determine a motion to dismiss for lack of jurisdiction, until such time as the court rules on the motion to dismiss.

(B) Discovery

If a defendant files a motion to dismiss under subsection (a)(3) on the grounds that it did not furnish raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, the court may permit discovery limited to issues that are directly relevant to—

(i) the pending motion to dismiss; or

(ii) the jurisdiction of the court.

(2) Affidavits

(A) Defendant

A defendant may submit affidavits supporting the grounds for dismissal contained in its motion to dismiss under subsection (a). If the motion is made under subsection (a)(1), the defendant may submit an affidavit demonstrating that the defendant has not included the implant on a list, if any, filed with the Secretary pursuant to section 360(j) of this title.

(B) Claimant

In response to a motion to dismiss, the claimant may submit affidavits demonstrating that—

(i) the Secretary has, with respect to the defendant and the implant that allegedly caused harm to the claimant, issued a declaration pursuant to section 1604(b)(2)(B) of this title; or

(ii) the defendant is a seller of the implant who is liable under section 1604(c) of this title.

(3) Basis of ruling on motion to dismiss

The court shall rule on a motion to dismiss filed under subsection (a) solely on the basis of the pleadings and affidavits of the parties made pursuant to this subsection. The court shall grant a motion to dismiss filed under subsection (a)—

(A) unless the claimant submits a valid affidavit that demonstrates that the defendant is not a biomaterials supplier;

(B) unless the court determines, to the extent raised in the pleadings and affidavits, that one or more of the following apply:

(i) the defendant may be liable as a manufacturer, as provided in section 1604(b) of this title;

(ii) the defendant may be liable as a seller, as provided in section 1604(c) of this title; or

(iii) the defendant may be liable for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in section 1604(d) of this title; or

(C) if the claimant did not name the manufacturer as a party to the action, as provided in subsection (b).

(4) Treatment of motion as motion for summary judgment

The court may treat a motion to dismiss as a motion for summary judgment subject to subsection (d) in order to determine whether the pleadings and affidavits, in connection with such action, raise genuine issues of material fact concerning whether the defendant furnished raw materials or component parts of the implant that failed to meet applicable contractual requirements or specifications as provided in section 1604(d) of this title.

(d) Summary judgment

(1) In general

(A) Basis for entry of judgment

If a motion to dismiss of a biomaterials supplier is to be treated as a motion for summary judgment under subsection (c)(4) or if a biomaterials supplier moves for summary judgment, the biomaterials supplier shall be entitled to entry of judgment without trial if the court finds there is no genuine issue of material fact for each applicable element set forth in paragraphs (1) and (2) of section 1604(d) of this title.

(B) Issues of material fact

With respect to a finding made under subparagraph (A), the court shall consider a genuine issue of material fact to exist only if the evidence submitted by the claimant would be sufficient to allow a reasonable jury to reach a verdict for the claimant if the jury found the evidence to be credible.

(2) Discovery made prior to a ruling on a motion for summary judgment

If, under applicable rules, the court permits discovery prior to a ruling on a motion for summary judgment governed by section 1604(d) of this title, such discovery shall be limited solely to establishing whether a genuine issue of material fact exists as to the applicable elements set forth in paragraphs (1) and (2) of section 1604(d) of this title.

(3) Discovery with respect to a biomaterials supplier

A biomaterials supplier shall be subject to discovery in connection with a motion seeking dismissal or summary judgment on the basis of the inapplicability of section 1604(d) of this title or the failure to establish the applicable elements of section 1604(d) of this title solely to the extent permitted by the applicable Federal or State rules for discovery against nonparties.

(e) Dismissal with prejudice

An order granting a motion to dismiss or for summary judgment pursuant to this section shall be entered with prejudice, except insofar as the moving defendant may be rejoined to the action as provided in section 1606 of this title.

(f) Manufacturer conduct of litigation

The manufacturer of an implant that is the subject of an action covered under this chapter shall be permitted to conduct litigation on any motion for summary judgment or dismissal filed by a biomaterials supplier who is a defendant under this section on behalf of such supplier if the manufacturer and any other defendant in such action enter into a valid and applicable contractual agreement under which the manufacturer agrees to bear the cost of such litigation or to conduct such litigation.

(Pub. L. 105–230, §6, Aug. 13, 1998, 112 Stat. 1526.)

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

§1606. Subsequent impleader of dismissed biomaterials supplier

(a) Impleading of dismissed defendant

A court, upon motion by a manufacturer or a claimant within 90 days after entry of a final judgment in an action by the claimant against a manufacturer, and notwithstanding any otherwise applicable statute of limitations, may implead a biomaterials supplier who has been dismissed from the action pursuant to this chapter if—

(1) the manufacturer has made an assertion, either in a motion or other pleading filed with the court or in an opening or closing statement at trial, or as part of a claim for contribution or indemnification, and the court finds based on the court's independent review of the evidence contained in the record of the action, that under applicable law—

(A) the negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the claimant; and

(B) the manufacturer's liability for damages should be reduced in whole or in part because of such negligence or intentionally tortious conduct; or

(2) the claimant has moved to implead the supplier and the court finds, based on the court's independent review of the evidence contained in the record of the action, that under applicable law—

(A) the negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the claimant; and

(B) the claimant is unlikely to be able to recover the full amount of its damages from the remaining defendants.

(b) Standard of liability

Notwithstanding any preliminary finding under subsection (a), a biomaterials supplier who has been impleaded into an action covered by this chapter, as provided for in this section—

(1) may, prior to entry of judgment on the claim against it, supplement the record of the proceeding that was developed prior to the grant of the motion for impleader under subsection (a); and

(2) may be found liable to a manufacturer or a claimant only to the extent required and permitted by any applicable State or Federal law other than this chapter.

(c) Discovery

Nothing in this section shall give a claimant or any other party the right to obtain discovery from a biomaterials supplier at any time prior to grant of a motion for impleader beyond that allowed under section 1605 of this title.

(Pub. L. 105–230, §7, Aug. 13, 1998, 112 Stat. 1528.)

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

CHAPTER 22—NATIONAL DRUG CONTROL POLICY

        

§1701. Definitions

In this chapter:

(1) Agency

The term "agency" has the meaning given the term "executive agency" in section 102 of title 31.

(2) Appropriate congressional committees

(A) In general

The term "appropriate congressional committees" means—

(i) the Committee on the Judiciary, the Committee on Appropriations, and the Committee on Health, Education, Labor, and Pensions of the Senate; and

(ii) the Committee on Oversight and Government Reform, the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives.

(B) Submission to Congress

Any submission to Congress shall mean submission to the appropriate congressional committees.

(3) Demand reduction

The term "demand reduction" means any activity conducted by a National Drug Control Program agency, other than an enforcement activity, that is intended to reduce or prevent the use of drugs or support, expand, or provide treatment and recovery efforts, including—

(A) education about the dangers of illicit drug use;

(B) services, programs, or strategies to prevent substance use disorder, including evidence-based education campaigns, community-based prevention programs, collection and disposal of unused prescription drugs, and services to at-risk populations to prevent or delay initial use of an illicit drug;

(C) substance use disorder treatment;

(D) support for long-term recovery from substance use disorders;

(E) drug-free workplace programs;

(F) drug testing, including the testing of employees;

(G) interventions for illicit drug use and dependence;

(H) expanding availability of access to health care services for the treatment of substance use disorders;

(I) international drug control coordination and cooperation with respect to activities described in this paragraph;

(J) pre- and post-arrest criminal justice interventions such as diversion programs, drug courts, and the provision of evidence-based treatment to individuals with substance use disorders who are arrested or under some form of criminal justice supervision, including medication assisted treatment;

(K) other coordinated and joint initiatives among Federal, State, local, and Tribal agencies to promote comprehensive drug control strategies designed to reduce the demand for, and the availability of, illegal drugs;

(L) international illicit drug use education, prevention, treatment, recovery, research, rehabilitation activities, and interventions for illicit drug use and dependence; and

(M) research related to illicit drug use and any of the activities described in this paragraph.

(4) Director

The term "Director" means the Director of National Drug Control Policy.

(5) Drug

The term "drug" has the meaning given the term "controlled substance" in section 802(6) of this title.

(6) Drug control

The term "drug control" means any activity conducted by a National Drug Control Program agency involving supply reduction or demand reduction.

(7) Emerging drug threat

The term "emerging drug threat" means the occurrence of a new and growing trend in the use of an illicit drug or class of drugs, including rapid expansion in the supply of or demand for such drug.

(8) Illicit drug use; illicit drugs; illegal drugs

The terms "illicit drug use", "illicit drugs", and "illegal drugs" include the illegal or illicit use of prescription drugs.

(9) Law enforcement

The term "law enforcement" or "drug law enforcement" means all efforts by a Federal, State, local, or Tribal government agency to enforce the drug laws of the United States or any State, including investigation, arrest, prosecution, and incarceration or other punishments or penalties.

(10) National Drug Control Program

The term "National Drug Control Program" means programs, policies, and activities undertaken by National Drug Control Program agencies pursuant to the responsibilities of such agencies under the National Drug Control Strategy, including any activities involving supply reduction, demand reduction, or State, local, and tribal ¹ affairs.

(11) National Drug Control Program agency

The term "National Drug Control Program agency" means any agency (or bureau, office, independent agency, board, division, commission, subdivision, unit, or other component thereof) that is responsible for implementing any aspect of the National Drug Control Strategy, including any agency that receives Federal funds to implement any aspect of the National Drug Control Strategy, but does not include any agency that receives funds for drug control activity solely under the National Intelligence Program or the Joint Military Intelligence Program.

(12) National Drug Control Strategy

The term "National Drug Control Strategy" or "Strategy" means the strategy developed and submitted to Congress under section 1705 of this title, including any report, plan, or strategy required to be incorporated into or issued concurrently with such strategy.

(13) Nonprofit organization

The term "nonprofit organization" means an organization that is described in section 501(c)(3) of title 26 and exempt from tax under section 501(a) of such title.

(14) Office

The term "Office" means the Office of National Drug Control Policy established under section 1702(a) of this title.

(15) State, local, and Tribal affairs

The term "State, local, and Tribal affairs" means domestic activities conducted by a National Drug Control Program agency that are intended to reduce the availability and use of illegal drugs, including—

(A) coordination and enhancement of Federal, State, local, and Tribal law enforcement drug control efforts;

(B) coordination and enhancement of efforts among National Drug Control Program agencies and State, local, and Tribal demand reduction and supply reduction agencies;

(C) coordination and enhancement of Federal, State, local, and Tribal law enforcement initiatives to gather, analyze, and disseminate information and law enforcement intelligence relating to drug control among domestic law enforcement agencies; and

(D) other coordinated and joint initiatives among Federal, State, local, and Tribal agencies to promote comprehensive drug control strategies designed to reduce the demand for, and the availability of, illegal drugs.

(16) Substance use disorder treatment

The term "substance use disorder treatment" means an evidence-based, professionally directed, deliberate, and planned regimen including evaluation, observation, medical monitoring, and rehabilitative services and interventions such as pharmacotherapy, behavioral therapy, and individual and group counseling, on an inpatient or outpatient basis, to help patients with substance use disorder reach recovery.

(17) Supply reduction

The term "supply reduction" means any activity or program conducted by a National Drug Control Program agency that is intended to reduce the availability or use of illegal drugs in the United States or abroad, including—

(A) law enforcement outside the United States;

(B) domestic law enforcement;

(C) source country programs, including economic development programs primarily intended to reduce the production or trafficking of illicit drugs;

(D) activities to control international trafficking in, and availability of, illegal drugs, including—

(i) accurate assessment and monitoring of international drug production and interdiction programs and policies; and

(ii) coordination and promotion of compliance with international treaties relating to the production, transportation, or interdiction of illegal drugs;

(E) activities to conduct and promote international law enforcement programs and policies to reduce the supply of drugs;

(F) activities to facilitate and enhance the sharing of domestic and foreign intelligence information among National Drug Control Program agencies, relating to the production and trafficking of drugs in the United States and in foreign countries;

(G) activities to prevent the diversion of drugs for their illicit use; and

(H) research related to any of the activities described in this paragraph.

(Pub. L. 105–277, div. C, title VII, §§702, 715, Oct. 21, 1998, 112 Stat. 2681–670, 2681-693; Pub. L. 109–469, title I, §101, title VI, §602, Dec. 29, 2006, 120 Stat. 3503, 3533; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8216, Oct. 24, 2018, 132 Stat. 4110, 4117; Pub. L. 116–74, §2(a)(1), (3), Nov. 27, 2019, 133 Stat. 1155.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title VII of div. C of Pub. L. 105–277, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out below and Tables.

Amendments

2019—Pars. (3), (11). Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency".

Par. (15). Pub. L. 116–74, §2(a)(3), substituted "Tribal" for "tribal" wherever appearing.

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out below.

Pars. (1), (2). Pub. L. 115–271, §8216(6), added pars. (1) and (2). Former pars. (1) and (2) redesignated (3) and (4), respectively.

Par. (3). Pub. L. 115–271, §8216(5), (7), redesignated par. (1) as (3) and amended it generally. Prior to amendment, par. defined demand reduction.

Par. (4). Pub. L. 115–271, §8216(5), redesignated par. (2) as (4). Former par. (4) redesignated (6).

Par. (5). Pub. L. 115–271, §8216(1), (5), redesignated par. (3) as (5) and struck out former par. (5) which defined the term "Fund" as the fund established under section 1702(d) of this title.

Par. (6). Pub. L. 115–271, §8216(5), redesignated par. (4) as (6). Former par. (6) redesignated (10).

Pars. (7) to (9). Pub. L. 115–271, §8216(8), added pars. (7) to (9). Former pars. (7), (8), and (9) redesignated (11), (12), and (14), respectively.

Par. (10). Pub. L. 115–271, §8216(4), redesignated par. (6) as (10). Former par. (10) redesignated (15).

Par. (11). Pub. L. 115–271, §8216(4), (9), redesignated par. (7) as (11) and amended it generally. Prior to amendment, text read as follows: "The term 'National Drug Control Program agency' means any agency that is responsible for implementing any aspect of the National Drug Control Strategy, including any agency that receives Federal funds to implement any aspect of the National Drug Control Strategy, but does not include any agency that receives funds for drug control activity solely under the National Intelligence Program, the Joint Military Intelligence Program or Tactical Intelligence and Related Activities, or (for purposes of section 1703(d) of this title) an agency that is described in section 530C(a) of title 28, unless such agency has been designated—

"(A) by the President; or

"(B) jointly by the Director and the head of the agency."

Par. (12). Pub. L. 115–271, §8216(10), inserted "or 'Strategy' " before "means" and ", including any report, plan, or strategy required to be incorporated into or issued concurrently with such strategy" before period at end.

Pub. L. 115–271, §8216(1), (4), redesignated par. (8) as (12) and struck out former par. (12). Prior to amendment, text of par. (12) read as follows: "Except where otherwise provided, the term 'appropriate congressional committees' means the Committee on the Judiciary, the Committee on Appropriations, and the Caucus on International Narcotics Control of the Senate and the Committee on Government Reform, the Committee on the Judiciary, and the Committee on Appropriations of the House of Representatives."

Par. (13). Pub. L. 115–271, §8216(1), (11), added par. (13) and struck out former par. (13). Prior to amendment, text read as follows: "The term 'law enforcement' or 'drug law enforcement' means all efforts by a Federal, State, local, or tribal government agency to enforce the drug laws of the United States or any State, including investigation, arrest, prosecution, and incarceration or other punishments or penalties."

Par. (14). Pub. L. 115–271, §8216(3), (12), redesignated par. (9) as (14) and substituted "The" for "Unless the context clearly indicates otherwise, the".

Par. (15). Pub. L. 115–271, §8216(3), redesignated par. (10) as (15).

Par. (16). Pub. L. 115–271, §8216(13), added par. (16).

Par. (17). Pub. L. 115–271, §8216(2), redesignated par. (11) as (17).

Par. (17)(B) to (H). Pub. L. 115–271, §8216(14), added subpar. (B), redesignated former subpars. (B) to (E) as (C) to (F), respectively, and added subpars. (G) and (H).

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Par. (1)(G). Pub. L. 109–469, §101(a)(2), substituted ", including the testing of employees;" for period at end.

Par. (1)(H) to (J). Pub. L. 109–469, §101(a)(1), (3), added subpars. (H) to (J).

Par. (6). Pub. L. 109–469, §101(b), inserted ", including any activities involving supply reduction, demand reduction, or State, local, and tribal affairs" before period at end.

Par. (7). Pub. L. 109–469, §101(c), in introductory provisions, substituted "National Intelligence Program," for "National Foreign Intelligence Program," and inserted "or (for purposes of section 1703(d) of this title) an agency that is described in section 530C(a) of title 28," after "Related Activities,".

Par. (9). Pub. L. 109–469, §101(d), substituted "indicates" for "implicates".

Par. (10). Pub. L. 109–469, §101(e), amended par. (10) generally. Prior to amendment, text defined the term "State and local affairs".

Par. (11). Pub. L. 109–469, §101(f), amended par. (11) generally. Prior to amendment, text defined the term "supply reduction".

Pars. (12), (13). Pub. L. 109–469, §101(g), added pars. (12) and (13).

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Oversight and Government Reform of House of Representatives changed to Committee on Oversight and Reform of House of Representatives by House Resolution No. 6, One Hundred Sixteenth Congress, Jan. 9, 2019. Committee on Oversight and Reform of House of Representatives changed to Committee on Oversight and Accountability of House of Representatives by House Resolution No. 5, One Hundred Eighteenth Congress, Jan. 9, 2023.

Short Title of 2019 Amendment

Pub. L. 116–74, §1, Nov. 27, 2019, 133 Stat. 1155, provided that: "This Act [see Tables for classification] may be cited as the 'ONDCP Technical Corrections Act of 2019'."

Short Title of 2018 Amendment

Pub. L. 115–271, title VIII, §8201, Oct. 24, 2018, 132 Stat. 4110, provided that: "This subtitle [subtitle K (§§8201–8222) of title VIII of Pub. L. 115–271, see Tables for classification] may be cited as the 'Substance Abuse Prevention Act of 2018'."

Short Title of 2010 Amendment

Pub. L. 111–356, §1, Jan. 4, 2011, 124 Stat. 3976, provided that: "This Act [amending provisions set out as a note under section 1705 of this title] may be cited as the 'Northern Border Counternarcotics Strategy Act of 2010'."

Short Title of 2006 Amendment

Pub. L. 109–469, §1(a), Dec. 29, 2006, 120 Stat. 3502, provided that: "This Act [enacting sections 1708a, 1714, 2001 to 2003, and 2011 to 2014 of this title, amending this section, sections 823, 1524, 1532, 1702 to 1708, 1710 to 1712 of this title, and section 458 of Title 6, Domestic Security, repealing sections 1509, 1709, and 1801 to 1804 of this title, enacting provisions set out as notes under this section, sections 1532, 1705, 1706, and 2001 of this title, and section 112 of Title 32, National Guard, amending provisions set out as a note under section 1521 of this title, and repealing provisions set out as a note under section 1801 of this title] may be cited as the 'Office of National Drug Control Policy Reauthorization Act of 2006'."

Pub. L. 109–469, title III, §302(a), Dec. 29, 2006, 120 Stat. 3524, provided that: "This section [amending section 1706 of this title and enacting provisions set out as a note under section 1706 of this title] may be cited as the 'Dawson Family Community Protection Act'."

Short Title

Pub. L. 105–277, div. C, title VII, §§701, 715, Oct. 21, 1998, 112 Stat. 2681–670, 2681-693, as amended by Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202(a), (b)(2), Oct. 24, 2018, 132 Stat. 4110, provided that: "This title [enacting this chapter and amending section 1509 of this title, sections 5312 to 5314 of Title 5, Government Organization and Employees, section 1105 of Title 31, Money and Finance, and section 402 of Title 50, War and National Defense] may be cited as the 'Office of National Drug Control Policy Reauthorization Act of 1998'."

Reauthorization of the Office of National Drug Control Policy and Revival of Office of National Drug Control Policy Reauthorization Act of 1998

Pub. L. 115–271, title VIII, §8202(a), Oct. 24, 2018, 132 Stat. 4110, provided that:

"(1) In general.—The Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.) [title VII of div. C of Pub. L. 105–277, see Short Title note set out above], as in effect on September 29, 2003, and as amended by the laws described in paragraph (2), is revived and restored.

"(2) Laws described.—The laws described in this paragraph are:

"(A) The Office of National Drug Control Policy Reauthorization Act of 2006 (Public Law 109–469; 120 Stat. 3502) [see Short Title of 2006 Amendment note set out above].

"(B) The Presidential Appointment Efficiency and Streamlining Act of 2011 (Public Law 112–166; 126 Stat. 1283) [see Short Title of 2012 Amendment note set out under section 101 of Title 5, Government Organization and Employees]."

Model Acts

Pub. L. 109–469, title XI, §1105, Dec. 29, 2006, 120 Stat. 3541, which directed the Director of the Office of National Drug Control Policy to enter into an agreement with a non-profit corporation to advise States on establishing laws and policies to address alcohol and other drug issues based on the model State drug laws developed by the President's Commission on Model State Drug Laws in 1993, was repealed by Pub. L. 115–271, title VIII, §8217(h), Oct. 24, 2018, 132 Stat. 4125. See section 1703(i) of this title.

Executive Documents

Ex. Ord. No. 13165. White House Task Force on Drug Use in Sports and United States Representative on the Board of the World Anti-Doping Agency

Ex. Ord. No. 13165, Aug. 9, 2000, 65 F.R. 49469, as amended by Ex. Ord. No. 13286, §11, Feb. 28, 2003, 68 F.R. 10622, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Office of National Drug Control [Policy] Reauthorization Act of 1998, (21 U.S.C. 1701 et seq.), and in order to develop recommendations for Federal agency actions to address the use of drugs in sports, in particular among young people, it is hereby ordered as follows:

Section 1. Policy. The use of drugs in sports has reached a level that endangers not just the legitimacy of athletic competition but also the lives and health of athletes—from the elite ranks to youth leagues. The National Household Survey on Drug Abuse issued in 1999 found that in just 1 year's time the rate of steroid use among young people rose roughly 50 percent among both sexes and across all age groups. It is the policy of my Administration to take the steps needed to help eliminate illicit or otherwise banned drug use and doping in sports at the State, national, and international level.

Sec. 2. Establishment of a White House Task Force on Drug Use in Sports. (a) There is established a White House Task Force on Drug Use in Sports (Task Force). The Task Force shall comprise the co-vice chairs of the White House Olympic Task Force (the "Olympic Task Force Vice Chairs"), and representatives designated by the Office of National Drug Control Policy, the Department of Health and Human Services, the Department of Labor, the President's Council on Physical Fitness and Sports [now President's Council on Fitness, Sports, and Nutrition], the Office of Management and Budget, the National Security Council, the Department of State, the Department of the Treasury, the Department of Education, the Department of Justice, the Department of Transportation, the Department of Homeland Security, the National Institute on Drug Abuse, and the Substance Abuse and Mental Health Services Administration.

(b) The Task Force shall develop recommendations for the President on further executive and legislative actions that can be undertaken to address the problem of doping and drug use in sports. In developing the recommendations, the Task Force shall consider, among other things: (i) the health and safety of America's athletes, in particular our Nation's young people; (ii) the integrity of honest athletic competition; and (iii) the views and recommendations of State and local governments, the private sector, citizens, community groups, and nonprofit organizations, on actions to address this threat. The Task Force, through its Chairs, shall submit its recommendations to the President.

(c) The Director of the Office of National Drug Control Policy (the Director), the Secretary of the Department of Health and Human Services, and the Olympic Task Force Vice Chairs or their designees shall serve as the Task Force Chairs.

(d) To the extent permitted by law and at the request of the Chairs, agencies shall cooperate with and provide information to the Task Force.

Sec. 3. Participation in the World Anti-Doping Agency. (a) As part of my Administration's efforts to address the problem of drug use in sports, the United States has played a leading role in the formation of a World Anti-Doping Agency (WADA) by the Olympic and sports community and the nations of the world. Through these efforts, the United States has been selected to serve as a governmental representative on the board of the WADA. This order will authorize the Director to serve as the United States Government's representative on the WADA board.

(b) Pursuant to 21 U.S.C. 1701 et seq., the Director, or in his absence his designee, is hereby authorized to take all necessary and proper actions to execute his responsibilities as United States representative to the WADA.

(c) To assist the Director in carrying out these responsibilities as the United States Government representative to the WADA and to the extent permitted by law, Federal employees may serve in their official capacity, inter alia, on WADA Committees or WADA advisory committees, serving as experts to the WADA.

¹ So in original. Probably should be "Tribal".

§1702. Office of National Drug Control Policy

(a) Establishment of Office

There is established in the Executive Office of the President an Office of National Drug Control Policy, which shall—

(1) lead the national drug control effort, including coordinating with the National Drug Control Program agencies;

(2) coordinate and oversee the implementation of the national drug control policy, including the National Drug Control Strategy;

(3) assess and certify the adequacy of National Drug Control Programs and the budget for those programs;

(4) evaluate the effectiveness of national drug control policy efforts, including the National Drug Control Program Agencies' ¹ programs, by developing and applying specific goals and performance measurements and monitoring the agencies' program-level spending;

(5) identify and respond to emerging drug threats related to illicit drug use;

(6) administer the Drug-Free Communities Program, the High Intensity Drug Trafficking Areas Program, and other grant programs directly authorized to be administered by the Office in furtherance of the National Drug Control Strategy; and

(7) facilitate broad-scale information sharing and data standardization among Federal, State, and local entities to support the national drug control efforts.

(b) Repealed. Pub. L. 115–271, title VIII, §8222(1), Oct. 24, 2018, 132 Stat. 4142

(c) Access by Congress

The location of the Office in the Executive Office of the President shall not be construed as affecting access by Congress, or any committee of the House of Representatives or the Senate, to any—

(1) information, document, or study in the possession of, or conducted by or at the direction of the Director; or

(2) personnel of the Office.

(d) Office of National Drug Control Policy Gift Fund

(1) Establishment

There is established in the Treasury of the United States a fund for the receipt of gifts, both real and personal, for the purpose of aiding or facilitating the work of the Office under section 1703(c) of this title.

(2) Contributions

The Office may accept, hold, and administer contributions to the Fund.

(3) Use of amounts deposited

Amounts deposited in the Fund are authorized to be appropriated, to remain available until expended for authorized purposes at the discretion of the Director.

(4) Ethics guidelines

The Director shall establish written guidelines setting forth the criteria to be used in determining whether a gift or donation should be declined under this subsection because the acceptance of the gift or donation would—

(A) reflect unfavorably upon the ability of the Director or the Office, or any employee of the Office, to carry out responsibilities or official duties under this chapter in a fair and objective manner; or

(B) compromise the integrity or the appearance of integrity of programs or services provided under this chapter or of any official involved in those programs or services.

(5) Registry of gifts

The Director shall maintain a list of—

(A) the source and amount of each gift or donation accepted by the Office; and

(B) the source and amount of each gift or donation accepted by a contractor to be used in its performance of a contract for the Office.

(6) Report to Congress

The Director shall include in the annual assessment under section 1705(g) of this title a copy of the registry maintained under paragraph (5).

(Pub. L. 105–277, div. C, title VII, §§703, 715, Oct. 21, 1998, 112 Stat. 2681–672, 2681-693; Pub. L. 109–469, title I, §102, title VI, §602, title XI, §1120, Dec. 29, 2006, 120 Stat. 3505, 3533, 3548; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8217(a), (b), 8222(1), Oct. 24, 2018, 132 Stat. 4110, 4119, 4142; Pub. L. 116–74, §2(a)(2), (4), Nov. 27, 2019, 133 Stat. 1155.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (d)(4), was in the original a reference to "this title", meaning title VII of Pub. L. 105–277, div. C, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out under section 1701 of this title and Tables.

Amendments

2019—Subsec. (a)(1). Pub. L. 116–74, §2(a)(2), substituted "National Drug Control Program agencies" for "National Drug Control Program Agencies".

Subsec. (a)(4). Pub. L. 116–74, §2(a)(4)(A)(i), substituted "programs," for "program,".

Subsec. (a)(6). Pub. L. 116–74, §2(a)(4)(A)(ii), substituted "High Intensity" for "High-Intensity".

Subsec. (d)(4). Pub. L. 116–74, §2(a)(4)(B), made technical amendment to reference in original act which appears in text as reference to this chapter in subpars. (A) and (B).

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

Subsec. (a). Pub. L. 115–271, §8217(a)(4), struck out concluding provisions which read as follows: "When developing the national drug control policy, any policy of the Director relating to syringe exchange programs for intravenous drug users shall be based on the best available medical and scientific evidence regarding their effectiveness in promoting individual health and preventing the spread of infectious disease, and their impact on drug addiction and use. In making any policy relating to syringe exchange programs, the Director shall consult with the National Institutes of Health and the National Academy of Sciences."

Subsec. (a)(1). Pub. L. 115–271, §8217(a)(1), added par. (1) and struck out former par. (1) which read as follows: "develop national drug control policy;".

Subsec. (a)(2). Pub. L. 115–271, §8217(a)(2), inserted before semicolon at end ", including the National Drug Control Strategy".

Subsec. (a)(4) to (7). Pub. L. 115–271, §8217(a)(3), (4), added pars. (4) to (7) and struck out former par. (4) which read as follows: "evaluate the effectiveness of the national drug control policy and the National Drug Control Program agencies' programs, by developing and applying specific goals and performance measurements."

Subsec. (b). Pub. L. 115–271, §8222(1), struck out subsec. (b) which related to Director of National Drug Control Policy and Deputy Directors.

Subsec. (d)(4) to (6). Pub. L. 115–271, §8217(b), added pars. (4) to (6).

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Subsec. (a). Pub. L. 109–469, §1120, inserted concluding provisions.

Pub. L. 109–469, §102(a), amended subsec. (a) generally. Prior to amendment, subsec. (a) related to establishment of Office of National Drug Control Policy.

Subsec. (b). Pub. L. 109–469, §102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to Director and Deputy Directors of National Drug Control Policy.

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Gifts to Office of National Drug Control Policy

Pub. L. 117–328, div. E, title II, Dec. 29, 2022, 136 Stat. 4664, provided in part: "That the Office [of National Drug Control Policy] is authorized to accept, hold, administer, and utilize gifts, both real and personal, public and private, without fiscal year limitation, for the purpose of aiding or facilitating the work of the Office."

Similar provisions were contained in the following prior appropriation acts:

Pub. L. 117–103, div. E, title II, Mar. 15, 2022, 136 Stat. 253.

Pub. L. 116–260, div. E, title II, Dec. 27, 2020, 134 Stat. 1394.

Pub. L. 116–93, div. C, title II, Dec. 20, 2019, 133 Stat. 2448.

Pub. L. 116–6, div. D, title II, Feb. 15, 2019, 133 Stat. 152.

Pub. L. 115–141, div. E, title II, Mar. 23, 2018, 132 Stat. 549.

Pub. L. 115–31, div. E, title II, May 5, 2017, 131 Stat. 340.

Pub. L. 114–113, div. E, title II, Dec. 18, 2015, 129 Stat. 2436.

Pub. L. 113–235, div. E, title II, Dec. 16, 2014, 128 Stat. 2344.

Pub. L. 113–76, div. E, title II, Jan. 17, 2014, 128 Stat. 195.

Pub. L. 112–74, div. C, title II, Dec. 23, 2011, 125 Stat. 895.

Pub. L. 111–117, div. C, title II, Dec. 16, 2009, 123 Stat. 3170.

Pub. L. 111–8, div. D, title II, Mar. 11, 2009, 123 Stat. 641.

Pub. L. 110–161, div. D, title II, Dec. 26, 2007, 121 Stat. 1983.

Pub. L. 109–115, div. A, title V, Nov. 30, 2005, 119 Stat. 2475.

Pub. L. 108–447, div. H, title III, Dec. 8, 2004, 118 Stat. 3249.

Pub. L. 108–199, div. F, title III, Jan. 23, 2004, 118 Stat. 324.

Pub. L. 108–7, div. J, title III, Feb. 20, 2003, 117 Stat. 446.

Pub. L. 107–67, title III, Nov. 12, 2001, 115 Stat. 530.

Pub. L. 106–554, §1(a)(3) [title III], Dec. 21, 2000, 114 Stat. 2763, 2763A-139.

Pub. L. 106–58, title III, Sept. 29, 1999, 113 Stat. 447.

Pub. L. 105–277, div. A, §101(h) [title III], Oct. 21, 1998, 112 Stat. 2681–480, 2681-496.

Pub. L. 105–61, title III, Oct. 10, 1997, 111 Stat. 1293.

Pub. L. 104–208, div. A, title I, §101(f) [title III], Sept. 30, 1996, 110 Stat. 3009–314, 3009-329.

Pub. L. 104–52, title III, Nov. 19, 1995, 109 Stat. 479.

Pub. L. 103–329, title III, Sept. 30, 1994, 108 Stat. 2394.

Pub. L. 103–123, title III, Oct. 28, 1993, 107 Stat. 1237.

Pub. L. 102–393, title III, Oct. 6, 1992, 106 Stat. 1741.

Pub. L. 102–141, title III, Oct. 28, 1991, 105 Stat. 847.

Pub. L. 101–509, title III, Nov. 5, 1990, 104 Stat. 1402.

Pub. L. 101–136, title III, Nov. 3, 1989, 103 Stat. 793.

Executive Documents

Ex. Ord. No. 12911. Seal for Office of National Drug Control Policy

Ex. Ord. No. 12911, Apr. 25, 1994, 59 F.R. 21121 [22121], provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. There is approved for the Office of National Drug Control Policy in the Executive Office of the President an official seal described as follows:

On a blue disc the Arms of the United States proper above a curved gold scroll inscribed "OFFICE OF NATIONAL DRUG CONTROL POLICY" in blue letters, all within a white border edged in gold and inscribed "EXECUTIVE OFFICE OF THE PRESIDENT OF THE UNITED STATES" in blue letters.

This design is appropriate for the Office of National Drug Control Policy. The dark blue in this seal is suggested by the Seal of the President and denotes the direct organizational link of the Office of National Drug Control Policy with the Presidential office. The Arms of the United States refer to the entire Nation and represent the involvement in drug control policies that are necessary to assist the President in his role as Chief Executive of the United States.

Sec. 2. The seal shall be of the design that is attached hereto and made a part of this order.

William J. Clinton.      

¹ So in original. Probably should be "agencies' ".

§1703. Appointment and duties of Director and Deputy Directors

(a) Appointment

(1) In general

(A) Director

(i) In general

There shall be at the head of the Office a Director who shall hold the same rank and status as the head of an executive department listed in section 101 of title 5.

(ii) Appointment

The Director shall be appointed by the President, by and with the advice and consent of the Senate, and shall serve at the pleasure of the President.

(B) Deputy Director

There shall be a Deputy Director who shall report directly to the Director, and who shall be appointed by the President, and shall serve at the pleasure of the President.

(C) Coordinators

The following coordinators shall be appointed by the Director:

(i) Performance Budget Coordinator, as described in subsection (c)(5).

(ii) Interdiction Coordinator, as described in section 1710 of this title.

(iii) Emerging and Continuing Threats Coordinator, as described in section 1708 of this title.

(iv) State, Local, and Tribal Affairs Coordinator, to carry out the activities described in subsection (j).

(v) Demand Reduction Coordinator, as described in subparagraph (D).

(D) Demand Reduction Coordinator

The Director shall designate or appoint a United States Demand Reduction Coordinator to be responsible for the activities described in section 1701(3) of this title. For purposes of carrying out the previous sentence, the Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent).

(2) Duties of Deputy Director of National Drug Control Policy

The Deputy Director of National Drug Control Policy shall—

(A) carry out the duties and powers prescribed by the Director; and

(B) serve as the Director in the absence of the Director or during any period in which the office of the Director is vacant.

(3) Acting Director

If the Director dies, resigns, or is otherwise unable to perform the functions and duties of the office, the Deputy Director shall perform the functions and duties of the Director temporarily in an acting capacity pursuant to subchapter III of chapter 33 of title 5.

(4) Prohibition

No person shall serve as Director or a Deputy Director while serving in any other position in the Federal Government.

(5) Prohibition on political campaigning

Any officer or employee of the Office who is appointed to that position by the President, by and with the advice and consent of the Senate, may not participate in Federal election campaign activities, except that such officer or employee is not prohibited by this paragraph from making contributions to individual candidates.

(6) Prohibition on the use of funds for ballot initiatives

No funds authorized under this chapter may be obligated for the purpose of expressly advocating the passage or defeat of a State or local ballot initiative.

(b) Responsibilities

The Director—

(1) shall assist the President in the establishment of policies, goals, objectives, and priorities for the National Drug Control Program;

(2) shall promulgate the National Drug Control Strategy under section 1705(a) of this title and each report under section 1705(b) ¹ of this title in accordance with section 1705 of this title;

(3) shall coordinate and oversee the implementation by the National Drug Control Program agencies of the policies, goals, objectives, and priorities established under paragraph (1) and the fulfillment of the responsibilities of such agencies under the National Drug Control Strategy and make recommendations to National Drug Control Program agency heads with respect to implementation of Federal counter-drug programs;

(4) shall make such recommendations to the President as the Director determines are appropriate regarding changes in the organization, management, and budgets of National Drug Control Program agencies, and changes in the allocation of personnel to and within those departments and agencies, to implement the policies, goals, priorities, and objectives established under paragraph (1) and the National Drug Control Strategy;

(5) shall consult with and assist State and local governments with respect to the formulation and implementation of National Drug Control Policy and their relations with the National Drug Control Program agencies;

(6) shall appear before duly constituted committees and subcommittees of the House of Representatives and of the Senate to represent the drug policies of the executive branch;

(7) shall notify any National Drug Control Program agency if its policies are not in compliance with the responsibilities of the agency under the National Drug Control Strategy, transmit a copy of each such notification to the President and the appropriate congressional committees, and maintain a copy of each such notification;

(8) shall provide, by July 1 of each year, budget recommendations, including requests for specific initiatives that are consistent with the priorities of the President under the National Drug Control Strategy, to the heads of departments and agencies with responsibilities under the National Drug Control Program, which recommendations shall—

(A) apply to the next budget year scheduled for formulation under chapter 11 of title 31, and each of the 4 subsequent fiscal years; and

(B) address funding priorities developed in the National Drug Control Strategy;

(9) may serve as representative of the President in appearing before Congress on all issues relating to the National Drug Control Program;

(10) shall, in any matter affecting national security interests, work in conjunction with the Assistant to the President for National Security Affairs;

(11) may serve as spokesperson of the Administration on drug issues;

(12) shall ensure that no Federal funds appropriated to the Office of National Drug Control Policy shall be expended for any study or contract relating to the legalization (for a medical use or any other use) of a substance listed in schedule I of section 812 of this title and take such actions as necessary to oppose any attempt to legalize the use of a substance (in any form) that—

(A) is listed in schedule I of section 812 of this title; and

(B) has not been approved for use for medical purposes by the Food and Drug Administration;

(13) Repealed. Pub. L. 115–271, title VIII, §8221(b)(1)(A), Oct. 24, 2018, 132 Stat. 4142.

(14) shall submit to the appropriate congressional committees on an annual basis, not later than 60 days after the date of the last day of the applicable period, a summary of—

(A) each of the evaluations received by the Director under section 1705(g)(2) of this title; and

(B) the progress of each National Drug Control Program agency toward the drug control program goals of the agency using the performance measures for the agency developed under section 1705(c) ² of this title;

(15) shall ensure that drug prevention and drug treatment research and information is effectively disseminated by National Drug Control Program agencies to State and local governments and nongovernmental entities involved in demand reduction by—

(A) encouraging formal consultation between any such agency that conducts or sponsors research, and any such agency that disseminates information in developing research and information product development agendas;

(B) encouraging such agencies (as appropriate) to develop and implement dissemination plans that specifically target State and local governments and nongovernmental entities involved in demand reduction; and

(C) supporting the substance abuse information clearinghouse administered by the Administrator of the Substance Abuse and Mental Health Services Administration and established in section 290aa(d)(16) of title 42 by—

(i) encouraging all National Drug Control Program agencies to provide all appropriate and relevant information; and

(ii) supporting the dissemination of information to all interested entities;

(16) shall coordinate with the private sector to promote private research and development of medications to treat addiction;

(17) Repealed. Pub. L. 115–271, title VIII, §8221(b)(1)(A), Oct. 24, 2018, 132 Stat. 4142.

(18) shall monitor and evaluate the allocation of resources among Federal law enforcement agencies in response to significant local and regional drug trafficking and production threats;

(19) shall submit an annual report to Congress detailing how the Office of National Drug Control Policy has consulted with and assisted State, local, and tribal governments with respect to the formulation and implementation of the National Drug Control Strategy and other relevant issues;

(20) shall, within 1 year after December 29, 2006, report to Congress on the impact of each Federal drug reduction strategy upon the availability, addiction rate, use rate, and other harms of illegal drugs; and

(21) in order to formulate the national drug control policies, goals, objectives, and priorities—

(A) shall consult with and assist—

(i) State and local governments;

(ii) National Drug Control Program agencies;

(iii) each committee, working group, council, or other entity established under this chapter, as appropriate;

(iv) the public;

(v) appropriate congressional committees; and

(vi) any other person in the discretion of the Director; and

(B) may—

(i) establish advisory councils;

(ii) acquire data from agencies; and

(iii) request data from any other entity.

(c) National Drug Control Program budget

(1) Responsibilities of National Drug Control Program agencies

(A) In general

For each fiscal year, the head of each department, agency, or program of the Federal Government with responsibilities under the National Drug Control Program Strategy shall transmit to the Director a copy of the proposed drug control budget request of the department, agency, or program at the same time as that budget request is submitted to their superiors (and before submission to the Office of Management and Budget) in the preparation of the budget of the President submitted to Congress under section 1105(a) of title 31.

(B) Submission of drug control budget requests

The head of each National Drug Control Program agency shall ensure timely development and submission to the Director of each proposed drug control budget request transmitted pursuant to this paragraph, in such format as may be designated by the Director with the concurrence of the Director of the Office of Management and Budget.

(C) Content of drug control budget requests

A drug control budget request submitted by a department, agency, or program under this paragraph shall include all requests for funds for any drug control activity undertaken by that department, agency, or program, including demand reduction, supply reduction, and State, local, and tribal affairs, including any drug law enforcement activities. If an activity has both drug control and nondrug control purposes or applications, the department, agency, or program shall estimate by a documented calculation the total funds requested for that activity that would be used for drug control, and shall set forth in its request the basis and method for making the estimate.

(2) National Drug Control Program budget proposal

For each fiscal year, following the transmission of proposed drug control budget requests to the Director under paragraph (1), the Director shall, in consultation with the head of each National Drug Control Program agency and the head of each major national organization that represents law enforcement officers, agencies, or associations—

(A) develop a consolidated National Drug Control Program budget proposal designed to implement the National Drug Control Strategy and to inform Congress and the public about the total amount proposed to be spent on all supply reduction, demand reduction, State, local, and tribal affairs, including any drug law enforcement, and other drug control activities by the Federal Government, which shall conform to the content requirements set forth in paragraph (1)(C) and include—

(i) the funding level for each National Drug Control Program agency; and

(ii) alternative funding structures that could improve progress on achieving the goals of the National Drug Control Strategy; and

(B) submit the consolidated budget proposal to the President and Congress.

(3) Review and certification of budget requests and budget submissions of National Drug Control Program agencies

(A) In general

The Director shall review each drug control budget request submitted to the Director under paragraph (1).

(B) Review of budget requests

(i) Inadequate requests

If the Director concludes that a budget request submitted under paragraph (1) is inadequate, in whole or in part, to implement the objectives of the National Drug Control Strategy with respect to the department, agency, or program at issue for the year for which the request is submitted, the Director shall submit to the head of the applicable National Drug Control Program agency a written description of funding levels and specific initiatives that would, in the determination of the Director, make the request adequate to implement those objectives.

(ii) Adequate requests

If the Director concludes that a budget request submitted under paragraph (1) is adequate to implement the objectives of the National Drug Control Strategy with respect to the department, agency, or program at issue for the year for which the request is submitted, the Director shall submit to the head of the applicable National Drug Control Program agency a written statement confirming the adequacy of the request.

(iii) Record

The Director shall maintain a record of each description submitted under clause (i) and each statement submitted under clause (ii).

(C) Specific requests

The Director shall not confirm the adequacy of any budget request that requests a level of funding that will not enable achievement of the goals of the National Drug Control Strategy, including—

(i) requests funding for Federal law enforcement activities that do not adequately compensate for transfers of drug enforcement resources and personnel to law enforcement and investigation activities;

(ii) requests funding for law enforcement activities on the borders of the United States that do not adequately direct resources to drug interdiction and enforcement;

(iii) requests funding for substance use disorder prevention and treatment activities that do not provide adequate results and accountability measures; and

(iv) requests funding for drug treatment activities that do not adequately support and enhance Federal drug treatment programs and capacity.

(D) Agency response

(i) In general

The head of a National Drug Control Program agency that receives a description under subparagraph (B)(i) shall include the funding levels and initiatives described by the Director in the budget submission for that agency to the Office of Management and Budget.

(ii) Impact statement

The head of a National Drug Control Program agency that has altered its budget submission under this subparagraph shall include as an appendix to the budget submission for that agency to the Office of Management and Budget an impact statement that summarizes—

(I) the changes made to the budget under this subparagraph; and

(II) the impact of those changes on the ability of that agency to perform its other responsibilities, including any impact on specific missions or programs of the agency.

(iii) Congressional notification

The head of a National Drug Control Program agency shall submit a copy of any impact statement under clause (ii) to the Senate and the House of Representatives and the appropriate congressional committees, at the time the budget for that agency is submitted to Congress under section 1105(a) of title 31.

(E) Certification of budget submissions

(i) In general

At the time a National Drug Control Program agency submits its budget request to the Office of Management and Budget, the head of the National Drug Control Program agency shall submit a copy of the budget request to the Director.

(ii) Certification

The Director shall—

(I) review each budget submission submitted under clause (i);

(II) based on the review under subclause (I), make a determination as to whether the budget submission of a National Drug Control Program agency includes the funding levels and initiatives described in subparagraph (B); and

(III) submit to the appropriate congressional committees—

(aa) a written statement that either—

(AA) certifies that the budget submission includes sufficient funding; or

(BB) decertifies the budget submission as not including sufficient funding;

(bb) a copy of the description made under subparagraph (B); and

(cc) the budget recommendations made under subsection (b)(8).

(4) Reprogramming and transfer requests

(A) In general

No National Drug Control Program agency shall submit to Congress a reprogramming or transfer request with respect to any amount of appropriated funds in an amount exceeding $5,000,000 or 10 percent of a specific program or account that is included in the National Drug Control Program budget unless the request has been approved by the Director. If the Director has not responded to a request for reprogramming subject to this subparagraph within 30 days after receiving notice of the request having been made, the request shall be deemed approved by the Director under this subparagraph and forwarded to Congress.

(B) Appeal

The head of any National Drug Control Program agency may appeal to the President any disapproval by the Director of a reprogramming or transfer request under this paragraph.

(5) Performance-Budget Coordinator

(A) Designation

The Director shall designate or appoint a United States Performance-Budget Coordinator to—

(i) ensure the Director has sufficient information necessary to analyze the performance of each National Drug Control Program agency, the impact Federal funding has had on the goals in the Strategy, and the likely contributions to the goals of the Strategy based on funding levels of each National Drug Control Program agency, to make an independent assessment of the budget request of each agency under this subsection;

(ii) advise the Director on agency budgets, performance measures and targets, and additional data and research needed to make informed policy decisions under this section and section 1705 of this title; and

(iii) other duties as may be determined by the Director with respect to measuring or assessing performance or agency budgets.

(B) Determination of position

For purposes of carrying out subparagraph (A), the Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent).

(6) Budget estimate or request submission to Congress

Whenever the Director submits any budget estimate or request to the President or the Office of Management and Budget, the Director shall concurrently transmit to the appropriate congressional committees a detailed statement of the budgetary needs of the Office to execute its mission based on the good-faith assessment of the Director.

(d) Powers of the Director

In carrying out subsection (b), the Director may—

(1) select, appoint, employ, and fix compensation of such officers and employees of the Office as may be necessary to carry out the functions of the Office under this chapter;

(2) subject to subsection (e)(3), request the head of a department or agency, or program of the Federal Government to place department, agency, or program personnel who are engaged in drug control activities on temporary detail to another department, agency, or program in order to implement the National Drug Control Strategy, and the head of the department or agency shall comply with such a request;

(3) use for administrative purposes, on a reimbursable basis, the available services, equipment, personnel, and facilities of Federal, State, and local agencies;

(4) procure the services of experts and consultants in accordance with section 3109 of title 5, relating to appointments in the Federal Service, at rates of compensation for individuals not to exceed the daily equivalent of the rate of pay payable under level IV of the Executive Schedule under section 5311 of title 5;

(5) accept and use gifts and donations of property from Federal, State, and local government agencies, and from the private sector, as authorized in section 1702(d) of this title;

(6) use the mails in the same manner as any other department or agency of the executive branch;

(7) monitor implementation of the National Drug Control Program, including—

(A) conducting program and performance audits and evaluations; and

(B) requesting assistance from the Inspector General of the relevant agency in such audits and evaluations;

(8) transfer funds made available to a National Drug Control Program agency for National Drug Control Strategy programs and activities to another account within such agency or to another National Drug Control Program agency for National Drug Control Strategy programs and activities, except that—

(A) the authority under this paragraph may be limited in an annual appropriations Act or other provision of Federal law;

(B) the Director may exercise the authority under this paragraph only with the concurrence of the head of each affected agency;

(C) in the case of an interagency transfer, the total amount of transfers under this paragraph may not exceed 3 percent of the total amount of funds made available for National Drug Control Strategy programs and activities to the agency from which those funds are to be transferred;

(D) funds transferred to an agency under this paragraph may only be used to increase the funding for programs or activities authorized by law;

(E) the Director shall—

(i) submit to the appropriate congressional committees and any other applicable committees of jurisdiction, a reprogramming or transfer request in advance of any transfer under this paragraph in accordance with the regulations of the affected agency; and

(ii) annually submit to the appropriate congressional committees a report describing the effect of all transfers of funds made pursuant to this paragraph or subsection (c)(4) during the 12-month period preceding the date on which the report is submitted; and

(F) funds may only be used for—

(i) expansion of demand reduction activities;

(ii) interdiction of illicit drugs on the high seas, in United States territorial waters, and at United States ports of entry by officers and employees of National Drug Control Program agencies and domestic and foreign law enforcement officers;

(iii) accurate assessment and monitoring of international drug production and interdiction programs and policies;

(iv) activities to facilitate and enhance the sharing of domestic and foreign intelligence information among National Drug Control Program agencies related to the production and trafficking of drugs in the United States and foreign countries; and

(v) research related to any of these activities;

(9) issue to the head of a National Drug Control Program agency a fund control notice described in subsection (f) to ensure compliance with the National Drug Control Program Strategy and notify the appropriate congressional committees of any fund control notice issued in accordance with subsection (f)(5); and

(10) participate in the drug certification process pursuant to section 2291j of title 22 and section 2291j–1 of title 22.

(e) Personnel detailed to Office

(1) Evaluations

Notwithstanding any provision of chapter 43 of title 5, the Director shall perform the evaluation of the performance of any employee detailed to the Office for purposes of the applicable performance appraisal system established under such chapter for any rating period, or part thereof, that such employee is detailed to such office.

(2) Compensation

(A) Bonus payments

Subject to the availability of appropriations, the Director may provide periodic bonus payments to any employee detailed to the Office.

(B) Restrictions

An amount paid under this paragraph to an employee for any period—

(i) shall not be greater than 20 percent of the basic pay paid or payable to such employee for such period; and

(ii) shall be in addition to the basic pay of such employee.

(C) Aggregate amount

The aggregate amount paid during any fiscal year to an employee detailed to the Office as basic pay, awards, bonuses, and other compensation shall not exceed the annual rate payable at the end of such fiscal year for positions at level III of the Executive Schedule.

(3) Maximum number of detailees

The maximum number of personnel who may be detailed to another department or agency (including the Office) under subsection (d)(2) during any fiscal year is—

(A) for the Department of Defense, 50; and

(B) for any other department or agency, 10.

(f) Fund control notices

(1) In general

A fund control notice may direct that all or part of an amount appropriated to the National Drug Control Program agency account be obligated by—

(A) months, fiscal year quarters, or other time periods; and

(B) activities, functions, projects, or object classes.

(2) Unauthorized obligation or expenditure prohibited

An officer or employee of a National Drug Control Program agency shall not make or authorize an expenditure or obligation contrary to a fund control notice issued by the Director.

(3) Disciplinary action for violation

In the case of a violation of paragraph (2) by an officer or employee of a National Drug Control Program agency, the head of the agency, upon the request of and in consultation with the Director, may subject the officer or employee to appropriate administrative discipline, including, when circumstances warrant, suspension from duty without pay or removal from office.

(4) Congressional notice

A copy of each fund control notice shall be transmitted to the appropriate congressional committees.

(5) Restrictions

The Director shall not issue a fund control notice to direct that all or part of an amount appropriated to the National Drug Control Program agency account be obligated, modified, or altered in any manner contrary, in whole or in part, to a specific appropriation or statute.

(g) Inapplicability to certain programs

The provisions of this section shall not apply to the National Intelligence Program, the Joint Military Intelligence Program, and Tactical and Related Activities, unless such program or an element of such program is designated as a National Drug Control Program—

(1) by the President; or

(2) jointly by—

(A) in the case of the National Intelligence Program, the Director and the Director of National Intelligence; or

(B) in the case of the Joint Military Intelligence Program and Tactical and Related Activities, the Director, the Director of National Intelligence, and the Secretary of Defense.

(h) Construction

Nothing in this chapter shall be construed as derogating the authorities and responsibilities of the Director of National Intelligence or the Director of the Central Intelligence Agency contained in the National Security Act of 1947 [50 U.S.C. 3001 et seq.], the Central Intelligence Agency Act of 1949 [50 U.S.C. 3501 et seq.], or any other law.

(i) Model acts program

(1) In general

The Director shall provide for or shall enter into an agreement with a nonprofit organization to—

(A) advise States on establishing laws and policies to address illicit drug use issues; and

(B) revise such model State drug laws and draft supplementary model State laws to take into consideration changes in illicit drug use issues in the State involved.

(2) Authorization of appropriations

There is authorized to be appropriated to carry out this subsection $1,250,000 for each of fiscal years 2018 through 2023.

(j) State, Local, and Tribal Affairs Coordinator

The Director shall designate or appoint a United States State, Local, and Tribal Affairs Coordinator to perform the duties of the Office outlined in this section and section 1705 of this title and such other duties as may be determined by the Director with respect to coordination of drug control efforts between agencies and State, local, and Tribal governments. For purposes of carrying out the previous sentence, the Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent).

(k) Harm reduction programs

When developing the national drug control policy, any policy of the Director, including policies relating to syringe exchange programs for intravenous drug users, shall be based on the best available medical and scientific evidence regarding the effectiveness of such policy in promoting individual health and preventing the spread of infectious disease and the impact of such policy on drug addiction and use. In making any policy relating to harm reduction programs, the Director shall consult with the National Institutes of Health and the National Academy of Sciences.

(Pub. L. 105–277, div. C, title VII, §§704, 715, Oct. 21, 1998, 112 Stat. 2681–672, 2681-693; Pub. L. 109–469, title I, §§103(a)–(e), (f)(3), 105, title VI, §602, Dec. 29, 2006, 120 Stat. 3506, 3507, 3510, 3511, 3533; Pub. L. 112–166, §2(t), Aug. 10, 2012, 126 Stat. 1288; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8217(c)–(f), 8221(b)(1), 8222(2), Oct. 24, 2018, 132 Stat. 4110, 4120-4122, 4142; Pub. L. 116–74, §2(a)(1), (2), (5), Nov. 27, 2019, 133 Stat. 1155.)

Editorial Notes

References in Text

Section 1705 of this title, referred to in subsec. (b)(2), (14)(B), was amended by Pub. L. 115–271, title VIII, §8221(a), Oct. 24, 2018, 132 Stat. 4134. Subsec. (b) of section 1705 no longer relates to reports for National Drug Control Program Agencies, but similar provisions can be found elsewhere in that section. Subsec. (c) of section 1705 was redesignated (h).

This chapter, referred to in subsec. (b)(21)(A)(iii), was in the original a reference to "this title", meaning title VII of Pub. L. 105–277, div. C, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out under section 1701 of this title and Tables.

The General Schedule, referred to in subsecs. (c)(5)(B) and (j), is set out under section 5332 of Title 5, Government Organization and Employees.

Levels III and IV of the Executive Schedule, referred to in subsecs. (d)(4) and (e)(2)(C), are set out in sections 5314 and 5315, respectively, of Title 5, Government Organization and Employees.

This chapter, referred to in subsec. (h), was in the original "this Act" and was translated as reading "this title", meaning title VII of Pub. L. 105–277, div. C, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter, to reflect the probable intent of Congress. For complete classification of title VII to the Code, see Short Title note set out under section 1701 of this title and Tables.

The National Security Act of 1947, referred to in subsec. (h), is act July 26, 1947, ch. 343, 61 Stat. 495, which was formerly classified principally to chapter 15 (§401 et seq.) of Title 50, War and National Defense, prior to editorial reclassification in Title 50, and is now classified principally to chapter 44 (§3001 et seq.) of Title 50. For complete classification of this Act to the Code, see Tables.

The Central Intelligence Agency Act of 1949, referred to in subsec. (h), is act June 20, 1949, ch. 227, 63 Stat. 208, which was formerly classified generally to section 403a et seq. of Title 50, War and National Defense, prior to editorial reclassification in Title 50, and is now classified generally to chapter 46 (§3501 et seq.) of Title 50. For complete classification of this Act to the Code, see Tables.

Codification

In subsec. (b)(8)(A), "chapter 11 of title 31" substituted for "the Budget and Accounting Act of 1921" on authority of Pub. L. 97–258, §4(b), Sept. 13, 1982, 96 Stat. 1067, the first section of which enacted Title 31, Money and Finance.

Amendments

2019—Pub. L. 116–74, §2(a)(2), substituted "National Drug Control Program agencies" for "National Drug Control Program Agencies" wherever appearing.

Subsec. (a)(1)(C)(i). Pub. L. 116–74, §2(a)(5)(A)(i)(I), substituted "subsection (c)(5)" for "subsection (c)(4)".

Subsec. (a)(1)(C)(iv). Pub. L. 116–74, §2(a)(5)(A)(i)(II), made technical amendment to reference in original act which appears in text as reference to subsection (j).

Subsec. (a)(1)(D). Pub. L. 116–74, §2(a)(5)(A)(ii), substituted "For purposes of carrying out the previous sentence, the Director shall designate or appoint an" for "The Director shall determine whether the coordinator position is a noncareer" and "or an appointee" for "or a career appointee".

Subsec. (b)(21)(A)(iii). Pub. L. 116–74, §2(a)(5)(B), made technical amendment to reference in original act which appears in text as reference to this chapter.

Subsec. (c)(2)(A)(ii). Pub. L. 116–74, §2(a)(5)(C)(i), substituted "of" for "fo".

Subsec. (c)(3)(E)(ii)(I). Pub. L. 116–74, §2(a)(5)(C)(ii)(I), substituted "clause (i)" for "subparagraph (A)".

Subsec. (c)(3)(E)(ii)(II). Pub. L. 116–74, §2(a)(5)(C)(ii)(II), substituted "subclause (I)" for "clause (i)".

Subsec. (c)(5)(A)(i). Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency" in two places.

Subsec. (c)(5)(B). Pub. L. 116–74, §2(a)(5)(C)(iii), substituted "For purposes of carrying out subparagraph (A), the Director shall designate or appoint an" for 'The Director shall determine whether the coordinator position is a noncareer".

Subsec. (d)(8)(F). Pub. L. 116–74, §2(a)(5)(D)(i), redesignated subpar. (E)(iii) as subpar. (F), redesignated subcls. (I) to (V) of former subpar. (E)(iii) as cls. (i) to (v) of subpar. (F), respectively, realigned margins, and substituted "activities;" for "activities." in cl. (v).

Subsec. (d)(9). Pub. L. 116–74, §2(a)(5)(D)(ii), made technical amendment to reference in original act which appears in text as reference to subsection (f)(5), and inserted "and" at end.

Subsec. (j). Pub. L. 116–74, §2(a)(5)(E), substituted "For purposes of carrying out the previous sentence, the Director shall designate or appoint an" for "The Director shall determine whether the coordinator position is a noncareer" and "or an appointee" for "or a career appointee", and inserted "section" before "1705".

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

Subsec. (a)(1). Pub. L. 115–271, §8217(c)(1), added subpars. (A) to (D) and struck out former subpars. (A) to (C) which related to appointment of Director, Deputy Directors, and Deputy Director for Demand Reduction, respectively.

Subsec. (a)(5). Pub. L. 115–271, §8217(c)(2), substituted "such officer or employee" for "such official".

Subsec. (a)(6). Pub. L. 115–271, §8217(c)(3), added par. (6).

Subsec. (b)(13). Pub. L. 115–271, §8221(b)(1)(A), struck out par. (13) which required each National Drug Control Program agency to submit annual progress reports.

Subsec. (b)(14)(A). Pub. L. 115–271, §8221(b)(1)(B), substituted "section 1705(g)(2) of this title" for "paragraph (13)".

Subsec. (b)(17). Pub. L. 115–271, §8221(b)(1)(A), struck out par. (17) which read as follows: "shall seek the support and commitment of State, local, and tribal officials in the formulation and implementation of the National Drug Control Strategy;".

Subsec. (b)(21). Pub. L. 115–271, §8217(d), added par. (21).

Subsec. (c)(2)(A). Pub. L. 115–271, §8217(e)(1)(A), substituted "paragraph (1)(C) and include—" for "paragraph (1)(C);" and added cls. (i) and (ii).

Subsec. (c)(2)(B). Pub. L. 115–271, §8217(e)(1)(B), substituted "the President and Congress." for "the President; and".

Subsec. (c)(2)(C). Pub. L. 115–271, §8217(e)(1)(C), struck out subpar. (C) which read as follows: "after submission under subparagraph (B), submit the consolidated budget proposal to Congress."

Subsec. (c)(3)(C). Pub. L. 115–271, §8222(2)(A)(i)(I), inserted "requests a level of funding that will not enable achievement of the goals of the National Drug Control Strategy, including" after "request that" in introductory provisions.

Subsec. (c)(3)(C)(iii). Pub. L. 115–271, §8222(2)(A)(i)(II), substituted "substance use disorder prevention and treatment" for "drug treatment" and "; and" for semicolon at end.

Subsec. (c)(3)(C)(iv), (v). Pub. L. 115–271, §8222(2)(A)(i)(III)–(V), redesignated cl. (v) as (iv), substituted period for semicolon at end, and struck out former cl. (iv) which read as follows: "requests funding for any activities of the Safe and Drug-Free Schools Program that do not include a clear anti-drug message or purpose intended to reduce drug use;".

Subsec. (c)(3)(C)(vi), (vii). Pub. L. 115–271, §8222(2)(A)(i)(III), struck out cls. (vi) and (vii) which read as follows:

"(vi) requests funding for fiscal year 2007 for activities of the Department of Education, unless it is accompanied by a report setting forth a plan for providing expedited consideration of student loan applications for all individuals who submitted an application for any Federal grant, loan, or work assistance that was rejected or denied pursuant to 1091(r)(1) of title 20 by reason of a conviction for a drug-related offense not occurring during a period of enrollment for which the individual was receiving any Federal grant, loan, or work assistance; and

"(vii) requests funding for the operations and management of the Department of Homeland Security that does not include a specific request for funds for the Office of Counternarcotics Enforcement to carry out its responsibilities under section 458 of title 6."

Subsec. (c)(3)(E)(ii). Pub. L. 115–271, §8217(e)(2), added cl. (ii) and struck out former cl. (ii) which related to certification by Director of National Drug Control Program agency budget submissions.

Subsec. (c)(4)(A). Pub. L. 115–271, §8222(2)(A)(ii), substituted "$5,000,000 or 10 percent of a specific program or account" for "$1,000,000".

Subsec. (c)(5), (6). Pub. L. 115–271, §8217(e)(3), added pars. (5) and (6).

Subsec. (d)(8)(D). Pub. L. 115–271, §8217(f)(1)(A), struck out "and" at end.

Subsec. (d)(8)(E)(i). Pub. L. 115–271, §8217(f)(1)(B)(i), substituted "the appropriate congressional committees" for "Congress, including to the Committees on Appropriations of the Senate and the House of Representatives, the authorizing committees for the Office," and struck out "or agencies" after "affected agency".

Subsec. (d)(8)(E)(ii). Pub. L. 115–271, §8217(f)(1)(B)(ii), substituted "the appropriate congressional committees" for "Congress" and inserted "and" at end.

Subsec. (d)(8)(E)(iii). Pub. L. 115–271, §8217(f)(1)(B)(iii), added cl. (iii).

Subsec. (e)(2)(A). Pub. L. 115–271, §8217(f)(2), substituted "Subject to the availability of appropriations" for "Notwithstanding any other provision of law".

Subsec. (f)(4). Pub. L. 115–271, §8217(2)(B)(ii), which directed the amendment of subsec. (f) by striking "the second paragraph (4)", was executed by striking the par. (4) added by Pub. L. 109–469, §105(f), to reflect the probable intent of Congress. Text read as follows: "A copy of each fund control notice shall be transmitted to the appropriate congressional committees."

Subsec. (f)(5). Pub. L. 115–271, §8217(2)(B)(i), which directed the amendment of subsec. (f) by striking "the first paragraph (5)", was executed by striking the par. (5) added by Pub. L. 109–469, §103(e), to reflect the probable intent of Congress. Text read as follows: "The Director shall not issue a fund control notice to direct that all or part of an amount appropriated to the National Drug Control Program agency account be obligated, modified, or altered in any manner—

"(A) contrary, in whole or in part, to a specific appropriation; or

"(B) contrary, in whole or in part, to the expressed intent of Congress."

Subsecs. (i) to (k). Pub. L. 115–271, §8217(f)(3), added subsecs. (i) to (k).

2012—Subsec. (a)(1). Pub. L. 112–166 amended par. (1) generally. Prior to amendment, text read as follows: "The Director, the Deputy Director of National Drug Control Policy, the Deputy Director for Demand Reduction, the Deputy Director for Supply Reduction, and the Deputy Director for State and Local Affairs, shall each be appointed by the President, by and with the advice and consent of the Senate, and shall serve at the pleasure of the President. In appointing the Deputy Director for Demand Reduction under this paragraph, the President shall take into consideration the scientific, educational or professional background of the individual, and whether the individual has experience in the fields of substance abuse prevention, education, or treatment."

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Subsec. (a)(3). Pub. L. 109–469, §103(a), amended par. (3) generally. Prior to amendment, text read as follows: "In the absence of the Deputy Director, or if the Office of the Deputy Director is vacant, the Director shall designate such other permanent employee of the Office to serve as the Director, if the Director is absent or unable to serve."

Subsec. (b)(4). Pub. L. 109–469, §103(b)(1), substituted "National Drug Control Program agencies" for "Federal departments and agencies engaged in drug enforcement".

Subsec. (b)(7). Pub. L. 109–469, §103(b)(2), inserted "and the appropriate congressional committees" after "President".

Subsec. (b)(13). Pub. L. 109–469, §103(b)(3), struck out "(beginning in 1999)" after "basis" in introductory provisions.

Subsec. (b)(14). Pub. L. 109–469, §103(b)(4), added par. (14) and struck out former par. (14) which read as follows: "shall submit to the Appropriations committees and the authorizing committees of jurisdiction of the House of Representatives and the Senate on an annual basis, not later than 60 days after the date of the last day of the applicable period, a summary of—

"(A) each of the evaluations received by the Director under paragraph (13); and

"(B) the progress of each National Drug Control Program agency toward the drug control program goals of the agency using the performance measures for the agency developed under section 1705(c) of this title; and".

Subsec. (b)(15)(C). Pub. L. 109–469, §103(b)(5), added subpar. (C) and struck out former subpar. (C) which read as follows: "developing a single interagency clearinghouse for the dissemination of research and information by such agencies to State and local governments and nongovernmental agencies involved in demand reduction."

Subsec. (b)(16) to (20). Pub. L. 109–469, §103(b)(6), added pars. (16) to (20).

Subsec. (c)(1)(C). Pub. L. 109–469, §105(a), added subpar. (C).

Subsec. (c)(2). Pub. L. 109–469, §105(b)(1), inserted "and the head of each major national organization that represents law enforcement officers, agencies, or associations" after "agency" in introductory provisions.

Subsec. (c)(2)(A). Pub. L. 109–469, §105(b)(2), inserted "and to inform Congress and the public about the total amount proposed to be spent on all supply reduction, demand reduction, State, local, and tribal affairs, including any drug law enforcement, and other drug control activities by the Federal Government, which shall conform to the content requirements set forth in paragraph (1)(C)" before semicolon at end.

Subsec. (c)(3)(C). Pub. L. 109–469, §105(c)(2), added subpar. (C). Former subpar. (C) redesignated (D).

Subsec. (c)(3)(C)(iii). Pub. L. 109–469, §103(c)(1), inserted "and the appropriate congressional committees," after "House of Representatives".

Subsec. (c)(3)(D). Pub. L. 109–469, §105(c)(1), redesignated subpar. (C) as (D). Former subpar. (D) redesignated (E).

Subsec. (c)(3)(D)(ii)(II)(bb). Pub. L. 109–469, §103(c)(2), inserted "and the appropriate congressional committees," after "House of Representatives".

Subsec. (c)(3)(D)(iii). Pub. L. 109–469, §105(c)(3), which directed amendment of cl. (iii) by inserting "and the appropriate congressional committees," after "House of Representatives", was not executed in view of the identical amendment made by Pub. L. 109–469, §103(c)(1) to subpar. (C)(iii) prior to its redesignation as (D)(iii). See above.

Subsec. (c)(3)(E). Pub. L. 109–469, §105(c)(1), redesignated subpar. (D) as (E).

Subsec. (c)(3)(E)(ii)(II)(bb). Pub. L. 109–469, §105(c)(4), which directed amendment of item (bb) by inserting "and the appropriate congressional committees," after "House of Representatives", was not executed in view of the identical amendment made by Pub. L. 109–469, §103(c)(2) to subpar. (D)(ii)(II)(bb) prior to its redesignation as (E)(ii)(II)(bb). See above.

Subsec. (c)(4)(A). Pub. L. 109–469, §105(d), substituted "$1,000,000" for "$5,000,000" and inserted at end "If the Director has not responded to a request for reprogramming subject to this subparagraph within 30 days after receiving notice of the request having been made, the request shall be deemed approved by the Director under this subparagraph and forwarded to Congress."

Subsec. (d)(8)(D). Pub. L. 109–469, §105(e)(1), substituted "authorized by law;" for "have been authorized by Congress;".

Subsec. (d)(9). Pub. L. 109–469, §105(e)(2), which directed the substitution of "Strategy and notify the appropriate congressional committees of any fund control notice issued; and" for "Strategy; and", could not be executed because the words "Strategy; and" did not appear subsequent to amendment by Pub. L. 109–469, §103(d)(1). See below.

Pub. L. 109–469, §103(d)(1), substituted "Strategy and notify the appropriate congressional committees of any fund control notice issued in accordance with subsection (f)(5);" for "Strategy; and".

Subsec. (d)(10). Pub. L. 109–469, §§103(d)(2) and 105(e)(3), made identical amendments, inserting "and section 2291j–1 of title 22" before period at end.

Subsec. (f)(4), (5). Pub. L. 109–469, §105(f), added pars. (4) and (5) set out second.

Pub. L. 109–469, §103(e), added pars. (4) and (5) set out first.

Subsec. (g). Pub. L. 109–469, §103(f)(3)(A), amended subsec. (g) generally. Prior to amendment, text read as follows: "The provisions of this section shall not apply to the National Foreign Intelligence Program, the Joint Military Intelligence Program and Tactical Intelligence and Related Activities unless the agency that carries out such program is designated as a National Drug Control Program agency by the President or jointly by the Director and the head of the agency."

Subsec. (h). Pub. L. 109–469, §103(f)(3)(B), amended subsec. (h) generally. Prior to amendment, text read as follows: "Nothing in this chapter shall be construed as derogating the authorities and responsibilities of the Director of Central Intelligence contained in sections 403–4 and 414 of title 50 or any other law."

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–166 effective 60 days after Aug. 10, 2012, and applicable to appointments made on and after that effective date, including any nomination pending in the Senate on that date, see section 6(a) of Pub. L. 112–166, set out as a note under section 113 of Title 6, Domestic Security.

Report on Streamlining Federal Prevention and Treatment Efforts

Pub. L. 105–277, div. D, title II, §221, Oct. 21, 1998, 112 Stat. 2681–758, expressed sense of Congress that efforts of the Federal Government to reduce demand for illegal drugs in United States are frustrated by fragmentation of those efforts across multiple departments and agencies, and improvement of those efforts can best be achieved through consolidation and coordination, and further provided that not later than 18 months after Oct. 21, 1998, Director of the Office of National Drug Control Policy was to prepare and submit to Congress a report evaluating options for increasing efficacy of drug prevention and treatment programs, including a thorough review of activities and potential consolidation of existing Federal drug information clearinghouses.

Executive Documents

Ex. Ord. No. 12880. National Drug Control Program

Ex. Ord. No. 12880, Nov. 16, 1993, 58 F.R. 60989, as amended by Ex. Ord. No. 13008, June 3, 1996, 61 F.R. 28721, provided:

The Office of National Drug Control Policy has the lead responsibility within the Executive Office of the President to establish policies, priorities, and objectives for the Nation's drug control program, with the goal of reducing the production, availability, and use of illegal drugs. All lawful and reasonable means must be used to ensure that the United States has a comprehensive and effective National Drug Control Strategy.

Therefore, by the authority vested in me as President by the Constitution and the laws of the United States of America, including the National Narcotics Leadership Act of 1988, as amended (former 21 U.S.C. 1501 et seq.), and in order to provide for the effective management of the drug abuse policies of the United States, it is hereby ordered as follows:

Section 1. General Provisions. (a) Because the United States considers the operations of international criminal narcotics syndicates as a national security threat requiring an extraordinary and coordinated response by civilian and military agencies involved in national security, the Director of the Office of National Drug Control Policy (Director), in his role as the principal adviser to the National Security Council on national drug control policy (50 U.S.C. 402(f)) [now 50 U.S.C. 3021(f)], shall provide drug policy guidance and direction in the development of related national security programs.

(b) The Director shall provide oversight and direction for all international counternarcotics policy development and implementation, in coordination with other concerned Cabinet members, as appropriate.

(c) An Interagency Working Group (IWG) on international counternarcotics policy, chaired by the Office of National Drug Control Policy, shall develop and ensure coordinated implementation of an international counternarcotics policy. The IWG shall report its activities and differences of views among agencies to the Director for review, mediation, and resolution with concerned Cabinet members, and if necessary, by the President.

(d) A coordinator for drug interdiction shall be designated by the Director to ensure that assets dedicated by Federal drug program agencies for interdiction are sufficient and that their use is properly integrated and optimized. The coordinator shall ensure that interdiction efforts and priorities are consistent with overall U.S. international counternarcotics policy.

(e) The Director shall examine the number and structure of command/control and drug intelligence centers operated by drug control program agencies involved in international counter-narcotics and suggest improvements to the current structure for consideration by the President and concerned members of the Cabinet.

(f) The Director, utilizing the services of the Drugs and Crime Data Center and Department of Justice Clearinghouse, shall assist in coordinating and enhancing the dissemination of statistics and studies relating to anti-drug abuse policy.

(g) The Director shall provide advice to agencies regarding ways to achieve efficiencies in spending and improvements to interagency cooperation that could enhance the delivery of drug control treatment and prevention services to the public. The Director may request agencies to provide studies, information, and analyses in support of this order.

Sec. 2. Goals, Direction, Duties and Responsibilities with Respect to the National Drug Control Program. (a) Budget Matters. (1) In addition to the budgetary authorities and responsibilities provided to the Director by statute, [former] 21 U.S.C. 1502, for those agency budget requests that are not certified as adequate to implement the objectives of the National Drug Control Strategy, the Director shall include in such certifications initiatives or funding levels that would make such requests adequate.

(2) The Director shall provide, by July 1 of each year, budget recommendations to the heads of departments and agencies with responsibilities under the National Drug Control Program. The recommendations shall apply to the second following fiscal year and address funding priorities developed in the annual National Drug Control Strategy.

(b) Measurement of National Drug Control Strategy Outcomes. (1) The National Drug Control Strategy shall include long-range goals for reducing drug use and the consequences of drug use in the United States, including burdens on hospital emergency rooms, drug use among arrestees, the extent of drug-related crime, high school dropout rates, the number of infants exposed annually to illicit drugs in utero, national drug abuse treatment capacity, and the annual national health care costs of drug use.

(2) The National Drug Control Strategy shall also include an assessment of the quality of techniques and instruments to measure current drug use and supply and demand reduction activities, and the adequacy of the coverage of existing national drug use instruments and techniques to measure the total illicit drug user population and groups at-risk for drug use.

(3) The Director shall coordinate an effort among the relevant drug control program agencies to assess the quality, access, management, effectiveness, and standards of accountability of drug abuse treatment, prevention, education, and other demand reduction activities.

(c) Provision of Reports. To the extent permitted by law, heads of departments and agencies with responsibilities under the National Drug Control Program shall make available to the Office of National Drug Control Policy, appropriate statistics, studies, and reports, pertaining to Federal drug abuse control.

William J. Clinton.      

¹ See References in Text note below.

² Probably should be "1705(h)".

§1704. Coordination with National Drug Control Program agencies in demand reduction, supply reduction, and State and local affairs

(a) Access to information

(1) In general

Upon the request of the Director, the head of any National Drug Control Program agency shall cooperate with and provide to the Director any statistics, studies, reports, and other information prepared or collected by the agency concerning the responsibilities of the agency under the National Drug Control Strategy that relate to—

(A) drug control; or

(B) the manner in which amounts made available to that agency for drug control are being used by that agency.

(2) Protection of intelligence information

(A) In general

The authorities conferred on the Office and the Director by this chapter shall be exercised in a manner consistent with provisions of the National Security Act of 1947 [50 U.S.C. 3001 et seq.]. The Director of National Intelligence shall prescribe such regulations as may be necessary to protect information provided pursuant to this chapter regarding intelligence sources and methods.

(B) Duties of Director

The Director of National Intelligence and the Director of the Central Intelligence Agency shall, to the maximum extent practicable in accordance with subparagraph (A), render full assistance and support to the Office and the Director.

(3) Required reports

(A) Secretaries of the Interior and Agriculture

Not later than July 1 of each year, the Secretaries of Agriculture and the Interior shall jointly submit to the Director and the appropriate congressional committees an assessment of the quantity of illegal drug cultivation and manufacturing in the United States on lands owned or under the jurisdiction of the Federal Government for the preceding year.

(B) Secretary of Homeland Security

Not later than July 1 of each year, the Secretary of Homeland Security shall submit to the Director and the appropriate congressional committees information for the preceding year regarding—

(i) the number and type of seizures of drugs by each component of the Department of Homeland Security seizing drugs, as well as statistical information on the geographic areas of such seizures; and

(ii) the number of air and maritime patrol hours primarily dedicated to drug supply reduction missions undertaken by each component of the Department of Homeland Security.

(C) Secretary of Defense

The Secretary of Defense shall, by July 1 of each year, submit to the Director and the appropriate congressional committees information for the preceding year regarding the number of air and maritime patrol hours primarily dedicated to drug supply reduction missions undertaken by each component of the Department of Defense.

(D) Attorney General

The Attorney General shall, by July 1 of each year, submit to the Director and the appropriate congressional committees information for the preceding year regarding the number and type of—

(i) arrests for drug violations;

(ii) prosecutions for drug violations by United States Attorneys; and

(iii) seizures of drugs by each component of the Department of Justice seizing drugs, as well as statistical information on the geographic areas of such seizures.

(b) Certification of policy changes to Director

(1) In general

Subject to paragraph (2), the head of a National Drug Control Program agency shall, unless exigent circumstances require otherwise, notify the Director in writing regarding any proposed change in policies relating to the activities of that agency under the National Drug Control Program prior to implementation of such change. The Director shall promptly review such proposed change and certify to the head of that agency in writing whether such change is consistent with the National Drug Control Strategy.

(2) Exception

If prior notice of a proposed change under paragraph (1) is not practicable—

(A) the head of the National Drug Control Program agency shall notify the Director of the proposed change as soon as practicable; and

(B) upon such notification, the Director shall review the change and certify to the head of that agency in writing whether the change is consistent with the National Drug Control Strategy.

(c) General Services Administration

The Administrator of General Services shall provide to the Director, on a reimbursable basis, such administrative support services as the Director may request.

(d) Accounting of funds expended

(1) In general

Not later than February 1 of each year, in accordance with guidance issued by the Director, the head of each National Drug Control Program agency shall submit to the Director a detailed accounting of all funds expended by the agency for National Drug Control Program activities during the previous fiscal year and shall ensure such detailed accounting is authenticated for the previous fiscal year by the Inspector General for such agency prior to the submission to the Director as frequently as determined by the Inspector General but not less frequently than every 3 years.

(2) Submission to Congress

The Director shall submit to Congress not later than April 1 of each year the information submitted to the Director under paragraph (1).

(e) Drug court training and technical assistance program

(1) Grants authorized

The Director may make a grant to a nonprofit organization for the purpose of providing training and technical assistance to drug courts.

(2) Authorization of appropriations

There is authorized to be appropriated to carry out this subsection $2,000,000 for each of fiscal years 2018 through 2023.

(f) Tracking system for federally funded grant programs

(1) Establishment

The Director, or the head of an agency designated by the Director, in coordination with the Secretary of Health and Human Services, shall track federally-funded grant programs to—

(A) ensure the public has electronic access to information identifying:

(i) all drug control grants and pertinent identifying information for each grant; and

(ii) any available performance metrics, evaluations, or other information indicating the effectiveness of such programs;

(B) facilitate efforts to identify duplication, overlap, or gaps in funding to provide increased accountability of Federally-funded grants for substance use disorder treatment, prevention, and enforcement; and

(C) identify barriers that may impede applicants in the grant application process.

(2) National Drug Control Program Agencies

The head of each National Drug Control Program agency shall provide to the Director a complete list of all drug control program grant programs and any other relevant information for inclusion in the system developed under paragraph (1) and annually update such list.

(3) Updating existing systems

The Director may meet the requirements of this subsection by utilizing, updating, or improving existing Federal information systems to ensure they meet the requirements of this subsection.

(4) Report

Not later than 3 years after October 24, 2018, the Comptroller General of the United States shall submit to Congress a report examining implementation of this subsection.

(Pub. L. 105–277, div. C, title VII, §§705, 715, Oct. 21, 1998, 112 Stat. 2681–680, 2681-693; Pub. L. 109–469, title I, §104, title VI, §602, Dec. 29, 2006, 120 Stat. 3510, 3533; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8207, 8217(g), Oct. 24, 2018, 132 Stat. 4110, 4113, 4124; Pub. L. 116–74, §2(a)(1), (6), Nov. 27, 2019, 133 Stat. 1155, 1156.)

Editorial Notes

References in Text

The National Security Act of 1947, referred to in subsec. (a)(2)(A), is act July 26, 1947, ch. 343, 61 Stat. 495, which was formerly classified principally to chapter 15 (§401 et seq.) of Title 50, War and National Defense, prior to editorial reclassification in Title 50, and is now classified principally to chapter 44 (§3001 et seq.) of Title 50. For complete classification of this Act to the Code, see Tables.

Amendments

2019—Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency" wherever appearing.

Subsec. (d)(1). Pub. L. 116–74, §2(a)(6)(A), substituted "than every" for "that every".

Subsec. (f)(1)(A)(i). Pub. L. 116–74, §2(a)(6)(B)(i)(I), substituted "grant; and" for "grant;".

Subsec. (f)(1)(C). Pub. L. 116–74, §2(a)(6)(B)(i)(II), inserted "that may impede applicants" after "barriers" and struck out "impediments that applicants currently have in the grant application process with applicable agencies" before period at end.

Subsec. (f)(2). Pub. L. 116–74, §2(a)(6)(B)(ii), substituted "Drug Control Program" for "Drug Control" in heading.

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

Subsec. (d). Pub. L. 115–271, §8217(g)(1), amended subsec. (d) generally. Prior to amendment, text read as follows: "The Director shall—

"(A) require the National Drug Control Program agencies to submit to the Director not later than February 1 of each year a detailed accounting of all funds expended by the agencies for National Drug Control Program activities during the previous fiscal year, and require such accounting to be authenticated by the Inspector General for each agency prior to submission to the Director; and

"(B) submit to Congress not later than April 1 of each year the information submitted to the Director under subparagraph (A)."

Subsec. (e). Pub. L. 115–271, §8207, added subsec. (e).

Subsec. (f). Pub. L. 115–271, §8217(g)(2), added subsec. (f).

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Subsec. (a)(1)(A). Pub. L. 109–469, §104(1), struck out "abuse" after "drug".

Subsec. (a)(2)(A). Pub. L. 109–469, §104(2), substituted "Director of National Intelligence" for "Director of Central Intelligence".

Subsec. (a)(2)(B). Pub. L. 109–469, §104(3), substituted "Director of National Intelligence and the Director of the Central Intelligence Agency" for "Director of Central Intelligence".

Subsec. (a)(3). Pub. L. 109–469, §104(4), amended par. (3) generally. Prior to amendment, text read as follows: "The Secretary of Agriculture shall annually submit to the Director an assessment of the acreage of illegal drug cultivation in the United States."

Subsec. (b)(2)(B). Pub. L. 109–469, §104(5), substituted "Strategy" for "Program".

Subsec. (c). Pub. L. 109–469, §104(6), substituted "on" for "in".

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

§1705. Development, submission, implementation, and assessment of National Drug Control Strategy

(a) In general

(1) Statement of drug policy priorities

The Director shall release a statement of drug control policy priorities in the calendar year of a Presidential inauguration following the inauguration, but not later than April 1.

(2) National Drug Control Strategy submitted by the President

Not later than the first Monday in February following the year in which the term of the President commences, and every 2 years thereafter, the President shall submit to Congress a National Drug Control Strategy.

(b) Development of the National Drug Control Strategy

(1) Promulgation

The Director shall promulgate the National Drug Control Strategy, which shall set forth a comprehensive plan to reduce illicit drug use and the consequences of such illicit drug use in the United States by limiting the availability of and reducing the demand for illegal drugs and promoting prevention, early intervention, treatment, and recovery support for individuals with substance use disorders.

(2) State and local commitment

The Director shall seek the support and commitment of State, local, and Tribal officials in the formulation and implementation of the National Drug Control Strategy.

(3) Strategy based on evidence

The Director shall ensure the National Drug Control Strategy is based on the best available evidence regarding the policies that are most effective in reducing the demand for and supply of illegal drugs.

(4) Process for development and submission of National Drug Control Strategy

In developing and effectively implementing the National Drug Control Strategy, the Director—

(A) shall consult with—

(i) the heads of the National Drug Control Program agencies;

(ii) each Coordinator listed in section 1703 of this title;

(iii) the Interdiction Committee and the Emerging Threats Committee;

(iv) the appropriate congressional committees and any other committee of jurisdiction;

(v) State, local, and Tribal officials;

(vi) private citizens and organizations, including community and faith-based organizations, with experience and expertise in demand reduction;

(vii) private citizens and organizations with experience and expertise in supply reduction; and

(viii) appropriate representatives of foreign governments; and

(B) in satisfying the requirements of subparagraph (A), shall ensure, to the maximum extent possible, that State, local, and Tribal officials and relevant private organizations commit to support and take steps to achieve the goals and objectives of the National Drug Control Strategy.

(c) Contents of the National Drug Control Strategy

(1) In general

The National Drug Control Strategy submitted under subsection (a)(2) shall include the following:

(A) A mission statement detailing the major functions of the National Drug Control Program.

(B) Comprehensive, research-based, long-range, quantifiable goals for reducing illicit drug use, and the consequences of illicit drug use in the United States.

(C) Annual quantifiable and measurable objectives and specific targets to accomplish long-term quantifiable goals that the Director determines may be achieved during each year beginning on the date on which the National Drug Control Strategy is submitted.

(D) A 5-year projection for the National Drug Control Program and budget priorities.

(E) A review of international, State, local, and private sector drug control activities to ensure that the United States pursues coordinated and effective drug control at all levels of government.

(F) A description of how each goal established under subparagraph (B) will be achieved, including for each goal—

(i) a list of each relevant National Drug Control Program agency and each such agency's related programs, activities, and available assets and the role of each such program, activity, and asset in achieving such goal;

(ii) a list of relevant stakeholders and each such stakeholder's role in achieving such goal;

(iii) an estimate of Federal funding and other resources needed to achieve such goal;

(iv) a list of each existing or new coordinating mechanism needed to achieve such goal; and

(v) a description of the Office's role in facilitating the achievement of such goal.

(G) For each year covered by the Strategy, a performance evaluation plan for each goal established under subparagraph (B) for each National Drug Control Program agency, including—

(i) specific performance measures for each National Drug Control Program agency;

(ii) annual and, to the extent practicable, quarterly objectives and targets for each performance measure; and

(iii) an estimate of Federal funding and other resources needed to achieve each performance objective and target.

(H) A list identifying existing data sources or a description of data collection needed to evaluate performance, including a description of how the Director will obtain such data.

(I) A list of any anticipated challenges to achieving the National Drug Control Strategy goals and planned actions to address such challenges.

(J) A description of how each goal established under subparagraph (B) was determined, including—

(i) a description of each required consultation and a description of how such consultation was incorporated; and

(ii) data, research, or other information used to inform the determination to establish the goal.

(K) A description of the current prevalence of illicit drug use in the United States, including both the availability of illicit drugs and the prevalence of substance use disorders.

(L) Such other statistical data and information as the Director considers appropriate to demonstrate and assess trends relating to illicit drug use, the effects and consequences of illicit drug use (including the effects on children), supply reduction, demand reduction, drug-related law enforcement, and the implementation of the National Drug Control Strategy.

(M) A systematic plan for increasing data collection to enable real time surveillance of drug control threats, developing analysis and monitoring capabilities, and identifying and addressing policy questions related to the National Drug Control Strategy and Program, which shall include—

(i) a list of policy-relevant questions for which the Director and each National Drug Control Program agency intends to develop evidence to support the National Drug Control Program and Strategy;

(ii) a list of data the Director and each National Drug Control Program agency intends to collect, use, or acquire to facilitate the use of evidence in drug control policymaking and monitoring;

(iii) a list of methods and analytical approaches that may be used to develop evidence to support the National Drug Control Program and Strategy and related policy;

(iv) a list of any challenges to developing evidence to support policymaking, including any barriers to accessing, collecting, or using relevant data;

(v) a description of the steps the Director and the head of each National Drug Control Program agency will take to effectuate the plan; and

(vi) any other relevant information as determined by the Director.

(N) A plan to expand treatment of substance use disorders, which shall—

(i) identify unmet needs for treatment for substance use disorders and a strategy for closing the gap between available and needed treatment;

(ii) describe the specific roles and responsibilities of the relevant National Drug Control Program agencies for implementing the plan;

(iii) identify the specific resources required to enable the relevant National Drug Control Program agencies to implement that strategy; and

(iv) identify the resources, including private sources, required to eliminate the unmet need for evidence-based substance use disorder treatment.

(2) Consultation

In developing the plan required under paragraph (1)(M), the Director shall consult with the following:

(A) The public.

(B) Any evaluation or analysis units and personnel of the Office.

(C) Office officials responsible for implementing privacy policy.

(D) Office officials responsible for data governance.

(E) The appropriate congressional committees.

(F) Any other individual or entity as determined by the Director.

(3) Additional strategies

(A) In general

The Director shall include in the National Drug Control Strategy the additional strategies described under this paragraph and shall comply with the following:

(i) Provide a copy of the additional strategies to the appropriate congressional committees and to the Committee on Armed Services and the Committee on Homeland Security of the House of Representatives, and the Committee on Homeland Security and Governmental Affairs and the Committee on Armed Services of the Senate.

(ii) Issue the additional strategies in consultation with the head of each relevant National Drug Control Program agency, any relevant official of a State, local, or Tribal government, and the government of other relevant countries.

(iii) Not change any existing agency authority or construe any strategy described under this paragraph to amend or modify any law governing interagency relationship but may include recommendations about changes to such authority or law.

(iv) Present separately from the rest of any strategy described under this paragraph any information classified under criteria established by an Executive order, or whose public disclosure, as determined by the Director or the head of any relevant National Drug Control Program agency, would be detrimental to the law enforcement or national security activities of any Federal, State, local, or Tribal agency.

(B) Requirement for Southwest Border Counternarcotics Strategy

(i) Purposes

The Southwest Border Counternarcotics Strategy shall—

(I) set forth the Government's strategy for preventing the illegal trafficking of drugs across the international border between the United States and Mexico, including through ports of entry and between ports of entry on that border;

(II) state the specific roles and responsibilities of the relevant National Drug Control Program agencies for implementing that strategy; and

(III) identify the specific resources required to enable the relevant National Drug Control Program agencies to implement that strategy.

(ii) Specific content related to drug tunnels between the United States and Mexico

The Southwest Border Counternarcotics Strategy shall include—

(I) a strategy to end the construction and use of tunnels and subterranean passages that cross the international border between the United States and Mexico for the purpose of illegal trafficking of drugs across such border; and

(II) recommendations for criminal penalties for persons who construct or use such a tunnel or subterranean passage for such a purpose.

(C) Requirement for Northern Border Counternarcotics Strategy

(i) Purposes

The Northern Border Counternarcotics Strategy shall—

(I) set forth the strategy of the Federal Government for preventing the illegal trafficking of drugs across the international border between the United States and Canada, including through ports of entry and between ports of entry on the border;

(II) state the specific roles and responsibilities of each relevant National Drug Control Program agency for implementing the strategy;

(III) identify the specific resources required to enable the relevant National Drug Control Program agencies to implement the strategy;

(IV) be designed to promote, and not hinder, legitimate trade and travel; and

(V) reflect the unique nature of small communities along the international border between the United States and Canada, ongoing cooperation and coordination with Canadian law,¹ enforcement authorities, and variations in the volumes of vehicles and pedestrians crossing through ports of entry along the international border between the United States and Canada.

(ii) Specific content related to cross-border Indian reservations

The Northern Border Counternarcotics Strategy shall include—

(I) a strategy to end the illegal trafficking of drugs to or through Indian reservations on or near the international border between the United States and Canada; and

(II) recommendations for additional assistance, if any, needed by Tribal law enforcement agencies relating to the strategy, including an evaluation of Federal technical and financial assistance, infrastructure capacity building, and interoperability deficiencies.

(4) Classified information

Any contents of the National Drug Control Strategy that involve information properly classified under criteria established by an Executive order shall be presented to Congress separately from the rest of the National Drug Control Strategy.

(5) Selection of data and information

In selecting data and information for inclusion in the Strategy, the Director shall ensure—

(A) the inclusion of data and information that will permit analysis of current trends against previously compiled data and information where the Director believes such analysis enhances long-term assessment of the National Drug Control Strategy; and

(B) the inclusion of data and information to permit a standardized and uniform assessment of the effectiveness of drug treatment programs in the United States.

(d) Submission of revised Strategy

The President may submit to Congress a revised National Drug Control Strategy that meets the requirements of this section—

(1) at any time, upon a determination of the President, in consultation with the Director, that the National Drug Control Strategy in effect is not sufficiently effective; or

(2) if a new President or Director takes office.

(e) Failure of Director to Submit National Drug Control Strategy

If the Director does not submit a National Drug Control Strategy to Congress in accordance with subsection (a)(2), not later than five days after the first Monday in February following the year in which the term of the President commences, the Director shall send a notification to the appropriate congressional committees—

(1) explaining why the Strategy was not submitted; and

(2) specifying the date by which the Strategy will be submitted.

(f) Drug Control Data Dashboard

(1) In general

The Director shall collect and disseminate, as appropriate, such information as the Director determines is appropriate, but not less than the information described in this subsection. The data shall be publicly available in a machine-readable format on the online portal of the Office, and to the extent practicable on the Drug Control Data Dashboard.

(2) Establishment

The Director shall publish to the online portal of the Office in a machine-readable, sortable, and searchable format, or to the extent practicable, establish and maintain a data dashboard on the online portal of the Office to be known as the "Drug Control Data Dashboard". To the extent practicable, when establishing the Drug Control Dashboard, the Director shall ensure the user interface of the dashboard is constructed with modern design standards. To the extent practicable, the data made available on the dashboard shall be publicly available in a machine-readable format and searchable by year, agency, drug, and location.

(3) Data

The data included in the Drug Control Data Dashboard shall be updated quarterly to the extent practicable, but not less frequently than annually and shall include, at a minimum, the following:

(A) For each substance identified by the Director as having a significant impact on the prevalence of illicit drug use—

(i) data sufficient to show the quantities of such substance available in the United States, including—

(I) the total amount seized and disrupted in the calendar year and each of the previous 3 calendar years, including to the extent practicable the amount seized by State, local, and Tribal governments;

(II) the known and estimated flows into the United States from all sources in the calendar year and each of the previous 3 calendar years;

(III) the total amount of known flows that could not be interdicted or disrupted in the calendar year and each of the previous 3 calendar years;

(IV) the known and estimated levels of domestic production in the calendar year and each of the previous three calendar years, including the levels of domestic production if the drug is a prescription drug, as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], for which a listing is in effect under section 812 of this title;

(V) the average street price for the calendar year and the highest known street price during the preceding 10-year period; and

(VI) to the extent practicable, related prosecutions by State, local, and Tribal governments; ²

(ii) data sufficient to show the frequency of use of such substance, including—

(I) use of such substance in the workplace and productivity lost by such use;

(II) use of such substance by arrestees, probationers, and parolees;

(III) crime and criminal activity related to such substance; and

(IV) to the extent practicable, related prosecutions by State, local, and Tribal governments.

(B) For the calendar year and each of the previous three years data sufficient to show, disaggregated by State and, to the extent feasible, by region within a State, county, or city, the following:

(i) The number of fatal and non-fatal overdoses caused by each drug identified under subparagraph (A)(i).

(ii) The prevalence of substance use disorders.

(iii) The number of individuals who have received substance use disorder treatment, including medication assisted treatment, for a substance use disorder, including treatment provided through publicly-financed health care programs.

(iv) The extent of the unmet need for substance use disorder treatment, including the unmet need for medication-assisted treatment.

(C) Data sufficient to show the extent of prescription drug diversion, trafficking, and misuse in the calendar year and each of the previous 3 calendar years.

(D) Any quantifiable measures the Director determines to be appropriate to detail progress toward the achievement of the goals of the National Drug Control Strategy.

(g) Development of an annual national drug control assessment

(1) Timing

Not later than the first Monday in February of each year, the Director shall submit to the President, Congress, and the appropriate congressional committees, a report assessing the progress of each National Drug Control Program agency toward achieving each goal, objective, and target contained in the National Drug Control Strategy applicable to the prior fiscal year.

(2) Process for development of the annual assessment

Not later than November 1 of each year, the head of each National Drug Control Program agency shall submit, in accordance with guidance issued by the Director, to the Director an evaluation of progress by the agency with respect to the National Drug Control Strategy goals using the performance measures for the agency developed under this chapter, including progress with respect to—

(A) success in achieving the goals of the National Drug Control Strategy;

(B) success in reducing domestic and foreign sources of illegal drugs;

(C) success in expanding access to and increasing the effectiveness of substance use disorder treatment;

(D) success in protecting the borders of the United States (and in particular the Southwestern border of the United States) from penetration by illegal narcotics;

(E) success in reducing crime associated with drug use in the United States;

(F) success in reducing the negative health and social consequences of drug use in the United States;

(G) implementation of evidence-based substance use disorder treatment and prevention programs in the United States and improvements in the adequacy and effectiveness of such programs; and

(H) success in increasing the prevention of illicit drug use.

(3) Contents of the annual assessment

The Director shall include in the annual assessment required under paragraph (1)—

(A) a summary of each evaluation received by the Director under paragraph (2);

(B) a summary of the progress of each National Drug Control Program agency toward the National Drug Control Strategy goals of the agency using the performance measures for the agency developed under this chapter;

(C) an assessment of the effectiveness of each National Drug Control Program agency and program in achieving the National Drug Control Strategy for the previous year, including a specific evaluation of whether the applicable goals, measures, objectives, and targets for the previous year were met; and

(D) the assessments required under this subsection shall be based on the Performance Measurement System.³

(h) Performance measurement system

Not later than February 1 of each year, the Director shall submit to Congress as part of the National Drug Control Strategy, a description of a national drug control performance measurement system, that—

(1) develops 2-year and 5-year performance measures and targets for each National Drug Control Strategy goal and objective established for reducing drug use, availability, and the consequences of drug use;

(2) describes the sources of information and data that will be used for each performance measure incorporated into the performance measurement system;

(3) identifies major programs and activities of the National Drug Control Program agencies that support the goals and annual objectives of the National Drug Control Strategy;

(4) evaluates the contribution of demand reduction and supply reduction activities as defined in section 1701 of this title implemented by each National Drug Control Program agency in support of the National Drug Control Strategy;

(5) monitors consistency between the drug-related goals and objectives of the National Drug Control Program agencies and ensures that each agency's goals and budgets support and are fully consistent with the National Drug Control Strategy;

(6) coordinates the development and implementation of national drug control data collection and reporting systems to support policy formulation and performance measurement, including an assessment of—

(A) the quality of current drug use measurement instruments and techniques to measure supply reduction and demand reduction activities;

(B) the adequacy of the coverage of existing national drug use measurement instruments and techniques to measure the illicit drug user population, and groups that are at risk for illicit drug use;

(C) the adequacy of the coverage of existing national treatment outcome monitoring systems to measure the effectiveness of drug abuse treatment in reducing illicit drug use and criminal behavior during and after the completion of substance abuse treatment; and

(D) the actions the Director shall take to correct any deficiencies and limitations identified pursuant to subparagraphs (A) and (B) of this subsection; and

(7) develops performance measures and targets for the National Drug Control Strategy for supplemental strategies (the Southwest Border, Northern Border, and Caribbean Border Counternarcotics Strategies) to effectively evaluate region-specific goals, to the extent the performance measurement system does not adequately measure the effectiveness of the strategies, as determined by the Director, such strategies may evaluate interdiction efforts at and between ports of entry, interdiction technology, intelligence sharing, diplomacy, and other appropriate metrics, specific to each supplemental strategies region, as determined by the Director.

(i) Modifications

A description of any modifications made during the preceding year to the national drug performance measurement system described in subsection (c) ⁴ shall be included in each report submitted under subsection (b).⁵

(Pub. L. 105–277, div. C, title VII, §§706, 715, Oct. 21, 1998, 112 Stat. 2681–681, 2681-693; Pub. L. 109–469, title II, §§201, 202, title VI, §602, Dec. 29, 2006, 120 Stat. 3513, 3517, 3533; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8221(a), Oct. 24, 2018, 132 Stat. 4110, 4134; Pub. L. 116–74, §2(a)(1), (2), (c)(1)(B), (d), Nov. 27, 2019, 133 Stat. 1155, 1158; Pub. L. 117–263, div. E, title LIII, §5302, Dec. 23, 2022, 136 Stat. 3249.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (f)(3)(A)(i)(IV), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This chapter, referred to in subsec. (g)(2), (3)(B), was in the original "this title", meaning title VII of div. C of Pub. L. 105–277, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out under section 1701 of this title and Tables.

Amendments

2022—Subsec. (h)(7). Pub. L. 117–263 added par. (7).

2019—Pub. L. 116–74, §2(c)(1)(B), amended directory language of Pub. L. 115–271, §8221(a). See 2018 Amendment note below.

Pub. L. 116–74, §2(a)(2), substituted "National Drug Control Program agencies" for "National Drug Control Program Agencies" wherever appearing.

Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency" wherever appearing.

Subsec. (c)(1)(N)(ii). Pub. L. 116–74, §2(d)(1)(A), substituted "Program agencies" for "Programs".

Subsec. (c)(1)(N)(iii). Pub. L. 116–74, §2(d)(1)(B), substituted "Program agencies" for "Agencies".

Subsec. (c)(2). Pub. L. 116–74, §2(d)(2), substituted "paragraph (1)(M)" for "paragraph (1)" in introductory provisions.

Subsec. (f)(2). Pub. L. 116–74, §2(d)(3)(A), substituted "Office" for "office".

Subsec. (f)(3)(A)(ii)(III). Pub. L. 116–74, §2(d)(3)(B)(i), substituted "substance; and" for "substance;".

Subsec. (f)(3)(A)(ii)(IV). Pub. L. 116–74, §2(d)(3)(B)(ii), substituted "governments." for "governments;".

Subsec. (g)(3)(B). Pub. L. 116–74, §2(d)(4), made technical amendment to reference in original act which appears in text as reference to this chapter.

2018—Pub. L. 115–271, §8221(a), as amended by Pub. L. 116–74, §2(c)(1)(B)(ii), added subsecs. (a) to (g), redesignated former subsecs. (c) and (d) as (h) and (i), respectively, and struck out former subsecs. (a) and (b) which related to submission of the National Drug Control Strategy and submission of a revised strategy.

Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Pub. L. 109–469, §201, amended section generally. Prior to amendment, section related to development, submission, implementation, and assessment of National Drug Control Strategy.

Subsecs. (c), (d). Pub. L. 109–469, §202, added subsecs. (c) and (d).

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by section 2(c)(1)(B) of Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

Requirement for Southwest Border Counternarcotics Strategy

Pub. L. 109–469, title XI, §1110, Dec. 29, 2006, 120 Stat. 3543, which directed the Director of National Drug Control Policy to submit to Congress every two years a Southwest Border Counternarcotics Strategy, was repealed by Pub. L. 115–271, title VIII, §8221(b)(2), Oct. 24, 2018, 132 Stat. 4142. See subsection (c)(3)(B) of this section.

Requirement for Northern Border Counternarcotics Strategy

Pub. L. 109–469, title XI, §1110A, as added by Pub. L. 111–356, §2, Jan. 4, 2011, 124 Stat. 3976, which directed the Director of National Drug Control Policy to develop, in consultation with the head of each relevant National Drug Control Program Agency, and to submit to Congress every two years, a Northern Border Counternarcotics Strategy, was repealed by Pub. L. 115–271, title VIII, §8221(b)(2), Oct. 24, 2018, 132 Stat. 4142. See subsection (c)(3)(C) of this section.

¹ So in original. The comma probably should not appear.

² So in original. Probably should be followed by "and".

³ So in original.

⁴ Probably should be "(h)".

⁵ Probably should be "(d)".

§1706. High Intensity Drug Trafficking Areas Program

(a) Establishment

(1) In general

There is established in the Office a program to be known as the High Intensity Drug Trafficking Areas Program (in this section referred to as the "Program").

(2) Purpose

The purpose of the Program is to reduce drug trafficking and drug production in the United States by—

(A) facilitating cooperation among Federal, State, local, and tribal law enforcement agencies to share information and implement coordinated enforcement activities;

(B) enhancing law enforcement intelligence sharing among Federal, State, local, and tribal law enforcement agencies;

(C) providing reliable law enforcement intelligence to law enforcement agencies needed to design effective enforcement strategies and operations; and

(D) supporting coordinated law enforcement strategies which maximize use of available resources to reduce the supply of illegal drugs in designated areas and in the United States as a whole.

(b) Designation

(1) In general

The Director, in consultation with the Attorney General, the Secretary of the Treasury, the Secretary of Homeland Security, heads of the National Drug Control Program agencies, and the Governor of each applicable State, may designate any specified area of the United States as a high intensity drug trafficking area.

(2) Activities

After making a designation under paragraph (1) and in order to provide Federal assistance to the area so designated, the Director may—

(A) obligate such sums as are appropriated for the Program;

(B) direct the temporary reassignment of Federal personnel to such area, subject to the approval of the head of the department or agency that employs such personnel;

(C) take any other action authorized under section 1703 of this title to provide increased Federal assistance to those areas; and

(D) coordinate activities under this section (specifically administrative, recordkeeping, and funds management activities) with State, local, and tribal officials.

(c) Petitions for designation

The Director shall establish regulations under which a coalition of interested law enforcement agencies from an area may petition for designation as a high intensity drug trafficking area. Such regulations shall provide for a regular review by the Director of the petition, including a recommendation regarding the merit of the petition to the Director by a panel of qualified, independent experts.

(d) Factors for consideration

In considering whether to designate an area under this section as a high intensity drug trafficking area, the Director shall consider, in addition to such other criteria as the Director considers to be appropriate, the extent to which—

(1) the area is a significant center of illegal drug production, manufacturing, importation, or distribution;

(2) State, local, and tribal law enforcement agencies have committed resources to respond to the drug trafficking problem in the area, thereby indicating a determination to respond aggressively to the problem;

(3) drug-related activities in the area are having a significant harmful impact in the area, and in other areas of the country; and

(4) a significant increase in allocation of Federal resources is necessary to respond adequately to drug-related activities in the area.

(e) Organization of high intensity drug trafficking areas

(1) Executive Board and officers

To be eligible for funds appropriated under this section, each high intensity drug trafficking area shall be governed by an Executive Board. The Executive Board shall designate a chairman, vice chairman, and any other officers to the Executive Board that it determines are necessary.

(2) Responsibilities

The Executive Board of a high intensity drug trafficking area shall be responsible for—

(A) providing direction and oversight in establishing and achieving the goals of the high intensity drug trafficking area;

(B) managing the funds of the high intensity drug trafficking area;

(C) reviewing and approving all funding proposals consistent with the overall objective of the high intensity drug trafficking area; and

(D) reviewing and approving all reports to the Director on the activities of the high intensity drug trafficking area.

(3) Board representation

None of the funds appropriated under this section may be expended for any high intensity drug trafficking area, or for a partnership or region of a high intensity drug trafficking area, if the Executive Board for such area, region, or partnership, does not apportion an equal number of votes between representatives of participating Federal agencies and representatives of participating State, local, and tribal agencies. Where it is impractical for an equal number of representatives of Federal agencies and State, local, and tribal agencies to attend a meeting of an Executive Board in person, the Executive Board may use a system of proxy votes or weighted votes to achieve the voting balance required by this paragraph.

(4) No agency relationship

The eligibility requirements of this section are intended to ensure the responsible use of Federal funds. Nothing in this section is intended to create an agency relationship between individual high intensity drug trafficking areas and the Federal Government.

(f) Use of funds

The Director shall ensure that not more than a total of 5 percent of Federal funds appropriated for the Program are expended for substance use disorder treatment programs and drug prevention programs.

(g) Counterterrorism activities

(1) Assistance authorized

The Director may authorize use of resources available for the Program to assist Federal, State, local, and tribal law enforcement agencies in investigations and activities related to terrorism and prevention of terrorism, especially but not exclusively with respect to such investigations and activities that are also related to drug trafficking.

(2) Limitation

The Director shall ensure—

(A) that assistance provided under paragraph (1) remains incidental to the purpose of the Program to reduce drug availability and carry out drug-related law enforcement activities; and

(B) that significant resources of the Program are not redirected to activities exclusively related to terrorism, except on a temporary basis under extraordinary circumstances, as determined by the Director.

(h) Role of Drug Enforcement Administration

The Director, in consultation with the Attorney General, shall ensure that a representative of the Drug Enforcement Administration is included in the Intelligence Support Center for each high intensity drug trafficking area.

(i) Annual HIDTA Program budget submissions

As part of the documentation that supports the President's annual budget request for the Office, the Director shall submit to Congress a budget justification that includes—

(1) the amount proposed for each high intensity drug trafficking area, conditional upon a review by the Office of the request submitted by the HIDTA and the performance of the HIDTA, with supporting narrative descriptions and rationale for each request;

(2) a detailed justification that explains—

(A) the reasons for the proposed funding level; how such funding level was determined based on a current assessment of the drug trafficking threat in each high intensity drug trafficking area;

(B) how such funding will ensure that the goals and objectives of each such area will be achieved; and

(C) how such funding supports the National Drug Control Strategy; and

(3) the amount of HIDTA funds used to investigate and prosecute organizations and individuals trafficking in methamphetamine in the prior calendar year, and a description of how those funds were used.

(j) Emerging threat response fund

(1) In general

Subject to the availability of appropriations, the Director may expend up to 10 percent of the amounts appropriated under this section on a discretionary basis, to respond to any emerging drug trafficking threat in an existing high intensity drug trafficking area, or to establish a new high intensity drug trafficking area or expand an existing high intensity drug trafficking area, in accordance with the criteria established under paragraph (2).

(2) Consideration of impact

In allocating funds under this subsection, the Director shall consider—

(A) the impact of activities funded on reducing overall drug traffic in the United States, or minimizing the probability that an emerging drug trafficking threat will spread to other areas of the United States; and

(B) such other criteria as the Director considers appropriate.

(k) Evaluation

(1) Initial report

Not later than 90 days after December 29, 2006, the Director shall, after consulting with the Executive Boards of each designated high intensity drug trafficking area, submit a report to Congress that describes, for each designated high intensity drug trafficking area—

(A) the specific purposes for the high intensity drug trafficking area;

(B) the specific long-term and short-term goals and objectives for the high intensity drug trafficking area;

(C) the measurements that will be used to evaluate the performance of the high intensity drug trafficking area in achieving the long-term and short-term goals; and

(D) the reporting requirements needed to evaluate the performance of the high intensity drug trafficking area in achieving the long-term and short-term goals.

(2) Evaluation of HIDTA Program as part of National Drug Control Strategy

For each designated high intensity drug trafficking area, the Director shall submit, as part of the annual National Drug Control Strategy report, a report that—

(A) describes—

(i) the specific purposes for the high intensity drug trafficking area; and

(ii) the specific long-term and short-term goals and objectives for the high intensity drug trafficking area; and

(B) includes an evaluation of the performance of the high intensity drug trafficking area in accomplishing the specific long-term and short-term goals and objectives identified under paragraph (1)(B).

(l) Assessment of drug enforcement task forces in high intensity drug trafficking areas

Not later than 1 year after December 29, 2006, and as part of each subsequent annual National Drug Control Strategy report, the Director shall submit to Congress a report—

(1) assessing the number and operation of all federally funded drug enforcement task forces within each high intensity drug trafficking area; and

(2) describing—

(A) each Federal, State, local, and tribal drug enforcement task force operating in the high intensity drug trafficking area;

(B) how such task forces coordinate with each other, with any high intensity drug trafficking area task force, and with investigations receiving funds from the Organized Crime and Drug Enforcement Task Force;

(C) what steps, if any, each such task force takes to share information regarding drug trafficking and drug production with other federally funded drug enforcement task forces in the high intensity drug trafficking area;

(D) the role of the high intensity drug trafficking area in coordinating the sharing of such information among task forces;

(E) the nature and extent of cooperation by each Federal, State, local, and tribal participant in ensuring that such information is shared among law enforcement agencies and with the high intensity drug trafficking area;

(F) the nature and extent to which information sharing and enforcement activities are coordinated with joint terrorism task forces in the high intensity drug trafficking area; and

(G) any recommendations for measures needed to ensure that task force resources are utilized efficiently and effectively to reduce the availability of illegal drugs in the high intensity drug trafficking areas.

(m) Assessment of law enforcement intelligence sharing in High Intensity Drug Trafficking Areas Program

Not later than 180 days after December 29, 2006, and as part of each subsequent annual National Drug Control Strategy report, the Director, in consultation with the Director of National Intelligence, shall submit to Congress a report—

(1) evaluating existing and planned law enforcement intelligence systems supported by each high intensity drug trafficking area, or utilized by task forces receiving any funding under the Program, including the extent to which such systems ensure access and availability of law enforcement intelligence to Federal, State, local, and tribal law enforcement agencies within the high intensity drug trafficking area and outside of it;

(2) the extent to which Federal, State, local, and tribal law enforcement agencies participating in each high intensity drug trafficking area are sharing law enforcement intelligence information to assess current drug trafficking threats and design appropriate enforcement strategies; and

(3) the measures needed to improve effective sharing of information and law enforcement intelligence regarding drug trafficking and drug production among Federal, State, local, and tribal law enforcement participating in a high intensity drug trafficking area, and between such agencies and similar agencies outside the high intensity drug trafficking area.

(n) Coordination of Law enforcement intelligence sharing with Organized Crime Drug Enforcement Task Force program

The Director, in consultation with the Attorney General, shall ensure that any drug enforcement intelligence obtained by the Intelligence Support Center for each high intensity drug trafficking area is shared, on a timely basis, with the drug intelligence fusion center operated by the Organized Crime Drug Enforcement Task Force of the Department of Justice.

(o) Use of funds to combat methamphetamine trafficking

(1) Requirement

As part of the documentation that supports the President's annual budget request for the Office, the Director shall submit to Congress a report describing the use of HIDTA funds to investigate and prosecute organizations and individuals trafficking in methamphetamine in the prior calendar year.

(2) Contents

The report shall include—

(A) the number of methamphetamine manufacturing facilities discovered through HIDTA-funded initiatives in the previous fiscal year;

(B) the amounts of methamphetamine or listed chemicals (as that term is defined in section 802(33) of this title) seized by HIDTA-funded initiatives in the area during the previous year; and

(C) law enforcement intelligence and predictive data from the Drug Enforcement Administration showing patterns and trends in abuse, trafficking, and transportation in methamphetamine and listed chemicals.

(3) Certification

Before the Director awards any funds to a high intensity drug trafficking area, the Director shall certify that the law enforcement entities participating in that HIDTA are providing laboratory seizure data to the national clandestine laboratory database at the El Paso Intelligence Center.

(p) Authorization of appropriations

There is authorized to be appropriated to the Office of National Drug Control Policy to carry out this section—

(1) $240,000,000 for fiscal year 2007;

(2) $250,000,000 for fiscal year 2008;

(3) $260,000,000 for fiscal year 2009;

(4) $270,000,000 for fiscal year 2010;

(5) $280,000,000 for each of ¹ fiscal year 2011; and

(6) $280,000,000 for each of fiscal years 2018 through 2023.

(q) Specific purposes

(1) In general

The Director shall ensure that, of the amounts appropriated for a fiscal year for the Program, at least $7,000,000 is used in high intensity drug trafficking areas with severe neighborhood safety and illegal drug distribution problems.

(2) Required uses

The funds used under paragraph (1) shall be used to ensure the safety of neighborhoods and the protection of communities, including the prevention of the intimidation of witnesses of illegal drug distribution and related activities and the establishment of, or support for, programs that provide protection or assistance to witnesses in court proceedings.

(3) Best practice models

The Director shall work with HIDTAs to develop and maintain best practice models to assist State, local, and Tribal governments in addressing witness safety, relocation, financial and housing assistance, or any other services related to witness protection or assistance in cases of illegal drug distribution and related activities. The Director shall ensure dissemination of the best practice models to each HIDTA.

(r) Drug overdose response strategy implementation

The Director may use funds appropriated to carry out this section to implement a drug overdose response strategy in high intensity drug trafficking areas on a nationwide basis by—

(1) coordinating multi-disciplinary efforts to prevent, reduce, and respond to drug overdoses, including the uniform reporting of fatal and non-fatal overdoses to public health and safety officials;

(2) increasing data sharing among public safety and public health officials concerning drug-related abuse trends, including new psychoactive substances, and related crime; and

(3) enabling collaborative deployment of prevention, intervention, and enforcement resources to address substance use addiction and narcotics trafficking.

(s) Supplemental grants

The Director is authorized to use not more than $10,000,000 of the amounts otherwise appropriated to carry out this section to provide supplemental competitive grants to high intensity drug trafficking areas that have experienced high seizures of fentanyl and new psychoactive substances for the purposes of—

(1) purchasing portable equipment to test for fentanyl and other substances;

(2) training law enforcement officers and other first responders on best practices for handling fentanyl and other substances; and

(3) purchasing protective equipment, including overdose reversal drugs.

(Pub. L. 105–277, div. C, title VII, §§707, 715, Oct. 21, 1998, 112 Stat. 2681–686, 2681-693; Pub. L. 109–469, title III, §§301, §302(c), title VI, §602, Dec. 29, 2006, 120 Stat. 3518, 3525, 3533; Pub. L. 115–271, title VIII, §§8202(a), 8202(b)(2), 8205, 8208, 8209, Oct. 24, 2018, 132 Stat. 4110, 4113, 4114; Pub. L. 116–74, §2(a)(7), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

References in Text

December 29, 2006, referred to in subsecs. (k)(1), (l), and (m) was in the original "the date of the enactment of this section", which was translated as meaning the date of enactment of Pub. L. 109–469, which amended this section generally, to reflect the probable intent of Congress.

Amendments

2019—Subsec. (o)(2)(B). Pub. L. 116–74 substituted "802(33) of this title)" for "802(33) of this title".

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

Subsec. (f). Pub. L. 115–271, §8205(1), substituted "not more than a total of 5 percent of Federal funds appropriated for the Program are expended for substance use disorder treatment programs and drug prevention programs." for "no Federal funds appropriated for the Program are expended for the establishment or expansion of drug treatment programs, and shall ensure that not more than 5 percent of the Federal funds appropriated for the Program are expended for the establishment of drug prevention programs."

Subsec. (p)(6). Pub. L. 115–271, §8205(2), added par. (6).

Subsec. (q)(2). Pub. L. 115–271, §8205(3)(A), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: "The funds used under paragraph (1) shall be used—

"(A) to ensure the safety of neighborhoods and the protection of communities, including the prevention of the intimidation of potential witnesses of illegal drug distribution and related activities; and

"(B) to combat illegal drug trafficking through such methods as the Director considers appropriate, such as establishing or operating (or both) a toll-free telephone hotline for use by the public to provide information about illegal drug-related activities."

Subsec. (q)(3). Pub. L. 115–271, §8205(3)(B), added par. (3).

Subsec. (r). Pub. L. 115–271, §8208, added subsec. (r).

Subsec. (s). Pub. L. 115–271, §8209, added subsec. (s).

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Pub. L. 109–469, §301, amended section generally. Prior to amendment, section related to the High Intensity Drug Trafficking Areas Program.

Subsec. (q). Pub. L. 109–469, §302(c), added subsec. (q).

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Findings

Pub. L. 109–469, title III, §302(b), Dec. 29, 2006, 120 Stat. 3524, provided that: "Congress finds the following:

"(1) In the early morning hours of October 16, 2002, the home of Carnell and Angela Dawson was firebombed in apparent retaliation for Mrs. Dawson's notification to police about persistent drug distribution activity in their East Baltimore City neighborhood.

"(2) The arson claimed the lives of Mr. and Mrs. Dawson and their 5 young children, aged 9 to 14.

"(3) The horrific murder of the Dawson family is a stark example of domestic narco-terrorism.

"(4) In all phases of counternarcotics law enforcement—from prevention to investigation to prosecution to reentry—the voluntary cooperation of ordinary citizens is a critical component.

"(5) Voluntary cooperation is difficult for law enforcement officials to obtain when citizens feel that cooperation carries the risk of violent retaliation by illegal drug trafficking organizations and their affiliates.

"(6) Public confidence that law enforcement is doing all it can to make communities safe is a prerequisite for voluntary cooperation among people who may be subject to intimidation or reprisal (or both).

"(7) Witness protection programs are insufficient on their own to provide security because many individuals and families who strive every day to make distressed neighborhoods livable for their children, other relatives, and neighbors will resist or refuse offers of relocation by local, State, and Federal prosecutorial agencies and because, moreover, the continued presence of strong individuals and families is critical to preserving and strengthening the social fabric in such communities.

"(8) Where (as in certain sections of Baltimore City) interstate trafficking of illegal drugs has severe ancillary local consequences within areas designated as high intensity drug trafficking areas, it is important that supplementary High Intensity Drug Trafficking Areas Program funds be committed to support initiatives aimed at making the affected communities safe for the residents of those communities and encouraging their cooperation with tribal, local, State, and Federal law enforcement efforts to combat illegal drug trafficking."

Combating Methamphetamine and Amphetamine in High Intensity Drug Trafficking Areas

Pub. L. 106–310, div. B, title XXXVI, §3624, Oct. 17, 2000, 114 Stat. 1232, provided that:

"(a) In General.—

"(1) In general.—The Director of National Drug Control Policy shall use amounts available under this section to combat the trafficking of methamphetamine and amphetamine in areas designated by the Director as high intensity drug trafficking areas.

"(2) Activities.—In meeting the requirement in paragraph (1), the Director shall transfer funds to appropriate Federal, State, and local governmental agencies for employing additional Federal law enforcement personnel, or facilitating the employment of additional State and local law enforcement personnel, including agents, investigators, prosecutors, laboratory technicians, chemists, investigative assistants, and drug-prevention specialists.

"(b) Authorization of Appropriations.—There is authorized to be appropriated to carry out this section—

"(1) $15,000,000 for fiscal year 2000; and

"(2) such sums as may be necessary for each of fiscal years 2001 through 2004.

"(c) Apportionment of Funds.—

"(1) Factors in apportionment.—The Director shall apportion amounts appropriated for a fiscal year pursuant to the authorization of appropriations in subsection (b) for activities under subsection (a) among and within areas designated by the Director as high intensity drug trafficking areas based on the following factors:

"(A) The number of methamphetamine manufacturing facilities and amphetamine manufacturing facilities discovered by Federal, State, or local law enforcement officials in the previous fiscal year.

"(B) The number of methamphetamine prosecutions and amphetamine prosecutions in Federal, State, or local courts in the previous fiscal year.

"(C) The number of methamphetamine arrests and amphetamine arrests by Federal, State, or local law enforcement officials in the previous fiscal year.

"(D) The amounts of methamphetamine, amphetamine, or listed chemicals (as that term is defined in section 102(33) of the Controlled Substances Act (21 U.S.C. 802(33)) seized by Federal, State, or local law enforcement officials in the previous fiscal year.

"(E) Intelligence and predictive data from the Drug Enforcement Administration and the Department of Health and Human Services showing patterns and trends in abuse, trafficking, and transportation in methamphetamine, amphetamine, and listed chemicals (as that term is so defined).

"(2) Certification.—Before the Director apportions any funds under this subsection to a high intensity drug trafficking area, the Director shall certify that the law enforcement entities responsible for clandestine methamphetamine and amphetamine laboratory seizures in that area are providing laboratory seizure data to the national clandestine laboratory database at the El Paso Intelligence Center.

"(d) Limitation on Administrative Costs.—Not more than 5 percent of the amount appropriated in a fiscal year pursuant to the authorization of appropriations for that fiscal year in subsection (b) may be available in that fiscal year for administrative costs associated with activities under subsection (a)."

Funding for High Intensity Drug Trafficking Areas Program

Pub. L. 106–58, title III, Sept. 29, 1999, 113 Stat. 448, provided in part: "That, hereafter, of the amount appropriated for fiscal year 2000 or any succeeding fiscal year for the High Intensity Drug Trafficking Areas Program, the funds to be obligated or expended during such fiscal year for programs addressing the treatment or prevention of drug use as part of the approved strategy for a designated High Intensity Drug Trafficking Area (HIDTA) shall not be less than the funds obligated or expended for such programs during fiscal year 1999 for each designated HIDTA without the prior approval of the Committees on Appropriations".

¹ So in original.

§1707. Repealed. Pub. L. 115–271, title VIII, §8222(3), Oct. 24, 2018, 132 Stat. 4143

Section, Pub. L. 105–277, div. C, title VII, §§708, 715, Oct. 21, 1998, 112 Stat. 2681–687, 2681-693; Pub. L. 109–469, title IV, §401, title VI, §602, Dec. 29, 2006, 120 Stat. 3525, 3533; Pub. L. 115–271, title VIII, §8202(a), (b)(2), Oct. 24, 2018, 132 Stat. 4110, related to Counter-Drug Technology Assessment Center.

§1708. Emerging Threats Committee, plan, and media campaign

(a) Emerging and Continuing Threats Coordinator

The Director shall designate or appoint a United States Emerging and Continuing Threats Coordinator to perform the duties of that position described in this section and such other duties as may be determined by the Director. For purposes of carrying out the previous sentence, the Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent).

(b) Emerging Threats Committee

(1) In general

The Emerging Threats Committee shall—

(A) monitor evolving and emerging drug threats in the United States;

(B) identify and discuss evolving and emerging drug trends in the United States using the criteria required to be established under paragraph (6);

(C) assist in the formulation of and oversee implementation of any plan described in subsection (d);

(D) provide such other advice to the Coordinator and Director concerning strategy and policies for emerging drug threats and trends as the Committee determines to be appropriate; and

(E) disseminate and facilitate the sharing with Federal, State, local, and Tribal officials and other entities as determined by the Director of pertinent information and data relating to—

(i) recent trends in drug supply and demand;

(ii) fatal and nonfatal overdoses;

(iii) demand for and availability of evidence-based substance use disorder treatment, including the extent of the unmet treatment need, and treatment admission trends;

(iv) recent trends in drug interdiction, supply, and demand from State, local, and Tribal law enforcement agencies; and

(v) other subject matter as determined necessary by the Director.

(2) Chairperson

The Director shall designate one of the members of the Emerging Threats Committee to serve as Chairperson.

(3) Members

The Director shall appoint other members of the Committee, which shall include—

(A) representatives from National Drug Control Program agencies or other agencies;

(B) representatives from State, local, and Tribal governments; and

(C) representatives from other entities as designated by the Director.

(4) Meetings

The members of the Emerging Threats Committee shall meet, in person and not through any delegate or representative, not less frequently than once per calendar year, before June 1. At the call of the Director or the Chairperson, the Emerging Threats Committee may hold additional meetings as the members may choose.

(5) Contract, agreement, and other authority

The Director may award contracts, enter into interagency agreements, manage individual projects, and conduct other activities in support of the identification of emerging drug threats and in support of the development, implementation, and assessment of any Emerging Threat Response Plan.

(6) Criteria to identify emerging drug threats

Not later than 180 days after the date on which the Committee first meets, the Committee shall develop and recommend to the Director criteria to be used to identify an emerging drug threat or the termination of an emerging drug threat designation based on information gathered by the Committee, statistical data, and other evidence.

(c) Designation

(1) In general

The Director, in consultation with the Coordinator, the Committee, and the head of each National Drug Control Program agency, may designate an emerging drug threat in the United States.

(2) Standards for designation

The Director, in consultation with the Coordinator, shall promulgate and make publicly available standards by which a designation under paragraph (1) and the termination of such designation may be made. In developing such standards, the Director shall consider the recommendations of the committee and other criteria the Director considers to be appropriate.

(3) Public statement required

The Director shall publish a public written statement on the portal of the Office explaining the designation of an emerging drug threat or the termination of such designation and shall notify the appropriate congressional committees of the availability of such statement when a designation or termination of such designation has been made.

(d) Plan

(1) Public availability of plan

Not later than 90 days after making a designation under subsection (c), the Director shall publish and make publicly available an Emerging Threat Response Plan and notify the President and the appropriate congressional committees of such plan's availability.

(2) Timing

Concurrently with the annual submissions under section 1705(g) of this title, the Director shall update the plan and report on implementation of the plan, until the Director issues the public statement required under subsection (c)(3) to terminate the emerging drug threat designation.

(3) Contents of an emerging threat response plan

The Director shall include in the plan required under this subsection—

(A) a comprehensive strategic assessment of the emerging drug threat, including the current availability of, demand for, and effectiveness of evidence-based prevention, treatment, and enforcement programs and efforts to respond to the emerging drug threat;

(B) comprehensive, research-based, short- and long-term, quantifiable goals for addressing the emerging drug threat, including for reducing the supply of the drug designated as the emerging drug threat and for expanding the availability and effectiveness of evidence-based substance use disorder treatment and prevention programs to reduce the demand for the emerging drug threat;

(C) performance measures pertaining to the plan's goals, including quantifiable and measurable objectives and specific targets;

(D) the level of funding needed to implement the plan, including whether funding is available to be reprogrammed or transferred to support implementation of the plan or whether additional appropriations are necessary to implement the plan;

(E) an implementation strategy for the media campaign under subsection (f), including goals as described under subparagraph (B) of this paragraph and performance measures, objectives, and targets, as described under subparagraph (C) of this paragraph; and

(F) any other information necessary to inform the public of the status, progress, or response to an emerging drug threat.

(4) Implementation

(A) In general

Not later than 120 days after the date on which a designation is made under subsection (c), the Director, in consultation with the President, the appropriate congressional committees, and the head of each National Drug Control Program agency, shall issue guidance on implementation of the plan described in this subsection to the National Drug Control Program agencies and any other relevant agency determined to be necessary by the Director.

(B) Coordinator's responsibilities

The Coordinator shall—

(i) direct the implementation of the plan among the agencies identified in the plan, State, local, and Tribal governments, and other relevant entities;

(ii) facilitate information-sharing between agencies identified in the plan, State, local, and Tribal governments, and other relevant entities; and

(iii) monitor implementation of the plan by coordinating the development and implementation of collection and reporting systems to support performance measurement and adherence to the plan by agencies identified in the plan, where appropriate.

(C) Reporting

Not later than 180 days after the date on which a designation is made under subsection (c) and in accordance with subparagraph (A), the head of each agency identified in the plan shall submit to the Coordinator a report on implementation of the plan.

(e) Evaluation of media campaign

Upon designation of an emerging drug threat, the Director shall evaluate whether a media campaign would be appropriate to address that threat.

(f) National anti-drug media campaign

(1) In general

The Director shall, to the extent feasible and appropriate, conduct a national anti-drug media campaign (referred to in this subsection as the "national media campaign") in accordance with this subsection for the purposes of—

(A) preventing substance abuse among people in the United States;

(B) educating the public about the dangers and negative consequences of substance use and abuse, including patient and family education about the characteristics and hazards of substance abuse and methods to safeguard against substance use, to include the safe disposal of prescription medications;

(C) supporting evidence-based prevention programs targeting the attitudes, perception, and beliefs of persons concerning substance use and intentions to initiate or continue such use;

(D) encouraging individuals affected by substance use disorders to seek treatment and providing such individuals with information on—

(i) how to recognize addiction issues;

(ii) what forms of evidence-based treatment options are available; and

(iii) how to access such treatment;

(E) combating the stigma of addiction and substance use disorders, including the stigma of treating such disorders with medication-assisted treatment therapies; and

(F) informing the public about the dangers of any drug identified by the Director as an emerging drug threat as appropriate.

(2) Use of funds

(A) In general

Amounts made available to carry out this subsection for the national media campaign may only be used for the following:

(i) The purchase of media time and space, including the strategic planning for, tracking, and accounting of, such purchases.

(ii) Creative and talent costs, consistent with subparagraph (B)(i).

(iii) Advertising production costs, which may include television, radio, internet, social media, and other commercial marketing venues.

(iv) Testing and evaluation of advertising.

(v) Evaluation of the effectiveness of the national media campaign.

(vi) Costs of contracts to carry out activities authorized by this subsection.

(vii) Partnerships with professional and civic groups, community-based organizations, including faith-based organizations, and government organizations related to the national media campaign.

(viii) Entertainment industry outreach, interactive outreach, media projects and activities, public information, news media outreach, and corporate sponsorship and participation.

(ix) Operational and management expenses.

(B) Specific requirements

(i) Creative services

In using amounts for creative and talent costs under subparagraph (A)(ii), the Director shall use creative services donated at no cost to the Government wherever feasible and may only procure creative services for advertising—

(I) responding to high-priority or emergent campaign needs that cannot timely be obtained at no cost; or

(II) intended to reach a minority, ethnic, or other special audience that cannot reasonably be obtained at no cost.

(ii) Testing and evaluation of advertising

In using amounts for testing and evaluation of advertising under subparagraph (A)(iv), the Director shall test all advertisements prior to use in the national media campaign to ensure that the advertisements are effective with the target audience and meet industry-accepted standards. The Director may waive this requirement for advertisements using no more than 10 percent of the purchase of advertising time purchased under this subsection in a fiscal year and no more than 10 percent of the advertising space purchased under this subsection in a fiscal year, if the advertisements respond to emergent and time-sensitive campaign needs or the advertisements will not be widely utilized in the national media campaign.

(iii) Consultation

For the planning of the campaign under paragraph (1), the Director may consult with—

(I) the head of any appropriate National Drug Control Program agency;

(II) experts on the designated drug;

(III) State, local, and Tribal government officials and relevant agencies;

(IV) communications professionals;

(V) the public; and

(VI) appropriate congressional committees.

(iv) Evaluation of effectiveness of national media campaign

In using amounts for the evaluation of the effectiveness of the national media campaign under subparagraph (A)(v), the Director shall—

(I) designate an independent entity to evaluate by April 20 of each year the effectiveness of the national media campaign based on data from—

(aa) the Monitoring the Future Study published by the Department of Health and Human Services;

(bb) the National Survey on Drug Use and Health; and

(cc) other relevant studies or publications, as determined by the Director, including tracking and evaluation data collected according to marketing and advertising industry standards; and

(II) ensure that the effectiveness of the national media campaign is evaluated in a manner that enables consideration of whether the national media campaign has contributed to changes in attitude or behaviors among the target audience with respect to substance use and such other measures of evaluation as the Director determines are appropriate.

(3) Advertising

In carrying out this subsection, the Director shall ensure that sufficient funds are allocated to meet the stated goals of the national media campaign.

(4) Responsibilities and functions under the program

(A) In general

The Director shall determine the overall purposes and strategy of the national media campaign.

(B) Director

(i) In general

The Director shall approve—

(I) the strategy of the national media campaign;

(II) all advertising and promotional material used in the national media campaign; and

(III) the plan for the purchase of advertising time and space for the national media campaign.

(ii) Implementation

The Director shall be responsible for implementing a focused national media campaign to meet the purposes set forth in paragraph (1) and shall ensure—

(I) information disseminated through the campaign is accurate and scientifically valid; and

(II) the campaign is designed using strategies demonstrated to be the most effective at achieving the goals and requirements of paragraph (1), which may include—

(aa) a media campaign, as described in paragraph (2);

(bb) local, regional, or population specific messaging;

(cc) the development of websites to publicize and disseminate information;

(dd) conducting outreach and providing educational resources for parents;

(ee) collaborating with law enforcement agencies; and

(ff) providing support for school-based public health education classes to improve teen knowledge about the effects of substance use.

(5) Prohibitions

None of the amounts made available under paragraph (2) may be obligated or expended for any of the following:

(A) To supplant current anti-drug community-based coalitions.

(B) To supplant pro bono public service time donated by national and local broadcasting networks for other public service campaigns.

(C) For partisan political purposes, or to express advocacy in support of or to defeat any clearly identified candidate, clearly identified ballot initiative, or clearly identified legislative or regulatory proposal.

(D) To fund advertising that features any elected officials, persons seeking elected office, cabinet level officials, or other Federal officials employed pursuant to section 213 of Schedule C of title 5, Code of Federal Regulations.

(E) To fund advertising that does not contain a primary message intended to reduce or prevent substance use.

(F) To fund advertising containing a primary message intended to promote support for the national media campaign or private sector contributions to the national media campaign.

(6) Matching requirement

(A) In general

Amounts made available under paragraph (2) for media time and space shall be matched by an equal amount of non-Federal funds for the national media campaign, or be matched with in-kind contributions of the same value.

(B) No-cost match advertising direct relationship requirement

The Director shall ensure that not less than 85 percent of no-cost match advertising directly relates to substance abuse prevention consistent with the specific purposes of the national media campaign.

(C) No-cost match advertising not directly related

The Director shall ensure that no-cost match advertising that does not directly relate to substance abuse prevention consistent with the purposes of the national media campaign includes a clear anti-drug message. Such message is not required to be the primary message of the match advertising.

(7) Financial and performance accountability

The Director shall cause to be performed—

(A) audits and reviews of costs of the national media campaign pursuant to section 4706 of title 41; and

(B) an audit to determine whether the costs of the national media campaign are allowable under chapter 43 of title 41.

(8) Report to Congress

The Director shall submit on an annual basis a report to Congress that describes—

(A) the strategy of the national media campaign and whether specific objectives of the national media campaign were accomplished;

(B) steps taken to ensure that the national media campaign operates in an effective and efficient manner consistent with the overall strategy and focus of the national media campaign;

(C) plans to purchase advertising time and space;

(D) policies and practices implemented to ensure that Federal funds are used responsibly to purchase advertising time and space and eliminate the potential for waste, fraud, and abuse;

(E) all contracts entered into with a corporation, partnership, or individual working on behalf of the national media campaign;

(F) the results of any financial audit of the national media campaign;

(G) a description of any evidence used to develop the national media campaign;

(H) specific policies and steps implemented to ensure compliance with this section;

(I) a detailed accounting of the amount of funds obligated during the previous fiscal year for carrying out the national media campaign, including each recipient of funds, the purpose of each expenditure, the amount of each expenditure, any available outcome information, and any other information necessary to provide a complete accounting of the funds expended; and

(J) a review and evaluation of the effectiveness of the national media campaign strategy for the past year.

(9) Required notice for communication from the Office

Any communication, including an advertisement, paid for or otherwise disseminated by the Office directly or through a contract awarded by the Office shall include a prominent notice informing the audience that the communication was paid for by the Office.

(g) Authorization of appropriations

There is authorized to be appropriated to the Office to carry out this section, $25,000,000 for each of fiscal years 2018 through 2023.

(Pub. L. 105–277, div. C, title VII, §§709, 715, Oct. 21, 1998, 112 Stat. 2681–688, 2681-693; Pub. L. 109–469, title V, §501(a), title VI, §602, Dec. 29, 2006, 120 Stat. 3527, 3533; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8218(a), Oct. 24, 2018, 132 Stat. 4110, 4125; Pub. L. 116–74, §2(a)(1), (2), (8), Nov. 27, 2019, 133 Stat. 1155, 1157.)

Editorial Notes

References in Text

The General Schedule, referred to in subsec. (a), is set out under section 5332 of Title 5, Government Organization and Employees.

Amendments

2019—Pub. L. 116–74, §2(a)(2), substituted "National Drug Control Program agencies" for "National Drug Control Program Agencies" wherever appearing.

Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency" wherever appearing.

Subsec. (a). Pub. L. 116–74, §2(a)(8)(A), in heading, inserted "and Continuing" before "Threats", and in text, substituted "For purposes of carrying out the previous sentence, the Director shall designate or appoint an" for "The Director shall determine whether the coordinator position is a noncareer" and "an appointee" for "a career appointee".

Subsec. (d)(3)(F). Pub. L. 116–74, §2(a)(8)(B)(i), substituted "response to" for "response of".

Subsec. (d)(4)(B)(iii). Pub. L. 116–74, §2(a)(8)(B)(ii), inserted "the" before "plan, where".

Subsec. (f)(1). Pub. L. 116–74, §2(a)(8)(C), substituted "subsection" for "chapter".

2018—Pub. L. 115–271, §8218(a), amended section generally. Prior to amendment, section related to national youth anti-drug media campaign.

Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Pub. L. 109–469, §501(a), amended section catchline and text generally. Prior to amendment, section related to the President's Council on Counter-Narcotics.

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Methamphetamine Response

Pub. L. 117–99, Mar. 14, 2022, 136 Stat. 43, provided that:

"SECTION 1. SHORT TITLE.

"This Act may be cited as the 'Methamphetamine Response Act of 2021'.

"SEC. 2. DECLARATION OF EMERGING THREAT.

"(a) In General.—Congress declares methamphetamine an emerging drug threat, as defined in section 702 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701), in the United States.

"(b) Required Emerging Threat Response Plan.—Not later than 90 days after the date of enactment of this Act [Mar. 14, 2022], the Director of the Office of National Drug Control Policy shall establish and implement an Emerging Threat Response Plan that is specific to methamphetamine in accordance with section 709(d) of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1708(d))."

Executive Documents

Ex. Ord. No. 12992. President's Council on Counter-Narcotics

Ex. Ord. No. 12992, Mar. 15, 1996, 61 F.R. 11287, as amended by Ex. Ord. No. 13023, §§2, 3, Nov. 6, 1996, 61 F.R. 57767; Ex. Ord. No. 13284, §8, Jan. 23, 2003, 68 F.R. 4076, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, it is hereby ordered as follows:

Section 1. Establishment. There is established the President's Drug Policy Council ("Council").

Sec. 2. Membership. The Council shall comprise the:

(a) President, who shall serve as Chairman of the Council;

(b) Vice President;

(c) Secretary of State;

(d) Secretary of the Treasury;

(e) Secretary of Defense;

(f) Attorney General;

(g) Secretary of the Interior;

(h) Secretary of Agriculture;

(i) Secretary of Health and Human Services;

(j) Secretary of Housing and Urban Development;

(k) Secretary of Transportation;

(l) Secretary of Education;

(m) Secretary of Veterans Affairs;

(n) Secretary of Homeland Security;

(o) Representative of the United States of America to the United Nations;

(p) Director of the Office of Management and Budget;

(q) Chief of Staff to the President;

(r) Director of National Drug Control Policy;

(s) Director of Central Intelligence;

(t) Assistant to the President for National Security Affairs;

(u) Counsel to the President;

(v) Chairman, Joint Chiefs of Staff;

(w) National Security Advisor to the Vice President; and

(x) Assistant to the President for Domestic Policy.

As applicable, the Council shall also comprise such other officials of the departments and agencies as the President may, from time to time, designate.

Sec. 3. Meetings of the Council. The President, or upon his direction, the Vice President, may convene meetings of the Council. The President shall preside over meetings of the Council, provided that in his absence, the Vice President will preside. The Council will meet at least quarterly.

Sec. 4. Functions. (a) The functions of the Council are to advise and assist the President in: (1) providing direction and oversight for the national drug control strategy, including relating drug control policy to other national security interests and establishing priorities; and (2) ensuring coordination among departments and agencies concerning implementation of the President's national drug control strategy.

(b) The Director of National Drug Control Policy will continue to be the senior drug control policy official in the executive branch and the President's chief drug control policy spokesman.

(c) In matters affecting national security interests, the Director of National Drug Control Policy shall work in conjunction with the Assistant to the President for National Security Affairs.

Sec. 5. Administration. (a) The Council may utilize established or ad hoc committees, task forces, or interagency groups chaired by the Director of National Drug Control Policy or his representative, in carrying out its functions under this order.

(b) The staff of the Office of National Drug Control Policy, in coordination with the staffs of the Vice President and the Assistant to the President for National Security Affairs, shall act as staff for the Council.

(c) All executive departments and agencies shall cooperate with the Council and provide such assistance, information, and advice as the Council may request, to the extent permitted by law.

Ex. Ord. No. 13023. Expanding and Changing Name of President's Council on Counter-Narcotics

Ex. Ord. No. 13023, Nov. 6, 1996, 61 F.R. 57767, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, and in order to change the name of the "President's Council on Counter-Narcotics" to the "President's Drug Policy Council" and to make the Secretaries of the Interior, Agriculture, Health and Human Services, Housing and Urban Development, Education, Veterans Affairs, and the Assistant to the President for Domestic Policy, permanent members of the Council, it is hereby ordered as follows:

Section 1. The Council established by Executive Order 12992 [set out above] shall henceforth be called the "President's Drug Policy Council."

[Secs. 2, 3. Amended Ex. Ord. No. 12992, set out above.]

William J. Clinton.      

§1708a. Repealed. Pub. L. 116–74, §2(b)(1), Nov. 27, 2019, 133 Stat. 1157

Section, Pub. L. 109–469, title II, §203, Dec. 29, 2006, 120 Stat. 3517; Pub. L. 112–234, §2(c), Dec. 28, 2012, 126 Stat. 1624; Pub. L. 115–271, title VIII, §8218(b), Oct. 24, 2018, 132 Stat. 4132, required the Government Accountability Office to conduct and supervise an audit and investigation and prepare and report every 3 years.

§1709. Repealed. Pub. L. 109–469, title XI, §1101(a), Dec. 29, 2006, 120 Stat. 3539

Section, Pub. L. 105–277, div. C, title VII, §710, Oct. 21, 1998, 112 Stat. 2681–689, related to Parents Advisory Council on Youth Drug Abuse.

§1710. Drug Interdiction Coordinator and Committee

(a) United States Interdiction Coordinator

(1) In general

The Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent) as the United States Interdiction Coordinator to perform the duties of that position described in paragraph (2) and such other duties as may be determined by the Director with respect to coordination of efforts to interdict illicit drugs from entering the United States.

(2) Responsibilities

The United States Interdiction Coordinator shall be responsible to the Director for—

(A) coordinating the interdiction activities of the National Drug Control Program agencies to ensure consistency with the National Drug Control Strategy;

(B) on behalf of the Director, developing and issuing, on or before September 1 of each year and in accordance with paragraph (4), a National Interdiction Command and Control Plan to ensure the coordination and consistency described in subparagraph (A);

(C) assessing the sufficiency of assets committed to illicit drug interdiction by the relevant National Drug Control Program agencies; and

(D) advising the Director on the efforts of each National Drug Control Program agency to implement the National Interdiction Command and Control Plan.

(3) Staff

The Director shall assign such permanent staff of the Office as he considers appropriate to assist the United States Interdiction Coordinator to carry out the responsibilities described in paragraph (2), and may request that appropriate National Drug Control Program agencies detail or assign staff to assist in carrying out such responsibilities.

(4) National Interdiction Command and Control Plan

(A) Purposes

The National Interdiction Command and Control Plan shall—

(i) set forth the Government's strategy for drug interdiction;

(ii) state the specific roles and responsibilities of the relevant National Drug Control Program agencies for implementing that strategy; and

(iii) identify the specific resources required to enable the relevant National Drug Control Program agencies to implement that strategy.

(B) Consultation with other agencies

Before submission of the National Drug Control Strategy or annual assessment required under section 1705 of this title, as applicable, the United States Interdiction Coordinator shall issue the National Interdiction Command and Control Plan in consultation with the other members of the Interdiction Committee described in subsection (b).

(C) Report to Congress

On or before September 1 of each year, the Director, acting through the United States Interdiction Coordinator, shall provide to the appropriate congressional committees, to the Committee on Armed Services and the Committee on Homeland Security of the House of Representatives, and to the Committee on Homeland Security and Governmental Affairs and the Committee on Armed Services of the Senate a report that—

(i) includes—

(I) a copy of that year's National Interdiction Command and Control Plan, including information about how each National Drug Control Program agency conducting drug interdiction activities is engaging with relevant international partners;

(II) information for the previous 10 years regarding the number and type of seizures of drugs by each National Drug Control Program agency conducting drug interdiction activities and statistical information on the geographic areas of such seizures; and

(III) information for the previous 10 years regarding the number of air and maritime patrol hours undertaken by each National Drug Control Program agency conducting drug interdiction activities and statistical information on the geographic areas in which such patrol hours took place; and

(ii) may include recommendations for changes to existing agency authorities or laws governing interagency relationships.

(D) Classified annex

Each report required to be submitted under subparagraph (C) shall be in unclassified form, but may include a classified annex.

(b) Interdiction Committee

(1) In general

The Interdiction Committee shall meet to—

(A) discuss and resolve issues related to the coordination, oversight and integration of international, border, and domestic drug interdiction efforts in support of the National Drug Control Strategy;

(B) review the annual National Interdiction Command and Control Plan, and provide advice to the Director and the United States Interdiction Coordinator concerning that plan and how to strengthen international partnerships to better achieve the goals of that plan; and

(C) provide such other advice to the Director concerning drug interdiction strategy and policies as the committee determines is appropriate.

(2) Chairperson

The Director shall designate one of the members of the Interdiction Committee to serve as Chairperson.

(3) Meetings

The members of the Interdiction Committee shall meet, in person and not through any delegate or representative, at least once per calendar year, before June 1. At the call of the Director or the Chairperson, the Interdiction Committee may hold additional meetings, which shall be attended by the members in person, or through such delegates or representatives as the members may choose.

(4) Report

Not later than September 30 of each year, the Chairperson of the Interdiction Committee shall submit to the Director and to the appropriate congressional committees a report describing the results of the meetings and any significant findings of the Committee during the previous 12 months. The report required under this paragraph shall be in unclassified form, but may include a classified annex.

(c) International coordination

The Director may facilitate international drug control coordination efforts.

(Pub. L. 105–277, div. C, title VII, §711, as added Pub. L. 109–469, title I, §103(f)(1), Dec. 29, 2006, 120 Stat. 3507; amended Pub. L. 105–277, div. C, title VII, §715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8219, Oct. 24, 2018, 132 Stat. 4110, 4132.)

Editorial Notes

References in Text

The General Schedule, referred to in subsec. (a)(1), is set out under section 5332 of Title 5, Government Organization and Employees.

Prior Provisions

A prior section 711 of Pub. L. 105–277, div. C, title VII, Oct. 21, 1998, 112 Stat. 2681–691; Pub. L. 105–277, div. C, title VII, §715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3553, related to drug interdiction, prior to repeal by Pub. L. 115–271, title VIII, §8219(a), Oct. 24, 2018, 132 Stat. 4132. See 2018 and 2006 Amendment notes below.

Amendments

2018—Pub. L. 115–271, §8219(a), repealed Pub. L. 105–277, div. C, title VII, §711, Oct. 21, 1998, 112 Stat. 2681–691. See 2006 Amendment note below.

Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

Subsec. (a)(1). Pub. L. 115–271, §8219(b)(1)(A), substituted "The Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent) as the United" for "The United" and "to perform" for "shall perform".

Subsec. (a)(2)(B). Pub. L. 115–271, §8219(b)(1)(B), substituted "September 1" for "March 1" and "paragraph (4)" for "paragraph (3)".

Subsec. (a)(3). Pub. L. 115–271, §8219(b)(1)(C), struck out "also, at his discretion," after "and may" and substituted "assist in carrying out such responsibilities" for "the Office of Supply Reduction for that purpose".

Subsec. (a)(4)(B). Pub. L. 115–271, §8219(b)(1)(D)(i), substituted "Before submission of the National Drug Control Strategy or annual assessment required under section 1705 of this title, as applicable, the United" for "The United".

Subsec. (a)(4)(C). Pub. L. 115–271, §8219(b)(1)(D)(iv)(I), in introductory provisions, substituted "September 1" for "March 1" and "a report that" for ", which shall include", inserted "the Director, acting through" after "each year," and a comma after "Coordinator", and struck out "a report on behalf of the Director" after "shall provide".

Pub. L. 115–271, §8219(b)(1)(D)(ii), (iii), redesignated subpar. (D) as (C) and struck out former subpar. (C). Prior to amendment, text of subpar. (C) read as follows: "The National Interdiction Command and Control Plan shall not change existing agency authorities or the laws governing interagency relationships, but may include recommendations about changes to such authorities or laws."

Subsec. (a)(4)(C)(i). Pub. L. 115–271, §8219(b)(1)(D)(iv)(II), (III), inserted cl. (i) designation and introductory provisions and redesignated former cls. (i) to (iii) as subcls. (I) to (III), respectively, of cl. (i).

Subsec. (a)(4)(C)(i)(I). Pub. L. 115–271, §8219(b)(1)(D)(iv)(IV)(aa), inserted ", including information about how each National Drug Control Program agency conducting drug interdiction activities is engaging with relevant international partners" after "Plan".

Subsec. (a)(4)(C)(i)(II). Pub. L. 115–271, §8219(b)(1)(D)(iv)(IV)(bb), substituted "and statistical" for ", as well as statistical".

Subsec. (a)(4)(C)(i)(III). Pub. L. 115–271, §8219(b)(1)(D)(iv)(IV)(cc), substituted "and statistical" for ", as well as statistical" and "; and" for period at end.

Subsec. (a)(4)(C)(ii). Pub. L. 115–271, §8219(b)(1)(D)(iv)(V), added cl. (ii). Former cl. (ii) redesignated subcl. (II) of cl. (i).

Subsec. (a)(4)(C)(iii). Pub. L. 115–271, §8219(b)(1)(D)(iv)(II), redesignated cl. (iii) as subcl. (III) of cl. (i).

Subsec. (a)(4)(D). Pub. L. 115–271, §8219(b)(1)(D)(v), added subpar. (D).

Subsec. (b)(1)(B). Pub. L. 115–271, §8219(b)(2)(A), inserted "and how to strengthen international partnerships to better achieve the goals of that plan" after "that plan".

Subsec. (b)(2). Pub. L. 115–271, §8219(b)(2)(B), substituted "Chairperson" for "Chairman" in heading and for "chairman" in text.

Subsec. (b)(3). Pub. L. 115–271, §8219(b)(2)(C), substituted "before June 1" for "prior to March 1", "Chairperson" for "current chairman", and "the members may" for "they may" and struck out "either" after "the call of" and after "by the members".

Subsec. (b)(4). Pub. L. 115–271, §8219(b)(2)(D), struck out "a report" after "shall submit", inserted "a report" after "committees", and substituted "Chairperson of the Interdiction Committee" for "chairman of the Interdiction Committee" and "The report required under this paragraph shall be in unclassified form, but may include a classified annex." for "Any content of such a report that involves information classified under criteria established by an Executive order, or whose public disclosure, as determined by the Director, the chairman, or any member, would be detrimental to the law enforcement or national security activities of any Federal, State, local, or tribal agency, shall be presented to Congress separately from the rest of the report."

Subsec. (c). Pub. L. 115–271, §8219(b)(3), added subsec. (c).

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Pub. L. 109–469, §103(f)(1), directed that section 711 of Office of National Drug Control Policy Reauthorization Act of 1998 (Pub. L. 105–277, div. C, title VII) be amended by "adding at the end" a new section 711, which comprises this section. A prior section 711 of the Act was repealed by Pub. L. 115–271, §8219(a). See 2018 Amendment note above.

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of title VII of the Office of National Drug Control Policy Reauthorization Act of 1988 (Pub. L. 105–277, div. C, title VII) effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

§1710a. Requirement for disclosure of Federal sponsorship of all Federal advertising or other communication materials

(a) Requirement

Each advertisement or other communication paid for by the Office, either directly or through a contract awarded by the Office, shall include a prominent notice informing the target audience that the advertisement or other communication is paid for by the Office.

(b) Advertisement or other communication

In this section, the term "advertisement or other communication" includes—

(1) an advertisement disseminated in any form, including print or by any electronic means; and

(2) a communication by an individual in any form, including speech, print, or by any electronic means.

(Pub. L. 105–277, div. C, title VII, §712, as added Pub. L. 109–469, title XI, §1118, Dec. 29, 2006, 120 Stat. 3546; amended Pub. L. 105–277, div. C. title VII, §715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202(a), (b)(2), Oct. 24, 2018, 132 Stat. 4110.)

Editorial Notes

Codification

Another section 712 of title VII of div. C of Pub. L. 105–277 amended former section 1509 of this title.

Amendments

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

§1711. Authorization of appropriations

There are authorized to be appropriated to carry out this chapter except activities otherwise specified, to remain available until expended, $18,400,000 for each of fiscal years 2018 through 2023.

(Pub. L. 105–277, div. C, title VII, §§714, 715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §§601, 602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202, Oct. 24, 2018, 132 Stat. 4110.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title VII of Pub. L. 105–277, div. C, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out under section 1701 of this title and Tables.

Amendments

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(b)(1), substituted "$18,400,000 for each of fiscal years 2018 through 2023" for "such sums as may be necessary for each of fiscal years 2006 through 2010".

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Pub. L. 109–469, §601, substituted "chapter except activities otherwise specified," for "chapter," and "2006 through 2010" for "1999 through 2003".

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Appropriations

Provisions appropriating funds to carry out activities authorized by the Office of National Drug Control Policy Reauthorization Act of 1998, which enacted this chapter, were contained in the following appropriation acts:

Pub. L. 109–115, div. A, title V, Nov. 30, 2005, 119 Stat. 2475.

Pub. L. 108–447, div. H, title III, Dec. 8, 2004, 118 Stat. 3249, 3250.

Pub. L. 108–199, div. F, title III, Jan. 23, 2004, 118 Stat. 324.

§1712. Repealed. Pub. L. 115–271, title VIII, §8202(b)(2), Oct. 24, 2018, 132 Stat. 4110

Section, Pub. L. 105–277, div. C, title VII, §715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202(a), Oct. 24, 2018, 132 Stat. 4110, provided for the termination of Office of National Drug Control Policy and repealed this chapter effective Sept. 30, 2010.

§1713. Authorization of use of environmentally-approved herbicides to eliminate illicit narcotics crops

The Secretary of State, the Attorney General, the Secretary of Agriculture, the Secretary of Defense, the Director of the Office of National Drug Control Policy, and the Administrator of the Environmental Protection Agency are authorized to support the development and use of environmentally-approved herbicides to eliminate illicit narcotics crops, including coca, cannabis, and opium poppy, both in the United States and in foreign countries.

(Pub. L. 105–277, div. C, title VIII, §834, Oct. 21, 1998, 112 Stat. 2681–702.)

Editorial Notes

Codification

Section was enacted as part of the Western Hemisphere Drug Elimination Act, and not as part of the Office of National Drug Control Policy Reauthorization Act of 1998 which comprises this chapter.

§1714. Awards for demonstration programs by local partnerships to coerce abstinence in chronic hard-drug users under community supervision through the use of drug testing and sanctions

(a) Awards required

The Director shall make competitive awards to fund demonstration programs by eligible partnerships for the purpose of reducing the use of illicit drugs by chronic hard-drug users living in the community while under the supervision of the criminal justice system.

(b) Use of award amounts

Award amounts received under this section shall be used—

(1) to support the efforts of the agencies, organizations, and researchers included in the eligible partnership;

(2) to develop and field a drug testing and graduated sanctions program for chronic hard-drug users living in the community under criminal justice supervision; and

(3) to assist individuals described in subsection (a) by strengthening rehabilitation efforts through such means as job training, drug treatment, or other services.

(c) Eligible partnership defined

In this section, the term "eligible partnership" means a working group whose application to the Director—

(1) identifies the roles played, and certifies the involvement of, two or more agencies or organizations, which may include—

(A) State, local, or tribal agencies (such as those carrying out police, probation, prosecution, courts, corrections, parole, or treatment functions);

(B) Federal agencies (such as the Drug Enforcement Agency, the Bureau of Alcohol, Tobacco, Firearms, and Explosives, and United States Attorney offices); and

(C) community-based organizations;

(2) includes a qualified researcher;

(3) includes a plan for using judicial or other criminal justice authority to administer drug tests to individuals described in subsection (a) at least twice a week, and to swiftly and certainly impose a known set of graduated sanctions for non-compliance with community-release provisions relating to drug abstinence (whether imposed as a pre-trial, probation, or parole condition or otherwise);

(4) includes a strategy for responding to a range of substance use and abuse problems and a range of criminal histories;

(5) includes a plan for integrating data infrastructure among the agencies and organizations included in the eligible partnership to enable seamless, real-time tracking of individuals described in subsection (a);

(6) includes a plan to monitor and measure the progress toward reducing the percentage of the population of individuals described in subsection (a) who, upon being summoned for a drug test, either fail to show up or who test positive for drugs.

(d) Reports to Congress

(1) Interim report

Not later than June 1, 2009, the Director shall submit to Congress a report that identifies the best practices in reducing the use of illicit drugs by chronic hard-drug users, including the best practices identified through the activities funded under this section.

(2) Final report

Not later than June 1, 2010, the Director shall submit to Congress a report on the demonstration programs funded under this section, including on the matters specified in paragraph (1).

(e) Authorization of appropriations

There is authorized to be appropriated to carry out this section $4,900,000 for each of fiscal years 2007 through 2009.

(Pub. L. 105–277, div. C, title VII, §716, as added Pub. L. 109–469, title XI, §1119, Dec. 29, 2006, 120 Stat. 3547; amended Pub. L. 105–277, div. C. title VII, §715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202(a), (b)(2), Oct. 24, 2018, 132 Stat. 4110.)

Editorial Notes

Amendments

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

2006—Pub. L. 109–469 amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

§1715. GAO audit

Not later than 4 years after October 24, 2018, and every 4 years thereafter, the Comptroller General of the United States shall—

(1) conduct an audit relating to the programs and operations of—

(A) the Office; ¹ and

(B) certain programs within the Office,¹ including—

(i) the High Intensity Drug Trafficking Areas Program;

(ii) the Drug-Free Communities Program; and

(iii) the campaign under section 1708(f) of this title; and

(2) submit to the Director ¹ and the appropriate congressional committees ¹ a report containing an evaluation of and recommendations on the—

(A) policies and activities of the programs and operations subject to the audit;

(B) economy, efficiency, and effectiveness in the administration of the reviewed programs and operations; and

(C) policy or management changes needed to prevent and detect fraud and abuse in such programs and operations.

(Pub. L. 115–271, title VIII, §8220, Oct. 24, 2018, 132 Stat. 4134.)

Editorial Notes

References in Text

The terms "Office", "Director", and "appropriate congressional committees", referred to in text, probably have the meanings given such terms in section 1701 of this title.

Codification

Section was enacted as part of the Substance Abuse Prevention Act of 2018, and also as part of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act, and not as part of the Office of National Drug Control Policy Reauthorization Act of 1998 which comprises this chapter.

¹ See References in Text note below.

CHAPTER 23—NATIONAL YOUTH ANTI-DRUG MEDIA CAMPAIGN

§§1801 to 1804. Repealed. Pub. L. 109–469, title V, §501(b), Dec. 29, 2006, 120 Stat. 3533

Section 1801, Pub. L. 105–277, div. D, title I, §102, Oct. 21, 1998, 112 Stat. 2681–752, related to requirement to conduct national media campaign.

Section 1802, Pub. L. 105–277, div. D, title I, §103, Oct. 21, 1998, 112 Stat. 2681–752, related to use of funds.

Section 1803, Pub. L. 105–277, div. D, title I, §104, Oct. 21, 1998, 112 Stat. 2681–753, related to reports to Congress.

Section 1804, Pub. L. 105–277, div. D, title I, §105, Oct. 21, 1998, 112 Stat. 2681–753, related to authorization of appropriations.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 105–277, div. D, §1(a), Oct. 21, 1998, 112 Stat. 2681–751, provided that: "This division [enacting this chapter and section 7144 of Title 20, Education, and enacting provisions set out as notes under this section, section 1703 of this title, section 6301 of Title 20, and section 3751 of Title 42, The Public Health and Welfare] may be cited as the 'Drug Demand Reduction Act'."

Pub. L. 105–277, div. D, title I, §101, Oct. 21, 1998, 112 Stat. 2681–752, which provided that subtitle A (§§101–105) of title I of div. D of Pub. L. 105–277, enacting this chapter, was to be cited as the "Drug-Free Media Campaign Act of 1998", was repealed by Pub. L. 109–469, title V, §501(b), Dec. 29, 2006, 120 Stat. 3533.

CHAPTER 24—INTERNATIONAL NARCOTICS TRAFFICKING

        

§1901. Findings and policy

(a) Findings

Congress makes the following findings:

(1) Presidential Decision Directive 42, issued on October 21, 1995, ordered agencies of the executive branch of the United States Government to, inter alia, increase the priority and resources devoted to the direct and immediate threat international crime presents to national security, work more closely with other governments to develop a global response to this threat, and use aggressively and creatively all legal means available to combat international crime.

(2) Executive Order No. 12978 of October 21, 1995, provides for the use of the authorities in the International Emergency Economic Powers Act (IEEPA) (50 U.S.C. 1701 et seq.) to target and apply sanctions to four international narcotics traffickers and their organizations that operate from Colombia.

(3) IEEPA was successfully applied to international narcotics traffickers in Colombia and based on that successful case study, Congress believes similar authorities should be applied worldwide.

(4) There is a national emergency resulting from the activities of international narcotics traffickers and their organizations that threatens the national security, foreign policy, and economy of the United States.

(b) Policy

It shall be the policy of the United States to apply economic and other financial sanctions to significant foreign narcotics traffickers and their organizations worldwide to protect the national security, foreign policy, and economy of the United States from the threat described in subsection (a)(4).

(Pub. L. 106–120, title VIII, §802, Dec. 3, 1999, 113 Stat. 1626.)

Editorial Notes

References in Text

Executive Order No. 12978, referred to in subsec. (a)(2), is Ex. Ord. No. 12978, Oct. 21, 1995, 60 F.R. 54579, which is listed in a table under section 1701 of Title 50, War and National Defense.

The International Emergency Economic Powers Act, referred to in subsec. (a)(2), is title II of Pub. L. 95–223, Dec. 28, 1977, 91 Stat. 1626, which is classified generally to chapter 35 (§1701 et seq.) of Title 50, War and National Defense. For complete classification of this Act to the Code, see Short Title note set out under section 1701 of Title 50 and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 106–120, title VIII, §811, Dec. 3, 1999, 113 Stat. 1636, provided that: "This title [see Short Title note set out below] shall take effect on the date of the enactment of this Act [Dec. 3, 1999]."

Short Title

Pub. L. 106–120, title VIII, §801, Dec. 3, 1999, 113 Stat. 1626, provided that: "This title [enacting this chapter and amending section 1182 of Title 8, Aliens and Nationality] may be cited as the 'Foreign Narcotics Kingpin Designation Act'."

§1902. Purpose

The purpose of this chapter is to provide authority for the identification of, and application of sanctions on a worldwide basis to, significant foreign narcotics traffickers, their organizations, and the foreign persons who provide support to those significant foreign narcotics traffickers and their organizations, whose activities threaten the national security, foreign policy, and economy of the United States.

(Pub. L. 106–120, title VIII, §803, Dec. 3, 1999, 113 Stat. 1626.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title VIII of Pub. L. 106–120, Dec. 3, 1999, 113 Stat. 1626, which is classified generally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1901 of this title and Tables.

§1903. Public identification of significant foreign narcotics traffickers and required reports

(a) Provision of information to the President

The Secretary of the Treasury, the Attorney General, the Secretary of Defense, the Secretary of State, and the Director of Central Intelligence shall consult among themselves and provide the appropriate and necessary information to enable the President to submit the report under subsection (b). This information shall also be provided to the Director of the Office of National Drug Control Policy.

(b) Public identification and sanctioning of significant foreign narcotics traffickers

Not later than June 1, 2000, and not later than June 1 of each year thereafter, the President shall submit a report to the Permanent Select Committee on Intelligence, and the Committees on the Judiciary, International Relations, Armed Services, and Ways and Means of the House of Representatives; and to the Select Committee on Intelligence, and the Committees on the Judiciary, Foreign Relations, Armed Services, and Finance of the Senate—

(1) identifying publicly the foreign persons that the President determines are appropriate for sanctions pursuant to this chapter; and

(2) detailing publicly the President's intent to impose sanctions upon these significant foreign narcotics traffickers pursuant to this chapter.

The report required in this subsection shall not include information on persons upon which United States sanctions imposed under this chapter, or otherwise on account of narcotics trafficking, are already in effect.

(c) Unclassified report required

The report required by subsection (b) shall be submitted in unclassified form and made available to the public.

(d) Classified report

(1) Not later than July 1, 2000, and not later than July 1 of each year thereafter, the President shall provide the Permanent Select Committee on Intelligence of the House of Representatives and the Select Committee on Intelligence of the Senate with a report in classified form describing in detail the status of the sanctions imposed under this chapter, including the personnel and resources directed towards the imposition of such sanctions during the preceding fiscal year, and providing background information with respect to newly-identified significant foreign narcotics traffickers and their activities.

(2) Such classified report shall describe actions the President intends to undertake or has undertaken with respect to such significant foreign narcotics traffickers.

(3) The report required under this subsection is in addition to the President's obligations to keep the intelligence committees of Congress fully and currently informed pursuant to the provisions of the National Security Act of 1947.

(e) Exclusion of certain information

(1) Intelligence

Notwithstanding any other provision of this section, the reports described in subsections (b) and (d) shall not disclose the identity of any person, if the Director of Central Intelligence determines that such disclosure could compromise an intelligence operation, activity, source, or method of the United States.

(2) Law enforcement

Notwithstanding any other provision of this section, the reports described in subsections (b) and (d) shall not disclose the name of any person if the Attorney General, in coordination as appropriate with the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, and the Secretary of the Treasury, determines that such disclosure could reasonably be expected to—

(A) compromise the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution that furnished information on a confidential basis;

(B) jeopardize the integrity or success of an ongoing criminal investigation or prosecution;

(C) endanger the life or physical safety of any person; or

(D) cause substantial harm to physical property.

(f) Notification required

(1) Whenever either the Director of Central Intelligence or the Attorney General makes a determination under subsection (e), the Director of Central Intelligence or the Attorney General shall notify the Permanent Select Committee on Intelligence of the House of Representatives and the Select Committee on Intelligence of the Senate, and explain the reasons for such determination.

(2) The notification required under this subsection shall be submitted to the Permanent Select Committee on Intelligence of the House of Representatives and the Select Committee on Intelligence of the Senate not later than July 1, 2000, and on an annual basis thereafter.

(g) Determinations not to apply sanctions

(1) The President may waive the application to a significant foreign narcotics trafficker of any sanction authorized by this chapter if the President determines that the application of sanctions under this chapter would significantly harm the national security of the United States.

(2) When the President determines not to apply sanctions that are authorized by this chapter to any significant foreign narcotics trafficker, the President shall notify the Permanent Select Committee on Intelligence, and the Committees on the Judiciary, International Relations, Armed Services, and Ways and Means of the House of Representatives, and the Select Committee on Intelligence, and the Committees on the Judiciary, Foreign Relations, Armed Services, and Finance of the Senate not later than 21 days after making such determination.

(h) Changes in determinations to impose sanctions

(1) Additional determinations

(A) If at any time after the report required under subsection (b) the President finds that a foreign person is a significant foreign narcotics trafficker and such foreign person has not been publicly identified in a report required under subsection (b), the President shall submit an additional public report containing the information described in subsection (b) with respect to such foreign person to the Permanent Select Committee on Intelligence, and the Committees on the Judiciary, International Relations, Armed Services, and Ways and Means of the House of Representatives, and the Select Committee on Intelligence, and the Committees on the Judiciary, Foreign Relations, Armed Services, and Finance of the Senate.

(B) The President may apply sanctions authorized under this chapter to the significant foreign narcotics trafficker identified in the report submitted under subparagraph (A) as if the trafficker were originally included in the report submitted pursuant to subsection (b) of this section.

(C) The President shall notify the Secretary of the Treasury of any determination made under this paragraph.

(2) Revocation of determination

(A) Whenever the President finds that a foreign person that has been publicly identified as a significant foreign narcotics trafficker in the report required under subsection (b) or this subsection no longer engages in those activities for which sanctions under this chapter may be applied, the President shall issue public notice of such a finding.

(B) Not later than the date of the public notice issued pursuant to subparagraph (A), the President shall notify, in writing and in classified or unclassified form, the Permanent Select Committee on Intelligence, and the Committees on the Judiciary, International Relations, Armed Services, and Ways and Means of the House of Representatives, and the Select Committee on Intelligence, and the Committees on the Judiciary, Foreign Relations, Armed Services, and Finance of the Senate of actions taken under this paragraph and a description of the basis for such actions.

(i) Protection of classified information in Federal court challenges relating to designations

In any judicial review of a determination made under this section, if the determination was based on classified information (as defined in section 1(a) of the Classified Information Procedures Act) such information may be submitted to the reviewing court ex parte and in camera. This subsection does not confer or imply any right to judicial review.

(Pub. L. 106–120, title VIII, §804, Dec. 3, 1999, 113 Stat. 1626; Pub. L. 114–198, title VIII, §801, July 22, 2016, 130 Stat. 755.)

Editorial Notes

References in Text

The National Security Act of 1947, referred to in subsec. (d)(3), is act July 26, 1947, ch. 343, 61 Stat. 495, which was formerly classified principally to chapter 15 (§401 et seq.) of Title 50, War and National Defense, prior to editorial reclassification in Title 50, and is now classified principally to chapter 44 (§3001 et seq.) of Title 50. For complete classification of this Act to the Code, see Tables.

Section 1(a) of the Classified Information Procedures Act, referred to in subsec. (i), is section 1(a) of Pub. L. 96–456, Oct. 15, 1980, 94 Stat. 2025, which is set out in the Appendix to Title 18, Crimes and Criminal Procedure.

Amendments

2016—Subsec. (i). Pub. L. 114–198 added subsec. (i).

Statutory Notes and Related Subsidiaries

Change of Name

Committee on International Relations of House of Representatives changed to Committee on Foreign Affairs of House of Representatives by House Resolution No. 6, One Hundred Tenth Congress, Jan. 5, 2007.

Reference to the Director of Central Intelligence or the Director of the Central Intelligence Agency in the Director's capacity as the head of the intelligence community deemed to be a reference to the Director of National Intelligence. Reference to the Director of Central Intelligence or the Director of the Central Intelligence Agency in the Director's capacity as the head of the Central Intelligence Agency deemed to be a reference to the Director of the Central Intelligence Agency. See section 1081(a), (b) of Pub. L. 108–458, set out as a note under section 3001 of Title 50, War and National Defense.

Executive Documents

Delegation of Functions

For delegation of Congressional reporting functions of President under subsec. (d) of this section, see section 1 of Ex. Ord. No. 13313, July 31, 2003, 68 F.R. 46075, set out as a note under section 301 of Title 3, The President.

Delegation of Functions Under Section 804(h)(2)(A) of the Foreign Narcotics Kingpin Designation Act

Memorandum of President of the United States, May 31, 2013, 78 F.R. 33943, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby delegate the functions conferred upon the President by section 804(h)(2)(A) of the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1903(h)(2)(A)), to the Secretary of the Treasury.

You are authorized and directed to publish this memorandum in the Federal Register.

Barack Obama.      

Delegation of Functions Under the Foreign Narcotics Kingpin Designation Act

Memorandum of President of the United States, May 15, 2015, 80 F.R. 29201, provided:

Memorandum for the Secretary of the Treasury

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby delegate the functions conferred upon the President by sections 804(b), (c), (g), and (h) of the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1903(b), (c), (g), and (h)), to the Secretary of the Treasury.

You are authorized and directed to publish this memorandum in the Federal Register.

Barack Obama.      

§1904. Blocking assets and prohibiting transactions

(a) Applicability of sanctions

A significant foreign narcotics trafficker publicly identified in the report required under subsection (b) or (h)(1) of section 1903 of this title and foreign persons designated by the Secretary of the Treasury pursuant to subsection (b) of this section shall be subject to any and all sanctions as authorized by this chapter. The application of sanctions on any foreign person pursuant to subsection (b) or (h)(1) of section 1903 of this title or subsection (b) of this section shall remain in effect until revoked pursuant to section 1903(h)(2) of this title or subsection (e)(1)(A) of this section or waived pursuant to section 1903(g)(1) of this title.

(b) Blocking of assets

Except to the extent provided in regulations, orders, instructions, licenses, or directives issued pursuant to this chapter, and notwithstanding any contract entered into or any license or permit granted prior to the date on which the President submits the report required under subsection (b) or (h)(1) of section 1903 of this title, there are blocked as of such date, and any date thereafter, all such property and interests in property within the United States, or within the possession or control of any United States person, which are owned or controlled by—

(1) any significant foreign narcotics trafficker publicly identified by the President in the report required under subsection (b) or (h)(1) of section 1903 of this title;

(2) any foreign person that the Secretary of the Treasury, in consultation with the Attorney General, the Director of Central Intelligence, the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of Defense, and the Secretary of State, designates as materially assisting in, or providing financial or technological support for or to, or providing goods or services in support of, the international narcotics trafficking activities of a significant foreign narcotics trafficker so identified in the report required under subsection (b) or (h)(1) of section 1903 of this title, or foreign persons designated by the Secretary of the Treasury pursuant to this subsection;

(3) any foreign person that the Secretary of the Treasury, in consultation with the Attorney General, the Director of Central Intelligence, the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of Defense, and the Secretary of State, designates as owned, controlled, or directed by, or acting for or on behalf of, a significant foreign narcotics trafficker so identified in the report required under subsection (b) or (h)(1) of section 1903 of this title, or foreign persons designated by the Secretary of the Treasury pursuant to this subsection; and

(4) any foreign person that the Secretary of the Treasury, in consultation with the Attorney General, the Director of Central Intelligence, the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of Defense, and the Secretary of State, designates as playing a significant role in international narcotics trafficking.

(c) Prohibited transactions

Except to the extent provided in regulations, orders, instructions, licenses, or directives issued pursuant to this chapter, and notwithstanding any contract entered into or any license or permit granted prior to the date on which the President submits the report required under subsection (b) or (h)(1) of section 1903 of this title, the following transactions are prohibited:

(1) Any transaction or dealing by a United States person, or within the United States, in property or interests in property of any significant foreign narcotics trafficker so identified in the report required pursuant to subsection (b) or (h)(1) of section 1903 of this title, and foreign persons designated by the Secretary of the Treasury pursuant to subsection (b) of this section.

(2) Any transaction or dealing by a United States person, or within the United States, that evades or avoids, or has the effect of evading or avoiding, and any endeavor, attempt, or conspiracy to violate, any of the prohibitions contained in this chapter.

(d) Law enforcement and intelligence activities not affected

Nothing in this chapter prohibits or otherwise limits the authorized law enforcement or intelligence activities of the United States, or the law enforcement activities of any State or subdivision thereof.

(e) Implementation

(1) The Secretary of the Treasury, in consultation with the Attorney General, the Director of Central Intelligence, the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of Defense, and the Secretary of State, is authorized to take such actions as may be necessary to carry out this chapter, including—

(A) making those designations authorized by paragraphs (2), (3), and (4) of subsection (b) of this section and revocation thereof;

(B) promulgating rules and regulations permitted under this chapter; and

(C) employing all powers conferred on the Secretary of the Treasury under this chapter.

(2) Each agency of the United States shall take all appropriate measures within its authority to carry out the provisions of this chapter.

(3) Section 552(a)(3) of title 5 shall not apply to any record or information obtained or created in the implementation of this chapter.

(Pub. L. 106–120, title VIII, §805, Dec. 3, 1999, 113 Stat. 1629; Pub. L. 107–108, title III, §307, Dec. 28, 2001, 115 Stat. 1399.)

Editorial Notes

Amendments

2001—Subsec. (f). Pub. L. 107–108 struck out heading and text of subsec. (f). Text read as follows: "The determinations, identifications, findings, and designations made pursuant to section 1903 of this title and subsection (b) of this section shall not be subject to judicial review."

Statutory Notes and Related Subsidiaries

Change of Name

Reference to the Director of Central Intelligence or the Director of the Central Intelligence Agency in the Director's capacity as the head of the intelligence community deemed to be a reference to the Director of National Intelligence. Reference to the Director of Central Intelligence or the Director of the Central Intelligence Agency in the Director's capacity as the head of the Central Intelligence Agency deemed to be a reference to the Director of the Central Intelligence Agency. See section 1081(a), (b) of Pub. L. 108–458, set out as a note under section 3001 of Title 50, War and National Defense.

§1905. Authorities

(a) In general

To carry out the purposes of this chapter, the Secretary of the Treasury may, under such regulations as he may prescribe, by means of instructions, licenses, or otherwise—

(1) investigate, regulate, or prohibit—

(A) any transactions in foreign exchange, currency, or securities; and

(B) transfers of credit or payments between, by, through, or to any banking institution, to the extent that such transfers or payments involve any interests of any foreign country or a national thereof; and

(2) investigate, block during the pendency of an investigation, regulate, direct and compel, nullify, void, prevent, or prohibit any acquisition, holding, withholding, use, transfer, withdrawal, transportation, placement into foreign or domestic commerce of, or dealing in, or exercising any right, power, or privilege with respect to, or transactions involving, any property in which any foreign country or a national thereof has any interest,

by any person, or with respect to any property, subject to the jurisdiction of the United States.

(b) Recordkeeping

Pursuant to subsection (a), the Secretary of the Treasury may require recordkeeping, reporting, and production of documents to carry out the purposes of this chapter.

(c) Defenses

(1) Full and actual compliance with any regulation, order, license, instruction, or direction issued under this chapter shall be a defense in any proceeding alleging a violation of any of the provisions of this chapter.

(2) No person shall be held liable in any court for or with respect to anything done or omitted in good faith in connection with the administration of, or pursuant to, and in reliance on this chapter, or any regulation, instruction, or direction issued under this chapter.

(d) Rulemaking

The Secretary of the Treasury may issue such other regulations or orders, including regulations prescribing recordkeeping, reporting, and production of documents, definitions, licenses, instructions, or directions, as may be necessary for the exercise of the authorities granted by this chapter.

(Pub. L. 106–120, title VIII, §806, Dec. 3, 1999, 113 Stat. 1631.)

§1906. Enforcement

(a) Criminal penalties

(1) Whoever willfully violates the provisions of this chapter, or any license rule, or regulation issued pursuant to this chapter, or willfully neglects or refuses to comply with any order of the President issued under this chapter shall be—

(A) imprisoned for not more than 10 years,

(B) fined in the amount provided in title 18 or, in the case of an entity, fined not more than $10,000,000,

or both.

(2) Any officer, director, or agent of any entity who knowingly participates in a violation of the provisions of this chapter shall be imprisoned for not more than 30 years, fined not more than $5,000,000, or both.

(b) Civil penalties

A civil penalty not to exceed $1,000,000 may be imposed by the Secretary of the Treasury on any person who violates any license, order, rule, or regulation issued in compliance with the provisions of this chapter.

(c) Judicial review of civil penalty

Any penalty imposed under subsection (b) shall be subject to judicial review only to the extent provided in section 702 of title 5.

(Pub. L. 106–120, title VIII, §807, Dec. 3, 1999, 113 Stat. 1631.)

§1907. Definitions

As used in this chapter:

(1) Entity

The term "entity" means a partnership, joint venture, association, corporation, organization, network, group, or subgroup, or any form of business collaboration.

(2) Foreign person

The term "foreign person" means any citizen or national of a foreign state or any entity not organized under the laws of the United States, but does not include a foreign state.

(3) Narcotics trafficking

The term "narcotics trafficking" means any illicit activity to cultivate, produce, manufacture, distribute, sell, finance, or transport narcotic drugs, controlled substances, or listed chemicals, or otherwise endeavor or attempt to do so, or to assist, abet, conspire, or collude with others to do so.

(4) Narcotic drug; controlled substance; listed chemical

The terms "narcotic drug", "controlled substance", and "listed chemical" have the meanings given those terms in section 802 of this title.

(5) Person

The term "person" means an individual or entity.

(6) United States person

The term "United States person" means any United States citizen or national, permanent resident alien, an entity organized under the laws of the United States (including its foreign branches), or any person within the United States.

(7) Significant foreign narcotics trafficker

The term "significant foreign narcotics trafficker" means any foreign person that plays a significant role in international narcotics trafficking, that the President has determined to be appropriate for sanctions pursuant to this chapter, and that the President has publicly identified in the report required under subsection (b) or (h)(1) of section 1903 of this title.

(Pub. L. 106–120, title VIII, §808, Dec. 3, 1999, 113 Stat. 1632.)

§1908. Judicial Review Commission on Foreign Asset Control

(a) Establishment

There is established a commission to be known as the "Judicial Review Commission on Foreign Asset Control" (in this section referred to as the "Commission").

(b) Membership and procedural matters

(1) The Commission shall be composed of five members, as follows:

(A) One member shall be appointed by the Chairman of the Select Committee on Intelligence of the Senate.

(B) One member shall be appointed by the Vice Chairman of the Select Committee on Intelligence of the Senate.

(C) One member shall be appointed by the Chairman of the Permanent Select Committee on Intelligence of the House of Representatives.

(D) One member shall be appointed by the Ranking Minority Member of the Permanent Select Committee on Intelligence of the House of Representatives.

(E) One member shall be appointed jointly by the members appointed under subparagraphs (A) through (D).

(2) Each member of the Commission shall, for purposes of the activities of the Commission under this section, possess or obtain an appropriate security clearance in accordance with applicable laws and regulations regarding the handling of classified information.

(3) The members of the Commission shall choose the chairman of the Commission from among the members of the Commission.

(4) The members of the Commission shall establish rules governing the procedures and proceedings of the Commission.

(c) Duties

The Commission shall have as its duties the following:

(1) To conduct a review of the current judicial, regulatory, and administrative authorities relating to the blocking of assets of foreign persons by the United States Government.

(2) To conduct a detailed examination and evaluation of the remedies available to United States persons affected by the blocking of assets of foreign persons by the United States Government.

(d) Powers

(1) The Commission may hold such hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Commission considers advisable to carry out the purposes of this section.

(2) The Commission may secure directly from any executive department, agency, bureau, board, commission, office, independent establishment, or instrumentality of the Government information, suggestions, estimates, and statistics for the purposes of this section. Each such department, agency, bureau, board, commission, office, establishment, or instrumentality shall, to the extent authorized by law, furnish such information, suggestions, estimates, and statistics directly to the Commission, upon request of the chairman of the Commission. The Commission shall handle and protect all classified information provided to it under this section in accordance with applicable statutes and regulations.

(3) The Attorney General and the Secretary of the Treasury shall provide to the Commission, on a nonreimbursable basis, such administrative services, funds, facilities, and other support services as are necessary for the performance of the Commission's duties under this section.

(4) The Commission shall receive the full and timely cooperation of any official, department, or agency of the United States Government whose assistance is necessary for the fulfillment of the duties of the Commission under this section, including the provision of full and current briefings and analyses.

(5) No department or agency of the Government may withhold information from the Commission on the grounds that providing the information to the Commission would constitute the unauthorized disclosure of classified information or information relating to intelligence sources or methods.

(6) The Commission may use the United States mails in the same manner and under the same conditions as the departments and agencies of the United States.

(e) Staff

(1) Subject to paragraph (2), the chairman of the Commission, in accordance with rules agreed upon by the Commission, shall appoint and fix the compensation of a staff director and such other personnel as may be necessary to enable the Commission to carry out its duties, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III or ¹ chapter 53 of such title relating to classification and General Schedule pay rates, except that no rate of pay fixed under this subsection may exceed the equivalent of that payable to a person occupying a position at level V of the Executive Schedule under section 5316 of such title.

(2)(A) Any employee of a department or agency referred to in subparagraph (B) may be detailed to the Commission without reimbursement from the Commission, and such detailee shall retain the rights, status, and privileges of his or her regular employment without interruption.

(B) The departments and agencies referred to in this subparagraph are as follows:

(i) The Department of Justice.

(ii) The Department of the Treasury.

(iii) The Central Intelligence Agency.

(3) All staff of the Commission shall possess a security clearance in accordance with applicable laws and regulations concerning the handling of classified information.

(f) Compensation and travel expenses

(1)(A) Except as provided in subparagraph (B), each member of the Commission may be compensated at not to exceed the daily equivalent of the annual rate of basic pay in effect for a position at level IV of the Executive Schedule under section 5315 of title 5 for each day during which that member is engaged in the actual performance of the duties of the Commission under this section.

(B) Members of the Commission who are officers or employees of the United States shall receive no additional pay by reason of their service on the Commission.

(2) While away from their homes or regular places of business in the performance of services for the Commission, members of the Commission may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in the Government service are allowed expenses under section 5703(b) ² of title 5.

(g) Report

(1) Not later than 1 year after December 3, 1999, the Commissions ³ shall submit to the committees of Congress referred to in paragraph (4) a report on the activities of the Commission under this section, including the findings, conclusions, and recommendations, if any, of the Commission as a result of the review under subsection (c)(1) and the examination and evaluation under subsection (c)(2).

(2) The report under paragraph (1) shall include any additional or dissenting views of a member of the Commission upon the request of the member.

(3) The report under paragraph (1) shall be submitted in unclassified form, but may include a classified annex.

(4) The committees of Congress referred to in this paragraph are the following:

(A) The Select Committee on Intelligence and the Committees on Foreign Relations and the Judiciary of the Senate.

(B) The Permanent Select Committee on Intelligence and the Committees on International Relations and the Judiciary of the House of Representatives.

(h) Termination

The Commission shall terminate at the end of the 60-day period beginning on the date on which the report required by subsection (g) is submitted to the committees of Congress referred to in that subsection.

(i) Inapplicability of certain administrative provisions

(1) The provisions of chapter 10 of title 5 shall not apply to the activities of the Commission under this section.

(2) The provisions of section 552 of title 5 (commonly referred to as the Freedom of Information Act) shall not apply to the activities, records, and proceedings of the Commission under this chapter.

(j) Funding

The Attorney General shall, from amounts authorized to be appropriated to the Attorney General by this Act, make available to the Commission $1,000,000 for purposes of the activities of the Commission under this section. Amounts made available to the Commission under the preceding sentence shall remain available until expended.

(Pub. L. 106–120, title VIII, §810, Dec. 3, 1999, 113 Stat. 1633; Pub. L. 117–286, §4(a)(162), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

References in Text

This Act, referred to in subsec. (j), is Pub. L. 106–120, Dec. 3, 1999, 113 Stat. 1606, known as the Intelligence Authorization Act for Fiscal Year 2000. For complete classification of this Act to the Code, see Tables.

Amendments

2022—Subsec. (i)(1). Pub. L. 117–286 substituted "chapter 10 of title 5" for "the Federal Advisory Committee Act (5 U.S.C. App.)".

Statutory Notes and Related Subsidiaries

Change of Name

Committee on International Relations of House of Representatives changed to Committee on Foreign Affairs of House of Representatives by House Resolution No. 6, One Hundred Tenth Congress, Jan. 5, 2007.

¹ So in original. Probably should be "of".

² So in original. Section 5703 of title 5 does not contain a subsec. (b).

³ So in original. Probably should be "Commission".

CHAPTER 25—MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS

SUBCHAPTER I—ANTI-DOPING AGENCY

        

SUBCHAPTER II—NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE

        

SUBCHAPTER I—ANTI-DOPING AGENCY

§2001. Designation of United States Anti-Doping Agency

(a) Definitions

In this subchapter:

(1) United States Olympic Committee

The term "United States Olympic Committee" means the organization established by the "Ted Stevens Olympic and Amateur Sports Act" (36 U.S.C. 220501 et seq.).

(2) Amateur athletic competition

The term "amateur athletic competition" means a contest, game, meet, match, tournament, regatta, or other event in which amateur athletes compete (36 U.S.C. 220501(b)(2)).

(3) Amateur athlete

The term "amateur athlete" means an athlete who meets the eligibility standards established by the national governing body or paralympic sports organization for the sport in which the athlete competes (36 U.S.C. 22501(b)(1)).¹

(b) In general

The United States Anti-Doping Agency shall—

(1)(A) serve as the independent anti-doping organization for the amateur athletic competitions recognized by the United States Olympic and Paralympic Committee;

(B) be responsible for certifying in advance any testing conducted by international organizations under the World Anti-Doping Code for international amateur athletes and athletic competitions occurring within the jurisdiction of the United States; and

(C) be recognized worldwide as the independent national anti-doping organization for the United States;

(2) ensure that athletes participating in amateur athletic activities recognized by the United States Olympic Committee are prevented from using performance-enhancing drugs or prohibited performance-enhancing methods adopted by the Agency;

(3) implement anti-doping education, research, testing, and adjudication programs to prevent United States Amateur Athletes participating in any activity recognized by the United States Olympic Committee from using performance-enhancing drugs or prohibited performance-enhancing methods adopted by the Agency;

(4) serve as the United States representative responsible for coordination with other anti-doping organizations coordinating amateur athletic competitions recognized by the United States Olympic Committee to ensure the integrity of athletic competition, the health of the athletes, and the prevention of use by United States amateur athletes of performance-enhancing drugs or prohibited performance-enhancing methods adopted by the Agency; and

(5) promote a positive youth sport experience by using a portion of the funding of the United States Anti-Doping Agency to provide educational materials on sportsmanship, character building, and healthy performance for the athletes, parents, and coaches who participate in youth sports.

(c) Due process in arbitration proceedings

Any action taken by the United States Anti-Doping Agency to enforce a policy, procedure, or requirement of the United States Anti-Doping Agency against a person with respect to a violation of Federal law, including an investigation, a disciplinary action, a sanction, or any other administrative action, shall be carried out in a manner that provides due process protection to the person.

(Pub. L. 109–469, title VII, §701, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 113–280, §2, Dec. 18, 2014, 128 Stat. 3020; Pub. L. 117–103, div. Q, title III, §303, Mar. 15, 2022, 136 Stat. 817.)

Editorial Notes

References in Text

The Ted Stevens Olympic and Amateur Sports Act, referred to in subsec. (a)(1), is chapter 2205 of Title 36, Patriotic and National Observances, Ceremonies, and Organizations.

Amendments

2022—Subsec. (b)(1). Pub. L. 117–103, §303(1)(A), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "serve as the independent anti-doping organization for the amateur athletic competitions recognized by the United States Olympic Committee and be recognized worldwide as the independent national anti-doping organization for the United States;".

Subsec. (b)(5). Pub. L. 117–103, §303(1)(B), (C), added par. (5).

Subsec. (c). Pub. L. 117–103, §303(2), added subsec. (c).

2014—Subsec. (a)(4). Pub. L. 113–280, §2(1), struck out par. (4). Text read as follows: "The term 'gene doping' means the nontherapeutic use of cells, genes, genetic elements, or of the modulation of gene expression, having the capacity to enhance athletic performance."

Subsec. (b)(1). Pub. L. 113–280, §2(2)(A), inserted "and be recognized worldwide as the independent national anti-doping organization for the United States" after "Committee".

Subsec. (b)(2). Pub. L. 113–280, §2(2)(B), substituted "or prohibited performance-enhancing methods adopted by the Agency" for ", or performance-enhancing genetic modifications accomplished through gene-doping".

Subsec. (b)(3). Pub. L. 113–280, §2(2)(C), substituted "or prohibited performance-enhancing methods adopted by the Agency" for ", or performance-enhancing genetic modifications accomplished through gene-doping".

Subsec. (b)(4). Pub. L. 113–280, §2(2)(D), substituted ", and the prevention of use by United States amateur athletes of performance-enhancing drugs or prohibited performance-enhancing methods adopted by the Agency." for "and the prevention of use of performance-enhancing drugs, or performance-enhancing genetic modifications accomplished through gene-doping by United States amateur athletes; and".

Subsec. (b)(5). Pub. L. 113–280, §2(2)(E), struck out par. (5) which read as follows: "permanently include 'gene doping' among any list of prohibited substances adopted by the Agency."

Statutory Notes and Related Subsidiaries

Change of Name

References to the United States Olympic Committee deemed to refer to the United States Olympic and Paralympic Committee, see section 220502(c) of Title 36, Patriotic and National Observances, Ceremonies, and Organizations.

Short Title of 2022 Amendment

Pub. L. 117–103, div. Q, title III, §301, Mar. 15, 2022, 136 Stat. 816, provided that: "This title [enacting section 2004 of this title, amending this section and section 2003 of this title, and enacting provisions set out as a note below] may be cited as the 'United States Anti-Doping Agency Reauthorization Act of 2022'."

Short Title of 2014 Amendment

Pub. L. 113–280, §1, Dec. 18, 2014, 128 Stat. 3020, provided that: "This Act [amending this section and section 2003 of this title] may be cited as the 'United States Anti-Doping Agency Reauthorization Act'."

Short Title

Pub. L. 109–469, title X, §1001, Dec. 29, 2006, 120 Stat. 3537, provided that: "This title [enacting subchapter II of this chapter] may be cited as the 'National Methamphetamine Information Clearinghouse Act of 2006'."

Findings

Pub. L. 117–103, div. Q, title III, §302, Mar. 15, 2022, 136 Stat. 816, provided that: "Congress makes the following findings:

"(1) The United States Anti-Doping Agency—

"(A) is the independent national anti-doping organization of the United States; and

"(B) manages the anti-doping program, results management processes, drug reference resources, and athlete education for all United States Olympic Committee-recognized national governing bodies and the athletes and events of such national governing bodies.

"(2) The United States Anti-Doping Agency contributes to the advancement of clean sport through scientific research, anti-doping education, and outreach programs, and the mission of the United States Anti-Doping Agency is to preserve the integrity of competition and protect the rights of athletes.

"(3) Participation in youth sports has the potential to equip young athletes with important skills and values necessary for success in life, and it is essential that the culture of youth sports emphasizes such skills and values.

"(4) The TrueSport program of the United States Anti-Doping Agency partners with youth sport organizations across the United States to promote sportsmanship, character building, and healthy performance through the use of targeted educational materials designed to promote a positive youth sport experience.

"(5) In modifying the authority of the United States Anti-Doping Agency to include the promotion of the positive values of youth sport, Congress sends a strong signal that the goals of youth sport should include instilling in young athletes the values of integrity, respect, teamwork, courage, and responsibility.

"(6) Due to the unique leadership position of the United States in the global community, adequate funding of the anti-doping and clean sport programs of the United States Anti-Doping Agency is imperative to the preparation for the 2028 Summer Olympic Games, which will be held in Los Angeles, California.

"(7) Increased appropriations for fiscal years 2023 through 2031 would enable the United States Anti-Doping Agency to directly affect the integrity and well-being of sport, both domestically and internationally."

¹ So in original. Probably should be "220501(b)(1))."

§2002. Records, audit, and report

(a) Records

The United States Anti-Doping Agency shall keep correct and complete records of account.

(b) Report

The United States Anti-Doping Agency shall submit an annual report to Congress which shall include—

(1) an audit conducted and submitted in accordance with section 10101 of title 36; and

(2) a description of the activities of the agency.

(Pub. L. 109–469, title VII, §702, Dec. 29, 2006, 120 Stat. 3534.)

§2003. Authorization of appropriations

There are authorized to be appropriated to the United States Anti-Doping Agency—

(1) for fiscal year 2023, $15,500,000;

(2) for fiscal year 2024, $16,200,000;

(3) for fiscal year 2025, $16,900,000;

(4) for fiscal year 2026, $17,700,000;

(5) for fiscal year 2027, $18,500,000;

(6) for fiscal year 2028, $19,800,000;

(7) for fiscal year 2029, $22,100,000;

(8) for fiscal year 2030, $24,900,000; and

(9) for fiscal year 2031, $23,700,000.

(Pub. L. 109–469, title VII, §703, Dec. 29, 2006, 120 Stat. 3534; Pub. L. 113–280, §3, Dec. 18, 2014, 128 Stat. 3020; Pub. L. 117–103, div. Q, title III, §304, Mar. 15, 2022, 136 Stat. 817.)

Editorial Notes

Amendments

2022—Pub. L. 117–103 amended section generally. Prior to amendment, section related to appropriations for fiscal years 2014 to 2020.

2014—Pub. L. 113–280 amended section generally. Prior to amendment, section related to authorization of appropriations for fiscal years 2007 to 2011.

§2004. Information sharing

Except as otherwise prohibited by law and except in cases in which the integrity of a criminal investigation would be affected, pursuant to the obligation of the United States under Article 7 of the United Nations Educational, Scientific, and Cultural Organization International Convention Against Doping in Sport done at Paris October 19, 2005, and ratified by the United States in 2008, the Attorney General, the Secretary of Homeland Security, and the Commissioner of Food and Drugs shall provide to the United States Anti-Doping Agency any relevant information relating to the prevention of the use of performance-enhancing drugs or the prohibition of performance-enhancing methods.

(Pub. L. 117–103, div. Q, title III, §305, Mar. 15, 2022, 136 Stat. 817.)

Editorial Notes

Codification

Section was enacted as part of the United States Anti-Doping Agency Reauthorization Act of 2022 and also as part of the Consolidated Appropriations Act, 2022, and not as part of title VII of Pub. L. 109–469 which comprises this chapter.

SUBCHAPTER II—NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE

§2011. Definitions

In this subchapter—

(1) the term "Council" means the National Methamphetamine Advisory Council established under section 2012(b)(1) of this title;

(2) the term "drug endangered children" means children whose physical, mental, or emotional health are at risk because of the production, use, or other effects of methamphetamine production or use by another person;

(3) the term "National Methamphetamine Information Clearinghouse" or "NMIC" means the information clearinghouse established under section 2012(a) of this title; and

(4) the term "qualified entity" means a State, local, or tribal government, school board, or public health, law enforcement, nonprofit, community anti-drug coalition, or other nongovernmental organization providing services related to methamphetamines.

(Pub. L. 109–469, title X, §1002, Dec. 29, 2006, 120 Stat. 3537.)

§2012. Establishment of clearinghouse and advisory council

(a) Clearinghouse

There is established, under the supervision of the Attorney General of the United States, an information clearinghouse to be known as the National Methamphetamine Information Clearinghouse.

(b) Advisory council

(1) In general

There is established an advisory council to be known as the National Methamphetamine Advisory Council.

(2) Membership

The Council shall consist of 10 members appointed by the Attorney General—

(A) not fewer than 3 of whom shall be representatives of law enforcement agencies;

(B) not fewer than 4 of whom shall be representatives of nongovernmental and nonprofit organizations providing services or training and implementing programs or strategies related to methamphetamines; and

(C) 1 of whom shall be a representative of the Department of Health and Human Services.

(3) Period of appointment; vacancies

Members shall be appointed for 3 years. Any vacancy in the Council shall not affect its powers, but shall be filled in the same manner as the original appointment.

(4) Personnel matters

(A) Travel expenses

The members of the Council shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title 5, while away from their homes or regular places of business in the performance of services for the Council.

(B) No compensation

The members of the Council shall not receive compensation for the performance of the duties of a member of the Council.

(Pub. L. 109–469, title X, §1003, Dec. 29, 2006, 120 Stat. 3538.)

§2013. NMIC requirements and review

(a) In general

The NMIC shall promote sharing information regarding successful law enforcement, treatment, environmental, prevention, social services, and other programs related to the production, use, or effects of methamphetamine and grants available for such programs.

(b) Components

The NMIC shall include—

(1) a toll-free number; and

(2) a website that provides a searchable database, which—

(A) provides information on the short-term and long-term effects of methamphetamine use;

(B) provides information regarding methamphetamine treatment and prevention programs and strategies and programs for drug endangered children, including descriptions of successful programs and strategies and contact information for such programs and strategies;

(C) provides information regarding grants for methamphetamine-related programs, including contact information and links to websites;

(D) allows a qualified entity to submit items to be posted on the website regarding successful public or private programs or other useful information related to the production, use, or effects of methamphetamine;

(E) includes a restricted section that may only be accessed by a law enforcement organization that contains successful strategies, training techniques, and other information that the Council determines helpful to law enforcement agency efforts to identify or combat the production, use, or effects of methamphetamine;

(F) allows public access to all information not in a restricted section; and

(G) contains any additional information the Council determines may be useful in identifying or combating the production, use, or effects of methamphetamine.

Thirty days after the website in paragraph (2) is operational, no funds shall be expended to continue the website methresources.gov.

(c) Review of posted information

(1) In general

Not later than 30 days after the date of submission of an item by a qualified entity, the Council shall review an item submitted for posting on the website described in subsection (b)(2)—

(A) to evaluate and determine whether the item, as submitted or as modified, meets the requirements for posting; and

(B) in consultation with the Attorney General, to determine whether the item should be posted in a restricted section of the website.

(2) Determination

Not later than 45 days after the date of submission of an item, the Council shall—

(A) post the item on the website described in subsection (b)(2); or

(B) notify the qualified entity that submitted the item regarding the reason such item shall not be posted and modifications, if any, that the qualified entity may make to allow the item to be posted.

(Pub. L. 109–469, title X, §1004, Dec. 29, 2006, 120 Stat. 3538.)

§2014. Authorization of appropriations

There are authorized to be appropriated—

(1) for fiscal year 2007—

(A) $500,000 to establish the NMIC and Council; and

(B) such sums as are necessary for the operation of the NMIC and Council; and

(2) for each of fiscal years 2008 and 2009, such sums as are necessary for the operation of the NMIC and Council.

(Pub. L. 109–469, title X, §1005, Dec. 29, 2006, 120 Stat. 3539.)

CHAPTER 26—FOOD SAFETY

        

§2101. Findings

Congress finds that—

(1) the safety and integrity of the United States food supply are vital to public health, to public confidence in the food supply, and to the success of the food sector of the Nation's economy;

(2) illnesses and deaths of individuals and companion animals caused by contaminated food—

(A) have contributed to a loss of public confidence in food safety; and

(B) have caused significant economic losses to manufacturers and producers not responsible for contaminated food items;

(3) the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to—

(A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;

(B) an increasing volume of imported food from a wide variety of countries; and

(C) a shortage of adequate resources for monitoring and inspection;

(4) according to the Economic Research Service of the Department of Agriculture, the United States is increasing the amount of food that it imports such that—

(A) from 2003 to 2007, the value of food imports has increased from $45,600,000,000 to $64,000,000,000; and

(B) imported food accounts for 13 percent of the average American diet including 31 percent of fruits, juices, and nuts, 9.5 percent of red meat, and 78.6 percent of fish and shellfish; and

(5) the number of full-time equivalent Food and Drug Administration employees conducting inspections has decreased from 2003 to 2007.

(Pub. L. 110–85, title X, §1001, Sept. 27, 2007, 121 Stat. 962.)

§2102. Ensuring the safety of pet food

(a) Processing and ingredient standards

Not later than 2 years after September 27, 2007, the Secretary of Health and Human Services (referred to in this chapter as the "Secretary"), in consultation with the Association of American Feed Control Officials and other relevant stakeholder groups, including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by regulation establish—

(1) processing standards for pet food; and

(2) updated standards for the labeling of pet food that include nutritional and ingredient information.

(b) Early warning surveillance systems and notification during pet food recalls

Not later than 1 year after September 27, 2007, the Secretary shall establish an early warning and surveillance system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food. In establishing such system, the Secretary shall—

(1) consider using surveillance and monitoring mechanisms similar to, or in coordination with, those used to monitor human or animal health, such as the Foodborne Diseases Active Surveillance Network (FoodNet) and PulseNet of the Centers for Disease Control and Prevention, the Food Emergency Response Network of the Food and Drug Administration and the Department of Agriculture, and the National Animal Health Laboratory Network of the Department of Agriculture;

(2) consult with relevant professional associations and private sector veterinary hospitals;

(3) work with the National Companion Animal Surveillance Program, the Health Alert Network, or other notification networks as appropriate to inform veterinarians and relevant stakeholders during any recall of pet food; and

(4) use such information and conduct such other activities as the Secretary deems appropriate.

(Pub. L. 110–85, title X, §1002, Sept. 27, 2007, 121 Stat. 963; Pub. L. 115–234, title III, §306(b), Aug. 14, 2018, 132 Stat. 2441.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this title", meaning title X of Pub. L. 110–85, Sept. 27, 2007, 121 Stat. 962, which enacted this chapter and section 350f of this title, amended sections 321 and 331 of this title, and enacted provisions set out as notes under sections 350f and 2110 of this title. For complete classification of title X to the Code, see Tables.

Amendments

2018—Subsec. (a). Pub. L. 115–234 redesignated pars. (2) and (3) as (1) and (2), respectively, and struck out former par. (1) which read as follows: "ingredient standards and definitions with respect to pet food;".

§2103. Ensuring efficient and effective communications during a recall

The Secretary shall, during an ongoing recall of human or pet food regulated by the Secretary—

(1) work with companies, relevant professional associations, and other organizations to collect and aggregate information pertaining to the recall;

(2) use existing networks of communication, including electronic forms of information dissemination, to enhance the quality and speed of communication with the public; and

(3) post information regarding recalled human and pet foods on the Internet Web site of the Food and Drug Administration in a single location, which shall include a searchable database of recalled human foods and a searchable database of recalled pet foods, that is easily accessed and understood by the public.

(Pub. L. 110–85, title X, §1003, Sept. 27, 2007, 121 Stat. 963.)

§2104. State and Federal cooperation

(a) In general

The Secretary shall work with the States in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that State food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage States to—

(1) establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and

(2) establish procedures and requirements for ensuring that processed produce under the jurisdiction of State food safety programs is not unsafe for human consumption.

(b) Assistance

The Secretary may provide to a State, for planning, developing, and implementing such a food safety program—

(1) advisory assistance;

(2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and

(3) financial and other assistance.

(c) Service agreements

The Secretary may, under an agreement entered into with a Federal, State, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under this subsection may provide for training of State employees.

(Pub. L. 110–85, title X, §1004, Sept. 27, 2007, 121 Stat. 964.)

§2105. Enhanced aquaculture and seafood inspection

(a) Findings

Congress finds the following:

(1) In 2007, there has been an overwhelming increase in the volume of aquaculture and seafood that has been found to contain substances that are not approved for use in food in the United States.

(2) As of May 2007, inspection programs are not able to satisfactorily accomplish the goals of ensuring the food safety of the United States.

(3) To protect the health and safety of consumers in the United States, the ability of the Secretary to perform inspection functions must be enhanced.

(b) Heightened inspections

The Secretary is authorized to enhance, as necessary, the inspection regime of the Food and Drug Administration for aquaculture and seafood, consistent with obligations of the United States under international agreements and United States law.

(c) Report to Congress

Not later than 180 days after September 27, 2007, the Secretary shall submit to Congress a report that—

(1) describes the specifics of the aquaculture and seafood inspection program;

(2) describes the feasibility of developing a traceability system for all catfish and seafood products, both domestic and imported, for the purpose of identifying the processing plant of origin of such products; and

(3) provides for an assessment of the risks associated with particular contaminants and banned substances.

(d) Partnerships with States

Upon the request by any State, the Secretary may enter into partnership agreements, as soon as practicable after the request is made, to implement inspection programs to Federal standards regarding the importation of aquaculture and seafood.

(Pub. L. 110–85, title X, §1006, Sept. 27, 2007, 121 Stat. 969.)

Statutory Notes and Related Subsidiaries

Regulation of Export of Shrimp to the United States

Pub. L. 116–260, div. A, title VII, §787, Dec. 27, 2020, 134 Stat. 1230, provided that:

"(a) The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (Commissioner), shall develop and, if it determines feasible, implement a number of options for regulating the export of shrimp to the United States from other countries, including the three largest exporting countries by volume to the United States over the last three calendar years, such as sampling of products prior to export to the United States, increasing foreign inspections of export facilities, increased seafood importer inspections, foreign surveillance inspections at overseas manufacturing sites, enhanced import screening, higher rates of examination and sampling, use of third-party audits, and formal seafood arrangements with foreign competent authorities.

"(b) The Commissioner shall especially give priority consideration to the following with the funds appropriated—

"(1) that appropriate controls are applied to shrimp feed and production ponds, processing plants, and facilities throughout the chain of distribution to determine compliance with seafood safety requirements;

"(2) dedicate its inspectional effort to determine compliance with seafood arrangements, once established, from any dedicated funds;

"(3) provide an annual report to the Committee before the end of fiscal years 2021, 2022, and 2023 with the reporting requirement goal being to provide the Committee information related to FDA's oversight of the safety of shrimp products imported into the United States."

§2106. Consultation regarding genetically engineered seafood products

The Commissioner of Food and Drugs shall consult with the Assistant Administrator of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration to produce a report on any environmental risks associated with genetically engineered seafood products, including the impact on wild fish stocks.

(Pub. L. 110–85, title X, §1007, Sept. 27, 2007, 121 Stat. 969.)

§2107. Sense of Congress

It is the sense of Congress that—

(1) it is vital for Congress to provide the Food and Drug Administration with additional resources, authorities, and direction with respect to ensuring the safety of the food supply of the United States;

(2) additional inspectors are required to improve the Food and Drug Administration's ability to safeguard the food supply of the United States;

(3) because of the increasing volume of international trade in food products the Secretary should make it a priority to enter into agreements with the trading partners of the United States with respect to food safety; and

(4) Congress should work to develop a comprehensive response to the issue of food safety.

(Pub. L. 110–85, title X, §1008, Sept. 27, 2007, 121 Stat. 970.)

§2108. Annual report to Congress

The Secretary shall, on an annual basis, submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report that includes, with respect to the preceding 1-year period—

(1) the number and amount of food products regulated by the Food and Drug Administration imported into the United States, aggregated by country and type of food;

(2) a listing of the number of Food and Drug Administration inspectors of imported food products referenced in paragraph (1) and the number of Food and Drug Administration inspections performed on such products; and

(3) aggregated data on the findings of such inspections, including data related to violations of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and enforcement actions used to follow-up on such findings and violations.

(Pub. L. 110–85, title X, §1009, Sept. 27, 2007, 121 Stat. 970.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in par. (3), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

§2109. Publication of annual reports

(a) In general

The Commissioner of Food and Drugs shall annually submit to Congress and publish on the Internet Web site of the Food and Drug Administration, a report concerning the results of the Administration's pesticide residue monitoring program, that includes—

(1) information and analysis similar to that contained in the report entitled "Food and Drug Administration Pesticide Program Residue Monitoring 2003" as released in June of 2005;

(2) based on an analysis of previous samples, an identification of products or countries (for imports) that require special attention and additional study based on a comparison with equivalent products manufactured, distributed, or sold in the United States (including details on the plans for such additional studies), including in the initial report (and subsequent reports as determined necessary) the results and analysis of the Ginseng Dietary Supplements Special Survey as described on page 13 of the report entitled "Food and Drug Administration Pesticide Program Residue Monitoring 2003";

(3) information on the relative number of interstate and imported shipments of each tested commodity that were sampled, including recommendations on whether sampling is statistically significant, provides confidence intervals or other related statistical information, and whether the number of samples should be increased and the details of any plans to provide for such increase; and

(4) a description of whether certain commodities are being improperly imported as another commodity, including a description of additional steps that are being planned to prevent such smuggling.

(b) Initial reports

Annual reports under subsection (a) for fiscal years 2004 through 2006 may be combined into a single report, by not later than June 1, 2008, for purposes of publication under subsection (a). Thereafter such reports shall be completed by June 1 of each year for the data collected for the year that was 2-years prior to the year in which the report is published.

(c) Memorandum of understanding

The Commissioner of Food and Drugs, the Administrator of the Food Safety and Inspection Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall enter into a memorandum of understanding to permit inclusion of data in the reports under subsection (a) relating to testing carried out by the Food Safety and Inspection Service and the Agricultural Marketing Service on meat, poultry, eggs, and certain raw agricultural products, respectively.

(Pub. L. 110–85, title X, §1010, Sept. 27, 2007, 121 Stat. 970.)

§2110. Rule of construction

Nothing in this chapter (or an amendment made by this chapter) shall be construed to affect—

(1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103–417); or

(2) the adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462).

(Pub. L. 110–85, title X, §1011, Sept. 27, 2007, 121 Stat. 971.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title X of Pub. L. 110–85, Sept. 27, 2007, 121 Stat. 962, which enacted this chapter and section 350f of this title, amended sections 321 and 331 of this title, and enacted provisions set out as notes under this section and section 350f of this title. For complete classification of title X to the Code, see Tables.

The Dietary Supplement Health and Education Act of 1994, referred to in par. (1), is Pub. L. 103–417, Oct. 25, 1994, 108 Stat. 4325, which enacted sections 343–2 and 350b of this title and section 287c–11 of Title 42, The Public Health and Welfare, amended sections 321, 331, 342, 343, and 350 of this title and section 281 of Title 42, and enacted provisions set out as notes under sections 321 and 343 of this title. For complete classification of this Act to the Code, see Short Title of 1994 Amendments note set out under section 301 of this title and Tables.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act, referred to in par. (2), is Pub. L. 109–462, Dec. 22, 2006, 120 Stat. 3469, which enacted sections 379aa and 379aa–1 of this title, amended sections 331, 343, 352, and 381 of this title, and enacted provisions set out as notes under sections 331, 343, 352, 379aa, and 381 of this title. For complete classification of this Act to the Code, see Short Title of 2006 Amendment note set out under section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 110–85, title X, §1005(g), Sept. 27, 2007, 121 Stat. 969, provided that: "Nothing in this title [enacting this chapter and section 350f of this title, amending sections 321 and 331 of this title, and enacting provisions set out as notes under section 350f of this title], or an amendment made by this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations."

CHAPTER 27—FOOD SAFETY MODERNIZATION

SUBCHAPTER I—IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

        

SUBCHAPTER II—IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS

        

SUBCHAPTER III—IMPROVING THE SAFETY OF IMPORTED FOOD

        

SUBCHAPTER IV—MISCELLANEOUS PROVISIONS

        

SUBCHAPTER I—IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

§2201. Performance standards

(a) In general

The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants.

(b) Guidance documents and regulations

Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under section 342 of this title or to prevent the spread by food of communicable disease under section 264 of title 42, the Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations. Such guidance, including guidance regarding action levels, or regulations—

(1) shall apply to products or product classes;

(2) shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and

(3) shall not be written to be facility-specific.

(c) No duplication of efforts

The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants.

(d) Review

The Secretary shall periodically review and revise, as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section.

(Pub. L. 111–353, title I, §104, Jan. 4, 2011, 124 Stat. 3899.)

Editorial Notes

References in Text

The Secretary, referred to in text, probably means the Secretary of Health and Human Services.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 111–353, §1(a), Jan. 4, 2011, 124 Stat. 3885, provided that: "This Act [enacting this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amending sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacting provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title] may be cited as the 'FDA Food Safety Modernization Act'."

§2202. National Agriculture and Food Defense Strategy

(a) Development and submission of strategy

(1) In general

Not later than 1 year after January 4, 2011, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and transmit to the relevant committees of Congress, and make publicly available on the Internet Web sites of the Department of Health and Human Services and the Department of Agriculture, the National Agriculture and Food Defense Strategy.

(2) Implementation plan

The strategy shall include an implementation plan for use by the Secretaries described under paragraph (1) in carrying out the strategy.

(3) Research

The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the goals and activities described in paragraphs (1) and (2) of subsection (b).

(4) Revisions

Not later than 4 years after the date on which the strategy is submitted to the relevant committees of Congress under paragraph (1), and not less frequently than every 4 years thereafter, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall revise and submit to the relevant committees of Congress the strategy.

(5) Consistency with existing plans

The strategy described in paragraph (1) shall be consistent with—

(A) the National Incident Management System;

(B) the National Response Framework;

(C) the National Infrastructure Protection Plan;

(D) the National Preparedness Goals; and

(E) other relevant national strategies.

(b) Components

(1) In general

The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security—

(A) to achieve each goal described in paragraph (2); and

(B) to evaluate the progress made by Federal, State, local, and tribal governments towards the achievement of each goal described in paragraph (2).

(2) Goals

The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security to achieve the following goals:

(A) Preparedness goal

Enhance the preparedness of the agriculture and food system by—

(i) conducting vulnerability assessments of the agriculture and food system;

(ii) mitigating vulnerabilities of the system;

(iii) improving communication and training relating to the system;

(iv) developing and conducting exercises to test decontamination and disposal plans;

(v) developing modeling tools to improve event consequence assessment and decision support; and

(vi) preparing risk communication tools and enhancing public awareness through outreach.

(B) Detection goal

Improve agriculture and food system detection capabilities by—

(i) identifying contamination in food products at the earliest possible time; and

(ii) conducting surveillance to prevent the spread of diseases.

(C) Emergency response goal

Ensure an efficient response to agriculture and food emergencies by—

(i) immediately investigating animal disease outbreaks and suspected food contamination;

(ii) preventing additional human illnesses;

(iii) organizing, training, and equipping animal, plant, and food emergency response teams of—

(I) the Federal Government; and

(II) State, local, and tribal governments;

(iv) designing, developing, and evaluating training and exercises carried out under agriculture and food defense plans; and

(v) ensuring consistent and organized risk communication to the public by—

(I) the Federal Government;

(II) State, local, and tribal governments; and

(III) the private sector.

(D) Recovery goal

Secure agriculture and food production after an agriculture or food emergency by—

(i) working with the private sector to develop business recovery plans to rapidly resume agriculture, food production, and international trade;

(ii) conducting exercises of the plans described in subparagraph (C) with the goal of long-term recovery results;

(iii) rapidly removing, and effectively disposing of—

(I) contaminated agriculture and food products; and

(II) infected plants and animals; and

(iv) decontaminating and restoring areas affected by an agriculture or food emergency.

(3) Evaluation

The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall—

(A) develop metrics to measure progress for the evaluation process described in paragraph (1)(B); and

(B) report on the progress measured in subparagraph (A) as part of the National Agriculture and Food Defense strategy described in subsection (a)(1).

(c) Limited distribution

In the interest of national security, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, may determine the manner and format in which the National Agriculture and Food Defense strategy established under this section is made publicly available on the Internet Web sites of the Department of Health and Human Services, the Department of Homeland Security, and the Department of Agriculture, as described in subsection (a)(1).

(Pub. L. 111–353, title I, §108, Jan. 4, 2011, 124 Stat. 3910.)

Editorial Notes

References in Text

The Secretary, referred to in subsec. (b)(3), probably means the Secretary of Health and Human Services.

§2203. Food and Agriculture Coordinating Councils

The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within 180 days of January 4, 2011, and annually thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on—

(1) facilitating partnerships between public and private entities to help coordinate and enhance the protection of the agriculture and food system of the United States;

(2) providing for the regular and timely interchange of information between each council relating to the security of the agriculture and food system (including intelligence information);

(3) identifying best practices and methods for improving the coordination among Federal, State, local, and private sector preparedness and response plans for agriculture and food defense; and

(4) recommending methods by which to protect the economy and the public health of the United States from the effects of—

(A) animal or plant disease outbreaks;

(B) food contamination; and

(C) natural disasters affecting agriculture and food.

(Pub. L. 111–353, title I, §109, Jan. 4, 2011, 124 Stat. 3912.)

§2204. Building domestic capacity

(a) In general

(1) Initial report

The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after January 4, 2011, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following:

(A) Analysis of the need for further regulations or guidance to industry.

(B) Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils referred to in section 2203 of this title, to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats.

(C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies.

(D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated.

(E) Surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards, including how such systems and networks are integrated.

(F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 2202 and 2224 of this title.

(G) The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period.

(H) The impact of requirements under this Act (including amendments made by this Act) on certified organic farms and facilities (as defined in section 350d of this title.¹

(I) Specific efforts taken pursuant to the agreements authorized under section 350j(c) of this title (as added by section 201),² together with, as necessary, a description of any additional authorities necessary to improve seafood safety.

(2) Biennial reports

On a biennial basis following the submission of the report under paragraph (1), the Secretary shall submit to Congress a report that—

(A) reviews previous food safety programs and practices;

(B) outlines the success of those programs and practices;

(C) identifies future programs and practices; and

(D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary.

(b) Risk-based activities

The report developed under subsection (a)(1) shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply.

(c) Capability for laboratory analyses; research

The report developed under subsection (a)(1) shall provide a description of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry and by Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities and progress toward laboratory accreditation under section 350k of this title (as added by section 202).²

(d) Information technology

The report developed under subsection (a)(1) shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system under section 350d of this title, and the prior notice system under section 381(m) of this title with other information technology systems that are used by the Federal Government for the processing of food offered for import into the United States.

(e) Automated risk assessment

The report developed under subsection (a)(1) shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources.

(f) Traceback and surveillance report

The Secretary shall include in the report developed under subsection (a)(1) an analysis of the Food and Drug Administration's performance in foodborne illness outbreaks during the 5-year period preceding January 4, 2011, involving fruits and vegetables that are raw agricultural commodities (as defined in section 321(r) of this title) and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, industry, and State and local governments, as such communication and coordination relates to outbreak identification and traceback.

(g) Biennial food safety and food defense research plan

The Secretary, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of foodborne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period.

(h) Effectiveness of programs administered by the Department of Health and Human Services

(1) In general

To determine whether existing Federal programs administered by the Department of Health and Human Services are effective in achieving the stated goals of such programs, the Secretary shall, beginning not later than 1 year after January 4, 2011—

(A) conduct an annual evaluation of each program of such Department to determine the effectiveness of each such program in achieving legislated intent, purposes, and objectives; and

(B) submit to Congress a report concerning such evaluation.

(2) Content

The report described under paragraph (1)(B) shall—

(A) include conclusions concerning the reasons that such existing programs have proven successful or not successful and what factors contributed to such conclusions;

(B) include recommendations for consolidation and elimination to reduce duplication and inefficiencies in such programs at such Department as identified during the evaluation conduct ³ under this subsection; and

(C) be made publicly available in a publication entitled "Guide to the U.S. Department of Health and Human Services Programs".

(i) Unique identification numbers

(1) In general

Not later than 1 year after January 4, 2011, the Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study regarding the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each food facility registered with the Secretary and, as appropriate, each broker that imports food into the United States. Such study shall include an evaluation of the costs associated with development and implementation of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system.

(2) Report

Not later than 15 months after January 4, 2011, the Secretary shall submit to Congress a report that describes the findings of the study conducted under paragraph (1) and that includes any recommendations determined appropriate by the Secretary.

(Pub. L. 111–353, title I, §110, Jan. 4, 2011, 124 Stat. 3913.)

Editorial Notes

References in Text

The Secretary, referred to in subsecs. (a), (b), (d), (f), (g), (h)(1), and (i), probably means the Secretary of Health and Human Services.

This Act, referred to in subsec. (a)(1)(H), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Section 350d of this title, referred to in subsec. (a)(1)(H), and section 321(r) of this title, referred to in subsec. (f), were in the original "section 415 (21 U.S.C. 350d)" and "section 201(r) (21 U.S.C. 321(r))", respectively, and were translated as meaning sections 415 and 201(r) of the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, to reflect the probable intent of Congress.

Section 201, referred to in subsec. (a)(1)(I), and section 202, referred to in subsec. (c), mean sections 201 and 202, respectively, of Pub. L. 111–353.

¹ So in original. Probably should be "title)."

² See References in Text note below.

³ So in original. Probably should be "conducted".

§2205. Food allergy and anaphylaxis management

(a) Definitions

In this section:

(1) Early childhood education program

The term "early childhood education program" means—

(A) a Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831 et seq.);

(B) a State licensed or regulated child care program or school; or

(C) a State prekindergarten program that serves children from birth through kindergarten.

(2) ESEA definitions

The terms "local educational agency", "secondary school", "elementary school", and "parent" have the meanings given the terms in section 7801 of title 20.

(3) School

The term "school" includes public—

(A) kindergartens;

(B) elementary schools; and

(C) secondary schools.

(4) Secretary

The term "Secretary" means the Secretary of Health and Human Services.

(b) Establishment of voluntary food allergy and anaphylaxis management guidelines

(1) Establishment

(A) In general

Not later than 1 year after January 4, 2011, the Secretary, in consultation with the Secretary of Education, shall—

(i) develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; and

(ii) make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only.

(B) Applicability of FERPA

Each plan described in subparagraph (A) that is developed for an individual shall be considered an education record for the purpose of section 1232g of title 20 (commonly referred to as the "Family Educational Rights and Privacy Act of 1974").

(2) Contents

The voluntary guidelines developed by the Secretary under paragraph (1) shall address each of the following and may be updated as the Secretary determines necessary:

(A) Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with—

(i) documentation from their child's physician or nurse—

(I) supporting a diagnosis of food allergy, and any risk of anaphylaxis, if applicable;

(II) identifying any food to which the child is allergic;

(III) describing, if appropriate, any prior history of anaphylaxis;

(IV) listing any medication prescribed for the child for the treatment of anaphylaxis;

(V) detailing emergency treatment procedures in the event of a reaction;

(VI) listing the signs and symptoms of a reaction; and

(VII) assessing the child's readiness for self-administration of prescription medication; and

(ii) a list of substitute meals that may be offered to the child by school or early childhood education program food service personnel.

(B) The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where—

(i) the children are capable of self-administering medication; and

(ii) such administration is not prohibited by State law.

(C) Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response.

(D) Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias.

(E) The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children.

(F) Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies.

(G) The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available.

(H) The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available.

(I) The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs,¹ and school-sponsored or early childhood education program-sponsored programs held on weekends.

(J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents.

(K) Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs.

(3) Relation to State law

Nothing in this section or the guidelines developed by the Secretary under paragraph (1) shall be construed to preempt State law, including any State law regarding whether students at risk for anaphylaxis may self-administer medication.

(c) School-based food allergy management grants

(1) In general

The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection (b).

(2) Application

(A) In general

To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.

(B) Contents

Each application submitted under subparagraph (A) shall include—

(i) an assurance that the local educational agency has developed plans in accordance with the food allergy and anaphylaxis management guidelines described in subsection (b);

(ii) a description of the activities to be funded by the grant in carrying out the food allergy and anaphylaxis management guidelines, including—

(I) how the guidelines will be carried out at individual schools served by the local educational agency;

(II) how the local educational agency will inform parents and students of the guidelines in place;

(III) how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; and

(IV) any other activities that the Secretary determines appropriate;

(iii) an itemization of how grant funds received under this subsection will be expended;

(iv) a description of how adoption of the guidelines and implementation of grant activities will be monitored; and

(v) an agreement by the local educational agency to report information required by the Secretary to conduct evaluations under this subsection.

(3) Use of funds

Each local educational agency that receives a grant under this subsection may use the grant funds for the following:

(A) Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable wet wipes, to support carrying out the food allergy and anaphylaxis management guidelines described in subsection (b).

(B) In partnership with local health departments, school nurse, teacher, and personnel training for food allergy management.

(C) Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock.

(D) Outreach to parents.

(E) Any other activities consistent with the guidelines described in subsection (b).

(4) Duration of awards

The Secretary may award grants under this subsection for a period of not more than 2 years. In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.

(5) Limitation on grant funding

The Secretary may not provide grant funding to a local educational agency under this subsection after such local educational agency has received 2 years of grant funding under this subsection.

(6) Maximum amount of annual awards

A grant awarded under this subsection may not be made in an amount that is more than $50,000 annually.

(7) Priority

In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section 6333(c) of title 20.

(8) Matching funds

(A) In general

The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant.

(B) Determination of amount of non-Federal contribution

Non-Federal funds required under subparagraph (A) may be cash or in kind, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non-Federal funds.

(9) Administrative funds

A local educational agency that receives a grant under this subsection may use not more than 2 percent of the grant amount for administrative costs related to carrying out this subsection.

(10) Progress and evaluations

At the completion of the grant period referred to in paragraph (4), a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection (b).

(11) Supplement, not supplant

Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection.

(12) Authorization of appropriations

There is authorized to be appropriated to carry out this subsection $30,000,000 for fiscal year 2011 and such sums as may be necessary for each of the 4 succeeding fiscal years.

(d) Voluntary nature of guidelines

(1) In general

The food allergy and anaphylaxis management guidelines developed by the Secretary under subsection (b) are voluntary. Nothing in this section or the guidelines developed by the Secretary under subsection (b) shall be construed to require a local educational agency to implement such guidelines.

(2) Exception

Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c).

(Pub. L. 111–353, title I, §112, Jan. 4, 2011, 124 Stat. 3916; Pub. L. 114–95, title IX, §9215(jj), Dec. 10, 2015, 129 Stat. 2175.)

Editorial Notes

References in Text

The Head Start Act, referred to in subsec. (a)(1)(A), is subchapter B (§635 et seq.) of chapter 8 of subtitle A of title VI of Pub. L. 97–35, Aug. 13, 1981, 95 Stat. 499, which is classified generally to subchapter II (§9831 et seq.) of chapter 105 of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 9801 of Title 42 and Tables.

Amendments

2015—Subsec. (a)(2). Pub. L. 114–95 made technical amendment to reference in original act which appears in text as reference to section 7801 of title 20.

Statutory Notes and Related Subsidiaries

Effective Date of 2015 Amendment

Amendment by Pub. L. 114–95 effective Dec. 10, 2015, except with respect to certain noncompetitive programs and competitive programs, see section 5 of Pub. L. 114–95, set out as a note under section 6301 of Title 20, Education.

¹ So in original.

§2206. Alcohol-related facilities

(a) In general

Except as provided by sections 102, 206, 207, 302, 304, 402, 403, and 404 of this Act, and the amendments made by such sections, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that—

(1) under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and

(2) under section 350d of this title is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages, with respect to the activities of such facility that relate to the manufacturing, processing, packing, or holding of alcoholic beverages.

(b) Limited receipt and distribution of non-alcohol food

Subsection (a) shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph that receives and distributes non-alcohol food, provided such food is received and distributed—

(1) in a prepackaged form that prevents any direct human contact with such food; and

(2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.

(c) Rule of construction

Except as provided in subsections (a) and (b), this section shall not be construed to exempt any food, other than alcoholic beverages, as defined in section 214 ¹ of the Federal Alcohol Administration Act (27 U.S.C. 214), from the requirements of this Act (including the amendments made by this Act).

(Pub. L. 111–353, title I, §116, Jan. 4, 2011, 124 Stat. 3922.)

Editorial Notes

References in Text

This Act, referred to in subsecs. (a) and (c), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. Sections 102, 206, 207, 302, 304, 402, 403, and 404 of the Act enacted sections 350l, 350l–1, 384b, 399d, 2251, and 2252 of this title, amended sections 331, 333, 334, 350d, and 381 of this title, and enacted provisions set out as notes under sections 334, 350d, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

The Federal Alcohol Administration Act, referred to in subsecs. (a)(1) and (c), is act Aug. 29, 1935, ch. 814, 49 Stat. 977, which is classified generally to subchapter I (§201 et seq.) of chapter 8 of Title 27, Intoxicating Liquors. Section 214 of the Act probably means section 203 of the Act, which is classified to section 214 of Title 27 and defines "alcoholic beverage". For complete classification of this Act to the Code, see section 201 of Title 27 and Tables.

The Internal Revenue Code of 1986, referred to in subsec. (a)(1), is classified generally to Title 26, Internal Revenue Code.

¹ See References in Text note below.

SUBCHAPTER II—IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS

§2221. Food emergency response network

The Secretary, in coordination with the Secretary of Agriculture, the Secretary of Homeland Security, and State, local, and tribal governments shall, not later than 180 days after January 4, 2011, and biennially thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Health and Human Services, a report on the progress in implementing a national food emergency response laboratory network that—

(1) provides ongoing surveillance, rapid detection, and surge capacity for large-scale food-related emergencies, including intentional adulteration of the food supply;

(2) coordinates the food laboratory capacities of State, local, and tribal food laboratories, including the adoption of novel surveillance and identification technologies and the sharing of data between Federal agencies and State laboratories to develop national situational awareness;

(3) provides accessible, timely, accurate, and consistent food laboratory services throughout the United States;

(4) develops and implements a methods repository for use by Federal, State, and local officials;

(5) responds to food-related emergencies; and

(6) is integrated with relevant laboratory networks administered by other Federal agencies.

(Pub. L. 111–353, title II, §202(b), Jan. 4, 2011, 124 Stat. 3929.)

Editorial Notes

References in Text

The Secretary, referred to in text, probably means the Secretary of Health and Human Services.

§2222. Integrated consortium of laboratory networks

(a) In general

The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of Commerce, and the Administrator of the Environmental Protection Agency, shall maintain an agreement through which relevant laboratory network members, as determined by the Secretary of Homeland Security, shall—

(1) agree on common laboratory methods in order to reduce the time required to detect and respond to foodborne illness outbreaks and facilitate the sharing of knowledge and information relating to animal health, agriculture, and human health;

(2) identify means by which laboratory network members could work cooperatively—

(A) to optimize national laboratory preparedness; and

(B) to provide surge capacity during emergencies; and

(3) engage in ongoing dialogue and build relationships that will support a more effective and integrated response during emergencies.

(b) Reporting requirement

The Secretary of Homeland Security shall, on a biennial basis, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the progress of the integrated consortium of laboratory networks, as established under subsection (a), in carrying out this section.

(Pub. L. 111–353, title II, §203, Jan. 4, 2011, 124 Stat. 3929.)

§2223. Enhancing tracking and tracing of food and recordkeeping

(a) Pilot projects

(1) In general

Not later than 270 days after January 4, 2011, the Secretary of Health and Human Services (referred to in this section as the "Secretary"), taking into account recommendations from the Secretary of Agriculture and representatives of State departments of health and agriculture, shall establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(2) Content

The Secretary shall conduct 1 or more pilot projects under paragraph (1) in coordination with the processed food sector and 1 or more such pilot projects in coordination with processors or distributors of fruits and vegetables that are raw agricultural commodities. The Secretary shall ensure that the pilot projects under paragraph (1) reflect the diversity of the food supply and include at least 3 different types of foods that have been the subject of significant outbreaks during the 5-year period preceding January 4, 2011, and are selected in order to—

(A) develop and demonstrate methods for rapid and effective tracking and tracing of foods in a manner that is practicable for facilities of varying sizes, including small businesses;

(B) develop and demonstrate appropriate technologies, including technologies existing on January 4, 2011, that enhance the tracking and tracing of food; and

(C) inform the promulgation of regulations under subsection (d).

(3) Report

Not later than 18 months after January 4, 2011, the Secretary shall report to Congress on the findings of the pilot projects under this subsection together with recommendations for improving the tracking and tracing of food.

(b) Additional data gathering

(1) In general

The Secretary, in coordination with the Secretary of Agriculture and multiple representatives of State departments of health and agriculture, shall assess—

(A) the costs and benefits associated with the adoption and use of several product tracing technologies, including technologies used in the pilot projects under subsection (a);

(B) the feasibility of such technologies for different sectors of the food industry, including small businesses; and

(C) whether such technologies are compatible with the requirements of this subsection.

(2) Requirements

To the extent practicable, in carrying out paragraph (1), the Secretary shall—

(A) evaluate domestic and international product tracing practices in commercial use;

(B) consider international efforts, including an assessment of whether product tracing requirements developed under this section are compatible with global tracing systems, as appropriate; and

(C) consult with a diverse and broad range of experts and stakeholders, including representatives of the food industry, agricultural producers, and nongovernmental organizations that represent the interests of consumers.

(c) Product tracing system

The Secretary, in consultation with the Secretary of Agriculture, shall, as appropriate, establish within the Food and Drug Administration a product tracing system to receive information that improves the capacity of the Secretary to effectively and rapidly track and trace food that is in the United States or offered for import into the United States. Prior to the establishment of such product tracing system, the Secretary shall examine the results of applicable pilot projects and shall ensure that the activities of such system are adequately supported by the results of such pilot projects.

(d) Additional recordkeeping requirements for high risk foods

(1) In general

In order to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 342 of this title or misbranded under section 343(w) of this title, not later than 2 years after January 4, 2011, the Secretary shall publish a notice of proposed rulemaking to establish recordkeeping requirements, in addition to the requirements under section 350c of this title and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations), for facilities that manufacture, process, pack, or hold foods that the Secretary designates under paragraph (2) as high-risk foods. The Secretary shall set an appropriate effective date of such additional requirements for foods designated as high risk that takes into account the length of time necessary to comply with such requirements. Such requirements shall—

(A) relate only to information that is reasonably available and appropriate;

(B) be science-based;

(C) not prescribe specific technologies for the maintenance of records;

(D) ensure that the public health benefits of imposing additional recordkeeping requirements outweigh the cost of compliance with such requirements;

(E) be scale-appropriate and practicable for facilities of varying sizes and capabilities with respect to costs and recordkeeping burdens, and not require the creation and maintenance of duplicate records where the information is contained in other company records kept in the normal course of business;

(F) minimize the number of different recordkeeping requirements for facilities that handle more than 1 type of food;

(G) to the extent practicable, not require a facility to change business systems to comply with such requirements;

(H) allow any person subject to this subsection to maintain records required under this subsection at a central or reasonably accessible location provided that such records can be made available to the Secretary not later than 24 hours after the Secretary requests such records; and ¹

(I) include a process by which the Secretary may issue a waiver of the requirements under this subsection if the Secretary determines that such requirements would result in an economic hardship for an individual facility or a type of facility;

(J) be commensurate with the known safety risks of the designated food;

(K) take into account international trade obligations;

(L) not require—

(i) a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food;

(ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or

(iii) product tracking to the case level by persons subject to such requirements; and

(M) include a process by which the Secretary may remove a high-risk food designation developed under paragraph (2) for a food or type of food.

(2) Designation of high-risk foods

(A) In general

Not later than 1 year after January 4, 2011, and thereafter as the Secretary determines necessary, the Secretary shall designate high-risk foods for which the additional recordkeeping requirements described in paragraph (1) are appropriate and necessary to protect the public health. Each such designation shall be based on—

(i) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;

(ii) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;

(iii) the point in the manufacturing process of the food where contamination is most likely to occur;

(iv) the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;

(v) the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and

(vi) the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

(B) List of high-risk foods

At the time the Secretary promulgates the final rules under paragraph (1), the Secretary shall publish the list of the foods designated under subparagraph (A) as high-risk foods on the Internet website of the Food and Drug Administration. The Secretary may update the list to designate new high-risk foods and to remove foods that are no longer deemed to be high-risk foods, provided that each such update to the list is consistent with the requirements of this subsection and notice of such update is published in the Federal Register.

(3) Protection of sensitive information

In promulgating regulations under this subsection, the Secretary shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section, including periodic risk assessment and planning to prevent unauthorized release and controls to—

(A) prevent unauthorized reproduction of trade secret or confidential information;

(B) prevent unauthorized access to trade secret or confidential information; and

(C) maintain records with respect to access by any person to trade secret or confidential information maintained by the agency.

(4) Public input

During the comment period in the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.

(5) Retention of records

Except as otherwise provided in this subsection, the Secretary may require that a facility retain records under this subsection for not more than 2 years, taking into consideration the risk of spoilage, loss of value, or loss of palatability of the applicable food when determining the appropriate timeframes.

(6) Limitations

(A) Farm to school programs

In establishing requirements under this subsection, the Secretary shall, in consultation with the Secretary of Agriculture, consider the impact of requirements on farm to school or farm to institution programs of the Department of Agriculture and other farm to school and farm to institution programs outside such agency, and shall modify the requirements under this subsection, as appropriate, with respect to such programs so that the requirements do not place undue burdens on farm to school or farm to institution programs.

(B) Identity-preserved labels with respect to farm sales of food that is produced and packaged on a farm

The requirements under this subsection shall not apply to a food that is produced and packaged on a farm if—

(i) the packaging of the food maintains the integrity of the product and prevents subsequent contamination or alteration of the product; and

(ii) the labeling of the food includes the name, complete address (street address, town, State, country, and zip or other postal code), and business phone number of the farm, unless the Secretary waives the requirement to include a business phone number of the farm, as appropriate, in order to accommodate a religious belief of the individual in charge of such farm.

(C) Fishing vessels

The requirements under this subsection with respect to a food that is produced through the use of a fishing vessel (as defined in section 1802(18) of title 16) shall be limited to the requirements under subparagraph (F) until such time as the food is sold by the owner, operator, or agent in charge of such fishing vessel.

(D) Commingled raw agricultural commodities

(i) Limitation on extent of tracing

Recordkeeping requirements under this subsection with regard to any commingled raw agricultural commodity shall be limited to the requirements under subparagraph (F).

(ii) Definitions

For the purposes of this subparagraph—

(I) the term "commingled raw agricultural commodity" means any commodity that is combined or mixed after harvesting, but before processing;

(II) the term "commingled raw agricultural commodity" shall not include types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that standards promulgated under section 350h of this title (as added by section 105) ² would minimize the risk of serious adverse health consequences or death; and

(III) the term "processing" means operations that alter the general state of the commodity, such as canning, cooking, freezing, dehydration, milling, grinding, pasteurization, or homogenization.

(E) Exemption of other foods

The Secretary may, by notice in the Federal Register, modify the requirements under this subsection with respect to, or exempt a food or a type of facility from, the requirements of this subsection (other than the requirements under subparagraph (F), if applicable) if the Secretary determines that product tracing requirements for such food (such as bulk or commingled ingredients that are intended to be processed to destroy pathogens) or type of facility is not necessary to protect the public health.

(F) Recordkeeping regarding previous sources and subsequent recipients

In the case of a person or food to which a limitation or exemption under subparagraph (C), (D), or (E) applies, if such person, or a person who manufactures, processes, packs, or holds such food, is required to register with the Secretary under section 350d of this title with respect to the manufacturing, processing, packing, or holding of the applicable food, the Secretary shall require such person to maintain records that identify the immediate previous source of such food and the immediate subsequent recipient of such food.

(G) Grocery stores

With respect to a sale of a food described in subparagraph (H) to a grocery store, the Secretary shall not require such grocery store to maintain records under this subsection other than records documenting the farm that was the source of such food. The Secretary shall not require that such records be kept for more than 180 days.

(H) Farm sales to consumers

The Secretary shall not require a farm to maintain any distribution records under this subsection with respect to a sale of a food described in subparagraph (I) (including a sale of a food that is produced and packaged on such farm), if such sale is made by the farm directly to a consumer.

(I) Sale of a food

A sale of a food described in this subparagraph is a sale of a food in which—

(i) the food is produced on a farm; and

(ii) the sale is made by the owner, operator, or agent in charge of such farm directly to a consumer or grocery store.

(7) No impact on non-high-risk foods

The recordkeeping requirements established under paragraph (1) shall have no effect on foods that are not designated by the Secretary under paragraph (2) as high-risk foods. Foods described in the preceding sentence shall be subject solely to the recordkeeping requirements under section 350c of this title and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations).

(e) Evaluation and recommendations

(1) Report

Not later than 1 year after the effective date of the final rule promulgated under subsection (d)(1), the Comptroller General of the United States shall submit to Congress a report, taking into consideration the costs of compliance and other regulatory burdens on small businesses and Federal, State, and local food safety practices and requirements, that evaluates the public health benefits and risks, if any, of limiting—

(A) the product tracing requirements under subsection (d) to foods identified under paragraph (2) of such subsection, including whether such requirements provide adequate assurance of traceability in the event of intentional adulteration, including by acts of terrorism; and

(B) the participation of restaurants in the recordkeeping requirements.

(2) Determination and recommendations

In conducting the evaluation and report under paragraph (1), if the Comptroller General of the United States determines that the limitations described in such paragraph do not adequately protect the public health, the Comptroller General shall submit to Congress recommendations, if appropriate, regarding recordkeeping requirements for restaurants and additional foods, in order to protect the public health.

(f) Farms

(1) Request for information

Notwithstanding subsection (d), during an active investigation of a foodborne illness outbreak, or if the Secretary determines it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak, the Secretary, in consultation and coordination with State and local agencies responsible for food safety, as appropriate, may request that the owner, operator, or agent of a farm identify potential immediate recipients, other than consumers, of an article of the food that is the subject of such investigation if the Secretary reasonably believes such article of food—

(A) is adulterated under section 342 of this title;

(B) presents a threat of serious adverse health consequences or death to humans or animals; and

(C) was adulterated as described in subparagraph (A) on a particular farm (as defined in section 1.227 of chapter ³ 21, Code of Federal Regulations (or any successor regulation)).

(2) Manner of request

In making a request under paragraph (1), the Secretary, in consultation and coordination with State and local agencies responsible for food safety, as appropriate, shall issue a written notice to the owner, operator, or agent of the farm to which the article of food has been traced. The individual providing such notice shall present to such owner, operator, or agent appropriate credentials and shall deliver such notice at reasonable times and within reasonable limits and in a reasonable manner.

(3) Delivery of information requested

The owner, operator, or agent of a farm shall deliver the information requested under paragraph (1) in a prompt and reasonable manner. Such information may consist of records kept in the normal course of business, and may be in electronic or non-electronic format.

(4) Limitation

A request made under paragraph (1) shall not include a request for information relating to the finances, pricing of commodities produced, personnel, research, sales (other than information relating to shipping), or other disclosures that may reveal trade secrets or confidential information from the farm to which the article of food has been traced, other than information necessary to identify potential immediate recipients of such food. Section 331(j) of this title and the Freedom of Information Act [5 U.S.C. 552] shall apply with respect to any confidential commercial information that is disclosed to the Food and Drug Administration in the course of responding to a request under paragraph (1).

(5) Records

Except with respect to identifying potential immediate recipients in response to a request under this subsection, nothing in this subsection shall require the establishment or maintenance by farms of new records.

(g) No Limitation on commingling of food

Nothing in this section shall be construed to authorize the Secretary to impose any limitation on the commingling of food.

(h) Small entity compliance guide

Not later than 180 days after promulgation of a final rule under subsection (d), the Secretary shall issue a small entity compliance guide setting forth in plain language the requirements of the regulations under such subsection in order to assist small entities, including farms and small businesses, in complying with the recordkeeping requirements under such subsection.

(i) Flexibility for small businesses

Notwithstanding any other provision of law, the regulations promulgated under subsection (d) shall apply—

(1) to small businesses (as defined by the Secretary in section 350g of this title, not later than 90 days after January 4, 2011) beginning on the date that is 1 year after the effective date of the final regulations promulgated under subsection (d); and

(2) to very small businesses (as defined by the Secretary in section 350g of this title, not later than 90 days after January 4, 2011) beginning on the date that is 2 years after the effective date of the final regulations promulgated under subsection (d).

(Pub. L. 111–353, title II, §204, Jan. 4, 2011, 124 Stat. 3930.)

Editorial Notes

References in Text

Section 105, referred to in subsec. (d)(6)(D)(ii)(II), means section 105 of Pub. L. 111–353.

Section 350g of this title, referred to in subsec. (i), was in the original "section 103", meaning section 103 of Pub. L. 111–353, which enacted section 350g of this title, amended section 331 of this title, and enacted provisions set out as notes under sections 342, 350d, and 350g of this title, and was translated as section 350g of this title to reflect the probable intent of Congress because section 350g(n) of this title directs the Secretary of Health and Human Services to define "small business" and "very small business".

Codification

Section is comprised of section 204 of Pub. L. 111–353. Subsec. (j) of section 204 of Pub. L. 111–353 amended sections 331 and 381 of this title.

¹ So in original. The word "and" probably should not appear.

² See References in Text note below.

³ So in original. Probably should be "title".

§2224. Surveillance

(a) Definition of foodborne illness outbreak

In this Act, the term "foodborne illness outbreak" means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a certain food.

(b) Foodborne illness surveillance systems

(1) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall enhance foodborne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses by—

(A) coordinating Federal, State and local foodborne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories;

(B) facilitating sharing of surveillance information on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, the Department of Homeland Security, and State and local agencies, and with the public;

(C) developing improved epidemiological tools for obtaining quality exposure data and microbiological methods for classifying cases;

(D) augmenting such systems to improve attribution of a foodborne illness outbreak to a specific food;

(E) expanding capacity of such systems, including working toward automatic electronic searches, for implementation of identification practices, including fingerprinting strategies, for foodborne infectious agents, in order to identify new or rarely documented causes of foodborne illness and submit standardized information to a centralized database;

(F) allowing timely public access to aggregated, de-identified surveillance data;

(G) at least annually, publishing current reports on findings from such systems;

(H) establishing a flexible mechanism for rapidly initiating scientific research by academic institutions;

(I) integrating foodborne illness surveillance systems and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and local levels, including by sharing foodborne illness surveillance data with the National Biosurveillance Integration Center; and

(J) other activities as determined appropriate by the Secretary.

(2) Working group

The Secretary shall support and maintain a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food and food testing industries, consumer organizations, and academia. Such working group shall provide the Secretary, through at least annual meetings of the working group and an annual public report, advice and recommendations on an ongoing and regular basis regarding the improvement of foodborne illness surveillance and implementation of this section, including advice and recommendations on—

(A) the priority needs of regulatory agencies, the food industry, and consumers for information and analysis on foodborne illness and its causes;

(B) opportunities to improve the effectiveness of initiatives at the Federal, State, and local levels, including coordination and integration of activities among Federal agencies, and between the Federal, State, and local levels of government;

(C) improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic researchers, and consumers to foodborne illness aggregated, de-identified surveillance data collected by government agencies at all levels, including data compiled by the Centers for Disease Control and Prevention;

(D) key barriers at Federal, State, and local levels to improving foodborne illness surveillance and the utility of such surveillance for preventing foodborne illness;

(E) the capabilities needed for establishing automatic electronic searches of surveillance data; and

(F) specific actions to reduce barriers to improvement, implement the working group's recommendations, and achieve the purposes of this section, with measurable objectives and timelines, and identification of resource and staffing needs.

(3) Authorization of appropriations

To carry out the activities described in paragraph (1), there is authorized to be appropriated $24,000,000 for each ¹ fiscal years 2011 through 2015.

(c) Improving food safety and defense capacity at the State and local level

(1) In general

The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the following goals:

(A) Improve foodborne illness outbreak response and containment.

(B) Accelerate foodborne illness surveillance and outbreak investigation, including rapid shipment of clinical isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews.

(C) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards.

(D) Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of foodborne illness.

(E) Share information on a timely basis among public health and food regulatory agencies, with the food industry, with health care providers, and with the public.

(F) Strengthen the capacity of State and local agencies to achieve the goals described in section 2202 of this title.

(2) Review

In developing of the strategies required by paragraph (1), the Secretary shall, not later than 1 year after January 4, 2011, complete a review of State and local capacities, and needs for enhancement, which may include a survey with respect to—

(A) staffing levels and expertise available to perform food safety and defense functions;

(B) laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities;

(C) information systems to support data management and sharing of food safety and defense information among State and local agencies and with counterparts at the Federal level; and

(D) other State and local activities and needs as determined appropriate by the Secretary.

(Pub. L. 111–353, title II, §205, Jan. 4, 2011, 124 Stat. 3937.)

Editorial Notes

References in Text

This Act, referred to in subsec. (a), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

The Secretary, referred to in subsecs. (b) and (c)(1), (2)(D), probably means the Secretary of Health and Human Services.

Codification

Section is comprised of section 205 of Pub. L. 111–353. Subsec. (d) of section 205 of Pub. L. 111–353 amended section 247b–20 of Title 42, The Public Health and Welfare.

¹ So in original. Probably should be followed by "of".

§2225. Decontamination and disposal standards and plans

(a) In general

The Administrator of the Environmental Protection Agency (referred to in this section as the "Administrator"), in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, and Secretary of Agriculture, shall provide support for, and technical assistance to, State, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency.

(b) Development of standards

In carrying out subsection (a), the Administrator, in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, Secretary of Agriculture, and State, local, and tribal governments, shall develop and disseminate specific standards and protocols to undertake clean-up, clearance, and recovery activities following the decontamination and disposal of specific threat agents and foreign animal diseases.

(c) Development of model plans

In carrying out subsection (a), the Administrator, the Secretary of Health and Human Services, and the Secretary of Agriculture shall jointly develop and disseminate model plans for—

(1) the decontamination of individuals, equipment, and facilities following an intentional contamination of agriculture or food; and

(2) the disposal of large quantities of animals, plants, or food products that have been infected or contaminated by specific threat agents and foreign animal diseases.

(d) Exercises

In carrying out subsection (a), the Administrator, in coordination with the entities described under subsection (b), shall conduct exercises at least annually to evaluate and identify weaknesses in the decontamination and disposal model plans described in subsection (c). Such exercises shall be carried out, to the maximum extent practicable, as part of the national exercise program under section 748(b)(1) of title 6.

(e) Modifications

Based on the exercises described in subsection (d), the Administrator, in coordination with the entities described in subsection (b), shall review and modify as necessary the plans described in subsection (c) not less frequently than biennially.

(f) Prioritization

The Administrator, in coordination with the entities described in subsection (b), shall develop standards and plans under subsections (b) and (c) in an identified order of priority that takes into account—

(1) highest-risk biological, chemical, and radiological threat agents;

(2) agents that could cause the greatest economic devastation to the agriculture and food system; and

(3) agents that are most difficult to clean or remediate.

(Pub. L. 111–353, title II, §208, Jan. 4, 2011, 124 Stat. 3944.)

SUBCHAPTER III—IMPROVING THE SAFETY OF IMPORTED FOOD

§2241. Inspection by the Secretary of Commerce

(1) In general

The Secretary of Commerce, in coordination with the Secretary of Health and Human Services, may send 1 or more inspectors to a country or facility of an exporter from which seafood imported into the United States originates. The inspectors shall assess practices and processes used in connection with the farming, cultivation, harvesting, preparation for market, or transportation of such seafood and may provide technical assistance related to such activities.

(2) Inspection report

(A) In general

The Secretary of Health and Human Services, in coordination with the Secretary of Commerce, shall—

(i) prepare an inspection report for each inspection conducted under paragraph (1);

(ii) provide the report to the country or exporter that is the subject of the report; and

(iii) provide a 30-day period during which the country or exporter may provide a rebuttal or other comments on the findings of the report to the Secretary of Health and Human Services.

(B) Distribution and use of report

The Secretary of Health and Human Services shall consider the inspection reports described in subparagraph (A) in distributing inspection resources under section 350j of this title.

(Pub. L. 111–353, title III, §306(b), Jan. 4, 2011, 124 Stat. 3959.)

§2242. Foreign offices of the Food and Drug Administration

(a) In general

The Secretary shall establish offices of the Food and Drug Administration in foreign countries selected by the Secretary, to provide assistance to the appropriate governmental entities of such countries with respect to measures to provide for the safety of articles of food and other products regulated by the Food and Drug Administration exported by such country to the United States, including by directly conducting risk-based inspections of such articles and supporting such inspections by such governmental entity.

(b) Consultation

In establishing the foreign offices described in subsection (a), the Secretary shall consult with the Secretary of State, the Secretary of Homeland Security, and the United States Trade Representative.

(c) Report

Not later than October 1, 2011, the Secretary shall submit to Congress a report on the basis for the selection by the Secretary of the foreign countries in which the Secretary established offices, the progress which such offices have made with respect to assisting the governments of such countries in providing for the safety of articles of food and other products regulated by the Food and Drug Administration exported to the United States, and the plans of the Secretary for establishing additional foreign offices of the Food and Drug Administration, as appropriate.

(Pub. L. 111–353, title III, §308, Jan. 4, 2011, 124 Stat. 3966.)

Editorial Notes

References in Text

The Secretary, referred to in text, probably means the Secretary of Health and Human Services.

§2243. Smuggled food

(a) In general

Not later than 180 days after January 4, 2011, the Secretary shall, in coordination with the Secretary of Homeland Security, develop and implement a strategy to better identify smuggled food and prevent entry of such food into the United States.

(b) Notification to Homeland Security

Not later than 10 days after the Secretary identifies a smuggled food that the Secretary believes would cause serious adverse health consequences or death to humans or animals, the Secretary shall provide to the Secretary of Homeland Security a notification under section 350f(n) of this title describing the smuggled food and, if available, the names of the individuals or entities that attempted to import such food into the United States.

(c) Public notification

If the Secretary—

(1) identifies a smuggled food;

(2) reasonably believes exposure to the food would cause serious adverse health consequences or death to humans or animals; and

(3) reasonably believes that the food has entered domestic commerce and is likely to be consumed,

the Secretary shall promptly issue a press release describing that food and shall use other emergency communication or recall networks, as appropriate, to warn consumers and vendors about the potential threat.

(d) Effect of section

Nothing in this section shall affect the authority of the Secretary to issue public notifications under other circumstances.

(e) Definition

In this subsection, the term "smuggled food" means any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead.

(Pub. L. 111–353, title III, §309, Jan. 4, 2011, 124 Stat. 3966.)

Editorial Notes

References in Text

The Secretary, referred to in text, probably means the Secretary of Health and Human Services.

SUBCHAPTER IV—MISCELLANEOUS PROVISIONS

§2251. Jurisdiction; authorities

Nothing in this Act, or an amendment made by this Act, shall be construed to—

(1) alter the jurisdiction between the Secretary of Agriculture and the Secretary of Health and Human Services, under applicable statutes, regulations, or agreements regarding voluntary inspection of non-amenable species under the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.);

(2) alter the jurisdiction between the Alcohol and Tobacco Tax and Trade Bureau and the Secretary of Health and Human Services, under applicable statutes and regulations;

(3) limit the authority of the Secretary of Health and Human Services under—

(A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as in effect on the day before January 4, 2011; or

(B) the Public Health Service Act [42 U.S.C. 201 et seq.] as in effect on the day before January 4, 2011;

(4) alter or limit the authority of the Secretary of Agriculture under the laws administered by such Secretary, including—

(A) the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);

(B) the Poultry Products Inspection Act (21 U.S.C. 451 et seq.);

(C) the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);

(D) the United States Grain Standards Act (7 U.S.C. 71 et seq.);

(E) the Packers and Stockyards Act, 1921 (7 U.S.C. 181 et seq.);

(F) the United States Warehouse Act (7 U.S.C. 241 et seq.);

(G) the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.); and

(H) the Agricultural Adjustment Act (7 U.S.C. 601 et seq.), reenacted with the amendments made by the Agricultural Marketing Agreement Act of 1937; or

(5) alter, impede, or affect the authority of the Secretary of Homeland Security under the Homeland Security Act of 2002 (6 U.S.C. 101 et seq.) or any other statute, including any authority related to securing the borders of the United States, managing ports of entry, or agricultural import and entry inspection activities.

(Pub. L. 111–353, title IV, §403, Jan. 4, 2011, 124 Stat. 3972.)

Editorial Notes

References in Text

This Act, referred to in text, is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

The Agricultural Marketing Act of 1946, referred to in pars. (1) and (4)(G), is title II of act Aug. 14, 1946, ch. 966, 60 Stat. 1087, which is classified generally to chapter 38 (§1621 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 1621 of Title 7 and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in par. (3)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

The Public Health Service Act, referred to in par. (3)(B), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

The Federal Meat Inspection Act, referred to in par. (4)(A), is titles I to V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, §11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

The Poultry Products Inspection Act, referred to in par. (4)(B), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.

The Egg Products Inspection Act, referred to in par. (4)(C), is Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to chapter 15 (§1031 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The United States Grain Standards Act, referred to in par. (4)(D), is part B of act Aug. 11, 1916, ch. 313, 39 Stat. 482, which is classified generally to chapter 3 (§71 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see section 71 of Title 7 and Tables.

The Packers and Stockyards Act, 1921, referred to in par. (4)(E), is act Aug. 15, 1921, ch. 64, 42 Stat. 159, which is classified generally to chapter 9 (§181 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see section 181 of Title 7 and Tables.

The United States Warehouse Act, referred to in par. (4)(F), is part C of act Aug. 11, 1916, ch. 313, 39 Stat. 486, which is classified generally to chapter 10 (§241 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 241 of Title 7 and Tables.

The Agricultural Adjustment Act (7 U.S.C. 601 et seq.), reenacted with the amendments made by the Agricultural Marketing Agreement Act of 1937, referred to in par. (4)(H), is title I of act May 12, 1933, ch. 25, 48 Stat. 31, which is classified generally to chapter 26 (§601 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 601 of Title 7 and Tables.

The Homeland Security Act of 2002, referred to in par. (5), is Pub. L. 107–296, Nov. 25, 2002, 116 Stat. 2135, which is classified principally to chapter 1 (§101 et seq.) of Title 6, Domestic Security. For complete classification of this Act to the Code, see Short Title note set out under section 101 of Title 6 and Tables.

§2252. Compliance with international agreements

Nothing in this Act (or an amendment made by this Act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party.

(Pub. L. 111–353, title IV, §404, Jan. 4, 2011, 124 Stat. 3972.)

Editorial Notes

References in Text

This Act, referred to in text, is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

CHAPTER 28—SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS

        

SUBCHAPTER I—SANCTIONS WITH RESPECT TO FOREIGN OPIOID TRAFFICKERS

        

SUBCHAPTER II—OTHER MATTERS

        

Termination of Chapter

For termination of chapter 7 years after Dec. 20, 2019, see section 2334 of this title.

§2301. Sense of Congress

It is the sense of Congress that—

(1) the United States should apply economic and other financial sanctions to foreign traffickers of illicit opioids to protect the national security, foreign policy, and economy of the United States and the health of the people of the United States;

(2) it is imperative that the People's Republic of China follow through on full implementation of the new regulations, adopted May 1, 2019, to treat all fentanyl analogues as controlled substances under the laws of the People's Republic of China, including by devoting sufficient resources for implementation and strict enforcement of the new regulations; and

(3) the effective enforcement of the new regulations should result in diminished trafficking of illicit fentanyl originating from the People's Republic of China into the United States.

(Pub. L. 116–92, div. F, title LXXII, §7202, Dec. 20, 2019, 133 Stat. 2262.)

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 116–92, div. F, title LXXII, §7201, Dec. 20, 2019, 133 Stat. 2262, provided that: "This title [enacting this chapter and amending section 2291h of Title 22, Foreign Relations and Intercourse] may be cited as the 'Fentanyl Sanctions Act'."

§2302. Definitions

In this chapter:

(1) Alien; national; national of the United States

The terms "alien", "national", and "national of the United States" have the meanings given those terms in section 1101 of title 8.

(2) Appropriate congressional committees and leadership

The term "appropriate congressional committees and leadership" means—

(A) the Committee on Appropriations, the Committee on Armed Services, the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, the Committee on Homeland Security and Governmental Affairs, the Committee on the Judiciary, the Select Committee on Intelligence, and the majority leader and the minority leader of the Senate; and

(B) the Committee on Appropriations, the Committee on Armed Services, the Committee on Financial Services, the Committee on Foreign Affairs, the Committee on Homeland Security, the Committee on the Judiciary, the Committee on Oversight and Reform, the Permanent Select Committee on Intelligence, and the Speaker and the minority leader of the House of Representatives.

(3) Controlled substance; listed chemical

The terms "controlled substance", "listed chemical", "narcotic drug", and "opioid" have the meanings given those terms in section 802 of this title.

(4) Entity

The term "entity" means a partnership, joint venture, association, corporation, organization, network, group, or subgroup, or any form of business collaboration.

(5) Foreign opioid trafficker

The term "foreign opioid trafficker" means any foreign person that the President determines plays a significant role in opioid trafficking.

(6) Foreign person

The term "foreign person"—

(A) means—

(i) any citizen or national of a foreign country; or

(ii) any entity not organized under the laws of the United States or a jurisdiction within the United States; and

(B) does not include the government of a foreign country.

(7) Knowingly

The term "knowingly", with respect to conduct, a circumstance, or a result, means that a person has actual knowledge, or should have known, of the conduct, the circumstance, or the result.

(8) Opioid trafficking

The term "opioid trafficking" means any illicit activity—

(A) to produce, manufacture, distribute, sell, or knowingly finance or transport—

(i) synthetic opioids, including controlled substances that are synthetic opioids and listed chemicals that are synthetic opioids; or

(ii) active pharmaceutical ingredients or chemicals that are used in the production of controlled substances that are synthetic opioids;

(B) to attempt to carry out an activity described in subparagraph (A); or

(C) to assist, abet, conspire, or collude with other persons to carry out such an activity.

(9) Person

The term "person" means an individual or entity.

(10) United States person

The term "United States person" means—

(A) any citizen or national of the United States;

(B) any alien lawfully admitted for permanent residence in the United States;

(C) any entity organized under the laws of the United States or any jurisdiction within the United States (including a foreign branch of such an entity); or

(D) any person located in the United States.

(Pub. L. 116–92, div. F, title LXXII, §7203, Dec. 20, 2019, 133 Stat. 2262.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title LXXII of div. F of Pub. L. 116–92, Dec. 20, 2019, 133 Stat. 2262, known as the Fentanyl Sanctions Act, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 2301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Oversight and Reform of House of Representatives changed to Committee on Oversight and Accountability of House of Representatives by House Resolution No. 5, One Hundred Eighteenth Congress, Jan. 9, 2023.

SUBCHAPTER I—SANCTIONS WITH RESPECT TO FOREIGN OPIOID TRAFFICKERS

§2311. Identification of foreign opioid traffickers

(a) Public report

(1) In general

The President shall submit to the appropriate congressional committees and leadership, in accordance with subsection (c), a report—

(A) identifying the foreign persons that the President determines are foreign opioid traffickers;

(B) detailing progress the President has made in implementing this subchapter; and

(C) providing an update on cooperative efforts with the governments of Mexico, the People's Republic of China, and other countries of concern with respect to combating foreign opioid traffickers.

(2) Identification of additional persons

If, at any time after submitting a report required by paragraph (1) and before the submission of the next such report, the President determines that a foreign person not identified in the report is a foreign opioid trafficker, the President shall submit to the appropriate congressional committees and leadership an additional report containing the information required by paragraph (1) with respect to the foreign person.

(3) Exclusion

The President shall not be required to include in a report under paragraph (1) or (2) any persons with respect to which the United States has imposed sanctions before the date of the report under this subchapter or any other provision of law with respect to opioid trafficking.

(4) Form of report

(A) In general

Each report required by paragraph (1) or (2) shall be submitted in unclassified form but may include a classified annex.

(B) Availability to public

The unclassified portion of a report required by paragraph (1) or (2) shall be made available to the public.

(b) Classified report

(1) In general

The President shall submit to the appropriate congressional committees and leadership, in accordance with subsection (c), a report, in classified form—

(A) describing in detail the status of sanctions imposed under this subchapter, including the personnel and resources directed toward the imposition of such sanctions during the preceding fiscal year;

(B) providing background information with respect to persons newly identified as foreign opioid traffickers and their illicit activities;

(C) describing actions the President intends to undertake or has undertaken to implement this subchapter; and

(D) providing a strategy for identifying additional foreign opioid traffickers.

(2) Effect on other reporting requirements

The report required by paragraph (1) is in addition to, and in no way delimits or restricts, the obligations of the President to keep Congress fully and currently informed pursuant to the provisions of the National Security Act of 1947 (50 U.S.C. 3001 et seq.).

(c) Submission of reports

Not later than 180 days after December 20, 2019, and annually thereafter until the date that is 5 years after December 20, 2019, the President shall submit the reports required by subsections (a) and (b) to the appropriate congressional committees and leadership.

(d) Exclusion of certain information

(1) Intelligence

Notwithstanding any other provision of this section, a report required by subsection (a) or (b) shall not disclose the identity of any person if the Director of National Intelligence determines that such disclosure could compromise an intelligence operation, activity, source, or method of the United States.

(2) Law enforcement

Notwithstanding any other provision of this section, a report required by subsection (a) or (b) shall not disclose the identity of any person if the Attorney General, in coordination, as appropriate, with the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of the Treasury, the Secretary of State, and the head of any other appropriate Federal law enforcement agency, determines that such disclosure could reasonably be expected—

(A) to compromise the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution that furnished information on a confidential basis;

(B) to jeopardize the integrity or success of an ongoing criminal investigation or prosecution;

(C) to endanger the life or physical safety of any person; or

(D) to cause substantial harm to physical property.

(3) Notification required

If the Director of National Intelligence makes a determination under paragraph (1) or the Attorney General makes a determination under paragraph (2), the Director or the Attorney General, as the case may be, shall notify the appropriate congressional committees and leadership of the determination and the reasons for the determination.

(4) Rule of construction

Nothing in this section may be construed to authorize or compel the disclosure of information determined by the President to be law enforcement information, classified information, national security information, or other information the disclosure of which is prohibited by any other provision of law.

(e) Provision of information required for reports

The Secretary of the Treasury, the Attorney General, the Secretary of Defense, the Secretary of State, the Secretary of Homeland Security, and the Director of National Intelligence shall consult among themselves and provide to the President and the Director of the Office of National Drug Control Policy the appropriate and necessary information to enable the President to submit the reports required by subsection (a).

(Pub. L. 116–92, div. F, title LXXII, §7211, Dec. 20, 2019, 133 Stat. 2263.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a)(1)(B), (3) and (b)(1)(A), (C), was in the original "this subtitle", meaning subtitle A (§§7211–7217) of title LXXII of div. F of Pub. L. 116–92, which is classified principally to this subchapter. For complete classification of subtitle A to the Code, see Tables.

The National Security Act of 1947, referred to in subsec. (b)(2), is act July 26, 1947, ch. 343, 61 Stat. 495, which is classified principally to chapter 44 (§3001 et seq.) of Title 50, War and National Defense. For complete classification of this Act to the Code, see Tables.

Executive Documents

Delegation of Certain Functions and Authorities Under the National Defense Authorization Act for Fiscal Year 2020

Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, provided:

Memorandum for the Secretary of State[,] the Secretary of the Treasury[,] the Secretary of Defense[, and] the Director of National Drug Control Policy

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby order as follows:

Section 1. (a) I hereby delegate to the Secretary of State the functions and authorities vested in the President by section 7426 of the National Defense Authorization Act for Fiscal Year 2020 (Public Law 116–92) (the "Act") [22 U.S.C. 8791 note].

(b) I hereby delegate to the Secretary of State, in consultation with the Secretary of the Treasury, the functions and authorities vested in the President by the following provisions of the Act:

(i) section 7214 [21 U.S.C. 2314];

(ii) section 7413 [22 U.S.C. 8791 note];

(iii) section 7431 [22 U.S.C. 8791 note]; and

(iv) section 7432 [22 U.S.C. 8791 note].

(c) I hereby delegate to the Secretary of State, in consultation with the Secretary of the Treasury and the Director of National Drug Control Policy, the functions and authorities vested in the President by section 7211(a)(1)(C) of the Act [21 U.S.C. 2311(a)(1)(C)].

(d) I hereby delegate to the Secretary of the Treasury, in consultation with the Secretary of State, the functions and authorities vested in the President by the following provisions of the Act:

(i) section 7211(a)(1)(A)–(B) [21 U.S.C. 2311(a)(1)(A), (B)];

(ii) section 7211(a)(2)–(3) [21 U.S.C. 2311(a)(2), (3)];

(iii) section 7211(b) [21 U.S.C. 2311(b)];

(iv) section 7211(c) [21 U.S.C. 2311(c)];

(v) section 7212 [21 U.S.C. 2312];

(vi) section 7213(a)(4)–(9) [21 U.S.C. 2313(a)(4) to (9)];

(vii) section 7213(d) [21 U.S.C. 2313(d)];

(viii) section 7215(a) [21 U.S.C. 2315(a)];

(ix) section 7233 [21 U.S.C. 2333];

(x) section 7412(a) [22 U.S.C. 8791 note]; and

(xi) section 7412(b)(1)(A) [22 U.S.C. 8791 note].

(e) I hereby delegate to the Secretary of the Treasury the functions and authorities vested in the President by section 7433 of the Act [22 U.S.C. 8791 note].

(f) I hereby delegate to the Secretary of State and the Secretary of Defense the functions and authorities vested in the President by section 7423 of the Act [22 U.S.C. 8791 note].

Sec. 2. The delegations in this memorandum shall apply to any provisions of any future public laws that are the same or substantially the same as those provisions referenced in this memorandum.

Sec. 3. The Secretary of State is authorized and directed to publish this memorandum in the Federal Register.

Donald J. Trump.      

§2312. Imposition of sanctions

The President shall impose five or more of the sanctions described in section 2313 of this title with respect to each foreign person that is an entity, and four or more of such sanctions with respect to each foreign person that is an individual, that—

(1) is identified as a foreign opioid trafficker in a report submitted under section 2311(a) of this title; or

(2) the President determines is owned, controlled, directed by, knowingly supplying or sourcing precursors for, or knowingly acting for or on behalf of, such a foreign opioid trafficker.

(Pub. L. 116–92, div. F, title LXXII, §7212, Dec. 20, 2019, 133 Stat. 2265.)

Executive Documents

Delegation of Functions

Functions and authorities of President under this section delegated to Secretary of the Treasury, in consultation with the Secretary of State, by section 1(d)(v) of Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, set out as a note under section 2311 of this title.

§2313. Description of sanctions

(a) In general

The sanctions that may be imposed with respect to a foreign person under section 2312 of this title are the following:

(1) Loans from United States financial institutions

The United States Government may prohibit any United States financial institution from making loans or providing credits to the foreign person.

(2) Prohibitions on financial institutions

The following prohibitions may be imposed with respect to a foreign person that is a financial institution:

(A) Prohibition on designation as primary dealer

Neither the Board of Governors of the Federal Reserve System nor the Federal Reserve Bank of New York may designate, or permit the continuation of any prior designation of, the financial institution as a primary dealer in United States Government debt instruments.

(B) Prohibition on service as a repository of Government funds

The financial institution may not serve as agent of the United States Government or serve as repository for United States Government funds.

The imposition of either sanction under subparagraph (A) or (B) shall be treated as one sanction for purposes of section 2312 of this title, and the imposition of both such sanctions shall be treated as 2 sanctions for purposes of that section.

(3) Procurement ban

The United States Government may not procure, or enter into any contract for the procurement of, any goods or services from the foreign person.

(4) Foreign exchange

The President may, pursuant to such regulations as the President may prescribe, prohibit any transactions in foreign exchange that are subject to the jurisdiction of the United States and in which the foreign person has any interest.

(5) Banking transactions

The President may, pursuant to such regulations as the President may prescribe, prohibit any transfers of credit or payments between financial institutions or by, through, or to any financial institution, to the extent that such transfers or payments are subject to the jurisdiction of the United States and involve any interest of the foreign person.

(6) Property transactions

The President may, pursuant to such regulations as the President may prescribe, prohibit any person from—

(A) acquiring, holding, withholding, using, transferring, withdrawing, or transporting any property that is subject to the jurisdiction of the United States and with respect to which the foreign person has any interest;

(B) dealing in or exercising any right, power, or privilege with respect to such property; or

(C) conducting any transaction involving such property.

(7) Ban on investment in equity or debt of sanctioned person

The President may, pursuant to such regulations or guidelines as the President may prescribe, prohibit any United States person from investing in or purchasing significant amounts of equity or debt instruments of the foreign person.

(8) Exclusion of corporate officers

The President may direct the Secretary of State to deny a visa to, and the Secretary of Homeland Security to exclude from the United States, any alien that the President determines is a corporate officer or principal of, or a shareholder with a controlling interest in, the foreign person.

(9) Sanctions on principal executive officers

The President may impose on the principal executive officer or officers of the foreign person, or on individuals performing similar functions and with similar authorities as such officer or officers, any of the sanctions described in paragraphs (1) through (8) that are applicable.

(b) Penalties

A person that violates, attempts to violate, conspires to violate, or causes a violation of any regulation, license, or order issued to carry out subsection (a) shall be subject to the penalties set forth in subsections (b) and (c) of section 1705 of title 50 to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

(c) Exceptions

(1) Intelligence and law enforcement activities

Sanctions under this section shall not apply with respect to—

(A) any activity subject to the reporting requirements under title V of the National Security Act of 1947 (50 U.S.C. 3091 et seq.); or

(B) any authorized intelligence or law enforcement activities of the United States.

(2) Exception to comply with United Nations headquarters agreement

Sanctions under subsection (a)(8) shall not apply to an alien if admitting the alien into the United States is necessary to permit the United States to comply with the Agreement regarding the Headquarters of the United Nations, signed at Lake Success June 26, 1947, and entered into force November 21, 1947, between the United Nations and the United States, the Convention on Consular Relations, done at Vienna April 24, 1963, and entered into force March 19, 1967, or other applicable international obligations.

(d) Implementation

The President may exercise all authorities provided under sections 1702 and 1704 of title 50 to carry out this section.

(Pub. L. 116–92, div. F, title LXXII, §7213, Dec. 20, 2019, 133 Stat. 2266.)

Editorial Notes

References in Text

The National Security Act of 1947, referred to in subsec. (c)(1)(A), is act July 26, 1947, ch. 343, 61 Stat. 495. Title V of the Act is classified generally to subchapter III (§3091 et seq.) of chapter 44 of Title 50, War and National Defense. For complete classification of this Act to the Code, see Tables.

Executive Documents

Delegation of Functions

Functions and authorities of President under subsections (a)(4) to (9) and (d) of this section delegated to Secretary of the Treasury, in consultation with the Secretary of State, by section 1(d)(vi) and (vii) of Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, set out as a note under section 2311 of this title.

§2314. Waivers

(a) Waiver for state-owned entities in countries that cooperate in multilateral anti-trafficking efforts

(1) In general

The President may waive for a period of not more than 12 months the application of sanctions under this subchapter with respect to an entity that is owned or controlled, directly or indirectly, by a foreign government or any political subdivision, agency, or instrumentality of a foreign government, if, not less than 15 days before the waiver is to take effect, the President certifies to the appropriate congressional committees and leadership that the foreign government is closely cooperating with the United States in efforts to prevent opioid trafficking.

(2) Certification

The President may certify under paragraph (1) that a foreign government is closely cooperating with the United States in efforts to prevent opioid trafficking if that government is—

(A) implementing domestic laws to schedule all fentanyl analogues as controlled substances; and

(B) doing two or more of the following:

(i) Implementing substantial improvements in regulations involving the chemical and pharmaceutical production and export of illicit opioids.

(ii) Implementing substantial improvements in judicial regulations to combat transnational criminal organizations that traffic opioids.

(iii) Increasing efforts to prosecute foreign opioid traffickers.

(iv) Increasing intelligence sharing and law enforcement cooperation with the United States with respect to opioid trafficking.

(3) Subsequent renewal of waiver

The President may renew a waiver under paragraph (1) for subsequent periods of not more than 12 months each if, not less than 15 days before the renewal is to take effect, the Secretary of State certifies to the appropriate congressional committees and leadership that the government of the country to which the waiver applies has effectively implemented and is effectively enforcing the measures that formed the basis for the certification under paragraph (2).

(b) Waivers for national security and access to prescription medications

(1) In general

The President may waive the application of sanctions under this subchapter if the President determines that the application of such sanctions would harm—

(A) the national security interests of the United States; or

(B) subject to paragraph (2), the access of United States persons to prescription medications.

(2) Monitoring

The President shall establish a monitoring program to verify that a person that receives a waiver under paragraph (1)(B) is not trafficking illicit opioids.

(3) Notification

Not later than 15 days after making a determination under paragraph (1), the President shall notify the appropriate congressional committees and leadership of the determination and the reasons for the determination.

(c) Humanitarian waiver

The President may waive, for renewable periods of 180 days, the application of the sanctions under this subchapter if the President certifies to the appropriate congressional committees and leadership that the waiver is necessary for the provision of humanitarian assistance.

(Pub. L. 116–92, div. F, title LXXII, §7214, Dec. 20, 2019, 133 Stat. 2267.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a)(1), (b)(1), and (c), was in the original "this subtitle", meaning subtitle A (§§7211–7217) of title LXXII of div. F of Pub. L. 116–92, which is classified principally to this subchapter. For complete classification of subtitle A to the Code, see Tables.

Executive Documents

Delegation of Functions

Functions and authorities of President under this section delegated to Secretary of State, in consultation with the Secretary of the Treasury, by section 1(b)(i) of Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, set out as a note under section 2311 of this title.

§2315. Procedures for judicial review of classified information

(a) In general

If a finding under this subchapter, or a prohibition, condition, or penalty imposed as a result of any such finding, is based on classified information (as defined in section 1(a) of the Classified Information Procedures Act (18 U.S.C. App.)) and a court reviews the finding or the imposition of the prohibition, condition, or penalty, the President may submit such information to the court ex parte and in camera.

(b) Rule of construction

Nothing in this section shall be construed—

(1) to confer or imply any right to judicial review of any finding under this subchapter, or any prohibition, condition, or penalty imposed as a result of any such finding; or

(2) to limit or restrict any other practice, procedure, right, remedy, or safeguard that—

(A) relates to the protection of classified information; and

(B) is available to the United States in connection with any type of administrative hearing, litigation, or other proceeding.

(Pub. L. 116–92, div. F, title LXXII, §7215, Dec. 20, 2019, 133 Stat. 2268.)

Editorial Notes

References in Text

Section 1(a) of the Classified Information Procedures Act, referred to in subsec.(a), is section 1(a) of Pub. L. 95–456, Oct. 15, 1980, 94 Stat. 2025, which is set out in the Appendix to Title 18, Crimes and Criminal Procedure.

This subchapter, referred to in subsecs. (a) and (b)(1), was in the original "this subtitle", meaning subtitle A (§§7211–7217) of title LXXII of div. F of Pub. L. 116–92, which is classified principally to this subchapter. For complete classification of subtitle A to the Code, see Tables.

Executive Documents

Delegation of Functions

Functions and authorities of President under subsection (a) of this section delegated to Secretary of the Treasury, in consultation with the Secretary of State, by section 1(d)(viii) of Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, set out as a note under section 2311 of this title.

§2316. Briefings on implementation

Not later than 90 days after December 20, 2019, and every 180 days thereafter until the date that is 5 years after December 20, 2019, the President, acting through the Secretary of State and the Director of National Intelligence, in coordination with the Secretary of the Treasury, shall provide to the appropriate congressional committees and leadership a comprehensive briefing on efforts to implement this subchapter.

(Pub. L. 116–92, div. F, title LXXII, §7216, Dec. 20, 2019, 133 Stat. 2269.)

Editorial Notes

References in Text

This subchapter, referred to in text, was in the original "this subtitle", meaning subtitle A (§§7211–7217) of title LXXII of div. F of Pub. L. 116–92, which is classified principally to this subchapter. For complete classification of subtitle A to the Code, see Tables.

SUBCHAPTER II—OTHER MATTERS

§2331. Director of National Intelligence program on use of intelligence resources in efforts to sanction foreign opioid traffickers

(a) Program required

(1) In general

The Director of National Intelligence shall, in consultation with the Director of the Office of National Drug Control Policy, carry out a program to allocate and enhance use of resources of the intelligence community, including intelligence collection and analysis, to assist the Secretary of the Treasury, the Secretary of State, and the Administrator of the Drug Enforcement Administration in efforts to identify and impose sanctions with respect to foreign opioid traffickers under subchapter I.

(2) Focus on illicit finance

To the extent practicable, efforts described in paragraph (1) shall—

(A) take into account specific illicit finance risks related to narcotics trafficking; and

(B) be developed in consultation with the Undersecretary of the Treasury for Terrorism and Financial Crimes, appropriate officials of the Office of Intelligence and Analysis of the Department of the Treasury, the Director of the Financial Crimes Enforcement Network, and appropriate Federal law enforcement agencies.

(b) Review of counternarcotics efforts of the intelligence community

The Director of National Intelligence shall, in coordination with the Director of the Office of National Drug Control Policy, carry out a comprehensive review of the current intelligence collection priorities of the intelligence community for counternarcotics purposes in order to identify whether such priorities are appropriate and sufficient in light of the number of lives lost in the United States each year due to use of illegal drugs.

(c) Reports and briefings

(1) Reports and briefings on program

(A) Annual reports

Not later than 90 days after December 20, 2019, and annually thereafter, the Director of National Intelligence and the Director of the Office of National Drug Control Policy shall jointly submit to the appropriate congressional committees and leadership a report on the status and accomplishments of the program required by subsection (a) during the year ending on the date of the report. The first report under this subparagraph shall also include a description of the amount of funds devoted by the intelligence community to the efforts described in subsection (a) during each of fiscal years 2017 and 2018.

(B) Semiannual briefings

On a semiannual basis, the Director of National Intelligence and the Director of the Office of National Drug Control Policy shall jointly brief the appropriate congressional committees and leadership on the status and accomplishments of the program required by subsection (a).

(2) Report on review

Not later than 120 days after December 20, 2019, the Director of National Intelligence, in consultation with the Director of the Office of National Drug Control Policy and other relevant agencies, shall submit to the appropriate congressional committees and leadership—

(A) a comprehensive description of the results of the review required by subsection (b); and

(B) an assessment of whether—

(i) the priorities described in that subsection are appropriate and sufficient in light of the number of lives lost in the United States each year due to use of illegal drugs; and

(ii) any changes to such priorities are necessary.

(d) Intelligence community defined

In this section, the term "intelligence community" has the meaning given that term in section 3003(4) of title 50.

(Pub. L. 116–92, div. F, title LXXII, §7231, Dec. 20, 2019, 133 Stat. 2273; Pub. L. 117–263, div. F, title LXVIII, §6811(h), Dec. 23, 2022, 136 Stat. 3601.)

Editorial Notes

References in Text

Subchapter I, referred to in subsec. (a)(1), was in the original "subtitle A", meaning subtitle A (§§7211–7217) of title LXXII of div. F of Pub. L. 116–92, which is classified principally to subchapter I of this chapter. For complete classification of subtitle A to the Code, see Tables.

Amendments

2022—Subsec. (c). Pub. L. 117–263, §6811(h)(1), inserted "and briefings" after "Reports" in heading.

Subsec. (c)(1). Pub. L. 117–263, §6811(h)(2), substituted "Reports and briefings on program" for "Quarterly reports on program" in par. heading; designated existing provisions as subpar. (A) and inserted subpar. heading; in subpar. (A), substituted "annually" for "every 90 days", "year" for "90-day period", and "under this subparagraph" for "under this paragraph"; and added subpar. (B).

§2332. Authorization of appropriations

(a) Department of the Treasury

There are authorized to be appropriated to the Secretary of the Treasury such sums as may be necessary for fiscal year 2020 to carry out operations and activities of the Department of the Treasury solely for purposes of carrying out this chapter.

(b) Commission on Combating Synthetic Opioid Trafficking

Of the amount authorized to be appropriated by section 1403 for fiscal year 2020 [133 Stat. 1711] and available for Drug Interdiction and Counter-Drug Activities, Defense-wide, as specified in the funding table in section 4501 [133 Stat. 2086], the Secretary of Defense may, notwithstanding section 2215 of title 10, transfer $5,000,000 to the Commission on Combating Synthetic Opioid Trafficking established under section 7221 [133 Stat. 2270] in order to carry out the duties of the Commission.

(c) Supplement not supplant

Amounts authorized to be appropriated by subsection (a) shall supplement and not supplant other amounts available to carry out operations and activities described in such subsections.

(d) Notification requirement

Amounts authorized to be appropriated by subsection (a) may not be obligated until 15 days after the date on which the President notifies the appropriate committees of Congress of the President's intention to obligate such funds.

(e) Appropriate committees of Congress defined

In this section, the term "appropriate committees of Congress" means—

(1) the Committee on Armed Services, the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, the Select Committee on Intelligence, the Committee on the Judiciary, and the Committee on Appropriations of the Senate; and

(2) the Committee on Armed Services, the Committee on Financial Services, the Committee on Foreign Affairs, the Permanent Select Committee on Intelligence, the Committee on Oversight and Reform, and the Committee on Appropriations of the House of Representatives.

(Pub. L. 116–92, div. F, title LXXII, §7232, Dec. 20, 2019, 133 Stat. 2274.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this title", meaning title LXXII of div. F of Pub. L. 116–92, known as the Fentanyl Sanctions Act, which is classified principally to this chapter. For complete classification of this Act to the Code, see Tables.

Sections 1403, 4501, and section 7221, referred to in subsec. (b), mean sections sections 1403, 4501, and section 7221 of Pub. L. 116–92, respectively, which are not classified to the Code.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Oversight and Reform of House of Representatives changed to Committee on Oversight and Accountability of House of Representatives by House Resolution No. 5, One Hundred Eighteenth Congress, Jan. 9, 2023.

§2333. Regulatory authority

Not later than 90 days after December 20, 2019, the President shall issue such regulations as are necessary to carry out this chapter, including guidance with respect to what activities are included under the definition of "opioid trafficking" under section 2302(8) of this title.

(Pub. L. 116–92, div. F, title LXXII, §7233, Dec. 20, 2019, 133 Stat. 2275.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title LXXII of div. F of Pub. L. 116–92, known as the Fentanyl Sanctions Act, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 2301 of this title and Tables.

Executive Documents

Delegation of Functions

Functions and authorities of President under this section delegated to Secretary of the Treasury, in consultation with the Secretary of State, by section 1(d)(ix) of Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, set out as a note under section 2311 of this title.

§2334. Termination

The provisions of this chapter, and any sanctions imposed pursuant to this chapter, shall terminate on the date that is 7 years after December 20, 2019.

(Pub. L. 116–92, div. F, title LXXII, §7234, Dec. 20, 2019, 133 Stat. 2275.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title LXXII of div. F of Pub. L. 116–92, known as the Fentanyl Sanctions Act, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 2301 of this title and Tables.

§2335. Exception relating to importation of goods

(a) In general

The authorities and requirements to impose sanctions under this chapter shall not include the authority or a requirement to impose sanctions on the importation of goods.

(b) Good defined

In this section, the term "good" means any article, natural or manmade substance, material, supply, or manufactured product, including inspection and test equipment, and excluding technical data.

(Pub. L. 116–92, div. F, title LXXII, §7235, Dec. 20, 2019, 133 Stat. 2275.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this title", meaning title LXXII of div. F of Pub. L. 116–92, known as the Fentanyl Sanctions Act, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 2301 of this title and Tables.

CHAPTER 29—INTERNATIONAL SPORTS DOPING

        

§2401. Definitions

(1) Anti-doping organization

The term "anti-doping organization" has the meaning given the term in Article 2 of the Convention.

(2) Athlete

The term "athlete" has the meaning given the term in Article 2 of the Convention.

(3) Code

The term "Code" means the World Anti-Doping Code most recently adopted by WADA on March 5, 2003.

(4) Convention

The term "Convention" means the United Nations Educational, Scientific, and Cultural Organization International Convention Against Doping in Sport done at Paris October 19, 2005, and ratified by the United States in 2008.

(5) Major international sport competition

The term "Major International Sport Competition"— ¹

(A) means a competition—

(i) in which one or more United States athletes and three or more athletes from other countries participate;

(ii) that is governed by the anti-doping rules and principles of the Code; and

(iii) in which—

(I) the competition organizer or sanctioning body receives sponsorship or other financial support from an organization doing business in the United States; or

(II) the competition organizer or sanctioning body receives compensation for the right to broadcast the competition in the United States; and

(B) includes a competition that is a single event or a competition that consists of a series of events held at different times which, when combined, qualify an athlete or team for an award or other recognition.

(6) Person

The term "person" means any individual, partnership, corporation, association, or other entity.

(7) Prohibited method

The term "prohibited method" has the meaning given the term in Article 2 of the Convention.

(8) Prohibited substance

The term "prohibited substance" has the meaning given the term in Article 2 of the Convention.

(9) Scheme in commerce

The term "scheme in commerce" means any scheme effectuated in whole or in part through the use in interstate or foreign commerce of any facility for transportation or communication.

(10) USADA

The term "USADA" means the United States Anti-Doping Agency.

(11) WADA

The term "WADA" means the World Anti-Doping Agency.

(Pub. L. 116–206, §2, Dec. 4, 2020, 134 Stat. 998.)

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 116–206, §1, Dec. 4, 2020, 134 Stat. 998, provided that: "This Act [enacting this chapter and amending section 3663A of Title 18, Crimes and Criminal Procedure] may be cited as the 'Rodchenkov Anti-Doping Act of 2019'."

¹ So in original. Term is not capitalized as used in this chapter.

§2402. Major international doping fraud conspiracies

(a) In general

It shall be unlawful for any person, other than an athlete, to knowingly carry into effect, attempt to carry into effect, or conspire with any other person to carry into effect a scheme in commerce to influence by use of a prohibited substance or prohibited method any major international sports competition.

(b) Extraterritorial jurisdiction

There is extraterritorial Federal jurisdiction over an offense under this section.

(Pub. L. 116–206, §3, Dec. 4, 2020, 134 Stat. 999.)

§2403. Criminal penalties and statute of limitations

(a) In general

(1) Criminal penalty

Whoever violates section 2402 of this title shall be sentenced to a term of imprisonment for not more than 10 years, fined $250,000 if the person is an individual or $1,000,000 if the defendant is other than an individual, or both.

(2) Forfeiture

Any property real or personal, tangible or intangible, may be seized and criminally forfeited to the United States if that property—

(A) is used or intended to be used, in any manner, to commit or facilitate a violation of section 2402 of this title; or

(B) constitutes or is traceable to the proceeds taken, obtained, or retained in connection with or as a result of a violation of section 2402 of this title.

(b) Limitation on prosecution

(1) In general

No person shall be prosecuted, tried, or punished for violation of section 2402 of this title unless the indictment is returned or the information is filed within 10 years after the date on which the offense was completed.

(2) Tolling

Upon application in the United States, filed before a return of an indictment, indicating that evidence of an offense under this chapter is in a foreign country, the district court before which a grand jury is impaneled to investigate the offense shall suspend the running of this statute of limitation for the offense if the court finds by a preponderance of the evidence that an official request has been made for such evidence and that it reasonably appears, or reasonably appeared at the time the request was made, that such evidence is, or was, in such foreign country.

(Pub. L. 116–206, §4, Dec. 4, 2020, 134 Stat. 999.)

§2404. Coordination and sharing of information with USADA

Except as otherwise prohibited by law and except in cases in which the integrity of a criminal investigation would be affected, in furtherance of the obligation of the United States under Article 7 of the Convention, the Department of Justice, the Department of Homeland Security, and the Food and Drug Administration shall coordinate with USADA with regard to any investigation related to a potential violation of section 2402 of this title, to include sharing with USADA all information in the possession of the Department of Justice, the Department of Homeland Security, or the Food and Drug Administration which may be relevant to any such potential violation.

(Pub. L. 116–206, §6, Dec. 4, 2020, 134 Stat. 1000.)