§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, 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 of this title and shall request that if any drugs and devices 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 and devices 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, 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 ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph ¹ 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 [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 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, 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 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) 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.

(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) 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.

(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 262(a) of title 42 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 264 of title 42.

(e) Exports

(1) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this chapter 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 drug, animal drug, or device may request that the Secretary-

(i) certify in writing that the exported drug, animal drug, or device meets the requirements of paragraph (1) or section 382 of this title; or

(ii) certify in writing that the drug, animal drug, or device being exported meets the applicable requirements of this chapter upon a showing that the 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.

(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) of this section 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) of this section 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) of this section 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) of this section; 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.

(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.)

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 , as amended, 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.

Amendments

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.

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.

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.

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.

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 41 of this title.

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."

Section Referred to in Other Sections

This section is referred to in sections 331, 333, 334, 360, 371, 382, 384 of this title; title 15 section 1456; title 42 section 262.

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