§356. Certification of drugs containing insulin

(a) Standards for certification

The Secretary, pursuant to regulations promulgated by him, shall provide for the certification of batches of drugs composed wholly or partly of insulin. A batch of any such drug shall be certified if such drug has such characteristics of identity and such batch has such characteristics of strength, quality, and purity, as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof.

(b) Regulations

Regulations providing for such certification shall contain such provisions as are necessary to carry out the purposes of this section, including provisions prescribing (1) standards of identity and of strength, quality, and purity; (2) tests and methods of assay to determine compliance with such standards; (3) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (4) administration and procedure; and (5) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe no standard of identity or of strength, quality, or purity for any drug different from the standard of identity, strength, quality, or purity set forth for such drug in an official compendium.

(c) Tests or methods of assay; revision

Such regulations, insofar as they prescribe tests or methods of assay to determine strength, quality, or purity of any drug, different from the tests or methods of assay set forth for such drug in an official compendium, shall be prescribed, after notice and opportunity for revision of such compendium, in the manner provided in the second sentence of section 351(b) of this title. The provisions of subsections (e), (f), and (g) of section 371 of this title shall be applicable to such portion of any regulation as prescribes any such different test or method, but shall not be applicable to any other portion of any such regulation.

(June 25, 1938, ch. 675, §506, as added Dec. 22, 1941, ch. 613, §3, 55 Stat. 851 ; amended June 16, 1992, Pub. L. 102–300, §6(b)(2), 106 Stat. 240 ; Aug. 13, 1993, Pub. L. 103–80, §3(o), 107 Stat. 777 .)

Amendments

1993-Subsec. (a). Pub. L. 103–80 substituted "Secretary" for "Federal Security Administrator" in first sentence and for "Administrator" in two other places.

1992-Subsec. (a). Pub. L. 102–300, which directed the amendment of subsec. (a) 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.

Regulations

Section 4 of act Dec. 22, 1941, directed that regulations initially prescribed under this section were to be promulgated and made effective within forty-five days after Dec. 22, 1941.

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.

Section Referred to in Other Sections

This section is referred to in sections 331, 352, 360 of this title; title 15 section 1459; title 38 section 8126; title 42 section 1396r–8.