55 STAT.] 77TH CONG., IST SESS.-CH. 613-DEC. 22, 1941 [CHAPTER 613] AN ACT To amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of insulin, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 301 (i) of the Federal Food, Drug, and Cosmetic Act, of June 25, 1938, as amended, is amended by inserting "506," before the phrase "or 604." at the end thereof. SEC. 2. Section 502 of such Act, as amended, is amended by insert- ing a new paragraph at the end thereof, as follows: "(k) If it is, or purports to be, or is represented as a drug com- posed 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 506, and (2) such certificate or release is in effect with respect to such drug." SEC. 3. Chapter V of such Act, as amended, is amended by adding a new section at the end thereof, as follows: "CERTIFICATION OF DRUGS CONTAINING INSULIN "SEC. 506. (a) The Federal Security Administrator, 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 character- istics of identity and such batch has such characteristics of strength, quality, and purity, as the Administrator prescribes in such regula- tions 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 Administrator, 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 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) 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 501 (b). The provisions of subsections (e), (f), and (g) of section 701 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." 851 December 22, 1941 [H. R . 6251] [Public Law 366] Federal Food, Drug, and Cosmetic Act, amendments. 52 Stat. 1042. 21U. S. C. §331 (i). 52 Stat. 1050. 21 U.S. C.§352. Misbranded insulin. Infra. 52 Stat. 1049. 21 U. S. .C . 351-355. Certification of drugs containing in- sulin. Release in lieu of certification. Regulations pre- scribing standards, etc. Different tests or methods of assay. 52 Stat. 1049. 21U.S.C.j351(b). 52 Stat. 105. 21 U. . . 1. 71 (e)4-7 (g).
�
