Page:United States Statutes at Large Volume 82.djvu/393

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[82 STAT. 351]
[82 STAT. 351]
PUBLIC LAW 90-000—MMMM. DD, 1968

82 STAT. ]

PUBLIC LAW 90-399-JULY 13, 1968

351

"(3) Whenever, in the judgment of the Secretary, the requirements of this subsection with respect to any drug or class of drugs are not necessary to insure that such drug conforms to the standards of identity, strength, quality, and purity applicable thereto under paragraph (1) of this subsection, the Secretary shall promulgate regulations exempting such dru^ or class of drugs from such requirements. The provisions of subsection (c) of section 507 of this Act (other than the 59 Stat. 464; first sentence thereof) shall apply under this paragraph. '^^2rusc 357. "(4) The Secretary shall promulgate regulations exempting from Exemptions. any requirement of this subsection— " (A) drugs which are to be stored, processed, labeled, or repacked at establishments other than those where manufactured, on condition that such drugs comply with all such requirements upon removal from such establishments; and " (B) drugs which conform to applicable standards of identity, strength, quality, and purity prescribed pursuant to this subsection and are intended for use in manufacturing other drugs. "(5) On petition of any interested person for the issuance, amendment, or repeal of any regulation contemplated by this subsection, the procedure shall be in accordance with subsection (f) of section 507 of this Act. " (6) Where any drug is subject to this subsection and not exempted therefrom by regulations, the compliance of such drug with sections 501(b) and 502(g) shall be determined by the application of the jius^cs^^' standards of strength, quality, and purity applicable under para- 352. graph (1) of this subsectionj the tests and methods of assay applicable under provisions of regulations referred to in paragraph (2)(A) of this subsection, and the requirements of packaging and labeling on the basis of which the application with respect to such drug filed under subsection (b) of this section was approved." DEFINITIONS

SEC. 102. Section 201 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by— (a) inserting "(except a new animal drug or an animal feed bearing or containing a new animal d r u g) " after "Any drug" in subparagraph (1) of paragraph (p); 2ius^c32°r' (b) inserting "(except a new animal drug or an animal feed bearing or containing a new animal d r u g) " after "Any drug" in subparagraph (2) of paragraph (p); (c) striking out the period at the end of subparagraph (4) of paragraph (s) and inserting in lieu thereof "; or", and by adding ^^ ^*^* ^^^'*' a new subparagraph (5) to read as follows: "(5) a new animal drug."; (d) inserting ". 512," after "409" in paragraph (u); and (e) adding at the end of such section the following new para- 79 Stat. 227. graphs: " (w) The term 'new animal drug' means any drug intended for use "New animai for animals other than man, including any drug intended for use in '^'^"^"" animal feed but not including such animal feed,— "(1) the comf)Osition 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;