Page:United States Statutes at Large Volume 82.djvu/395

 82 STAT. ]

PUBLIC LAW 90-399-JULY 13, 1968 A N I M A L DRUGS FOR

EXPORT

SEC. 106. Section 801(d) of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by adding at the end thereof the following: "Nothing in this subsection 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 512 of this

353

Act."

52 Stat. loss. ^^ "^^ ^^^^• An^e, p. 343.

AMENDMENT W I T H RESPECT TO VI R U S, S E R U M, TO X I N, A N D A N A L 0 ( i 0 U S PRODUCTS ACTS

SEC. 107. Section J>02(c) of the Federal Food, Drug, and Cosmetic Act is amended by striking out "the virus, serum, and toxin Act of July 1, 1902 (U.S.C. 1934 ed., title 42, chap. 4); " and inserting in lieu thereof the following: "section 351 of Public Health Service Act (relating to viruses, serums, toxins, and analogous products applicable to m a n); 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);•'. EFFECTIVE DATE AND T R A N S I T I O N A L

21 USC 392.

42 us^c 26^ ^2

21 USC 151-158.

PROVISIONS

SEC. 108, (a) Except?s otherwise provided in this section, the amendments made by the foregoing sections shall take effect on the first day of the thirteenth calendar month which begins after the date of enactment of this Act. (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; 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 regulation, shall continue in effect, and shall be subject to change in accordance with the provisions of the basic Act as amended by this Act. (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) intended for use in animals other tlian 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 as then in force, and (C) was not covered by an effective application under section 505 of that Act, the words "effectiveness" and "effective" contained in section 201 (w) as added by this Act to the basic 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. (4) Rpjxulations providing tor 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 shall, except as the Secretary may otherwise l)rescribe, be deemed to apply also under section 512(n) of the basic Act, and appropriations of fees (and of advancs deposits to cover fees) available for the purposes specified in such section 507 as in effect prior to the effective date shall also be available for the purposes specified in section 512(n), including preparatory work or proceedings prior to that date. Approved July 13, 1968.

Definitions.

^"^^' P- ^^O. 52 Stat. 1041 21 USC 321. 76 Stat. 781785. 21 USC 355. Ante, p. 351.

59 stat^ 463;

76 Stat. 785-78S 21 USC 357.

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