Page:United States Statutes at Large Volume 82.djvu/394

 352

PUBLIC LAW 90-399-JULY 13, 1968

[82 STAT.

Exception.

except that such a drug not so recognized shall not be deemed to be a 'new animal drug' if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as 52^stat°\o59^' amended, and if at such time its labeling contained the same 21 USC 1-15 representations concerning the conditions of its use; or "°'^^"(2) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions; or "(3) which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof, except when there is in effect a published order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A) the requirement of certification of batches of such drug, as provided for in Ante, p. 350. section 512(u), is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and (B) that neither subparagraph (1) nor (2) of this paragraph (w) applies to such drug. "Animal feed." " (x) The term 'animal feed', as used in paragraph (w) of this Anfe, pp. 351, section, lu section 512, and in provisions of this Act referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal." r R O III B l T E D ACTS A N D

788^ ^*^*' ^^'*' 21 USC 331. 52 Stat. 1042; 61 Stat. 11.

77stat^397^^^' 21 USC 342.

SEC. 103. Section 301 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by— (1) striking out "or" before "507," and inserting ", or 512 (j), C^)?"!" (m) " after "507 (d) or (g) " in paragraph (e),and (2) adding "512," after "507," in paragraph (j). A N I M A L DRUGS I N FEEDS A N D RESIDUES THE R E OF I N OTHER FOOD

SEC. 104. Section 402 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by— (1) striking out the word "or" before " ( i i i) " in clause (A) of Subparagraph (2) of paragraph (a) and inserting "; or (iv) a new animal drug" after the words "color additive" therein; and (2) adding before the semicolon following "commodity" at the end of the proviso to clause (C) of subparagraph (2) of paragraph (a) the following: "; or (D) if it is, or it bears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of section 512". ANTIBIOTIC

2??se35221 USC 357!

PENALTIES

DRUGS FOR

ANIMALS

SEC. 105. (a) Section 502 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by inserting "(except a drug for use in animals other than m a n) " after "represented as a drug" in paragrPh(l)(b) Section 507 of such Act is amended by inserting "(except drugs for use in animals other than m a n) " after "drugs" in the first sentence of subsection (a).

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