Page:United States Statutes at Large Volume 82.djvu/385

 82 STAT. ]

PUBLIC LAW 90-399-JULY 13, 1968 NEW ANIMAL

343

DRUGS

SEC. 101. (a) Section 501(a) of the Federal Food, Drug, and Cos52 Stat. metic Act, as amended, is amended by inserting before the period at 21 USC 31049. 51. the end thereof a semicolon and the following: "or (5) if it is a new animal drug which is unsafe within the meaning of section 512; or (6) In Ira. if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 512". (b) Chapter V of such Act is amended by adding at the end thereof 79 Stat. 3227. 21 USC 5 1 the following: aeoa "NEW ANIMAL DRUGS

"SEC. 512. (a)(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 501(a)(5) and section 402(a)(2)(D) unless— ^^^^^- ^^.^ " (A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such use or intended use of such drug, " (B) such drug, its labeling, and such use conform to such approved application, and " (C) in the case of a new animal drug subject to subsection (n) of this section and not exempted therefrom by regulations it is from a batch with respect to which a certificate or release issued pursuant to subsection (n) is in effect with respect to such drug. A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee— " (i) is the holder of an approved application under subsection (m) of this section; or "(ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under subsection (m) of this section. "(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of section 501(a)(6) ^^P'^unless— " (A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such drug, as used in such animal feed, " (B) there is in effect an approval of an application pursuant to subsection (m)(1) of this section with respect to such animal feed, and " (C) such animal feed, its labeling, and such use conform to the conditions and indications of use published pursuant to subsection (1) of this section and to the application with respect thereto approved under subsection (m) of this section.

�