Page:United States Statutes at Large Volume 118.djvu/933

 118 STAT. 903 PUBLIC LAW 108–282—AUG. 2, 2004 (F) Section 503(f) of the Federal Food, Drug, and Cos metic Act is amended— (i) in paragraph (1)(A)(ii) by striking ‘‘512’’ and inserting ‘‘512, a conditionally approved application under section 571, or an index listing under section 572’’; and (ii) in paragraph (3) by striking ‘‘section 512’’ and inserting ‘‘section 512, 571, or 572’’. (G) Section 504(a)(1) of the Federal Food, Drug, and Cosmetic Act is amended by striking ‘‘512(b)’’ and inserting ‘‘512(b), a conditionally approved application filed pursuant to section 571, or an index listing pursuant to section 572’’. (H) Sections 504(a)(2)(B) and 504(b) of the Federal Food, Drug, and Cosmetic Act are amended by striking ‘‘512(i)’’ each place it appears and inserting ‘‘512(i), or the index listing pursuant to section 572(e)’’. (I) Section 512(a) of the Federal Food, Drug, and Cos metic Act is amended by striking paragraphs (1) and (2) and inserting the following: ‘‘(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of section 501(a)(5) and section 402(a)(2)(C)(ii) unless— ‘‘(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application; ‘‘(B) there is in effect a conditional approval of an applica tion filed pursuant to section 571 with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved applica tion; or ‘‘(C) there is in effect an index listing pursuant to section 572 with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing. 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) holds a license issued under subsection (m) and has in its possession current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under subsection (m). ‘‘(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 purposes of section 501(a)(6) unless— ‘‘(A) there is in effect— ‘‘(i) an approval of an application filed pursuant to subsection (b) with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribu tion, holding, and use conform to such approved application; 21 USC 360b. 21 USC 354. 21 USC 353.

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