Page:United States Statutes at Large Volume 99 Part 2.djvu/545

 PUBLIC LAW 99-198—DEC. 23, 1985

99 STAT. 1655

circumstance (including production solely for intrastate use under a State-operated program), the Secretary may issue a special license under an expedited procedure on such conditions as are necessary to assure purity, safety, and a reasonable expectation of efficacy. The Secretary shall exempt by regulation from the requirement of preparation pursuant to an unsuspended and unrevoked license any virus, serum, toxin, or analogous product prepared by any person, firm, or corporation— "(1) solely for administration to animals of such person, firm, or corporation; "(2) solely for administration to animals under a veterinarianclient-patient relationship in the course of the State licensed professional practice of veterinary medicine by such person, firm, or corporation; or "(3) solely for distribution within the State of production pursuant to a license granted by such State under a program determined by the Secretary to meet criteria under which the State— "(A) may license virus, serum, toxin, and analogous products and establishments that produce such products; "(B) may review the purity, safety, potency, and efficacy of such products prior to licensure; "(C) may review product test results to assure compliance with applicable standards for purity, safety, and potency, prior to release to the market; "(D) may deal effectively with violations of State law regulating virus, serum, toxin, and analogous products; and through (D) consistent with the intent of this paragraph of prohibiting the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous products.". (d) The seventh sentence of such paragraph (21 U.S.C. 157) (as it existed before the amendments made by this section) is amended by striking out "licensed under this Act". (e) Such paragraph is amended by inserting after the eighth sentence (21 U.S.C. 158) (as it existed before the amendments made by this section) the following new sentences: "The procedures of sections 402, 403, and 404 of the Federal Meat Inspection Act (21 U.S.C. 672, 673, and 674) (relating to detentions, seizures and condemnations, and injunctions, respectively) shall apply to the enforcement of this paragraph with respect to any product prepared, sold, bartered, exchanged, or shipped in violation of this paragraph or a regulation promulgated under this paragraph. The provisions (including penalties) of section 405 of such Act (21 U.S.C. 675) shall apply to the performance of official duties under this paragraph. Congress finds that (i) the products and activities that are regulated under this paragraph are either in interstate or foreign commerce or substantially affect such commerce or the free flow thereof, and (ii) regulation of the products and activities as provided in this paragraph is necessary to prevent and eliminate burdens on such commerce and to effectively regulate such commerce.". (f)(1) Except as provided in paragraph (2), the amendments made by this section shall become effective on the date of enactment of this Act. (2)(A) Subject to subparagraphs (B) through (D), in the case of a person, firm, or corporation preparing, selling, bartering, exchang-
 * (E) exercises the authority referred to in subclauses (A)

51-194 O

QL. 3

Regulation. Corporations.

Animals.

21 USC 159

Effective date. 21 USC 151 note. Corporation, eommerce and trade.

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