C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS › PART 510—NEW ANIMAL DRUGS › Subpart A—General Provisions

21 C.F.R. § 510.4

Biologics; products subject to license control

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An animal drug produced and distributed in full conformance with the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ) and any regulations issued thereunder shall not be deemed to be subject to section 512 of the Federal Food, Drug, and Cosmetic Act.

Notes of Decisions
Cited in 1 case, 1992–1992 · leading case: United States v. Pro-Ag, Inc. Spencer W. Landswerk, 968 F.2d 681 (8th Cir. 1992).
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United States v. Pro-Ag, Inc. Spencer W. Landswerk, 968 F.2d 681 (8th Cir. 1992). “21 C.F.R. § 510.4 (1991) only exempts drugs that conform to the VSTA from FDA regulation.”
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