Code of Federal Regulations · Section
§ 510.4 — Biologics; Products Subject To License Control
21 C.F.R. § 510.4
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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.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321