21 CFR 510.4 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 590-599) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 590-599) — Animal Drugs, Feeds, And Related Products (Subpart A To Parts 590-599) — New Animal Drugs (§ 510.3 To § 510.600) — General Provisions (§ 510.3 To § 510.95) — Biologics; products subject to license control.

4 Aug 2016

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.

21 CFR 510.4