21 CFR 510.4
§ 510.4 Biologics; products subject to license control.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 510.4, § 510.4 Biologics; products subject to license control, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86911
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.