21 CFR § 510.4 - Biologics; products subject to license control.

---
identifier: "/us/cfr/t21/s510.4"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 510.4 - Biologics; products subject to license control."
title_number: 21
title_name: "Food and Drugs"
section_number: "510.4"
section_name: "Biologics; products subject to license control."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "510"
part_name: "NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e."
regulatory_source: "40 FR 13807, Mar. 27, 1975, unless otherwise noted."
cfr_part: "510"
---


# 510.4 Biologics; products subject to license control.

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.