21 CFR 310.4
§ 310.4 Biologics; products subject to license control.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 310.4, § 310.4 Biologics; products subject to license control, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86216
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Full text
(a) If a drug has an approved license under section 351 of the Public Health Service Act (42 U.S.C. 262 et seq.) or under the animal virus, serum, and toxin law of March 4, 1913 (21 U.S.C. 151 et seq.), it is not required to have an approved application under section 505 of the act.
(b) To obtain marketing approval for radioactive biological products for human use, as defined in § 600.3(ee) of this chapter, manufacturers must comply with the provisions of § 601.2(a) of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.