21 CFR § 310.4 - Biologics; products subject to license control.

---
identifier: "/us/cfr/t21/s310.4"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 310.4 - Biologics; products subject to license control."
title_number: 21
title_name: "Food and Drugs"
section_number: "310.4"
section_name: "Biologics; products subject to license control."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "310"
part_name: "NEW 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, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262."
cfr_part: "310"
---


# 310.4 Biologics; products subject to license control.

(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.

[64 FR 56448, Oct. 20, 1999, as amended at 70 FR 14981, Mar. 24, 2005]