CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR310.4]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 310 -- NEW DRUGS

Subpart A - General Provisions

Sec. 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]