§ 310.4. Biologics; products subject to license control.

102 words·~1 min read·/us/cfr/t21/s§ 310.4·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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]

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U.S. Code

Regulation of biological products
§ 262
Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments
§ 151

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§ 310.4

Biologics; products subject to license control.

U.S.C.§ 262

U.S.C.§ 151

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