---
kind: "section"
citation: "21 C.F.R. § 310.4"
title: "21"
number: "310.4"
heading: "Biologics; products subject to license control."
url: "https://uscodex.org/cfr/21/310.4"
---

# §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](/usc/42/262.md) et seq.) or under the animal virus, serum, and toxin law of March 4, 1913 ([21 U.S.C. 151](/usc/21/151.md) et seq.), it is not required to have an approved application under [section 505](/cfr/21/505.md) of the act.
- (b) To obtain marketing approval for radioactive biological products for human use, as defined in [§ 600.3(ee)](/cfr/21/600.3.md?p=ee) of this chapter, manufacturers must comply with the provisions of [§ 601.2(a)](/cfr/21/601.2.md?p=a) of this chapter.

## Notes

### Amendments

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

### Authority

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.

### Amendments

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