---
kind: "section"
citation: "21 C.F.R. § 201.115"
title: "21"
number: "201.115"
heading: "New drugs or new animal drugs."
url: "https://uscodex.org/cfr/21/201.115"
---

# §201.115. New drugs or new animal drugs.


A new drug shall be exempt from [section 502(f)(1)](/cfr/21/502.md?p=f-1) of the act:

- (a) To the extent to which such exemption is claimed in an approved application with respect to such drug under section [505](/cfr/21/505.md) or [512](/cfr/21/512.md) of the act or an index listing with respect to such drug under [section 572](/cfr/21/572.md) of the act; or
- (b) If no application under section [505](/cfr/21/505.md) or [512](/cfr/21/512.md) of the act is approved and no request for addition to the index is granted under [section 572](/cfr/21/572.md) with respect to such drug but it complies with section [505(i)](/cfr/21/505.md?p=i), [512(j)](/cfr/21/512.md?p=j), or [572(g)](/cfr/21/572.md?p=g) of the act and regulations thereunder.

## Notes

### Amendments

[40 FR 13998, Mar. 27, 1975, as amended at 72 FR 69119, Dec. 6, 2007]

### Authority

Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

### Source

Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

### Amendments

[40 FR 13998, Mar. 27, 1975, as amended at 72 FR 69119, Dec. 6, 2007]