---
kind: "section"
citation: "21 C.F.R. § 201.117"
title: "21"
number: "201.117"
heading: "Inactive ingredients."
url: "https://uscodex.org/cfr/21/201.117"
---

# §201.117. Inactive ingredients.


A harmless drug that is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, in the preparation of other drugs shall be exempt from [section 502(f)(1)](/cfr/21/502.md?p=f-1) of the act. This exemption shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an approved new-drug application provides for such use.


## Notes

### 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.