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) 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.
21 CFR Part 201 · Labeling
§ 201.117 Inactive ingredients
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Amendment history
Federal Register documents that created or amended this section.
- 40 FR 13998 27 Mar 1975