21 CFR 201.117
§ 201.117 Inactive ingredients.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 201.117, § 201.117 Inactive ingredients, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85791
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.