Code of Federal Regulations · Section
§ 201.117 — Inactive Ingredients
21 C.F.R. § 201.117
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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.
Authorizing Statute
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Regulations42 U.S.C. § 216
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Definitions; generally21 U.S.C. § 321