21 C.F.R. § 201.117 Inactive ingredients.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 201—LABELING
Subpart D—Exemptions From Adequate Directions for Use
§ 201.117 Inactive ingredients.
