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e-CFR data is current as of September 22, 2020

Title 21Chapter ISubchapter CPart 201Subpart D → §201.117


Title 21: Food and Drugs
PART 201—LABELING
Subpart D—Exemptions From Adequate Directions for Use


§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) 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.

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