{"data":{"id":"us/21-cfr-201.117","jurisdiction":"us","citation":"21 CFR 201.117","heading":"Inactive ingredients.","body":"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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER C—DRUGS: GENERAL","PART 201—LABELING","Subpart D—Exemptions From Adequate Directions for Use"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"efc239422c4cfb4ebc43829201625d8dcf6bf0fe2cbfbe90c8c089bb60ea7a59","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-201.116","next":"us/21-cfr-201.119"},"notice":"GroundRules: Original legal text. Not legal advice."}