21 CFR 201.117 - Inactive ingredients.

§ 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.

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 201 after this date.

  • 2017-02-07; vol. 82 # 24 - Tuesday, February 7, 2017
    1. 82 FR 9501 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Delayed Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of effective date.
      The effective date of the rule amending 21 CFR Chapter I published at 82 FR 2193 on January 9, 2017 is delayed until March 21, 2017.
      21 CFR Parts 201, 801, and 1100
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