U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs April 1998

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1998-D-1007
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Section 412 of Title IV of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act), signed into law by President Clinton on November 21, 1997, amended section 502(e) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(e)(1)) to require that the established name and quantity (or, if determined to be appropriate, the proportion) of each active ingredient appear on the label of all over-the-counter (OTC) drug products intended for human use.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1998-D-1007.

 
Back to Top