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GUIDANCE DOCUMENT

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

Final
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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.