- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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.