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Article: FDA establishes final rule for OTC drug monograph system; USP botanical monographs required. (Industry News).
- Article from:
- Pharmaceutical Processing
- Article date:
- April 1, 2002
CopyrightCOPYRIGHT 2002 Advantage Business Media. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The U.S. Food and Drug Administration (FDA) announced in a final regulation that over-the-counter (OTC) drugs included in the OTC drug monograph system must meet a United States Pharmacopeia and National Formulary (USP-NF) existing or proposed monograph(s) for active ingredients or botanical drug substances. The requirement is part of FDA's regulatory procedures for classifying OTC drugs as safe and effective. The OTC drug final regulation became effective Feb. 22, 2002 (Federal Register, Jan. 23, 2002, pages 3060 through 3076).
The FDA final regulation applies to those OTC drugs initially marketed in the United States after 1972 and those that are only marketed ...