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OTC monographs

This article was originally published in The Rose Sheet

Executive Summary

Antiperspirant monograph to be complete by December, according to FDA's semi-annual agenda published in the Federal Register April 24. Other final reg agenda items include skin protectant (poison ivy) by October, OTC drug labeling (Ca/Mg/K/Na) by December, labeling for topical drug products containing benzoyl peroxide by July 2001 and antimicrobial products (diaper rash) by March 2004. An advanced notice of proposed rulemaking for oral health care products (plaque/gingivitis) is slated for October release with a notice of proposed rulemaking to be complete by January 2001. A final reg on citizen petitions will be released by January 2001 and an NPRM on suspected adverse OTC drug reaction reporting and recordkeeping requirements is scheduled for September

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