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Antimicrobial monograph

This article was originally published in The Tan Sheet

Executive Summary

FDA is reopening administrative record for OTC topical antimicrobial drug products monograph until Aug. 27 to accept comments and data on OTC healthcare antiseptic drugs, agency says in 1May 29 Federal Register notice. Record for TFM closed in August 1995, but FDA has since received several petitions and comments containing new data on proposed non-monograph ingredients and testing criteria for antiseptic drugs. FDA has determined "good cause exists" to review new information, as it is relevant to final ingredient classification and testing criteria. Comments previously submitted need not be resubmitted, additional comments should only address data provided after 1995. Triclosan, salicylic acid among ingredients requested by industry for Category I status; CTFA and SDA have submitted data on test protocols, antimicrobial performance, filing four petitions in 2001 alone (2"The Tan Sheet" Dec. 10, 2001, p. 4)...

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