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TOPICAL ANTIMICROBIAL "BROAD SPECTRUM ACTIVITY" DEFINITION ADDED

This article was originally published in The Tan Sheet

Executive Summary

TOPICAL ANTIMICROBIAL "BROAD SPECTRUM ACTIVITY" DEFINITION ADDED to an amended tentative final monograph on OTC health care antiseptic products published in the June 17 Federal Register, FDA stated that the definition for broad spectrum activity is: "A properly formulated drug product, containing an ingredient included in the monograph, that possesses in vitro activity against the micro-organisms" listed in the testing procedures provided in the monograph "as demonstrated by in vitro minimum inhibitory concentration determinations."
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