This article was originally published in The Rose Sheet
CTFA will submit an application to establish a United States Pharmacopeia monograph for antimicrobial active ingredient triclocarban on behalf of industry group Interested Party Task Force, association announces. Application is intended to "establish a name for the active ingredient as well as establishing standards for identification and purity" under the monograph, CTFA notes. Triclocarban is currently designated Category III for efficacy under the OTC topical antimicrobial drug products tentative final monograph, but industry is seeking to change its status. Procter & Gamble submitted comments to FDA last year requesting the ingredient be designated Category 1 at levels of up to 1.5% (1"The Rose Sheet" Sept. 1, 2003, p. 6). Comments will be accepted by CTFA until April 15...
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