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Consent Decree Orders FDA Action On Triclosan OTC Monographs

This article was originally published in The Rose Sheet

Executive Summary

A Nov. 21 consent decree sets multiple deadlines over a five-year period to make FDA finalize its OTC topical antimicrobial drug products monograph with respect to triclosan. Under a pair of deadlines of note to triclosan product makers, the agency must publish a tentative final monograph for consumer antiseptic hand-wash products by Dec. 16, with a final monograph due Sept. 15, 2016.

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