Consent Decree Orders FDA Action On Triclosan OTC Monographs

 
• By Lauren Nardella

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.

Under a consent decree signed Nov. 21, FDA is required to finalize its OTC topical antimicrobial drug products monograph as it applies to triclosan and conform to multiple deadlines over a five-year period in the process to completion.

The decree comes under a settlement of a 2010 lawsuit filed by the National Resources Defense Council against the agency...

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