Consent Decree Orders FDA Action On Triclosan OTC Monographs

摘要

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 seeking an order that FDA issue its final regulatory position on antimicrobial triclosan use in OTC drugs.