In the September 6, 2016, Federal Register, FDA issued a final rule establishing that certain active ingredients used in over-the-counter ("OTC") consumer antiseptic products intended for use with water are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule—which finalizes the proposed rule published in the December 17, 2013, Federal Register and amends the 1994 tentative final monograph for OTC antiseptic drug products published in the June 17, 1994, Federal Register—after considering the recommendations of the Nonprescription Drugs Advisory Committee, public comments on the Agency's notices of proposed rulemaking, and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. The final rule is part of the ongoing review of OTC drug products conducted by FDA and covers only OTC consumer antiseptic washes that are intended for use as either a hand wash or a body wash; the rule does not cover health care antiseptics, consumer antiseptic rubs, first aid antiseptics, or antiseptics used by the food industry. The rule is effective September 6, 2017.
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