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FDA Establishes Antiseptic Ingredients Are Not GRAS/E

09/06/2016

Federal Register Final rule: FDA is issuing 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 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 its attention. This final rule amends the 1994 tentative final monograph for OTC antiseptic drug products that published in the 6/17/94 Federal Register. To view this notice, click here.

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