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FDA Publishes Final Rule for Consumer Antiseptic Washes

September 7, 2016, Covington Alert

Yesterday, FDA published its final rule regulating certain active ingredients found in over-the-counter (“OTC”) consumer antiseptic wash products that are intended to be used with water and rinsed off after use, such as hand or body washes, which FDA refers to as “consumer antiseptic washes” (the “Final Rule”). In the Final Rule, FDA deems 19 active ingredients to be “nonmonograph,” meaning that they are not generally recognized as safe and effective (“GRAS/GRAE”). As a result, once the Final Rule becomes effective, OTC consumer antiseptic washes containing these active ingredients will be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act and constitute new drugs for which premarket approval is required. FDA has deferred further rulemaking for three active ingredients to allow for the development and submission of new safety and effectiveness data.

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