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U.S. FDA Publishes Final Rule on Hand Sanitizer Active Ingredients
On April 12, 2019, the U.S. Food and Drug Administration (FDA) published the Final Rule for the Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. The final rule outlines active ingredients that are not Generally Recognized as Safe and Effective (GRASE) and therefore, not permitted in consumer over-the-counter (OTC) hand sanitizers.
The final rule also outlines the active ingredients that currently require additional information to determine the safety and efficacy.
The FDA has deferred rulemaking on Benzalkonium chloride, Ethyl alcohol (aka ethanol, alcohol), and Isopropyl alcohol for additional time to collect safety and efficacy data.
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