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FDA Finalizes Rule on Topical Antimicrobial Drug Products for Over-the-Counter Human Use

October 13, 2016

The US Food and Drug Administration (FDA) has released the Final Rule for the Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use on September 6, 2016.

The final rule establishes that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded.

This final rule bans 19 ingredients.

This final rule is effective stating September 6, 2016.

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