Consumer Antiseptic Wash Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability

Resumo

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Consumer Antiseptic Wash Final Rule Questions and Answers." We are issuing this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act to assist small businesses in better understanding and complying with the consumer antiseptic wash final rule, which established that certain active ingredients, including triclosan, used in over-the-counter (OTC) consumer antiseptic wash products are not generally recognized as safe and effective (GRASE). This guidance explains the scope of the final rule, how and when manufacturers must comply with the final rule, and which consumer antiseptic wash active ingredients were deferred from the final rule.