December 19, 2017

 

Dear Colleagues,

The FDA has finalized a rule first proposed in 2015 that finds that triclosan and 23 other active ingredients are not generally recognized as safe and effective (GRASE) for use in over-the-counter (OTC) health care antiseptic products – including health care personnel hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin preparations — because no additional safety and effectiveness data were provided to the FDA to support monograph conditions for these 24 active ingredients.

As a result, products containing these active ingredients, intended for use in OTC health care antiseptics by health care professionals in a hospital setting or other health care situations outside the hospital, are not allowed to be marketed without undergoing pre-market review. Health care antiseptic drug products containing one or more of these non-GRASE active ingredients will be considered new drugs for which approved new drug applications (NDAs) are required for marketing. Manufacturers will have one year to comply with this final rule by reformulating (revising or changing formulas) or removing their products from the market. Based on the proposed rule, manufacturers have already started removing these ingredients from their products. Of the 24 active ingredients that the FDA is finding non-GRASE, triclosan is the only active ingredient currently being used in any marketed health care antiseptic products. So most currently marketed health care antiseptics will not be impacted by this final rule.

In response to requests from industry, the FDA has deferred final rulemaking for one year, subject to renewal, on six specific active ingredients that are the most commonly used in currently marketed OTC health care antiseptic products ‒ alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX) – to provide manufacturers with more time to complete the scientific studies necessary to fill the data gaps identified so that the agency can make a safety and efficacy determination about these ingredients. In addition, the final rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.

Today’s action is part of the FDA’s ongoing, comprehensive review of OTC antiseptic active ingredients to ensure these ingredients are safe and effective. The FDA has previously issued a final rulemaking on consumer antiseptic washes (September 2016) and a proposed rule on consumer antiseptic rubs (June 2016).

For more information:

·        Final Rule: Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use

·        Q&A for Health Care Professionals: Health Care Antiseptics

·        Q&A for Consumers: Health Care Antiseptics

·        Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps

·        Topical Antiseptic Drug Products

·        Handwashing: Clean Hands Save Lives (CDC)

·        Consumer Update: 5 Things to Know About Triclosan

·        FDA News & Events: FDA Issues Final Rule on Safety and Effectiveness for Certain Active Ingredients in Over-the-Counter Health Care Antiseptic Hand Washes and Rubs in the Medical Setting

This message is being broadcast by the Division of Communications in the FDA’s Office of Regulatory Affairs (ORA).

Thank you,

FDA/ORA

Office of Communications and Quality Program Management

Division of Communications

Mailbox:  DivComm-ORA@fda.hhs.gov

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