FDA In Brief: 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

"Ensuring the safety and effectiveness of over-the-counter health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care settings, but also because of the role these products may play in contributing to antimicrobial resistance if they’re not manufactured or used appropriately,” said FDA Commissioner Scott Gottlieb, M.D. “Health care providers are on the front lines of care. They need and deserve to have safe and effective means for preventing the spread of infection. That’s why the FDA has been vigilant in seeking the data to support the continued use of 30 active ingredients used in over-the-counter (OTC) health care antiseptics. This action only concerns OTC products that are commonly marketed to health care providers and used primarily in medical settings like hospitals, health care clinics, and doctors’ offices. We’ve determined that 24 ingredients, including triclosan, most of which were infrequently used, cannot be used in OTC health care antiseptics without pre-market review because there was a lack of sufficient safety and efficacy data. However, it’s important to note that this action does not impact all health care antiseptic ingredients. Rather, given the public health importance of these products, the FDA is deferring final rulemaking on the six most commonly used ingredients while manufacturers collect the data needed to properly weigh their safety and efficacy. Manufacturers using these six active ingredients in OTC health care antiseptics have known since 2015 that the FDA sought additional information on these products. The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting. Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered."

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).