FDA Issues Final Rule on Use of Certain Antiseptic Ingredients

In an effort to ensure the safety and effectiveness of over-the-counter (OTC) health care antiseptics, the US Food and Drug Administration (FDA) has finalized a rule that certain active ingredients are not considered generally recognized as safe and effective (GRASE) due to insufficient data.

“Ensuring the safety and effectiveness of OTC 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,” FDA Commissioner Scott Gottlieb, MD, commented in a recent briefing. “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.”

Health care antiseptics include “patient preoperative skin preparations, surgical hand scrubs and rubs, and health care personnel hand washes and rubs,” according to the FDA.

In the rule, the FDA has determined that 24 ingredients—including triclosan—can no longer be used in OTC health care antiseptics without pre-market review. The good news is that many of these ingredients are infrequently used and manufacturers have already been actively removing them from their products. In fact, the FDA reports that triclosan is the only active ingredient that is “currently being used in any marketed health care antiseptic products,” and so most currently marketed health care antiseptics will be unaffected by this rule. Products that still comprise 1 or more of these ingredients will be considered new drugs and thus, will require approved new drug applications (NDAs) in order to be marketed.

Antiseptic manufactures have 1 year to comply with the rule, during which time they can reformulate or remove their products from the market.

Based on industry requests, the FDA will defer final rulemaking on 6 specific active ingredients—alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX)—that are commonly used in many OTC health care antiseptics for 1 year. Doing this will allow manufacturers more time to conduct the necessary studies to provide the safety and effectiveness data the FDA requires.

“Manufacturers using these 6 active ingredients in OTC health care antiseptics have known since 2015 that the FDA sought additional information on these products,” Dr. Gottlieb said. “The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting.”

He also noted that this ruling does not necessarily mean that those 6 ingredients are unsafe or ineffective. In fact, these 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," Dr. Gottlieb said.

Health care antiseptics that are currently marketed under regular and abbreviated NDAs will not be impacted by this ruling.