The Food and Drug Administration just issued a final rule this morning that it says is designed to help ensure that hand sanitizers available over-the-counter (OTC) are safe and effective for those who rely on them. Certain active ingredients, including the much debated chemical triclosan are no longer permitted to be used in OTC hand sanitizers intended for use without water and are marketed under the FDA’s OTC Drug Review.
The regulations will also support the agency’s safety and effectiveness evaluations and determinations for consumer antiseptic rub active ingredients are consistent, up-to-date and accurately represent current scientific knowledge and increasing use patterns. FDA purports that less than three percent of the marketplace will be affected by the final rule, as most OTC consumer antiseptic rubs use ethyl alcohol as the active ingredient.
“In today’s final regulation we finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research in a prepared statement. “We’ve also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers.”
The Centers for Disease Control and Prevention advises that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
As part of the June 30, 2016 proposed rule on consumer antiseptic rubs, the FDA requested additional scientific data to support the safety and effectiveness of active ingredients used in OTC consumer antiseptic rubs.
At this time, three active ingredients - benzalkonium chloride, ethyl alcohol, and isopropyl alcohol - are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.
This final rule completes a series of rulemaking actions in the FDA’s ongoing review of OTC antiseptic active ingredients to determine whether these ingredients are safe and effective for their intended uses. The FDA previously issued final rules on consumer antiseptic washes (Sept. 2016) and healthcare antiseptics (Dec. 2017).
As for hand hygiene in general, last year The Joint Commission provided more motivation for better-performing hand-hygiene programs. Effective January 1, 2018, “. . . any observation by surveyors of individual failure to perform hand hygiene in the process of direct patient care will be cited as a deficiency resulting in a Requirement for Improvement (RFI) under the Infection Prevention and Control (IC) chapter for all accreditation programs.”
