by Beth Raper
On April 12, 2019, the US Food and Drug Administration (FDA) issued a final rule on hand sanitizers available over-the-counter (OTC). The final rule applies to active ingredients used in consumer antiseptic rub products sometimes also known as rubs, leave-on products, or hand ‘sanitizers’, as well as antiseptic wipes.
These products are intended to be used when soap and water are not available and are left on and not rinsed off with water. The final rule also seeks to ensure that the agency’s safety and effectiveness evaluations and determinations for consumer antiseptic rub active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and increasing use patterns.
“Our action today aims to help provide consumers with confidence that the over-the-counter hand sanitizers they’re using are safe and effective when they don’t have access to water to wash with soap,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
Requests were made that benzalkonium chloride, ethyl alcohol, and isopropyl alcohol be deferred from consideration in this consumer antiseptic rub document to allow more time for interested parties to complete necessary studies to fill the safety and effectiveness data gaps identified in the 2016 Consumer Antiseptic Rub proposed rule for these ingredients.
For each active ingredient, FDA has deferred rulemaking for 1 year, with the possibility of renewal, which allows the Agency to monitor the continued progress of the studies being conducted.
Consumer antiseptic hand sanitizers provide a convenient alternative when hand washing with plain soap and water is unavailable, said FDA. Millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands.
The Centers for Disease Control and Prevention, (CDC), 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.
The effective date of the final rule is April 13, 2020.
Food and Drug Administration. “Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use” Federal Register 84 (12 April 2019): 14847-14864.
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