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US FDA issues final rule to ensure effectiveness of OTC hand sanitisers
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Saturday, 13 April, 2019, 08 : 00 AM [IST]
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Washington, D C
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The US Food and Drug Administration recently issued a final rule designed to help ensure that hand sanitisers available over-the-counter (OTC) were safe and effective for those who relied on them. The rule established that certain active ingredients were not allowed to be used in OTC hand sanitisers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that were marketed under the FDA’s OTC Drug Review.
The final rule also sought to ensure that the agency’s safety and effectiveness evaluations and determinations for consumer antiseptic rub active ingredients were consistent, up-to-date and appropriately reflected the current scientific knowledge and increasing use patterns.
“Our action today aims to help provide consumers with confidence that the over-the-counter hand sanitisers they are using are safe and effective when they do not have access to water to wash with soap,” said Janet Woodcock, director, Centre for Drug Evaluation and Research, FDA.
“In today’s final regulation we finalised 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,” she added.
“We have also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitisers, to help the agency ensure that these products are safe and effective for regular use by consumers. We believe industry has made good progress toward providing data and we will continue to provide updates to the public about the progress of collecting this data,” Woodcock said.
Consumer antiseptic hand sanitisers provide a convenient alternative when hand washing with plain soap and water is unavailable. Millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands.
The Centres for Disease Control and Prevention (CDC) advised that washing hands with plain soap and running water was one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water were not available, the CDC recommended using an alcohol-based hand sanitiser that contained at least 60 per cent 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 recognised 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, FDA does not intend to take action to remove hand sanitisers containing these three active ingredients from the market.
Less than three per cent of the marketplace will be affected by the issuance of this final rule, as most OTC consumer antiseptic rubs use ethyl alcohol as the active ingredient.
FDA is aware that retailers and pharmacies continue to market a very low number of consumer hand sanitisers containing benzethonium chloride, but that they stopped marketing hand sanitisers containing triclosan.
Drug products containing any ineligible active ingredients will require approval under a new drug application or abbreviated new drug application prior to marketing.
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 (in September 2016) and health care antiseptics (in December 2017).
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