The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water and marketed under the FDA’s OTC Drug Review.
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.
At press time, FDA said 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. Less than 3% 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.
This final rule completes a series of rulemaking actions in the FDA’s ongoing review of OTC antiseptic active ingredients.