FDA issues final rule on hand sanitizers

April 23, 2019

The Food and Drug Administration (FDA) recently issued a final rule on hand sanitizers available over-the-counter, according to an article on the Infection Control Today website.

The rule says certain active ingredients are not allowed to be used.

It also sets out guidelines to ensure the agency’s safety and effectiveness evaluations and determinations are consistent, up-to-date and appropriately reflect current scientific knowledge and increasing use patterns.

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 consumer antiseptic rub products. 

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