FDA Withdrawing Temporary Guidance For Alcohol-Based Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has announced the withdrawal of temporary guidance for alcohol-based hand sanitizers. The withdrawal effects guidance originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the COVID-19 public health emergency.

“The FDA is committed to providing timely guidance to support continuity and response efforts during the COVID-19 pandemic,” says Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “Throughout the pandemic, the agency has continuously assessed the needs and circumstances related to hand sanitizers and issued temporary guidance to provide regulatory flexibility to certain firms to help meet the increased demand.”

Cavazzoni adds, “As relevant needs and circumstances evolve, the FDA updates, modifies or withdraws policies as appropriate. In recent months, the supply of alcohol-based hand sanitizer from traditional suppliers has increased, and now, most consumers and health-care personnel are no longer having difficulty obtaining these products. Therefore, we have determined it’s appropriate to withdraw the temporary guidance and are providing manufacturers time to adjust their business plans related to production of these products under these temporary policies.”

Effective Dec. 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. After that date, manufacturers wishing to continue producing hand sanitizer can do so provided they comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements.

Manufacturers that no longer plan to produce these products are able to deregister by following the instructions on the Electronic Drug Registration and Listing Instructions page. Hand sanitizers manufactured before or on December 31 and produced under the temporary guidance must no longer be sold to wholesalers or retailers by March 31, 2022.

“The FDA commends all manufacturers, big and small, who stepped in to provide American consumers and health-care professionals with hand sanitizer products while they were in high demand during the pandemic,” says Cavazzoni. “We stand ready to help those who no longer plan to produce hand sanitizers, as well as help those who wish to continue doing so, to ensure they are complying with the appropriate requirements.”

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