FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers

FDA in Brief

• For Immediate Release: October 12, 2021

The following quote is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research:

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“The FDA is committed to providing timely guidance to support continuity and response efforts during the COVID-19 pandemic. Throughout the pandemic, the agency has continuously assessed the needs and circumstances related to hand sanitizers and issued temporary guidances to provide regulatory flexibility to certain firms to help meet the increased demand.

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 healthcare personnel are no longer having difficulty obtaining these products. Therefore, we have determined it’s appropriate to withdraw the temporary guidances and are providing manufacturers time to adjust their business plans related to production of these products under these temporary policies.

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. 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.”

Additional Information

• Today, the U.S. Food and Drug Administration announced that it intends to withdraw, effective Dec. 31, 2021, guidances 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 public health emergency.
• 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 who 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, 2021, and produced under the temporary guidances can no longer be sold or distributed by manufacturers after March 31, 2022.