FDA Withdrawing Temporary Policies for Non-Drug Manufacturers Producing Hand Sanitizer Products During the COVID-19 Public Health Emergency

Womble Bond Dickinson

Womble Bond Dickinson

On Tuesday, October 12, 2021, the US Food and Drug Administration (FDA) announced that it will withdraw the temporary policies1,2 originally issued in March 2020 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. Effective December 31, 2021, companies that are manufacturing alcohol-based hand sanitizers or alcohol for use in hand sanitizers, relying on the FDA temporary policies1,2 must cease production of these products. All hand sanitizers produced under the temporary policies1,2 and manufactured before or on December 31, 2021, must no longer be sold to wholesalers or retailers after March 31, 2022.

The FDA press release noted that “the agency has continuously assessed the needs and circumstances related to hand sanitizers and issued temporary policies to provide regulatory flexibility to certain firms to help meet the increased demand.” FDA is withdrawing the temporary policies because FDA determined that “consumers and healthcare personnel are no longer having difficulty obtaining these products.” Following the December 31, 2021 expiration of the temporary policies1,2, manufacturers who wish to continue producing these products will need to “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.”

If manufacturers do not plan to continue producing these products, then they will need to deregister their facility on the Electronic Drug Registration and Listing System (eDRLS)

1Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), March 2020
2Guidance for Industry: Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), March 2020; updated February 10, 2021

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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