FDA Withdrawing Temporary Policies for Production of Hand Sanitiz

Healthcare Industry Team at Womble Bond Dickinson

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

by: Healthcare Industry Team at Womble Bond Dickinson of Womble Bond Dickinson (US) LLP - Client Alert

Friday, October 15, 2021

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On Tuesday, October 12, 2021, the US Food and Drug Administration (FDA) announced that it will withdraw the temporary policies^1,2 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 policies^1,2 must cease production of these products. All hand sanitizers produced under the temporary policies^1,2 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 policies^1,2, 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