FDA Withdraws Temporary Guidance Documents for Alcohol-Based Hand Sanitizers

Oct. 26 2021

The US FDA has found that the supply of alcohol-based hand sanitizers from traditional suppliers has increased and the hand-sanitizer market has stabilized. Therefore, they are withdrawing three temporary guidance documents that provided flexibilities to companies to help meet the increased demand of alcohol-based hand sanitizers during the COVID-19 public health emergency.

The U.S. Food and Drug Administration (FDA) intends to withdraw three temporary guidance documents that provided flexibilities for companies that have not traditionally manufactured alcohol-based hand sanitizers. The guidance documents include, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry, Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), and Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.

“Effective December 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.” However, companies may sell through existing stock following the temporary guidance procedures that was manufactured before or on December 31, 2021 until March 31, 2022. “If, after March 31, 2022, manufacturers still have undistributed hand sanitizer that was prepared under the temporary policies (products produced on or before December 31, 2021), manufacturers should destroy these products.” It should be noted that “even after April 1, 2022, retailers may continue to sell their stock of hand sanitizer produced under the guidances.”

Link to the Press Announcement:
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers

Link to FAQ:
https://www.fda.gov/drugs/drug-safety-and-availability/qa-industry-withdrawal-temporary-hand-sanitizer-guidances

Link to Federal Register Posting:
https://www.federalregister.gov/d/2021-22108

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