FDA Announces Withdrawal of Temporary Guidance Documents Concerning Alcohol-Based Hand Sanitizer Products
The Food and Drug Administration (FDA) published a Federal Register notice on October 13, 2021, announcing the withdrawal of three guidance documents: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”; “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”; and “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” 86 Fed. Reg. 56960. According to the notice, FDA is withdrawing the guidance documents “because current data indicate that consumers and healthcare personnel are no longer experiencing difficulties accessing alcohol-based hand sanitizer products, and these temporary policies are no longer needed to help meet demand for alcohol-based hand sanitizer products or for alcohol for use in alcohol-based hand sanitizer.” The withdrawal date for the guidance documents is December 31, 2021. The notice states that firms manufacturing alcohol under the temporary policies for use in alcohol-based hand sanitizers and firms preparing alcohol-based hand sanitizers under the temporary policies must cease production of these products by December 31, 2021. Firms must cease, by March 31, 2022, distribution of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. After March 31, 2022, FDA states that it intends to cease its temporary policy of not taking action with regard to distribution of hand sanitizers, or alcohol for use in alcohol-based hand sanitizers, prepared consistent with the circumstances described in the guidance documents.
The withdrawal of these documents is not unexpected. FDA issued the documents in March 2020 to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). FDA states that it has determined that the demand for alcohol-based hand sanitizer has decreased and the supply of hand sanitizer from traditional manufacturers (i.e., firms other than those that entered into the over-the-counter drug industry for the first time to supply hand sanitizers during the PHE) has increased. FDA notes that although the temporary policies are being withdrawn, firms may continue to manufacture alcohol-based hand sanitizer products without an approved application, provided they comply with the applicable tentative final monograph and other applicable requirements, including current good manufacturing practice requirements under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. FDA reminds distributors, re-packagers, and importers that they are also responsible for the safety and quality of the drugs they introduce into interstate commerce. Firms that registered and submitted drug product listing(s) for hand sanitizer(s) only but no longer manufacture such product, or plan to cease manufacturing such product, can deregister and delist their hand sanitizer product listing(s) by following the Electronic Drug Registration and Listing Instructions.