Companies may no longer manufacture under Temporary Guidance beyond December 31, 2021.
The Temporary Emergency Use Authorization (EUA) on hand sanitizers was first authorized by the US FDA in March 2020 given the difficulties consumers and health care professionals experienced accessing alcohol-based hand sanitizers at the start of the COVID-19 pandemic. Hand sanitizers are regulated as an Over-the-Counter (OTC) drug in the US and must meet all of safety requirements outlined by the FDA. The temporary EUA relaxed some of the requirements to allow for other companies to support the need/demand for hand sanitizers. Hand Sanitizers manufactured under the US FDA’s Temporary EUA may no longer be manufactured/imported in the US after December 31, 2021. Distributors/Resellers may continue to sell/distribute products manufactured under the EUA until March 31, 2022. Retailers may continue to sell existing inventory until depleted or until the expiry date of the product, whichever occurs first.
The FDA announced its removal of the Temporary EUA on October 12, 2021. There were multiple factors which led to the FDA removing the emergency temporary authorization including: multiple hand sanitizer products containing unacceptable limits of hazardous chemicals (e.g., methanol, benzene, acetaldehyde, and others); products having been tested and shown to have microbial contamination; as well as multiple “sub-potent” products having less than the required amount of “active ingredient” (e.g., ethanol, isopropanol or benzalkonium chloride) present, among other factors. There have been over 270 products/product lines that have been recalled due to one or more of these factors.
Companies that have been manufacturing hand sanitizers under the temporary policy, and who wish to continue to do so after December 31, 2021, must ensure that the hand sanitizers 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 (21 CFR Part 210/211).
For companies that have been manufacturing under the temporary policy and which plan to discontinue manufacture, it is imperative to deregister from FDA’s database (eDRLS) by following the instructions on the Electronic Drug Registration and Listing Instructions page.
For companies that have ceased manufacture under and temporary EUA but do not deregister within eDRLS by December 31, 2021, the FDA will begin to charge drug facility fees ($20,322 for manufacturing facilities) in 2022.
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