In March 2020, the Food and Drug Administration (FDA) issued temporary guidance documents allowing for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak. Due to that guidance, most consumers and healthcare personnel have been able to obtain hand sanitizer without difficulty. Now the FDA plans to withdraw the temporary guidance on December 31st, 2021. This withdrawal impacts any company manufacturing alcohol-based hand sanitizers under the temporary policies.
If the manufacturer wishes to continue producing hand sanitizer, it must comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice (CGMP) regulations. These regulations contain the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product, including hand sanitizer. In addition, manufacturers will begin paying the annual Over-The-Counter Monograph Drug User Fees.
If the manufacturer plans to discontinue producing hand sanitizer, it must deregister its establishment with the FDA. Establishment deregistration must be submitted electronically through the Electronic Drug Registration and Listing System (eDRLS). If deregistration does not occur by the end of 2021, manufacturers will be required to pay the annual Over-The-Counter Monograph Drug User Fees.
Regardless of whether the manufacturer plans to continue or discontinue hand sanitizer production, any hand sanitizer manufactured before or on December 31st, 2021, under the temporary guidelines, cannot be sold or distributed after March 31st, 2022.
Husch Blackwell is experienced navigating the regulatory requirements of FDA. Our FDA and Alcohol and Beverage lawyers are available to discuss these developments and how companies can comply with this new guidance, including the CGMP regulations, eDRLS deregistration, Over-The-Counter Monograph Drug User Fees, as well as navigating state and federal alcohol beverage requirements. Contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney.