In an announcement today, the FDA reminded manufacturers of alcohol-based hand sanitizers that they can no longer distribute products made under the temporary policy, which was withdrawn on December 31, 2021 and gave manufacturers until March 31, 2022 to comply (see the announcement here).
The Agency notes that distribution from manufacturers to all outlets, which include wholesalers, retailers, and hospitals, must stop by the March 2022 date. “Only hand sanitizer prepared in compliance with all applicable requirements, including the tentative final monograph for over-the-counter topical antiseptics, as amended, may be distributed by manufacturers after March 31, 2022.”
After that date, manufacturers that operated under the temporary policy should destroy their remaining inventories in an appropriate manner and in conjunction with advice from their local EPA offices and local authorities. Firms should maintain records of destroyed material and document “the product name, manufacturer, lot number, quantity, disposition date, and disposition method.”
The FDA has no objections to retailers continuing to sell their existing stock of products made under the temporary policy. The Agency also reminded manufacturers that are no longer producing product to delist their establishment if appropriate (that is if they are not making other products that require drug listing) to avoid OTC facility fees that may be associated with their registration.
