Mar 25 2022
FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (guidance documents withdrawn on December 31, 2021), they must stop distribution of any remaining hand sanitizer produced consistent with the temporary policies by March 31, 2022. This includes distribution to wholesalers, retailers, and hospitals.
In addition, manufacturers are reminded that all hand sanitizer manufactured since January 1, 2022, must be in full compliance with the Federal Food, Drug and Cosmetic Act, including current good manufacturing practice (CGMP) regulations, and alcohol used must be fully compliant with the United States Pharmacopeia monograph and CGMP requirements.
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 should destroy undistributed hand sanitizer prepared consistent with the temporary policies. Manufacturers should maintain records with information concerning a product’s destruction, including the product name, manufacturer, lot number, quantity, disposition date, and disposition method.
Contact the Environmental Protection Agency and your local waste management and recycling center for information on safe disposal.
After April 1, 2022, as indicated on FDA’s Q&A for Industry website, FDA does not intend to object if retailers continue to sell their stock of hand sanitizer produced consistent with the temporary policies.
FDA asks manufacturers to deregister their establishment if they are no longer producing drug products by following the instructions on the Electronic Drug Registration and Listing Instructions page. If a manufacturer is no longer producing hand sanitizer but is continuing to produce other drugs and would like to remain registered, they can renew their registration and drug listing for the other products and just delist the hand sanitizer products.
Additional information on delisting hand sanitizers can be found in the October Federal Register notice.
Our services allow manufacturers to spend more time developing their products
rather than searching for distributors, negotiating contracts, and learning regulations.
If you have any questions about FDA regulation of OTC Drugs and Cosmetics,
Registration and labeling compliance... , please CONTACT US.