APC: FDA to withdraw temporary guidance for hand sanitizers

October 12, 2021

FDA to withdraw temporary guidance for hand sanitizers

IMPORTANT: The FDA announced today that, effective December 31, 2021, it was withdrawing the March 2020 temporary guidance that, among other things,  allowed “manufacturers that were not drug manufacturers” to produce alcohol-based hand sanitizer.

Effective Dec. 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. After that date, manufacturers wishing to continue producing hand sanitizer can do so provided they 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.

Got questions? You’re not alone. The FDA has some answers posted already, and it’s holding a listen-only Zoom call on Thursday October 14, 2021, at 11:00 AM EDT:


Meeting ID: 161 107 9023 

Passcode: Y0$Kaa