At the outset of the COVID-19 pandemic, many in the alcohol beverage industry recognized a significant problem facing our communities and pivoted their production to alcohol-based hand sanitizer. These products were donated to first responders and provided to the public-at-large to provide a resource that quickly became a scarce commodity in the fight against the spread of COVID-19. In response to this desire to help, the Food and Drug Administration (“FDA”) issued several temporary policies beginning in March 2020 to help regulate the production of alcohol-based hand sanitizer.
As mass-produced commercial hand sanitizer became more widely available, we believe a majority of alcohol beverage producers returned to doing what they do best, producing high-quality craft products. However, if there are any producers still manufacturing alcohol-based hand sanitizer, this post is for you.
In tomorrow’s (October 13, 2021) Federal Register, the FDA will announce the withdrawal of the temporary guidance related to alcohol-based hand sanitizer production. Essentially, FDA has determined that there is plenty of available hand-sanitizer in the market and thus no need for continued use of alcohol in hand sanitizer production.
If you are currently manufacturing alcohol-based hand sanitizer following the FDA’s temporary guidance, you must cease production by December 31, 2021. Similarly, distribution of these products under FDA’s temporary rules must end by March 31, 2022. After December 31, 2021, alcohol-based hand sanitizers may still be produced and distributed, however producers and distributors must follow FDA rules and regulations for tentative final monograph (“TFM”) category III drugs and any other applicable requirements. These requirements and regulations, include, but are not limited to, producing the drugs based on good manufacturing practices, pre-sale drug testing, and drug facility registration. Failure to follow all relevant drug manufacturing requirements may result in enforcement action from FDA.
You can find the full unpublished text of FDA’s notice here. As of October 13, 2021, the previous link will take you to the official, published FDA notice.
The post FDA to Withdraw Temporary Alcohol-Based Hand Sanitizer Guidance appeared first on Lehrman Beverage Law.