FDA Will End Temporary Guidance on Hand Sanitizer Production

The US Food & Drug Administration (FDA) yesterday announced that it intends to withdraw, effective Dec. 31, 2021, guidance documents outlining temporary policies that allowed non-drug makers and manufacturers to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers. 
 
The initial guidance was put in place in March 2020 during the COVID-19 public health emergency. 
 
Effective Dec. 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances, must no longer be sold to wholesalers or retailers by March 31, 2022, said FDA.
 
“The FDA is committed to providing timely guidance to support continuity and response efforts during the COVID-19 pandemic. Throughout the pandemic, the agency has continuously assessed the needs and circumstances related to hand sanitizers and issued temporary guidances to provide regulatory flexibility to certain firms to help meet the increased demand,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement released yesterday.
 
“As relevant needs and circumstances evolve, the FDA updates, modifies or withdraws policies as appropriate. In recent months, the supply of alcohol-based hand sanitizer from traditional suppliers has increased, and now, most consumers and healthcare personnel are no longer having difficulty obtaining these products. Therefore, we have determined it’s appropriate to withdraw the temporary guidances and are providing manufacturers time to adjust their business plans related to production of these products under these temporary policies.”
 
Cavazzoni added, “The FDA commends all manufacturers, big and small, who stepped in to provide American consumers and health care professionals with hand sanitizer products while they were in high demand during the pandemic. We stand ready to help those who no longer plan to produce hand sanitizers, as well as help those who wish to continue doing so, to ensure they are complying with the appropriate requirements.”
 
During the pandemic, many hand sanitizers flooded the market–and not all were up to safety standards. FDA found many entering the market that had substandard ingredients (methanol, 1-propanol, benzene, acetaldehyde, or acetal) that posed a risk to consumers, as reported by Happi on numerous occasions.
 
The FDA’s list can be found here. 

FDA said manufacturers who no longer plan to produce these products are able to deregister by following the instructions on the Electronic Drug Registration and Listing Instructions page.