FDA issues hand sanitizer manufacturing guidelines

The Food and Drug Administration (FDA) issued Friday two guidelines regarding the temporary manufacturing of certain alcohol-based hand sanitizer products in the wake of the COVID-19 pandemic.

“We are aware of significant supply disruptions for alcohol-based hand sanitizers,” FDA Commissioner Stephen M. Hahn said. “Many manufacturers make hand sanitizers, and several have indicated that they are working to increase supply. In the meantime, these guidances provide flexibility to help meet demand during this outbreak. We will continue to work with manufacturers, compounders, state boards of pharmacy, and the public to increase the supply of alcohol-based hand sanitizer available to Americans.”

The Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) guidance is immediately in effect. It outlines the agency does not intend to take action against manufacturing firms preparing alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during the ongoing public health emergency.

Meanwhile, authorities indicated the second guidance – Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, addresses the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities.

The agency indicated compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a tailor-made medication.