In response to the shortage of alcohol-based hand sanitizer due
to the COVID-19 pandemic, distillers and other entities that
manufacture alcohol have stepped in to assist in the production of
alcohol-based hand sanitizer. On March 24, 2020, the U.S.
Food and Drug Administration (“FDA”) issued Guidance directed to these new alcohol-based
hand sanitizer manufacturers.
The Guidance explains that the FDA “does not intend to
take action against alcohol production firms that manufacture
alcohol (i.e., ethanol or ethyl alcohol) for use as the Active
Pharmaceutical Ingredient (API) in alcohol-based hand sanitizers
for consumer use and for use as health care personnel hand rubs for
the duration of the [COVID-19] public health emergency” so
long as certain requirements are met. These requirements
specify that: