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ARTICLE · 27 APRIL 2020

FDA Issues Guidance Regarding Alcohol-Based Hand Sanitizers For COVID-19 Prevention

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...

United StatesCoronavirus (COVID-19)

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:

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