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April 22, 2020

New FDA Guidance to Non-Drug Manufacturers for Alcohol-Based Hand Sanitizers to Combat COVID-19

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The COVID-19 crisis has impacted virtually all aspects of our daily lives. At Bowman and Brooke, we have heard from many clients (including breweries, distillers, and specialty chemical manufacturers) that want to repurpose their chemical manufacturing capacity to prepare alcohol-based hand sanitizers. We have taken a deep dive into the potential product liability issues and FDA regulatory implications for companies that make – or will make for the first time – alcohol-based hand sanitizer.  

Our legal update provides updates on how the applicable FDA guidance document provide exceptions to the “normal” FDA drug registration process for alcohol-based hand sanitizer, how the PREP Act Declaration from the Secretary of Health and Human Services can provide civil liability immunity for manufacturers of alcohol-based hand sanitizer, and recommendations for clients to reduce future exposure for both regulatory actions and civil lawsuits.  

Click here to read our full legal update.