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FDA Updates Hand Sanitizer Enforcement Discretion Guidance to Provide More Information Regarding Ethanol Sourcing

June 4, 2020, Covington Alert

Today, FDA issued updates to its guidance document "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),"("Temporary Policy") and related guidance document, that primarily provide more detailed information about potential ethanol sources for companies seeking to prepare hand sanitizer or produce ethanol used in the production of hand sanitizer under the agency's COVID-19 specific enforcement discretion policies. This is the fourth update that FDA has made to these guidance documents since initially issuing them in March, with each previous update providing additional enforcement discretion regarding ethanol that can be used to produce sanitizer under the temporary policy.

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