FDA Updated Its Earlier Guidance for Hand Sanitizer Production

On April 15, 2020, the FDA updated and issued as”final” the three guidance documents it had prepared to promote the availability of hand sanitizers during the COVID-19 crisis, found at: (1) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health; (2) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during; and (3) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during. None of the three updates to the guidances retract the FDA’s initial advisory announcements that for the duration of the [...]

FDA ISSUES ADDITIONAL GUIDANCE TO PROMOTE AVAILABILITY OF HAND SANITIZERS DURING COVID-19 EMERGENCY

As noted in our prior post, in response to the demand for hand sanitizers created by the COVID 19 crisis, the FDA announced it would not pursue actions during the pendency of the crisis against state-licensed pharmacies or Federal facilities or registered outsourcing facilities for the compounding of alcohol-based hand sanitizers, provided the resulting products [...]