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 [...]

Hand Sanitizers, COVID19 and FDA Regulatory Actions – Recent Developments

Wow! What a different world we are in than just a month ago.  As consumers lives have been shifted by the sudden emergence of the threat of the COVID-19 virus, the FDA has acted quickly to show that it is not asleep at the wheel, and that it will act both to increase the availability [...]