FDA does not approve OTC hand sanitizers, you can sell hand sanitizers by complying with “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry” . You can find an overview of the FDA’s temporary policy on our website. FDAbasics can assist you to comply with the below requirements.
Disclaimer – This article reflects current understanding of FDAbasics LLC , does not constitute legal bindings. FDAbasics LLC is a private regulatory not associated with US FDA.
