FDA plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.

As part of these efforts, FDA published three guidance’s to help meet the increased demand for hand sanitizers during the Coronavirus Disease 2019 (COVID-19) public health emergency. During the COVID-19 public health emergency, entities that are not currently registered drug manufacturers can register as over-the-counter (OTC) drug manufacturers and make alcohol-based hand sanitizers, pharmacies and registered outsourcing facilities can compound certain alcohol-based hand sanitizers, and alcohol production firms can produce alcohol for making hand sanitizers provided they follow the conditions outlined in the FDA guidance’s for industry.

Guidance to Domestic Industry Making Hand Sanitizer: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/hand-sanitizers-covid-19

Hand Sanitizers and Antibacterial Soaps: https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-soaps