FDA plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. Throughout the pandemic, the agency has continuously assessed the needs and circumstances related to alcohol-based hand sanitizers and issued temporary guidance to provide regulatory flexibility to certain manufacturers to help meet the increased demand for these products.

The supply of alcohol-based hand sanitizer from traditional manufacturers (i.e., manufacturers other than those that began manufacturing over-the-counter (OTC) drugs during the public health emergency in order to supply hand sanitizers during the COVID–19 pandemic) has increased, and now, most consumers and healthcare personnel are no longer having difficulty obtaining alcohol-based hand sanitizers. Therefore, FDA has withdrawn three guidance documents, originally issued in March 2020, that had outlined temporary policies for manufacturers that were not drug manufacturers before the public health emergency to produce certain alcohol-based hand sanitizers and alcohol for use in hand sanitizers.