Making Hand Sanitizers Available to Americans
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 guidances 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 guidances for industry.
Firms that choose to temporarily produce hand sanitizers and the alcohol used in them should follow the formulas and processes outlined in FDA guidance for industry.
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) – Enabling entities that are not currently registered drug manufacturers the ability to temporarily register as over-the-counter (OTC) drug manufacturers and prepare alcohol-based hand sanitizers during the COVID-19 public health emergency
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency– Enabling pharmacies and registered outsourcing facilities to temporarily compound certain alcohol-based hand sanitizers
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)– Enabling alcohol production firms to temporarily produce alcohol for incorporation into alcohol-based hand sanitizers during the COVID-19 public health emergency
For more guidances on this topic and a comprehensive list, see COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders.
FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. Consumers should check hand sanitizer products in their home and before purchasing to determine if a product is on this list of hand sanitizers with potential methanol contamination. Visit FDA Updates on Hand Sanitizers with Methanol for more information on methanol contamination in certain hand sanitizers.
Hand hygiene is an important part of the U.S. response to COVID-19. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol (also referred to as ethanol or ethyl alcohol).
Consumers are reminded to keep hand sanitizers out of the reach of children and, in case of ingestion, to get medical help or contact a Poison Control Center immediately. Very small amounts of hand sanitizer can be toxic, even lethal, to young children.
If you have questions related to the following topics, please use the appropriate contact provided in the table below.
|Drug Establishment Registration and Product Listingfirstname.lastname@example.org|
|Fraudulent COVID-19 Products||FDA-COVID-19-Fraudulent-Products@fda.hhs.gov|
|Disinfectants (that are not hand sanitizers)||AD_Efficacy@epa.gov|
|Alcohol Taxation Questions||U.S. Alcohol and Tobacco Tax and Trade Bureau|
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