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 guidance documents 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.

Guidance Documents for Industry

FDA intends to withdraw three guidance documentss originally issued in March 2020 outlining 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. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances  by can no longer be sold or distributed by manufacturers after March 31, 2022.

After that date, manufacturers wishing to continue producing hand sanitizer can do so provided they comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements. Manufacturers who no longer plan to produce these products are able to deregister by following the instructions on the Electronic Drug Registration and Listing Instructions page.

FDA is advising importers, consignees, distributors, retailers and others not to distribute or sell certain hand sanitizers, even if the manufacturer of the product has not recalled it, due to the dangers of methanol or 1-propanol contamination, including death. The agency is maintaining a list of dangerous hand sanitizers and recommends entities involved in distributing and selling hand sanitizers continuously check this list as it is being updated regularly. FDA considers all of the hand sanitizers on the list to be adulterated, and it is prohibited under federal law to distribute or sell these products interstate.

• Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)

• Q&A for Industry | Withdrawal of Temporary Hand Sanitizer Guidances

• For more guidances on this topic and a comprehensive list, see COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders.

Consumers

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, 1-propanol, or other contaminants. 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. FDA also is warning consumers and health care providers about hand sanitizer products that are packaged in containers that resembles water bottles, or are subpotent, meaning they contain less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride.

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 consumers should not use for more information on methanol or 1-propanol contamination in certain hand sanitizers and other safety issues with 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.

For more information, visit Q&A for Consumers: Hand Sanitizers and COVID-19, Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?, and Safely Using Hand Sanitizer.

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