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. 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 Therefore, FDA has withdrawn three guidance documents, originally issued in March 2020, that had outlined temporary policies for manufacturers that were not drug manufacturers before the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.

Companies manufacturing alcohol-based hand sanitizers and alcohol for use in alcohol-based hand sanitizers under the temporary policies must have ceased production of these products by December 31, 2021. Alcohol-based hand sanitizers manufactured before or on December 31, 2021 and produced under the temporary guidances cannot be sold or distributed by manufacturers after March 31, 2022. In addition, manufacturers must not use ethanol that was prepared under the temporary policies to manufacture a finished alcohol-based hand sanitizer product after March 31, 2022.

Hand Sanitizer Production and Distribution

Manufacturers that plan 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 FDA’s Current Good Manufacturing Practice requirements. Manufacturers who no longer plan to produce these products should deregister and delist their hand sanitizer products 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 these products, including death. The agency is maintaining a list of hand sanitizers that consumers should not use 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/or misbranded, 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.

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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