This web page is for informational purposes and is intended to address shortages of alcohol-based hand sanitizers associated with the COVID-19 pandemic. USP is actively monitoring the evolving situation and will update this document accordingly. Parties relying on the information in this document bear independent responsibility for awareness of, and compliance with, any applicable federal, state, or local laws and requirements.
Updated: March 10, 2022
During the COVID-19 pandemic, the demand for alcohol-based hand sanitizers from traditional large-scale commercial manufacturing surpassed its supply and some of the ingredients traditionally used in hand sanitizers were in shortage. In response to this, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and other public health organizations developed important guidance for compounding hand sanitizers, and for the preparation of hand sanitizers by manufacturers and other facilities, such as distilleries. USP also issued recommendations developed by its Compounding Expert Committee for the compounding of hand sanitizers, including different formulations and utilizing alternative ingredients.
For consumers, hand washing with soap and water provides effective hand hygiene against COVID-19 and should be utilized as the primary mode of hand hygiene. Hand sanitizers, made properly with the correct ingredients, also are effective but should be utilized only when soap and clean water are not available for hand washing. It is important to conserve hand sanitizers for settings where soap and clean water are not available. The CDC provides guidance on good hand washing practices.
In the healthcare setting, CDC states that hand washing mechanically removes pathogens, while laboratory data demonstrate that 60% ethanol and 70% isopropanol, the active ingredients in CDC-recommended alcohol-based hand sanitizers, inactivates viruses that are genetically related to, and with similar physical properties as, the 2019-nCoV.
FDA has provided updates regarding methanol contamination in hand sanitizers. Refer to FDA’s website for additional information.
FDA also issued its “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” which is intended to alert pharmaceutical manufacturers and pharmacists who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol, and to the importance of properly testing pharmaceutical alcohol to detect methanol contamination or substitution.
On December 31, 2021, the FDA withdrew its temporary hand sanitizer guidance documents:
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry
- Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
In withdrawing the guidance documents, the FDA stated that “current data indicate that consumers and health care professionals are no longer experiencing difficulties accessing alcohol-based hand sanitizer products, and these temporary policies are no longer needed to help meet demand.” Hand sanitizers produced before or on December 31, 2021, under the temporary guidances can no longer be sold or distributed by manufacturers after March 31, 2022.
Companies in the United States wishing to continue manufacturing alcohol-based hand sanitizer can do so provided they comply with the tentative final monograph for over-the-counter topical antiseptics and all applicable statutory and regulatory requirements, including current good manufacturing practice (CGMP) requirements, use of denaturants, registration and listing requirements under section 510 of the Federal Food, Drug, & Cosmetic (FD&C Act), and any other requirements to be marketed in conformance with section 505G of the FD&C Act.
In addition, FDA has provided updates regarding methanol contamination in hand sanitizers. Refer to FDA’s website for additional information.
FDA also issued its “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” which is intended to alert pharmaceutical manufacturers and pharmacists who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol, and to the importance of properly testing pharmaceutical alcohol to detect methanol contamination or substitution.
WHO
The WHO provides a practical guide for use at the pharmacy bench during the actual preparation of the hand sanitizer formulations. Information in the guide includes materials required for small volume production and 10-liter preparations. Formulations include starting material of ethanol 96% for final product concentration of ethanol 80% (v/v) or starting material of isopropyl alcohol 99.8% for final product concentration of isopropyl alcohol 75% (v/v).
FDA
On December 31, 2021, FDA withdrew its “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry.” Companies producing alcohol-based hand sanitizers under this temporary policy must cease production and can no longer be sold or distributed after March 31, 2022.
USP
In March 2020, USP created a document outlining recommendations from its Compounding Expert Committee (EC) intended to address shortages of alcohol-based hand sanitizers associated with the COVID-19 pandemic. The Compounding EC revised this document on January 11, 2022 due to FDA’s December 31, 2021, withdrawal of its “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry.”
Frequently asked questions are available for compounding alcohol-based hand sanitizer during the COVID-19 pandemic.
FDA
On December 31, 2021, FDA withdrew its “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry.” Companies producing alcohol-based hand sanitizers under this temporary policy must cease production and can no longer be sold or distributed after March 31, 2022.
FDA
On December 31, 2021, FDA withdrew its “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry.”
Alcohol and Tobacco, Tax, and Trade Bureau (TTB)
In March 2020, the TTB posted guidance that it would waive provisions of internal revenue law with regard to distilled spirits and provide exemptions to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand during the public health emergency. Due to the withdrawal of FDA’s temporary hand sanitizers guidances, TTB will not renew the authorizations provided in TTB G 2020-1D. Industry members may continue to distribute hand sanitizer produced under TTB’s guidance through March 31, 2022, consistent with FDA’s announcement.
In response to methanol contamination in hand sanitizers, the USP alcohol monographs, including Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, and Azeotropic Isopropyl Alcohol monographs, were revised to include the Limit of Methanol test in the Identification (ID) section, among other revisions. See Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, and Azeotropic Isopropyl Alcohol monographs Revision Bulletins and Frequently Asked Questions for additional information.
We are offering a resource of USP-NF and FCC standards related to alcohol-based hand sanitizers. In addition to the monographs themselves, it also includes standards referenced within the monographs.
