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: August 17, 2020
Demand for alcohol-based hand sanitizers from traditional large-scale commercial manufacturing has surpassed its supply and some of the ingredients traditionally used in hand sanitizers are 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 have developed important guidance for compounding hand sanitizers, and for the preparation of hand sanitizers by manufacturers and other facilities, such as distilleries. USP has 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.
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
The FDA issued “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency” Immediately in Effect Guidance for Industry.” The guidance explains that FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency provided certain circumstances are present. The circumstances include the following:
- The hand sanitizer is compounded according to the following formula consistent with WHO recommendations:
- alcohol (ethanol) (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or isopropyl alcohol (75%, v/v) in an aqueous solution
- alcohol (ethanol) (if derived from synthetic processes, is used only if it meets USP or FCC grade), that is not less than 94.9% ethanol by volume;
- glycerol (1.45%, v/v)
- glycerin (glycerol) USP or FCC (also known as “food grade”)
- hydrogen peroxide (0.125%, v/v)
- USP Hydrogen Peroxide Concentrate or USP Hydrogen Peroxide Topical Solution
- sterile water (e.g., by boiling, distillation or other process that results in water that meets the specifications for Purified Water USP).
- alcohol (ethanol) (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or isopropyl alcohol (75%, v/v) in an aqueous solution
- The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product. See Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20 and 21.
- The hand sanitizer is prepared under conditions routinely used by the compounder to compound similar nonsterile drugs (USP General Chapter <795>).
USP
USP created a document outlining recommendations from its Compounding Expert Committee intended to address shortages of alcohol-based hand sanitizers associated with the COVID-19 pandemic. The document includes three formulations for the compounding of hand sanitizer and appropriate ingredient substitutions based on shortage issues.
- Formulation 1 – starting ingredient of ethanol 96% for final product concentration of ethanol 80% (v/v)
- Formulation 2 - starting ingredient of isopropyl alcohol 99% for final product concentration of isopropyl alcohol 75% (v/v)
- Formulation 3 – starting ingredient of isopropyl alcohol 91% for final product concentration of isopropyl alcohol 75% (v/v)
The starting ingredients for Formulations 2 and 3 provide alternatives to WHO’s formula using isopropyl alcohol 99.8%, due to shortage concerns.
The hand sanitizer should be prepared under conditions routinely used by the compounder to compound similar nonsterile drugs (USP General Chapter <795>).
- Frequently asked questions are available for compounding alcohol-based hand sanitizer during the COVID-19 pandemic
NASPA
The National Alliance of State Pharmacy Associations (NASPA) is providing information from the States related to compounding hand sanitizers.
FDA
FDA issued “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)” Guidance for Industry. The guidance explains that FDA does not intend to take action against firms that register as over-the-counter (OTC) drug manufacturers that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency provided certain circumstances are present. The circumstances, in part, include the following:
- The hand sanitizer is manufactured according to the following formula consistent with WHO recommendations:
- alcohol (ethanol) (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or isopropyl alcohol (75%, v/v) in an aqueous solution
- alcohol (ethanol) (if derived from synthetic processes, is used only if it USP or FCC grade), that is not less than 94.9% ethanol by volume;
- glycerol (1.45%, v/v)
- glycerin (glycerol) USP or FCC (also known as “food grade”)
- hydrogen peroxide (0.125%, v/v)
- USP Hydrogen Peroxide Concentrate or USP Hydrogen Peroxide Topical Solution
- sterile water (e.g., by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP).
- alcohol (ethanol) (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or isopropyl alcohol (75%, v/v) in an aqueous solution
- The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product. See Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20 and 21.
FDA
FDA issued “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry.”The guidance explains that FDA does not intend to take action against alcohol production firms that register their facilities with FDA and that manufacture alcohol for use as the active pharmaceutical ingredient (API) in alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency provided certain circumstances are present. The circumstances include the following:
- The alcohol (ethanol) is not less than 94.9% ethanol by volume, consistent with USP and FCC requirements for purity (if purity lower than USP and grade requirements, the product meets this condition if labeled accordingly and the content is sufficient to enable the finished hand sanitizer to meet the ethanol volume to content concentration of 80%.)
- Sterile water (e.g., by boiling, distillation or other process that results in water that meets the specifications for Purified Water USP).
- The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product. See Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20 and 21.
Alcohol and Tobacco, Tax, and Trade Bureau (TTB)
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.
In response to methanol contamination in hand sanitizers, the USP Alcohol and Dehydrated Alcohol monographs are revised to include the Limit of Methanol test in the Identification (ID) section. See Alcohol and Dehydrated Alcohol 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.
