Recommendations for compounded hand sanitizers during COVID-19

Early in the COVID-19 pandemic, the US supply chain was stretched thin on many necessary products, including hand sanitizer. In response to this shortage, many health systems, manufacturers, and non-traditional institutions (eg, distilleries) sought to compound hand sanitizer to meet this need. To ensure safe compounding practices, in March 2020 the US Food and Drug Administration (FDA) released guidance for the temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency.¹ In addition, the United States Pharmacopeia (USP) provided recommendations on compounding alcohol-based hand sanitizer during the COVID-19 pandemic.² These guidance documents provided recommendations regarding ingredients, facilities, and labeling in accordance with the World Health Organization’s (WHO) recommended recipe.³ These documents support the use of two formulas that result in either an ethanol antiseptic topical solution containing ethanol 80% (v/v) or an isopropyl alcohol antiseptic topical solution with a final concentration of 75% (v/v).1,2,3 According to the USP guidance, compounded hand sanitizers have a beyond use date of 30 days which is significantly shorter than commercially available products.² The FDA does not recommend the public manufacture their own hand sanitizers due to risk for poor efficacy if made incorrectly and reports of skin burns.⁴ The hand sanitizer should be labeled with the alcohol percentage and can be stored at controlled room temperature.¹

The CDC recommends using alcohol-based hand sanitizer only when soap and water are unavailable. Therefore, it is crucial that the final concentration of hand sanitizer is at least 60% alcohol (ethanol or isopropyl alcohol) to avoid getting sick and spreading germs to others.⁵ Hand sanitizer should be used by covering all hand surfaces and rubbing one’s hands together, for approximately 20 seconds, or until they feel dry.⁶ Soap and water should be used whenever possible and always during food preparation, wound care, using the restroom, or caring for pets.⁶

Hand sanitizer, when used by children, must be under the direct supervision of adults to prevent accidental ingestion.⁵

Note from Dr. Lee: Numerous brands and types of hand sanitizers have emerged in the market place and they are NOT regulated by the FDA. It is extremely important to review all contents and their concentration to assure its effectiveness and safe use. The CDC and FDA are excellent resources for updated information for hand sanitizers (eg, potential harmful effects of methanol containing products). —Carlton Lee, PharmD, MPH, FASHP, FPPAG

References

1. Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry. U. S. Food and Drug Administration. https://www.fda.gov/media/136118/download. Published in March 2020, Last Updated on June 1, 2020, Accessed on July 13, 2020.
2. Compounding Alcohol-Based Hand Sanitizer During COVID-19 Pandemic. United States Pharmacopoeia. https://www.usp.org/sites/default/files/usp/document/about/public-policy/usp-covid19-handrub.pdf. Published on March 18, 2020. Last Updated on March 25, 2020. Accessed on July 13, 2020.
3. Guide to Local Production: WHO-recommended Handrub Formulations. World Health Organization. https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf. Last Updated in April 2010. Accessed on July 13, 2020.
4. Q&A for Consumers: Hand Sanitizers and COVID 19: FDA. https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19. Accessed on July 13, 2020.
5. Show Me the Science – When & How to Use Hand Sanitizer in Community Settings, Centers for Disease Control and Prevention. https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html. Last Updated on March 3, 2020. Accessed on July 13, 2020.
6. Hand Sanitizer Use Out and About. Centers for Disease Control and Prevention. https://www.cdc.gov/handwashing/hand-sanitizer-use.html. Last Updated on April 13, 2020, Accessed on July 13, 2020.
7. FDA Updates on Hand Sanitizers with Methanol. U. S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-methanol?utm_campaign=FDA%20MedWatch%20-%20Hand%20Sanitizers%20with%20Methanol&utm_medium=email&utm_source=Eloqua#products. Last Updated on July 2, 2020. Accessed on July 13, 2020.
8. Hand Sanitizers with Methanol: FDA Updates. MedWatch - The FDA Safety Information and Adverse Event Reporting Program. http://s2027422842.t.en25.com/e/es?s=2027422842&e=349602&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=2ea8b9246c7f46c89ae20013d2c01819&elqaid=13243&elqat=1. Accessed on July 13, 2020.