FDA to Take No Action Against Compounders Preparing Hand Sanitizer
The new guidance for industry (GFI) document, “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products,” was released Saturday.
The FDA has announced it will take no enforcement action against compounders who prepare alcohol-based hand sanitizers during the novel coronavirus (COVID-19) pandemic. The new guidance for industry (GFI) document, “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products,” was released Saturday.1,2
"We understand that some consumers are currently experiencing difficulties accessing alcohol-based hand sanitizers containing at least 60% alcohol. We are also aware of reports that some consumers are producing hand sanitizers for personal use; the agency lacks information on the methods being used to prepare such products, and whether they are safe for use on human skin. We further recognize that compounders, relative to untrained consumers, are more familiar with standards and methods for producing drug products," the document states.3
According to the FDA, the guidance allows for temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in state-licensed pharmacies or federal facilities, and registered outsourcing facilities for the duration of the public health emergency, which was declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.1,2 The GFI applies to hand sanitizer that is compounded using only certain United States Pharmacopoeia grade ingredients in the preparation of the product, consistent with World Health Organization recommendations.3
The FDA’s action came after the agency received a number of queries regarding compounding of alcohol-based hand sanitizers.1 Those urging the action included the Alliance for Pharmacy Compounding (APC), which had sought to allow compounders to help meet consumer demand for FDA-approved hand sanitizers.2
“We’re grateful to FDA for acknowledging this need and issuing this guidance, which will allow compounders to serve their communities in this time of shortage,” said Shawn Hodges, president of the APC, in a prepared statement.2 “It’s a commonsense response to a serious need.”
In an interview with Pharmacy Times, Hodges said the organization has reached out to the FDA for further clarification. Due to shortages on key ingredients for hand sanitizers, Hodges said they are seeking guidance regarding approved formulations. Currently, the FDA guidance allows for compounding of alcohol-based formulations, but Hodges added that peroxide is also effective.
Jennifer Burch, PharmD and owner of Central Compounding Center, said in an interview with Pharmacy Times that she expects many compounding pharmacists will begin providing hand sanitizers.
"It seems like it's going to be quite common," Burch said. "We're getting requests for it on a daily basis from consumers." She added that there have also been requests for hand sanitizers from medical facilities because they are unable to get it from vendors.
According to the APC, the organization continues to urge the FDA to allow compounding of other over-the-counter products in shortage as a result of the COVID-19 threat.2
“Pharmacy compounders are well qualified, and eager to do much more to help in this crisis, if FDA will empower us to do so,” said Hodges.2
The APC also urges compounders to read the FDA guidance document carefully, and to check with their state board of pharmacy to assure compliance with state laws and regulations.2
- FDA. Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency. Office of Medical Products and Tobacco, Center for Drug Evaluation and Research. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health?fbclid=IwAR0G7DgfTuzrQ978Oop_SCU_U-7VBVJlICzlx3FZ5g7G2OTgaOZPDJfb88k. Published March 14, 2020. Accessed March 14, 2020.
- Alliance for Pharmacy Compounding. FDA Suspends Enforcement Against Compounders for Preparing Hand Sanitizers During Health Emergency. [news release]. March 14, 2020: [email]. Accessed March 14, 2020.
- US Department of Health and Human Services. Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry. FDA website. https://www.fda.gov/media/136118/download. Published March 2020. Accessed March 14, 2020.