FDA issues guidance on alcohol-based hand sanitizer production

The U.S. Food and Drug Administration has issued two guidance documents to communicate its policymakers for the temporary manufacture of certain alcohol-based hand sanitizer products.

These guidance documents will help monitor quality assurance and will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

There has been an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic. As a result, there have been reports of some consumers attempting to make 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.

The ability of hand hygiene, including hand washing or the use of alcohol-based hand sanitizers to prevent infections is related to reductions in the number of viable pathogens that transiently contaminate the hands. The laboratory data demonstrates 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.

"We are aware of significant supply disruptions for alcohol-based hand sanitizers. Many manufacturers make hand sanitizers, and several have indicated that they are working to increase supply," said FDA Commissioner Stephen M. Hahn, M.D. "In the meantime, these guidances provide flexibility to help meet demand during this outbreak. We will continue to work with manufacturers, compounders, state boards of pharmacy and the public to increase the supply of alcohol-based hand sanitizer available to Americans."

The guidance Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), is immediately in effect and outlines that the agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during this ongoing public health emergency as described in the guidance .

The second guidance, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, is in effect for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a tailor-made medication. The temporary policy outlined by the agency does not require compounders to obtain a patient-specific prescription.

The FDA's guidance documents apply only to handrub products prepared using the United States Pharmacopoeia or Food Chemical Codex grade ingredients specifically described in the guidance, consistent with World Health Organization recommendations. The guidance documents also discuss product labeling and certain manufacturing methods and reporting requirements, such as that manufacturers must have a way to accept and submit adverse event reports to FDA for any products they manufacture.

The agency realizes that manufacturers and compounders will need time to ramp up production as they obtain the ingredients needed to make these hand sanitizers. During this time the FDA will work to assist them as they develop hand sanitizers to make available for the American public.

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