New guidance from the FDA could make it easier for compounding pharmacies to produce hand sanitizer without a patient-specific prescription.

As pharmacists well know, drugstore shelves have been stripped bare of the product because of the novel coronavirus (COVID-19) pandemic. In response, the FDA has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand-sanitizer products. 

According to the agency, the policies 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.

“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, MD. “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 FDA notes that, because of an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, some consumers have attempted to make hand sanitizers for personal use, adding, “The agency lacks information on the methods being used to prepare such products and whether they are safe for use on human skin.”

In light of that, the guidance “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),” has immediately been put in effect. The FDA says it does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as healthcare personnel hand rubs during the ongoing public-health emergency.

The second guidance, “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency,” directly impacts 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 FDA explains. “The temporary policy outlined by the agency does not require compounders to obtain a patient-specific prescription.”

It further advises that the guidance documents apply only to hand-rub products prepared using the United States Pharmacopoeia- or Food Chemical Codex-grade ingredients specifically described in accordance with World Health Organization recommendations.

Also required are 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,” according to the press release.
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