FDA Keeps Hand Sanitizer Flowing With Guidance for Coronavirus

The FDA wants to boost the supply of hand sanitizer to combat the coronavirus outbreak, issuing a pair of guidance documents Friday.

The first guidance permits temporary manufacture of certain alcohol-based hand sanitizer and says the Food and Drug Administration will not take action against those who produce it. The move is a response to the fact that the increase in coronavirus cases has led consumers to make hand sanitizers for personal use. The agency isn’t sure whether those homebrew sanitizers are safe for human skin.

“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,” FDA Commissioner Stephen M. Hahn said in a statement.

“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 second guidance, which is also linked to hand sanitizers, allows pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities to compound these alcohol-based products, which means they can alter ingredients of a drug to create a tailor-made medication, according to the FDA.

The agency also released a third guidance allowing doctors to keep tabs on their patients remotely using non-invasive monitoring devices like some over-the-counter electrocardiographs, pulse oximetry, some blood pressure monitors, electronic stethoscopes, cardiac monitors, and clinical electronic thermometers.

“Allowing these devices to be used remotely can help health care providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” FDA Principal Deputy Commissioner Amy Abernethy said.

“Such devices include technologies capable of enabling remote interactions to provide crucial information to be used as an adjunctive when health care providers diagnose or treat Covid-19 or co-existing conditions. During this public health emergency, it is imperative that the FDA provide regulatory relief and adapt as the situation warrants to act upon measures to save lives.”

All three policies, issued by the Department of Health and Human Services, will remain in effect only until the end of the public health emergency related to the coronavirus.