FDA takes action to protect public health; increase supply of hand sanitizer

June 2, 2020

The FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency. With consumer and healthcare personnel safety as a top priority for FDA, an important part of FDA’s mission is to protect the public from harm, including an increased supply of hand sanitizer. “To that end, we have updated our guidance to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in hand sanitizer,” the FDA said in a statement.

FDA Commissioner Stephen M. Hahn, MD, said “The FDA appreciates the industry’s willingness to help meet the increasing demand for alcohol-based hand sanitizers during the COVID-19 pandemic. Early on during the public health emergency, as demand for alcohol-based hand sanitizer had dramatically increased, we issued temporary policies to provide flexibility to help meet this demand and to help get supply quickly to where it was needed, whether it was for healthcare professionals or for individuals and their families.

Although it is our understanding that some larger hospital systems have been able to replenish their supply of hand sanitizer, we continue to hear that some smaller hospital systems and outpatient facilities are still experiencing difficulties accessing alcohol-based hand sanitizers. We also recognize that some consumers may not be able to find alcohol-based hand sanitizer in their local area, and, when they do, it is in limited quantities. Washing our hands with soap and water, for at least 20 seconds, continues to be one of our best defenses to prevent the spread of COVID-19. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol (also referred to as ethanol or ethyl alcohol).”

He added, “The FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products. Based on careful review and consideration of available data, we are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer.”

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