Reed Smith Client Alerts

In the wake of the global pandemic, physicians, pharmacies, and outsourcing facilities are playing a critical role in ensuring that patients continue to obtain the medications they need, which has included filling the gap in production of hand sanitizer products. In addition to the U.S. Food and Drug Administration’s (FDA) recent hand sanitizer guidance, discussed further below, state boards of pharmacy across the country are implementing new measures that allow pharmacies to best treat their patients during this unprecedented time.
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FDA authorizes certain compounders to compound alcohol-based hand sanitizers to ensure consumer demands can be met

FDA recognizes that the potential public health threat posed by COVID-19 is high, both globally and to United States residents. Hand hygiene (that is, hand washing and hand sanitizing) is a critical part of the United States response to COVID-19. When soap and water are not available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol. Due to this formal recommendation for hand sanitizing, hand sanitizers containing at least 60–70 percent alcohol or isopropyl alcohol are both in high demand and nearing shortage.

This is why just last week, FDA announced the availability of a guidance for industry entitled “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency” (the Guidance). The Guidance permits compounders to compound alcohol-based hand sanitizers, subject to certain restrictions, for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency.