Reed Smith Client Alerts

Resuming a blitz of activity in response to the public health emergency related to COVID-19, the U.S. Food and Drug Administration (FDA) has issued another Temporary Guidance document, this one relating to the repackaging and combining of propofol drug products (Propofol Guidance). Once again, FDA is recognizing that compounders play a crucial role in the U.S. health care system and serve as an essential resource for the most vulnerable patients during the COVID-19 pandemic.

Authors: Rachael G. Pontikes Emily L. Hussey David T. Hartmann Kelly J. Kearney

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Propofol is needed for intubation but supplies are limited

As with certain other drug products, FDA has received reports from hospitals that are having difficulty obtaining adequate supplies of FDA-approved propofol injectable emulsion, 10 mg per mL, used to support COVID-19 patients, particularly those who have been sedated and intubated. In fact, FDA-approved propofol products are so scarce that propofol is currently listed on FDA’s Drug Shortage List.

In order to fill this critical gap in care, traditional compounding pharmacies and outsourcing facilities with access to FDA-approved propofol products have signaled a desire to repackage or combine units of finished, FDA-approved propofol products to provide to hospitals treating patients infected with COVID-19. Giving larger supplies of propofol products to these hospitals will help to minimize exposure between patients and hospital staff and to conserve vital personal protective equipment.

In recognition of the important role that traditional compounding pharmacies and outsourcing facilities play in the U.S. health-care system’s response to the coronavirus pandemic, FDA has issued new guidance to allow traditional compounding pharmacies and outsourcing facilities to repackage and combine FDA-approved propofol products under certain conditions.

Compounding facilities will fill the critical gap in care

While existing FDA guidance addresses the repackaging of certain human drug products by traditional compounding pharmacies and outsourcing facilities (Repackaging Guidance), the Propofol Guidance is intended to address product changes that fall outside FDA’s Repackaging Guidance. For example, the Repackaging Guidance states that the drug products must be repackaged in a manner that does not conflict with its approved labeling, however, the critical shortage of propofol necessitates repackaging propofol drug products in a way that deviates from the Repackaging Guidance.