US FDA Green-Lights Outsourcing Facilities, Pharmacies To Compound COVID-19 Treatments
Executive Summary
Hospital shortages of critical FDA-approved drugs used for treating COVID-19 patients has prompted the US FDA to loosen restrictions against compounding these drugs. In a related action, the FDA will now allow outsourcing facilities and compounding pharmacies to repackage propofol, also in short supply.
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Outsourcing Facilities Need More Regulatory Transparency From FDA To Compound Drugs In Shortage
Greater clarity on which drugs outsourcing facilities can compound from bulk ingredients and what good manufacturing practice requirements they will have to meet would go a long way toward enabling them to help prevent and resolve drug shortages, Pew report says. Another factor to consider: whether any loosening of restrictions during the pandemic will continue afterward.