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.
You may also be interested in...
The US Food and Drug Administration should require that outsourcing facilities collect bioavailability data for compounded bioidentical hormone replacement therapy products, while compounding pharmacies should be required to report adverse events to state pharmacy boards and the FDA. Such actions would help resolve some of the safety concerns for these products, says a 1 July report from the National Academy of Sciences, Engineering and Medicine.
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.
FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use. The IACP applauds the move.