US FDA Green-Lights Outsourcing Facilities, Pharmacies To Compound COVID-19 Treatments
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.
You may also be interested in...
Although compounding of certain shortage drugs is allowed during the public health emergency, remdesivir is off limits due to its complexity. Providers should only use the FDA-approved version of the drug, Gilead’s Veklury, the agency says.
The crisis of nitrosamine contamination in prescription drug products continues to roil the world’s health authorities and prompts debate on the different approaches used to measure these impurities. Meanwhile, an Austrian firm gets inspected despite the pandemic and yet another homeopathic firm gets an FDA warning letter.
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.