Outsourcing Compounder Receives Warning Letter Due To Sterility Issues

Another outsourcer compounding a REMS-protected opioid has been hit with an FDA Warning Letter due to issues with sterility. FDA posted this week a Warning Letter dated Oct. 10 to US Compounding, which currently compounds over 30 types of drugs, including morphine sulfate. The outsourcer in 2015 recalled all lots of sterile products distributed within a seven-month period due to similar issues, and has continued to struggle with guaranteeing sterility of its compounded products. Inside Health Policy first reported...