Outsourcer Compounding Opioids Recalls Products Due To Possible Contamination

An outsourcer compounding four REMS-protected opioids is issuing a voluntary recall due to potential microbial contamination. The company, SCA Pharmaceuticals, has a history of compliance issues related to sterility. Inside Health Policy first reported that at least six opioids that appear to be subject to REMS with restricted distribution systems are currently being compounded by outsourcers, one of which is SCA Pharmaceuticals. Section 503B(a)(7) of the Drug Quality and Security Act requires that outsourcers compounding REMS drugs demonstrate that...