Outsourcers Currently Compounding Six REMS-Protected Opioids

At least six opioids that appear to be subject to Risk Evaluation and Mitigation Strategies with restricted distribution systems are currently being compounded by outsourcers, according to Inside Health Policy’ s review of newly released FDA data. While the Drug Quality and Security Act (DQSA) requires outsourcers certify they use controls similar to those required under the REMS, FDA has yet to issue guidance on how outsourcers are to comply with those regulations. The creation of opioids by this sector,...