FDA issues revised guidance for outsourcing facilities that compound drugs

The Food and Drug Administration yesterday released revised draft guidance for facilities that compound human drugs as outsourcing facilities. “We’ve heard the feedback from stakeholders to our proposed 2014 draft guidance that certain [current good manufacturing practice] policies would have made it difficult for outsourcing facilities to fill smaller orders and that some compounded drug products that practitioners requested for office stock were not available from outsourcing facilities due to those policies,” said FDA Commissioner Scott Gottlieb, M.D. “We want to advance policies that make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality. This revised draft guidance includes changes intended to help achieve this goal, particularly through revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between production of sterile and non-sterile drug products.”