FDA Unveils Ramped-up Regulatory Initiatives for Drug Compounders
On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s recent efforts to continue to regulate drugs compounded by section 503B outsourcing facilities.1 FDA’s efforts include:
- Publishing a report that provides a list of all the drugs that outsourcing facilities have compounded
- Publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key regulatory information applicable to outsourcing facilities
- Conducting the sixth intergovernmental meeting on drug compounding, allowing intergovernmental agencies to coordinate their regulatory efforts
FDA represents that these efforts are both an attempt to help the medical community identify what medications are compounded by outsourcing facilities, and to clarify the DQSA framework for outsourcing facilities.