Reed Smith Client Alerts

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of all the drugs that outsourcing facilities have compounded; (2) publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key regulatory information applicable to outsourcing facilities; and (3) conducting the sixth intergovernmental meeting on drug compounding allowing intergovernmental agencies to coordinate their regulatory efforts for all compounders. These efforts demonstrate that FDA is continuing to actively oversee the regulation of drug compounding and is looking to work closer with state boards of pharmacy to coordinate its various enforcement initiatives. Drug compounders should continue to closely monitor their compliance with all applicable state and federal regulation and guidance.

Authors: Rachael G. Pontikes Emily L. Hussey John D. Kendzior

Type: Client Alerts

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.