Just prior to departing the FDA (U.S. Food and Drug Administration) Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram issued a statement (the “Statement”) on the Agency’s 2019 goals to improve the quality of compounded drugs. While the change of leadership at the Agency may affect how these efforts will be managed and implemented, the Statement provides helpful insight into the timing of Agency action in the compounding space, including:
- Maintaining Quality and Compliance for Outsourcing Facilities and Traditional Compounding Pharmacies
- Regulating Compounding from Bulk Drug Substances
- Finalizing the Agency’s Memorandum of Understanding with the States
- Compounding by Hospital and Health Systems
- Additional Compounding Priorities
Please read our client alert for a deeper summary of the Statement written by our compounding pharmacy team.