Center of Excellence on Compounding


As reported by Zachary Brennan (Feb 14, 2018), FDA Commissionner Gottlieb outlined FDA plans for FY 2019. Of specific interest to the Compounding world: FDA is proposing to create, as it did for oncology, a “Center of Excellence on Compounding for Outsourcing Facilities,” with expanded FDA engagement with outsourcing facilities and states to help the pharmacy outsourcing industry grow to meet its intended function and adhere to higher quality standards to protect patient health.

“The Center of Excellence would identify and propose solutions to market barriers to lower the cost for pharmacies to become outsourcing facilities. The Center would provide much-needed education and training to improve product quality, safety and purchaser confidence, and help the FDA adjust its regulatory oversight to better match the scope of production of an individual compounding pharmacy,” Gottlieb said.

Funding for the Center of Excellence on Compounding is proposed in the FDA’s FY 2019 budget request (p.7).

The FY 2019 Budget includes $25 million to create a “Center of Excellence on Compounding for Outsourcing Facilities.” With these resources, FDA will expand engagement with outsourcing facilities and states to help the pharmacy outsourcing industry grow to meet its intended function and adhere to higher quality standards to protect patient health. The Center of Excellence will identify and propose solutions to market barriers to lower the cost for pharmacies to become outsourcing facilities. The Center will provide much-needed education and training to improve product quality, safety, and purchaser confidence, and help the FDA adjust its regulatory oversight to better match the scope of production of an individual compounding pharmacy. FDA will work with industry to improve manufacturing practices, create new programs relating to requested review of method design and stability study protocols, and work with state partners to
reduce challenges associated with state regulatory diversity and support state-based oversight of pharmacies.

If funded (22.3M requested) the Center of Excellence on Compounding will have 17 full time employees assigned to CDRE (p. 79) with functions as described above.  Additionally, the Office of Regulatory Affairs (ORA) will add 10 full time employees (2.7M requested)  ORA will support the Center of Excellence on Compounding for Outsourcing Facilities and provide hands-on assistance to these facilities to improve compliance. ORA also will support training and outreach initiatives to strengthen state oversight of compounding, as well as a pilot program of contracted state inspections.  In addition, ORA will establish a specialized group of investigators who will spend a majority of their time on outsourcing facility inspectional activities (p. 80).

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