Compounding Quality Center of Excellence
FDA established the Compounding Quality Center of Excellence to support outsourcing facilities and related stakeholders in their efforts to provide high quality drugs for patients who need them.
Experts across the FDA work within the Center of Excellence to develop programs that promote quality, education, research, and communication on compounded drugs. Because compounded drugs are not reviewed by the agency for safety, effectiveness or quality before they are marketed, they pose unique risks. Patient safety is the shared responsibility of FDA, compounders, including outsourcing facilities, state regulators, and pharmacy associations. The Center of Excellence engages proactively with these stakeholders to enhance the quality of compounded prescription drugs for human use.
The Center of Excellence developed the following programs to support stakeholders in their efforts to provide quality compounded drugs.
On-demand Training
- Take self-paced on-demand courses on compounding regulation and Current Good Manufacturing Practice (CGMP) and earn continuing education credits for pharmacists, pharmacy technicians, physicians and nurses. View recorded webinars and download training presentations. Subscribe to be notified when new training is available.
Live, Instructor Led Trainings
- Register for free Current Good Manufacturing (CGMP) courses with live instruction. Space is prioritized for outsourcing facilities with limited availability for regulators, pharmacy compounders, and other stakeholders. These multi-day trainings are offered on a limited basis and provides continuing education credits for pharmacists, pharmacy technicians, physicians, and nurses. Early registration is recommended.
Annual Conference
- The Compounding Quality Center of Excellence holds an annual virtual conference open to the public, outsourcing facilities, compounders interested in becoming outsourcing facilities, regulatory bodies, and other stakeholders to learn and engage on emerging trends and compounding best practices. Registration is free and open to the public.
Stakeholder Engagement
- FDA, as part of the larger compounding program, is holding listening sessions with outsourcing facilities and other stakeholders to stay informed about issues of importance to the compounding sector. As part of the Compounding Quality Center of Excellence, the FDA established a cross-sector stakeholder group to engage on issues that affect outsourcing facilities, health care providers that purchase and use their products, and other stakeholders in the ecosystem.
Outsourcing Facilities Annual Study
- To better understand the opportunities and challenges outsourcing facilities face, and the dynamics of the larger stakeholder ecosystem interacting with outsourcing facilities, the Center of Excellence oversees a research effort. Drawing from both analytical and social science methodologies, the research focuses primarily on the areas of business viability, quality practices, compliance with federal law, and interactions between FDA and outsourcing facilities. This research effort has deepened FDA’s understanding of the outsourcing facility sector and will further enhance the ability of the Center of Excellence to serve as a valuable resource to outsourcing facilities, the FDA, and other stakeholders. Select, high-level results from the annual study are available by viewing the presentations: State of the Outsourcing Facility Sector and Possibilities for the Future and Areas of Customer Need for Outsourcing Facility Products.
Contact the Compounding Quality Center of Excellence
- Your feedback is essential to the success of the Center of Excellence. Please feel free to email us at: [email protected].