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  1. Human Drug Compounding

Compounding Quality Center of Excellence

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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 outsourcing facilities, compounders interested in becoming outsourcing facilities, regulatory bodies, other stakeholders, and the public. Attendees will be able to engage with FDA and learn about emerging trends in the outsourcing facility industry and best practices. Registration is free.
  • The 2023 Annual Conference will be held on September 12-13, 2023, with a pre-conference session on September 11. This year’s theme is Ten Years as a Regulated Outsourcing Facility Industry: Addressing Challenges to Improve Patient Care. Register for the virtual conference here.

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

  • Since 2019, the FDA Compounding Quality Center of Excellence has conducted the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as well as dynamics between suppliers and purchasers. 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.

Contact the Compounding Quality Center of Excellence

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