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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 pharmacy, physician and nursing continuing education credits. 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 provide continuing education credits. 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. Subscribe to be alerted when registration opens.

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].
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