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Location: Virtual Conference

Agenda | Slides

This year, the theme of the Compounding Quality Center of Excellence’s conference is, “The Shared Pursuit of Compounding Excellence." The conference will highlight how stakeholders can protect patients from unsafe, ineffective, and poor-quality compounded drugs while preserving access to compounded drugs for patients who have a medical need for them.

Conference Program

• In-depth sessions on CGMP topics, including visual inspection during stability and release testing, and qualification of container closure systems
• Pre-conference session on outsourcing facility nuts and bolts: product and adverse event reporting, registration, and other requirements
• Updates on FDA policies and FDA topics

Intended Audience

• Outsourcing facilities—management and staff
• Compounders interested in becoming outsourcing facilities
• State pharmacy regulators
• Hospitals utilizing compounding facilities
• Suppliers of APIs and other materials and supplies to outsourcing facilities
• Customers of outsourcing facilities (hospitals, clinics, ambulatory centers, group purchasing organizations, etc.)
• Consultants focused on outsourcing facilities and compounding pharmacies
• General public and healthcare professionals interested in outsourcing facility topics

Contact

Please contact CompoundingQualityCoE@fda.hhs.gov with questions. 

More Information

• Compounding Quality Center of Excellence

Conference Slides

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

• 503B Outsourcing Facilities: Regulations and Product Reporting Submission Using CDER Direct
• 503B Product Reporting Compounded Products Update NDC Directory
• Adverse Event Reporting for Outsourcing Facilities
• Areas of Customer Need for Outsourcing Facility Products
• Building Connections Co-Presentation
• Characteristics of Pharmaceutical Elastomers in Container Closure Systems
• Development of 503B Bulks List
• FDA Compounding Quality Center of Excellence Annual Conference Agenda 2022
• Hospital and Health System Compounding Under Section 503A of the FD&C Act
• Implementation of Emerging Technologies (Automation)
• Overview of Outsourcing Facility Inspections
• Quality Risk Management Moderated Discussion
• Safety Reporting Portal (SRP) Registration and Adverse Event Reporting Process for 503B Registered Outsourcing Facilities
• Understanding the Form FDA 483 Process and Timeline
• Visual Inspection of Injectable Products