FDA’s Compounding Quality Center of Excellence supports building networks and fostering a culture of quality within the industry.
Supporting Outsourcing Facilities
Outsourcing facilities that participate in the Center of Excellence help promote quality across the industry by collaborating and learning with other outsourcing facilities and stakeholders who provide valuable insights. Patient safety is our shared responsibility, and industry partners play a role in ensuring that only quality compounded drugs reach patients.
Engaging with other outsourcing facilities and across the broader health care community provides many benefits to the industry, including sharing common issues and practices and finding solutions. We look forward to a productive dialogue as we collaborate to fulfill our shared responsibility to ensure that only quality compounded drugs reach patients.
Opportunities to Collaborate
The Center of Excellence offers two discussion series - one for newly registered outsourcing facilities and one focused on quality, and we encourage outsourcing facilities and related stakeholders to get involved.
New Outsourcing Facility Discussion Series
The New Outsourcing Facility Discussion Series is tailored to newly registered outsourcing facilities. The goal of this series is to educate new outsourcing facilities and build a community among all outsourcing facilities to share knowledge across the industry. These discussions will take place several times a year and will provide opportunities for newly registered outsourcing facilities to learn from more experienced outsourcing facilities.
July 18, 2024: Establishing an Outsourcing Facility: Sharing Experiences
Join us from 1 to 2 p.m. ET, July 18, 2024, for a discussion on Establishing an Outsourcing Facility: Sharing Experiences. This discussion will include:
- Panel of outsourcing facility representatives who will share a brief description of their experiences establishing and growing their outsourcing facility
- Panel includes perspectives from a compounding pharmacy that registered as an outsourcing facility, a drug manufacturer that formed a registered outsourcing facility and a startup that registered as an outsourcing facility
- Q&A
Who should attend:
- Outsourcing facilities management and staff
- Consultants helping newly registered outsourcing facilities
- Compounders interested in becoming outsourcing facilities
Quality Discussion Series
The Quality Discussion Series is tailored for outsourcing facilities interested in advancing quality and will focus on topics related to quality culture and best practices. These discussions will take place several times a year and aim to build a robust community of outsourcing facilities with a strong commitment to quality and current good manufacturing practice requirements. This series also provides the industry with an opportunity to share quality practices across the industry that positively impact patient safety.
September 17, 2024: What is Quality Culture?
Registration Coming Soon
Join us from 1 to 2:30 p.m. ET, September 17, 2024, for a discussion on What is Quality Culture? This discussion will include:
- FDA staff will give a brief presentation on quality expectations
- Panel discussion with outsourcing facility representatives providing their perspectives of quality culture at their organization
- Q&A
Who should attend:
- Outsourcing facilities management and staff
- Purchasers of compounded drugs
- Pharmacy organizations
- Active pharmaceutical ingredient manufacturers who produce API used in compounded drugs
- Consultants for the outsourcing facility industry
- Consultants for the outsourcing facility industry
Cross-Sector Stakeholder Group
Additionally, the Cross-Sector Stakeholder Group is a small group of industry experts who discuss issues impacting outsourcing facilities, such as drug shortages and the future of the industry.
