Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of Excellence

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.

Who should attend:

Outsourcing facilities management and staff
Consultants helping newly registered outsourcing facilities
Compounders interested in becoming outsourcing facilities

June 16, 2025: Exploring Resources that Support Outsourcing Facilities

Join us from 12 to 1:30 p.m. ET, June 16, 2025, to hear from:

FDA Compounding Quality Center of Excellence
Parenteral Drug Association (PDA)
International Society for Pharmaceutical Engineering (ISPE)
American Society for Health-System Pharmacists (ASHP)

September 11, 2025: Understanding Inspections

Join us from 12 to 1:30 p.m. ET, September 11, 2025, for a discussion about FDA inspections, including:

Brief presentation by FDA investigators on inspection resources and expectations.
Panel discussion with industry representatives sharing experiences with FDA inspections and tips for a productive inspection.

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.

Who should attend:

Outsourcing facilities management and staff
Purchasers of compounded drugs
Pharmacy organizations

July 10, 2025: Designing an Organization with Quality in Mind

Join us from 12 to 1:30 p.m. ET, July 10, 2025, for a discussion on how to design an organization with quality in mind, including:

Panel discussion with outsourcing facility representatives sharing how they made intentional decisions about their organization and facility structure to promote and optimize quality.
Q&A

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.