Setting the Standard: How Two Premier Members Are Redefining Pharmacy Compounding Excellence

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Key Takeaways:

• Leading health systems like University Hospitals and BayCare are leveraging Premier's collaboratives, data and advisory expertise to build safer, more efficient compounding operations, turning compliance into a catalyst for innovation and resilience.
• The two health systems are adopting advanced technologies and centralized governance structures to enhance USP <795/797/800> compliance, ensure accuracy and safeguard patients.
• By engaging in Premier's Compounding Collaborative and 503B Advisory Group, members share data, benchmark performance and shape national best practices, setting new standards for quality, reliability and access to compounded medications.

In an era defined by persistent drug shortages, staffing challenges and increasingly complex regulatory expectations, pharmacy compounding has emerged as a critical pillar of health system resilience. For hospitals and health systems nationwide, the need to ensure reliable access to safe, high-quality compounded medications has never been greater.

Premier member organizations are leading the way - demonstrating how strong governance, technology-driven precision and collaborative partnerships can elevate compounding practice across the continuum of care. Their success underscores that achieving compliance with United States Pharmacopeia (USP) standards - <795> for nonsterile compounding, <797> for sterile compounding and <800> for hazardous drug handling - isn't just about meeting requirements. It's about driving operational excellence, patient safety and supply chain stability in the face of disruption.

Below, two health systems - University Hospitals and BayCare- share how collaboration with Premier helped them build best-in-class compounding programs that are setting new industry benchmarks.

University Hospitals: Integrating Governance, Data and Technology for Continuous Improvement

University Hospitals (UH) has built a highly integrated, technology-enabled compounding model that exemplifies what modern pharmacy leadership looks like. Working closely with Premier's 503B Advisory Group and Compounding Collaborative, UH has developed a governance and compliance structure that's scalable across large health systems.

Key elements of their success include:

• Systemwide governance: A USP Compliance Committee and Designated Responsible Individuals (DRIs) oversee compliance, audits and continuous improvement across every UH site.
• Technology-driven safety: Barcode verification, gravimetric checks and image capture create closed-loop assurance for all sterile preparations.
• Measurable results: USP <797> compliance rose from 85 percent to 96 percent, and USP <800> from 65 percent to 98 percent, driven by structured audits and data-driven reviews.
• Premier partnership impact: Through active participation in Premier's Compounding Collaborative, UH shares its scalable compliance model nationally, influencing best practices and peer benchmarking across the network.

UH's collaboration with Premier enables continuous learning and shared innovation, making them not just a model of compliance, but a system that's shaping the future of safe, patient-centered compounding.

BayCare: Building an FDA-Registered 503B to Secure Supply and Strengthen Quality

When national sterile compounding capacity contracted sharply between 2017 and 2020, BayCare Health System made a bold strategic decision: to build its own FDA-registered 503B compounding facility.

Working closely with Premier's Central Pharmacy Collaborative and the 503B Advisory Group, BayCare designed a cGMP-compliant, robotics-enabled pharmacy that ensures consistent, safe and cost-effective medication access for its hospitals.

• Centralized compounding excellence: Since launching in 2019, BayCare's 503B has produced over 640,000 sterile doses and more than 7,500 iohexol doses during national contrast shortages.
• Regulatory leadership: BayCare is one of only five U.S. health systems with an FDA-approved 503B facility, successfully completing two FDA inspections with minimal findings.
• Advocacy and influence: Through Premier, BayCare's compounding leader Kenneth Jozefczyk collaborates with FDA panels and national workgroups to advocate for health-system-based compounding standards.

BayCare's experience - supported by Premier data, safety assessments and peer collaboration - illustrates how a health system can turn regulatory challenge into strategic advantage.

A Blueprint for the Future

Across these two leaders, one theme is constant: collaboration is the cornerstone of compounding excellence. Whether it's shared benchmarking through Premier collaboratives, joint advocacy for regulatory clarity or data-driven analytics to optimize sourcing, these organizations demonstrate that the future of safe, efficient and compliant compounding is built together.

Health systems like University Hospitals and BayCare demonstrate that compounding done well is more than compliance - it's a catalyst for confidence and care continuity. Their example underscores that in today's complex healthcare landscape, compounding isn't a niche function. It's a cornerstone of resilience.

Through its national network, data assets, and advisory expertise, Premier continues to empower members to lead with innovation, ensure compliance and strengthen the medication supply chain - so that every compounded dose is safe, traceable and ready when patients need it most.

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