Day 2Wednesday, 10 June 2026 - ET (Eastern Time, GMT-05:00)

As regulatory expectations tighten, 503A pharmacies are under increasing pressure to not only interpret—but effectively operationalize—USP requirements. This session delivers a practical roadmap for embedding compliance into everyday workflow without disrupting patient care.

• Clarify how to interpret overlapping USP 795, 797, and 800 standards for sterile and non-sterile operations.
• Learn how to streamline documentation, training, and competency assessments for smaller teams.
• Address environmental sampling, out-of-spec results, and state-specific interpretation challenges.
• Explore real-world strategies for sustaining compliance while optimizing efficiency and quality.

As market pressures grow and regulatory expectations tighten, many 503A pharmacies are asking the same question: Is it time to take the leap to 503B? This session explores the strategic, financial, and operational realities behind that decision—what it takes to scale responsibly, and whether the benefits outweigh the challenges.

• Understand the regulatory divide between USP standards and full cGMP compliance—and what changes when you move under FDA oversight.
• Examine key factors in determining readiness, including facility design, staffing, quality systems, and financial investment.
• Learn from consultants and operators who have guided or undergone the transition process—what they wish they’d known before starting.
• Discuss emerging hybrid models and whether a new “middle tier” standard may eventually bridge the gap between 503A and 503B operations.

Bridging USP and GMP expectations while building sustainable systems for quality and regulatory success

• Balancing USP and GMP Standards: Explore when and how adopting select GMP principles can enhance 503A operations, assess where costs may outweigh benefits, and consider a practical middle-ground framework that reflects real-world operational realities.
• Validating Alternative Methods Under USP 797: Learn how to scientifically justify and validate alternative approaches to ensure regulatory acceptance and compliance.
• Strengthening Documentation and Quality Controls: Review the testing, documentation, and quality assurance measures needed to support innovative yet compliant practices.
• Inspection Readiness as a Culture: Decode emerging State Board priorities and inspection trends, identify common deficiencies before they appear on a 483, and build a lasting readiness culture that empowers staff and strengthens operational consistency year-round.
• Real-World Lessons: Examine case studies illustrating successful corrective actions, CAPA implementation, and strategies for integrating 503A pharmacies into health systems while maintaining quality assurance over time.

Integrated Delivery Networks and health systems are increasingly partnering with 503B outsourcing facilities to ensure compliance, quality, and supply chain resilience. This session explores how these partnerships are evaluated, built, and sustained—highlighting the role of communication, education, and alignment from both the purchaser’s and the 503B’s perspective.

Key Discussion Points:

• Understanding the Landscape
  • Who are the key 503B stakeholders within health systems and IDNs?
  • What drives health systems to partner with 503Bs beyond cost and availability?
• Perspectives on Partnership
  • How the relationship is viewed from the purchaser’s side
  • What success looks like from the 503B perspective
• Auditing, Compliance, and Trust
  • How health systems audit and evaluate 503B partners
  • Common compliance and communication gaps that impact confidence
• Communication and Education as a Partnership Enabler
  • How clear, consistent communication supports provider alignment and reduces confusion around compounded therapies
  • Best practices for educating clinicians and internal stakeholders to strengthen long-term collaboration
• Open Discussion
  • What health systems look for in a 503B partner
  • What 503Bs need from health-system partnerships to scale responsibly

Explore the next generation of compliance through AI and data integration.

• Learn how automation reduces human error in weighing, mixing, and batch verification.
• Discover digital quality systems that simplify documentation and real-time monitoring.
• Discuss regulatory considerations for AI-assisted compounding tools.

This dynamic three-part session is designed to spark collaboration and shared learning between 503A and 503B pharmacies:

1. Introductions & Insights (20 mins)
   Hear from expert speakers as they set the stage with key compliance challenges and opportunities unique to each model.

2. Focused Breakouts (20 mins)
   Attendees split into 503A and 503B groups for candid discussions on pressing issues, best practices, and lessons learned.

3. Cross-Pollination Exchange (20 mins)
   Rejoin for a collaborative dialogue where speakers highlight overlapping challenges and strategies for success in compounding pharmacy compliance.