Compounding Pharmacy Oversight: Quality, Safety, and Regulatory Expectation

Overview:

This webinar provides a practical overview of compounding pharmacy oversight from a quality and regulatory perspective. We will review the regulatory landscape for 503A and 503B entities, expectations for sterile and non-sterile compounding, and the roles of federal vs. state regulators. The session will walk through core quality system elements that must be in place-procedures, training, environmental monitoring, documentation, labeling, and complaint/recall management-and how to assess both in-house and outsourced compounding activities. Participants will leave with concrete tools and questions to strengthen their oversight framework and support safer, more compliant compounding practices.

Why you should Attend:

If your compounding oversight relies mainly on “what we’ve always done” or minimal state compliance, you may already be exposed to serious patient safety risks and regulatory findings. Gaps in environmental monitoring, documentation, beyond-use dating, and supplier controls can quickly escalate into recalls, board actions, or civil liability. This webinar shows you where oversight commonly breaks down-and what you must have in place now to demonstrate control of compounded products, whether you’re operating a 503A pharmacy, partnering with a 503B outsourcer, or overseeing compounding services within a health system

Areas Covered in the Session:

• Regulatory framework for compounding pharmacies
• Differences between 503A and 503B entities
• Roles of FDA, state boards of pharmacy, and accrediting bodies
• Key quality and safety expectations for sterile and non-sterile compounding
• Core elements of an effective oversight program:
• • Policies, procedures, and documentation
  • Personnel qualification, training, and competency
  • Facility, equipment, and environmental controls
• Beyond-use dating, stability, and risk-based decision-making
• Supplier qualification and incoming material controls (APIs, excipients, containers)
• Complaint handling, adverse event reporting, and recall readiness
• Risk assessment tools for identifying and prioritizing oversight gaps
• Working with 503B outsourcing facilities—what to verify, what to document
• Inspection preparation and responding to findings impacting compounding operations

Who Will Benefit:

• Pharmacy Directors and Managers
• Supervising / Lead Pharmacists (hospital, health-system, retail, specialty)
• Compounding Pharmacists and Pharmacy Technicians
• Quality Assurance / Quality Improvement staff in pharmacies and health systems
• Regulatory/Compliance Officers overseeing pharmacy services
• Risk Management and Patient Safety professionals
• Consultants supporting compounding pharmacies or health-system compounding