Risk to Regulatory Readiness: A Modern Guide to Sterile Compounding Compliance
Complimentary
Learning Level: Intermediate
Time: 1000 - 1200 ET
Session Length: 2 hours
In today's world of evolving standards, especially in the United States of America, and increasing regulatory scrutiny by the state board of pharmacy and accreditation bodies, achieving and maintaining compliance in sterile compounding is both a critical safety priority and a complex operational challenge. The revised USP <797> and <800> standards demand robust systems, a culture of continuous quality improvement, and proactive leadership to mitigate risk and ensure patient safety. This presentation will provide a comprehensive roadmap to help pharmacy leaders, managers, the designated person per USP requirement and frontline staff assess current practices, address compliance gaps, and build sustainable strategies to meet regulatory expectations.
Using real-world case studies, evidence base strategies, regulatory insights and practical experiences, we will explore common key areas of non-compliance. These include environmental monitoring, personnel training and qualification, documentation, hazardous drug handling, and quality assurance. Grey areas and strategies to overcome them not well defined in the USP chapters will also be addressed. Participants will also gain practical tools for leading change, preparing for inspections, and aligning sterile compounding operations with institutional goals.
The session is designed to empower attendees with the knowledge and confidence to transform compliance from a reactive obligation into a proactive framework for excellence. Attendees will leave equipped to elevate sterile compounding practices, strengthen regulatory readiness, and lead safe, compliant, and resilient pharmacy operations where compliance, timely and efficient patient care can all be achieved simultaneously.
Learning Objectives
- Interpret current regulatory requirements and updates related to USP <797> and <800> standards for sterile compounding.
- Identify common compliance gaps in sterile compounding operations and outline strategies to mitigate risk and improve regulatory readiness.
- Apply practical tools and quality assurance frameworks to strengthen inspection preparedness, documentation, and staff competency in sterile compounding environments.
