Day 1Monday, 2 June 2025 - ET (Eastern Time, GMT-05:00)

Hear directly from the FDA on updates to the compounding policy landscape.

• Gain a refresher on the latest USP updates and how compounders have adapted to ensure regulatory compliance since they’ve been implemented
• Discuss progress and pitfalls compounders have faced since the requirements changed, related to interpretation and operationalization of the updates, and how to assess current status and what gaps might still need to be covered

• Hear a comprehensive overview of the multitude of challenges directly impacting the compounding pharmacy landscape today, including complexities surrounding GLP-1s, animal compounding, and other barriers to patient access
• Analyze current public policy affecting compounding and its potential effects on the future of compounding practices and patient access to compounded medications

• Hear an overview of current FDA audits and 483s to better equip compounding pharmacists with the knowledge and tools to navigate the intricacies of FDA audits and 483s
• Dive into understanding the FDA inspection process, analyze common 483s and underlying causes, and explore proactive compliance strategies

• Discuss the current regulatory landscape for compounding GLP-1 medications, including the industry impact of recently implemented USP updates and FDA areas of focus
• Delve into lessons learned since the USP updates, specific challenges in compounding GLP-1s in this new regulatory environment, and compliance strategies to ensure regulatory adherence

• Develop a comprehensive understanding of how 503As and 503Bs serve patients differently and gain insights into the nuances between services, operations, and regulatory requirements
• Explore opportunities for fostering collaborative relationships between 503As and 503Bs to ensure optimal patient outcomes and regulatory compliance

Join forces with fellow compounders to dissect the most pressing regulatory and operational challenges facing compounding practices today. This session brings attendees together to dive deeper into hot topics and explore the most pressing “what about” questions in today’s compounding environment, including federal and state regulatory adherence and optimizing operations to ensure compliance and quality control. This is a unique chance to bring forward any topics you wished had been explored further and dive deeper into the questions still on your mind. Come ready to collaborate, connect and leave inspired by the collective wisdom of the group.