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Navigating 503B Compounding Compliance: The Evolving Regulatory Landscape of Semaglutides
Event: 2025 Developments in Pharmacy Law XXXVI
[11/07/2025 - 1:30 PM-2:30 PM]
Synopsis:
The regulation of drug compounding under Section 503B of the Federal Food, Drug and Cosmetic Act (“FDCA”) continues to evolve, particularly with increased scrutiny over compounded semaglutides. The growing demand for compounded versions of this GLP-1 receptor agonist has placed heightened regulatory pressure on outsourcing facilities to ensure compliance with FDA guidelines while meeting market demand. This session will provide an in-depth analysis of the legal and regulatory considerations surrounding the compounding of semaglutides, including FDA enforcement trends, bulk substance restrictions, recent guidances and practical compliance strategies for 503B outsourcing facilities. Attendees will gain a deeper understanding of the intersection between clinical necessity, business pressures and regulatory risks in this complex area. The presentation will also explore recent enforcement actions and litigation impacting the 503B landscape.
Learning Objectives:
- Analyze the legal and regulatory requirements governing 503B outsourcing facilities, particularly regarding the compounding of semaglutides.
- Evaluate FDA guidance on bulk substances and its impact on outsourcing facilities’ ability to compound semaglutides.
- Identify key compliance strategies to mitigate enforcement risks while navigating evolving regulations.
- Discuss recent enforcement actions and legal challenges that may shape the future of compounded semaglutides.
Conference Information: Link
Speaker(s): Carolina M. Wirth and Benjamin A. Lockwood
Organizer: American Society for Pharmacy Law
Venue: Westin Fort Lauderdale Beach Resort - Get A Map
