Agenda for Day 1– Wednesday December 9, 2026 - US/Eastern
- Samantha Elizondo - Conference Producer, Informa Connect
Compounding Pharmacies continue to face evolving regulatory scrutiny, increasing operational complexity, and shifting market opportunities. This opening session will provide a comprehensive overview of the developments most likely to impact pharmacy operations, compliance programs, and growth strategies heading into 2027.
Discussion Topics
FDA enforcement trends and inspection activity
State board developments and regulatory priorities
USP implementation considerations
Ongoing market shifts following GLP-1 demand growth
Emerging business and compliance risks
As compounding pharmacies pursue new growth opportunities, they are increasingly evaluating partnerships with telehealth organizations, med spas, and other pharmacies. This panel examines how to structure these relationships while navigating regulatory expectations, contractual obligations, and operational responsibilities.
Discussion Topics
- Structuring compliant 503A–503B business relationships
- Telehealth partnerships, referral models, and vertical integration
- Working with med spas while maintaining compliance
- Contracting, governance, and allocation of compliance responsibilities
- Patient-specific prescription and fulfillment considerations within partnership models
- Due diligence, documentation, and risk management
- Recent enforcement activity and lessons learned
- Edgar Gonzalez - General Counsel, Empower Pharmacy
Join pharmacy regulators for a candid discussion on inspection trends, enforcement priorities, and the compliance issues receiving the greatest attention from state boards.
Discussion Topics
Common inspection findings
Enforcement priorities
Telehealth-related concerns
Nonresident pharmacy oversight
Preparing for successful inspections
- Timothy Fensky - Board Member, Massachusetts Board of Registration in Pharmacy
As pharmacies continue expanding nationally, regulatory requirements continue to diverge. This session examines how organizations are operationalizing compliance across multiple jurisdictions.
Discussion Topics
State licensing requirements
Shipping restrictions
Inspection expectations
Telehealth-related regulations
Building scalable compliance systems
- Tenille Davis - Chief Advocacy Officer, Alliance for Pharmacy Compounding
Even well-prepared compounding facilities can face unanticipated challenges during regulatory inspections. In this candid case study, Jack Korbutov, Founder & President of The Art of Medicine Compounding Facility, will share his experience with a unique DEA disciplinary action and the critical lessons learned that can help others safeguard their operations before similar issues arise.
Discussion Topics
Overview of the DEA inspection and disciplinary action
Compliance vulnerabilities that standard preparation may not address
Unexpected findings and regulatory interpretation challenges
Actionable strategies to strengthen DEA readiness
Best practices for navigating inspections and protecting your license
Compounded peptides, GLP-1 products, and other emerging therapies continue to reshape the compounding landscape amid evolving FDA oversight and heightened regulatory scrutiny. This session provides a year-end update on the most significant legal, regulatory, and market developments, including the implications of the FDA’s July peptide review and what they mean for pharmacies moving forward.
Discussion Topics
Key takeaways from the FDA’s July review of 14 commonly compounded peptides
Implications for therapies such as BPC-157, Thymosin Alpha-1, and TB-500
FDA enforcement priorities and recent regulatory developments
GLP-1 enforcement, marketing, and advertising considerations
Litigation updates and emerging peptide regulations
How pharmacies and prescribers are adapting to the evolving regulatory landscape
Compliance strategies to mitigate regulatory risk
Looking ahead: the future of compounded peptides and other emerging therapies
- Melissa Stefko - Senior Vice President of Regulatory Affairs, Wells Pharmacy Network
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.
For pharmacies considering outsourcing facility registration, understanding the operational, financial, and regulatory realities is critical.
Discussion Topics
Capital investment requirements
Quality system expectations
cGMP readiness
Regulatory obligations
Lessons learned from successful transitions
- Victor Hill - Director of Quality, Vios Compounding
- Jamal Almustapha - Vice President of Quality, Strive Pharmacy
Hear directly from Alliance for Pharmacy Compounding leadership on the most important regulatory, legislative, and advocacy developments impacting pharmacies nationwide.
Discussion Topics
Federal and state legislative priorities
Ongoing FDA engagement efforts
GLP-1 and peptide developments
Industry advocacy initiatives
Key issues expected to shape 2027
- Scott Brunner - Chief Executive Officer, Alliance for Pharmacy Compounding
