Day 1 - December 9thWednesday, 10 December 2025 - US/Eastern

Compounding GLP-1s requires navigating a patchwork of state regulations, enforcement priorities, and oversight frameworks. This session will explore how requirements differ across states, how FDA guidance intersects with local rules, and what pharmacies must know to maintain compliance in an evolving regulatory environment.

You’ll learn how to:

• Understand the most common state-level requirements for GLP-1 compounding

• Anticipate differences in licensure, inspections, and enforcement actions

• Align operations with both state rules and FDA expectations

• Avoid pitfalls by learning from recent regulatory trends

With GLP-1 demand at the center of public and regulatory scrutiny, compounding pharmacies have an opportunity to solidify and elevate their credibility. This session will explore:

• Clearing up common myths and misconceptions about compounded GLP-1s while emphasizing what is permissible in patient care
• Building stronger relationships with healthcare providers through transparent communication and evidence-based outreach
• Incorporating patient perspectives on safety, access, and the role of compounded GLP-1s in modern treatment plans

Clear, compliant communication around GLP-1s is critical as regulators and patients scrutinize pharmacy claims. This session will outline:

• Key legal and regulatory boundaries for how GLP-1s can be described in advertising, patient communications, and provider outreach
• Common compliance pitfalls in GLP-1 marketing, including language that may be misleading or trigger enforcement risk
• Practical strategies for aligning promotional efforts with pharmacy operations and clinical practice while protecting patient trust

With compounding of GLP-1s under intense scrutiny, pharmacies must navigate a complex web of federal and state requirements. This session will address:

• Key regulatory issues including essential copy provisions, ongoing Novo Nordisk lawsuits, and Lilly patent protections
• Oversight considerations for 503A and 503B pharmacies from the FDA and state boards, and how requirements differ
• Compliance risks tied to formulation practices such as microdosing to avoid essential copy restrictions and the addition of ingredients like B12 or glycine

As demand for GLP-1s grows, both pharmacies and telehealth companies are facing different supply chain challenges. This session will cover:

• How compounding pharmacies are approaching vendor vetting, ingredient consistency, and quality safeguards for APIs and excipients
• The pressures telehealth companies face in securing reliable finished product supply and meeting prescription demand
• Emerging strategies such as vertical integration, highlighted by examples like Try Eden’s acquisition of Contigo, to reduce risk and ensure continuity of care

The next year will be pivotal for compounded GLP-1s as regulatory, payer, and market dynamics evolve. This forward-looking discussion will explore:

• Near-term compliance and policy developments that will shape market access and commercialization pathways
• How payer decisions, reimbursement trends, and patient demand are influencing the ability to sell compounded GLP-1 products
• Competitive and supply pressures, including manufacturer actions and market entrants, that will impact sales strategies and growth potential