Stay ahead of the curve with our webinar series navigating the evolving regulatory landscape for GLP-1 compounding.
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Watch Webinar Series: Navigating GLP-1 Compounding
Part 4: 503A GLP-1 Compounding Compliance, Trends, and Risks: Today, Tomorrow, and the Future
Aired on: May 15, 2025
As demand for GLP-1 medications continues to surge, so do the legal and regulatory challenges for 503A compounders, prescribers, and industry stakeholders.
In this timely session, Frier Levitt attorney Arielle Miliambro breaks down what you need to know to stay ahead of evolving compliance risks.
Key Takeaways:
- Strategies for navigating the evolving GLP-1 landscape as regulatory and market pressures converge
- Insights into recent lawsuits from brand manufacturers, including claims related to medical necessity and the corporate practice of medicine (CPOM)
- An overview of new GLP-1 formulations emerging to meet patient demand
- The expanding role of health insurers, PBMs, and other payers in a market previously dominated by cash-pay models
- Key considerations for clinicians prescribing GLP-1s in a shifting legal and regulatory environment
Part 3: Prescriber Insights: Navigating FDA Updates on Semaglutide & Tirzepatide for Clinicians
Aired on: March 17, 2025
With the evolving landscape surrounding 503A GLP-1 compounding, it’s essential for prescribers to stay informed. Recent FDA guidance has introduced key changes affecting 503A compounding, prescribing, and patient access. Frier Levitt attorney Arielle Miliambro breaks down the latest FDA updates and provide actionable strategies for healthcare providers to maintain compliance while ensuring continued patient care.
Key Takeaways:
- Understanding the FDA’s New Guidance on Compounded GLP-1s
- What the removal from the shortage list means for compounding pharmacies
- Key regulatory changes impacting prescribing and dispensing
- How Providers Can Continue Writing for Compounded Semaglutide & Tirzepatide
- Legal pathways and compliance considerations for ongoing patient care
- Strategies for ensuring access while adhering to FDA regulations
- Ensuring Compliance & Best Practices for Optimizing Patient Health
- Key steps providers must take to remain compliant
- Navigating pharmacy partnerships and prescription protocols effectively
Part 2: Litigation and Business Strategies for 503A GLP-1 Compounding – Navigating Regulatory and Legal Risks
Aired on: February 13, 2025
With the increasing regulatory scrutiny and litigation risks surrounding 503A GLP-1 compounding, this webinar offers critical updates and actionable insights. Our panel, Jesse Dresser and Matthew Modafferi, will delve into FDA policies, recent litigation trends, and essential risk management strategies to help compounders assess and mitigate business and legal challenges effectively.
Key Takeaways:
- Understand the evolving FDA rules for 503A compounding of GLP-1s during and after removal from the 506E Drug Shortage List.
- Analyze recent trends in GLP-1 litigation, including the status of pending cases.
- Identify potential intellectual property risks, such as the likelihood of future patent infringement lawsuits.
- Develop robust business strategies to address common legal and regulatory hurdles in GLP-1 compounding operations.
Part 1: Navigating GLP-1 Compounding – FDA and State Boards of Pharmacy Perspectives
Aired on: January 29, 2025
Our speakers discuss recent FDA policies, State Board of Pharmacy considerations, and the implications for compounders navigating this complex and rapidly changing area.
Key Takeaways:
- Gain clarity on the 503A compounding requirements for GLP-1s before, during, and after removal from the FDA 506E Drug Shortage List.
- Evaluate the potential impact of manufacturer petitions to classify GLP-1s as “demonstrably difficult to compound” and what this means for 503A compounders.
- Identify common USP <797> compliance challenges for 503A compounders and how Boards of Pharmacy inspections have evolved.
- Assess the latest trends in non-resident pharmacy sterile compounding, including the roles of Boards of Pharmacy and NABP Compounding Accreditation.
Catch Up On Our Must-See Webinar Series: “Mastering GLP-1 Compounding”
Missed it? No problem! Access our comprehensive 3-part webinar series on-demand and unlock the tools and strategies you need to elevate your compounding pharmacy.
Webinar Highlights:
- Part 1: Understanding FDA Regulations – Key insights for 503A and 503B compounding.
- Part 2: Innovative Business Models & Reimbursement Strategies – Navigate telehealth, kickback regulations, and payment challenges.
- Part 3: Navigating Litigation & Intellectual Property in 503A Compounding – Challenges and risk mitigation strategies.
