Stay ahead in 2025: Discover what’s on the horizon for GLP-1 compounding as we navigate evolving FDA guidelines and state Boards of Pharmacy regulations.
Don’t miss out on these critical updates. Stay informed and ensure your business is prepared for 2025 and beyond.
- The latest updates on regulatory and legal risks.
- Insights into litigation trends and outcomes.
- Effective business strategies tailored for 503A compounding.
Unlock the full potential of your compounding pharmacy with our comprehensive 3-part webinar series covering critical aspects of GLP-1 compounding, including regulations on popular Semaglutides, enabling your compounding practice to:
- Remain Compliant
- Avoid Penalties
- Maximize Profitability with Innovative Business Models
- Mitigate Legal Risks
- Safeguard Intellectual Property
- Enhance Patient Care
Who Should Watch: Access our GLP-1 Compounding webinar anytime, anywhere, fitting seamlessly into the busy schedules of pharmacy owners, pharmacists and pharmacy technicians.
Key Insights and Actionable GLP-1 Compounding Solutions Covered
Part 1: Understanding FDA Regulations: Key Insights for 503A and 503B Compounding
This session covers:
- Key Insights into 503A and 503B Standards: Learn the distinctions and regulatory nuances between 503A and 503B compounding, and how to navigate them effectively.
- Regulatory Requirements for Compounding GLP-1: Understand the specific FDA requirements for compounding including compliance with the Drug Quality and Security Act (DQSA) and relevant FDA guidances.
- Strategies to Ensure Compliance: Gain actionable strategies to ensure your compounding practices meet federal and state regulations, avoiding costly penalties and ensuring patient safety.
Part 2: Innovative Business Models and Reimbursement Strategies: Navigating Telehealth, Kickback Regulations, and Payment Challenges
In this session of the series, Jesse C. Dresser and Arielle T. Miliambro cover:
- Exploration of Various Business Models: Dive into different business structures including standard insurance, partial insurance, and cash options for compounding and sourcing semaglutide products.”
- Telehealth Considerations: Understand the key aspects of telehealth integration, including licensing requirements, establishing practitioner-patient relationships, and compliant prescribing practices.
- Effective Reimbursement Strategies: Learn how to navigate reimbursement challenges, manage contract limitations, and optimize usual and customary (U&C) pricing.
Related Article: Compounding Semaglutide – What Stakeholders Need To Know
Part 3: Navigating Litigation and Intellectual Property in 503A Compounding: Challenges and Risk Mitigation Strategies
In the final session, Matthew J. Modafferi delves into:
- Understanding Litigation Trends: Get insights into common litigation issues compounding pharmacies face, including false advertising, patent infringement, and regulatory compliance challenges.
- Intellectual Property Protection: Explore the complexities of trademarks, copyrights, patents, and trade secrets, and learn how to protect your intellectual property effectively.
- Best Practices for Advertising and Marketing: Discover strategies to market your compounded medications without violating FDA guidelines, ensuring truthful and non-misleading communication.
- Risk Mitigation Strategies: Implement practical steps to mitigate legal risks, including third-party testing, avoiding proprietary drug names, and ensuring all compounded medications meet quality standards.
On-Demand Access: Mastering GLP-1 Compounding Series Q&A Roundup
Frier Levitt’s healthcare and pharmacy law attorneys present a follow-up webinar“Mastering GLP-1 Compounding Series Q&A Roundup” where they tackle key issues based on the most pressing questions from our recent GLP-1 Compounding Series. Listen in to learn more about GLP-1 compounding, legal updates, critical topics ranging from due diligence in pharmacy operations, to compounding regulations.
