Compounded GLP-1 drugs such as semaglutide and tirzepatide are facing mounting legal, regulatory, and financial pressures. Recent federal rulings have narrowed the scope for permissible compounding, requiring proof of patient-specific clinical differences. At the same time, manufacturers have filed lawsuits in more than 30 states challenging the legitimacy of compounded products, while PBMs and insurers continue to limit coverage, shift formularies, and keep reimbursement rates low. Telehealth platforms also face heightened risk of corporate practice of medicine violations when operating outside state laws, exposing both physicians and companies to significant liability.
Frier Levitt partner Arielle Miliambro sheds light on these developments in her Dispense Times article, “GLP-1 Compounding Under Fire: Legal, Regulatory, and Compliance Risks for Pharmacies, Telehealth Platforms and Prescribers.” She outlines key compliance priorities such as ensuring compliant business structures, separating clinical and administrative functions, reviewing marketing content for legal risks, and documenting individualized medical necessities. The article further explores future headwinds, including increased scrutiny of combination products, potential oral GLP-1 launches, coverage-related discrimination lawsuits, and unresolved legislative gaps.
Read the article: Dispense Times
