The surge in demand for GLP-1 receptor agonists like tirzepatide and semaglutide for weight loss treatments has dramatically impacted the health care and pharmaceutical industries. Medications such as Eli Lilly’s Mounjaro and Zepbound, as well as Novo Nordisk’s Ozempic and Wegovy, have gained popularity not only for their intended use in diabetes management but also for their off-label weight loss benefits. During the recent drug shortages, many clinics turned to compounding pharmacies as a temporary solution to meet patient demand.
For a timeline and critical insights into the evolving regulatory landscape surrounding tirzepatide and semaglutide view our additional articles:
- 02/24/25: FDA Confirms End of Tirzepatide Drug Shortage
- 12/20/24: FDA Removes Semaglutide from Drug Shortage List
- 10/02/24: Tirzepatide No Longer on FDA’s Drug Shortage List
- 08/19/24: Tirzepatide and Semaglutide Still on the Drug Shortage List, But for How Long?
Recent Court Ruling
On March 5, 2025, a U.S. District Court judge denied a motion for a preliminary injunction that would have allowed certain compounding pharmacies to continue producing compounded versions of tirzepatide. The court’s ruling prevents the continued compounding of tirzepatide while the lawsuit is ongoing, but it is important to note that the underlying litigation remains active. As a result of the court ruling, this marks the end of the Food and Drug Administration’s (“FDA”) enforcement discretion as follows:
- Small-scale compounders (i.e. 503A facilities), licensed by individual states and physician compounding, must stop producing compounded tirzepatide immediately.
- Larger-scale federally licensed compounders (503B outsourcing facilities) have until March 19, 2025, to wind down their production and distribution of compounded tirzepatide.
Implications for Health Care Providers
Health care providers should take proactive steps to ensure compliance while maintaining patient care standards.
- Meeting the Standard of Care After March 19, 2025: Clinics currently offering compounded tirzepatide will need to ensure all compounded products used after March 19, 2025 are utilized consistent with the standard of care and will need to discuss with their patients, if and/or when they will offer non-compounded tirzepatide medications.
- Review Patient Consents: Medical practices should update patient consent forms to reflect the transition from compounded tirzepatide to FDA-approved medications. This includes ensuring that patients are fully informed of the changes in their treatment.
- Update Marketing Materials: Practices should review and revise all marketing materials to remove references to compounded tirzepatide. Compliance with advertising and promotional regulations is critical to avoid regulatory scrutiny.
- Transition Patients to FDA-Approved Products: Health care providers should begin transitioning patients to the FDA-approved Mounjaro or Zepbound. This transition process should include counseling patients on the benefits of FDA-approved medications and addressing any concerns related to cost or access.
- Monitor Ongoing Litigation: As the lawsuit continues, additional changes to the legal landscape are possible. Providers should remain vigilant and be prepared to adjust practices based on future legal developments.
For a deeper dive into the compliance and regulatory challenges associated with the medical weight loss industry, listen to our podcast episode: Special: Compliance Considerations for Medical Weight Loss. This episode features industry experts who discuss the rapid growth of medical weight loss treatments and best practices for avoiding regulatory pitfalls.
ByrdAdatto Can Help You Maintain Compliance
Stay up to date with ongoing litigation surrounding weight loss medications and protect your practice. Contact ByrdAdatto for guidance on navigating the complexities of medical weight loss to prioritize patient safety and protect your practice.
