Eli Lilly has taken another firm legal stance against compounding pharmacies producing unapproved versions of its blockbuster weight-loss and diabetes drugs, Mounjaro and Zepbound (tirzepatide). On April 1, 2025, the pharmaceutical giant filed lawsuits against two mass compounders–Strive Pharmacy LLC and Empower Clinic Services LLC–accusing them of selling unapproved versions of tirzepatide and making false claims about the safety and efficacy of their compounded products.
Background: Compounders and Tirzepatide Shortages
Compounding pharmacies were previously permitted to produce and sell tirzepatide-based formulations under a temporary FDA allowance due to drug shortages. However, a U.S. federal judge recently ruled that compounders could no longer manufacture these drugs, reinforcing the position that only FDA-approved versions of the medication should be sold in the U.S.
Despite this ruling, Lilly has continued to see a proliferation of unauthorized versions of tirzepatide, prompting legal action. The lawsuits against Strive and Empower are part of a broader crackdown, which has already included more than two dozen medical spas, wellness centers, and compounding pharmacies.
The Allegations Against Strive and Empower
Lilly’s complaint highlights specific concerns about how these compounders are marketing their products:
- Strive Pharmacy LLC: Allegedly sells compounded tirzepatide with vitamin B12 or glycine, implying that these additions enhance safety and efficacy compared to FDA-approved versions.
- Empower Clinic Services LLC: Offers compounded tirzepatide as both an oral pill and an injectable with vitamin B3, allegedly citing Lilly’s clinical studies to falsely suggest comparable effectiveness.
The lawsuits were filed in different federal courts, with the complaint against Strive in Delaware and against Empower in New Jersey.
A Broader Enforcement Effort
Beyond these lawsuits, Lilly has announced plans to send approximately 50 cease-and-desist letters to other compounding pharmacies and telehealth providers. These letters demand confirmation that they have ceased unauthorized mass compounding of tirzepatide-based products.
What This Means for Medical Spas and Wellness Centers
For medical spas and wellness centers that have been selling or considering offering compounded weight-loss medications, this case serves as a stark warning: the FDA’s regulatory stance and Lilly’s aggressive litigation actions make it clear that offering non-FDA-approved versions of tirzepatide carries significant legal risk. Businesses should carefully review their weight-loss medication offerings to ensure full compliance with FDA regulations and avoid potential litigation.
As the landscape around weight-loss drugs continues to evolve, staying informed and compliant is crucial for any healthcare or wellness provider. If you have questions about the legal implications of offering weight-loss treatments in your practice, consulting with a healthcare attorney can help you navigate these complex regulatory issues.