Compounders just lost their case to put obesity drug tirzepatide back in shortage

# Tirzepatide Compounding Legal Battle Concluded:
FDA Decision Upheld

A court has ruled in favor of the FDA, denying an injunction on tirzepatide compounding
FDA removed tirzepatide from the drug shortage list in December 2024
March 19, 2025 was set as the deadline for compounders to stop producing tirzepatide
Eli Lilly has sued four telehealth providers for continuing to sell compounded versions
The case involved the Outsourcing Facilities Association (OFA) challenging the FDA's decision

The legal battle over compounded versions of the popular weight-loss drug tirzepatide has reached a conclusion, with compounders losing their case to have the medication placed back on the FDA's drug shortage list. This ruling effectively affirms the FDA's December 2024 decision that the shortage of tirzepatide injection has been resolved13.

Background of the Dispute

The FDA had determined in October 2024 that tirzepatide, a glucagon-like peptide 1 (GLP-1) medication marketed as Zepbound for weight loss and Mounjaro for diabetes, was no longer in shortage. The agency confirmed with the manufacturer, Eli Lilly, that their "product availability and manufacturing capacity can meet the present and projected national demand"1.

This determination was contested by the Outsourcing Facilities Association (OFA), which filed a lawsuit challenging the FDA's decision. The OFA argued that removing tirzepatide from the shortage list unfairly restricted compounders' ability to produce versions of the drug3.

Court Decision and Enforcement

In March 2025, a Texas judge denied both a preliminary injunction motion and a request to stay the FDA's enforcement actions regarding tirzepatide compounding4. This ruling effectively supported the FDA's position and allowed the agency to enforce its March 19, 2025 deadline, after which compounders would be legally barred from producing and distributing knockoff versions of tirzepatide24.

Eli Lilly's Legal Actions

Following the FDA's determination and the court ruling, Eli Lilly has taken aggressive legal action against entities still producing compounded versions of tirzepatide. In April 2025, the pharmaceutical company sued four telehealth providers for "promoting and selling compounded versions" of the drug2.

A Lilly spokesperson noted that while many compounders have ceased operations following the FDA's decision, "some bad actors have not" complied with the regulations. The company accused these telehealth platforms of "putting patients at risk by engaging in dangerous, deceptive, and unlawful practices"2.

Regulatory Implications

The FDA has reminded compounders of the legal restrictions on making copies of FDA-approved drugs. The agency emphasized that compounded drugs are not FDA-approved and have not undergone the same rigorous safety, effectiveness, and quality reviews as part of the premarket approval process1.

This case has fundamentally altered the regulatory landscape for compounding under section 503A of the Federal Food, Drug, and Cosmetic Act, particularly regarding medications that were previously in shortage but are now adequately supplied by their manufacturers5.

Sources:

1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

2. https://www.biospace.com/policy/lilly-takes-four-compounders-to-court-for-allegedly-producing-knockoff-tirzepatide

3. https://www.onthepen.com/post/a-legal-twist-in-the-tirzepatide-shortage-saga

4. https://natlawreview.com/article/compounded-glp-1-drugs-texas-judge-denies-pi-motion-and-request-stay-fdas

5. https://www.bipc.com/tirzepatide-fda-and-compounding-understanding-the-current-landscape