Background: FDA's Removal of Tirzepatide from Shortage List

In late 2024, the U.S. Food and Drug Administration (FDA) removed tirzepatide—the active ingredient in Eli Lilly's weight-loss drug Zepbound and diabetes medication Mounjaro—from its drug shortage list. This action effectively prohibited compounding pharmacies from producing their own versions of these medications, as federal regulations allow such compounding only when there is a documented shortage of the drug. ​

Legal Challenge by Compounding Industry

In response, the Outsourcing Facility Association (OFA), representing compounding pharmacies, filed a lawsuit challenging the FDA's decision. The OFA argued that tirzepatide remained in short supply and sought a preliminary injunction to continue compounding the drug while the case proceeded. ​

Court's Decision: Injunction Denied

On March 5, 2025, U.S. District Judge Mark Pittman denied the OFA's request for a preliminary injunction. This ruling supports the FDA's authority to regulate drug compounding practices and maintains the prohibition on producing compounded versions of tirzepatide without an active shortage designation. ​

Implications for Compounding Pharmacies

As a result of the court's decision, smaller compounding pharmacies, primarily regulated by individual states, must immediately cease the production of tirzepatide copies. Larger outsourcing facilities, overseen by the FDA, have been granted until March 19 to comply. ​

Industry Reactions

The OFA expressed surprise and disappointment at the ruling, stating they are considering their legal options moving forward. Eli Lilly welcomed the decision, emphasizing that it "marks the end of the road for mass compounding" of its drugs and that the company will collaborate with regulators and law enforcement to prevent the sale of unauthorized copies.

Broader Context: Ongoing Legal Battles

This ruling is part of a broader legal landscape where pharmaceutical companies are actively protecting their products from unauthorized compounding. Novo Nordisk, for instance, has intervened in similar lawsuits concerning its weight-loss drugs, highlighting the industry's concerted efforts to safeguard intellectual property and ensure patient safety. ​

Conclusion

The court's decision underscores the FDA's regulatory authority over drug compounding practices and reinforces the importance of adhering to established guidelines to ensure the safety and efficacy of medications available to patients.​

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