District court denies the compounders' preliminary injunction on tirzepatide

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied a preliminary injunction motion filed by compounders in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 (N.D. Tex.) ^[1]. The ruling left tirzepatide — the active ingredient in Eli Lilly's Mounjaro and Zepbound — off the FDA's drug shortage list, and locked in the agency's timeline for winding down large-scale compounded copies of the drug ^[1].

FDA posted a timeline update five days later, on March 10, 2025. It said that for state-licensed pharmacies and physicians compounding under section 503A of the Food, Drug, and Cosmetic Act, the period of enforcement discretion had already ended ^[1]. For outsourcing facilities operating under section 503B, FDA said it did not intend to take action for violations arising from conditions that depend on tirzepatide's inclusion on the shortage list until March 19, 2025 ^[1]. Those dates came from FDA's December 19, 2024 decision, which gave 503A compounders 60 days and 503B outsourcing facilities 90 days to adjust ^[1].

How the case got here

FDA added Mounjaro to its shortage list in December 2022 and Zepbound in April 2024 ^[2]. While the drugs were listed, compounders could make versions that would otherwise be barred as "essentially copies" of an approved drug ^[2]. FDA declared the tirzepatide shortage resolved on October 2, 2024, then agreed to a voluntary remand after the Outsourcing Facilities Association sued, and reaffirmed the delisting on December 19, 2024 ^[1][2][4]. The agency concluded Lilly's supply would "meet or exceed projected demand" after the company spent roughly $23 billion expanding manufacturing capacity ^[2].

The compounders argued FDA should have used notice-and-comment rulemaking and that the shortage determination was arbitrary and capricious ^[2][4]. The district court found they were unlikely to succeed on the merits, saying the regulatory scheme is "seemingly silent" on what procedure FDA must use for shortage determinations and that FDA "did not abuse its discretion by choosing to proceed through adjudication" ^[2].

Why it matters for patients

Many people have been getting compounded tirzepatide, often through telehealth platforms, at prices below the brand-name products. The March 5 ruling meant the legal basis for that supply was ending on schedule rather than being paused by a court ^[1][3]. After March 19, 2025, outsourcing facilities lost the general protection from FDA enforcement that applied during the discretionary period, and compounders generally could no longer rely on the shortage exception to make essentially copies of tirzepatide injections ^[3].

Compounding did not become impossible overnight in every case. Compounders can still make products that are not essentially copies — for example, a product that is not the same, similar or easily substitutable strength, or that uses a different route of administration — or where a prescriber documents a significant difference for an individual patient ^[1][3]. FDA has also said it does not intend to act against a compounder that fills four or fewer prescriptions of an essentially-copy product in a calendar month ^[1]. What none of the sources address is how individual pharmacies or telehealth sellers actually changed their offerings, or what any of this cost patients.

What happens next

Semaglutide followed a parallel track. FDA declared the semaglutide injection shortage resolved on February 21, 2025, with enforcement discretion running until April 22, 2025 for 503A compounders and May 22, 2025 for 503B outsourcing facilities, or the date of a district court ruling on a new injunction motion in OFA v. FDA, 4:25-cv-00174, whichever was later ^[1]. That motion was denied on April 24, 2025 ^[1].

On May 7, 2025, the same district court upheld FDA's removal of the two tirzepatide products from the shortage list ^[3]. The Fifth Circuit affirmed on August 27, 2026, finding any procedural misstep harmless and the shortage determination not arbitrary or capricious ^[2][4]. Court documents cited Lilly supply data showing an 11.6 million-dose surplus by November 2024 ^[4]. As of that ruling, a parallel semaglutide appeal was still pending before the same panel ^[4]. Neither tirzepatide nor semaglutide currently appears on FDA's 503B bulks list or its drug shortage list ^[1].