Judge upholds FDA removal of Mounjaro and Zepbound from shortage list

A federal judge in Texas ruled on May 7, 2025 that the FDA acted within its authority when it removed tirzepatide injection products — the diabetes drug Mounjaro and the obesity drug Zepbound — from the agency's drug shortage list, rejecting a challenge from compounding pharmacies and outsourcing facilities ^[3][4]. The Fifth Circuit later affirmed that outcome ^[1][5].

The FDA declared the tirzepatide shortage resolved on October 2, 2024, then reversed course three weeks later after the Outsourcing Facilities Association sued and public pressure mounted. The agency remanded the decision to itself for reevaluation and confirmed on December 19, 2024 that the shortage was resolved, concluding that Eli Lilly's supply would "meet or exceed projected demand" ^[1][2][5]. The agency has treated tirzepatide injection products as available since then ^[4].

Mounjaro was approved in May 2022 and Zepbound in November 2023, both as pre-filled, single-dose pens. Mounjaro went on the shortage list in December 2022 and Zepbound in April 2024 ^[1]. While a drug is on that list, federal law temporarily suspends a ban on compounding drugs that are "essentially copies" of approved products, which allowed pharmacies and outsourcing facilities to make tirzepatide copies ^[1][2]. Those compounded copies sold for substantially less than the brand-name products, according to STAT ^[3].

The compounders argued the FDA should have used formal notice-and-comment rulemaking and that its shortage determination was arbitrary and capricious ^[1][5]. The district court rejected both arguments, concluding the FDA did not abuse its discretion by proceeding through adjudication and that its treatment of the submitted evidence was reasonable ^[1]. The court also found the plaintiffs had not shown sufficient harm to warrant judicial intervention ^[4].

The Outsourcing Facilities Association and North American Custom Laboratories, doing business as FarmaKeio Custom Compounding, maintained that the FDA relied solely on Lilly's statements even though patients still had trouble getting the drugs ^[3]. In its August 27, 2026 opinion, the Fifth Circuit said the compounders had actual notice and a real chance to weigh in — the reevaluation period ran nearly 60 days, double the Administrative Procedure Act's standard comment window — so any procedural misstep was harmless. On the merits, the panel said the FDA reasonably relied on Lilly's supply data, which showed an 11.6 million-dose surplus by November 2024 after about $23 billion in manufacturing investment, over less reliable evidence such as wholesaler screenshots and patient surveys ^[5]. The appeals court assumed, without deciding, that the FDA erred on notice and comment but found the compounders had not met their burden to show prejudice ^[1].

Why it matters for patients

With tirzepatide off the shortage list, compounding pharmacies, outsourcing facilities and providers generally cannot rely on the shortage exception to compound "essentially copies" of tirzepatide injections ^[4]. Under FDA guidance, a compounded product is essentially a copy if it contains the same active ingredient in the same, similar or easily substitutable strength and is given by the same route as the commercially available product ^[2]. The FDA has said it does not intend to take action against a compounder that fills four or fewer prescriptions of such a compounded product in a calendar month ^[2]. Tirzepatide and semaglutide appear on neither the 503B bulks list nor the shortage list ^[2].

The FDA's periods of enforcement discretion for tirzepatide ended February 18, 2025 for state-licensed pharmacies and physicians under section 503A and March 19, 2025 for outsourcing facilities under section 503B ^[2][4]. The agency says it may still act on other violations, such as products that may be substandard or unsafe ^[2]. Attorneys at McDermott Will & Schulte wrote that the decision clears the way for increased enforcement against noncompliant compounding practices ^[4]. It has not been disclosed what patients who were buying compounded tirzepatide now pay, or how many have moved to brand-name products.

What happens next

A parallel case over Novo Nordisk's semaglutide products, filed in February 2025, is pending before the same Fifth Circuit panel ^[5]. The FDA determined semaglutide's shortage was resolved on February 21, 2025, with enforcement discretion ending April 22, 2025 for 503A compounders and May 22, 2025 for 503B outsourcing facilities ^[2]. Lilly's exclusivity on tirzepatide products extends to 2027 ^[1].