The FDA GLP-1 shortage list lawsuits ended in wins for the agency at the district court level, and both are now pending on appeal at the Fifth Circuit. In two suits brought by the Outsourcing Facilities Association in the Northern District of Texas, Judge Mark Pittman upheld the FDA’s decisions to declare the tirzepatide and semaglutide shortages resolved, cleared the way for the phase-out deadlines to take effect, and dismissed the semaglutide case with prejudice. The OFA has appealed both judgments.
Why Removal From the Shortage List Was the Whole Fight
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act generally bar compounding pharmacies and outsourcing facilities from making drugs that are “essentially a copy” of a commercially available, FDA-approved product. The exception is section 506E: while a drug sits on the FDA shortage list, it is not treated as “commercially available,” and compounders can make copies at scale.1FDA. Compounding When Drugs Are on the FDA’s Drug Shortages List
When the FDA takes a drug off the list, that exception disappears. 503A pharmacies must stop immediately; 503B outsourcing facilities get a short wind-down to fill existing orders.2FDA. For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B After that, compounding is only permissible where a specific patient needs a formulation with a documented clinical difference from the approved product. Price is not a clinical difference.
That mattered enormously for GLP-1s. Semaglutide had been in shortage since March 2022 and tirzepatide for more than two years, and a large compounding industry serving telehealth platforms had grown up around them.3BioPharma Dive. Novo Nordisk Semaglutide Shortage, Doses Available in US4American Bar Association. FDA Removes Tirzepatide Injection From Shortage List Semaglutide prescriptions rose 442% between January 2021 and December 2023.5Medical Economics. Semaglutide’s Removal From the FDA Shortages List Sets the Stage for More Novo Nordisk Lawsuits Ending the shortages cut off that supply chain.
The Tirzepatide Case
The OFA and FarmaKeio Superior Custom Compounding sued in October 2024 in the Northern District of Texas, Fort Worth Division. The case (4:24-cv-00953) was assigned to Judge Mark Pittman. The FDA had declared the tirzepatide shortage resolved on December 19, 2024, and set phase-out deadlines of February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities.4American Bar Association. FDA Removes Tirzepatide Injection From Shortage List
In January 2025, the court allowed Eli Lilly to intervene as a defendant.6Fierce Pharma. FDA Obesity Drug Battle: Texas Court Allows Novo Nordisk to Weigh In Judge Pittman denied the OFA’s preliminary injunction on March 5, 2025.7Foley & Lardner. Compounded GLP-1 Drugs: Texas Judge Denies PI Motion The OFA filed an interlocutory appeal five days later, then voluntarily dismissed it after the district court expedited summary judgment.
On May 6, 2026, Judge Pittman granted summary judgment for the FDA, upholding the removal of tirzepatide from the shortage list.8Reuters. US Judge Sides With FDA’s Removal of Lilly’s Weight Loss Drug From Shortage List9Courthouse News Service. OFA v. FDA Appellants Brief10PACER Monitor. Outsourcing Facilities Association et al v. United States Food and Drug Administration et al
The Semaglutide Case
On February 21, 2025, the FDA issued a Declaratory Order ending the semaglutide shortage, finding that Novo Nordisk could meet projected demand. The agency acknowledged that “significant compounding of semaglutide injection products is occurring” but concluded the record did not show Novo Nordisk would be unable to supply the market.11Fortune. Novo Nordisk Wegovy Ozempic Semaglutide GLP-1 Shortage Declared Over Novo Nordisk had reported $6.5 billion in U.S. manufacturing investments in 2025 to expand capacity. The FDA set grace periods of 60 days for 503A pharmacies (through April 22, 2025) and 90 days for 503B facilities (through May 22, 2025).12FDA. FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
Three days later, on February 24, 2025, the OFA and North American Custom Laboratories sued (Case No. 4:25-cv-00174).13Cardiovascular Business. FDA Sued Over Semaglutide Drug Shortage List They called the removal “arbitrary, capricious, and contrary to law,” alleged the FDA “acted to benefit special interests,” and argued the decision would “deprive patients of a vital treatment for type 2 diabetes, obesity, cardiovascular disease and other serious medical conditions.” A key legal theory was that the removal was a “rule” under the Administrative Procedure Act requiring notice-and-comment rulemaking that never happened.
The case was assigned briefly to Judge Reed O’Connor and then transferred to Judge Pittman. Novo Nordisk intervened without opposition on March 5, 2025.6Fierce Pharma. FDA Obesity Drug Battle: Texas Court Allows Novo Nordisk to Weigh In The court denied the OFA’s preliminary injunction on April 24, 2025, in an opinion initially filed under seal.5Medical Economics. Semaglutide’s Removal From the FDA Shortages List Sets the Stage for More Novo Nordisk Lawsuits The removal took effect April 28, 2025.
On June 13, 2025, Judge Pittman granted summary judgment to the FDA and Novo Nordisk, finding the agency had “properly determined that a national semaglutide shortage was resolved.”14Aimed Alliance. Litigation Case Law Tracker The case was dismissed with prejudice on June 17, 2025, and the OFA filed a notice of appeal the same day.15The Hill. FDA Ozempic Wegovy Drug Shortage List The appeal (No. 25-10758) remains pending at the Fifth Circuit.16PACER Monitor. Outsourcing Facilities Association et al v. Food and Drug Administration et al
What the Court Rejected
Judge Pittman’s summary judgment ruling in the semaglutide case explains why the OFA’s core arguments fell short. The judge found it reasonable for the FDA to discount a survey submitted by Hims & Hers, because the survey lacked verification of participant numbers and its definition of “inability to access” the drugs was unclear.15The Hill. FDA Ozempic Wegovy Drug Shortage List
He also wrote that the OFA appeared to have “misread the record they were citing multiple times” when it argued Novo Nordisk had acknowledged compounded drugs satisfied 20 percent of the market, describing this as part of a “consistent and pervasive pattern of similar mistakes.” The judge held it was not arbitrary for the FDA to disregard a 10-page chart the plaintiffs submitted because it had not been part of the administrative record when the agency made its decision. Together, those findings gutted the APA challenge that formed the backbone of the case.
Related Litigation Reshaping the Same Market
The shortage-list rulings are only one piece of what compounders now face. Eli Lilly has run a parallel litigation campaign, suing Strive Pharmacy and Empower Pharmacy on April 1, 2025 over what it called “mass producing altered versions of tirzepatide” falsely marketed as personalized and clinically tested.17CNBC. Eli Lilly Sues Strive and Empower Over Compounded Tirzepatide The Strive case was dismissed without prejudice on October 8, 2025 for lack of personal jurisdiction over the Arizona-based pharmacy.18U.S. District Court for the District of Delaware. Eli Lilly v. Strive Pharmacy, No. 1:25-cv-00401-SB The Empower case was partially dismissed in April 2026, with some claims proceeding.19Endpoints News. Court Dismisses Part of Lilly Lawsuit Against Empower; Some Claims Can Proceed
Lilly also sued four telehealth companies in California federal courts on April 23, 2025: Mochi Health, Willow Health, Fella Health and Delilah, and Henry Meds. The complaints described reformulations that added ingredients like niacinamide, unapproved oral versions, and improper references to Lilly’s clinical trials.20NPR. Eli Lilly Sues Companies Selling Alternative Versions of Its Weight Loss Drug In April 2026, a California federal court largely denied Mochi’s motion to dismiss, letting Lanham Act and California Unfair Competition Law claims proceed while trimming a civil conspiracy count.21Courthouse News Service. Eli Lilly v. Mochi Health, Order on Motion to Dismiss
Novo Nordisk took a different route with Hims & Hers, filing a patent infringement suit on February 9, 2026 in the District of Delaware (1:26-cv-00143-CFC) over U.S. Patent No. 8,129,343, which does not expire until 2032.22STAT News. Novo Sues Hims, Infringing Wegovy Patent By March 2026 the parties settled: Novo dropped the case, and Hims & Hers agreed to sell Novo’s branded semaglutide products at standard telehealth pricing, stop mass marketing of compounded GLP-1s, limit compounded prescriptions to rare FDA-compliant cases, and transition existing patients to approved medicines when clinically appropriate.23CNBC. Novo Nordisk Ends Legal Proceedings With Hims and Hers Over Compounded Weight Loss Drugs
The Proposed 503B Bulks List Exclusion
On April 30, 2026, the FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list. If finalized, outsourcing facilities would be permanently barred from compounding these drugs from bulk active pharmaceutical ingredients unless the drugs return to the shortage list.24FDA. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide From the 503B Bulks List The agency said it “did not identify sufficient evidence” of a clinical need for outsourcing facilities to compound these drugs when approved versions are available. Comments on the proposed rule (Federal Register notice 2026-08552) close June 29, 2026.25Orrick. FDA Moves to Shut the Door on Large-Scale Compounding of GLP-1 Drugs A win for the OFA on appeal would not undo this rule if it is finalized.
What Compounding Is Still Allowed
The rulings did not eliminate all GLP-1 compounding. 503A pharmacies can still compound semaglutide or tirzepatide when there is documented, individualized medical necessity for a specific patient. Preference and cost savings do not count. The FDA has also indicated it will not pursue compounders who fill four or fewer prescriptions of an “essentially a copy” product per calendar month. Enforcement discretion beyond that ended March 19, 2025 for tirzepatide, April 22, 2025 for semaglutide 503A pharmacies, and May 22, 2025 for semaglutide 503B facilities.12FDA. FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
The FDA has followed through with warning letters. In September 2025 it wrote to a Germany-based entity, GLP-1 Solution, over false claims implying equivalence to Ozempic and Mounjaro.26FDA. Warning Letter: GLP-1 Solution In March 2026 it issued 30 warning letters in a single batch to telehealth companies over “false or misleading claims” about compounded GLP-1s.27FDA. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s Commissioner Marty Makary said “compounded drugs can be important for overcoming shortages or meeting unique patient needs — but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”
For now, the district courts have sided with the FDA, the shortage-list removals stand, and the fate of large-scale GLP-1 compounding turns on the Fifth Circuit appeals and the outcome of the proposed 503B bulks list rule.