Is Tirzepatide Still in Shortage? FDA Status and Timeline
No. Tirzepatide injection (Mounjaro, Zepbound) came off the FDA drug shortage list on October 2, 2024, and FDA re-confirmed that decision on December 19, 2024. An appeals court upheld the removal on August 27, 2026.
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No, tirzepatide is not in shortage. FDA removed tirzepatide injection products (Mounjaro and Zepbound) from its drug shortage list on October 2, 2024, after confirming with manufacturer Eli Lilly that availability and manufacturing capacity could meet present and projected national demand [1][2][7]. A lawsuit forced FDA to reevaluate that decision, and on December 19, 2024, the agency issued a declaratory order revoking and replacing the October 2 decision while reaching the same conclusion: the tirzepatide shortage is resolved [2][9]. On August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit affirmed FDA’s delisting in full [4].
As of an FDA page dated April 1, 2026, neither tirzepatide nor semaglutide appears on the drug shortage list or on the 503B bulks list [1]. That does not mean every pharmacy always has every dose in stock. FDA has repeatedly acknowledged that patients and prescribers may still see intermittent, localized supply disruptions as products move from the manufacturer through distributors to local pharmacies [1][2].
What is the FDA drug shortage list, and why does a listing matter?
Under the Federal Food, Drug, and Cosmetic Act, a drug shortage is “a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug” (FD&C Act section 506C(h)(2)), and FDA must maintain an up-to-date list of drugs determined to be in shortage (section 506E(a)) [2][4][7]. FDA evaluates supply and demand on a nationwide level, across the entire market, not at the local level [2][7].
The listing matters because of compounding law. Under section 503A, a pharmacy or physician generally may not compound drugs that are essentially copies of a commercially available drug. Under section 503B, an outsourcing facility may not compound with a bulk drug substance unless that substance appears on the 503B bulks list or the drug is on FDA’s shortage list at the time of compounding, distribution, and dispensing [1][5]. The compounding restrictions are temporarily suspended while a drug is on the shortage list; once FDA delisted tirzepatide, compounding copies of it became unlawful, as the Fifth Circuit later put it [4].
When did tirzepatide products go into shortage, and when did the shortage end?
Tirzepatide injection products were first added to the shortage list on December 15, 2022, because of high demand [2][7]. Mounjaro single-dose pens were approved in May 2022 (NDA 215866) and added to the list in December 2022. Zepbound single-dose pens were approved in November 2023 (NDA 217806) and added to the list in April 2024 [2][4].
The vial products were a different story. Mounjaro single-dose vials were approved in July 2023 but are not marketed in the United States and have never been on the shortage list. Zepbound single-dose vials were approved in March 2024; only the 2.5 mg and 5 mg strengths are marketed in the United States, and the vials have never been on the shortage list [2]. Since August 2024, Lilly has sold Zepbound 2.5 mg and 5 mg vials directly to patients with prescriptions through LillyDirect, and in December 2024 Lilly reached an agreement to market the vials through the telehealth platform Ro. Lilly has reported that the vials’ cumulative supply has exceeded cumulative demand [7].
| Date | Event |
|---|---|
| December 15, 2022 | Tirzepatide injection first added to FDA’s drug shortage list [2][7] |
| April 2024 | Zepbound pens added to the shortage list [2][4] |
| October 2, 2024 | FDA removes tirzepatide from the shortage list [1][2][7] |
| October 7, 2024 | Compounders sue FDA in the Northern District of Texas [2][3] |
| October 11, 2024 | Court remands the decision to FDA for reevaluation [2][3] |
| December 19, 2024 | FDA issues declaratory order: shortage resolved [2][9] |
| February 18, 2025 | 503A enforcement-discretion period ends [1][2][7] |
| March 19, 2025 | 503B enforcement-discretion period ends [1][2][7] |
| August 27, 2026 | Fifth Circuit affirms the delisting [4] |
What happened with the October 2024 delisting and the lawsuit?
On October 2, 2024, FDA determined the tirzepatide shortage was resolved after confirming with the manufacturer that stated product availability and manufacturing capacity could meet present and projected national demand [1]. Lilly had stated since August 2, 2024, that it could meet or exceed demand for all strengths of Mounjaro and Zepbound in the United States [7].
Five days later, on October 7, 2024, the Outsourcing Facilities Association and North American Custom Laboratories, LLC (doing business as Farmakeio Custom Compounding) sued FDA in the U.S. District Court for the Northern District of Texas, case No. 4:24-cv-953, challenging the removal [2][3]. On October 11, 2024, on FDA’s own motion, the court remanded the decision to the agency for reevaluation [2][3].
During the reevaluation period, FDA told compounders it would not enforce the shortage-dependent compounding restrictions against them. In an October 17, 2024 letter from Gail Bormel, director of FDA’s Office of Compounding Quality and Compliance, to the head of the Alliance for Pharmacy Compounding, FDA stated it did not intend to take action against any compounder for violations tied to tirzepatide’s shortage-list status during the reevaluation, until two weeks after the agency’s decision or until the court resolved any preliminary injunction motion [3][8]. FDA noted it could still act on other violations, such as findings that a product is of substandard quality or otherwise unsafe [3].
What did the December 19, 2024 order find?
FDA’s declaratory order, backed by a same-day decision memorandum, concluded that Lilly’s supply was meeting or exceeding demand and would continue to do so [2][7]. The analysis rested on Lilly’s data: stock reports showing quantities supplied and demanded and inventory held for all strengths; cumulative 2024 supply and demand figures; projected supply and demand for future months; and wholesaler inventory data [2][7]. FDA concluded that Lilly had reserves in finished product inventory, significant units of semi-finished product, and substantial additional production scheduled [2][7].
FDA also weighed reports from patients, healthcare providers, and compounders, including accounts that some patients and pharmacists could not obtain the approved drugs. The agency acknowledged that some, and even many, individuals had trouble filling prescriptions, and that some may still have been encountering challenges. But it attributed those intermittent problems to the practical dynamics of the supply chain between Lilly and individual customers, including wholesale distributors and retailers, rather than to a continuing national shortage [2][7].
While the products were listed, Lilly spent approximately $23 billion expanding manufacturing capacity in the United States and Europe, according to the Fifth Circuit’s later opinion [4]. A law firm analysis published December 20, 2024 described FDA’s 12-page order as re-confirming the delisting [9].
When did compounders have to stop making tirzepatide?
The December 19, 2024 order gave compounders transition periods so patients would not face abrupt treatment disruption. State-licensed pharmacies and physicians compounding under section 503A had 60 calendar days, until February 18, 2025. Outsourcing facilities under section 503B had 90 days, until March 19, 2025 [1][2][7][9]. FDA stated it could still take action on other statutory or regulatory violations, including quality and safety problems [1][2].
Those deadlines shifted with the litigation. On February 11, 2025, FDA clarified that the periods ran until February 18 or March 19, 2025, or until the date of the district court’s ruling on the plaintiffs’ preliminary injunction motion, whichever was longer [1][8]. The Alliance for Pharmacy Compounding told state boards of pharmacy in a February 17, 2025 memo that the deadlines were not firm; the preliminary injunction motion had been filed January 28 [8]. On March 5, 2025, the district court denied the preliminary injunction, and FDA’s March 10, 2025 update stated that the 503A period had ended and the 503B period would run until March 19, 2025 [1].
For comparison, the semaglutide shortage was declared resolved on February 21, 2025, with enforcement-discretion periods running until April 22, 2025 for 503A compounders and May 22, 2025 for 503B facilities [1].
What did the courts decide, and why?
FDA framed its delisting as an informal adjudication, issuing a declaratory order under 5 U.S.C. 554(e) rather than going through notice-and-comment rulemaking [2][4]. The agency’s stated reason: much of the shortage data it analyzes is the manufacturer’s trade secret or confidential commercial information, exempt from public disclosure under FOIA exemption 4 and protected by the Trade Secrets Act, so it could not be released for public comment [2].
The compounders pressed two arguments on appeal: that FDA should have used notice-and-comment procedures, and that the shortage determination was arbitrary and capricious [4]. The district court denied their preliminary injunction motion, an earlier Fifth Circuit panel affirmed that denial, and the district court later granted summary judgment to FDA and Lilly [4].
On August 27, 2026, a Fifth Circuit panel of Judges Richman, Duncan, and Oldham issued an unpublished per curiam opinion in case No. 25-10600, with Eli Lilly as intervenor-appellee [4]. The court assumed without deciding that FDA erred by skipping notice and comment, but held the compounders had not shown prejudice. It also held the shortage determination was not arbitrary or capricious, and affirmed [4]. A companion case involving semaglutide and Novo Nordisk was before the same panel and was decided in a separate opinion [4].
Why is my pharmacy out of Mounjaro or Zepbound if there is no shortage?
FDA’s order includes a footnote acknowledging that even with the shortage resolved, patients and prescribers may see intermittent localized supply disruptions as products move from the manufacturer to wholesale distributors and pharmacies [2]. The same caveat appears in FDA’s October 2, 2024 announcement and its February 21, 2025 semaglutide post [1].
FDA’s decision memorandum reviewed wholesaler shipment and average daily inventory data by strength, and Lilly stated it has not limited wholesalers’ ability to place orders for any quantities of Mounjaro or Zepbound [7]. In other words, in FDA’s assessment, a stockout at one pharmacy reflects distribution dynamics between Lilly and that store, not a national shortfall. If you cannot fill a prescription, questions about your specific situation and treatment are best directed to your pharmacist or healthcare provider.
Could tirzepatide go back on the shortage list, and what rules apply to compounding now?
FDA has stated it will continue to monitor supply and demand for these products and whether any tirzepatide injection products should be included on the drug shortage list in the future [2][7].
On April 30, 2026, FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. Comments were due by June 29, 2026, and the agency said it will consider submitted comments before making a final determination [5].
For 503A pharmacies, FDA has stated it does not intend to take action against a compounder for compounding an essentially-copy product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that product during a calendar month [1]. FDA’s guidance also allows compounding when a prescriber determines and documents that the compounded product contains a change producing a significant difference for an identified individual patient [1]. Lilly’s exclusivity for tirzepatide extends to 2027 under 21 U.S.C. 355(c)(3)(E)(ii) [4].
How can I check the current shortage status myself?
FDA’s drug shortage list is public at dps.fda.gov/drugshortages [2]. FDA’s compounding policy page carries dated updates running from October 2, 2024 through April 1, 2026, including the current status of tirzepatide and semaglutide [1]. The primary documents behind the delisting are the December 19, 2024 declaratory order and the accompanying decision memorandum [2][7].
Sources
- US Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.
- US Food and Drug Administration. Declaratory order: Resolution of shortages of tirzepatide injection products (Mounjaro and Zepbound). December 19, 2024.
- US Food and Drug Administration. Letter to Scott Brunner, Chief Executive Officer, Alliance for Pharmacy Compounding. October 17, 2024.
- US Court of Appeals for the Fifth Circuit. Outsourcing Facilities Association v. FDA, No. 25-10600. August 27, 2026.
- US Food and Drug Administration. FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list.
- US Food and Drug Administration. Drug shortages database entry for tirzepatide injection.
- US Food and Drug Administration. Resolution of tirzepatide injection product shortage and supply status. December 19, 2024.
- Alliance for Pharmacy Compounding. Memo to state boards of pharmacy: Clarification on tirzepatide injection shortage and FDA enforcement discretion. February 17, 2025.
- Foley & Lardner. GLP-1 drugs: FDA “re-confirms” decision removing tirzepatide from the drug shortage list. December 20, 2024.
Frequently asked questions
Is Mounjaro still on the FDA shortage list?
No. Tirzepatide injection products, including Mounjaro, were removed from FDA's drug shortage list on October 2, 2024, and FDA re-confirmed the resolution on December 19, 2024 after a court-ordered reevaluation. An FDA page dated April 1, 2026 states tirzepatide does not appear on the shortage list or the 503B bulks list.
Is Zepbound in shortage in 2026?
No. Zepbound pens were removed from the shortage list along with other tirzepatide injection products on October 2, 2024, and the Fifth Circuit affirmed that delisting on August 27, 2026. Zepbound single-dose vials were never on the shortage list at all.
When exactly did the tirzepatide shortage end?
FDA first declared the shortage resolved on October 2, 2024. After a lawsuit and a court remand, FDA revoked that decision and issued a new declaratory order on December 19, 2024 again determining the shortage was resolved. That order is the operative decision.
Is compounded tirzepatide still legal?
The delisting made compounding copies of tirzepatide unlawful, as the Fifth Circuit put it, and the enforcement-discretion transition periods ended on February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities. FDA has stated it does not intend to act against a 503A compounder filling four or fewer prescriptions of an essentially-copy product per calendar month, and prescriber-documented significant differences are also recognized.
Why is my pharmacy out of Mounjaro if there is no shortage?
FDA evaluates shortages nationwide, not store by store. The agency has acknowledged that even with the shortage resolved, patients may see intermittent localized supply disruptions as products move from the manufacturer through distributors to local pharmacies. FDA attributed such gaps to supply-chain dynamics, not a national shortfall.
Were Zepbound vials ever in shortage?
No. Zepbound single-dose vials were approved in March 2024, and only the 2.5 mg and 5 mg strengths are marketed in the United States. The vial products have never been on FDA's shortage list. Lilly has sold them through LillyDirect since August 2024 and reported cumulative supply exceeding demand.
Is semaglutide still in shortage?
No. FDA determined the semaglutide injection shortage was resolved on February 21, 2025, with enforcement-discretion periods ending April 22, 2025 for 503A compounders and May 22, 2025 for 503B facilities. An FDA page dated April 1, 2026 states semaglutide is not on the shortage list or the 503B bulks list.
What did the Fifth Circuit decide in August 2026?
On August 27, 2026, in Outsourcing Facilities Association v. FDA, No. 25-10600, a Fifth Circuit panel affirmed FDA's delisting. It assumed without deciding that skipping notice-and-comment procedures was an error but found no prejudice, and it held the shortage determination was not arbitrary or capricious. A companion semaglutide case was decided separately.
This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.