Is Tirzepatide Still in Shortage? The Full Mounjaro and Zepbound Timeline

Short answer: no. Tirzepatide has not been on the FDA drug shortage list since October 2, 2024. The agency reconsidered that decision under legal pressure, then reaffirmed it in a formal order on December 19, 2024, and two federal courts have now upheld it.

But “not in shortage” and “always available at your pharmacy” are different things, and the gap between them is where most of the confusion lives. This page walks through the whole timeline, explains why a two-year listing mattered so much, and separates a national shortage from the local stock problem you might be dealing with this week.

What does the FDA drug shortage list actually do?

The FDA is required by law to keep an up-to-date list of drugs it has determined are in shortage. The statute defines a shortage as a period when demand or projected demand for a drug in the United States exceeds its supply [2].

Two things follow from a listing that matter to ordinary patients.

First, the agency starts working with the manufacturer on supply. Second, and far more visibly in the GLP-1 story, a listing switches on a set of exemptions in the compounding law. Under section 503A of the Federal Food, Drug, and Cosmetic Act, a pharmacy generally may not compound a drug that is essentially a copy of a commercially available product. Under section 503B, an outsourcing facility generally may not use a bulk drug substance unless it is on an approved list, or unless the drug made from it is on the shortage list at the time of compounding [1].

While tirzepatide was listed, both of those gates were open. That is why compounded tirzepatide became a national retail business almost overnight, and why the delisting was such a high-stakes event.

When did tirzepatide go into shortage?

December 15, 2022. FDA’s December 2024 declaratory order states that tirzepatide injection products were first added to the drug shortage list on that date, because of high demand [2]. Mounjaro had launched about seven months earlier.

There is a detail here that matters for anyone evaluating claims about supply. The listing covered the pre-filled single-dose pens. FDA’s order notes that Mounjaro single-dose vials were approved in a supplement in July 2023 but are not marketed in the United States and have never been on the shortage list. It also notes that Zepbound’s pre-filled pens were added to the shortage list in April 2024 because of high demand, while Zepbound single-dose vials, approved in March 2024, have never been on the list at all [2].

So even at the peak of the tirzepatide shortage, a legally available, FDA-approved vial presentation of tirzepatide existed.

When did the shortage end?

October 2, 2024, the first time. The FDA posted that it had determined the shortage of tirzepatide injection was resolved, having confirmed with Lilly that stated product availability and manufacturing capacity could meet present and projected national demand. In the same post, the agency reminded compounders of the legal restrictions on making copies of FDA-approved drugs [1].

Tirzepatide was the first of the major GLP-1 medicines to come off the list. Semaglutide stayed on it until February 2025.

Five days later, on October 7, 2024, the Outsourcing Facilities Association and North American Custom Laboratories, doing business as FarmaKeio Custom Compounding, sued the FDA in the US District Court for the Northern District of Texas [2]. On October 11, 2024, on the agency’s own unopposed motion, the court remanded the decision back to the FDA for reevaluation [2].

That remand left everyone in limbo. On October 17, 2024, the director of the FDA’s Office of Compounding Quality and Compliance wrote to the Alliance for Pharmacy Compounding about the agency’s intended approach during the reevaluation. Compounding trade groups read the letter as enforcement discretion, meaning FDA did not intend to act against compounders making tirzepatide copies for the duration of the preliminary injunction phase, as long as every other condition of section 503A was met [3][8].

What did the December 19, 2024 order say?

The FDA came back with a document that looks nothing like a website update. The declaratory order revokes and replaces the October 2 decision and again finds the shortage resolved, but it spends most of its pages explaining the agency’s legal method [2].

The core finding is straightforward. FDA concluded that the data Lilly provided, covering stock reports, quantities supplied and demanded, wholesaler inventory and projected demand, showed supply currently meeting or exceeding demand, with reserves in finished inventory, significant semi-finished product, and substantial additional production scheduled [2].

The agency also addressed, directly, the reports it had received from patients, pharmacists and compounders saying the approved drugs were still hard to get. Its answer is worth quoting in substance: FDA said those reports are not inconsistent with national supply meeting demand, and that intermittent problems of that kind are most likely explained by “the practical dynamics of the portion of the supply chain between Lilly and the individual customers, including wholesale distributors and retailers,” rather than a continuing national shortage [2].

The order then did something the October decision had not. It set explicit wind-down dates for compounders:

• February 18, 2025 for state-licensed pharmacists or physicians compounding under section 503A, 60 calendar days from the order.
• March 19, 2025 for outsourcing facilities under section 503B, 90 calendar days from the order [2].

Law firm analyses published the following day described the December order as the FDA “re-confirming” the delisting on a far sturdier record than the October posting [9].

A large chunk of the document argues that shortage determinations are informal adjudications under the Administrative Procedure Act rather than rulemaking. FDA’s practical reason is blunt: much of the information it relies on is the manufacturer’s trade secret and confidential commercial information, which it is legally barred from publishing, so it cannot run a notice-and-comment process that would require exposing the data [2]. That argument is exactly what the compounders challenged in court.

What happened in court?

The litigation moved fast and went against the compounders at every stage.

On February 11, 2025, with the 503A deadline days away, the FDA posted a clarification: the enforcement windows ran to February 18 and March 19, 2025 respectively, or to the date of the district court’s decision on the preliminary injunction motion, whichever was longer [1].

On March 5, 2025, the district court denied that motion [1]. Five days later the FDA confirmed that, consistent with its February update, the 503A period had ended and the 503B period would close on March 19, 2025 [1]. On May 7, 2025, the court granted summary judgment for the FDA on the merits.

On August 27, 2026, the US Court of Appeals for the Fifth Circuit affirmed in an unpublished per curiam opinion, No. 25-10600. The panel described the two arguments squarely: that the FDA should have proceeded through notice-and-comment rulemaking, and that its shortage determination was arbitrary and capricious. It rejected both. Eli Lilly appears in the caption as intervenor-appellee alongside the FDA [4]. A companion opinion in the semaglutide case followed on September 1, 2026.

So why is my pharmacy out of Mounjaro?

This is the question that sends most people to this page, and the honest answer is that a resolved national shortage does not guarantee your specific dose is on your specific pharmacy’s shelf this week.

The FDA anticipated exactly that. A footnote in the December 2024 order says: “Notwithstanding resolution of the shortage, FDA understands that patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer to wholesale distributors and pharmacies” [2].

Practical things that can cause a local gap without a national shortage include wholesaler allocation, a single dose strength moving faster than others, a pharmacy’s ordering cycle, and prescription volume spikes in one area. None of those put a drug back on the FDA list.

If you are hitting a wall, the things within your control are calling ahead to other pharmacies, asking the prescribing office whether they have supply information, and checking the FDA Drug Shortages database yourself, which is free and public [6]. What dose to take, or whether to change anything about treatment, is a question for a healthcare provider, not a website.

Could tirzepatide go back into shortage?

Yes, in principle. The FDA states in the order that it will continue to monitor supply and demand and whether any tirzepatide injection products should be included on the shortage list in future [2].

But relisting would no longer automatically reopen the compounding floodgates the way it did in 2022. On April 30, 2026 the FDA proposed placing semaglutide, tirzepatide and liraglutide in the “do not include” category of the 503B bulks list [5]. If that proposal is finalized in that form, outsourcing facilities would be barred from using tirzepatide bulk substance regardless of shortage status. The comment docket closed on June 29, 2026, and the FDA said it would consider the comments before making a final determination. As of September 14, 2026, no final determination had been published.

How do I check the current status myself?

Three sources, all free:

1. FDA Drug Shortages database at dps.fda.gov, the official list. The tirzepatide injection entry sits under resolved shortages [6].
2. FDA’s compounding policy page, which carries a dated running log of every tirzepatide and semaglutide milestone from October 2024 onward [1].
3. The December 2024 declaratory order and decision memorandum, if you want the underlying reasoning rather than a summary [2][7].

If a telehealth site tells you tirzepatide is “in shortage” and uses that to justify selling a compounded version, check the FDA database before you believe it. As of September 14, 2026 that claim is not accurate.

Sources

1. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize — FDA
2. Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products, December 19, 2024 — FDA
3. Letter from CDER Office of Compounding Quality and Compliance, October 17, 2024 — FDA
4. Outsourcing Facilities Association v. FDA, No. 25-10600 — US Court of Appeals for the Fifth Circuit
5. FDA Proposes to Exclude Semaglutide, Tirzepatide and Liraglutide from the 503B Bulks List — FDA
6. Drug Shortages database entry, tirzepatide injection — FDA
7. Resolution of Tirzepatide Injection Product Shortage and Supply Status decision memorandum — FDA
8. Memo to state boards of pharmacy on tirzepatide shortage and enforcement discretion — Alliance for Pharmacy Compounding
9. FDA re-confirms decision removing tirzepatide from the drug shortage list — Foley & Lardner