When Did the Tirzepatide Shortage End? The Dates

When did the tirzepatide shortage end? The FDA first said so on October 2, 2024, two years ago this week, when it announced that tirzepatide injection, the drug in Mounjaro and Zepbound, was no longer in national shortage. Compounders challenged that in court, so the agency looked again and confirmed it on December 19, 2024. The grace periods for pharmacies making copies ran out in March 2025.

So October 2 is when the shortage was first declared over, and December 19 is the decision that stands today.

The document: the FDA's October 2, 2024 notice

It sits on an FDA page the agency kept updating for the next year and a half, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. The entry is dated 10/02/2024 and opens plainly: "The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved."

The FDA said it "confirmed with the drug's manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand." Then came a caution that turned out to matter: "Patients and prescribers may still see intermittent localized supply disruptions."

That caution points at the key word. In federal law, a 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." It's a national measure. Your pharmacy running out of one strength isn't, by itself, a shortage in that sense.

The day before: nearly two years on the shortage list

On October 1, 2024, tirzepatide had been on the FDA's shortage list since December 15, 2022. Mounjaro, approved in May 2022 for type 2 diabetes, was added that December "due to high demand," according to the FDA's December 2024 order. Zepbound, approved for weight management in November 2023, joined the list in April 2024.

The interest isn't hard to trace. In June 2022, a trial of 2,539 adults without diabetes called SURMOUNT-1 reported average weight changes of −15.0% to −20.9% over 72 weeks across three tirzepatide doses, against −3.1% on placebo (Jastreboff et al., New England Journal of Medicine, 2022). At the top dose, that's about a fifth of body weight, on average.

While a drug is on the shortage list, the law's usual limits on copying it relax, so pharmacies filled the gap by compounding, meaning they prepared the medicine themselves. By December 2024 the FDA wrote, "We recognize that significant compounding of tirzepatide injection products is occurring."

What the notice changed for compounded copies

The October notice put the consequence in one sentence: "When a drug shortage is resolved, FDA generally considers the drug to be commercially available."

That mattered for two kinds of compounder. A 503A pharmacy is a state-licensed pharmacy preparing medicine for one named patient on a prescription; it may not make copies of a commercially available drug "regularly or in inordinate amounts." A 503B outsourcing facility is a larger, FDA-registered operation that can make stock without individual prescriptions; it generally may not copy an approved drug unless that drug is on the shortage list.

"Essentially a copy" means, roughly, the same active ingredient in the same or a similar strength, given the same way. Once tirzepatide came off the list, the shortage stopped being a broad reason to make those copies.

When did the tirzepatide shortage end, exactly?

On October 7, 2024, an outsourcing-facility trade group and a compounding pharmacy sued the FDA in federal court in Texas. Four days later, at the agency's own request, the court sent the decision back to the FDA to re-examine.

On December 19, 2024, the FDA issued a formal order that "revokes and replaces FDA's October 2, 2024 decision" and again found the shortage resolved. Lilly's data, the order says, showed supply "currently meeting or exceeding demand," with reserves in stock. Reports from patients and pharmacists who still couldn't fill prescriptions were, in the agency's view, most likely explained by the supply chain between the manufacturer and the pharmacy counter, not a national shortfall.

The order set wind-down dates of February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B facilities. The FDA later said they would stretch until the court ruled on the compounders' request for a preliminary injunction, an order that would have paused the FDA's decision while the case went on. The court denied it on March 5, 2025, and the FDA's March 10 update said the 503A grace period "has ended."

What happened next, 2025 to today

Compounding didn't disappear. From August to October 2025, University of Colorado researchers posed as customers at 75 weight-loss clinics and medical spas in West Virginia and Oklahoma; 42 offered compounded GLP-1s combined with B vitamins. The products traced to 23 compounding facilities, and 4 of the 21 the team could check weren't licensed for sterile compounding, the clean-room work injectables need (DiStefano et al., JAMA Health Forum, 2026). It's a two-state study, published July 2, 2026, not a national count.

On April 1, 2026, the FDA restated that tirzepatide and semaglutide "do not currently appear on the 503B bulks list or on FDA's drug shortage list." A separate proposal to keep tirzepatide off the 503B ingredient list is still pending; the 503B proposal explainer tracks it. On August 27, 2026, the Fifth Circuit affirmed the judgment for the FDA, and the shortage court ruling explains what it did and didn't decide.

As of September 23, 2026, the day this article was written, the latest FDA document to look back on the shortage was a warning letter dated September 18, 2026 to a Texas compounding pharmacy. Its footnote says the 503A grace period "ended with respect to tirzepatide injection products on March 5, 2025." A warning letter states the FDA's position; it isn't a court ruling.

Is tirzepatide still in shortage?

No. As of September 23, 2026, the day this article was written, the FDA's drug shortage database listed tirzepatide injection as "Resolved," and it wasn't among current shortages.

That doesn't mean every pharmacy has every strength every day. In its December order, the FDA said it would keep watching "whether any tirzepatide injection products should be included on the drug shortage list in the future." A drug can return to the list if national supply falls behind; nothing in the FDA's record today says that's happening.

What it means if you're prescribed tirzepatide now

For Mounjaro or Zepbound, it mostly means the FDA judges supply to be meeting national demand.

For compounded tirzepatide, the end of the shortage closed the broad route for making copies. It didn't end patient-specific compounding. Under the FDA's current policy, a 503A pharmacy prepares medicine for an identified patient on a prescription, and the copy restriction applies unless the prescriber determines and documents that a change makes a significant difference for that patient. A prescription alone doesn't settle that, and adding an ingredient doesn't settle it by itself either.

Through Promise, tirzepatide is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. A licensed provider may still prescribe a compounded formulation when they judge it appropriate; that decision is between you and your doctor. At Promise, a licensed provider reviews every request, and not everyone qualifies.

Three plain questions are worth asking about any compounded prescription: which pharmacy prepares it, whether that pharmacy is licensed for sterile compounding in its state, and whose name is on the label.