FDA first declares the tirzepatide shortage resolved (October 2, 2024)
On October 2, 2024, the FDA declared the tirzepatide shortage over, removing Mounjaro and Zepbound from its shortage list and starting the clock on the end of legal compounded copies.
The FDA determined that the shortage of tirzepatide injection products was resolved and removed them from its drug shortage list on October 2, 2024 [3]. The decision was short-lived in its original form: after a lawsuit, a court sent it back to the agency for re-evaluation, and the FDA reaffirmed the resolution with a new order on December 19, 2024 [1][3].
Tirzepatide, the active ingredient in Eli Lilly's Mounjaro (for type 2 diabetes) and Zepbound (for obesity and overweight with a weight-related condition), was first added to the FDA's shortage list on December 15, 2022 [3]. Mounjaro pens went on the list in December 2022 because of high demand, and Zepbound pens were added in April 2024 [3]. The October 2 removal ended a 22-month stretch on the list [4].
That listing mattered because federal law ties compounding to shortages. While a drug is in shortage, compounders can make copies of it; once the shortage ends, those exemptions go away. When tirzepatide came off the list in October, reporting at the time noted that state-licensed 503A pharmacies had to stop production immediately, while larger 503B outsourcing facilities were given a 60-day grace period [4]. Shares of telehealth seller Hims & Hers fell 14% by mid-morning the next day [4]. Alliance for Pharmacy Compounding CEO Scott Brunner said patients "are being cut-off cold-turkey, their prescription no longer fillable," and predicted that a large-scale switch to branded product could push tirzepatide back into shortage [4].
The lawsuit and the second decision
On October 7, 2024, the FDA was sued in the U.S. District Court for the Northern District of Texas by the Outsourcing Facilities Association and North American Custom Laboratories, doing business as Farmakeio Custom Compounding, over the removal [3]. On October 11, 2024, on the FDA's own motion, the court remanded the decision back to the agency for re-evaluation [3]. The FDA's public webpage posted the remand in an October 22, 2024 update [1]. During the re-evaluation, the FDA held off on enforcement against compounders still making copies of branded tirzepatide [2].
On December 19, 2024, the FDA issued a new declaratory order that "revokes and replaces" the October 2 decision and again found the tirzepatide shortage resolved [3]. The agency said Lilly's data on stock, supply, demand, wholesaler inventory and scheduled production showed supply is "currently meeting or exceeding demand" and will meet or exceed projected demand [3]. The FDA acknowledged reports from patients, pharmacists and compounders that the approved drugs were still hard to get, but concluded those were most likely local supply chain issues rather than a national shortage [3].
The December order set wind-down clocks: 60 days for 503A pharmacists and physicians, until February 18, 2025, and 90 days for 503B outsourcing facilities, until March 19, 2025 [1][3]. The FDA said it could still act on other violations, such as products that are substandard or otherwise unsafe [1][3].
Why it matters for patients
For people using compounded tirzepatide, the October 2 decision was the start of the legal path that ended that supply. Lilly itself said at the time that some doses of Mounjaro and Zepbound might not be available immediately, noting that "the supply chain is complex, especially for refrigerated medicines" [4]. The FDA made the same point: even with a shortage resolved, patients may see intermittent, localized gaps at individual pharmacies [3].
Cost is the other practical issue. Lilly's LillyDirect pharmacy began selling single-dose Zepbound vials at a 50% discount to the list price of other GLP-1 medicines [4]. Whether that closes the gap for any given person depends on insurance and is not addressed in these sources.
What happens next
The litigation continued. On March 5, 2025, the district court denied the compounders' preliminary injunction motion, so the 503A enforcement discretion period ended and the 503B period ran to March 19, 2025 [1]. Semaglutide remained on the shortage list through December 2024 [1][2] and was declared resolved separately on February 21, 2025 [1]. As of the FDA's most recent update, neither tirzepatide nor semaglutide appears on the shortage list or the 503B bulks list [1].
Sources
- https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- https://www.frierlevitt.com/articles/fda-determines-again-the-tirzepatide-shortage-is-resolved-what-this-means-for-503a-and-503b-compounding/
- https://www.fda.gov/media/184606/download
- https://www.fiercepharma.com/pharma/eli-lillys-shortage-glp-1-drugs-over-halting-competition-knock-offs
- https://dps.fda.gov/drugshortages/resolved/tirzepatide-injection
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