FDA ends tirzepatide shortage and sets 2025 deadlines for compounders
The tirzepatide shortage is officially over, but compounded versions face phase-out dates in early 2025 and the FDA says some patients may still hit local supply gaps.
The FDA said on December 19, 2024 that the shortage of tirzepatide injection products is over, issuing a formal declaratory order that revokes and replaces the agency's October 2, 2024 decision on the same question [1][2]. Mounjaro and Zepbound are the only FDA-approved tirzepatide products [1].
What the order says
The order rests on production and inventory data that manufacturer Eli Lilly gave the agency, including stock reports showing quantities supplied, quantities demanded and inventory held for all strengths; cumulative quantities supplied to and demanded by customers in 2024; projected supply and demand for future months; and wholesaler inventory data [1]. The FDA concluded the data show Lilly's supply "is currently meeting or exceeding demand" and that reserves plus scheduled additional production mean supply will meet or exceed projected demand [1].
The approved products come in six strengths, from 2.5 mg to 15 mg per 0.5 mL [1].
The FDA also weighed information from patients, health care providers and others, including compounders, and wrote that the information has "important limitations." The agency said it received reports that some patients and pharmacists were not able to obtain the approved drugs, and that "a substantial amount of tirzepatide compounding is occurring," but concluded this did not outweigh Lilly's data [1]. The order says intermittent fill problems are most likely explained by the distribution chain between Lilly and individual customers rather than a continuing national shortage, and acknowledges some people may still be encountering such challenges [1].
Tirzepatide injection products were first added to the shortage list on December 15, 2022 [1]. Mounjaro pens were approved in May 2022 and added to the list that December due to high demand; Zepbound pens were approved in November 2023 and added in April 2024 [1]. Mounjaro single-dose vials were approved in July 2023 but are not currently marketed in the United States, and Zepbound vials, approved in March 2024, are marketed in only the 2.5 mg and 5 mg strengths; the vials have never been on the shortage list [1].
The order followed a lawsuit. The Outsourcing Facilities Association and North American Custom Laboratories, LLC, doing business as Farmakeio Custom Compounding, sued the FDA on October 7, 2024 over the removal of tirzepatide from the shortage list; on October 11, 2024, a court order remanded the decision to the agency for reevaluation [1].
Why it matters for patients
For people getting compounded tirzepatide, the order sets deadlines. The FDA said it does not intend to take action against state-licensed pharmacists or physicians compounding under section 503A for violations that depend on the drug's place on the shortage list for 60 days, until February 18, 2025, and against outsourcing facilities under section 503B for 90 days, until March 19, 2025 [1][2]. Those enforcement discretion periods cover rules against compounded drugs that are essentially copies of approved products and against compounding from bulk drug substances [1].
The agency may still act on other violations, such as products that may be of substandard quality or otherwise unsafe [1][2].
People taking Mounjaro or Zepbound may still see "intermittent localized supply disruptions" as products move from the manufacturer through distributors to pharmacies, even with the shortage resolved [1]. As of December 19, 2024, the FDA listed semaglutide injection, dulaglutide injection and liraglutide injection as still in shortage [2]. Whether those shortages will be resolved on a similar timeline has not been disclosed [2].
What happens next
The FDA said it will continue to monitor supply and demand and may add tirzepatide injection products back to the shortage list if warranted [1]. In later updates, the agency repeated the February 18 and March 19 dates and said the enforcement discretion periods run until the later of those dates or a court ruling on a preliminary injunction motion in the ongoing litigation [2].
Sources
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