FDA pulls back its tirzepatide shortage finding for review after compounders sue
The re-evaluation left patients who use compounded tirzepatide facing early-2025 wind-down deadlines while the FDA weighed whether brand-name supply was enough.
On October 2, 2024, the FDA posted on its website that the shortage of tirzepatide injection products was resolved [2]. Mounjaro, approved in May 2022 for type 2 diabetes, and Zepbound, approved in November 2023 for obesity and weight-related conditions, are the only FDA-approved products containing tirzepatide, and both are made by Eli Lilly [2].
When an FDA-approved drug is on the agency's shortage list, some federal restrictions on compounding it are suspended [2]. Mounjaro was added to the list in December 2022 and Zepbound in April 2024, which let pharmacies and outsourcing facilities that met certain conditions compound tirzepatide [2].
The October finding did not stay in place in its original form. Shortly after it was posted, the Outsourcing Facilities Association and North American Custom Laboratories, which does business as FarmaKeio Custom Compounding, sued the FDA [2]. The district court granted the FDA's unopposed motion for a voluntary remand and stay so the agency could re-evaluate its October decision [2]. That step pulled the decision back and reopened the record.
During the re-evaluation, the FDA said multiple interested parties submitted information, both before the October determination and during the review: Eli Lilly, individual patients, pharmacy compounders, outsourcing facilities, associations representing compounders, and telehealth companies [2].
On December 19, 2024, the FDA again determined the shortage was resolved [1]. The agency concluded that "supply meets or exceeds current demand, and . . . will also meet or exceed projected demand" [1], citing Eli Lilly's expanded manufacturing capacity and information and data from Lilly, patients, health care providers, compounders and others [2]. Eli Lilly spent approximately $23 billion to build, expand, acquire and obtain manufacturing facilities in the United States and Europe, and received FDA approval to sell single-dose vials of Mounjaro and Zepbound in addition to the already-approved pens [2]. The FDA said it would keep monitoring the situation and did not rule out adding tirzepatide back to the shortage list if warranted [1].
The agency also set enforcement grace periods to let compounders wind down. For 503A pharmacies, the FDA said it did not intend to take enforcement action for compounding an "essentially a copy" of branded tirzepatide for 60 days, a period expiring February 18, 2025 [1]. For 503B outsourcing facilities, the pause is 90 days, expiring March 19, 2025 [1]. The FDA said it would still act on violations of other statutory or regulatory requirements [1].
After those windows, 503B outsourcing facilities cannot compound tirzepatide because it is not on the shortage list or on the 503B Bulks List [1]. 503A pharmacies will still be able to compound the drug under a narrow set of circumstances, such as documentation of medical necessity, but cannot compound "essentially a copy" of the commercially available product [1].
The legal fight continued. As of January 2025, the 503B lawsuit was ongoing, and pharmacies were still reporting shortages [1]. On August 27, 2026, the Fifth Circuit upheld the FDA's decision to remove tirzepatide products from the shortage list [2]. The court assumed without deciding that the FDA erred by not using notice-and-comment rulemaking, but found the compounders had not shown prejudice, and held the shortage determination was not arbitrary or capricious [2]. The opinion also noted that Eli Lilly's exclusive right to manufacture tirzepatide products runs to 2027 [2].
Why it matters for patients
For people who get tirzepatide from a compounding pharmacy, the re-evaluation set a clock. The FDA's 60-day and 90-day enforcement pauses gave those pharmacies and facilities time to wind down compounding and dispensing rather than stopping immediately [1]. The two deadlines fell on different dates depending on the type of operation: February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities [1].
It also matters because compounded drugs are not FDA-approved. The FDA has said it does not review compounded drugs to evaluate their safety, effectiveness or quality before they reach patients [2].
Patients taking other GLP-1 medicines were not covered by this decision. The FDA continued to list dulaglutide injection, semaglutide injection and liraglutide injection as in shortage [1].
What happens next
The next dated milestones in the record were the end of the enforcement pauses on February 18, 2025 and March 19, 2025 [1], followed by the August 27, 2026 appeals court ruling that upheld the delisting [2].
Whether the FDA will put tirzepatide back on the shortage list has not been decided; the agency said it did not rule that out if warranted [1]. It has not been disclosed what the FDA's monitoring has shown since, or how individual compounding pharmacies and outsourcing facilities adjusted their practices in response.
Sources
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