FDA remands its tirzepatide shortage decision for re-evaluation

The Food and Drug Administration pulled back its decision declaring the tirzepatide shortage over and agreed to take a second look, after compounders sued. A federal district court in Texas granted the FDA's unopposed motion for a voluntary remand and stay so the agency could re-evaluate its October 2024 determination ^[2].

The dispute started on October 2, 2024, when the FDA posted a public update stating that the shortage of tirzepatide injection products was resolved ^[2]. Tirzepatide is the active ingredient in Eli Lilly's Mounjaro, approved in May 2022 for type 2 diabetes, and Zepbound, approved in November 2023 for obesity and related conditions ^[2]. Removing the drug from the shortage list matters because federal law generally bars pharmacies, physicians and outsourcing facilities from compounding copies of approved drugs — a restriction that is temporarily suspended while a drug is listed as in shortage ^[2]. Mounjaro was added to the shortage list in December 2022 and Zepbound in April 2024 ^[2].

The Outsourcing Facilities Association and North American Custom Laboratories, doing business as FarmaKeio Custom Compounding, filed suit shortly after the October posting ^[2]. During the remand, the FDA reopened the record and accepted information from interested parties. The agency later noted that Eli Lilly, individual patients, pharmacy compounders, outsourcing facilities, trade associations and telehealth companies all submitted information, both before the October determination and during the re-evaluation ^[2]. While that review was underway, the FDA held off on enforcement against pharmacies and outsourcing facilities that continued compounding what the agency calls "essentially a copy" of the branded product ^[1].

The pause did not last long. Court records state that three months later, on December 19, 2024, the FDA confirmed the shortage was resolved, concluding that Lilly's supply would "meet or exceed projected demand" in light of expanded manufacturing capacity and the data submitted ^[2]. The FDA memorialized that decision in a "Declaratory Order" and "Decision Memorandum," describing it as an informal adjudication rather than a rulemaking ^[2]. Lilly had spent roughly $23 billion building, expanding and acquiring manufacturing capacity in the United States and Europe while the drugs were listed, and had also won approval to sell single-dose vials in addition to prefilled pens ^[2].

Why it matters for patients

For people using compounded tirzepatide, the shortage list is the switch that controls legal supply. When the drug is listed, compounders can make versions of it; when it is delisted, they generally cannot make copies ^[2]. The remand in October 2024 briefly kept that door open while the agency reconsidered.

After the December re-determination, the FDA built in wind-down periods so treatment would not stop abruptly: 503A compounding pharmacies had 60 days, expiring February 18, 2025, and 503B outsourcing facilities had 90 days, expiring March 19, 2025, before the agency intended to enforce ^[1]. The FDA said the delay was meant "to avoid unnecessary disruption to patient treatment and to help facilitate an orderly transition" ^[2]. The agency still reserved the right to act on other violations ^[1].

One practical difference: 503B outsourcing facilities cannot compound tirzepatide unless it is on the shortage list or the 503B bulks list, while 503A pharmacies may still compound in narrow circumstances, such as documented medical necessity, but not copies of the commercially available product ^[1]. It is also worth noting that compounded drugs are not FDA-approved, meaning the agency does not review their safety, effectiveness or quality before they reach patients ^[2].

What happens next

As of the January 2025 analysis cited here, the FDA still listed dulaglutide injection, semaglutide injection and liraglutide injection as in shortage, and litigation over the tirzepatide decision continued ^[1]. The compounders lost a preliminary injunction and then summary judgment in district court, and on August 27, 2026, the Fifth Circuit affirmed, rejecting arguments that the FDA needed notice-and-comment rulemaking and that its shortage call was arbitrary and capricious ^[2]. Lilly's exclusivity over tirzepatide products runs to 2027 ^[2].