FDA reaffirms the tirzepatide shortage resolution and starts the wind-down clocks

The Food and Drug Administration issued a Declaratory Order on December 19, 2024 confirming that the shortage of tirzepatide injection products — Eli Lilly's Mounjaro and Zepbound — is resolved ^[3]. The order revokes and replaces FDA's earlier October 2, 2024 decision on the same question and starts two countdown clocks for compounders: 60 calendar days for state-licensed 503A pharmacies, until February 18, 2025, and 90 calendar days for 503B outsourcing facilities, until March 19, 2025 ^[3][2].

The re-evaluation came out of litigation. Tirzepatide injection was first added to FDA's drug shortage list on December 15, 2022, and removed on October 2, 2024 ^[3]. On October 7, 2024, the Outsourcing Facilities Association and North American Custom Laboratories (doing business as Farmakeio Custom Compounding) sued FDA in the U.S. District Court for the Northern District of Texas; on October 11, 2024, the court remanded the decision back to the agency for reconsideration ^[3]. The suit was put on hold, which allowed compounded versions to keep selling in the meantime ^[4].

FDA said its new decision rests on detailed production and inventory data from Lilly, including stock reports by strength, 2024 supply and demand totals, projected future demand, and wholesaler inventory ^[3]. The agency concluded that Lilly's supply "is currently meeting or exceeding demand" for the products, that Lilly holds finished-product reserves plus significant semi-finished product, and that scheduled production means "supply will meet or exceed projected demand" ^[3].

FDA acknowledged it received reports that some patients and pharmacists still could not get the approved drugs, and that "a substantial amount of tirzepatide compounding is occurring" ^[3]. It judged those problems to be local supply-chain dynamics between Lilly, wholesalers and retailers rather than a continuing national shortage, and said it expects some patients now on compounded product to seek the approved drugs once compounding is curtailed ^[3]. The agency said it will keep monitoring and did not rule out returning tirzepatide to the shortage list later ^[3][1].

Not everyone agreed. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, called the announcement expected but "not necessarily the end of the story," adding, "I'm just not persuaded that the data on which FDA is relying in this doubling-down on its shortage resolution decision is complete enough to say the shortage is really over" ^[4]. A Lilly spokesperson said anyone marketing or selling unapproved tirzepatide must stop and begin transitioning patients to FDA-approved medicines ^[4]. Bernstein analyst Courtney Breen said the decision suggested the end of the "compounder-spree" was near but would have only a modest effect on 2025 prescription volumes ^[4].

Why it matters for patients

Federal law lets compounders make copies of brand-name drugs mainly when those drugs are in short supply. Once tirzepatide is off the shortage list, 503B outsourcing facilities cannot compound it, because the bulk substance is neither on the 503B bulks list nor on the shortage list ^[1]. 503A pharmacies are barred from making products that are "essentially a copy" of the commercially available drug, though narrow situations remain — such as a prescriber documenting a medical necessity or a significant difference for an identified individual patient ^[1][2].

In practice, that means many people who had been buying compounded tirzepatide — often paying cash because insurers frequently cover these drugs for diabetes but not for weight loss ^[4] — faced the prospect of switching to branded Mounjaro or Zepbound after the deadlines. FDA also warned the grace periods do not shield compounders from action over other violations, such as substandard quality or unsafe products ^[2][3].

At the time of this order, FDA still listed semaglutide injection, dulaglutide injection and liraglutide injection as in shortage, even though manufacturers reported most presentations available ^[2]. That distinction mattered for compounded semaglutide, which remained permitted for the moment ^[4].

What happens next

• February 18, 2025: end of the 503A enforcement-discretion window ^[3].
• March 19, 2025: end of the 503B window ^[3].
• In a joint court filing on December 19, both sides said that if the Outsourcing Facilities Association filed a motion to block the decision within two weeks, FDA agreed not to take enforcement action while the court considered it ^[4].