FDA issues a formal declaratory order ending the tirzepatide shortage

FDA issued a formal declaratory order on December 19, 2024 concluding that the shortage of tirzepatide injection products — Eli Lilly's Mounjaro and Zepbound — is resolved. The order revoked and replaced the agency's October 2, 2024 decision on the same subject and set two wind-down dates for compounders: February 18, 2025 and March 19, 2025 ^[1].

The timeline behind the order matters. Tirzepatide injection products were first added to FDA's drug shortage list on December 15, 2022. FDA declared the shortage resolved and removed them from the list on October 2, 2024 ^[1]. On October 7, 2024, the agency was sued in the U.S. District Court for the Northern District of Texas by the Outsourcing Facilities Association and North American Custom Laboratories, LLC, doing business as Farmakeio Custom Compounding, over that removal. On October 11, 2024, at FDA's own request, the court remanded the decision back to the agency for reevaluation ^[1]. The December 19 order is the result of that reevaluation.

What FDA based the decision on

FDA said Lilly provided detailed production and inventory data, including stock reports showing quantities supplied and demanded and inventory on hand for all strengths, cumulative 2024 supply and demand figures, projected future supply and demand, and wholesaler inventory data. The agency concluded that Lilly's supply is currently meeting or exceeding demand, that Lilly holds finished-product reserves plus significant units of semi-finished product, and that substantial additional production is scheduled ^[1]. The public version of the order does not include the confidential commercial and trade secret information FDA analyzed, and the specific volumes are not disclosed ^[1].

FDA also 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." The agency said those reports have "important limitations" and do not outweigh Lilly's data. In FDA's assessment, intermittent problems are most likely explained by supply-chain dynamics between Lilly, wholesale distributors and retailers rather than a continuing national shortage. Shortage determinations are made nationwide, across the entire market, not at the local level ^[1]. FDA noted it recognizes that some patients now using compounded tirzepatide "can be expected to seek Lilly's approved products at a future point when compounding is curtailed" ^[1].

The order also spells out the enforcement wind-down. FDA said it does not intend to act against compounders for violations that depend on tirzepatide's presence on the shortage list — provisions covering essentially-a-copy compounding and bulk drug substances — for 60 calendar days for state-licensed pharmacists and physicians compounding under section 503A, until February 18, 2025, and for 90 calendar days for outsourcing facilities under section 503B, until March 19, 2025 ^[1].

At the time of the order, other GLP-1 drugs remained listed. As of December 19, 2024, semaglutide injection was still in shortage, with the manufacturer reporting all presentations available; dulaglutide was in shortage with all presentations available; and liraglutide was in shortage with two presentations available and three of limited availability ^[2].

Why it matters for patients

The legal condition that allowed large-scale compounded tirzepatide to be sold is tied to the shortage list. Once the shortage is declared resolved and the grace periods lapse, that pathway narrows sharply ^[1][2]. For people who had been getting compounded tirzepatide through telehealth or wellness clinics, the December 19 order set a clock on that supply.

FDA itself cautioned that resolving a national shortage does not guarantee a smooth experience at every pharmacy counter: patients and prescribers "may still see intermittent localized supply disruptions" as products move from manufacturer to distributors to local pharmacies ^[1]. Also worth noting: Mounjaro single-dose vials were approved in July 2023 but are not marketed in the U.S., and among Zepbound vials approved in March 2024, only the 2.5 mg and 5 mg strengths were being marketed ^[1].

What happened next

On February 11, 2025, FDA clarified that the 503A and 503B dates would run until February 18 and March 19, or until the district court ruled on the plaintiffs' preliminary injunction motion, whichever was longer ^[2]. The court denied that motion on March 5, 2025, ending the 503A discretion and leaving 503B discretion until March 19, 2025 ^[2]. FDA separately declared the semaglutide injection shortage resolved on February 21, 2025 ^[2].