FDA again declares the tirzepatide shortage resolved

FDA issued a declaratory order on December 19, 2024 finding that the shortage of tirzepatide injection products, sold by Eli Lilly as Mounjaro and Zepbound, is resolved. The order “revokes and replaces” a decision FDA made on October 2, 2024 on the same question.

Why FDA decided the same thing twice

Tirzepatide injections went on FDA’s drug shortage list on December 15, 2022. FDA took them off on October 2, 2024. Five days later, according to a footnote in the order, 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 over the removal. On October 11, at FDA’s request, the court sent the decision back to the agency to reevaluate (Outsourcing Facilities Ass’n v. FDA, No. 4:24-cv-953).

The December order is the result of that reevaluation. FDA’s public version leaves out Lilly’s confidential sales and inventory data, but explains the reasoning.

What the order says

FDA applied the statutory definition: a shortage is “a period of time when the demand or projected demand for the drug within the United States exceeds the supply.” It reviewed Lilly’s data on quantities supplied and demanded, inventory, wholesaler stock and projected production. It concluded that “Lilly’s supply is currently meeting or exceeding demand” and that Lilly held reserves.

FDA also addressed reports from pharmacies and patients who could not find the drug. It said local gaps can come from “the practical dynamics of the portion of the supply chain between Lilly and the individual customers,” such as wholesalers and retailers, rather than a national shortfall. It said the information submitted by compounders and others had “important limitations” and did not outweigh Lilly’s data.

Why it mattered to compounders

Under both 503A and 503B, pharmacies generally may not compound drugs that are “essentially a copy” of an approved drug, unless the drug is on the shortage list. Shortage status was the legal basis for mass-compounded tirzepatide. FDA’s companion policy page gave state-licensed 503A pharmacies until February 18, 2025, and 503B outsourcing facilities until March 19, 2025, before it would act on violations that depended on the shortage listing.

FDA reached the same conclusion for semaglutide on February 21, 2025 (our report). Our GLP-1 compounding explainer covers what compounders may still do.

What it did not cover

The shortage exception applies only to pharmacies and outsourcing facilities. Online sellers of tirzepatide labeled as being for research use only were never inside it. FDA treats those products as unapproved new drugs, as its warning letters show (explainer).