Court remands FDA's tirzepatide shortage decision for reevaluation

A federal court in Texas sent the Food and Drug Administration's decision to remove tirzepatide injection products from the national drug shortage list back to the agency for a second review ^[1]. The remand was issued October 11, 2024, at the FDA's own request, and it was not opposed ^[1].

What happened

Tirzepatide injection products were first added to the FDA's shortage list on December 15, 2022 ^[1]. Mounjaro, approved in May 2022 for type 2 diabetes, went on the list that December because of high demand ^[1]. Zepbound, approved in November 2023 for weight management, was added in April 2024, also because of high demand ^[1].

On October 2, 2024, the FDA determined the shortage was resolved and removed the products from the list ^[1]. Five days later, on October 7, 2024, the Outsourcing Facilities Association and North American Custom Laboratories, LLC, which does business as Farmakeio Custom Compounding, sued the agency in the U.S. District Court for the Northern District of Texas over that removal ^[1]. The case is Outsourcing Facilities Ass'n v. FDA, No. 4:24-cv-953 ^[1]. On October 11, the court remanded the decision for reevaluation ^[1].

The FDA then issued a declaratory order dated December 19, 2024, that revokes and replaces its October 2 decision and again finds the shortage resolved ^[1]. The agency said the conclusion rests on information from Eli Lilly, the maker of both products, including stock reports showing quantities supplied and demanded, inventory held for all strengths, cumulative quantities supplied to and demanded by customers in 2024, projected supply and demand for future months, and wholesaler inventory data ^[1]. The FDA said the data show Lilly's supply is "currently meeting or exceeding demand," and that the company holds reserves of finished and semi-finished product plus scheduled additional production ^[1].

The FDA also said it reviewed reports from patients, health care providers and compounders that some patients and pharmacists cannot get the approved drugs, and that substantial compounding is occurring ^[1]. The agency said that information "has important limitations" and does not outweigh Lilly's data ^[1]. It said such intermittent problems are most likely explained by the part of the supply chain between Lilly and individual customers, including wholesalers and retailers, rather than a continuing national shortage ^[1]. Shortages are judged nationwide, not locally, the agency said, and patients and prescribers may still see intermittent localized disruptions ^[1].

Why it matters for patients

Shortage-list status matters beyond supply. It affects whether compounding pharmacies and outsourcing facilities may legally prepare copies of the drug ^[1]. The FDA said it does not intend to take action against compounders for violations that depend on tirzepatide's place on the shortage list, for 60 days from the December 19 order — until February 18, 2025 — for state-licensed pharmacists and physicians compounding under section 503A, and for 90 days — until March 19, 2025 — for outsourcing facilities under section 503B ^[1].

For patients using FDA-approved Mounjaro or Zepbound, the order means the agency still considers the national shortage over, even while acknowledging that some people may still have trouble filling prescriptions at particular pharmacies ^[1]. Zepbound single-dose vials have never been on the shortage list, and Mounjaro single-dose vials are not currently marketed in the United States, the order says ^[1].

The order does not address whether the lawsuit has otherwise been resolved ^[1].

What happens next

The two compounding windows close February 18 and March 19, 2025 ^[1]. The FDA said it will keep monitoring supply and demand and will decide whether any tirzepatide injection products should go back on the shortage list in the future, as appropriate ^[1].