Court remands the tirzepatide shortage decision to FDA

A federal judge in Texas sent FDA's tirzepatide shortage decision back to the agency for reevaluation on October 11, 2024, acting on FDA's own unopposed motion for a voluntary remand and stay. The order came four days after compounding groups sued over FDA's removal of tirzepatide injection from the drug shortage list ^[1].

Tirzepatide is the active ingredient in Mounjaro, approved for type 2 diabetes, and Zepbound, approved for weight management in adults with obesity or overweight with at least one weight-related condition ^[1]. Tirzepatide injection products were first added to FDA's drug shortage list on December 15, 2022, and FDA declared the shortage resolved and removed them from the list on October 2, 2024 ^[1].

How the case got here

On October 7, 2024, FDA 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 the removal of tirzepatide injection from the shortage list ^[1]. On October 11, upon FDA's motion, the court remanded the decision to the agency for reevaluation in Outsourcing Facilities Ass'n v. FDA, No. 4:24-cv-953 ^[1].

The shortage list matters to compounders because several provisions of the Federal Food, Drug, and Cosmetic Act turn on whether a drug is listed. When a drug is not in shortage, restrictions apply to compounded products that are essentially copies of a commercially available or FDA-approved drug under section 503A(b)(1)(D), and to bulk drug substances used by outsourcing facilities under sections 503B(a)(2)(A) and (a)(5) ^[1]. FDA made representations about enforcement in October 2024 in connection with the litigation, and the agency's compounding office also sent a letter on that subject to the Alliance for Pharmacy Compounding on October 17, 2024 ^[1].

The listing history is more detailed than "tirzepatide." Mounjaro pens were approved in May 2022 and added to the shortage list in December 2022 due to high demand ^[1]. Mounjaro single-dose vials were approved in July 2023 but are not currently marketed in the United States and have never been on the shortage list ^[1]. Zepbound pens were approved in November 2023 and added to the shortage list in April 2024, also due to high demand; Zepbound single-dose vials were approved in March 2024, with only the 2.5 mg and 5 mg strengths marketed, and the vials have never been on the list ^[1].

Why it matters for patients

For people taking tirzepatide, the shortage list is the legal switch that governs whether pharmacies and outsourcing facilities can make compounded versions of the drug. The remand paused the effect of the October 2 delisting and returned the question to FDA rather than settling it in court ^[1].

It is also worth understanding how FDA defines a shortage. Under the statute, a shortage is a period when nationwide demand or projected demand exceeds supply, and FDA evaluates supply and demand across the entire national market, not locally ^[1]. FDA has acknowledged that even when a shortage is considered resolved, patients and prescribers may still see intermittent localized supply disruptions as products move from the manufacturer through wholesale distributors to pharmacies ^[1].

The sources do not describe how long the remand was expected to last, what deadline if any the court set, or what specific enforcement commitments FDA made during the litigation beyond the references above. Those details are not yet known from this record.

What happens next

FDA reevaluated the decision and issued a declaratory order on December 19, 2024, addressed to Eli Lilly and Company, that revoked and replaced the October 2, 2024 decision and again determined that the tirzepatide injection product shortage is resolved ^[1]. The agency said Lilly's data showed supply currently meeting or exceeding demand, finished-product reserves, significant semi-finished units, and substantial additional production scheduled ^[1].

That December order set two enforcement timelines. FDA said it does not intend to act against state-licensed pharmacists or physicians compounding under section 503A for 60 calendar days, until February 18, 2025, or against outsourcing facilities under section 503B for 90 calendar days, until March 19, 2025 ^[1]. FDA said it will continue to monitor supply and demand and whether tirzepatide products should be listed again in the future ^[1].