In a rare reversal, FDA agrees to revisit the tirzepatide delisting

The U.S. Food and Drug Administration told a federal court on Friday that it will reconsider its recent decision to remove tirzepatide — the active ingredient in Eli Lilly's Mounjaro and Zepbound — from its drug shortage list, and that it will not pursue regulatory action against certain compounding pharmacies making copies of the drug while that review is underway ^[1][2].

The move, disclosed in a court filing, is a sharp turnaround. On Sept. 30 the agency concluded that the years-long tirzepatide shortage had ended ^[1][2]. Under FDA guidance issued at the time, that determination meant compounding pharmacies and outsourcing facilities would no longer be permitted to make and dispense copies of the drug ^[2].

How the reversal happened

The Outsourcing Facilities Association, a trade group representing FDA-registered compounders known as 503B outsourcing facilities, sued the agency on Monday in Texas, arguing that tirzepatide was still in short supply and that the FDA's decision was "reckless and arbitrary" ^[1][2]. The group asked for a 14-day temporary restraining order that would bar the FDA from acting against any compounder that kept making copies ^[2].

After the FDA agreed on Friday to revisit the question, U.S. District Judge Mark Pittman in Fort Worth, Texas, put the lawsuit on hold ^[1]. The agency said it would allow compounding pharmacies and facilities to keep supplying the drug while it reviews whether a shortage of the active ingredient exists ^[1].

Outsourcing Facilities Association Chairman Lee Rosebush said the group was "greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision" ^[1].

The rules behind the fight

Compounded drugs are not FDA-approved before they are sold ^[1]. Compounding pharmacies can prepare drugs to fill prescriptions for specific patients, while outsourcing facilities make compounded products in bulk ^[1]. Federal rules allow compounded copies of an approved drug when that drug is in short supply; when there is no shortage, those copies cannot be made regularly or in large amounts ^[1].

That is why the shortage list matters so much. Mounjaro had been listed as in short supply since late 2022, and Zepbound was added in April ^[1]. Semaglutide — the active ingredient in Novo Nordisk's Ozempic and Wegovy — remains on the FDA's shortage list ^[1].

Lilly has been pushing back on the copies. The company began sending cease-and-desist letters in August to telehealth companies, wellness centers and medical spas selling compounded versions of Zepbound and Mounjaro, and has filed lawsuits against sellers falsely claiming to offer FDA-approved versions of the drug ^[1].

Why it matters for patients

For people who have been getting compounded tirzepatide, Friday's filing means that supply is not immediately cut off. Reuters reports that compounded versions are cheaper for patients than the brand-name drugs, and that while insurers generally cover drugs like tirzepatide for diabetes, many do not cover them for weight loss ^[1]. Losing the compounded option would have cut off access for many patients who relied on it during the shortage ^[1].

It is important to understand what this pause is and is not. The FDA has not said tirzepatide is back in shortage; it said it will review whether a shortage exists ^[1]. Compounded products still have not gone through FDA approval ^[1]. And the agency's enforcement pause applies while the review is pending — the sources do not say how long that will last or what the outcome will be.

What happens next

The FDA will review whether tirzepatide's active ingredient is in short supply ^[1]. No deadline for that decision appears in the court filing as described by these reports, so the timing — and whether compounders keep their legal footing after the review — is not yet known. The lawsuit remains on hold in the meantime ^[1]. Semaglutide's separate shortage status was unchanged as of Oct. 11 ^[1].