FDA agrees to revisit tirzepatide shortage listing after compounders sue

The Food and Drug Administration told a federal court on Oct. 11 that it will reconsider taking tirzepatide off the national drug shortage list, and that it will not pursue enforcement against compounding pharmacies that keep making copies of the medicine in the meantime. Tirzepatide is the active ingredient in Eli Lilly's Mounjaro, approved for diabetes, and Zepbound, approved for weight loss ^[1][2].

The agency's Sept. 30 decision had ended the arrangement that let compounders fill prescriptions with their own versions of the drug ^[1]. Under federal rules, a compounded copy of an FDA-approved product may be sold to meet demand while that product is scarce. Once regulators decide there is no shortage, those copies can no longer be produced on a regular basis or at high volume ^[1].

Mounjaro had carried a shortage designation since late 2022, and Zepbound joined the list in April, according to Reuters ^[1].

STAT News described the Oct. 11 court filing as a "stark reversal," noting that a week earlier the agency had said the years-long shortage was over and warned compounders they would no longer be allowed to make and dispense copies ^[2].

The change of course followed a lawsuit. The Outsourcing Facilities Association, which represents FDA-registered compounding pharmacies known as 503Bs, sued in Texas on Oct. 7, saying tirzepatide remained hard to get and calling the shortage-list removal "reckless and arbitrary." The group asked for a 14-day temporary restraining order that would have shielded any compounder continuing to produce copies ^[1][2]. After the FDA said it would revisit the question, U.S. District Judge Mark Pittman in Fort Worth paused the case ^[1].

Lee Rosebush, the association's chairman, said in a statement that members were "greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision" ^[1].

Eli Lilly has moved against compounders on other fronts. In August the company started sending cease-and-desist letters to telehealth companies, wellness centers and medical spas selling compounded Mounjaro and Zepbound, and it has sued sellers that falsely advertised FDA-approved versions of the drug ^[1].

Semaglutide, the ingredient in Novo Nordisk's Ozempic and Wegovy, stays on the shortage list, Reuters reported ^[1]. Demand for compounded copies has been driven by shortages of both companies' products ^[1].

Why it matters for patients

The compounded products generally cost patients less than the brand-name drugs ^[1], which is why they became a fallback for people who could not get or afford Mounjaro or Zepbound. Insurers commonly pay for tirzepatide when it is prescribed for diabetes, but many plans exclude it for weight loss ^[1]. The Sept. 30 action would have cut off the compounded alternative for many of those patients ^[1].

Compounded drugs are not FDA-approved the way brand-name and generic medicines are ^[1]. Two kinds of businesses make them: compounding pharmacies, which prepare a product for an individual prescription, and outsourcing facilities, which make compounded drugs in bulk ^[1].

If the agency concludes after its review that tirzepatide is no longer scarce, bulk and routine production of compounded copies would again be off limits, and patients relying on them would need another source or a different treatment ^[1]. Whether the agency will reach that conclusion, and what evidence it will weigh, has not been disclosed ^[1][2].

What happens next

No deadline for the review has been announced ^[1][2]. The lawsuit remains on hold while the agency works ^[1]. No further court dates have been reported, and the FDA has not said what it will do if it again determines there is no shortage ^[1][2].