Court upholds FDA authority over the tirzepatide shortage list

A federal judge has sided with the US Food and Drug Administration in a closely watched fight over compounded GLP-1 drugs. On May 7, 2025, the US District Court for the Northern District of Texas upheld the FDA's decision to remove two tirzepatide injection products from the agency's drug shortage list ^[1].

The case, Outsourcing Facilities Association v. FDA, was brought by compounding industry groups that wanted the shortage designation restored. The court concluded that the FDA acted within its statutory authority when it determined that tirzepatide was no longer in shortage, emphasized the agency's discretion in managing the shortage list, and found that the plaintiffs had not shown enough harm to justify a court stepping in ^[1]. The ruling upheld the earlier denial of a preliminary injunction ^[1].

What the ruling changes

Under federal law, pharmacies and outsourcing facilities can compound what amount to "essentially copies" of an approved drug when that drug is on the FDA's shortage list. Once the drug comes off the list, that exception generally goes away ^[1].

The FDA has considered the tirzepatide injection shortage resolved since October 2024, over objections from industry stakeholders, including an unsuccessful attempt in March 2025 to obtain a preliminary injunction blocking the agency's determination ^[1]. Because tirzepatide is now considered "available," compounders and healthcare providers can no longer lean on the shortage exception. Instead, any compounded tirzepatide product must not be substantially the same as a commercially available product, or must be given by a different route of administration ^[1].

Timing matters here. The FDA had set discretionary enforcement periods to let compounders adjust after the shortage ended. Those windows closed on February 18, 2025, for 503A compounding pharmacies and March 19, 2025, for outsourcing facilities ^[1]. During those periods, the agency said it did not intend to take action against compounders for Food, Drug, and Cosmetic Act violations tied to tirzepatide's prior place on the shortage list ^[1]. The May 7 decision came shortly after those protections lapsed ^[1].

The reasoning is not limited to one molecule. Other GLP-1 medications, including semaglutide, have also been removed from the FDA's drug shortage data, which the law firm analyzing the ruling described as a sign that the national shortage of certain GLP-1 medications appears to be ending ^[1]. The decision, the firm wrote, "clears the way for increased enforcement against noncompliant compounding practices" ^[1].

Why it matters for patients

During the 2023 and 2024 shortages, many people got compounded versions of semaglutide or tirzepatide, often through telehealth companies, at prices well below the brand products. The legal basis for mass-produced "essentially copies" rested largely on the shortage listing. With tirzepatide off the list and the court declining to reverse that call, that basis is gone for most compounders ^[1].

That means the supply of compounded copies is likely to keep shrinking, and providers that continue making them face a higher risk of FDA enforcement now that the discretionary periods have ended ^[1]. Compounding does not disappear entirely. Products that are not substantially the same as the approved drug, or that use a different route of administration, may still be permitted under the rules the court left in place ^[1]. Personalized compounding for an individual patient with a documented clinical need is a separate question the source does not address.

What the sources do not say is how many patients are currently using compounded versions, what specific products remain legally available, or whether the plaintiffs will appeal further. Those points are not yet known from this material.

What happens next

Key dates so far: the FDA declared the tirzepatide injection shortage resolved in October 2024; the 503A discretionary period ended February 18, 2025; the outsourcing facility period ended March 19, 2025; and the district court ruled for the FDA on May 7, 2025 ^[1]. Attorneys following the case say they expect the agency to work on aligning industry practice with current standards, which could mean more enforcement activity ahead ^[1].