Overview
On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This ruling will limit most compounding pharmacies, outsourcing facilities, and healthcare providers from using the FDA’s shortage list exception to compound “essentially copies” versions of tirzepatide injection products, likely impacting entity operations.
In this latest Outsourcing Facilities Association v. FDA decision, the court concluded that the FDA acted within its statutory authority in determining that tirzepatide was no longer in shortage. The court emphasized the agency’s discretion in managing the drug shortage list and found that the plaintiffs had not demonstrated sufficient harm to warrant judicial intervention. This decision effectively affirms the FDA’s position and clears the way for increased enforcement against noncompliant compounding practices.
In Depth
The FDA has considered the tirzepatide injection shortage resolved since October 2024 despite ongoing objections from industry stakeholders. These include an unsuccessful attempt in March 2025 to obtain a preliminary injunction to stay FDA’s tirzepatide shortage determination.
Since the FDA considers tirzepatide “available,” stakeholders can no longer rely on the FDA’s shortage list exception to compound “essentially copies” of tirzepatide injections. Instead, compounding pharmacies, outsourcing facilities, and healthcare providers must ensure that tirzepatide products are not substantially the same as, or not administered by the same route as, commercially available products. Other GLP-1 medications, such as semaglutide, have similarly been removed from the drug shortage data, suggesting the national shortage of certain GLP-1 medications appears to be coming to an end. Please see our previous On the Subject for a discussion of the semaglutide supply.
The May 7, 2025, decision came shortly after the end of the FDA’s discretionary periods for 503A and 503B compounders that are adjusting to the new post-tirzepatide-shortage compounding requirements. We discuss in detail the general requirements for 503A and 503B compounding entities in a previous On the Subject.
During the tirzepatide discretionary periods, which ended on February 18, 2025, for 503A compounding pharmacies and March 19, 2025, for 503 outsourcing facilities, the FDA announced that it did not intend to take action against compounders for violations of the Food, Drug, and Cosmetic Act based on tirzepatide injection products’ prior inclusion on the FDA’s drug shortage list.
Because the district court upheld the denial of the preliminary injunction on May 7, compounding pharmacies, outsourcing facilities, and other providers generally cannot rely on the shortage exception to compound “essentially copies” of tirzepatide – and they are not afforded the general protection from FDA enforcement that was available during the discretionary periods.
As a result, compounding entities should reevaluate their production and operational practices to comply with FDA compounding requirements. The resolution of shortages for tirzepatide and other GLP-1 medications, such as semaglutide, signals a potential shift toward increased FDA enforcement as the agency works to align industry practices with current regulatory standards.
We will continue to monitor changes in the GLP-1 medication shortage and assess impacts on the industry. For more information, please contact any of the authors of this article or any other member of McDermott’s Food, Drug & Medical Device Regulatory Group.
