Compounders Face Deadline to Stop Manufacturing Tirzepatide

The Outsourcing Facilities Association (OFA), an organization representing bulk compounders, has appealed a Texas federal judge’s ruling that ended its ability to make copies of the dual glucagon-like peptide 1 (GLP-1) and glucose dependent insulinotropic polypeptide receptor agonist tirzepatide. 

Just last week, district court judge Mark Pittman declined to grant OFA’s request for an injunction that would have barred the US Food and Drug Administration (FDA) from declaring that the tirzepatide shortage was over.

In the wake of the ruling, FDA announced that it would no longer exercise“enforcement discretion” for state-licensed and physician compounding, and that outsourcing facilities would have to stop making and selling copies of the drug by March 19.

In a statement shared with Medscape Medical News, the OFA said it had appealed the Texas decision to the US Court of Appeals for the Fifth Circuit in New Orleans. The appeal is the latest move in the compounders’ battle to continue making copies of tirzepatide and other GLP-1s, including semaglutide.

The FDA declared an end to the 2-year-old tirzepatide shortage in October 2024, after Eli Lilly — which sells the drug as Mounjaro for type 2 diabetes and Zepbound for obesity — ramped up production to meet ever-growing demand. 

Soon thereafter, the OFA sued, stating the FDA had erred in reaching its conclusion and that it was depriving patients of much-needed medications. The agency sought and was granted a pause on the litigation to reconsider but ultimately reaffirmed its decision in December.

Compounding pharmacies are allowed to make copies of approved drugs that appear on the FDA’s shortage list, but the compounded versions are not FDA-approved, and the agency does not verify their safety or effectiveness.

The FDA has periodically warned online vendors of GLP-1s to stop, and Eli Lilly and other GLP-1 manufacturers have sued medical spas, compounders, and others making copies of the medications, claiming in some cases that the compounded versions have been impure or ineffective.

The Alliance for Pharmacy Compounding released a “best practices” guide for compounding drugs in shortage in August 2024 in an effort to reassure the public.

Alliance CEO Scott Brunner told Medscape Medical News in a statement that when the FDA ended the tirzepatide shortage in October — based on what he called “incomplete data”— it “resulted in unnecessary patient angst and interruptions of therapy when pharmacies could not access the FDA-approved drugs for those patients.”

Brunner said that to determine shortages in the future, “the agency should be required to draw from a broader pool of reliable information — from hospitals, pharmacies, and other stakeholders.”

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.