**U.S. Judge Denies Compounding Pharmacies’ Request to Continue Producing Ozempic and Wegovy Copies**
A U.S. District Judge has ruled against compounding pharmacies seeking to continue manufacturing copies of Novo Nordisk’s diabetes and weight-loss medications, Ozempic and Wegovy, amid an ongoing legal dispute regarding drug shortages. This decision, made on April 24, follows a lawsuit filed in February by a compounding industry group challenging the U.S. Food and Drug Administration’s (FDA) determination that there is no longer a shortage of the active ingredient, semaglutide.
Previously, compounding pharmacies were permitted to produce large quantities of these medications while the FDA classified them as in short supply. However, with the FDA’s recent ruling, this allowance has been revoked. The ruling is particularly significant as it affects many telehealth companies, such as Hims & Hers, that distribute these compounded drugs.
Judge Mark Pittman, based in Texas, denied the pharmacies’ request for a preliminary injunction, which would have allowed them to continue production. Although the judge’s reasoning remains sealed, his decision upholds a timeline set by the FDA, requiring larger compounding facilities to cease operations by May 22. Smaller pharmacies, which primarily serve individual patients, must stop producing semaglutide immediately.
Lee Rosebush, chairman of the Outsourcing Facilities Association, the lead plaintiff in the case, stated that his organization had presented evidence of an ongoing shortage of semaglutide after the lawsuit was filed. However, the judge did not consider this evidence, citing its late submission. The FDA has indicated that it will refrain from taking enforcement action against compounding pharmacies until the court reaches a decision.
This ruling follows a similar decision earlier this year, where the judge also denied compounding pharmacies the ability to produce copies of Eli Lilly’s weight-loss and diabetes medications, Zepbound and Mounjaro. The implications of this ruling could significantly impact the availability of these essential medications for patients relying on them for diabetes management and weight loss.
**FAQ**
**Q: What does the recent ruling mean for compounding pharmacies?**
A: The ruling prohibits compounding pharmacies from producing copies of Ozempic and Wegovy, as the FDA has determined there is no longer a shortage of their active ingredient, semaglutide.
