The Food and Drug Administration (FDA) has announced that it will allow compounding pharmacies to continue producing compounded versions of tirzepatide — the active ingredient in Eli Lilly’s diabetes and weight loss medications Mounjaro and Zepbound — while it reevaluates its recent decision to remove the drug from its nationwide shortage list. This significant update comes following a legal challenge filed by compounding pharmacies, advocating for continued access to the drug amid growing patient demand.
The FDA’s filing late Friday marks a major victory for both compounding pharmacists and the many patients who rely on these alternative versions of the drug. Last month, on October 2, the FDA had declared the shortage of tirzepatide resolved, a move that prompted frustration and concern among pharmacists and patients alike. They argue that the drug remains in short supply, and that compounded versions are often more affordable and accessible compared to brand-name options.
Tirzepatide, initially approved as Mounjaro to treat Type 2 diabetes, has since become highly popular for weight loss purposes under the name Zepbound. The drug’s sudden surge in demand, especially for off-label weight loss use, has exacerbated the shortage.
Under FDA guidelines, compounding pharmacies are permitted to produce versions of drugs during shortages when the original medication is unavailable. However, manufacturers, particularly Eli Lilly, have strongly contested the legitimacy of these compounded drugs, citing concerns about their quality and safety.
Following the FDA’s announcement that the tirzepatide shortage had been resolved, the Outsourcing Facilities Association, a compounding industry group, filed a lawsuit, arguing that the drug was still in short supply and should remain on the FDA’s shortage list. The court filing sought to prevent the FDA from cracking down on compounded tirzepatide production, which many patients depend on.
In response, the FDA filed an update on Friday, stating that it would not take action against compounding pharmacies, at least temporarily, as it reevaluates its position on the drug’s availability. This provides a temporary reprieve for pharmacies and patients who fear losing access to an affordable alternative treatment.
Simone Williams, 50, from Spartanburg, South Carolina, is one of many patients who had been left in limbo after the FDA’s initial shortage resolution. Williams, who was using a compounded version of tirzepatide for weight loss after her Mounjaro savings card expired, expressed relief that her medication would not be immediately pulled from the market. “Until the FDA makes a solid decision, I was still nervous,” she said, noting the uncertainty that many patients continue to face.
For Elizabeth Kenly, 59, from Graham, North Carolina, the FDA’s move brought peace of mind. Kenly has been successfully using compounded tirzepatide to manage her weight loss, having already lost 30 pounds. “The compounding pharmacy is my lifeline,” she said, emphasizing the crucial role of affordable compounded medications in patient care.
The compounding pharmacy industry has long been at odds with drug manufacturers over the production of “copycat” versions of popular medications like tirzepatide. While the FDA’s ruling allows these pharmacies to continue making compounded versions, it remains to be seen whether Eli Lilly will push back further. A Lilly spokesperson has stressed that the brand-name versions of Mounjaro and Zepbound are available, urging patients to avoid unapproved compounded alternatives due to concerns over safety and efficacy.
Nonetheless, many patients and pharmacists assert that compounded medications remain a necessary alternative, especially for those unable to afford high-priced brand-name drugs. Michael Ganio, Senior Director of Pharmacy Practice at the American Society of Health-System Pharmacists, added that tirzepatide shortages may still persist and that it could take weeks for supply to stabilize across pharmacies.
As the FDA revisits its decision, the future of compounded tirzepatide production remains uncertain. In the meantime, compounding pharmacists and patient advocacy groups remain hopeful that the agency will make a favorable long-term decision that continues to prioritize patient access to essential medications.
Read More:
10 Cases Of Trichinellosis From Undercooked Bear Meat At NC Gathering
BrucePac Recalls 10 Million Pounds Of Chicken Products Amid Listeria Outbreak Concerns
Tirzepatide Shortage: FDA Rescinds Ban On Compounding Pharmacies
