Scott Brunner, CEO of Alliance Pharmacy, said that pharmacies continue to face challenges in acquiring sufficient FDA-approved tirzepatide drugs, despite federal claims that shortages have ended. This statement was made on LinkedIn.
"I'm just not persuaded that the data on which FDA is relying in this doubling-down on its shortage resolution decision is complete enough to say the shortage is really over," said Brunner, according to LinkedIn. "We continue to hear from pharmacies that the FDA-approved tirzepatide drugs are not attainable from wholesalers in quantities needed to meet demand by patients transitioning from compounded to commercial versions of the drug."
In December 2024, the U.S. Food and Drug Administration (FDA) removed tirzepatide drugs such as Mounjaro and Zepbound from its shortage list. This action ended the permission for compounding pharmacies to produce alternatives, according to WSGR. The decision followed improved manufacturing capacity by Eli Lilly and resulted in lawsuits from telehealth companies and compounders who cited concerns over access and pricing. The move has intensified debates regarding pharmaceutical pricing and compounded drug access within the U.S. healthcare system.
According to TechTarget, the FDA's decision to remove tirzepatide from the shortage list was based on reports from Eli Lilly confirming that wholesaler inventories of Mounjaro and Zepbound could now meet market demand. In response, the FDA ended temporary compounding policies in early 2025 to ensure patients received approved, standardized products. This decision aimed to restore stability to the pharmaceutical supply chain.
As reported by Lane Regional Medical Center, compounded medications often assist patients who are allergic to certain dyes, preservatives, or fillers commonly found in mass-produced drugs. Compounding allows pharmacists to customize drug forms, such as liquids or creams, for patients unable to take pills. This personalized approach can significantly improve treatment adherence and clinical outcomes.
According to the Houston Chronicle, compounding pharmacies like Empower Pharmacy have become essential providers of customized medications, including oral alternatives to injectable drugs such as semaglutide and tirzepatide. These pharmacies cater to patients with needle phobia or injection intolerance by offering formulations not commercially available. Empower operates both 503A and 503B facilities, enabling them to serve individual prescriptions and bulk orders for healthcare systems.
Brunner is also noted as having over 35 years of association management experience as CEO of the Alliance for Pharmacy Compounding (APC). He specializes in pharmaceutical policy advocacy and leads efforts to advance pharmacy compounding as a profession. Before joining APC, Brunner held executive roles at various healthcare and association organizations.
