The decision by the U.S. Food and Drug Administration (FDA) to end the shortage designation for semaglutide, the active ingredient in popular weight loss drugs like Ozempic and Wegovy, has sparked concerns among compounding pharmacies in Fort Worth. These pharmacies, which have been providing compounded versions of semaglutide, fear that the decision will lead to a loss of affordable alternatives for patients who need the medication.
The Impact of FDA’s Decision
Brad Hart, the owner of Forest Park Pharmacy in Fort Worth, has been filling prescriptions for compounded semaglutide since 2022, when the FDA declared a shortage of the drug. This shortage allowed compounding pharmacies to create generic versions of the popular weight loss drugs, offering patients a cheaper, more accessible alternative to the high-cost brand names. For many patients, semaglutide can cost upwards of $1,200 a month if obtained through insurance, making the compounded versions, which are significantly more affordable, a lifeline.
However, the FDA announced in February 2025 that the shortage was officially over, which means these compounded versions could soon be unavailable. While the compounded drugs are not FDA-approved (since they aren’t reviewed for safety, effectiveness, or quality before reaching patients), they have been filling a crucial gap for many people who rely on semaglutide for weight loss and managing conditions like Type 2 diabetes and cardiovascular disease.
Legal Challenges and Patient Concerns
Hart is among those worried about the consequences of this decision. He explained, “Only about 9% of patients have a chance to actually get the medication in the first place on their insurance, and if people are getting it off of insurance, it’s basically unaffordable.” The growing demand for semaglutide—especially for its use in reducing the risk of heart attacks and strokes—has compounded the issue.
In response to the FDA’s action, a Texas-based trade association representing FDA-registered compounding pharmacies filed a lawsuit against the government, arguing that the decision to declare the shortage over was “reckless and arbitrary.” The lawsuit states that many patients still cannot access semaglutide through regular channels, and its removal from the shortage list will deprive them of a vital treatment.
The lawsuit also highlights ongoing supply constraints, suggesting that the shortage has not truly ended, and will likely resurface once the compounded versions are no longer available.
The Road Ahead for Compounded Semaglutide
The FDA has set deadlines for pharmacies to comply with its new regulations. Pharmacies like Forest Park Pharmacy have until April 22, 2025, to stop dispensing compounded semaglutide unless the court rules otherwise. Outsourcing facilities, which provide semaglutide to compounding pharmacies, have until May 22, 2025, to comply.
If this ruling stands, many patients may lose access to affordable versions of semaglutide, further exacerbating the growing demand and making the drug even less accessible for people without sufficient insurance coverage. According to Scott Brunner, CEO of the Alliance for Pharmacy Compounding, the FDA’s action could have a ripple effect across the industry, restricting access to crucial medications for those who need them most.
A Mixed Future for Weight Loss Medication
While semaglutide is officially no longer considered in shortage, the reality on the ground remains uncertain. As Hart and other pharmacists point out, the need for affordable weight loss treatments remains critical. The ongoing legal battle over the FDA’s decision could determine the future availability of compounded versions of semaglutide, and, ultimately, whether patients will be able to continue accessing the treatment they rely on at an affordable price.
In the meantime, many patients and healthcare providers are left navigating a complex and uncertain landscape. The outcome of the lawsuit could have long-lasting implications for the affordability and accessibility of weight loss medications in the future.
Related Topics:
What Weight Loss Injections Are Covered By Insurance
