What the Researchers Actually Did
More than a year after federal regulators declared the semaglutide and tirzepatide shortages over, compounded versions of the drugs behind Ozempic, Wegovy, Mounjaro and Zepbound are still being sold across storefront weight loss clinics and medical spas, according to a study published July 17 in JAMA Health Forum.
Researchers at the University of Colorado Anschutz Medical Campus used a secret shopper design. Between August and October 2025, they placed standardized calls to 75 brick-and-mortar businesses in West Virginia and Oklahoma, two states the authors selected for potentially high demand. Callers asked what products were available, what was in them, who conducted consultations, how often patients were seen again, and which pharmacy supplied the medication.
The findings, summarized by Drug Topics, were consistent across the sample. Sixty-nine of the 75 businesses, or 92.0 percent, reported offering compounded semaglutide. Sixty-five, or 86.7 percent, offered compounded tirzepatide. Seven, or 9.3 percent, offered oral or sublingual formulations.
"Our findings suggest this market didn't shrink after the shortages ended as many expected," said lead author Michael J. DiStefano, PhD, MBE, an assistant professor at the university's Skaggs School of Pharmacy and Pharmaceutical Sciences, in a statement released with the study. "Instead, it has remained remarkably robust, raising important questions about how these products are regulated and how patients can know whether they're receiving medications that meet appropriate quality standards."
The regulatory backdrop matters for understanding why that is notable. The FDA removed tirzepatide from its shortage list in December 2024 and semaglutide in February 2025, and said it would resume enforcing the laws that restrict compounding of drugs not in short supply after May 22, 2025. Compounding pharmacies may still prepare patient-specific formulations for documented clinical reasons, but routine copies of commercially available products fall outside that allowance.
The Shift Toward Additives
The study's most revealing finding is not that the market survived, but how it appears to have adapted.
Forty-four of the 75 businesses, or 58.7 percent, confirmed that their compounded product contained an additive. B vitamins were by far the most common, reported by 42 businesses, or 56.0 percent. Levocarnitine appeared at five businesses, or 6.7 percent, and glycine at four, or 5.3 percent.
Adding an ingredient can convert a copy of an approved drug into something a pharmacy may argue is a distinct, patient-specific preparation. The clinical case for those additions is another matter. The authors noted that the benefit of these additives is not established, and DiStefano raised the question directly.
"One concern is whether we're seeing clinically meaningful personalization or changes that primarily allow compounded products to remain on the market," he said.
The study authors concluded that the FDA's decision to resume enforcement appears to have pushed the market toward additive-based products rather than shrinking it.
Why Sterile Technique Matters More for Injectables
The supplier findings are where the safety argument becomes concrete, and this is the part patients rarely see.
Researchers traced the 75 businesses back to 24 compounding pharmacy suppliers located across at least six states. Among the 21 facilities whose sterile compounding license status could be confirmed, four, or 19.0 percent, were not licensed to perform sterile compounding at all. One facility had received two FDA warning letters since 2023, both citing sterile compounding violations. Three of 22 facilities, or 13.6 percent, had faced state board of pharmacy disciplinary action.
A pill that is contaminated encounters the stomach, the liver, and the immune system before it reaches the bloodstream. An injection does not. GLP-1 products are injected into subcutaneous tissue, bypassing every barrier the body normally uses to filter what enters it. That is why sterile compounding is a separate licensing category with its own facility standards, air handling requirements, testing protocols, and personnel training.
If a sterile preparation is contaminated with bacteria or fungus, the result can be a bloodstream infection, an abscess at the injection site, or, in severe cases, sepsis. Sterility is also not something a patient can check. A contaminated vial looks the same as a clean one.
Consultation patterns in the study add a second layer. Most consultations were conducted by nurse practitioners or physician assistants, at 42 of 75 businesses or 56.0 percent, compared with physicians at 30 businesses or 40.0 percent. Fifty-two businesses, or 69.3 percent, required an in-person consultation, and 46, or 61.3 percent, required follow-up at least monthly. But 17 businesses, or 22.7 percent, required less frequent follow-up or none at all, which is relevant for a drug class that requires dose escalation and monitoring.
What the Study Does Not Show
This is a cross-sectional survey, not a clinical outcomes study, and its limits should be stated plainly rather than buried.
The researchers observed what 75 businesses in two states said on the phone during a three-month window in late 2025. They did not test any product, did not confirm that any specific vial was contaminated, and did not track what happened to any patient. Nothing in the study demonstrates that a person was harmed. What it documents is regulatory exposure: a supply chain in which some sources lack the license for the type of preparation they are supplying.
The sample is also narrow by design. West Virginia and Oklahoma were chosen for high potential demand, and results may not describe California or New York. The study looked only at storefront clinics and medical spas, deliberately excluding online telehealth, which the authors noted has received more scrutiny. And because the calls ended in October 2025, the picture may have shifted since.
What Patients Should Ask Before Buying
DiStefano offered one specific piece of guidance in comments to Healio: do not buy a compounded GLP-1 from any vendor unwilling to name the supplying pharmacy. Once the name is known, a patient can contact their state board of pharmacy to check licensure and disciplinary history.
Beyond that, the practical questions are whether the preparation contains additives and why, who will handle dose escalation, how often follow-up occurs, and whether the clinic can produce documentation of the pharmacy's sterile compounding license. Patients already using a compounded product should not stop abruptly on their own. Discontinuation and switching decisions belong with a treating clinician, particularly for people managing diabetes alongside weight.
Cost is the reason most people end up in this market at all, and that context is not a criticism of patients. Brand-name products remain expensive, and coverage has tightened. Manufacturer direct-purchase programs and patient assistance foundations run by Novo Nordisk and Eli Lilly are worth asking about before turning to a compounded source of unknown provenance.
What Happens Next
The regulatory pathway is narrowing. The FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulk drug substances list, which would prevent registered outsourcing facilities from compounding these drugs in bulk outside a declared shortage. That proposal would not directly govern 503A pharmacies, which compound against individual prescriptions under state board oversight.
The authors called for closer attention to how these products are regulated and how patients can verify quality. MedicalDaily will track the FDA's final action on the 503B bulk list, any enforcement against the supplier facilities identified in this line of research, and follow-up work extending the survey beyond two states.
Frequently Asked Questions
What did the study find? That 92.0 percent of 75 surveyed weight loss clinics and medical spas in West Virginia and Oklahoma still offered compounded semaglutide and 86.7 percent offered compounded tirzepatide, months after the FDA declared the shortages resolved.
Is compounded semaglutide illegal now? Routine copies of commercially available drugs are restricted. Compounding pharmacies may still prepare patient-specific formulations for documented clinical reasons, which is part of why additive-containing products have become common.
Did anyone get sick? The study did not examine patient outcomes and does not report any injury. It documents licensing and disciplinary gaps among suppliers, not confirmed contamination.
Why does sterile compounding matter so much here? Injected drugs bypass the skin and digestive tract, so contamination goes directly into tissue or bloodstream. Sterile compounding is a separate license category with its own facility and testing standards.
What are the additives in these products? Most commonly B vitamins, reported by 56.0 percent of businesses, followed by levocarnitine and glycine. The study noted the clinical benefit of these additions is not established.
What should I ask a clinic? Ask for the name of the supplying pharmacy, then check that pharmacy with your state board of pharmacy. Also ask about additives, sterile compounding licensure and follow-up schedule.
Should I stop a compounded GLP-1 I am already taking? Do not stop or switch on your own. Talk with a qualified clinician, especially if you also manage diabetes.
