Compounded GLP-1 medications help fill a necessary gap, but can have significant safety issues.

Compounded GLP-1 medications are largely unregulated and may contain contaminated ingredients.

Stronger oversight is needed to provide clearer public guidance about compounded GLP-1 medication.

A recent op-ed in the Washington Post describes the story of an author who decided he wanted to lose weight. Although he was healthy, he heard from friends how easy and effective GLP-1 medications could be. Instead of receiving a prescription from his health-care provider for a brand-name medication, he was prescribed a compounded injectable containing the active ingredient in Zepbound. He took it to a local pharmacy and had it filled. Instead of achieving the desired weight loss, within two weeks, he was in acute liver failure. Thankfully, he survived, but he required an emergency liver transplant. The pathology report that came back after surgery revealed that his liver had extensive cell death as a result of severe drug-induced injury.

According to an update published in JAMA, almost one in eight adults in the United States reports having tried a GLP-1 medication. Forty percent of these individuals said they intended to use these medications for weight loss. Almost the same proportion reported using them to treat chronic conditions such as diabetes or heart disease. Most respondents said the prescriptions they received were from their primary care physician or a specialist. However, almost 20 percent obtained theirs from other sources, such as weight-loss clinics, medical spas, or online providers.

Many respondents had health insurance that refused to pay for their prescription. In a different poll, nearly 30 percent of adults taking these medications said they paid out of pocket. These costs are not inconsequential. Without insurance, for example, a one‑month supply of brand-name medications like Wegovy, Ozempic, or Zepbound typically costs between $900 and $1,400.

According to an article in BMC Public Health, older adults in the United States from racial and ethnic minority groups, as well as those with lower socioeconomic status (SES), bear a disproportionate burden of obesity and related health problems. Because of this, and due to limited availability soon after these medications were released, patients increasingly turned to compounded drugs.

What Are Compounded Drugs?

According to the U.S. Food and Drug Administration (FDA), traditional pharmacy compounding is “combining, mixing, or altering ingredients to create a customized medication for an individual patient based on a licensed practitioner’s prescription.” Compounded drugs use FDA‑approved ingredients, but the customized medication itself is not FDA‑approved. This means the FDA does not specifically review the safety, effectiveness, or quality of compounded medications before they are given to patients.

While compounded medications help fill a necessary gap, they can have significant safety issues. Because of less stringent regulatory oversight, patient safety may be compromised by contamination, inaccurate potency, or inconsistent quality. A compounded GLP-1 product may not even contain the same active ingredient found in the branded versions. Differences in chemical ingredients can alter how the drug is absorbed, distributed, and metabolized in the body, leading to potential side effects. These inconsistencies can undermine the medication’s effectiveness and contribute to patient nonadherence. Marketed as more affordable and accessible, these formulations may seem like a practical solution. In reality, they represent a largely unregulated and potentially dangerous substitute for rigorously tested medications.

On March 12 of this year, Eli Lilly, the manufacturer of Zepbound, wrote an open letter warning of safety risks associated with compounded tirzepatide (the active ingredient in Zepbound) that was mixed with vitamin B12 in some off‑label formulations. They specifically noted, “Our testing has uncovered significant levels of an impurity that results from a chemical reaction between tirzepatide and B12.” You might wonder why combining this with a vitamin would be so worrisome. The reason is that the combination of these two ingredients can create a toxic substance that can harm patients. This was the case with the compounded medication taken by the op‑ed author. He took it to a local pharmacy, where it was compounded. Unfortunately, when compounding his prescription, one of the active pharmaceutical ingredients used was sourced from China, where many of these ingredients are produced in facilities not registered with or inspected by the FDA.

Because compounded versions are not approved by the FDA, they are not required to meet the same standards for safety, efficacy, or quality. FDA‑approved drugs undergo extensive clinical trials, standardized manufacturing processes, and ongoing safety surveillance. Compounded drugs do not. Even reputable compounding pharmacies cannot replicate the level of quality assurance required for FDA‑approved manufacturing. The result is a fragmented system in which patient safety depends heavily on the integrity of individual providers and pharmacies.

The Dangers of the Telehealth Boom

According to the New York Times, online weight-loss companies are generating massive revenue, driven by demand for GLP‑1 medications. One such platform, Medvi, is on track to earn almost $2 billion in sales. The rapid expansion of telehealth has further fueled the rise of compounded GLP‑1 drugs. Online clinics frequently advertise easy access, minimal screening, and rapid delivery. Although more convenient, this model often neglects the need for comprehensive medical evaluation and follow‑up. Not every website offering weight-loss medications operates legally or safely. There is a difference between licensed telehealth services and sellers on social media. Some online platforms do follow the rules: They require a virtual consultation, review your medical history, and prescribe medications only if deemed appropriate. These services are regulated, staffed by licensed physicians or nurse practitioners, and work with U.S.-licensed pharmacies.

However, there are others that do not require your medical history or a virtual appointment and promise to ship you something “just like Ozempic” without a prescription. These are dangerous and often operate outside U.S. regulations. The medications they send could be counterfeit, contaminated, or entirely different from what they claim. According to the FDA, many of these illegally operating online pharmacies have been caught selling fake or unapproved drugs. In some cases, pills labeled as weight-loss medication were found to contain completely unrelated or dangerous ingredients.

The growing reliance on compounded GLP‑1 drugs reflects real gaps in our health-care system, including drug pricing and access. However, substituting unregulated formulations for proven therapies is neither safe nor sustainable. Medical providers should encourage their patients to use FDA‑approved medications whenever possible. If compounded prescriptions are considered, it is essential to verify the compounding pharmacy's credentials and accreditation.

At a broader level, stronger regulatory oversight and clearer public guidance are urgently needed. Until then, both patients and providers must approach compounded GLP‑1 drugs with a critical eye and a commitment to evidence‑based care. Compounded GLP‑1 drugs may offer the promise of affordability and accessibility, but they do so by bypassing the very safeguards designed to protect patients. In medicine, shortcuts often come at a cost. When it comes to these powerful metabolic agents, the cost may be far greater than many realize.

U.S. Food and Drug Administration. "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss."

FDA Drug Safety Communications on compounded semaglutide and tirzepatide (2023–2024).

Folorunsho S, Ajayi V, Sanmori M. "Household income and obesity among older adults: the moderating role of race in a longitudinal analysis." BMC Public Health. 2025 Oct 2;25(1):3306.

Garg R, Singh H. "Safety of Compounded Medications." Cureus. 2025 Feb 5;17(2):

Griffith, Erin. "How A.I. Helped One Man (and His Brother) Build a $1.8 Billion Company" New York Times April 2, 2026.

Harris E. Poll: Roughly 12% of US Adults Have Used a GLP-1 Drug, Even If Unaffordable. JAMA. 2024;332(1):8.

Jastreboff AM, et al. "Tirzepatide Once Weekly for the Treatment of Obesity." New England Journal of Medicine. 2022.

Wilding JPH, et al. "Once-Weekly Semaglutide in Adults with Overweight or Obesity." New England Journal of Medicine. 2021.

Wilson, Jimmie. "How risky can the weight-loss drug boom be? I found out". The Washington Post, Opinion. April 4, 2026.

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