As demand for medications like Ozempic and Wegovy (semaglutide) and Mounjaro and Zepbound (tirzepatide) continues to surge, a growing number of patients are turning to compounded versions when they can’t access brand-name prescriptions or insurance coverage.
Featured Experts
- Dr. Caroline Messer is a board-certified endocinologist in New York
- Dr. Spencer Nadolsky is an obesity and lipid specialist in Portage, MI
- Dr. Sharon Giese is a board-certified plastic surgeon in New York
Why People Are Turning to Compounded Versions
Insurance coverage remains one of the biggest obstacles for people who need GLP-1 treatment. New York endocrinologist Caroline Messer, MD, explains that strict coverage rules often determine who can get access to FDA-approved medications.
“Semaglutide has two FDA-approved versions: Ozempic and Wegovy. Ozempic is only approved for adults with type 2 diabetes and Wegovy is only approved for weight management. The vast majority of patients with diabetes can obtain insurance coverage for Ozempic, but unfortunately, patients with borderline diabetes (prediabetes/insulin resistance) are excluded from coverage,” says Dr. Messer.
Even patients with confirmed obesity, she adds, frequently discover their plans exclude all weight loss medications altogether. Those denials are driving many toward compounded semaglutide or tirzepatide in hopes of continuing treatment without interruption.
What “Compounded” Really Means
Compounded medications are made in specialized pharmacies that mix and prepare customized versions of drugs. In this case, that means pharmacists are creating formulations that mimic semaglutide or tirzepatide, sometimes adding ingredients like vitamin B12 or L-carnitine. “Compounding pharmacies use the salt forms of semaglutide including semaglutide sodium and semaglutide acetate. These are different active ingredients than those used in the approved drugs. This alteration may change the bioavailability and strength of the medication,” says Dr. Messer. She notes that these differences, and the lack of standardized testing, can impact how the body absorbs and responds to the drug.
The same applies to tirzepatide, which is sold as Mounjaro for diabetes and Zepbound for chronic weight management, each with its own specific FDA indication and coverage requirements.
The Safety Question
Because compounded GLP-1s are not FDA-approved, their quality and consistency can vary between pharmacies. Dr. Messer cautions patients to understand the risks: “There is no way to guarantee the safety, efficacy, or potency of these formulations.”
Obesity specialist Dr. Spencer Nadolsky agrees that the lack of oversight is concerning: “There have been no studies assessing the safety or effectiveness of compounded versions of GLP-1 medications, which raises a significant concern. These compounds are not FDA-approved and have not undergone rigorous testing like the FDA-approved versions have undergone over many years in treating diabetes.”
Some Doctors See Benefits for Select Patients
Not every physician dismisses compounded GLP-1s outright. New York plastic surgeon Sharon Giese, MD, says some versions include added ingredients that may help offset side effects: “Many add an additional ingredient to differentiate it from the prescribed medication. I like B12 added for several reasons,” she says.
Dr. Giese has also seen encouraging patient outcomes: “I’ve encountered several otherwise healthy but obese patients whose primary care doctor prescribed medication, only to find that their insurance did not cover it. Or some whose doctor would not write for the script because they ‘do not write for weight loss meds.’ I have helped many patients lose 40 to 60 pounds or more.”
What Doctors Want GLP-1 Users to Know
Even among providers who have used compounded options successfully, the overall message remains one of caution. Dr. Messer notes that while some patients report similar results to brand-name medications, these versions don’t carry the same regulatory protections.
“Anecdotally, I have seen no difference in outcomes in my own practice after treating hundreds of patients with the compounded versions,” she says. “I place a strong emphasis on improving lifestyle and treating emotional eating for a more sustainable weight loss. For this reason, my practice employs a dietitian, two trainers and a psychologist. Since compounded medications lack insurance coverage, I encourage individuals to proactively set aside funds in health savings accounts for payment with pre-tax dollars.”
The Takeaway
Compounded semaglutide and tirzepatide have become an alternative for many people who can’t access brand-name GLP-1s, but these versions aren’t FDA-approved, standardized, or guaranteed for safety. While some patients may see good results, others could face inconsistencies in formulation or dosing.
If you’re considering a compounded GLP-1:
- Talk to your prescribing provider and ask which compounding pharmacy they use. Confirm that the pharmacy is state-licensed and accredited by the Pharmacy Compounding Accreditation Board (PCAB). Ask about ingredient sourcing, testing and storage.
- Continue monitoring your health and side effects closely with your doctor.
When possible, FDA-approved GLP-1 medications remain the safest, most studied options, but when access or cost become barriers, understanding the facts helps you make an informed, confident decision in your weight-loss journey.
