Kari Doherty, 38, decided in March 2025 that she wanted to start the obesity medication Zepbound (tirzepatide) to help her lose weight. But she balked at the out-of-pocket costs. “My health insurance specifically excludes weight loss medications from coverage,” says Doherty, an MBA student in Portland, Oregon. “I didn’t want to pay $1,300 each month – even though I could afford it, it seemed outrageous.”
Then she learned that there was another, more affordable option. Since there was currently a shortage of drugs like tirzepatide, the FDA allowed pharmacies to temporarily make compounded, or copycat, versions. These drugs were available at a fraction of the out-of-pocket costs of the actual medications, in some cases as low as $230 a month.
After some online searching, Doherty decided to get tirzepatide from a telehealth platform that provided compounded medications. At first, everything seemed to go smoothly. She filled out an online form, and shortly after she was approved to get the drug. Within two months, she’d dropped 15 pounds. “It may not sound like a lot, but I was working full time and in graduate school, which left little to no time to exercise,” Doherty says. “After having weight loss surgery and trying countless diets, I found it was the easiest way to manage my health.”
But two months in, she hit an unexpected roadblock when she learned that the FDA was beginning to phase out compounded versions. Her prescriptions were delayed, which led to lapses in her doses. When she finally got the medication, she learned that it had been mixed with niacinamide (a form of vitamin B3) to her tirzepatide in an effort to skirt FDA regulations. The new combination gives her terrible diarrhea that lasts for about three days after she takes the drug. Now, she’s unsure whether to continue.
“I feel frustrated that the FDA is taking compounded tirzepatide away,” Doherty says. “People deserve affordable access to these life-changing medications.”
What Are Compounded GLP-1 Medications?
Compounded GLP-1 medications are customized versions of GLP-1 medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound). These drugs mimic a hormone that’s naturally found in your body. They slow down how quickly food leaves your stomach, and they send fullness signals to your brain. They were initially approved by the FDA as Ozempic and Mounjaro to manage type 2 diabetes, but they have also been approved as Wegovy and Zepbound as weight loss drugs.
Compounded GLP-1 drugs are made by a special type of pharmacy known as a compounding pharmacy. “They’re designed to mimic GLP-1 drugs such as semaglutide and tirzepatide,” explains Amanda Velazquez, MD, director of obesity medicine at the Center for Weight Management and Metabolic Health at the Cedars-Sinai Medical Center in Los Angeles. But because they are customized, they differ from the actual GLP-1 drugs in three key ways:
- They aren’t FDA approved.
- They don’t go through clinical trials.
- They haven’t been reviewed by the FDA for safety, effectiveness, and quality.
National organizations like the Obesity Society, Obesity Action Coalition, and the Obesity Medicine Association don’t recommend compounded GLP-1 medications. “They can’t be vouched for. Because they are compounded, they can’t contain the exact same drug,” says Velazquez. “There’s no way to know if what’s in them is safe and even effective.”
What Are the FDA Shortage Rules for Compounded GLP-Medications?
Compounded GLP-1 medications cropped up in 2022 after manufacturer shortages for the brand-name weight loss drugs Wegovy and Zepbound. “The drugs themselves weren’t in short supply, but the autoinjector pen that delivers the medication was,” explains Velazquez. When a commercially available drug on patent is in shortage, the FDA allows compounding pharmacies to step in to meet any unmet need.
Three years later, the shortage ended. By February 2025, the FDA announced that supply issues for the two main GLP-1 drugs used for weight loss – semaglutide and tirzepatide – had been resolved. But some compounding pharmacies continued to make them for a few months. They were given grace periods to phase out these medications. The ability to legally copy Eli Lilly’s tirzepatide ran out in March 2025, as did the ability of state-licensed pharmacies to duplicate Novo Nordisk’s semaglutide in April. Larger compounded pharmacies that shipped products across state lines had a deadline of May 22, 2025.
Now, people who rely on compounded GLP-1 drugs to help them lose weight worry that they will lose access to them. “It’s been a roller coaster ride since the FDA announced the end of the semaglutide shortage back in October 2024,” says Amanda Bonello, 35, founder of the GLP-1 Collective, a nonprofit dedicated to helping people gain better access to these weight loss drugs.
Bonello, who has been on tirzepatide since late 2024, has lost over 50 pounds since she started the medication. Since her health insurance would not cover the drug – although she was prediabetic, with a family history of type 2 diabetes – she opted to pay out of pocket for a compounded version.
“It’s been life-changing,” she says. “I’d spent decades battling disordered eating, including bulimia. But once I started tirzepatide, all the food noise disappeared. I was no longer starving all the time.”
Bonello found a telehealth company in late 2024 that provided a yearlong supply of tirzepatide, but she worries what will happen when her stockpile runs out. “I feel like if my compounded tirzepatide is taken away, it also takes away my hope and my health,” she says.
What Are the Risks of Compounded GLP-1s?
The biggest risk when it comes to compounded GLP-1s is that you don’t know what’s in these medications, says Velazquez. This is especially true now that these medications have been phased out. You may still come across advertisements for compounded GLP-1s online. In these cases, companies may try to skirt FDA rules by prescribing the drugs in different doses, or with added ingredients to try to make them differ from commercially available products, says Louis Aronne, MD, Director of the Comprehensive Weight Control Center at Weill Cornell Medicine in New York City. That’s not safe, either.
Here are some of the biggest concerns about these compounded GLP-1s:
Overdoses. Unlike actual GLP-1s, which come in autoinjectors that are individually dosed, compounded products come in multi-dose vials with syringes. This means that you have to measure the dose yourself, which can lead to errors. The FDA has received reports of overdoses of compounded GLP-1 drugs, where people administered five to 20 times more than the intended dose.
Added ingredients. Some compounded GLP-1s include fillers such as vitamin B12. “The companies are trying to skirt FDA compounding rules by claiming that their medication is customized for their patients,” explains Aronne. “That’s very concerning, especially since we don’t know how safe these added ingredients are when they’re mixed into the same injection as a GLP-1. It’s a recipe for disaster.”
Counterfeit medications. In April 2025, the FDA issued a warning about counterfeit versions of Ozempic (semaglutide) circulating throughout the United States. “There’s just no way to tell what’s in them,” says Aronne. Case in point: In the past, the FDA has issued warnings that some compounded forms of semaglutide didn’t contain the same active ingredients as the approved versions for type 2 diabetes and weight loss. Instead, they contained the salt forms of semaglutide, like semaglutide sodium and semaglutide acetate, which haven’t been shown to be safe and effective.
Side effects. Like the regular versions of GLP-1 medications, the compounded versions can cause side effects such as nausea, vomiting, and diarrhea. But since people don’t get these drugs from their doctor, they may be uncomfortable letting them know about them.
“When I took my compound tirzepatide that was mixed with vitamin B12, within about 36 hours I developed diarrhea so intense it felt like I was dying,” says Doherty. Though she did go to her doctor, she did not let them know she was taking a compounded GLP-1. “They ended up running a bunch of tests to look for bacteria and parasites,” she says. “It wasn’t until all my results came back negative that I made the connection that it was most likely due to the compounded tirzepatide. But I was afraid to tell my doctor that I’d taken it. I worried about being judged.”
How to Switch From a Compounded to a Branded GLP-1
You may have started to use a compounded GLP-1 during the initial drug shortage. Or you turned to them as a more affordable option. While cost may still be a concern, there are ways to lessen the load on your wallet, reassures Aronne. Here are some steps to try.
Talk to your doctor. They may be able to help you get drug approval from your insurance company, says Aronne. While your plan may not cover GLP-1 drugs for weight loss, they may if you have another underlying condition. Zepbound (tirzepatide), for example, was FDA approved in 2024 to treat sleep apnea, while Wegovy (semaglutide) is often covered by insurance if you have type 2 diabetes or heart disease.
Go directly through the drug company. If your health insurance won’t cover the drugs, you can save hundreds of dollars if you get medications straight from the manufacturers, says Aronne. Zepbound is available through LillyDirect for $349 for a 2.5-milligram monthly vial, or for $499 for a 5-milligram, 7.5-milligram, or 10-milligram monthly vial. You can get Wegovy for $499 a month through NovoCare Pharmacy.
See if you qualify for patient assistance. The Novo Nordisk Patient Assistance Program (PAP) makes Ozempic (semaglutide) available at no cost to people who qualify. You need to be a United States citizen, have a total household income that’s at or below 400% of the federal poverty level ($128,600 for a family of four), and have Medicare or no insurance to be eligible.
Cut down on use. “I have patients who take the lowest possible dose and use it every 10 days instead of once a week,” says Aronne. “Will they get to their lowest possible weight? No. But they’re able to lose some weight while they save 25% on the cost.”
Try other weight loss treatments. “There are other tools in our toolbox that we can try to help you lose weight that are either covered by insurance or have much lower out-of-pocket costs,” says Velazquez. These include older weight loss medications such as phentermine/topiramate or bupropion/naltrexone. “Most people are able to lose 5% to 10% of their body weight, and they may lose more if we use two or three of these drugs together,” she explains. A 2024 study published in the journal Obesity found that people who used a GLP-1 medication for a year, then switched to one of these drugs were able to maintain their initial weight loss – and sometimes lose even more – for up to two years.
Also remember that these GLP-1 medications will become more affordable over time. “Prices won’t stay as high as they are forever,” says Aronne. “As more health insurance companies see the benefits of these medications, they will begin to cover them more frequently. There are also other weight loss medications in development, and as more become available, overall costs to consumers will go down.”
Takeaways
Glucagon-like peptide-1 (GLP-1) drugs like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) were in shortage starting in 2022. As a result, the FDA allowed companies to create compounded versions of these medications, which are considerably cheaper but aren’t FDA approved, so their safety and effectiveness are unknown. As of May 2025, compounded versions of these drugs are no longer allowed, but some companies are mixing the drugs with other fillers, like vitamin B12, to skirt these rules.
