Before the pandemic, Diane Kinkade lost weight with diet and exercise. But by 2026, she decided she needed to try something else. She had prediabetes and high blood pressure, in addition to being overweight, but her doctor declined to prescribe her a GLP-1 weight-loss medication, saying he thought the side effects outweighed the benefits. So she asked around and found a telehealth site that seemed more than happy to send her a prescription for a GLP-1 after a brief questionnaire.
But the telehealth site didn’t send her a brand-name drug. It instead partnered with a compounding pharmacy to send her tirzepatide, the active ingredient in Eli Lilly’s popular drug Zepbound. The compounded drug represented significant cost savings—$250 a month versus the $399 a month she would have paid through LillyDirect, the direct-to-consumer site that people often use when their insurance doesn’t cover the drug.
Kinkade, who is 72, says she wasn’t too worried about injecting herself with what the compounding pharmacy had sent, a combination of tirzepatide and vitamin B12. At first, she started to lose weight. But a few months into her injections, the telehealth site switched compounding pharmacies, and she had such bad side effects from the new medication (ordered with the same prescription) that she says she could barely function. Brain fog, nausea, diarrhea, and exhaustion all plagued her.
“I could barely get up from the couch for a week,” she says. She tried reaching out to the telehealth site for help, but they just sent her canned, AI-type responses, she says. So she stopped taking the medication.
If Eli Lilly had its way, patients seeking tirzepatide would not be able to receive anything but Zepbound, which is approved by the U.S. Food and Drug Administration (FDA). The company’s patent on the drug does not expire until 2036.
In a 2024 news release from Eli Lilly about litigation it had pursued against compounding pharmacies, the company says that it is “the only lawful supplier of FDA-approved tirzepatide medicines in the United States” and that “patients taking a product referred to only as ‘tirzepatide’ are not taking an FDA-approved product.”
But because of a loophole—or a lack of enforcement, depending on who you ask—compounding pharmacies have still been sending patients compounded versions of tirzepatide.
An estimated 5 million people are using compounded GLP-1s in the U.S., according to a Gallup poll released in July; of the 11% of U.S. adults taking GLP-1 medications for weight loss, nearly one in five uses compounding pharmacies.
Compounding pharmacies are set to boom even further because people may soon use them to get more peptides—short chains of amino acids that have become popular among influencers who tout their benefits (absent robust scientific evidence, in most cases) for a wide variety of ailments—than they previously could. In July, an FDA committee decided that compounding pharmacies should be allowed to prepare six peptides for consumers; the FDA has not yet decided whether it will adopt the recommendations.
But compounding pharmacies are much less regulated than the drug manufacturers that make brand-name drugs. As more telehealth sites prescribe these medications and pitch them as a way to lose weight while saving money, some patient advocates argue that more people like Kinkade will fall through the cracks of a broken regulatory system.
Many pharmacies can compound medications. Compounding involves preparing a customized medication for a specific patient’s needs.
“Compounding is absolutely essential,” says Dr. Anjali Deshmukh, a pediatrician and law professor at Seton Hall University. Deshmukh uses compounding pharmacies when, for example, she treats a 3-year-old with a serious disease who can’t swallow tablets and needs medication in a different form.
For much of U.S. history, pharmacists had to mix individual medicines themselves: in the 1930s, three-quarters of prescriptions required in-pharmacy compounding. In this sense, compounding pharmacies have existed for as long as pharmacies have. For decades, pharmacies that compound small amounts of medication have operated under what’s called Section 503A of the Federal Food, Drug, and Cosmetic Act. Called 503As for short, they’re regulated by state boards of pharmacy.
Because they dispense small amounts of medications for individual patients, only with a doctor’s prescription, most 503As aren’t subject to certain FDA rules that apply to traditional larger drug manufacturers. That includes what’s called “current good manufacturing practices,” which are regulatory standards that ensure drugmakers record and trace every batch of product they make and have their equipment tested regularly.
They must adhere to other regulations, however. For instance, they must follow U.S. Pharmacopeia (USP) guidelines, which are set by a private non-profit that develops science-based standards for medicines, dietary supplements, and food ingredients. And they must source their active ingredients from FDA-registered suppliers, says Scott Brunner, the chief executive officer of the Alliance for Pharmacy Compounding, a trade group.
Struggles with regulation
This regulatory system has broken down before. In 2012 a compounding pharmacy called the New England Compounding Center started mass-producing medications in a setting that had been flagged as unsanitary numerous times. It shipped thousands of vials of contaminated steroid injections to patients. Dozens of people died, and investigators later found severe safety lapses in the pharmacy’s production of sterile drugs. The owner of the pharmacy was later convicted of racketeering and other offenses by a federal jury.
In response, in 2013 Congress passed a law creating a new category for compounding pharmacies that serve a large number of people, which it calls outsourcing facilities. These compounding pharmacies, known as 503Bs, are more tightly controlled and closely watched; they are required to follow current good manufacturing practices and are subject to routine FDA inspection. Those pharmacies can compound and distribute drugs on a large scale to help overcome national drug shortages, or when drugmakers stop making a certain drug. Unlike 503As, they can prepare batches of drugs without an individual prescription from a provider. But there are less than 100 of them in the U.S.
Both of these types of compounding pharmacies were essential when GLP-1 drugs were first released, says Brunner. Almost immediately after Zepbound, Wegovy, and Mounjaro hit the market, there were shortages. Physicians who knew that 503As could make compounded versions of the drugs with a prescription reached out to 503As to see if they could help their patients, Brunner says.
“Prescribers knew that this was a wonder drug and started sending prescriptions, saying, ‘Hey, can you make this?’” he said. “And if you were a sterile compounding pharmacy, you determined whether you could acquire the [active ingredients], and that’s how it started.”
Once the drugs were officially added to FDA shortages lists, 503Bs revamped their facilities to start mass-producing them. (It takes much longer for a 503B to ramp up because they produce large amounts of medication and must adhere to current good manufacturing practices, Brunner says.)
Seeing that compounding pharmacies were making these drugs, telehealth sites started advertising that they could provide consumers with cheap versions of GLP-1s, and patients and doctors alike became more comfortable with the idea of buying them from pharmacies they’d never visited. The initial high cost of the drugs motivated many patients to seek out cheaper versions, Brunner says.
This is not supposed to be how compounding pharmacies work, says Shabbir Safdar, executive director of the Partnership for Safe Medicines, a public-health group that aims to protect consumers from counterfeit or unsafe medicines. In 2012, when Congress created 503Bs in response to the New England Compounding Center tragedy, it assumed that 503As would stop mass-producing drugs, he says. But “they didn’t count on the 503As saying, ‘Yeah, I know you did that, but I don’t care. I’m going to mass produce drugs.’” (The FDA said, in a response to a query from TIME, that federal law limits when compounders can make copies of FDA-approved drugs.)
Eli Lilly has taken a position similar to Safdar’s on compounding. “Everyone who needs medicine deserves real medicine that has been trialed, tested, and manufactured in compliance with the law,” an Eli Lilly spokesperson wrote in a statement to TIME. Many compounding pharmacies, the spokesperson said, have been “unlawfully mass-producing knockoff drugs.” The spokesperson added that “anyone selling mass compounded products—including by referring to them as ‘personalized’ or ‘tailored’—is breaking the law and putting patient safety at risk.” (Novo Nordisk did not return TIME’s request for comment.)
The GLP-1 boom that began in 2021 was great news for compounding pharmacies. That’s because at the time, many pharmacies were struggling. Consumer behavior was changing, and people were buying more of their goods and medications online. Pharmacists have long argued that middlemen called pharmacy benefit managers (PBM)—which manage prescription drug benefits for insurers—reimburse pharmacies too little for many medications, cutting into pharmacy margins.
Compounding provided a rare opportunity for many small pharmacies to turn a profit. With GLP-1s, “I don’t want to compare it to a gold mine, but it’s a very good revenue source for pharmacies,” says Dae Lee, an attorney who focuses on pharmacy at Buchanan Ingersoll & Rooney, a law firm. “PBM reimbursement rates are very bad, and pharmacies are losing money left and right.”
Pharmacies that submit claims for GLP-1s very often lose money by filling those prescriptions, he says, because the cost of acquiring the drugs is higher than the reimbursement they get from insurers.
With compounded GLP-1s, on the other hand, pharmacists don’t have to deal with insurance because consumers pay cash. (Because compounded drugs are not FDA-approved, insurance will largely not pay for them.)
Compounding allows pharmacies that may otherwise have to shut down to stay open, says Ilisa Bernstein, who worked at the FDA for 31 years in roles including heading human drug compounding. She is now a consultant for compounding pharmacies.
“Independent pharmacies are struggling, and they’re looking for ways to keep their doors open,” she says. “If they can meet their community's needs through compounding, they’re trying to figure it out.”
The rush in demand for peptides could provide a new revenue stream for many small pharmacies. Demand for peptides “is large and growing, and the potential volume is likely to dwarf the volumes seen with GLP-1s,” the National Association of Boards of Pharmacy wrote in its testimony for the FDA committee’s July hearing on peptides.
Can compounding pharmacies even legally sell GLP-1s?
It was easy for Kinkade to get her compounded drug. All she had to do was fill out a form with her current weight and the medications she was taking. She asked for tirzepatide and received it within a couple of days. Some telehealth sites do sell brand-name GLP-1s, but many instead sell compounded drugs; one 2026 study in which a secret shopper easily obtained GLP-1 prescriptions from telehealth sites found that out of 45 telehealth websites, only 6 offered brand-name drugs.
Compounding pharmacies claim that the drugs they are selling are different from what the big drug companies are selling. They do this by working with medical providers to get a prescription for a different formulation of the drugs, changing the dose that they sell so that it is slightly different from what the drug manufacturer makes. The active ingredient often comes from an overseas lab. In 2025, the FDA launched a “green list” to ensure that compounding pharmacies were getting their active pharmaceutical ingredients from facilities that the agency has inspected or evaluated.
Kinkade’s vial of tirzepatide, for instance, included the vitamin B12. Adding extra ingredients is one way compounding pharmacies have been trying to distinguish their product so that they’re not just appearing to sell a copy of a brand-name GLP-1.
“So long as the product is not essentially a copy of a commercially available product, then compounding pharmacies can compound ingredients using semaglutide and tirzepatide,” says Lee.
But what counts as “essentially a copy” is up for debate. In April 2026, the FDA clarified policies for compounders, saying that a drug is essentially a copy if it has the same active pharmaceutical ingredient as the commercially available drug product “in the same, similar, or an easily substitutable strength,” or if the commercially available product can be used by the “same route of administration” (injection, for instance) prescribed for the commercially available products.
Then in September, it issued the first warning letter to a compounding pharmacy that included violations based on making copies of FDA-approved GLP-1 drugs. “The FDA will continue taking action, where appropriate, to protect patients and consumers from illegally marketed drugs and to protect public health,” an FDA spokesperson said in a statement to TIME.
That warning letter was one of the first actions the FDA has taken on this topic, says Bernstein, the former FDA staffer. “FDA recently issued a novel warning letter that focuses on copies of GLP-1s,” she says. “The agency picks and chooses its actions—they can’t go after everything.” But, she adds, “the law was not intended for 503As to mass-produce these products in the volume that we’re seeing.”
Eli Lilly and Novo Nordisk have sued some telehealth sites for saying that they were selling name-brand drugs, but have been hesitant to sue compounding pharmacies for making copies of their drugs, says Zachary Silbersher, a patent attorney. That’s because such patent lawsuits can be extremely expensive, and it can be difficult to prove that compounders did anything wrong, especially if they have a valid prescription from a doctor. Proving patent infringement is much more difficult than most people think, he says.
“Suing individual pharmacies can take a lot more time and energy than you might realize,” he says. “The lawsuits might start costing more than they’re worth.”
Is it dangerous to buy drugs from compounding pharmacies?
Besides the deaths of a dozen people from the compounding pharmacy in New England, some groups have raised broader safety concerns about drugs from compounding pharmacies.
One research paper published in Expert Opinion on Drug Safety in 2025 found that people who had taken compounded GLP-1s tended to have worse side effects—including abdominal pain, diarrhea, and nausea—than people who had used the brand-name products between 2018 and 2024. Reports of prescribing and preparation errors were also higher for compounded medications, the researchers found.
Anecdotal examples of people having bad reactions to compounded GLP-1 drugs include a woman in North Carolina who says she was hospitalized for three days after being prescribed too high a dose of a compounded GLP-1, according to an investigation by KFF Health News, and a Kentucky woman who wrote in the Washington Post about needing a liver transplant after taking a compounded GLP-1 drug mixed with vitamin B12.
“I’m actually a little appalled that we’re very comfortable injecting ourselves with these substances,” says Safdar, whose group Partnership for Safe Medicines helped fund the 2025 study. “I don’t know when we crossed the Rubicon.”
Safdar argues that there’s no way to know if the GLP-1s from compounding pharmacies are safe because they are not getting the drug from an FDA-inspected manufacturer. (They are, however, supposed to be getting the active ingredient from an FDA-approved supplier.) And while manufacturers like Eli Lilly or Novo Nordisk have to follow current good manufacturing practices, he reiterates, compounding pharmacies don’t.
“When Lilly or Novo went to the FDA and got an approval for its drug, it was for an approval of the drug that included a quality control manufacturing process,” he says. “So if you’re a compounder and you’re saying it’s the same active ingredient—well, that’s just not true.”
Brunner says that the blanket statement that compounded drugs are less safe is “subjective and unprovable.”
And many compounding pharmacies take extra steps to ensure that the active ingredients they are using are safe. Lawrence Rossetti, the CEO of Drug Crafters, a 503A in Texas, says that in addition to sourcing active pharmaceutical ingredients from FDA-registered suppliers, Drug Crafters tests the raw material before making any order. If the testing confirms that the drug is what the pharmacy claims, that specific lot is approved for compounding. The pharmacy’s finished-product formulations “are tested for potency, antimicrobial effectiveness, container closure integrity, method suitability, and undergo endotoxin and sterility testing before they can be sent to any patient," he says.
Some providers and patients say that despite the lessened FDA oversight, compounding pharmacies may be the best option many people have to get the medication they want at the price they want. “I would argue that the drug makers have overpriced their drug, and compounding pharmacies have been the only reason that those prices have come down over the past three years or so,” Brunner says.
Of course, you could argue that you get what you pay for. After receiving unhelpful, automated emails from her telehealth site, Kinkade finally got a response from a nurse practitioner who had a suggestion for why the tirzepatide had made her so sick: it may have had to do with the fact that the telehealth site had switched the compounding pharmacy it used. She says that the nurse practitioner emailed her that different pharmacies can prepare the same drug at different concentrations, even with the same prescribed dose, and that she accidentally might have gotten a much stronger dose of tirzepatide than she’d been used to taking. If she developed severe or worsening symptoms, the nurse practitioner wrote, Kinkade should seek urgent medical care right away. The email did not tell her whether she should take any more doses of the medication.
Kinkade decided to lower the dose she was taking on her own, and she hasn’t had bad side effects since.
She hesitates to return to telehealth or compounding pharmacies since her experience. Kinkade recently went to her annual checkup, and her doctor was impressed by how much weight she’d lost, and how good her glucose and other numbers looked. This time, he agreed to prescribe her a brand-name GLP-1.
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