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.
“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.
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.”
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.
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.
“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.
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.
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.
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.
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.)
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.)
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.
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.
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.
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?
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.
“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.
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.
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.
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.
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.
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.
Brunner says that the blanket statement that compounded drugs are less safe is “subjective and unprovable.”
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.
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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