Compounded GLP-1s No More: What to Know

For the last 2 years, compounded versions of glucagon-like peptide 1 (GLP-1) medications have been big business. Nearly 137 million American adults are eligible to use these costly drugs to treat diabetes and obesity, or for secondary prevention of cardiovascular disease. That’s more than half of our adult population, so it’s no surprise the drugs have been in short supply. Compounding pharmacies stepped in to fill the gaps, as permitted by law during shortages, and millions of Americans turned to them for affordable, copycat drugs. But the US Food and Drug Administration (FDA) has now declared those shortages over. Compounding pharmacies will soon have to stop selling their mass-produced versions — at least, in theory.

“There is so much money to be made,” Robert Califf, MD, FDA commissioner under former President Joe Biden, told Reuters. “There’s just an endless number of tricks that compounders could use. So I don’t think it’s the end of it, but it certainly will bring us into a new era after the time period has passed and all the lawsuits are finished.”

Here’s what you should know.

Concerns About Compounded GLP-1s

As sales of these drugs boomed, problems emerged. Compounding pharmacies are regulated by the FDA, but the individual drugs they make don’t need to meet the same evidentiary standards as their brand-name counterparts. The brand-name drug has FDA approval, but the compounded version does not. Advertising for online vendors has walked a fine ethical line in terms of promises made, said Rena Conti, PhD, associate professor of markets, public policy, and law at Questrom School of Business at Boston University, Boston. She’s the co-author of a recent article in JAMA Health Forum that looked at marketing and safety concerns with compounded GLP-1s.

Questionable marketing isn’t the only issue.

“From a medical perspective, one challenge of dealing with the explosion of these products online is that it’s not clear whether your patients are using them,” she said. “Your medical record is not complete, and that creates challenges because these products have side effects and have interactions with other drugs and with the management of other conditions.”

There are risks specific to the way the drugs are dispensed, too. Brand-name GLP-1s generally come in prefilled injection pens. With compounded versions, patients must learn to fill an empty syringe from a vial. User error is common.

“All drugs have side effects, but what we’re documenting is that patient-reported problems with use of these products have exploded,” Conti said. “We think it has to do with these compounding products being dispensed in a way that patients don’t completely understand how to take them.”

By November 30, 2024, the FDA had received more than 600 reports of adverse events with compounded GLP-1s.

Accessibility and Affordability

As popular as they are, GLP-1 medications aren’t cheap. Brand-name prescriptions cost upward of $1000 per month. According to Becker’s Hospital Review, skyrocketing demand has led several insurers to post operating losses. Coverage was restrictive before, but it’s even more so in 2025.

According to GoodRX, which tracks how insurance companies handle these drugs, almost 5 million people lost coverage for Zepbound this year. And for patients whose insurance does cover some GLP-1s, 83% now must meet some additional requirement, like prior authorization.

This double whammy of limited accessibility and hard-to-swallow pricing helped drive patients to compounding pharmacies, where they’ve been able to get the medications for much less — for instance, telehealth company Hims & Hers has been offering a month’s supply of compounded semaglutide for $165. That company is currently trying to find a legal workaround to the FDA’s deadline.

“Some compounders think maybe they’ll keep producing,” said Jeanne Varner Powell, JD, senior legal risk consultant for the Mutual Insurance Company of Arizona Risk Team. “They may believe the FDA enforcement manpower is so weak that the FDA won’t be enforcing the prohibition that closely. Maybe they’ll keep producing. Physicians need to be aware of that. From a risk standpoint, I don’t think they’d want to be associated with a compounder that’s in violation of the law.”

Once the ban on large-scale compounding of GLP-1s takes effect, physicians should be on the lookout for — and warn their patients about — counterfeit versions that might fill the gap, Powell said. The FDA has already expressed concern about this.

Meanwhile, the drug companies behind brand-name GLP-1s are getting into the act, selling direct-to-consumers well below list price. Last summer, Eli Lilly began to offer a month’s supply of Zepbound for between $350 and $500 without insurance. The company told NPR that 100,000 people now buy direct each month. Recently, Novo Nordisk announced they’ll be dispensing Wegovy for $499 per month. Even at these lower prices, though, brand-name medications remain out of reach for many.

“It’s about managing expectations,” Powell said. “It’s important to tell patients, while these [compounded] drugs are still available, we expect there’s going to be an end. You have to consider if you can afford the cost of the name brand.”

How to Better Help Your Patients

So while the FDA may say shortages are over, compounded GLP-1s aren’t necessarily going away. They’ll still be permitted on an individual basis. For instance, to create a version of a drug that doesn’t contain a certain ingredient or in a dosage that isn’t readily available.

“That determination is made by the physician who has to write a prescription for a patient-specific drug that, in their opinion, will make a clinical difference for the patient,” Powell said. So if you have patients who need access to a specific kind of compounded GLP-1, you can still prescribe it. Advise your patient on how to find a trustworthy compounding pharmacy, and if necessary, show them how to administer the drugs to themselves.

But use this option judiciously, she cautioned. “I’d hope they wouldn’t get into a routine of copy-pasting, using the same rationale for each patient. If something happens — if an adverse outcome happens — they’re opening themselves to risk.”

Communication is key, Conti said. “If physicians are seeing patients drop weight over time that looks to be in the range of what’s possible with GLP-1s and they haven’t prescribed [the medication], they should educate their patients on the use of these products found online in a compounding format. Ask directly and document it in their medical records.”

Part of that communication calls for empathy and paying attention to each patient’s situation.

“Physicians should anticipate their patients might try to get medications from alternative sources if they can’t get the physician to write an individual compounding prescription, and they can’t afford brand-name prices,” Powell said. “It’s very likely the physician’s duty, as part of their relationship with the patient, to warn them there may be counterfeit drugs out there. Compounded versions should not be available, so they should be very skeptical about anything they see online.”