People who order low-cost versions of the hugely popular weight loss drugs Vegovi and Zepbound from so-called compounding pharmacies may soon see interference with their medication.
U.S. Food and Drug Administration Recently Announced Schemes To crack down on active pharmaceutical ingredients used in glucagonlike peptide 1 (GLP-1) drugs produced in compounding pharmacies, which create customized drugs when FDA-approved drugs are unavailable. This move by the agency has raised many questions about the safety and effectiveness of combination medicines.
What does the FDA’s “notice” actually crack down on?
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In recent years, thousands of retailers—some legitimate and some illegal-GLP-1 have emerged to offer compounded versions of weight loss drugs, usually taken as weekly injections, at extremely low prices, often without the need for a prescription. The high demand for these drugs means “there’s a lot of money to be made,” says medical toxicologist Joshua King of the University of Maryland, suggesting that financial opportunity has triggered this explosion of compounding pharmacies.
The FDA intends to remove questionable active ingredients from the GLP-1 drug market. But the agency’s plan could make it even more difficult for legal compounders to produce the drugs. The notice specifically calls out one of the largest providers of compounded GLP-1 drugs: His & Hers. Just a day later, the telehealth company suddenly canceled it GLP-1 pill launched for weight loss. Two days later, Novo Nordisk—the developer of Wegovi—filed a lawsuit Accused Hims & Hers of illegally mass-producing and advertising “knockoffs” of their patent medicine.
Himes and Hers wrote, “This lawsuit does not just attack a drug or a company – it directly attacks a well-established, important component of American pharmacy practice.” A statement posted on. in an e-mail to scientific American, Novo Nordisk Senior Vice President John F. Kuckelman wrote that “Nothing in our lawsuit will prevent pharmacies from compounding other drugs to meet the needs of American patients.”
The FDA’s notice is mentioned in Novo Nordisk’s press release about the lawsuit. When asked by scientific American The company did not say whether this was the reason for the lawsuit.
How compounded medicines work
Some say the FDA’s notice comes as the number of compounding pharmacies producing GLP-1 drugs has skyrocketed. Compounding pharmacies typically prepare versions of approved drugs that are not widely available, but they can also fill gaps in supply.
Two types exist: 503A and 503B pharmacies. A 503A compounding pharmacy makes small batches of a prescription drug to meet a person’s individual need – for example, a specific concentration, dosage or form of delivery (often useful for children, pets or zoo animals). If a person is unable to take the medication orally, for example, these pharmacies can make a compounded version as a cream or intravenous (IV) drip, King explains. 503B pharmacies operate on a very large scale, using outsourcing facilities to mass produce compounded medications, with or without prescriptions, at relatively low costs and sell them to health care retailers.
The FDA does not review or approve compounded drugs, so they do not undergo regulatory testing for safety, quality, or effectiveness. 503A compounding pharmacies are generally regulated by state pharmacy boards, while 503B compounders are subject to some FDA oversight. Compounded drugs should not be confused with generic drugs, which are exact copies of FDA-approved drugs whose patents have expired. Nor are they counterfeit versions of the drugs.
“Not all compounding pharmacies are created equal,” says Janice Jin Hwang, MD, a physician and endocrinologist at the University of North Carolina at Chapel Hill. “There are some that have very good quality-control standards, but others don’t.”
The Scoop on Compounded GLP-1 Drugs
This is how the story of compound GLP-1 drugs began: A few years ago the US faced shortages of semaglutide (the active ingredient in Vegovy and Ozempic) and tirazepate (the active ingredient in Eli Lilly’s weight loss drug Zepbound and its diabetes drug Monjaro). When the FDA placed both drugs on the national shortage list in 2022, compounding pharmacies were authorized to obtain the active ingredients and produce the drugs to help fill the gaps in access. The FDA officially removed tirazeptide from the reduction list in December 2024 and semaglutide in February 2025.
Yet compounding pharmacies continue to produce GLP-1 drugs by creating custom versions that include certain additives and supplements. Medications may include B vitamins, which are marketed to reduce nausea and gastrointestinal side effects that are associated with GLP-1 medications, or levocarnitineThat may help reverse muscle wasting, says Gina Moore, a pharmacist and pharmacy law expert at the University of Colorado Anschutz. But the benefits of those additives are “theoretical,” she says. “There are no safety or efficacy trials associated with it.”
Are combined GLP-1 drugs dangerous?
Safety concerns with combination medications are not hypothetical. America’s poison centers Reported increase in medical problems Associated with mixed GLP-1 drugs. In 2024 the FDA issued a warning about an increase in overdoses and adverse side effects, largely due to errors in dosing of these drugs. Unlike brand-name GLP-1 injections, which come in pre-filled pens, many compounded versions come with syringes that people use to make the medicine themselves. They may also have to convert the dosage into different measurements, says King, who is the medical director of the Maryland Poison Center.
“We get pictures that show instructions that say, ‘Inject 0.05 ml.’ Many patients don’t know what it means, and we’ve seen people injecting 0.5 ml,” he says.
Experts have also expressed concern about the safety of the material. Many active pharmaceutical ingredients used in compounded medications are imported from foreign facilities, which must be inspected and registered by the FDA. But with such large quantities of GLP-1 drugs moving through the system so quickly, “the FDA may not have the time or resources to inspect in such detail,” Moore says.
The Partnership for Safer Drugs, a public health group that focuses on the safety of prescription drugs, reviewed the FDA’s consignment database and found that 239 semaglutide and tirazepateide shipments – many of which were for compounding – were produced in unregistered factoriesFacilities that have not been inspected by the agency.
An FDA spokesperson said scientific American The agency monitors imported drugs and active ingredients to ensure that they meet the same federal requirements as domestically manufactured drugs. The FDA has created a “green list” alert to flag imported GLP-1 active ingredients that may have “quality concerns,” the spokeswoman said, but she noted the list does not create new limits on the legal combination of drugs.
Nevertheless, some organizations are concerned that the FDA’s plan to restrict active ingredients in compounded GLP-1 drugs could impact the compounding industry at large. In a linkedin postScott Bruner, chief executive of the Alliance for Pharmacy Compounding, cautioned the FDA “not to over-reform and hinder access to other compounded medications that patients need to lead normal lives.”
The lowest dosage of the FDA-approved Vegov pill starts at an out-of-pocket price of $149 per month, while Hims & Hers markets its GLP-1 pill at $49 per month. Novo Nordisk spokeswoman Liz Skrubakova says privately insured people may pay less for brand-name drugs. Novo Nordisk’s direct-to-consumer pharmacy She says, “Most commercial patients pay at least $25 a month for Wegovi. And for those (who) are not covered, they can use NovoCare.” A 2025 survey by KFF reported that 27 percent of people taking GLP-1 drugs who had health insurance said they would still have to pay the full cost of the drugs. out of pocketHowever.
Hwang is also keeping an eye on how any changes to combination GLP-1 drugs might affect access in the long run. “If I were a patient and I had the choice of taking Wegovi versus a mixed version, I would definitely take Wegovi — if the price was the same,” she says. “But the problem is making it accessible. You can’t shut down ways to get access to medicines that are incredibly helpful for people without providing us with alternative strategies.”
