This story mentions weight, weight loss, and/or GLP-1 drugs. In the last few years, GLP-1s, prescription weight-loss medications for adults with obesity or with overweight and at least one weight-related health condition, have become extremely popular, in part due to off-label use. At SELF, our job is to keep you—our reader—informed, which is why we wrote the article below.
While people can be healthy at every size, research suggests carrying extra weight may increase your risk for certain conditions. That said, the current medical classifications for overweight and obesity are far from perfect—they’re based on body mass index (BMI), which doesn’t capture the full picture of a person’s health. These conversations require nuance, and we hope to provide it. Before taking any medication or making decisions about your health, talk to your doctor or a health care professional.
To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded GLP-1s—medications containing the same active ingredients as blockbuster weight-loss drugs but sold at a much lower price. A mass influx of buzzy ads and even Super Bowl commercials for these products by trendy telehealth companies like Hims & Hers and Ro have pitched them as more accessible replicas of the brand-name meds Wegovy (the version of Ozempic approved for weight management) and Zepbound (the weight-loss-approved counterpart to Mounjaro). And estimates put the number of folks using these compounded drugs in the millions.
But the FDA has recently made moves that could pull these alternatives off the market completely—and are already limiting their legal availability. By removing both semaglutide and tirzepatide (the actives in Wegovy and Zepbound, respectively) from its drug shortage list, the agency is cutting off the primary legal route that allows compounders to make copycats. In response, brands like Hims & Hers and Eden have already announced that they will no longer offer certain compounded GLP-1s, and Ro dropped all compounded weight-loss options from its site (after striking a deal with Zepbound manufacturer Eli Lilly). Meanwhile, both Eli Lilly and Novo Nordisk (which makes Wegovy) have released ads directly targeting the compounders, suggesting consumers “check before you inject” and “be a healthy skeptic.” And of course, lawsuits are being filed left and right.
In theory, the FDA’s removal of GLP-1s from its shortage list should mean any patient who needs the brand-name drugs will be able to get them. But it’s more complicated than that. While the compounded options that have been filling the gap aren’t FDA-approved (a red flag), they have been available at much lower prices—making their imminent illegality a potential access issue. To understand what these changes mean for the millions of people who have been using compounded versions of GLP-1s, we asked experts to break down what compounding is, the major differences between brand-name drugs and compounded options, and exactly when we can expect the latter to come off the market.
First, let’s talk about what compounded drugs are and how they’ve changed the GLP-1 market.
Compounding is nothing new despite only being thrust into the spotlight as of late. Before the days of Big Pharma, every pharmacist “compounded” drugs by combining ingredients to create a medication for a patient. But since the advent of commercial drug manufacturing and the FDA’s creation of a strict regulatory process for bringing safe, effective medications to market, compounding has been legally relegated to two scenarios, Robin Feldman, JD, a professor at the University of California College of the Law in San Francisco and an expert on pharmaceutical law, tells SELF. Compounders can make drugs when a patient’s needs can’t be met by an existing FDA-approved drug—say, they’re allergic to a dye or binding agent in it or they can’t swallow pills or take it in whatever form is available—or when there’s a shortage of an FDA-approved drug.
The latter circumstance is what allowed for the rise of GLP-1 compounding. The designation of certain GLP-1s as weight-loss agents—starting with Wegovy in June 2021 and followed by Zepbound in November 2023—made these drugs available to a new, huge swath of people. Now anyone who is obese as defined by body mass index (BMI) or who is overweight per BMI and has at least one weight-related health condition is eligible for a GLP-1 prescription. Previously, meds in this class were just FDA-approved for type 2 diabetes. With promises of weight loss on the table, the demand surged so high that the pharma companies couldn’t keep up with it, and the drugs went into shortage and bam: Compounders stepped in to fill the gap.
Cut to now, when both Wegovy and Zepbound have been removed from the shortage list. Again, that would typically be a good thing, suggesting that folks taking compounded versions could switch to the brand-name options, which carry the added safety of having gone through the FDA approval process (more on this below). But the massive number of people taking compounded GLP-1s has raised questions about whether there actually is enough supply of the brand-name drugs to meet demand.
Looming even bigger is the cost issue. There might be enough brand-name drugs available now, but that certainly doesn’t mean they’ll be accessible. These meds have historically run upward of $1,000 without insurance (and coverage is still limited)—though both Eli Lilly (Zepbound) and Novo Nordisk (Wegovy) have recently cut that price in half, to $499 a month, for folks without coverage who opt in to direct-pay programs with the drugmakers. By contrast, compounded options generally cost around $200 a month.
The cost gap is what makes GLP-1 compounding such a unique situation. Usually drugs that go into shortage are cheap generics, not expensive brand-name ones that are still under patent, Tenille Davis, PharmD, chief advocacy officer at the Alliance for Pharmacy Compounding, tells SELF. So, while GLP-1 compounders have technically been operating to fill an availability void, they’ve also been de facto solving for the price issue. Hence why recent moves to cut them out of the picture could majorly slash access.
What’s the difference between a compounded GLP-1 drug and a brand-name one?
As mentioned, pharmacy compounding is meant to serve a few specific purposes, namely the creation of a custom form of a drug on a per-patient basis (e.g., when someone needs a formulation or dose that isn’t commercially made) or boosting supply during a drug shortage. Given the relatively lower risk of these kinds of small-batch and temporary operations, it isn’t legally necessary for compounders to jump through all the regulatory hoops that are required of commercial drug manufacturers to market a product, nor would it be feasible, Michael Ganio, PharmD, senior director of pharmacy practice and quality at American Society of Health-System Pharmacists, tells SELF. As a result, there are a few key differences to note in how brand-name and compounded GLP-1s come to be.
Process and safety checks
Commercial drugmakers have to receive the FDA’s stamp of approval on a new drug application for every item they bring to market. That requires doing research and clinical trials to prove efficacy; fine-tune the dose and route of administration; and ensure the final product abides by Current Good Manufacturing Processes (CGMP), which guarantees the medication is sterile if applicable (as in the case of injectables like GLP-1s) and will remain stable for usually a couple years. By contrast, compounders don’t go through the FDA approval process for their drugs and are not subject to these standards. This distinction also separates a compounded drug from a generic one: While the latter has an abbreviated FDA-approval process (since the existing brand-name drug has already been shown safe and efficacious), the maker still has to prove to the FDA that their version is equivalent to the OG on both fronts. A compounded drug doesn’t have that oversight. (The brand-name GLP-1s aren’t available as generics because the patents haven’t expired—Novo Nordisk has its US patent on semaglutide until 2032, and Eli Lilly on tirzepatide, until 2036.)
But to be clear, compounders do still operate within a regulatory framework, albeit a less stringent one. Which rules they have to follow depends on whether they’re a small operation (classified by the FDA as 503A) that whips up compounded items based on individual patient scripts, or a large outsourcing facility (called 503B) that makes a bunch of compounded drugs (in advance of getting prescriptions) and ships them across state lines.
As you might guess, the 503Bs—which have accounted for much of the compounded GLP-1 production—are subject to stronger regulations because their production processes pose a bigger risk. These facilities have to be registered with the FDA and comply with a version of the same manufacturing guidelines as drugmakers to ensure their products are safe, sterile (if applicable), and stable, usually for at least a few months, Dr. Ganio says. The smaller 503A pharmacies, however, are exempt from CGMP and just need to be licensed by their state board of pharmacy, which requires following rules set by the United States Pharmacopeia (USP) instead. For sterile items like GLP-1s, this still involves things like monitoring the air and surfaces in the pharmacy for microbes, wearing sterile gloves, and the like, Dr. Ganio says. But it’s less intensive than CGMP, so 503A products generally get a very short shelf life, often just a couple days, to help mitigate risk, he notes. Still, the lesser degree of surveillance leaves more leeway for something to go wrong.
Ingredient sourcing and formulation
It’s not just the manufacturing process that can differ between compounded and brand-name drugs; what, exactly, you’re getting in the final product might not be totally equivalent either.
On the sourcing front, compounders may not use quite the same type or quality of raw ingredients as the Big Pharma companies. Where drugmakers have to identify the manufacturer that’ll supply their materials in their FDA drug application and have them inspected (and will also typically do their own regular testing to verify what they receive), compounders just need to get ingredients from an FDA-registered facility, a.k.a. one that should theoretically uphold FDA standards. “That doesn’t mean the particular product they’re sourcing has been approved by the FDA, but just that it’s being made in a place that’s registered,” Dr. Ganio says, “which is where some of the unknown comes into play.”
Once compounders get the ingredients they’re using, there’s also a bit of guesswork in terms of concocting a product that matches the brand-name version. They can’t exactly go to Eli Lilly or Novo Nordisk and ask for their recipe and instructions; that information will only be made available several years from now when the companies’ respective patents expire and approved generics can be made. In the meantime, compounders use info available on product labels and in online databases like DailyMed to create a solution with either semaglutide or tirzepatide and ensure it’s both diluted to the right concentration and that it includes any preservatives necessary to keep it stable until the date they put on the package, Dr. Ganio says. Both state-licensed 503A pharmacies and FDA-registered 503B outsourcing facilities are plenty equipped to do this kind of work, so there’s a good chance you’ll receive something comparable to a brand-name product if you’re getting it from one of these legit entities. But the wiggle room here doesn’t give you a 100% guarantee.
Overall risk profile
Ultimately, less oversight across the board—in terms of process and product—makes any compounded drug an inherently riskier choice than a commercial option reviewed by the FDA. The American Diabetes Association and a group of obesity expert orgs have released statements advising patients against using them due to the potential for content and quality issues.
To that point, the FDA has recently identified a few issues in compounded GLP-1s on the market; certain ones have included actives that are similar but not the same as the ones in brand-name versions (like salt forms of semaglutide) as well as additional ingredients like vitamins B12 and B6…which may or may not be okay, since the OG products weren’t tested with these items added. There’s also been a spike in adverse reactions to compounded GLP-1s that the FDA suspects is due to accidental overdosing. Because these meds don’t have to abide by the same clear packaging and labeling requirements as their brand-name cousins (they can come in a variety of vials and pre-filled syringes in various concentrations), it may be easier to mess up their administration.
That said, it’s important to know that these drugs are not the same thing as counterfeit GLP-1s, though the two tend to be conflated, Dr. Davis says. “If you can access a GLP-1 drug without a legitimate health care provider issuing a prescription, that isn’t compounding—that’s illegal,” she explains. And the content of this knockoff product could be anything in that case, Dr. Ganio says. A recent study assessing online no-prescription-necessary semaglutide purchases identified items that were possibly contaminated and contained much higher levels than advertised of the active. To lower your risk of winding up with a counterfeit drug versus a compounded one, Dr. Ganio recommends asking the provider prescribing it where they’re filling that script, and then checking that the pharmacy is licensed in your state. (You can also look up larger outsourcing facilities to be sure they’re registered with the FDA.)
So what’s the current status of compounded GLP-1s, and are they all going to go off the market?
The outlook looks a bit different for compounded tirzepatide versus compounded semaglutide. Technically, when the FDA first yanked tirzepatide off its shortage list in October 2024, both 503As and 503Bs could no longer legally make copycats (with one notable exception for the smaller 503As, who could still fill individual prescriptions if there was a medical reason the patient needed a slightly different version than the brand-name drug—more on this later). But shortly after, a drug compounding industry group sued the FDA, claiming that its decision was “arbitrary” and suggesting it hadn’t fairly considered the entire market. Not only are there currently millions of people on these compounded drugs, all of whom would have to get new prescriptions to switch over to brand-name ones, but the market is ever-growing as these drugs gain new approved uses, like sleep apnea. Still, the FDA stood its ground, giving 503A facilities until February 18 to stop production, and 503Bs until March 19—but it wasn’t going to enforce any of this while the lawsuit was pending.
A decision on March 5 changed this trajectory: The judge on the case denied the pharmacists’ motion, siding with the FDA. So as of now, 503As can’t compound tirzepatide (at least on the basis of its being in shortage), since we’re past the February 18 deadline; and 503Bs have until March 19 to call it quits. But the compounders haven’t given up: They also appealed the judge’s call on March 10, which keeps things legally fuzzy.
As for semaglutide? The FDA similarly removed it from its shortage list on February 21, 2025, but this time, it designated off-ramps for production of compounded types right off the bat: Technically, 503A pharmacies have until April 22 to quit making semaglutide drugs, while 503B facilities have until May 22. But the same industry group that sued the FDA for the tirzepatide change also just sued the agency for removing semaglutide from its shortage list on essentially the same grounds—that they had “dismissed evidence” that the drug is still in short supply. As happened initially with the tirzepatide suit, the FDA isn’t going after any semaglutide compounders until the judge makes a call, leaving options available for now. But there’s reason to suspect he’ll side with the FDA again in this case—and that the pharmacies will again file an appeal.
If the FDA ultimately gets its way, any mass-compounding of GLP-1s at the 503B level will grind to a halt. But don’t forget the 503A exception: These small operations can legally keep mixing compounded GLP-1s outside of a shortage provided they’ve tweaked their version in a way that makes a “significant difference” for the patient—for instance, switching the dose or adding or removing an ingredient for a medical reason specified by a prescriber.
So long as the brand-name options remain pricy, there’s incentive for 503As to create these slightly changed versions. And even as market forces notch down the cost of Wegovy and Zepbound, it’s tough to see how drugmakers could possibly match the low prices of compounders who aren’t subject to nearly the same overhead. To that end, the pharma companies have wasted no time firing off cease and desist letters and suing compounders, alleging unfair competition—that they’re copying their patent-protected products and tricking consumers into thinking they’re getting the same thing. Meanwhile, compounders contend that they’re operating within the bounds of the FDA laws that allow them to create copycats for short-supply drugs and modify them slightly for patient needs, Feldman says.
The tricky thing is, there’s never been a drug shortage quite like this one, Dr. Davis says, for an item with such sky-high demand and market price. Whether the legal routes carved out for compounders can really fit this circumstance is bound to be hotly debated in court cases to come, Feldman says. For now, as shortages resolve, small compounders can continue to make patient-specific alternatives on the basis that medicine isn’t one-size-fits-all. But the real problem we’re facing now “isn’t wrong size,” she says. “It’s wrong price.”
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