What is compounded semaglutide and is it safe? The weight loss drugs Hims & Hers is selling, explained.

"They’re priced for profits, not patients.” That’s the critique from Hims & Hers Health’s buzzy — and controversial — Super Bowl ad, leveling the accusation against brand-name weight loss drugs. Set to the tune of Childish Gambino’s “This Is America,” the 60-second spot, which reportedly cost between $14 million and $16 million to air during the big game, is plugging “affordable” versions of these medications, known as compounded GLP-1s (short for “glucagon-like peptide-1”).

GLP-1s like Ozempic and Wegovy are expensive, with a month’s supply of Ozempic costing around $1,000 without insurance, on average, according to Drugs.com. Hims & Hers’ ad takes the issue head-on, but the more affordable solution the company offers falls under murky territory. Cheaper, compounded GLP-1s, often sold by online providers including, in addition to Hims & Hers, Ro, Eden and Weight Watchers, are legal and contain the same active ingredients as their pricier counterparts. But what makes them different is that they aren’t regulated by the Food and Drug Administration in the same way as noncompounded medications.

Some call these medications “generic Ozempic” (they’re not); others, “fake Ozempic” (nope, except when the ads are for illegal or nonexistent drugs). And last year, the FDA issued warnings about the drugs, but they haven’t been recalled and remain readily available.

So, what is going on with compounded semaglutide, and is it safe? How can you tell the difference between compounded and counterfeit drugs? It’s complicated. Let’s get into it.

First, what exactly is compounded semaglutide?

Compounded semaglutide is a legal copycat of the active ingredient in Ozempic and Wegovy. Normally, it would be illegal to make generic versions or copies of these medications until the patents for the drugs expire. But in special circumstances, including shortages, compounding pharmacies are permitted to manufacture otherwise protected drugs in order to meet demand.

Compounding pharmacies are required by law to follow the exact recipes provided by brand-name drugmakers when producing copies of their medications. So if all goes well, compounded medications should be identical to the brand-name ones. However, compounded medications aren’t regulated with the same FDA testing as others, although these pharmacies are required to use ingredients manufactured by FDA-registered facilities.

The second, more obvious distinction between noncompounded semaglutide (the active ingredient in Wegovy and Ozempic) and compounded semaglutide is how the drugs are administered. Ozempic and Wegovy come in special injector pens that make it easy to get the dosing right. But the company that makes those drugs, Novo Nordisk, has the exclusive right to make those injector pens. So compounded semaglutide is sold in a vial with a separate syringe.

What’s behind the rise in compounded semaglutide?

Compounding drugs isn’t a new practice. But due to the soaring demand for these weight loss drugs, it’s now a mainstream phenomenon. Semaglutide has been on the market for 20 years, but it was approved by the FDA in 2021 for chronic weight management. Since then, Novo Nordisk (Wegovy and Ozempic) and Eli Lilly (Mounjaro and Zepbound) have struggled to manufacture enough product and both of Novo Nordisk’s semaglutide medications have been on the FDA’s shortage list since early 2022.

Wegovy and Ozempic — both known generically as semaglutide — were taken off the FDA’s shortage list in late October 2024. One FDA page now lists semaglutide as “in shortage,” while another says that all doses are available. The shortage of tirzepatide, the drug used in Mounjaro and Zepbound, is now marked “resolved.” Some experts think this will make it much harder to get compounded versions of the drug. Compounding pharmacies are allowed to make copies of drugs in large batches only when they are in shortage. The FDA also permits compounding pharmacies to make “bespoke medications customized for a particular patient,” explains Scott Brunner, CEO of the Alliance for Pharmacy Compounding.

As previously stated, compounded drugs are legal to make and prescribe so long as they are in shortage. So as one problem, a shortage, is solved, another arises: Cheaper copycat drugs fall into an even grayer area of legality. And it’s unclear what the end of shortages will mean for Hims & Hers’ campaign to offer these cheaper options to their clientele.

Many people are taking compounded semaglutide. How many is unclear.

It’s hard to pin down exactly how many Americans are taking compounded versions of Ozempic and similar drugs because companies prescribing them keep data close to the chest. A poll last year estimated that as many as 1 in 8 Americans had taken some form of these blockbuster drugs, but didn’t differentiate between FDA-approved and compounded medications. The CEO of one large compounding company, Olympia Pharmaceuticals, told CBS News that some 2 million Americans are taking drugs made by firms like his.

Why are people taking copycat semaglutide instead of Ozempic or Wegovy?

Compounded drugs are often cheaper, in part because they don’t require the same expensive research, development and clinical trials that noncompounded prescriptions do. For example, telehealth company Hers advertises injection compounded semaglutide for a starting price of $165 per monthly supply; the same company charges $1,999 for 30 days’ worth of Wegovy, without insurance. Many telehealth companies have seized on the opportunity to prescribe blockbuster drugs to a huge swath of people; one study estimated that over 137 million Americans are eligible to receive semaglutide. Telehealth companies offer medical consultations — which are required to get a GLP-1 prescription — and reap the profits from both the appointments and the medications.

Sometimes these consultations involve a virtual meeting with a health care provider. But other companies, including Hims, reportedly prescribe GLP-1s on the basis of short surveys and never require patients to speak with anyone. (In a statement to Yahoo Life, Hims & Hers says they “provide a telehealth platform that connects customers with licensed healthcare providers who evaluate and prescribe treatment when appropriate, including compounded medication if clinically necessary. We stand by the quality of care we deliver and are confident that we actually inform our customers better given how closely we work with them through our platform.”)

Many consumers, in turn, have jumped at the chance to get cheaper weight loss drugs from virtual providers who may do less to verify that patients meet the prescribing criteria, as Wired reported.

The FDA has issued warnings about compounded semaglutide

Regulators’ concerns about these drugs fall into two categories: what’s in them and how easily someone can overdose. The FDA has cautioned about “impurities,” the use of an untested “salt” form of semaglutide in compounded drugs, and “adverse events,” which encompass everything from mild side effects like nausea to life-threatening reactions and even death.

Novo Nordisk, the pharmaceutical company that makes Ozempic and Wegovy, said that 442 cases of adverse events, including 99 hospitalizations and seven deaths, had been reported to the FDA in connection with compounded semaglutide as of March 31, 2024, the New York Times reports. Brunner says that the fact that these figures come from Novo Nordisk makes the findings biased. (For what it’s worth, Yahoo Life requested data to verify these numbers from the FDA but had not received any further information by the time of publication.)

Ultimately, the problem isn’t that compounded drugs are definitively unsafe; it’s that there aren’t the same guardrails and regulations in place to make sure that they are safe, whereas the FDA tightly governs noncompounded drugs. Instead, the compounding industry is governed by a separate set of standards, which require pharmacies to routinely test their ingredients and products for quality, strength and purity. Still, some experts aren’t convinced that that’s enough to guarantee safety. “Since they’re not regulated like manufacturing facilities, you have no idea what you’re getting,” Justin Ryder, an associate professor of pediatrics who researches obesity at Northwestern University Feinberg School of Medicine and Lurie Children’s Hospital, tells Yahoo Life.

Overdosing is a big concern

The FDA also issued a warning about overdoses of compounded semaglutide in late July. Brand-name forms of semaglutide, including Wegovy and Ozempic, come in specially designed injector pens, which help to ensure that patients get the correct dose. Compounded semaglutide comes in a vial with a standard syringe that patients fill and inject themselves. That may make it easier for patients to accidentally inject too much of the drug.

In some cases, patients were getting up to 20 times more of the drug than they should have, either because they were injecting themselves with larger doses than intended or because their prescribers were “miscalculating” the dose. In one case, a provider intending to prescribe 0.25 milliliters instead wrote 25 units, which comes out to five times more medication. This resulted in the patient experiencing severe vomiting.

Compounded semaglutide is not the same thing as ‘fake’ medication — but there are plenty of frauds online

Whatever risks compounded semaglutide may or may not carry, it’s a separate issue from counterfeit medications. However, it might be easy to confuse the two when browsing for a provider online. According to a recent JAMA Network Open study, nearly half of online pharmacies trying to sell “semaglutide” are illegal operations. “Unfortunately, I’m not surprised at all” by how common counterfeits are, study co-author and University of California, San Diego professor of global health Tim Mackey tells Yahoo Life. “Any time a product like this becomes popular through media or through patients [sharing their results], you’re going to get a counterfeit market that arises.”

Notably, none of the six fraudulent companies he and his team tried to place orders with required prescriptions for semaglutide, which is illegal, nor did they offer prescriptions as a legitimate telehealth company would. Only three companies actually shipped any product at all, while the other three requested money for customs, a common scam tactic, Mackey says. The products the researchers did receive were impure, potentially contaminated or contained much higher concentrations of semaglutide than their labels indicated, posing a serious risk of overdose.

How to tell if you’re getting real semaglutide — and how safe it is

The safest thing to do is always to use an FDA-approved medication. In this case, that means Ozempic, Wegovy, Mounjaro or Zepbound. Even Brunner, who represents compounding pharmacies, urges that if these brand-name versions are available, you should not use compounded semaglutide instead.

Second, real medications — compounded or not — will always require a prescription. So if you happen upon a website that says you can skip that step, it’s definitely not legitimate, warns Mackey.

If you cannot get the dose of brand-name semaglutide that you need, there are some steps you can take to get some sense of how likely it is that the compounded doses you receive will be safe. First of all, ask your prescriber where they will be sending the prescription to be filled and how long they’ve been working with that pharmacy, says Brunner. Once you have the pharmacy’s name, you can check that it’s registered with the FDA; that’s a good sign that it’s trustworthy. If you still have reservations, don’t be afraid to call the pharmacy and ask questions, like whether third parties test the ingredients they use and if the pharmacy makes and tests large batches of drugs, Brunner advises.

If you can’t find the pharmacy’s name before receiving the medication, the packaging should include the facility’s name, so these same checks can be done. It’s not guaranteed that that information will be available, but at least some companies — including, as of August, Hims & Hers — are promising to provide better transparency.