This content originally appeared on Everyday Health. Republished with permission.
By Kaitlin Sullivan
Medically Reviewed by Adam Gilden, MD, MSCE courtesy of American College of Lifestyle Medicine
Demand for Ozempic, Wegovy, Zepbound, and Mounjaro has led to the rise of online companies selling what they claim are cheaper versions of the once-a-week injectable medications. But regulation is murky, and it is unclear if these alternatives are safe or effective.
Patients face ongoing roadblocks to getting prescriptions and insurance coverage. Without a manufacturer’s coupon or insurance, Wegovy costs $1,350 a month, according to its producer, Novo Nordisk. Zepbound costs over $1,000, according to maker Eli Lilly.
Pharmaceutical companies are also straining to produce enough of these medications to keep up with demand, leading to shortages.
The result is the growth of a niche industry of so-called compounding pharmacies selling “homemade” versions of these weight loss drugs: compounded semaglutide (as a substitute for Ozempic or Wegovy) and compounded tirzepatide (as a stand-in for Mounjaro and Zepbound).
In early 2024, a warning by the U.S. Food and Drug Administration (FDA) focused on the potential dangers of compounded semaglutide, with the agency citing reports of unanticipated health problems in people using the medication.
It’s a risk many people appear willing to take in their quest to lose weight.
When Insurance Won’t Cover Wegovy, Desperation May Set In
Sunnie (full name withheld for privacy), 50, has always had a hard time quieting her mind when it comes to food. “I feel like I’m hardwired to overeat,” she says.
Obesity runs in her family. Her mother lost 100 pounds twice in her life but gained it back.
Sunnie slowly gained weight while bearing and raising her three children, reaching a body mass index of 45. Her doctor put her on Contrave, a weight loss pill that combines bupropion (an antidepressant) and naltrexone (a drug used to treat opioid and alcohol use disorders). Contrave costs about $100 per month and is FDA-approved for long-term use in weight management.
“It helped me control my thoughts about food by suppressing those desires and impulses in the brain,” says Sunnie. “But it stopped working.”
She was ready to try again when her doctor wrote her a prescription for the semaglutide drug Wegovy. Semaglutide is a GLP-1 receptor agonist, a medication that mimics a natural hormone called GLP-1 that is released in the gastrointestinal tract in response to eating. GLP-1 prompts the body to release insulin, which reduces blood sugar levels, and interacts with the brain to curb appetite and signal a feeling of fullness.[1]
The FDA approved Wegovy in 2021 for adults with obesity or for those who are overweight and have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol.
That’s when Sunnie ran into a wall: Because she doesn’t have a weight-related condition in addition to obesity, her insurance wouldn’t cover Wegovy.
“I felt so defeated. I was continuing to gain weight. I felt like I was out of control, and I needed something to get back in control,” she says.
Sunnie works at a hospital, which is where she heard about a cheaper alternative to Wegovy: compounded semaglutide, available through a nurse who told Sunnie she was reselling it from a compounding pharmacy. A few coworkers were taking the medication with success, so Sunnie decided to go for it, buying a month’s supply for less than $300.
“I understand there’s risk. I know it could be anything,” says Sunnie. “I feel desperate. I feel like gaining weight is bigger than me, and I’ve come to the realization that I need medication to help me.”
Sunnie started losing weight quickly, and noticed a drastic reduction in her appetite, something that used to control her.
“When I’m on weight loss medication, I can feel the difference between my brain telling me I’m hungry and my actual stomach telling me I’m hungry. I know I eat out of anxiety and boredom, and there are a lot of psychological reasons I eat, but I’m able to separate those on semaglutide,” she says.
Are Compounded Semaglutide and Tirzepatide Legal?
About 7,500 licensed pharmacies in the United States specialize in compounding.[2] These pharmacies mix, alter, or combine FDA-approved drugs with different ingredients for people with particular needs, such as individuals who may be allergic to a certain dye in the brand-name medication.
If there’s a shortage of a drug, compounded versions become legal in the United States. In May 2023, the FDA included both Ozempic and Wegovy on its drug shortages list, legalizing compounded versions of the drugs.
The FDA recognizes that compounded drugs can fill an important need, but it also warns that they “pose a higher risk to patients than FDA-approved drugs because they do not undergo FDA premarket review for safety, effectiveness, or quality.”[3]
Novo Nordisk says it does not sell its patented semaglutide for compounding, raising questions as to what exactly goes into compounded versions. However, the chemical formulas for semaglutide and tirzepatide are publicly available.
No generic form of semaglutide exists, though compounded drugs are often marketed as such. The company has filed at least a dozen lawsuits against medical spas, weight loss or wellness clinics, and compounding pharmacies selling questionable compounded or so-called generic versions of semaglutide.[4]
According to the FDA, compounded versions of Ozempic and Wegovy may swap out pure semaglutide for salt-based forms, which have not been shown to be safe and effective in clinical trials. The FDA has received reports of adverse effects from people who take compounded semaglutide.
Pharmacies selling compounded semaglutide sometimes include vitamins such as B12 in the mix to allegedly boost weight loss, a claim for which there is no solid proof.[5]
Compounded Semaglutide and Tirzepatide Are Too Risky, Experts Say
Juliana Simonetti, MD, a codirector of the comprehensive weight management program at the University of Utah in Salt Lake City, says that it is “absolute insanity” that insurance companies so often deny coverage for injectable weight loss drugs to people with obesity, even for patients who have used these medications to get prediabetes under control. She understands what’s driving people to seek alternatives.
But, she says, there is no way to know for sure the conditions that compounded drugs are created in, adding that anyone buying compounded drugs from a dubious source runs the risk of using medications that pose safety risks and may not even be sterile.
“I’m very clear in telling my patients to not get compounded versions. I feel their pain and desperation, but I’m telling them not to do it because these are dangerous practices,” she says.
Andrew Kraftson, MD, the director of the weight navigation program at Michigan Medicine in Ann Arbor, believes strongly in the value of medications like semaglutide and understands why people are scrambling to get the drugs. He points out that obesity is highly stigmatized and undertreated.
“There’s this sense of urgency that’s driving people to make rash decisions,” he says. “They feel like, This is out there now. I should have been on it yesterday.”
But without FDA oversight, Dr. Kraftson says, compounded versions are too risky. “It’s problematic that there is this inherent conflict of interest,” he says about providers who might be willing to compromise safety in pursuit of profit.
Plus, he says, people who buy weight loss medications on the cheap aren’t typically getting the nutritional counseling to ensure that they’re staying healthy when drastically cutting calories.
“Food as medicine is an important component here,” Kraftson says. “Anyone could lose weight on 800 calories a day in the form of Twinkies, but it doesn’t mean they should.”
Oral Semaglutide and Tirzepatide
Some online compounding pharmacies are now selling semaglutide and tirzepatide in the form of a pill or liquid. These substances, purportedly using the same active ingredients that are found in Wegovy and Zepbound, are not swallowed but instead dissolve under the tongue. This is referred to as sublingual delivery.
Are sublingual GLP-1 pills and liquid suspensions legal? Compounding pharmacies are allowed to change the form of prescription medications for patients when a doctor has indicated that “the commercially available medication is not appropriate,” says Tenille Davis, PharmD, the chief advocacy officer at the Alliance for Pharmacy Compounding. For patients with a severe fear of needles or allergies to inactive ingredients in injectable solutions, sublingual administration offers a solution. But there has never been any published study of sublingual GLP-1s, and the safety and efficacy of such substances may be extremely questionable.
Dr. Davis says that at least one large compounding pharmacy has conducted in-house studies showing that semaglutide salts can be absorbed in the oral cavity through dissolvable tablets or tinctures placed under the tongue. But other experts are skeptical, warning that it’s likely that only small amounts of the active ingredient are absorbed this way.
“I don’t think they will be effective,” says Dr. Simonetti. “We can’t take something that is injected and then just put it under our tongue and have it work the same way.”
Some Compounded Drugs Are Riskier Than Others
Simonetti empathizes with patients who are desperately trying to access these weight loss medications.
“I understand people are desperate and how the decision rolls around to choose these medications from a compounded pharmacy,” she says.
If someone does choose to purchase compounded semaglutide, Simonetti offers a few bits of advice to ensure the best possible safety. First, she recommends checking the FDA’s list of licensed compounding pharmacies.
“This is a good place to start. You still don’t know what you are getting, but going with a company on this list reduces the risk that you’re injecting yourself with bacteria if it’s getting under the skin,” she says.
The National Association of Boards of Pharmacy also has a database that allows people to search for pharmacies by their website to weed out ones that are fraudulent.
Explore our recommendations for the best online GLP-1 programs, including Henry Meds, Found, and Noom Med.
People should always ask the manufacturer for information about how many milligrams of active ingredients are in each dose. Though the precise nature of these ingredients may be a mystery, having at least an idea of how much semaglutide-like substance is in each dose can help clinicians aid their patients with diet and medication management.
“A lot of compounded drugs come in units,” Simonetti says. “I have no idea how many milligrams are in the unit, especially if they are mixing it with other ingredients.”
If you can talk to your doctor before reaching out to a compounding pharmacy, Davis recommends asking about compounding pharmacies they’ve worked with before and trust. She also says people should call the pharmacies and ask about their quality program and for information on the tests that have been performed on their sterile products. The pharmacy should be willing to provide a certificate of purity that says that the medicine is pure and sterile.
“If the pharmacist is hesitant to discuss these kinds of things, I would choose another pharmacy,” she says.
Beware of Illegal GLP-1 Drugs
While compounding pharmacies may seem to be operating in a regulatory gray area, other online suppliers engage in definitively illegal practices. A recent survey of the online marketplace identified more than a hundred websites claiming to sell semaglutide that can be ordered without a prescription. Pharmacies cannot legally provide GLP-1 drugs without a doctor’s prescription.
When researchers ordered semaglutide from six of these websites, three suppliers never sent any product at all, and instead demanded more money: They were outright scams. The other three providers did send some medicine containing semaglutide, but lab tests showed that the active ingredient was included in inaccurate concentrations. One of the samples was contaminated with endotoxin and may have been poisonous.[6]
Experts agree that using medications from illegal sources is especially dangerous, as the efficacy and safety of such medicines is completely unknown.
The Takeaway
Online compounding pharmacies have begun to offer a dizzying variety of knockoff GLP-1 drugs, but most experts are nervous about off-brand Ozempic and similar products. While the FDA has not assessed the safety or efficacy of any compounded drugs, you can take steps to reduce the risks of buying weight loss drugs online.
Resources We Trust
Mayo Clinic: Considering GLP-1 Medications? What They Are and Why Lifestyle Change Is Key to Sustained Weight Loss
American Pharmacists Association: Frequently Asked Questions About Pharmaceutical Compounding
Consumer Reports: Telehealth: Should You Try an Online Doctor?
Pew Trusts: What Are Compounded Drugs, and How Can They Be Kept Safe?
FDA: Compounding and the FDA: Questions and Answers
Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy. We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.
Sources
Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss. U.S. Food and Drug Administration. January 10, 2024.
Frequently Asked Questions About Pharmaceutical Compounding. American Pharmacists Association.
Drug Compounding and Drug Shortages. U.S. Food and Drug Administration. March 24, 2023.
Novo Nordisk Settles Two Lawsuits Over Copycat Versions of Ozempic and Wegovy. NBC News. February 9, 2024.
Are Vitamin B-12 Injections Helpful for Weight Loss? Mayo Clinic. September 13, 2022.
Ashraf AR, Mackey TK, Schmidt J, et al. Safety and Risk Assessment of No-Prescription Online Semaglutide Purchases. JAMA Network Open. August 2, 2024.