Are Compounded GLP-1 Weight Loss Drugs Really Banned?

In fact, compounding pharmacies still have considerable freedom under FDA regulations to fill prescriptions for GLP-1 drugs. They can make new GLP-1 equivalents that are not officially considered “copies” by significantly altering a drug's dosage or ingredients. As a result, these less-expensive weight loss drug alternatives remain available, though experts remain concerned about their safety and efficacy.

“A clear reading of FDA guidance says that a prescriber can authorize a custom formulation of semaglutide or tirzepatide,” says Scott Brunner, the CEO of the Alliance for Pharmacy Compounding.

These custom formulations, which are not technically drug copies, are created by altering the drug's composition. A prescribing physician can request that a compounding pharmacy make a number of alterations to semaglutide or tirzepatide that are not commercially available, including:

• A new dosage or potency
• A new drug combination, such as semaglutide mixed with vitamin B12
• A new drug form, such as a liquid or pill rather than an injection

While some online compounding pharmacies have stopped marketing GLP-1 drugs in response to the FDA's announcement, others are prominently advertising such “custom” formulations, a trend that Brunner thinks clinicians will increasingly take advantage of: “I think we'll see more prescribers move into the customized dosage side of compounding.”

In the meantime, however, online pharmacies that offer custom compounded GLP-1 doses appear to be operating entirely within the law, and will likely be able to do so for the foreseeable future.

“Some patients will be able to maintain these therapies at a price point they can afford in a customized formulation,” says Brunner.

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 and other conditions 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.”

Some online compounding pharmacies are now selling semaglutide and tirzepatide in the form of a pill or liquid. These products, purportedly containing the same active ingredients found in Wegovy and Zepbound, are not swallowed but instead dissolve under the tongue. This is referred to as sublingual delivery.

For patients with a severe fear of needles or who have 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 is not established.

“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.”

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.

For those who choose to purchase compounded semaglutide, Simonetti offers a few bits of advice. First, she recommends checking the FDA's list of registered compounding pharmacies that operate as outsourcing facilities for some online services offering GLP-1 drugs.

“This is a good place to start. You still don't know what you are getting, but going with a [pharmacy] on this list reduces the risk that you're injecting yourself with bacteria,” 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.

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.

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.

Experts agree that medications from illegal sources are especially dangerous, as the efficacy and safety of such medicines is completely unknown.

• Online compounding pharmacies will continue to offer GLP-1 weight loss medications, despite an FDA announcement that the semaglutide and tirzepatide drug shortages have ended.
• Compounding pharmacies offer weight loss drugs in novel forms — including new dosages, new combinations with other medications, or in new forms such as pills or liquids — that have not been studied.
• The FDA has not assessed the safety or efficacy of any compounded drugs, but there are steps you can take to reduce the risks associated with buying weight loss drugs online.