How to Access GLP-1 Medications Safely and Legally After the FDA’s New Rules

One way that telehealth providers are adapting to the recent ban on compounding semaglutide and tirzepatide is by changing their labels. Some providers are calling these same drugs “customized GLP-1” or “GLP-1/GIP protocols.” If you see a generic GLP-1 label, it means the medication is semaglutide. If you see ‘GLP-1/GIP’, it is tirzepatide. The customization comes into effect when these providers add ingredients like Vitamin B12 or adjust the dosage.

Dr. Blitz told me that according to the FDA, the compounded medication needs to provide “a clinical difference for an individual patient compared to the FDA-approved product. For GLP-1 medications like semaglutide or tirzepatide, legitimate examples of a documented clinical difference might include:

• A patient’s allergy to an excipient (e.g., phenol or sodium chloride) in the commercial formulation.
• A specific strength or dosage form not available on the market (e.g., a compounded oral liquid for a patient unable to inject).
• A required route of administration due to unique medical needs.”

However, adding non-essential ingredients like B12, L-carnitine and other non-tested ingredients, does not qualify as a documented clinical difference. “These modifications represent a false pretense of providing a meaningful medical benefit and are not a legitimate basis for compounding under federal law”.

Dr. Blitz also mentioned that slightly altering the strength or dosage of a brand-name medication without a clear, documented medical rationale does not constitute a clinical difference.

“These minor changes are often made solely to create the illusion that the patient requires a unique compounded formulation when, in reality, they do not.”

“What’s particularly telling is that many compounding pharmacies are offering the same additives or minor adjustments to large numbers of patients—i.e., “mass personalization—which clearly demonstrates a violation of FDA requirements for individualized compounding.”

The FDA makes it clear: providers should not sell or market compounded GLP-1 medications like semaglutide and tirzepatide unless a patient has a legitimate, documented clinical need.

According to the FDA, buying these drugs online from unlicensed or unregulated sources “can expose patients to potentially poor-quality products.” They also warn that promotional materials for compounded medications must be “truthful, non-misleading and accurate.” If not, the FDA says it will take enforcement action when needed.

Eli Lilly, the maker of Zepbound and Mounjaro, is also taking a firm stance. The company told me that compounders “must cease production” of tirzepatide knockoffs. They’ve filed lawsuits against businesses falsely advertising these drugs as “personalized” or “tailored,” and say such practices are “breaking the law and putting patients at risk.”

Novo Nordisk, which makes Ozempic and Wegovy, echoed Eli Lilly, stating that:

“Any compounder that mass produces or sells knockoff semaglutide drugs is breaking the law and compromising patient safety.”

They’ve already taken legal action against more than 120 companies, many of which have received permanent injunctions barring them from further illegal activity. The Bottom line? These companies, along with the FDA, are actively working to shut down the marketing and sale of compounded GLP-1s. If your provider is still offering them, that could be a major red flag.

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Over the last year, weight loss medications such as GLP-1s (such as compounded semaglutide, Ozempic or Wegovy) have become diet culture staples. A-list celebrities and media personalities like Elon Musk have credited their staggering weight loss formations to these “miracle” medications, which were once only intended for diabetes. Not only do they help regulate blood […]

Many telehealth providers are taking the FDA guidelines seriously and have stopped offering compounded medications altogether. However, there are still telehealth providers promoting compounded GLP-1 medications as semaglutide, tirzepatide or customized/personalized GLP-1 protocols (or similar language).

One provider, Agile Telehealth, markets and promotes “personalized” compounded GLP-1 medications. When I asked about this and how Agile can still offer these medications after the FDA ban, an Agile customer service agent told me:

“We do offer compounded GLP-1s. However, to ensure you receive the best treatment option tailored to your needs, we recommend calling our Patient Support Team to book an appointment with a provider.”

Another telehealth provider I researched and wrote an article on was MD Exam. They continue to market and promote compounded GLP-1 medications. In fact, their Google ad says “Lose 15%+ of your body weight in one year on average with FDA-approved GLP-1 medications”, which is a bit misleading because compounded medication is not FDA-approved. I reached out to MD Exam’s CEO, Sergio Padron, who did not respond to my request for a comment.

Another thing to consider is that many of these telehealth providers use a white-label provider, which means a third-party company handles their customer service, billing, marketing and other details of their business. I noticed an inconsistency with answers from these white-label providers. If a company can’t give you a clear answer on your compounding medication questions, it’s probably a good idea to find another provider who can.

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GLP-1 Pills: Do They Work? Experts Weigh In

When GLP-1s such as Ozempic or Wegovy come to mind, most people tend to think of injectable medications. But, more and more compounded pharmacies are manufacturing semaglutide pills. This would remove the need for a needle in the GLP-1 weight loss process. But what are the benefits and drawbacks? Dr. Lizzie Benge, MD, of Brigham […]

While the obvious risks of compounded medications are that they are not FDA-tested or approved, Dr. Blitz gets a bit more specific on why you should avoid them. “Adding untested ingredients, such as Vitamin B12, to compounded GLP-1s introduces significant risks without proven benefit:

• No clinical trials support the safety or efficacy of these combinations.
• Additives may alter the distribution, efficacy, metabolism, or excretion of the GLP-1 medication.
• There is an increased risk of injection site reactions, sterility failures, and contamination.”

Dr. Blitz goes on to say that “These formulations may mislead patients into believing they are receiving a superior or customized product, when in reality, they are being exposed to unvalidated risks without a clear medical benefit.”

When asked about compounded GLP-1s, Megahan Garcia-Webb, MD, a triple board-certified physician specializing in obesity medicine and producer of the YouTube series Weight Medicine with Dr. Meghan, told me:

“I don’t recommend compounded versions because they bypass the standard precautions, and there is no guarantee they are safe, not to mention effective. There are many oral and injectable options now that are FDA-approved, so it’s best to stick with medications that have been assessed by the standard safety/efficacy channels.”

GLP-1 expert, Dr. Spencer Nadolsky, told me last year that he was more open to compounded medications than he used to be (when they were legal), but preferred the name-brand options:

“I’m still cautious about it because I think it would be really nice to know more about it if it’s been studied more. In an ideal world, Eli Lilly and Novo Nordisk would have enough of this stuff and make it cheaper. That would completely squash the whole compounding thing anyway, because a lot of people are doing it because it’s cheaper. ”

One of the main reasons why compounded medications became so popular in the last few years is their affordability. With monthly doses of Ozempic sometimes being $1,000 or more without insurance, telehealth providers specifically offered compounded medications at a fraction of the cost. However, not only have prices come down on many of the name-brand medications, but there are additional ways to get affordable FDA-approved GLP-1 medications.

Dr. Blitz recommends applying for manufacturer assistance programs (e.g., NovoCare, Lilly Cares). NovoCare currently offers Wegovy to patients without insurance for $199 for your first month, then $499 per month when you refill.

A representative from Eli Lilly told me that “through the Zepbound savings program, eligible commercially insured patients can get Zepbound for as little as $25 a month. And even without insurance, patients with a prescription can access genuine Zepbound single-dose vials through LillyDirect’s self-pay pharmacy for as little as $349 a month.”

“Zepbound single-dose vial prices are less than, or at least comparable to, the cost of unapproved compounded tirzepatide from many sellers, including HenryMeds ($449), Willow ($399), RemedyMeds ($399), MangoRx ($399).”

While these prices are more expensive than some telehealth providers that offer compounded GLP-1s, remember that you’re getting an FDA-approved medication.

Telehealth Providers offering FDA-Approved Medications

• Mochi: Offers Wegovy, Ozempic, Mounjaro, Zepbound, Saxenda and Victoza
• Found: Offers Ozempic, Mounjaro and Zepbound
• Ro: Offers Ozempic, Wegovy and Zepbound (injectors and vials)

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Not long ago, the FDA announced there’s no longer a shortage of Ozempic, Wegovy, Zepbound or similar drugs used for weight loss. Is that good news for the millions of us who struggle with excess pounds? Not exactly. During the shortage, pharmacies were allowed to make special low-cost ‘compounded’ versions of the meds. But that […]

With the FDA officially banning compounded semaglutide and tirzepatide, the safest and most legal path forward is to stick with name-brand GLP-1 medications like Ozempic, Wegovy, Zepbound and Mounjaro. While some telehealth providers may still offer compounded versions under different names or vague “custom protocols,” these formulations are not FDA-approved, lack clinical testing and can expose patients to unknown health risks.

Thankfully, access to FDA-approved options is better than ever. Eli Lilly and Novo Nordisk now offer savings programs that can significantly reduce out-of-pocket costs, even for patients without insurance. Reputable telehealth platforms like Mochi, Found and Ro are also making it easier to get these medications legally and conveniently from licensed providers.

At the end of the day, your health isn’t worth the gamble. When it comes to GLP-1 medications, transparency, quality and FDA oversight matter. Always ask questions, check credentials and work with providers who put your safety first.

Statement from Dr. Blitz:
“Compounding medications like semaglutide and tirzepatide are only legally permitted under narrow circumstances—specifically, during an FDA-declared shortage or when a patient requires a true, documented clinical difference, such as an allergy to an ingredient in the branded product. Compounded medications are inherently less safe than FDA-approved drugs because they lack the rigorous testing required for safety, efficacy, and sterility. Adding unproven ingredients like vitamins, or making trivial dosage tweaks, does not create a legitimate clinical difference—these are often false pretenses designed to justify otherwise noncompliant compounding practices and clinics. While compounding during a shortage was a necessary solution, continuing to compound GLP-1s after the shortage has resolved—without a true, individualized clinical need—is neither legal, ethical, nor in the best interest of patient safety.”
— Dr. Arie Blitz, MD, MBA