If you’ve spent time scrolling social media, talking to friends, or researching weight loss medications online, chances are you’ve come across terms like “compounded semaglutide” or “compounded Ozempic.” You may have heard that these alternatives are often less expensive compared to brand-name GLP-1 drugs, like Ozempic and Wegovy, and offer similar benefits. But what exactly does “compounded” mean and, more importantly, is it safe? Let’s break it down so you can make the most informed decision for your health (and wallet).

What is a compounded GLP-1?

A compounded GLP-1 refers to a medication that has been custom-made by a licensed pharmacy rather than manufactured by a pharmaceutical company. Compounding pharmacies can mix, alter, or combine active ingredients to create a medication tailored for a patient’s specific needs. With GLP-1s, this often means preparing semaglutide formulations when brand-name drugs are too expensive or unavailable for the patient. Unlike branded drugs, compounded medications are not FDA-approved. In other words, they don’t undergo the same rigorous clinical trials or quality checks before reaching patients.

What is a branded GLP-1?

So, what is a branded GLP-1? They’re the FDA-approved versions you’ve probably heard of: Ozempic, Wegovy, Rybelsus, and Mounjaro. Unlike compounded GLP-1’s, branded versions are manufactured by major pharmaceutical companies under strict regulatory oversight. Each batch must meet specified safety, efficacy, and purity standards. Their efficacy is also rigorously tested and backed by large-scale clinical trials.

What is the difference between compounded and branded GLP-1s?

The biggest difference between compounded and branded GLP-1s comes down to regulation, safety, and consistency. Branded GLP-1s are FDA-approved, mass-produced, and subject to ongoing monitoring. Compounded versions, on the other hand, are produced in small batches and can have more variability in quality and formulation. This makes compounded drugs less predictable in terms of safety, dosing, and effectiveness. That’s why it’s so important to work with an experienced board-certified doctor and pharmacy.

Why are compounded GLP-1 medications available?

When there’s a shortage of a commercially available drug or when a patient requires a different formulation, pharmacies will compound the medication. Because demand for Ozempic and Wegovy has far outpaced supply in recent years, insurance providers have offered compounded semaglutide as an alternative for patients unable to access brand-name products. In certain cases, AEDIT Founder and Board-certified facial plastic and reconstructive surgeon Dr. William Kennedy shares, “Compounded GLP-1 formulations may be combined with additional agents like Vitamin B12 to ease gastrointestinal discomfort, low-dose naltrexone to combat cravings, and metformin to improve insulin sensitivity. These adjustments are tailored to the patient and can help support individual needs.”

Are compounded weight loss drugs legal?

Yes, compounded medications are legal when prepared by a state-licensed pharmacy or FDA-registered outsourcing facility. That being said, there have been instances of pharmacies not having strict protocols or standards and distributing improper dosing and/or impurities. Whenever starting a new medication, always consult with a reputable board-certified doctor.

Is compounded semaglutide safe?

Safety is the biggest concern with compounded versions of semaglutide. Because these medications don’t go through FDA approval, patients may face risks of impurities or incorrect dosing. While there are a number of telehealth services online that can prescribe compounded GLP-1, it’s essential that patients work with a trusted board-certified doctor to ensure the drugs are coming from a reliable pharmacy.

Why is compounded Ozempic so much cheaper?

Without insurance, branded GLP-1 prescriptions can cost more than $1,000 per month. Compounded versions, on the other hand, are often a fraction of that price—sometimes just a few hundred dollars a month. "Brand-name medications like Ozempic undergo FDA approval and extensive quality control, which adds significantly to their price. On the other hand, compounded versions avoid these costs, which is why they’re more affordable, but the level of testing can vary between pharmacies. It’s important for patients to use a reputable source," says board-certified facial plastic and reconstructive surgeon Dr. William Kennedy.

Has the FDA warned about compounded GLP-1s?

Unfortunately, yes, the FDA has issued multiple warnings cautioning patients and prescribers about compounded GLP-1s. Concerns are mainly around fraud, improper dosing, unapproved ingredients, and salt forms. The FDA strongly urges consumers to purchase from state-licensed pharmacies rather than buying online because there is a heightened risk of counterfeit drugs, impurities, and dosing errors.

Can you get Wegovy compounded?

Some compounding pharmacies do offer compounded versions marketed as “Wegovy,” though technically these are unapproved formulations of semaglutide. Earlier this year, the FDA gave pharmacies notice to cease production, saying the semaglutide shortage is resolved. Patients getting Wegovy compounded should understand that these products are not equivalent to the branded version. If you’re considering this route, it’s critical to ensure the pharmacy is reputable and legally compliant.

What are the risks of using compounded semaglutide or tirzepatide?

When receiving any drug that has been compounded, there is a risk that the formulation doesn’t contain the correct active ingredient or could even be contaminated with other ingredients. There’s also a possibility that the compounded drug has incorrect concentrations, which would mean the person is unknowingly under- or overdosing. These risks can have real consequences for health and weight loss goals.

How are compounded GLP-1 medications dosed and delivered compared to brand-name?

Branded GLP-1s come in pre-filled injection pens with standardized doses. Compounded versions, on the other hand, may be supplied in vials, requiring manual measurement and injection. Because there’s a risk of user error, there is an increased chance of dosing errors.

Are there risks of impurities with compounded GLP-1s?

Yes. Without strict FDA manufacturing requirements, compounded medications carry a higher risk of contamination or impurities. Even small inconsistencies can impact safety and effectiveness, especially for injectable medications like GLP-1s, which is why the FDA has warned consumers about the risks of compounded medications.

Are compounded GLP-1s as effective and have the same clinical outcomes as branded ones?

A GLP-1’s effectiveness will greatly depend on how well formulated it is. Dr. Kennedy explains, "When prepared correctly with the same active ingredient, compounded GLP-1 medications can be just as effective as branded versions in terms of clinical outcomes. The key difference is that brand-name drugs are backed by FDA approval and large-scale trials, while compounded formulations depend on the quality controls of the individual pharmacy."

Who should not take compounded versions?

Patients with complex medical histories, underlying health conditions, or those at higher risk of side effects should avoid compounded versions. If a patient is eligible for insurance coverage for weight loss drugs, there’s no need for a compounded version.

Where can I get compounded GLP-1s safely?

If you decide to pursue this option, make sure you are working with a state-licensed compounding pharmacy or an FDA-registered outsourcing facility. Always verify credentials, ask about ingredient sourcing, and confirm whether the pharmacy has experience with sterile injectable medications.

Will compounded GLP-1s remain available if brand-name shortages end?

Probably not. The FDA typically restricts compounded versions once branded supply returns to normal levels. That means compounded semaglutide or tirzepatide may not remain an option forever, especially if the only reason for compounding was a shortage.

How should patients or prescribers vet compounding pharmacies?

• Ask the right questions:
• Is the pharmacy licensed in your state?
• Is it registered with the FDA?
• Where are they sourcing semaglutide or tirzepatide?
• Are sterility and potency regularly tested?
• Do you test your medications for quality and safety?
• Are you following national standards?
• Can you show proof of testing results?

The Bottom Line

Compounded GLP-1s may seem appealing due to lower prices and easier access during shortages, but they come with real safety concerns. Branded medications like Ozempic, Wegovy, and Mounjaro are backed by rigorous research and regulatory oversight, making them the gold standard for treatment. Ultimately, the safest approach is to work closely with a trusted healthcare provider to find the right option for you.