What is compounded semaglutide made of?

In this article:

• Why is semaglutide compounded?
• What is compounded semaglutide made of?
• Are they all the same?
• Sourcing semaglutide
• Compounded semaglutide vs. brand-name

In this article

• Why is semaglutide compounded?
• What is compounded semaglutide made of?
• Are they all the same?
• Sourcing semaglutide
• Compounded semaglutide vs. brand-name

Semaglutide is an active ingredient in a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. These prescription drugs are used to treat Type 2 diabetes, promote weight loss, and reduce the risk of heart disease. Common brand-name drugs that contain this ingredient include Ozempic, Wegovy, and Rybelsus—all manufactured by Novo Nordisk, a Danish pharmaceutical company. Ozempic and Rybelsus are prescribed to control blood sugar levels in adults with Type 2 diabetes, and Wegovy is prescribed for weight management in adults with obesity (or those who are overweight with one or more weight-associated comorbidities). Ozempic and Wegovy are also used to reduce the risk of major cardiovascular events.

Due to the rising demand for weight loss drugs and the resulting drug shortages, some specialized compounding pharmacies make compounded semaglutide injections. Compounded versions of semaglutide contain varying ingredients, and they’re not approved by the U.S. Food and Drug Administration (FDA). It’s often easier and cheaper to obtain compounded semaglutide products compared to brand-name medications, but pharmacists and healthcare professionals warn that these products can come with risks.

Why and when semaglutide is compounded

According to the FDA, compounded drugs are made by licensed pharmacists (or under the supervision of pharmacists in outsourcing facilities) who combine, mix, or alter ingredients of a drug. Their purpose is to meet an individual patient’s specific needs when an FDA-approved drug doesn’t.

Why would an individual patient need a custom version of semaglutide when brand-name versions are available? There are a few times when compounding is necessary. A patient may be allergic to one of the ingredients in an FDA-approved medication or may require a different form, such as a liquid, per the FDA.

Compounded drugs are also made during drug shortages. The FDA has a drug shortage list, and injectable semaglutide is currently in low supply. During drug shortages, the FDA recognizes that patients may turn to compounded formulations of the medications they need.

Some patients unable to get brand-name semaglutide have turned their attention to compounded versions. “The growing demand for GLP-1 receptor agonists has driven a surge in compounded semaglutide products,” says Dazhi Liu, Pharm.D., a clinical pharmacy specialist in West New York, New Jersey. Additionally, the high cost of brand-name semaglutide may push patients toward compounded versions. However, there are other ways to save on these medications, such as using SingleCare coupons.

Ozempic coupons, Wegovy coupons, Rybelsus coupons

What is compounded semaglutide made of?

Compounded medications aren’t the same as brand-name or generic medications, so they may not contain the exact same ingredients. This is because compounded drugs are formulated with a custom blend of ingredients.

“Compounded semaglutide is a medicine that’s custom-made for the patient by a compounding pharmacy,” explains Inna Melamed, Pharm.D., a functional medicine practitioner and author of Digestive Reset. “It’s made of the same active ingredient, semaglutide, in brands like Wegovy and Ozempic.”

However, it’s not possible to know exactly what compounded semaglutide is made of because there isn’t a universal formula or standard. “Compounding pharmacies mix the ingredients, so it can vary,” says Supriya Rao, MD, a board-certified obesity medicine specialist practicing in the Boston area. “Compounded semaglutide could possibly be made of semaglutide, but it can also contain vitamins or other ingredients.” Vitamin B12 may be added to compounded semaglutide, for example.

It’s also possible for these compounded versions to be made with salt forms of semaglutide rather than the pure ingredient in the FDA-approved drugs. “Some compounded semaglutide might not even contain semaglutide,” Dr. Rao explains. “Sometimes a salt alternative that is chemically similar that may achieve the same result will be used.” The FDA warns that these salt forms, including semaglutide sodium and semaglutide acetate, should not be used.

Are all compounded semaglutides the same?

Compounded drugs containing the same active ingredient aren’t always the same because two patients may have different needs, resulting in various formulations. They’re not the same as name-brand medications either. “Compounded semaglutide is not identical to Ozempic or Wegovy,” Dr. Rao states. “With compounded semaglutide, there’s no way to be sure of what you are taking.”

People wishing to access weight-loss medications may turn to an online pharmacy for easily accessible and more affordable compounded semaglutide. However, healthcare professionals warn against this because these formulations aren’t standardized. “Compounding pharmacies may use different ingredients or processes, so the quality, formulation, and effectiveness will vary,” Dr. Rao explains. “Since compounded semaglutide is not an FDA-approved drug, the quality will vary greatly due to the lack of oversight.”

In addition to the lack of quality standards, there are concerns about the potential risks and side effects of compounded semaglutide products. Is compounded semaglutide safe? “Differences in the purity of the semaglutide source, formulation methods, and quality controls can lead to significant variability in effectiveness and safety,” Dr. Liu explains. “Compounded products lack bioequivalence testing and can result in dosing errors, reduced efficacy, and adverse events.”

The popularity of compounded semaglutide products raises significant safety concerns, Dr. Liu says. “My colleagues and I have noted troubling prescribing practices, including widespread use without adequate patient screening or integration with lifestyle modifications,” she adds. The American Diabetes Association issued a guidance statement on this topic, recommending against the use of non-FDA-approved compounded GLP-1 receptor agonist formulations like semaglutide out of concern related to content, safety, quality, and effectiveness. 

Sourcing semaglutide for compounding

Patients must get a prescription from a healthcare provider for compounded semaglutide, which specialized pharmacies can fill. But where do compounding pharmacies get their raw materials, and how do they ensure safety and sterility?

“Compounding pharmacies obtain semaglutide as a raw active pharmaceutical ingredient (API) from bulk suppliers,” Dr. Liu says. “While some suppliers meet acceptable standards, compounded products are not FDA-approved, and the final formulations may vary in purity, potency, and safety.”

FDA-approved drugs undergo a lengthy process, including research, rigorous testing, and clinical trials. The approval process determines whether a drug’s benefits outweigh its risks and side effects. It ultimately concludes whether a drug is safe to use in humans. Since compounded semaglutide doesn’t undergo this process, there are risks like dosing errors and counterfeit products, Dr. Liu says. There are also risks associated with contamination and sterility.

To mitigate the risks, the FDA recommends talking to your healthcare provider and filling prescriptions at state-licensed pharmacies. While compounded drugs aren’t FDA approved, this doesn’t mean accredited compounding pharmacies go unregulated. Some outsourcing facilities are FDA registered, which means they’re inspected by the FDA and expected to follow the same current good manufacturing practice regulations as drug manufacturers. There are also requirements set by each state’s board of pharmacy, which oversees pharmacy compounding.

How do I know if my semaglutide is compounded?

Generic semaglutide doesn’t exist, so that leaves just two options—brand-name and compounded. Both can share the same active ingredient, semaglutide, Dr. Melamed says. However, that doesn’t make them the same, and it’s important to do your due diligence, notes Dr. Liu. “While compounding has its place, not all compounding pharmacies are equal, and the risks of using unapproved medications should not be overlooked,” Dr. Liu says. “Patients and providers must prioritize safety, monitor for adverse events, and report concerns to the FDA.”

So how do you know which one you have? If you go the traditional route—consult a healthcare professional and pick up your prescription at your local pharmacy—you likely have brand-name semaglutide. Brand-name semaglutide comes in two forms—pre-filled injectable pens (Ozempic and Wegovy) and oral tablets (Rybelsus). You’ll know your semaglutide isn’t compounded if you spot the brand name on the packaging and information leaflet.

Compounded semaglutide can vary in appearance. For starters, it won’t have any brand names printed on it. It’s also packaged differently, which can be an easy identifier. Brand-name injectable semaglutide pens are pre-loaded, but compounded semaglutide doesn’t come in pre-filled injection pens. Compounded semaglutide comes in small glass vials and is administered by the patient using syringes.

If you’re unsure, ask your healthcare provider or pharmacist if your semaglutide is compounded.