Compounded semaglutide: What should patients know?

While most people are familiar with the brand names Ozempic and Wegovy, there are other semaglutide weight loss options available. There is no generic version of semaglutide available, but there are compounded semaglutide medications.

Compounded drugs are not considered generics. They are, instead, customized medications made by compounding pharmacists with the same active ingredient as the original.

When there is a drug shortage, or a need for customized medication (such as an allergy), compounded versions of the drug are created.

What is compounded semaglutide?

Compounded semaglutide is as close to a generic semaglutide medication as you can get. It contains the same active ingredient (semaglutide), but the inactive ingredients will vary by compounder.

According to the FDA, “when a drug is in shortage, compounders may be able to prepare a compounded version of that drug.” Ozempic and Wegovy, the more commonly used semaglutide medications, have intermittently appeared on the FDA’s drug shortage list since their introduction. The persistent high demand for these weight loss treatments has made it clear that compounded semaglutide might be necessary to meet patient needs.

Currently, Ozempic is available but Wegovy is listed as in shortage. Rybelsus, the tablet form of semaglutide, has not been in shortage.

Is compounded semaglutide the same as Ozempic?

Though it contains the same active ingredient, compounded semaglutide is not the same as the brand name medications. There are currently no FDA-approved semaglutide generics. So, if you are unable to access the brand name medications—whether due to shortage or cost—you will need to use a compounded medication.

Aside from the differing inactive ingredients, compounded semaglutide is also offered in a different delivery method. Ozempic and Wegovy come in pre-filled injection pens. Compounded semaglutide, on the other hand, comes in a vial; this means you will need to draw each dose with a syringe prior to injection.

Is compounded semaglutide safe?

This question is more difficult to answer. Yes, compounded semaglutide is safe—if the compounding pharmacy is reputable and uses the base form of semaglutide.

The FDA does not approve or regulate compounded medications. They aren’t required to go through the same rigorous testing and approval process as the brand names, which can lead to quality issues that impact the user.

The FDA has expressed concerns about many of the available compounded semaglutide medications.

The main concerns are:

Additional Ingredients. Some compounded semaglutide contains additional ingredients, like a compounded semaglutide with B12. While the B12 boost has many benefits and is added to combat the known issues with semaglutide and B12 deficiencies, it may not be beneficial. These haven’t been tested or studied alongside semaglutide, so the side effects can’t be determined.
Semaglutide Salts. Unfortunately, some compounded semaglutide medication may contain a salt form of the active ingredient, including semaglutide sodium and semaglutide acetate. Products containing these salts have not been shown to be safe and effective according to the FDA.
Unauthorized Sources. The semaglutide base must be manufactured in a facility that is registered with the FDA and meets the proper safety and quality control requirements. Novo Nordisk—the manufacturer of Ozempic, Wegovy, and Rybelsus—is the only U.S. company with FDA-approved semaglutide medications. They released a statement claiming they do not sell semaglutide for use in compounding.

These concerns do not inherently mean that compounded semaglutide is unsafe. It does, however, highlight the need for caution. Make sure you are doing your due diligence:

Verify the Source. Ask the compounding pharmacist or seller where they get their semaglutide base. Then, check with the FDA database to see if the facility is registered.
Verify Accreditation: Look for accreditation from organizations such as the Pharmacy Compounding Accreditation Board (PCAB) or other recognized bodies that certify compounding pharmacies. This can indicate adherence to higher standards of quality and safety.
Watch for Red Flags. If the compounded semaglutide is labeled or advertised as “compounded Ozempic” or “compounded Wegovy,” it is a major red flag. It is illegal to use the name brand in their marketing. Using brand names in marketing is illegal and may indicate broader regulatory issues.
Check for Reviews and References: Research the compounding pharmacy or seller’s reputation through online reviews and references from other patients or healthcare providers. A pharmacy with positive feedback is more likely to adhere to high standards.
Be Aware of Legal Issues: Stay informed about current regulations and legal issues related to compounded medications. Awareness of any recent changes or controversies can help you make more informed decisions about your treatment.

By taking these precautions, you can better protect yourself and ensure the compounded semaglutide is safe and meets the appropriate standards.

Compounded semaglutide side effects

Since the active ingredient in the compounded semaglutide medications is the same as the name brands (unless the salt base is used), the side effects will mostly be the same. Individuals may deal with:

Nausea
Abdominal pain
Diarrhea/constipation
Fatigue
Headache
Injection site reactions
And other more serious side effects

The inactive ingredients and additives can impact the side effects. It is also worth noting that if the medication is compounded incorrectly (with too much of the active ingredient, too high of a dosage, etc.), it may cause other adverse effects as well.

Does compounded semaglutide work?

Yes. Compounded semaglutide can be effective if it is made using the proper semaglutide base and does not contain additional ingredients that could affect its efficacy. When manufactured correctly, compounded semaglutide should maintain the same mechanism of action as the brand-name versions, providing similar benefits for weight loss and metabolic health.

Compounded semaglutide cost

A benefit of compounded semaglutide is the cost. This compounded version costs considerably less than its brand name equivalents. This is not due to poor quality. Instead, you save because you’re not paying for the high cost of manufacturing and distributing the medication.

Prices will vary by seller, so be sure to shop around—and do your due diligence for each option—before making a purchase decision.

Heally simplifies the process by connecting you with qualified healthcare providers online, sending medications directly to your door, and offering monthly subscription options so that you can save even more.

You can get a compunded semaglutide prescription through Heally for just $299 per month, plus additional savings with a 3- or 6-month package. Brand names like Ozempic and Wegovy are available at an additional cost.

How to get compounded semaglutide

Heally connects you with expert healthcare providers who can guide you through the process and help you save on your semaglutide prescription. Heally partners with reputable pharmacies, that will then send the medication directly to your home.

We make it easy to access the expertise you need. Register with Heally today and take the first step toward achieving your health goals with confidence.