What is compounded semaglutide and is it safe?

Compounded semaglutide is a custom-made medication produced by compounding pharmacies or facilities, as opposed to pharmaceutical manufacturers. It contains the same active ingredient as FDA-approved semaglutide medications like Ozempic, Wegovy, and Rybelsus. These medications are used to treat type 2 diabetes and for weight loss. Compounded preparations containing semaglutide are not FDA approved, and have not been tested to the same degree on safety and effectiveness as commercially-available products.

What is Compounded Semaglutide?

Compounded semaglutide is a product containing semaglutide that is usually made in a compounding pharmacy. These compounding pharmacies must obtain the active ingredient, semaglutide, from FDA-registered facilities. They can then create compounded semaglutide by combining, mixing, or altering ingredients based on a prescription from a healthcare provider to meet an individual patient's needs. Compounded products like semaglutide are not approved by the FDA. This means these preparations have not been verified for quality, safety, or effectiveness. It also is not the same as a generic drug.

Compounded semaglutide may be used for several reasons. It is typically used when medical needs are not met by an FDA-approved version of semaglutide. Some examples of this include availability of commercial preparations, inability to take available dosage forms, and allergies to inactive ingredients.

Compounded semaglutide differs from commercially-available semaglutide in several ways. For one, the other ingredients added in addition to semaglutide may differ from commercial versions of semaglutide. Some compounding pharmacies offer different dosages and formulations of semaglutide than what is commercially available, including nasal sprays and sublingual solutions. These products have not been tested by the FDA for safety or effectiveness.

Why You Would Want to Choose Compounded Semaglutide

Compounded semaglutide allows for personalized dosages and formulations to meet specific medical needs (e.g., for patients who need a dose not available in the commercial version). Other reasons for choosing compounded semaglutide include:

• Drug shortages: Semaglutide products might be backordered and not available at the patient’s pharmacy.
• Allergies: If a patient is allergic to an inactive ingredient in a commercially available medication, such as a dye or preservative, a compounded drug can be made without that ingredient.
• Inability to take certain dosage forms: If a patient cannot swallow tablets, a liquid version can be made by a compounding pharmacy.
• Flavoring: Compounding pharmacies can make flavored medications that are easier for children to take.

Compounding can provide an option when commercial versions are not available or suitable for certain patients.

Is Compounded Semaglutide Safe?

While compounded semaglutide is not FDA approved, they are made under strict guidelines by licensed pharmacies. What’s more, outsourcing facilities are inspected by the FDA to make sure they adhere to quality standards. Drugs compounded in outsourcing facilities are subject to good manufacturing practice (CGMP) requirements, but drugs compounded in licensed pharmacies are not. They do, however, need to be made in accordance with the conditions of section 503A of the FD&C Act.

In 2024, the FDA issued a Postmarket Drug Safety alert about compounded and counterfeit preparations of semaglutide. They cautioned that these preparations are not approved by the FDA and have not been reviewed for effectiveness, safety, or quality. Other concerns included dosing errors associated with compounded injectable semaglutide products, and salt forms of semaglutide being used in compounded products.

Semaglutide sodium and semaglutide acetate are two salt forms of semaglutide that should not be used in compounded semaglutide products. They are different from the active ingredient used in commercially-available semaglutide products, and have not been tested to see whether they work the same.

Another concern is adverse reactions from using compounded semaglutide products. As of November 30, 2024, the FDA has received about 400 reports of adverse events by people using compounded semaglutide products. It is not known if these side effects were caused by these products or other factors, but the FDA stated they were consistent with adverse events reported by people taking FDA-approved versions. These include nausea, diarrhea, and stomach upset.

Counterfeit Ozempic is illegal, and can contain the wrong ingredients, other harmful ingredients, and too much or too little of the active ingredient. The FDA urges patients to only purchase compounded semaglutide from state-licensed pharmacies. This includes online pharmacies.

Related questions

• Ozempic Side Effects to Watch For
• Wegovy vs Ozempic: Which is Right for You?
• Tirzepatide vs semaglutide: How do they compare?

How to Obtain Compounded Semaglutide

In order to get compounded semaglutide, you will need a prescription from a licensed healthcare provider. Only certain pharmacies are licensed to make compounded products that adhere to FDA safety guidelines. Some virtual care companies work with 503B compounding pharmacies to offer patients access to compounded semaglutide online. Talk to your healthcare provider about the best way to obtain compounded semaglutide.

Compounded semaglutide is generally not covered by insurance. Most insurance plans do not offer coverage for compounded medications, including compounded semaglutide. Call your individual plan to ask about coverage details for compounded medications. If it is not covered, you can expect to pay around $250 per month for compounded semaglutide. This will depend on things like the pharmacy you go to and how much you are purchasing.

Summary

• Compounded semaglutide contains semaglutide as the active ingredient, but may include ingredients not in commercially-available products.
• You may choose compounded semaglutide if you need a dose or dosage form that is not commercially available, or if you are allergic to an ingredient in a commercially-available product. Compounded medications may also be useful during drug shortages.
• Compounded semaglutide products are not FDA approved, and are only available from compounding pharmacies or facilities with a prescription from a healthcare provider.
• Insurance plans do not typically cover compounded medications, including compounded semaglutide. Prices vary and can cost around $250 per month.
• It is safest to obtain compounded semaglutide from a state-licensed compounding pharmacy or facility. This includes online pharmacies. Counterfeit semaglutide is illegal, and may contain different ingredients or different amounts of ingredients than what is written on the product.
• Speak with your healthcare provider to determine if compounded semaglutide is appropriate for you.