Is compounded semaglutide safe?

Key takeaways

• Compounded semaglutide is not approved by the FDA, and its safety and effectiveness cannot be verified because it doesn’t undergo the rigorous testing required for FDA-approved medications like Ozempic, Wegovy, and Rybelsus.
• Many compounded versions use salt forms of semaglutide (sodium or acetate) rather than the base form found in approved products, which may be absorbed differently and carry unknown risks, including vomiting, kidney injury, and low blood sugar.
• If considering compounded semaglutide, choose a pharmacy licensed in your state that sources ingredients from FDA-registered facilities, uses third-party lab testing, and is accredited by the Pharmacy Compounding Accreditation Board.

Overview

Doctors prescribe semaglutide to treat type 2 diabetes and support weight loss. It is not yet available in generic form, but you can purchase it under the brand names Ozempic and Wegovy.

Some pharmacies offer what’s known as compounded semaglutide. In a compounded drug, the ingredients are altered and combined with other ingredients tailored to your health needs. These were originally created due to shortages in supplies.

However, the compounded versions might not contain the same active chemical compound as the branded products. The Food and Drug Administration (FDA) hasn’t approved compounded semaglutide. Since the FDA does not monitor or test compounded drugs, the risks and safety profiles of compounded semaglutide are unknown. 

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Is compounded semaglutide safe? 

The FDA has expressed concern about compounded semaglutide, as they cannot verify if the drug is safe or effective. 

While commercial semaglutide products like Ozempic and Wegovy are FDA-approved, compounded semaglutide is not. Before a drug receives FDA approval, it must go through several phases during which the FDA assesses its safety and effectiveness. These stages include:

• preclinical testing using laboratory animals
• phase 1, 2, and 3 clinical trials on humans
• postmarket testing

Compounded drugs do not go through these stages, so their risk profiles are unknown. The FDA says a person should not use a compounded drug when an approved drug is available. 

Some pharmacies may use salt forms of semaglutide (semaglutide sodium and semaglutide acetate) to compound the drug. Since Ozempic and Wegovy use the base form of semaglutide, these compounded formulations do not have the same active ingredient. 

For a drug to be compounded, it must appear on the FDA’s “bulks list.” However, no form of semaglutide, neither salt nor base, appears on the bulks list. Additionally, even if a pharmacy were to obtain a semaglutide base, it must be sourced from an FDA-approved supplier.

The product then must be pharmaceutical grade and come with a certificate of analysis.

Risk factors of compounded semaglutide

The FDA’s MedWatch program invites people to tell the FDA if they have any unwanted side effects from taking a drug. They have received adverse event reports for compounded semaglutide.

Your system may absorb salt formulations of semaglutide differently from the base formulations. This carries unknown risks, especially when combined with inactive ingredients.

The risk factors of compounded semaglutide may include:

• vomiting
• constipation
• diarrhea
• pain in the abdomen
• kidney injury
• heartburn
• hypoglycemia (low blood sugar)

Medical perspective

Are compounded drugs safe?

“The safety of compounded medications is unknown. Compounded medications are often made during supply shortages announced by the FDA. They do not go through the rigorous clinical trials of branded medications and do not have FDA approval.”

— Jorge Moreno, MD

Note: Quotes represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.

Learn more about compounded GLP-1s

Benefits of compounded semaglutide

If you are able to get safe compounded semaglutide that complies with FDA regulations, you might get access to the drug in instances where FDA-approved products have limited availability.

When an approved drug is on the FDA’s drug shortages list, a compounded drug might be available with fewer FDA restrictions. In general, there are several requirements under federal law that apply to compounded drugs. The FDA might lift these requirements if a drug is in short supply, and a compounded drug might meet the remaining FDA requirements.

However, semaglutide is not currently on the shortages list.

Online care for GLP-1s

If a doctor has prescribed a GLP-1, it’s important to take the medication as directed for as long as your doctor recommends. However, some people might face barriers to accessing GLP-1s, including high costs and access to healthcare appointments.

With Optum Perks Online Care, you can request a new weight loss prescription, get a refill, or get help with an existing prescription. There’s no monthly membership needed — all you’ll pay is $39 for the appointment plus the cost of the medication.

With this service, you can submit an online form answering a few questions about your condition, and a licensed healthcare professional will respond soon after, without the need to make an in-person appointment.

What’s next?

If you’re looking into compounded semaglutide, here are some questions to ask to identify a reliable pharmacy. The Alliance for Pharmacy Compounding recommends asking the following questions of a compounder, especially if they are not in your immediate area:

• Do they have a license to dispense or ship to your state?
• Do they only source their active pharmaceutical ingredients from FDA-registered facilities?
• Do they have a third-party lab that periodically tests compounded medications?
• Do the compounding staff get special training?
• Does the Pharmacy Compounding Accreditation Board accredit this pharmacy?
• Can you explain this pharmacy’s compounding process?

A reputable compounding pharmacy will answer yes to all of these questions. 

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