Is compounded semaglutide safe?

Doctors prescribe semaglutide medication 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.

Due to recent shortages of commercially available semaglutide, some pharmacies offer compounded semaglutide. In a compounded drug form, its ingredients are altered and combined with other ingredients customized according to your health needs. The compounded versions might not contain the same active chemical compound as the branded products. 

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, and they cannot verify if the drug is safe or effective. 

While commercial semaglutide products like Rybelsus, 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. 

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.

Although semaglutide is on the FDA’s drug shortages list, compounded semaglutide might still not meet FDA requirements.

Some pharmacies may use salt forms of semaglutide (semaglutide sodium and semaglutide acetate) to compound the drug. Since Rybelsus, 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.” The New Jersey Board of Pharmacy notes that no form of semaglutide, neither salt nor base, appears on the “bulks list.” Additionally, even if a pharmacy were to obtain a semaglutide base, they must get it from a supplier approved by the FDA. The product 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 events reports for compounded semaglutide.

Your system may absorb salt formulations of semaglutide differently than 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)

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.

According to a 2022 study, injectible semaglutide improves craving control and positive mood when compared with placebo. The drug also resulted in greater reductions in total fat mass.

How to choose a reputable compounding 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. 

Summary

Semaglutide is an FDA-approved medication that can treat type 2 diabetes and promote weight loss. It is available in tablet form under the brand name Rybelsus and as an injection under the brand names Ozempic and Wegovy.

Some pharmacies may provide compound medication. They alter the ingredients in a compound medication to tailor your health needs. Compounded semaglutide is not FDA-approved, as it cannot be guaranteed safe or effective.

Some pharmacies might use salt forms of semaglutide (sodium or acetate) in compounded formulations. The salt form is an active ingredient different from FDA-approved semaglutide, which uses a semaglutide base.

The FDA has received adverse event reports about compounded semaglutide. You can choose a reputable compounding pharmacy by asking questions about its state license status, ingredient sourcing, and compounding process. 

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