What is semaglutide?

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood  (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.

There are currently three FDA-approved semaglutide products:

Ozempic injection and Rybelsus tablets are approved to lower blood sugar levels in adults with type 2 diabetes mellitus, in addition to diet and exercise. Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes mellitus and known heart disease.

Wegovy injection is approved to help adults and children aged 12 years and older with obesity or some adults with excess weight (overweight), who also have weight-related medical problems, to lose weight and keep the weight off, in addition to diet and exercise.

What is compounding?

Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.

Can semaglutide be compounded?

Yes, If done correctly, it can be compounded. However there is a lot of red tape on how to do it correctly.  

When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, Ozempic and Wegovy are both listed on FDA’s Drug Shortages list.

Additionally, FDA has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded. On April 27, 2023, FDA wrote to the National Association of Boards of Pharmacy expressing the agency’s concerns with use of the salt forms in compounded products.

What should patients know?

Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.

Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies ie (Webster Pharmacy) in Missouri.

Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards. 

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