Compounded semaglutide and Ozempic are different products. While both may be used to help manage blood sugar levels in people with type 2 diabetes, Ozempic is approved by the FDA, but compounded semaglutide is not.

Compounded drugs are custom-made medications that are mixed, combined, and altered to help meet a person’s specific needs, such as removing an ingredient they may be allergic to.

Also, compounded drugs may be useful in times of drug shortages. However, compounded drugs do not go through the same quality, effectiveness, and safety checks as drugs approved by the Food and Drug Administration (FDA).

Ozempic contains the active ingredient semaglutide. It is an FDA-approved injection to help people with type 2 diabetes manage blood sugar levels and lower certain risks in people who have heart disease, such as heart attack. Drug shortages of FDA-approved drugs that contain semaglutide mean people may need to use compounded semaglutide instead.

This article looks at the difference between compounded semaglutide and Ozempic, as well as the safety and effectiveness of compounded semaglutide.

female patient talking with doctorShare on Pinterest
NickyLloyd/Getty Images

Compounded semaglutide and Ozempic should contain the same active ingredient: semaglutide, which is a glucagon-like peptide-1 (GLP-1) receptor agonist.

A key difference between compounded semaglutide and Ozempic is the lack of FDA approval for compounded semaglutide. Some compounded semaglutide products may contain a salt form of the active ingredient in Ozempic, so safety and efficacy may not be known.

The FDA does not approve compounded medications. This means the FDA does not regulate the safety or quality of compounded drugs.

The FDA does not assess how effective compounded drugs are, so it is not known if compounded semaglutide is as effective as Ozempic.

In some cases, compounded drugs can be helpful if there is a shortage of FDA-approved drugs or if a drug requires altering to meet someone’s specific needs, such as avoiding an allergen.

Drug shortage

There is currently a shortage of FDA-approved injections that contain semaglutide, such as Ozempic. This shortage means compounded semaglutide may be available as an alternative.

If you’re unable to access Ozempic for medical needs, you may be considering compounded semaglutide as an alternative option.

If you’re thinking of using compounded semaglutide and have questions about the product, talk with your doctor or pharmacist.

The FDA has received reports of compounded semaglutide that may contain salt forms of semaglutide rather than the base form of semaglutide. (The base form of semaglutide is the active ingredient in FDA-approved drugs containing semaglutide, such as Ozempic.)

The salt forms include semaglutide sodium and semaglutide acetate. There is no evidence to show that the salt forms of semaglutide are safe or effective or that compounded drugs with semaglutide salts meet federal requirements.

High demand and costs for brand-name semaglutide products may lead people to use compounded semaglutide.

Novo Nordisk, the pharmaceutical company that currently produces FDA-approved semaglutide products, including Ozempic, does not sell semaglutide for compounding. This has led to concerns over the sources of compounded semaglutide and the use of different formulations, such as semaglutide sodium.

Currently, the FDA has only approved three brand-name semaglutide drugs, and there is no approval of any generic versions.

Get answers to some frequently asked questions about compounded semaglutide and Ozempic.

Do I need to take compounded semaglutide or Ozempic with vitamin B12?

It’s possible. A small 2024 study found there was a significant decrease in vitamin B12 levels in people taking semaglutide for 12 months.

Semaglutide may cause side effects in the digestive system and may affect the type of foods people eat and the balance of nutrients in the body. Researchers found that semaglutide increased carbohydrate intake but reduced protein intake. Sources of vitamin B12 in the diet include animal-based products, such as meat and dairy. So, a reduction in animal protein may reduce vitamin B12 intake.

These factors may affect how much vitamin B12 people are getting, as well as how the body is able to absorb it. Over time, a lack of vitamin B12 may lead to a deficiency.

Talk with your doctor about whether you need to make any dietary changes or start taking supplements with vitamin B12 while using Ozempic or compounded semaglutide. You can also check out this article on using compounded semaglutide with vitamin B12.

Is compounded semaglutide or Ozempic FDA-approved for weight loss?

No. Ozempic is not FDA-approved for weight loss, and compounded semaglutide is not FDA-approved for any purpose, although it may be available when there is a drug shortage for other FDA-approved semaglutide drugs.

Ozempic is FDA-approved to help people with type 2 diabetes manage blood sugar levels and lower certain risk in people who have heart disease, such as heart attack.

According to a 2023 article, there is a rising interest in using Ozempic for weight loss, but there is currently not enough evidence to support the safe and effective use of Ozempic for weight loss. Your doctor may prescribe Wegovy, which contains the same active ingredient as Ozempic. Wegovy is FDA-approved to be prescribed for weight management.

If you have questions about weight loss, talk with your doctor.

Due to a shortage in FDA-approved products containing semaglutide, such as Ozempic, compounded semaglutide may be available as an alternative option.

However, compounded semaglutide has not gone through the same review process as FDA-approved drugs, so it is unclear how safe or effective these products are.

If you are considering using compounded semaglutide, make sure to talk with your doctor or pharmacist. It is important to get a prescription for semaglutide and only get medications from a state-licensed pharmacy or FDA-registered facility.