Is compounded semaglutide the same as Ozempic?
Reviewed by Steve Silvestro, MD, Ro,
Written by Amelia Willson
Reviewed by Steve Silvestro, MD, Ro,
Written by Amelia Willson
last updated: Oct 22, 2024
4 min read
Key takeaways
Compounded semaglutide can be a version of semaglutide tailored to meet the needs of an individual patient or a copy version to help meet supply needs during a drug shortage.
Compounded semaglutide is not the same as Ozempic and Wegovy. In addition, while compounded drugs can be prescribed under federal law, they are not subject to FDA-approval.
Here's what we'll cover
Here's what we'll cover
Key takeaways
Compounded semaglutide can be a version of semaglutide tailored to meet the needs of an individual patient or a copy version to help meet supply needs during a drug shortage.
Compounded semaglutide is not the same as Ozempic and Wegovy. In addition, while compounded drugs can be prescribed under federal law, they are not subject to FDA-approval.
If you’ve been looking into Ozempic or Wegovy for weight loss or type 2 diabetes, you may have come across compounded semaglutide.
Compounded semaglutide is a custom-made version of semaglutide tailored to meet the needs of an individual patient or a copy version to help meet supply needs during a shortage. While certain compounding pharmacies may use the same active pharmaceutical ingredient as Ozempic and Wegovy to prepare compounded semaglutide, it’s not accurate to say compounded semaglutide is the same as Ozempic.
Read on as we explore the differences between compounded semaglutide and Ozempic, so you can make an informed decision about your treatment options.
Ozempic Important Safety Information: Read more about serious warnings and safety info.
Wegovy Important Safety Information: Read more about serious warnings and safety info.
Is compounded semaglutide the same as Ozempic?
This question is difficult to answer, in part due to the drug compounding process. Because drug compounding is often done to meet the needs of individual patients, there can be a lot of variability in the final product. One person may be allergic to one of the inactive ingredients in Ozempic, so a compounding pharmacy may make a version of the drug without that ingredient in it. Some people may be unable to administer injectable medications, so a compounding pharmacy could prepare compounded semaglutide in another form.
Dr. Beverly Tchang, MD, an endocrinologist who treats patients with obesity, and an advisor to Ro, summed this up well: “‘Compounded semaglutide’ is not standardized—one compounded semaglutide is not the same as another compounded semaglutide, and none of them have been tested in clinical trials for safety or efficacy.”
Compounding pharmacies also prepare compounded semaglutide to meet demand and patient needs during drug shortages, which have affected Ozempic and Wegovy on an on-and-off basis since March 2022. Compounded semaglutide prepared by reputable compounding pharmacies will include semaglutide base, which is the same active ingredient used in Ozempic and Wegovy. However, the FDA has warned that some compounding pharmacies are using semaglutide salts instead, which is not the same active ingredient that Ozempic and Wegovy contain.
At a basic level, compounded semaglutide cannot be exactly the same as Ozempic, simply because it’s not made by Novo Nordisk, which is the only company that has received approval for medications that contain semaglutide: Ozempic, Wegovy, and Rybelsus. Here’s a quick breakdown of the other key differences between compounded semaglutide vs. Ozempic:
Who makes it: Ozempic is produced and manufactured by the pharmaceutical company Novo Nordisk, while compounded semaglutide may be produced by various compounding pharmacies and other compounding facilities.
How it’s administered: Ozempic comes in injectable prescription pens. Each pen contains between 4–8 doses of the medication. You’ll need to attach a new needle for each injection. Injectable compounded semaglutide typically comes in small glass vials. You’ll use a syringe and draw up your own dose for each injection.
What it contains: Some forms of compounded semaglutide, like those offered by Ro, use semaglutide base, which is the same active ingredient as Ozempic. Other forms may use semaglutide salts, which are not the same active ingredient.
How much it costs: The cost of brand-name Ozempic is high, around $1,000. Compounded semaglutide tends to be more affordable, depending on where you fill your medication. For some people, compounded semaglutide may be a more affordable way to get semaglutide for weight loss until Novo Nordisk’s patent expires and a generic form of Ozempic becomes available. However, Ozempic and Wegovy have gone through the FDA approval process, whereas compounded semaglutide is not FDA approved and does not undergo safety, effectiveness, or manufacturing review by FDA.
Is compounded semaglutide as effective as Ozempic or Wegovy?
The answer to this is that we do not know for sure, said Dr. Tchang. “We do not know since compounded semaglutide has not been tested in clinical trials for safety or efficacy.”
To date, research on semaglutide is conducted using versions of semaglutide prepared by Novo Nordisk. Given the use case of drug compounding—to meet the needs of an individual patient or boost supply during a drug shortage—clinical trials are not performed with compounded drugs.
So, even when compounded semaglutide contains the same active ingredient as Ozempic, semaglutide base, and is prepared by a state-licensed compounding pharmacy, we cannot say with certainty that it is as effective as Ozempic or Wegovy simply because it has not been studied and gone through FDA approval process.
Is compounded semaglutide safe?
Again, because compounded semaglutide has not been tested in clinical trials, we don’t know if compounded semaglutide is safe or effective, said Dr. Tchang. The FDA has received reports of people experiencing side effects after using compounded semaglutide. They’ve also warned that some compounding pharmacies are using the salt forms of semaglutide, which include semaglutide sodium and semaglutide acetate. These semaglutide salts are different active ingredients than those in Ozempic and Wegovy, which use the base form of semaglutide.
Compounded drugs do not undergo the same amount of testing for safety, effectiveness, and quality that FDA-approved drugs do, so they naturally pose a higher risk to people taking them. Having said that, compounded semaglutide can be a helpful option during Ozempic and Wegovy shortages, as well as for people who cannot take Ozempic and Wegovy in their standard form. In addition, drug compounding is subject to federal and state requirements, including sterile compounding standards.
There are steps you can take to help ensure you are getting compounded semaglutide from a reputable compounder who uses semaglutide base, not salts. For example, Ro only works with state-licensed compounding pharmacies to produce compounded semaglutide, and each batch of medication undergoes quality checks by an accredited third-party lab. Ro’s compounded product only uses semaglutide base, which is the same active ingredient in Ozempic and Wegovy, and not semaglutide salts.
How do you know if compounded semaglutide is a good option for you? “This should be a discussion between a patient and their doctor since it deserves a full assessment of the risks, benefits, and alternatives to compounded semaglutide,” said Dr. Tchang.
Frequently asked questions about compounded semaglutide
Below we answer a few more common questions people have about compounded semaglutide.
Reduced B12 levels are not currently listed as a side effect of Ozempic or Wegovy, so more research is needed to know if lower B12 levels are possible with semaglutide Semaglutide does alter food cravings and appetite, especially for high-fat foods like meat, which are a common source of B12. So, it’s possible that some people taking Ozempic may start eating less meat after taking the medication, which could affect their B12 levels. If this is a concern for you, talk to your health provider about other ways to get more B12 in your diet, or consult a registered dietitian about adjusting your diet on Ozempic.
Compounded semaglutide can be a treatment option for people who have trouble finding Ozempic in stock during a drug shortage, or need the brand name medication modified in some way. Ro offers compounded semaglutide through its comprehensive Ro Body weight loss program, which includes:
A virtual consultation with a licensed healthcare provider
A prescription for compounded semaglutide or another GLP-1 medication, if appropriate
An insurance concierge to help you secure coverage for brand-name medications, if appropriate
Ongoing care and support for refills
Personalized coaching and tools to track your progress
GLP-1 Important Safety Information: Read more about serious warnings and safety info.
DISCLAIMER
If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.
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