Compounded Semaglutide: Are Ozempic and Wegovy Knock-Offs Safe?
Key takeaways:
Compounds are custom-made medications available through specialized pharmacies. They’re often prescribed when an FDA-approved medication, dose, or dosage form is unavailable.
FDA-approved semaglutide injections (Ozempic, Wegovy) were previously in shortage. Because of this, some pharmacies have been making compounded semaglutide injections. Unregulated semaglutide products are also being sold without a prescription.
Pharmacies are also compounding semaglutide sublingual drops, orally disintegrating tablets, and nasal sprays. But there aren’t clinical studies showing that these forms of semaglutide are safe or effective.
Semaglutide products made with semaglutide salts, chemicals used only for research, or ingredients from unregistered manufacturers do not meet legal FDA safety requirements.
Table of contents
Whether it’s due to an ingredient allergy or other reasons, compounding pharmacies can help tailor a custom-made medication to meet your needs. And when drug shortages happen, they can play an important role, too.
Two semaglutide injections, Ozempic and Wegovy, have been affected by shortages. Given the demand, some compounding pharmacies jumped at the opportunity to fill a medical need. By mixing up semaglutide injections from scratch, they could help people continue treatment until the shortage was over.
Under certain conditions, the FDA may allow pharmacies to make medications that are in shortage. But as of February 2025, the FDA declared that the semaglutide shortage was resolved. Even so, compounded semaglutide products may not disappear completely. In this case, compounded semaglutide may seem like a tempting alternative. But is it worth the risk?
What is compounded semaglutide?
Compounded semaglutide is a medication that’s custom-made for you by a compounding pharmacy. It contains the active ingredient semaglutide, which is found in three FDA-approved medications: Ozempic, Wegovy, and Rybelsus.
Does this mean that compounded semaglutide is the same as Ozempic, Wegovy, or Rybelsus? The short answer: No. And these products are not “generic Ozempic” or “generic Wegovy.” There are no FDA-approved generics of these mediations yet.
You may see compounded semaglutide in several different dosage forms, including:
Injections
Sublingual (under the tongue) drops
Orally disintegrating tablets (ODTs)
Oral capsules or tablets
Nasal sprays
Ozempic alternatives: Due to increased demand, it may be difficult to find Ozempic. Depending on your treatment goals and other factors, your prescriber may consider switching you to one of these Ozempic alternatives.
How to save: Glucagon-like peptide-1 (GLP-1) medications don’t need to break the bank. Explore ways to save on Wegovy, Ozempic, Zepbound, and other GLP-1 medications.
A natural boost: Medications like Wegovy work by mimicking the effects of a gut hormone called GLP-1. But did you know that there are foods and supplements that can increase GLP-1 naturally?
Compounded semaglutide medications are not FDA approved. Their safety and effectiveness haven’t been established. So it’s not guaranteed that you’ll get the same results as the FDA-approved products.
Why is semaglutide being compounded?
Some pharmacies were compounding semaglutide injections to help people access treatment while Ozempic and Wegovy were in shortage. But as of February 2025, the FDA announced that the shortage is resolved. Oral semaglutide (Rybelsus) was not affected by shortages and remains available.
Now that the shortage is resolved, the FDA is requiring pharmacies to phase out compounded semaglutide injections that are essentially copies of Ozempic or Wegovy by specific deadlines:
State-licensed pharmacies and physicians are no longer allowed to regularly compound semaglutide injections (the deadline has passed).
FDA-registered outsourcing facilities may continue to compound or dispense through May 22, 2025.
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After the deadlines pass, the FDA may still allow compounded semaglutide injections in limited cases of medical need. In these cases, the pharmacy needs to:
Use semaglutide base (the same form found in FDA-approved products)
Source ingredients from FDA-registered suppliers
Follow all applicable state and federal compounding regulations
Require a prescription from licensed healthcare professional
Cost isn’t considered a valid reason for compounding semaglutide injections when the FDA-approved product is available. And making small changes just to bypass FDA requirements isn’t allowed either. If you’ve been using compounded semaglutide, you may need to transition to Ozempic or Wegovy in order to continue treatment.
Compounded semaglutide vs. Ozempic and Wegovy
So what exactly is the difference between compounded semaglutide and Ozempic, Wegovy, and Rybelsus? Their testing and approval, ingredients, and dosage forms are a few differences to consider.
Testing and approval
Ozempic, Wegovy, and Rybelsus are all FDA-approved medications made by Novo Nordisk. This means they’ve gone through rigorous testing and review to ensure that they’re safe and effective for their intended uses. During the approval process, the FDA also signed off on where and how these medications are made.
Compounded semaglutide medications are made by specialized pharmacies that source ingredients and combine them to make a finished product. These medications are custom made. So they aren’t required to go through the same rigorous testing and approval process. This means they don’t have the same evidence for safety and efficacy as the commercial products.
Ingredients
When compounding semaglutide, pharmacies will use a recipe that’s likely different from Ozempic, Wegovy, or Rybelsus. The commercial medications serve as a reference, but there may be some minor changes in the inactive ingredients. This is typical with compounded medications.
But some compounded semaglutide medications may also contain extra ingredients that haven’t been tested with semaglutide, such as vitamin B12. It’s not fully known how these additions might affect the compounded medication. And in some cases, these extra ingredients are commercially available and can be administered separately if needed.
Concerns have also been raised about the ingredients used to make some compounded semaglutide products, including:
Semaglutide salts: Semaglutide salts, such as semaglutide acetate, do not meet FDA requirements for compounding. They’re different from what’s contained in Ozempic, Wegovy, and Rybelsus, which are made with semaglutide base.
Unauthorized sources: Semaglutide base must be manufactured by an FDA-registered facility in order to meet federal requirements. Some pharmacies may be purchasing semaglutide base from facilities that don’t meet this requirement, raising quality and safety concerns.
Non-pharmaceutical grade ingredients: Some pharmacies may be purchasing semaglutide that’s labeled “for research use only” to make their compounds. These chemicals are unregulated and are not meant to be used in people. So they don’t meet the federal requirements for compounding.
Medication delivery and storage
Ozempic and Wegovy are only available as prefilled injection pens. Compounded semaglutide injections are usually dispensed in a vial. That means you’ll need to draw up your specific dose with a syringe prior to injecting it.
Storage requirements and shelf life will also likely be different with compounded semaglutide. This can depend on how the injections are made.
Dosage forms
Ozempic and Wegovy are both injections, while Rybelsus is an oral tablet. All three medications have been carefully formulated and tested to ensure their effectiveness and safety. And studies have been done to understand the expected levels of semaglutide in the body when taking these specific forms and doses.
Compounded semaglutide comes in a variety of dosage forms beyond injections. Semaglutide in the form of sublingual drops, ODTs, and nasal sprays hasn’t been studied in humans. There aren’t any FDA-approved versions of these dosage forms to use as a reference. And the absorption rate of semaglutide in these forms is not well understood. So it’s difficult to know what to expect from taking these medications.
Is compounded semaglutide safe and effective?
It’s not possible to say for certain. This is because the FDA doesn’t evaluate the safety and effectiveness of compounded medications. But that doesn’t mean that they’re ineffective or dangerous. Compounded medications have an important place in medicine. Yet, they also have their own unique risks.
Unlike drug manufacturers, compounding pharmacies are regulated by state boards of pharmacy. Compounding regulations and the degree of oversight can vary by state. So not all compounding pharmacies are following the same set of quality standards. But some pharmacies may be accredited. This means that they’ve been found to meet a specific set of standards.
Some compounding pharmacies, known as outsourcing facilities, are registered with the FDA. These pharmacies are inspected by the FDA. They’re also required to follow the same strict regulations as drug manufacturers. These are called current good manufacturing practice regulations.
Keep in mind that the quality of compounded medications can vary across pharmacies. The pharmacy that fills your prescription, the ingredients they use, and how they make it matters.
What are the risks of using compounded semaglutide?
In addition to the risks outlined above, there are other potential risks associated with using compounded semaglutide. Examples of these include:
Inappropriate ingredients: As covered above, some pharmacies may be using ingredients that don’t meet FDA requirements. These ingredients may have unknown quality and purity. Or they may not work the same way as the original ingredient.
Potential contamination: There are risks of contamination with compounded semaglutide injections, especially if they’re not made properly or in a sterile environment. One study found that about 45% of drug recalls over a roughly 10-year period were from compounding pharmacies. These recalls were mostly due to sterility concerns.
Impurities: According to Novo Nordisk, compounded semaglutide products tested by the company were found to contain unknown impurities up to 33%.
Quality control processes: Compounding pharmacies may not have the same rigorous quality control processes as drug manufacturers. This can be particularly risky if they’re producing a large volume of these compounded medications.
Dosage errors: Compounded semaglutide vials don’t have the same safety features as the prefilled injection pens. So there can be a higher risk of injecting too much semaglutide. This may be more likely if you aren’t provided clear instructions with your prescription, or if you aren’t familiar with how to use a syringe to measure your dose.
Many of these risks are possible with any medication. But it’s especially important to be aware of them with compounded semaglutide. Working with an experienced, reputable pharmacy can help lower the risk of these potential issues.
What to look for when buying compounded semaglutide
As mentioned, compounded semaglutide injections are largely being phased out. This could change as a result of ongoing legal challenges, but there’s no guarantee. In most cases, your next step would be switching from compounded semaglutide to an FDA-approved product.
But if your prescriber believes that a custom compounded semaglutide product is medically necessary, here are a few things to look for in a pharmacy:
Accreditation: Accredited pharmacies have been found to comply with national standards for compounded medications. This can provide another layer of reassurance. Examples of accreditation programs include those through the National Association of Boards of Pharmacy and the Pharmacy Compounding Accreditation Board. Outsourcing facilities can be another option to consider since they’re required to meet more stringent requirements.
Proper licensing: The pharmacy should be properly licensed. The license(s) should be in a good standing — not expired, revoked, or have current disciplinary action. The pharmacy should also have a physical address and phone number in the U.S. For injections, some states require a separate sterile compounding license.
Readily available staff: You should be able to call the pharmacy and speak with a licensed pharmacist to answer your questions. They can help you understand how to use your medication properly to avoid errors.
False advertising: Be cautious of pharmacies or other companies advertising compounded semaglutide as “generic” versions of Ozempic or Wegovy. They also shouldn’t be making claims about compounded semaglutide’s effectiveness or safety.
Prescription requirements: Compounded semaglutide always requires a prescription. Steer clear from pharmacies that will sell you semaglutide without one. There’s a chance you could receive a counterfeit product.
The information covered above may not be readily available to you. So if you have any questions or want more information, contact the pharmacy. They can tell you about their ingredient sources, what’s in your medication, quality control processes, and more.
How to switch to FDA-approved semaglutide
But what should you do if you need to switch from compounded semaglutide to Ozempic or Wegovy? Here are a few tips to help make the transition as smooth as possible.
Talk to your healthcare team. They can help determine whether Ozempic or Wegovy is the right fit for your needs. If needed, they can also discuss potential alternatives.
Check your insurance coverage. Your prescriber may need to submit a prior authorization or documentation to help you get coverage.
Explore savings programs. You may be eligible for a manufacturer copay card or patient assistance program through Ozempic and Wegovy’s manufacturer.
Ask your pharmacy about availability. While the supply has improved, some doses may still be harder to find. Request refills early or check with multiple pharmacies if needed.
If you’re unsure where to start, your healthcare team can help you navigate the next steps.
Frequently asked questions
It’s possible that some people may see a decrease in their vitamin B12 levels after starting semaglutide. In this case, a vitamin B12 supplement may be recommended to prevent or treat low levels.
Some websites may claim that adding vitamin B12 helps boost your metabolism for added weight loss. But this hasn’t been confirmed in clinical studies.
Buying semaglutide online can increase the risk of receiving a counterfeit product. You can check to see if the website is legitimate by using NABP’s safe site search tool. If you’ve purchased Wegovy, Ozempic, or Rybelsus online, inspect your medication and its packaging before use. Take note of any differences in appearance compared to the real products.
If you’ve purchased compounded semaglutide online, it may be more difficult to know if it’s safe. The best way to protect yourself is to get your medication from an experienced, reputable pharmacy. Working with accredited pharmacies or outsourcing facilities can provide an additional layer of reassurance.
The best way to avoid buying counterfeit or illegal semaglutide is to get FDA-approved Wegovy, Ozempic, or Rybelsus from your local pharmacy. But if that’s not possible, the FDA has resources available if you’re thinking about purchasing medications from an online pharmacy. You can also check the website by using NABP’s safe site search tool.
The bottom line
As of February 2025, the semaglutide injection (Ozempic, Wegovy) shortage was resolved. As a result, compounded semaglutide injections are largely being phased out. While they may still be available in limited circumstances, it’s good to understand the potential risks.
Keep in mind that compounded semaglutide is different from Ozempic, Wegovy, and Rybelsus. So if you’re considering giving it a try, discuss the potential benefits and risks with your healthcare team. Ask questions so you understand what’s in the medication, and who you’ll be receiving it from. Avoid buying semaglutide that doesn’t require a prescription.
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References
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