Compounded semaglutide: is “knock-off” Ozempic safe?
LAST UPDATED: Jul 05, 2023
7 MIN READ
HERE'S WHAT WE'LL COVER
Have you seen advertisements for compounded semaglutide on social media lately? Posts showing a photo of a glass vial filled with a clear liquid, and a caption that says “Get compounded semaglutide online”. If so, you’re probably wondering if this “knock-off” or “off-brand Ozempic” version of semaglutide is safe and effective.
Semaglutide is the active ingredient in the injection medications Wegovy, Ozempic, and in Rybelsus, a pill. Given the high demand for (and high costs of) these medications, some people are seeking a more accessible and affordable alternative.
While compounded semaglutide may be an option in specific situations, the Food and Drug Administration (FDA) has had issues with some compound medications. Let’s explore.
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What is compounded semaglutide?
Compounded medications are custom-made from scratch by combining, mixing, or altering the ingredients in a medication for an individual patient. For example, a person may have an allergy to one of the ingredients in the brand name drug or be unable to swallow a pill, so they need another version of the drug to be made. In these scenarios, compounded drugs can be viable alternatives.
Compounded drugs can also be helpful when there is a drug shortage, like the one currently affecting Wegovy and Ozempic. In fact, because the brand name drugs Ozempic and Wegovy are in short supply, compounding pharmacies are allowed to purchase semaglutide from pharmaceutical ingredient manufacturers and compound it into an injectable medication. However, compounded drugs — including compounded semaglutide — are not regulated or approved by the FDA. As such, they do not have to undergo the same rigorous processes FDA-approved drugs do to ensure they are safe, effective, and made from quality ingredients. One of the very few guardrails is that compounding pharmacies can use active ingredients that come from facilities registered with the FDA.
So, since Wegovy and Ozempic are both currently listed on the FDA’s Drug Shortages list as of May 2023, you can get compounded semaglutide. But, you may want to be cautious when doing so. The FDA has raised concerns with the National Association of Boards of Pharmacy regarding the compounded semaglutide being provided by many pharmacies, as it contains a different form of semaglutide than Wegovy and Ozempic.
Is compounded semaglutide safe?
In general, compounded drugs can pose a higher risk for side effects and other unwanted results than FDA-approved medications. The simple reason is that the FDA does not verify compounded drugs' safety, quality, or effectiveness. Due to the potential risks of compounded drugs, the FDA only recommends using them if it is medically necessary.
While compounding pharmacies serve a real need, they don’t have to follow the same safety, efficacy, and quality requirements as FDA-approved drugs do. Some compounding pharmacies may take advantage of that, by not ensuring a sanitary production process, or falsely claiming that their drugs are FDA-approved. Indeed, the FDA has found instances of compounding pharmacies (unrelated to compounded semaglutide) operating in unsanitary conditions, such as having pet beds near sterile areas, using toaster ovens used for sterilization, or staff not wearing gloves when handling the drugs.
With a less controlled production process, mistakes can happen. And when it comes to compounding pharmacies, researchers have found that mistakes do happen. Sometimes these mistakes don’t end up hurting patients. Other times, the drug is contaminated or has the wrong concentration. In these situations, patients can be harmed. In 2012, a fungal meningitis outbreak was traced back to contaminated compounded steroid drugs for injection.
Is compounded semaglutide the same as Wegovy or Ozempic?
The short answer is no, compounded semaglutide is not the same as Wegovy or Ozempic. Just because a product is advertised as semaglutide does not mean that it contains the same base form of semaglutide as Wegovy or Ozempic. Beware of any site advertising semaglutide or compounded semaglutide without a prescription. Compounded medications require a prescription just like other FDA-approved medications.
For the longer answer, here are five major ways compounded semaglutide is different from Wegovy or Ozempic.
1. Compounded drugs don’t follow the same testing and approval process as FDA-approved medications
One of the biggest concerns about compounded drugs like compounded semaglutide is that they are not subject to the same rigorous testing and approval process of FDA-approved drugs like Wegovy and Ozempic. FDA-approved drugs undergo a thorough process to ensure that they are safe and effective before they go to market.
Compounded drugs are not subject to these same processes. Moreover, the manufacturing quality of compounded drugs is not reviewed by the FDA. In other words, unlike the brand names Ozempic and Wegovy, compounded semaglutide is not FDA-approved, and hasn’t been verified for safety or effectiveness.
This is not to say that compounded drugs follow no regulations whatsoever. Compounding pharmacies are exempt from certain regulations, but they still need to follow good manufacturing practices to ensure that their medications are produced in a clean and hygienic environment that maintains the quality and safety of the medication. Overall, however, the requirements for compounded drugs are much more lax than for FDA-approved medications.
And when these standards aren’t followed, compounded drugs can theoretically end up with too much (or too little) of the active ingredient. They could also be contaminated, or be improperly labeled — leading people to misuse them.
The lack of regulation opens up many potential risks for patients who take compounded drugs. For example, pharmacies may skirt the rules or produce drugs in unsanitary conditions, leading to quality issues that can be dangerous for patients.
2. Compounded semaglutide may use different ingredients than Wegovy or Ozempic
It is possible that a compounded drug may contain different inactive ingredients than the FDA-approved version. In some cases, this may be for a good reason, such as when a person needs a liquid version of a medication rather than a pill.
However, due to the lack of regulation for compounded drugs, some compounding pharmacies may use ingredients that are not proven to be safe or effective. In fact, this is one of the FDA’s concerns regarding compounded semaglutide. Some compounding pharmacies are using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, as the drug's active ingredient. The FDA-approved versions, however, use a base form of semaglutide.
The salt form of semaglutide has been proven neither safe nor effective. The FDA wrote a letter to the National Association Boards of Pharmacy to warn them that compounding pharmacies are doing this.
3. Compounded semaglutide is used differently than Wegovy or Ozempic
Another key difference between compounded semaglutide and Wegovy or Ozempic is how you inject the medication. Each pen of Wegovy comes pre-filled with a single dose of Wegovy and a needle attached. Each pen of Ozempic contains multiple doses of the medication, but you use a new needle each time you inject the medication. Both of these methods of administration make it relatively easy to give yourself an injection in a sanitary way.
Compounded semaglutide, however, often comes in a vial. Before each injection, you must use a syringe to extract your specific dose. The medication may also need to be stored differently than Wegovy or Ozempic.
4. Compounded semaglutide may cause side effects
When taking compounded drugs, it’s important to consider the potential side effects. Compounded drugs may cause different side effects than their FDA-approved counterparts.
The FDA says it has received reports of people experiencing side effects when taking compounded semaglutide. But, they have not described the specific side effects at this time.
5. Compounded drugs may be cheaper, but are not a long-term substitute for most people
Sometimes, compounded drugs are cheaper than brand-name medication. But, you don’t always know what you are getting, so the lower cost may not be worth the risk.
Moreover, taking compounded semaglutide is not a long-term solution for getting a cheaper version of Wegovy or Ozempic. Often, when the FDA allows compounding in the case of a shortage, you typically need to go back to taking the FDA-approved drug once the shortage is over (unless you were already taking a compounded version for a medical reason).
Novo Nordisk, the manufacturer of Wegovy and Ozempic, offers savings coupons for both medications. The Wegovy Savings Card is available to people with commercial insurance. Depending on your plan’s insurance coverage, it can help you save up to $225 – $500 on every 28-day supply of Wegovy. The Ozempic Savings Card is available to people with commercial or private insurance, and offers savings of up to $150 for a one-month supply of Ozempic, $300 for a two-month supply, and $450 for a 3-month supply.
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Where can you safely get Wegovy or Ozempic?
The safe way to get Wegovy or Ozempic is through a licensed pharmacy. Try these tips to find legitimate Wegovy or Ozempic.
1. Call around to local pharmacies
If your go-to pharmacy has run out of Wegovy or Ozempic, or they aren’t reliably refilling your prescription, call around to the other pharmacies in your area and ask them about their supply.
If needed, consider expanding your search area beyond the closest pharmacies closest to you. Many pharmacy chains offer mail-order services, so even if the pharmacy itself is located a long drive away, you can have them ship the prescription to your home.
Ask about 90-day supplies, as well. In some cases, these may be slightly cheaper than a 30-day supply. More importantly, they ensure you have the medication you need for at least the next three months.
2. Check online pharmacies
Online pharmacies offer the convenience of home delivery, and many include free shipping. Some online pharmacies, like Ro, even have a dedicated insurance concierge who will contact pharmacies to look for Wegovy and Ozempic on your behalf.
If this is your first time using an online pharmacy and you’re not sure you found a legit one, here are four signs of an online pharmacy you can trust:
The pharmacy requires a prescription from a licensed health provider
The pharmacy lists their physical address and U.S. phone number
The pharmacy has a licensed pharmacist you can talk to
The pharmacy is licensed with a state board of pharmacy
3. Try an alternative weight loss or diabetes medication
If you continue having trouble finding Wegovy or Ozempic, it may be worth talking to your healthcare provider about alternative medications.
Semaglutide is also available in an oral formulation, known as Rybelsus. And, there are other injectable medications in the same GLP-1 drug class as Wegovy and Ozempic, which are also FDA-approved to treat weight loss or diabetes. These include dulaglutide (brand name Trulicity), tirzepatide (Mounjaro), liraglutide (Saxenda or Victoza), and exenatide (Bydureon Bcise and Byetta).
Semaglutide is highly effective for weight loss and type 2 diabetes, but it is also expensive, and a shortage left many people wondering whether compounded semaglutide is a safe way to access this drug. The short answer is that the safer option may be to stick to Ozempic, Wegovy, or alternative medications for type 2 diabetes and weight management. The FDA doesn’t recommend using a compounded version of a drug unless it is medically necessary for you to do so. If you still want to use compounded semaglutide, talk to your healthcare provider who can help you find a reputable compounding pharmacy.
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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