Key takeaways
Wegovy is an FDA-approved drug with the active ingredient semaglutide. Compounded semaglutide products are made specifically for each patient and are not FDA approved.
The active ingredient in Wegovy is semaglutide in its base form. Depending on the compounding pharmacy or facility, compounded semaglutide may include additional ingredients or different salt forms of semaglutide, which the FDA does not approve for compounding.
Some examples of risks of compounded semaglutide include dosing errors and contamination, which can lead to serious side effects.
Consult your healthcare provider for more information about semaglutide weight loss medications and the best treatment option for you.
Wegovy (semaglutide) is a brand-name weekly injectable prescription medication. It is approved by the Food and Drug Administration (FDA) for weight loss and long-term weight management in adults and adolescents 12 years and older with obesity, as well as adults who are overweight and have at least one weight-related health condition, such as high cholesterol or Type 2 diabetes. Wegovy helps with weight loss by regulating appetite and calorie intake and helping quiet “food noise,” which are persistent thoughts of food that can undermine even the best dieting efforts. Wegovy is also FDA-approved to reduce the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke) in adults who have heart disease and are either overweight or have obesity. Wegovy is typically recommended to be used in combination with lifestyle changes like a reduced-calorie diet and exercise.
With the growing popularity of glucagon-like peptide 1 receptor agonists (GLP-1 receptor agonists) like Wegovy, you may have seen advertisements for compounded semaglutide products—but are these products exactly the same as Wegovy? Although compounded semaglutide may be similar to Wegovy, these products have not been tested for safety and effectiveness in clinical trials, and are not exactly the same.
What is compounded semaglutide?
The FDA describes a compounded drug as a medicine that is customized to the specific needs of an individual patient. Compounded drugs are prepared by a licensed pharmacist or other healthcare provider in a compounding pharmacy or outsourcing facility. A compounded drug may be mixed, altered, or combined to make a product that is specifically suited to an individual patient.
Usually, if a drug like Wegovy is available in pharmacies, compounding pharmacies or facilities are not permitted to compound the drug. However, the FDA says that when there is a shortage of a particular drug, compounding is allowed to ensure the patient can access treatment. As of Dec. 19, 2024, the FDA determined that the semaglutide shortage is ongoing, even though manufacturers report all doses are available. It remains to be seen how long the shortage will last and, once the shortage is resolved, whether compounding pharmacies will be permitted to continue to compound semaglutide.
It is important to note that compounded versions of drugs like Wegovy are not approved by the FDA. This means they have not been tested for safety, effectiveness, or quality control.
Novo Nordisk is the pharmaceutical company that manufactures FDA-approved semaglutide products. It currently makes three drugs that contain semaglutide, including:
- Wegovy, a once-weekly injectable medicine for weight loss and cardiovascular risk reduction
- Ozempic, a once-weekly injectable medicine for Type 2 diabetes and cardiovascular risk reduction, often prescribed off-label (for a non-FDA-approved use) for weight loss
- Rybelsus, a daily oral medicine for managing blood sugar levels in people with Type 2 diabetes, and sometimes prescribed off-label for weight loss
These three brand-name medicines are the only FDA-approved semaglutide products. There are no FDA-approved generic versions of these three drugs, and there are no other FDA-approved semaglutide products.
RELATED: Wegovy vs. Ozempic
Compounded semaglutide vs. Wegovy for weight loss
While both compounded semaglutide and Wegovy contain semaglutide, they are not exactly the same. Let’s review some of the similarities and differences, such as ingredients, dosage forms, and insurance coverage.
Ingredients
The active ingredient in Wegovy is called semaglutide, also known as semaglutide base. Compounded semaglutide products may be made with additional ingredients such as vitamin B-12, vitamin B-6, and L-carnitine. There are no studies on the safety and effectiveness of compounded semaglutide—either alone or in combination with these other ingredients. The FDA notes that compounding facilities may use different salt forms of semaglutide (such as semaglutide acetate or semaglutide sodium), rather than the original base form that was approved by the FDA. These salt forms are not exactly the same as the active ingredient in Wegovy, which is known as semaglutide base, and are not FDA-approved for use in compounding.
Dosage forms and dose
According to the prescribing information, Wegovy is supplied in the following dosages:
- 0.25 mg per pen
- 0.5 mg per pen
- 1 mg per pen
- 1.7 mg per pen
- 2.4 mg per pen
Each pen is for single-use only, so you will use one pen each week and then discard it in a sharps container after using it.
With compounded semaglutide products, various formulations are available, depending on the supplier, such as:
- Orally disintegrating tablets (tablets that dissolve in the mouth)
- Sublingual tablets (a tablet that is placed under the tongue to dissolve)
- Oral drops
- Injectable prefilled syringes
- Injections in a multiple-dose vial, which require you to draw up each dose with a syringe
Safety and efficacy
As an FDA-approved drug, Wegovy has been extensively tested in clinical trials for safety, quality, and efficacy. In these clinical trials, researchers study things like side effects and how well the drug works. The data from these studies ensure that Wegovy meets strict regulatory standards before being made available to the public.
On the other hand, compounded semaglutide products are not FDA approved. This means that they are not required to undergo the same testing for safety, effectiveness, and quality control as FDA-approved drugs like Wegovy. Without these trials and regulatory oversight, the safety and effectiveness of compounded semaglutide cannot be guaranteed.
Insurance coverage and cost
Insurance coverage for Wegovy varies by health insurance plan. Based on your plan, Wegovy may require prior authorization, which means the healthcare provider will need to tell the insurance company why you need this medicine before the insurance company will decide if they will provide coverage. You can visit the Novo Nordisk website to find out more about insurance coverage. You can also call your insurance plan for the most recent coverage and cost information.
On the other hand, compounded semaglutide is generally not covered by insurance because it is not an FDA-approved drug. As a result, patients often have to pay out-of-pocket for these products, which can vary widely in price depending on the compounding pharmacy or facility. However, there may be some exceptions where certain insurance plans cover compounded semaglutide under specific circumstances, such as when there is a short supply of the FDA-approved versions. Check with your plan for more information.
Is compounded semaglutide safe?
Below are some of the potential risks of compounded semaglutide, which can be significant. Be sure to discuss your concerns with your healthcare provider.
- Dosing errors: Dosing errors may occur due to factors such as measuring the wrong dose from a multidose vial or using the wrong syringe to measure a dose. These types of errors can also lead to severe side effects—which can last up to several weeks, as semaglutide has a long half-life and remains in the body for a long time. In some cases of dosing errors, patients have needed medical attention or had to go to the hospital. Adverse effects associated with dosing errors have included nausea, vomiting, abdominal pain, fainting, headache, dehydration, gallstones, and inflammation of the pancreas. Dosing errors have also occurred with compounded tirzepatide products, which many compounding pharmacies or facilities offer as an alternative to Mounjaro or Zepbound.
- Contamination: One company, for example, was using non-sterile products, resulting in contamination of the medicine. Injecting a non-sterile medication into your body could result in serious complications like infections and sepsis. Also, Novo Nordisk, the manufacturer of FDA-approved semaglutide products, has reported cases of impurities found in compounded semaglutide—with one specific product tested found to have over 24% impurities.
- Illegal sales: The FDA has discovered counterfeit semaglutide that may contain harmful ingredients or incorrect amounts of the active ingredient. Some illegally marketed semaglutide products have been sold with labels like “for research purposes” or “not for human consumption” but are still sold directly to consumers. The FDA warns that these products can be dangerous and should not be used.
- False claims: Some companies falsely claim that their compounded semaglutide products are FDA-approved or equivalent to FDA-approved medications. Additionally, compounded semaglutide is sometimes marketed without requiring a prescription from a healthcare provider. This is risky, as compounded medications, like all medicines, should only be used under the supervision of a licensed healthcare provider.
Where can I get compounded semaglutide?
Because of the potentially significant risks associated with compounded semaglutide products, the FDA strongly recommends using an FDA-approved semaglutide drug like Wegovy when it is available. However, despite these risks, if you are considering using a compounded semaglutide product, consult a healthcare provider. They can guide you on the safest course of action, which typically includes using FDA-approved drugs. If you decide to use compounded semaglutide, ask your healthcare provider if they have a trusted and reputable pharmacy they regularly work with. If you decide to use an online pharmacy, visit the FDA website for more information on safe online pharmacies. Avoid online pharmacies and facilities that are not licensed or reputable—as well as those that advertise compounded semaglutide without a prescription required, as these factors greatly increase the risk of unsafe or counterfeit drugs.
Bottom line: Is compounded semaglutide the same as Wegovy?
Wegovy is an FDA-approved drug made by Novo Nordisk. Compounded semaglutide, on the other hand, is not exactly the same. Although both contain semaglutide, compounded semaglutide products are not FDA-approved and have not been tested for safety, effectiveness, or quality in the same way as an FDA-approved drug like Wegovy. Consult your healthcare provider for more information and medical advice on the best treatment for your condition.
Sources
- What is food noise? A conceptual model of food cue reactivity, Nutrients (2023)
- Human drug compounding, Food and Drug Administration (2024)
- Compounding when drugs are on FDA’s drug shortages list, Food and Drug Administration (2024)
- Your guide to FDA-approved medicines that contain semaglutide, Novo Nordisk
- FDA alerts health care providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products, Food and Drug Administration (2024)
- FDA’s concerns with unapproved GLP-1 drugs used for weight loss, Food & Drug Administration (2024)
- Wegovy, DailyMed (2024)
- FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness, Food and Drug Administration (2024)
- Novo Nordisk escalates legal actions to safeguard patients from potentially harmful compounded “semaglutide” drugs, Novo Nordisk (2024)