What is compounded semaglutide? Benefits, risks, and costs
Maximize your weight loss journey with compounded semaglutide. Learn how it works, its potential advantages, and important safety considerations.
Key highlights
- Compounded semaglutide is a custom-made medication prepared by compounding pharmacies to meet the specific needs of patients, as prescribed by their healthcare providers.
- Like Ozempic and Wegovy, compounded semaglutide has semaglutide as an active ingredient, but the FDA has not approved it for weight management and type 2 diabetes.
- Compounded semaglutide may contain other ingredients like vitamin B12, which is not in Ozempic or Wegovy.
- It is essential to use a reputable, U.S.-certified compounding pharmacy to purchase compounded semaglutide to ensure the medication is safe and meets quality standards.
- Do not purchase compounded semaglutide that contains semaglutide salts such as semaglutide sodium and semaglutide acetate and those with “for research purpose only” labels.
Semaglutide is a GLP-1 receptor agonist known by three brand names: Ozempic, Wegovy, and Rybelsus. Ozempic and Rybelsus are FDA-approved for the management of type 2 diabetes. Wegovy is approved for chronic weight management in obese and overweight adults with at least one weight-related health condition.
Compounded semaglutide is a custom-made version of semaglutide prepared by compounding pharmacies. It is not approved or reviewed by the U.S. Food and Drug Administration (FDA) for safety and effectiveness.
The U.S. allows compounding medications during shortages or when a patient needs a specific dosage strength or form that is not commercially available. Compounded semaglutide has gained significant traction in the last few years due to its lower price than FDA-approved semaglutide and easy accessibility.
According to an Outsourcing Facilities Association report submitted to the FDA, compounding pharmacies filled approximately 80 million prescriptions for compounded semaglutide in the last 12 months.
This article explains what is compounded semaglutide, its benefits, risks, key considerations and how it differs from the FDA-approved versions.
What is compounded semaglutide?
Semaglutide contains the same active ingredient as the brand name medications. Semaglutide is a GLP-1 receptor agonist that mimics the action of naturally occurring hormone glucagon-like peptide-1. GLP-1 regulates appetite after food intake. Semaglutide has 94% structural similarity to GLP-1 hormones. By occupying GLP-1 receptors in the brain, semaglutide promotes insulin release, slows gastric emptying, reduces glucagon secretion from the liver, and affects the hunger control centre (lateral hypothalamus) of the brain to suppress appetite. This mechanism of action reduces hunger cravings and promotes blood sugar control, which helps manage chronic weight and type 2 diabetes.
Ozempic is indicated for type 2 diabetes patients, and to prevent the risk of cardiovascular death, worsening kidney disease, and kidney failure in patients with chronic kidney disease and type 2 diabetes. It is used off-label for weight management. Rybelsus is approved for type 2 diabetes only. Wegovy is FDA-approved for chronic weight management in adult patients with obesity and overweight. Ozempic and Wegovy are injectable forms of semaglutide, while Rybelsus comes in the form of oral tablets.
Compounded semaglutide is prepared by compounding pharmacies. It contains the same active ingredient as Wegovy and Ozempic and works similarly. However, it is not FDA-approved or reviewed for safety and effectiveness.
Compounding is a practice in which a licensed pharmacist or healthcare provider combines, mixes, or alters the ingredients of the medication to create a new version of the drug tailored to the patient’s needs.
Compounded semaglutide contains the active ingredient semaglutide, but may also contain other ingredients like vitamin B12 which is not present in Ozempic or Wegovy.
Compounded semaglutide comes in the following forms:
- Orally disintegrating tablets
- Oral capsules/tablets
- Injections
- Nasal sprays
- Sublingual drops (used under the tongue)
Why is semaglutide compounded?
Semaglutide is compounded due to the following reasons:
- Accessibility: Due to higher demand for Wegovy and Ozempic, the manufacturer, Novo Nordisk, has experienced drug shortages since May 2023. The shortage caused disruptions in patients’ medication adherence. Many patients shifted to compounded semaglutide, which is widely available at compounded pharmacies during drug shortages.
- Customization: As compounded semaglutide is a custom-made product, compounding pharmacies can make semaglutide in different formulations including combinations with other medications such as vitamin B12 and personalized dosing to help with medication adherence.
- Addressing specific patient needs: Compounding can address specific patient needs, such as allergies to certain ingredients in brand-name products. Compounded versions can exclude that ingredient from the medication that caused the allergy.
Wegovy and Ozempic cost around $1000 for a monthly supply, which makes it difficult for many patients to use the medication. In comparison, compounded semaglutide costs $200-$300 per month, which is quite affordable for most patients which has resulted in significant demand for the compounded product.
What does “compounded” mean?
Drug compounding is a process that involves licensed pharmacists and healthcare providers preparing the standard ingredients, and potentially mixing, and altering ingredients to make a custom-made medication that meets the patient’s needs.
Compounded medications are made when a specific dosage or formulation of a medication is needed, which is not commercially available.
A licensed pharmacist or healthcare provider can prepare compounded drugs in state-licensed pharmacies or federal facilities.
Due to current shortages, the FDA has allowed state-licensed pharmacies, physicians, and outsourcing facilities to compound, dispense, and distribute compounded semaglutide that should be essentially a copy of FDA-approved semaglutide under sections 503A and 503B.
Benefits and risks of compounded semaglutide
Benefits
- Compounded semaglutide is less expensive than the brand-name drugs Wegovy, Ozempic, and Rybelsus. Brand name drugs cost approximately $1,000 per month while compounded versions cost $200-300 for a monthly supply.
- Compounded semaglutide is easily accessible for patients who cannot afford or access FDA-approved versions.
- If you are allergic to a certain ingredient in FDA-approved semaglutide, you can get custom-made compounded semaglutide without that allergen.
- Compounded semaglutide has various customization options. You can get the medication in different dosages or formulations.
- Compounded semaglutide can meet the growing demand for GLP-1 medications during drug shortages. On Feb 25, 2025, the FDA allowed state and federal pharmacies to compound, dispense, and distribute compounded versions of semaglutide under sections 503A and 503B.
Risks
- Compounded semaglutide is not FDA-approved and has not undergone the same rigorous testing as the brand-name drugs. Some compounding pharmacies sell compounded semaglutide in combination with BPC-157 or in the form of sublingual tablets or troches which have not been studied in clinical trials. The FDA has prohibited the use of BPC-157 in compounding semaglutide.
- There are several risks associated with compounding, such as contamination, inaccurate dosing, and variations in quality. According to Novo Nordisk’s analysis of compounded semaglutide, compounded versions of the medication contain peptide-related impurities that are not found in FDA-approved semaglutide. Some samples had 33% unknown impurities. Additionally, a few compounded semaglutide samples had lower than labeled strengths (for example, 19% less strength than labeled). The report states that peptide-related impurities can activate immune reactions, which can lead to serious and life-threatening anaphylactic reactions.
- The effectiveness of compounded semaglutide may vary and may not be equivalent to FDA-approved products. It may contain little, or no active ingredient, or higher than the needed amount of active ingredient, which may affect the effectiveness of the medication.
- Compounded semaglutide is typically not covered by insurance. You should verify with your insurance company whether they cover compounded semaglutide for weight loss or type 2 diabetes.
- The FDA has issued a warning for compounded semaglutide. The agency states that the salt form of semaglutide, such as semaglutide sodium and semaglutide acetate, should not be used in compounding as these are different ingredients than the standard semaglutide. By November 30, 2024, the FDA received more than 392 reports of adverse events in patients using compounded semaglutide. Additionally, the FDA states that illegally marketed compounded semaglutide may be counterfeit, contain harmful or wrong ingredients, or contain too little, too much, or no active ingredient (semaglutide).
- The FDA has also warned that products labeled as “for research purposes only” or “not for human consumption” should not be purchased as they have unknown quality and might be harmful.
How much does compounded semaglutide cost?
Compounded semaglutide generally costs around $200 to $300 for a monthly supply.
The prices vary by compounding pharmacy, quantity and dosage.
Is compounded semaglutide safe?
Compounded semaglutide may be safe if you purchase it from a reputable pharmacy that meets the quality standards.
The FDA states that compounded versions of medications can fulfill the medical needs of certain individuals. However, the FDA emphasizes that the preparation of compounded medication should be done in state or federal pharmacies by licensed pharmacists, healthcare providers, and people working under the direct supervision of licensed pharmacists.
Who can use compounded semaglutide?
Compounded semaglutide is suitable for patients who cannot access the commercially available product when there are drug shortages or have specific medical needs such as allergies to a certain ingredient in Ozempic or Wegovy. They can get a compounded version of semaglutide that does not contain the specific ingredient.
Remember to purchase the medication from FDA-registered pharmacies to ensure the medication is safe and effective.
Always consult a healthcare provider before starting compounded semaglutide. They will assess your body weight, body mass index, blood sugar levels, levels of glycated hemoglobin (HbA1c), and vital stats to create a customized treatment plan for you.
Like Wegovy and Ozempic, compounded semaglutide can be used for managing chronic weight in obese (BMI of 30 or greater) and overweight (BMI of 27 or greater with at least one other weight-related condition) adults and type 2 diabetes, when used in combination with exercise and a reduced-calorie diet.
What to consider with compounded semaglutide
When starting compounded semaglutide, be mindful of the following considerations:
- Consult with your doctor: Never start any weight loss medication on your own without medical supervision as these medications are associated with potential side effects. Consult with a healthcare provider to discuss whether the medication is right for you. They will create a customized treatment plan tailored to your needs. Additionally, do not take a high or lower than the recommended dosage. Follow the dosage schedule provided by your healthcare provider.
- Choosing a reputable pharmacy: Always choose a reputable and licensed compounding pharmacy that meets the required quality standards. Compounded semaglutide is not reviewed or regulated by the FDA.
- Understanding the risks: Depending on the pharmacy you buy from, compounded semaglutide may not be as effective as Ozempic and Wegovy. It may contain impurities, extra ingredients, or contaminants, which can cause side effects.
- Insurance coverage: Compounded medications such as compounded semaglutide are not typically covered by insurance. You will likely have to pay for the medication out-of-pocket.
How to safely access compounded semaglutide
Here are a few tips to safely access compounded semaglutide:
- Find a reputable U.S.-certified compounding pharmacy to buy the medication. Some pharmacies such as outsourcing facilities are registered with the FDA. The agency inspects them directly and verifies that they follow the same strict rules and regulations as drug manufacturers. Opt for those pharmacies to ensure you get high-quality medications that are safe to use.
- You can ask your healthcare provider or pharmacist to recommend a reliable pharmacy.
- Watch out for red flags when choosing a pharmacy. These include unverified online sellers, and suppliers providing drugs with “for research purposes only” or “not for human consumption” labels. Do not purchase and consume these products as they could have unknown ingredients and their quality does not meet the required standards.
- Unlike Ozempic and Wegovy, compounded semaglutide is available in vials with syringes. Make sure the medication is stored properly as storage also affects the effectiveness of medications.
- Always check the expiration date (or beyond-use date) of the medication before using it.
Alternatives to compounded semaglutide
Alternatives to compounded semaglutide include the following:
- FDA-approved semaglutide options such as Ozempic, Wegovy, and Rybelsus. These contain the same active ingredient as compounded semaglutide and have undergone rigorous checks by the FDA.
- Other GLP-1 receptor agonists such as liraglutide and dulaglutide have the same mechanism of action as semaglutide.
- GLP-1 and GIP receptor agonists such as tirzepatide (Zepbound and Mounjaro) can also be used for weight loss and type 2 diabetes management.
- Lifestyle changes such as increased physical activity, reduced-calorie diet, and exercise can also be helpful in diabetes and weight management.
Compounded semaglutide side effects
Similar to Wegovy and Ozempic, the most common side effects of compounded semaglutide are:
- Nausea
- Abdominal discomfort
- Vomiting
- Diarrhea
- Constipation
Rare and serious side effects of the medication include:
- Severe stomach problems
- Changes in vision (due to diabetic retinopathy)
- Hypersensitivity/allergic reaction
- Acute pancreatitis
- Gallbladder problems
- Hypoglycemia (low blood sugar levels)
- Increased risk of aspiration in anesthesia and sedation
- Mood and behavioral changes
In rodents, semaglutide increases the risk of thyroid cancers. It is unclear if compounded semaglutide causes the same effect in humans. However, the medication is not recommended for patients with a history of medullary thyroid cancer (MTC) and MEN 2 syndrome (multiple endocrine neoplasia syndrome type 2). Compounded semaglutide is not safe for pregnant and lactating mothers and children.
Mild side effects usually subside over time. If you experience serious side effects, seek medical advice from your doctor before taking the next dosage. In case of an allergic reaction, immediately visit a nearby healthcare facility.
Frequently asked questions (FAQs)
Is compounded semaglutide safe?
Compounded semaglutide is safe if purchased from a legitimate source. To ensure the medication is properly prepared, you should purchase it from state-licensed compounding pharmacies or FDA-regulated outsourcing facilities. Compounded semaglutide from unverified online sellers and with “for research purposes only” or “not for human consumption” labels is not safe.
How much does compounded semaglutide cost?
Compounded semaglutide generally costs around $200 to $300 per month.
Is compounded semaglutide the same as Ozempic and Wegovy?
Compounded semaglutide has the same active ingredient (semaglutide) as Ozempic and Wegovy, but it has not been approved by the FDA. Compounded medications do not undergo vigorous testing like FDA-approved drugs. Ozempic and Wegovy are manufactured by Novo Nordisk only. Compounded semaglutide is prepared at compounding pharmacies and may contain extra ingredients like vitamin B12 or others as prescribed by healthcare providers.
Compounded semaglutide comes in vials, while Ozempic and Wegovy come in prefilled pens.
What are semaglutide salts?
Semaglutide sodium and semaglutide acetate are salt forms of semaglutide. The FDA warns compounding pharmacies about using these salts when preparing compounded semaglutide.
How long can compounded semaglutide be stored in the fridge?
The recommended storage duration of compounded semaglutide depends on the beyond-use date (BUD) of the product, which is provided by compounding pharmacies. It may differ by pharmacies. In most cases, compounded semaglutide can be stored for up to 30 days. After that, the medication might not be effective. Always check the expiration date before using the medication.
Can compounded semaglutide be used for weight loss?
Compounded semaglutide can be used for weight loss in obese and overweight adults with at least one weight-related health condition such as high blood pressure, heart disease, high cholesterol levels, and type 2 diabetes. Always consult your healthcare provider before starting compounded semaglutide for weight loss. Your doctor will assess your body weight, body mass index, blood sugar levels, and vital stats to create a customized treatment plan for you.
What are the side effects of compounded semaglutide?
Side effects of compounded semaglutide are similar to Wegovy and Ozempic. Mild side effects are nausea, vomiting, diarrhea, constipation, and abdominal pain. Serious side effects include acute pancreatitis, gallbladder issues, stomach problems, changes in vision, and allergic reactions to the medication.
Compounded semaglutide may increase the risk of medullary thyroid cancer and MEN2 syndrome. It is not recommended in patients with a history of thyroid tumors and endocrine neoplasias.
Is compounded semaglutide legal?
The FDA has allowed state-licensed pharmacies and physicians to compound, dispense, and distribute semaglutide injections that are essentially a copy of FDA-approved semaglutide. Compounded semaglutide is legal to compound, dispense, and distribute when there are drug shortages or the patient needs a specific formulation or dosage that is not commercially available.
Bottom line
Compounded semaglutide is a custom-made medication prepared by compounding pharmacies to meet the specific needs of patients. It has the same active ingredient as Wegovy and Ozempic, but it is not approved by the FDA.
Compounded semaglutide is an affordable alternative to Ozempic and Wegovy for patients with financial constraints. Due to recent drug shortages, the FDA has allowed compounding pharmacies to dispense and distribute compounded semaglutide under sections 503A and 503B.
Always choose a reliable and licensed pharmacy when purchasing compounded semaglutide. Do not purchase compounded semaglutide when labeled as “for research purposes only” or “not for human consumption” labels. These unapproved products have unknown ingredients and quality, which might not be safe.
If you plan to start your treatment with compounded semaglutide, consult with your healthcare professional to discuss if it is the right choice for you. They will assess your medical history before prescribing the medication.
