What is Compounded Semaglutide?
Compounded semaglutide is a custom-made medication prepared by a compounding pharmacy, as opposed to a major pharmaceutical manufacturer. The practice of compounding involves combining, mixing, or altering ingredients to create a medication tailored to a specific patient's needs. This can include adjusting dosage strengths, changing delivery methods, or removing allergenic ingredients. Historically, compounding was also permitted during national drug shortages to help meet patient demand when FDA-approved versions were unavailable. However, compounded products are not subject to the same premarket review for safety, effectiveness, or quality that FDA-approved drugs undergo.
How is Compounded Semaglutide Different from Branded Versions?
The most significant distinction between compounded semaglutide and FDA-approved versions like Ozempic and Wegovy lies in regulatory oversight and quality control. The branded medications are produced by a single manufacturer (Novo Nordisk) under strict FDA guidelines, ensuring consistent purity, potency, and dosage accuracy. In contrast, the formulation of compounded versions can vary from one pharmacy to another, leading to potential inconsistencies.
Ingredient variations: The active ingredient in FDA-approved semaglutide is the base form. The FDA has warned that some compounding pharmacies may illegally use different, unverified salt forms of semaglutide, such as semaglutide sodium or semaglutide acetate. These salt forms are not chemically identical to the base and have not been proven safe or effective. Additionally, some compounders may add other ingredients, such as vitamin B12, without proven data on the safety or effectiveness of these combinations.
Manufacturing and formulation: FDA-approved semaglutide is available in specific, controlled forms, such as pre-filled injection pens (Ozempic, Wegovy) or oral tablets (Rybelsus). Compounded versions, which may come in different vials and require patients to measure doses themselves, are not available in these standardized forms.
Dosing errors: The FDA has received multiple reports of dosing errors, some requiring hospitalization, associated with compounded semaglutide injections. Confusion over units of measurement (milligrams vs. milliliters vs. “units”) and unfamiliarity with self-administering from vials have contributed to patients accidentally taking five to 20 times the intended dose.
Legal and regulatory status: Compounded semaglutide is not FDA-approved, meaning it hasn't passed the rigorous safety and efficacy review process that FDA-approved drugs do. In early 2025, after resolving the national drug shortage for semaglutide, the FDA moved to restrict compounded versions, allowing them only in very specific cases where a patient cannot use an FDA-approved alternative. Illegal sales of unapproved, and potentially counterfeit, compounded GLP-1 drugs have also been reported by the FDA.
Comparison: Compounded Semaglutide vs. FDA-Approved Versions
| Feature | Compounded Semaglutide | FDA-Approved (Ozempic/Wegovy) |
|---|---|---|
| Regulatory Status | Not FDA-approved; lacks agency review for safety and efficacy. | Fully FDA-approved; subject to rigorous testing and review. |
| Ingredients | May use semaglutide base, but also unproven salt forms (sodium/acetate) or additional unverified ingredients. | Uses the highly regulated semaglutide base ingredient. |
| Manufacturing | Prepared by individual compounding pharmacies with varying processes and quality control. | Manufactured by Novo Nordisk under strict, consistent FDA guidelines. |
| Formulation | Typically comes in glass vials; may offer alternative forms like nasal sprays, not tested for safety/effectiveness. | Available in standard, pre-filled pens (Ozempic/Wegovy) or tablets (Rybelsus). |
| Dosing Consistency | Varies widely due to different compounding processes and ingredient sources. | Highly consistent dosage and formulation across all units. |
| Cost | Often significantly lower cost due to lack of FDA review and testing, but typically not covered by insurance. | High retail cost, but may be covered by insurance or manufacturer savings programs. |
| Risks | Higher risk of dosing errors, contamination, and potentially dangerous side effects from unverified ingredients or poor quality control. | Well-documented side effects established during clinical trials; lower risk of manufacturing issues. |
Regulatory Shifts and Patient Considerations
The FDA's decision to curb the compounding of semaglutide came after the manufacturer, Novo Nordisk, announced a stabilized supply of Ozempic and Wegovy. This effectively ended the justification for compounding based on a national shortage. As of mid-2025, state-licensed pharmacies and physicians operating under specific regulations were given deadlines to cease the compounding of semaglutide injection products that are essentially copies of FDA-approved ones.
For patients considering semaglutide for weight loss or type 2 diabetes, the change in regulation underscores the importance of using FDA-approved medications whenever possible. The FDA advises against using unapproved versions due to the inherent risks associated with lack of regulatory oversight. Patients should discuss all treatment options with a licensed healthcare provider, considering their specific medical needs, insurance coverage, and the proven safety and efficacy of FDA-approved products. Resources from the FDA and reputable medical information websites can help patients and prescribers understand the regulations and potential dangers of unapproved versions.
Conclusion
In conclusion, compounded semaglutide is not equivalent to FDA-approved branded versions like Ozempic and Wegovy, despite containing the same active ingredient. The lack of FDA oversight means that compounded products have not been reviewed for safety, effectiveness, or quality, and they may contain inconsistent ingredients, unproven salt forms, or risk dosing errors. While once a viable alternative during drug shortages, stricter regulations now limit the legal use of compounded versions to specific patient medical needs. For reliable and safe treatment, FDA-approved semaglutide remains the recommended choice, with costs potentially offset by insurance or manufacturer programs. Patients should always consult a licensed healthcare provider to make informed decisions about their treatment plan.
