When seeking weight loss medication, you previously could encounter two versions of semaglutide: FDA-approved Wegovy and compounded semaglutide. However, as of May 2025, compounded semaglutide is no longer legally available for routine compounding. Understanding how these options differ can help make informed choices about your health. Although both contain the same active ingredient, they vary notably in how they are produced, regulated, and in their potential risks.
What is Compounded Semaglutide?
Compounded semaglutide is a medication created by compounding pharmacies that contains the same active ingredient as Wegovy. Unlike mass-produced medications, compounded drugs are custom-made by pharmacists who combine, mix, or alter ingredients to create formulations that aren’t commercially available.
Compounding pharmacies typically create these versions by purchasing the raw semaglutide powder and mixing it with other ingredients to create injectable solutions. While compounding serves a legitimate purpose for patients with specific needs (like allergies to certain ingredients), it operates under different regulatory standards than FDA-approved medications.
The controversy surrounding compounded semaglutide stems from concerns about proper formulation, dosing consistency, and quality control. The FDA has issued warnings that some compounding pharmacies may be producing semaglutide products without meeting necessary quality standards or legal requirements.
Important Update: As of May 2025, compounded semaglutide is no longer available for routine compounding following the FDA’s determination that the semaglutide shortage has been resolved.
Key Differences Between Wegovy and Compounded Semaglutide
Manufacturing and Quality Control
Wegovy is manufactured by Novo Nordisk in FDA-approved facilities with strict quality control measures. Each pen contains precisely measured doses and undergoes rigorous testing to ensure purity, potency, and consistency. The production facilities are regularly inspected, and the manufacturing process must adhere to Good Manufacturing Practices.
Compounded semaglutide varies significantly between pharmacies. While reputable compounding pharmacies follow USP (United States Pharmacopeia) guidelines, they aren’t held to the same manufacturing standards as pharmaceutical companies. The quality control process may not be as comprehensive, which can lead to variations in potency and purity.
Regulatory Oversight
Wegovy underwent extensive clinical trials involving thousands of participants before receiving FDA approval. The agency reviewed data on safety, efficacy, proper dosing, and potential side effects. This approval means the medication consistently meets federal standards for quality and safety.
Compounded medications operate in a regulatory gray area. While compounding pharmacies are regulated primarily by state pharmacy boards (with some federal oversight), the medications they produce aren’t FDA-approved. The FDA doesn’t verify the safety, effectiveness, or quality of compounded drugs before they reach patients.
Formulation and Ingredients
Wegovy contains pharmaceutical-grade semaglutide along with stabilizers and preservatives that have been clinically tested for safety. Its precise formulation ensures consistent absorption and effectiveness.
Compounded versions may contain varying ingredients depending on the pharmacy. These could include different buffers, preservatives, or other components that haven’t been studied in combination with semaglutide. This variation can potentially affect how the medication works in your body.
Why Compounded Semaglutide Previously Appealed to Patients
Cost
As a cheaper semaglutide option, compounded versions previously cost less than Wegovy when they were legally available. The price difference can be substantial, making compounded alternatives more accessible for patients without insurance or with plans that don’t cover weight loss medications. Many patients report that the financial savings make compounded versions their only feasible option for ongoing treatment.
Availability
Previously, during ongoing shortages of FDA-approved GLP-1 medications, compounded versions served as alternatives when branded products weren’t available. However, the FDA declared the semaglutide shortage resolved in February 2025, and compounded versions are no longer legally available as of May 2025.
Convenience
Some compounding pharmacies provide mail-order or delivery services, which can be especially helpful for patients living in remote areas or those who face challenges traveling to a pharmacy. This added convenience may help ensure continuity of care, particularly for individuals with limited mobility or demanding schedules.
Personalization
In certain cases, compounding pharmacies can tailor medications by adjusting inactive ingredients to accommodate patients with allergies or sensitivities. While this level of customization is less common with semaglutide, it may be beneficial for individuals who have specific ingredient concerns that are not addressed by standard formulations. Patients considering personalized compounded medications should consult with a healthcare provider to discuss potential benefits and risks, as well as to ensure that any modifications are appropriate for their health needs.
What Risks To Consider?
- Without standardized manufacturing processes, the amount of active ingredient may vary between batches or pharmacies. This inconsistency could lead to getting too much or too little medication, affecting both efficacy and side effects.
- Compounded medications may have a higher risk of contamination if not prepared under proper sterile conditions. Since these are injectable medications, contamination poses serious health risks.
- The specific formulations of compounded semaglutide haven’t undergone the same clinical testing as Wegovy. Different inactive ingredients might affect how the drug works or interacts with other medications.
- If problems arise with compounded medications, tracking the source or establishing accountability can be more difficult than with FDA-approved drugs.
- The FDA has warned that some pharmacies may be improperly compounding semaglutide. Patients should be aware that not all compounded versions are being produced within legal parameters.
How to Choose the Right Option
- Since compounded semaglutide is no longer legally available as of May 2025, patients should consult healthcare professionals about FDA-approved options like Wegovy, which may now have improved availability and potential cost assistance programs.
- Investigating the reputation, accreditation, and compliance history of a compounding pharmacy is important for those considering compounded semaglutide. Pharmacies accredited by the Pharmacy Compounding Accreditation Board (PCAB) may offer additional assurance of quality.
- For individuals with complex medical histories or those taking multiple medications, the established safety profile and consistency of FDA-approved Wegovy may be considered preferable, despite higher costs.
- Reviewing patient experiences and feedback regarding compounded semaglutide can offer anecdotal insights into specific pharmacies or formulations, though such reports should be interpreted cautiously.
- Monitoring for side effects is important with any medication option, especially when starting treatment or adjusting dosages, to help identify any adverse reactions early.
While cost is important, safety should be the primary concern when choosing any medication. Schedule a consultation with Heally today to discuss the available options with a healthcare provider who can help navigate this decision based on individual health needs and circumstances.
Sources
SingleCare: Is compounded semaglutide the same as Wegovy?
GoodRx: Compounded Semaglutide: Are Ozempic and Wegovy Knock-Offs Safe?
NIH: Semaglutide (Wegovy): CADTH Reimbursement Review: Therapeutic area: Weight management [Internet].
NPR: Thinking of buying Wegovy online? Here’s what to know about compounding pharmacies
Science Direct: Biology of Incretins: GLP-1 and GIP
FDA: FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
Important Medical Information and Disclaimer
MEDICAL DISCLAIMER:
This content is for educational purposes only and is not intended as medical advice. Wegovy is an FDA-approved prescription medication for weight management. Always consult a qualified healthcare provider before starting, stopping, or changing any medication or treatment plan.
INDIVIDUAL RESULTS VARY:
Responses to Wegovy may differ based on factors such as adherence to treatment, lifestyle, metabolism, and underlying health conditions.
IMPORTANT SAFETY INFORMATION:
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Common side effects may include nausea, vomiting, diarrhea, decreased appetite, constipation, stomach pain, and injection site reactions.
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Serious side effects can occur, including pancreatitis, gallbladder problems, kidney issues, and severe allergic reactions.
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Always share your full medical history with your healthcare provider before starting Wegovy or any new medication.
FDA ADVERSE EVENT REPORTING:
To report side effects or adverse reactions to prescription medications, visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For personalized guidance on Wegovy storage and use, consult your healthcare provider or connect with a medical professional through Heally.