For many people seeking weight loss or diabetes management, medications like Wegovy® and Ozempic® (both containing semaglutide) have become well-known options. However, due to factors like high cost, insurance barriers, and past shortages, you may also have heard about a different option: compounded semaglutide. This article explains what compounded semaglutide is, how it differs from what you get at a standard pharmacy, and the important safety and regulatory information you need to know before considering it.
Can Semaglutide Be Compounded?
Yes, semaglutide can be compounded, but its legal status has recently changed. Pharmaceutical compounding is the practice of combining, mixing, or altering ingredients to create a customized medication for an individual patient based on a prescription. This can be vital for people who need a specific dosage form or have an allergy to an ingredient in a mass-produced drug.
Traditionally, to legally compound a drug that is a copy of an FDA-approved medication, there must be an official FDA-declared drug shortage. For much of 2023 and 2024, semaglutide injection products were on the FDA’s drug shortage list, which allowed licensed pharmacies to compound it under specific rules.
However, as of February 2025, the FDA has determined that the shortage of semaglutide injection products (like Wegovy and Ozempic) has been resolved. This significant change means that, barring rare exceptions (such as a documented allergy to a dye in the brand product), it is generally no longer legal for compounding pharmacies to make copies of these FDA-approved semaglutide products. Patients should be aware that this legal landscape is recent and some online or telehealth providers may still be offering these compounded versions based on older supply.
What is Compounded Semaglutide?
Compounding pharmacies prepare custom-made versions of semaglutide. While this medication contains the same active ingredient as FDA-approved Ozempic, Wegovy, and Rybelsus, the FDA has not reviewed or approved the final compounded product for safety, effectiveness, or quality.
Compounding pharmacies must source the semaglutide active ingredient from FDA-registered facilities. They then prepare it, often in a liquid form for injection, according to a provider’s prescription. Common formulations include semaglutide combined with other ingredients like Vitamin B12 or B6, which some providers suggest may help with energy or potential side effects. Importantly, some compounders have used different chemical forms, such as semaglutide sodium or semaglutide acetate. The FDA notes these salt forms are different from the active ingredient in the approved drugs and there is no information on whether they work the same way, raising serious safety concerns.
Differences from Commercial Semaglutide
The table below outlines the key differences between compounded and FDA-approved semaglutide products.
| Feature | Compounded Semaglutide | FDA-Approved Semaglutide (Ozempic®, Wegovy®, Rybelsus®) |
|---|---|---|
| Regulatory Status | Not FDA-approved. Made under specific pharmacy compounding rules. | FDA-approved. Reviewed for safety, efficacy, and quality before sale. |
| Formulation | May vary by pharmacy. Can include different additives (e.g., B12) or salt forms of the active ingredient. | Standardized, consistent formulation from batch to batch. |
| Dosage & Packaging | Often provided in multi-dose vials, requiring patients to measure each dose with a syringe. This increases the risk of dosing errors. | Provided in pre-filled, single-dose pens with clear dosing, minimizing user error. |
| Purpose | Historically used during shortages or for specific patient needs (e.g., dose customization, ingredient allergy). | Approved for specific medical conditions: Type 2 diabetes (Ozempic, Rybelsus) and/or chronic weight management (Wegovy). |
| Cost (Approx. Monthly) | Often lower cash price, typically $200 to $500 per month. Usually not covered by insurance. | High list price (~$1,000+). Cost with insurance varies widely; manufacturer savings cards may be available. |
Is Compounded Semaglutide Safe?
The FDA warns that unapproved compounded versions of semaglutide carry significant safety concerns. Unlike FDA-approved drugs, these products skip the agency’s rigorous review for safety, effectiveness, and quality.
Key Safety Risks You Need to Know:
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Quality and Contamination Risks: The FDA notes that some compounded products bear fraudulent labels or originate from unlicensed sources. Concerns include improper storage during shipping—which can spoil the medication—and the use of active ingredients from unregistered foreign suppliers that may fail quality standards.
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Major Dosing Errors: This poses one of the most serious dangers. Compounded semaglutide often arrives in vials, requiring patients to measure doses with a syringe. Confusion between milligrams (mg), milliliters (mL), and “units” has caused patients to accidentally inject 5 to 20 times the intended dose. These errors have led to severe side effects, emergency room visits, hospitalizations, and an FDA estimate links them to approximately 10 deaths and 100 hospitalizations.
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Adverse Events: As of July 2025, the FDA had received over 600 reports of adverse events tied to compounded semaglutide. While many reports show symptoms (like severe nausea, vomiting, diarrhea, and abdominal pain) similar to known side effects, the lack of a standardized product complicates pinpointing the exact cause.
Semaglutide-Based Compounded Medications
Pharmacies most commonly prepare compounded semaglutide as a once-weekly subcutaneous injection, similar to Ozempic® and Wegovy®. They often market this base formulation simply as “compounded semaglutide.”
Frequently, compounders promote formulations that combine semaglutide with other ingredients, most commonly Vitamin B12 (often with L-carnitine). They sell these as “semaglutide with B12,” claiming potential benefits for energy or side effects, despite lacking the robust evidence that supports FDA-approved drugs.
Some compounders also offer less common forms like oral lozenges, sublingual drops, or nasal sprays. Remember: FDA-approved oral semaglutide (Rybelsus®) contains a special absorption-enhancing ingredient. Most compounded oral versions omit this technology, making their effectiveness highly uncertain.
Conclusion
Compounded semaglutide is a custom-made version of a popular medication that emerged as an alternative during periods of high demand and shortage. While it offered potential benefits like lower upfront cost and access when brand-name drugs were unavailable, it carries significant and well-documented risks. These risks include potential quality issues, contamination, and a high risk of dangerous dosing errors.
Most critically, the legal landscape has changed. With the FDA’s declaration that the semaglutide shortage is resolved, the routine compounding of copycat semaglutide products is generally no longer permitted.
Compounded semaglutide served as a temporary bridge when the nation faced limited supply. With the shortage resolved and FDA’s enforcement discretion ended, routine compounding of semaglutide copies for weight management is not allowed. For safety, quality, and consistent dosing, talk with a licensed clinician about FDA-approved options like Wegovy—and use verified pharmacies and official savings resources to manage costs. Schedule a consultation with Heally today to review your options and build a personalized plan.
Sources
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U.S. Food and Drug Administration (FDA): FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
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U.S. Food and Drug Administration (FDA): FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
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American Pharmacists Association: Find a Compounding Pharmacy | APC Locator Tool
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Brown University Health and Wellness: Compounded Weight Loss Medications: What are They and What are Their Risks?
Important Medical Information and Disclaimers
MEDICAL DISCLAIMER
This information serves educational purposes only and does not provide medical advice, diagnosis, or treatment recommendations. The FDA does not approve compounded semaglutide for weight management or any other use. With the national shortage resolved, federal law prohibits pharmacies from routinely compounding products that are essentially copies of FDA-approved medications such as Wegovy. Compounded semaglutide may pose safety, quality, and dosing risks because it does not undergo the FDA’s review for safety, effectiveness, or manufacturing standards. Always consult a qualified healthcare provider before using any semaglutide product, and obtain prescriptions only for FDA-approved medications from licensed pharmacies.
INDIVIDUAL RESULTS VARY
Outcomes with semaglutide treatment vary from person to person. Clinical trial data may not reflect typical real-world experiences. A variety of factors can affect your results, including medication adherence, lifestyle habits such as diet and exercise, metabolic differences, other health conditions, and concurrent medications. No specific result is guaranteed.
IMPORTANT SAFETY INFORMATION
Common side effects of semaglutide may include: Nausea, Vomiting, Diarrhea, Constipation, Stomach pain, Decreased appetite, Indigestion, Belching or gas, Injection site reactions
These side effects are often mild and may lessen over time. Always inform your healthcare provider about any medical conditions, allergies, and all medications you are currently taking before starting semaglutide. Ongoing monitoring is recommended during treatment.
WARNING: Semaglutide has a boxed warning about the potential risk of thyroid C-cell tumors. Do not use this medication if you or a family member has a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
FDA ADVERSE EVENT REPORTING
You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration (FDA).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Adverse events may also be reported directly to the manufacturer.
