If you’ve seen terms like compounded semaglutide alongside brand names like Wegovy®, you’re not alone. During past supply shortages, some patients used compound semaglutide as a temporary workaround. However, the landscape has changed. The U.S. Food and Drug Administration (FDA) has declared the national shortage of semaglutide injections resolved and ended its temporary enforcement discretion that previously allowed compounding of products that were essentially copies of approved drugs. Today, patients seeking semaglutide for weight management should look to FDA-approved options—primarily Wegovy—under professional guidance.
Both Wegovy and Ozempic contain the active ingredient semaglutide, but they serve different medical purposes. Ozempic is FDA-approved for type 2 diabetes management, while Wegovy is FDA-approved for chronic weight management in adults with obesity or overweight. Throughout this article, any reference to semaglutide for weight loss refers to Wegovy. Mentions of semaglutide for blood sugar control refer to Ozempic.
What is compounded semaglutide?
Compounding creates customized medications for individual patients when a specific, documented need cannot be met by an approved product (for example, a true excipient allergy). Compounded drugs are not generics and do not undergo FDA premarket review for safety, effectiveness, or manufacturing quality. During a national shortage, the FDA may temporarily allow compounding to bridge access gaps. Outside those circumstances, making compounded copies of approved drugs is restricted by federal law.
Why compounding is no longer allowed for routine weight management
On February 21, 2025, the FDA formally determined that semaglutide injection shortages were resolved and announced short transition windows to wind down compounding of “essentially a copy” products. Those windows ended in April/May 2025 for traditional pharmacies (503A) and outsourcing facilities (503B). After those dates, routine compounding of semaglutide copies for weight management is not allowed under federal sections 503A/503B. The policy shift protects patients by steering them to medicines that have been reviewed for quality, safety, and consistency.
Safety considerations patients should know
The FDA has warned about multiple risks tied to compound semaglutide sold for weight loss, including products labeled with nonexistent pharmacies, dosing mistakes from multi-dose vials, and formulations made with semaglutide salts (e.g., acetate or sodium) rather than the approved base—differences that may affect safety and legality. These concerns are a key reason the agency now directs patients toward approved options.
Stay safe online and in clinics (quick checklist):
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Fill prescriptions through state-licensed pharmacies and use FDA’s BeSafeRx tools to evaluate online sources.
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Be cautious of ads for compound semaglutide that imply FDA approval or use brand names like “compounded Wegovy.” Such claims are red flags.
What to use instead for weight management
For chronic weight management, Wegovy (semaglutide) injection is the FDA-approved choice. In addition to its weight-management indication, FDA has also authorized Wegovy to reduce the risk of certain major cardiovascular events in qualifying adults with overweight or obesity—an important clinical benefit to discuss with your clinician as you consider therapy. Compound semaglutide is not a substitute for these approved uses now that supply has stabilized.
Costs, coverage, and ways to save
Many people turned to compound semaglutide during the shortage because it appeared cheaper. With compounding off the table for routine use, cost questions turn to the approved product:
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Manufacturer savings: Depending on eligibility and insurance, manufacturer programs may reduce out-of-pocket costs (for some commercially insured patients, promotional materials describe “as little as $0” offers up to a monthly maximum savings). Terms, caps, and eligibility apply and can change.
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If insurance doesn’t cover Wegovy: Some programs outline self-pay options (for example, informational pages have described a $499 per-month path for certain patients, subject to program terms). Always verify current details directly through official program pages before making decisions.
Heally can help you understand current coverage, navigate savings programs, and coordinate care with licensed clinicians who prescribe FDA-approved treatments when appropriate.
Professional guidance matters
Even approved medications can cause side effects and require thoughtful dosing, monitoring, and follow-up. A licensed clinician will review your medical history, evaluate potential risks, and help you create a comprehensive plan—including nutrition, activity, and behavioral supports—to make the most of treatment. This is especially important now that compound semaglutide is no longer a routine pathway and patients should transition to approved options when clinically appropriate.
Heally’s role in your care
Heally connects you with qualified healthcare providers who focus on safe, evidence-based weight management. Your clinician can determine if Wegovy fits your goals, check coverage and savings options, and ensure your prescription is filled by a state-licensed pharmacy. If you previously used compound semaglutide during the shortage, your provider can discuss next steps and help you transition to an approved approach aligned with current FDA guidance.
Conclusion About Compounded Semaglutide
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). Declaratory Order: Resolution of Shortages of Semaglutide Injection Products; enforcement-discretion wind-down dates. U.S. Food and Drug Administration
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FDA. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (shortage resolved; direction to approved products). U.S. Food and Drug Administration
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FDA. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (fraudulent labels, salts, dosing issues, safe-use tips). U.S. Food and Drug Administration
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FDA. BeSafeRx and “How to Buy Medicines Safely From an Online Pharmacy” (verifying licensed pharmacies). U.S. Food and Drug Administration
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Novo Nordisk. Wegovy approval details and prescribing information (weight management; cardiovascular risk-reduction indication). Novo Pi
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Novo Nordisk / NovoCare. Wegovy coverage and savings program information (eligibility, caps, and terms). NovoCare, NovoMedlink, Wegovy
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.
