Semaglutide and tirzepatide have become prominent in weight loss and diabetes management due to their proven effectiveness. While medical professionals widely agree on the significant benefits of these medications, there’s debate among providers and professional societies around the use of compounded versions. Pharmaceutical companies Eli Lilly and Novo Nordisk hold the patents for tirzepatide and semaglutide, limiting availability to only branded medications like Mounjaro, Zepbound, Ozempic, Wegovy, and Rybelsus, which can cost $800–$1,500 per month without insurance. As many insurance plans don't cover these, patients increasingly turn to compounded alternatives. However, it's essential to be cautious about the source and quality of these compounded medications
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Not all compounded weight loss medications are created equally. Here’s why you should be cautious:
The Importance of Quality and Purity
Unlike FDA-approved medications, compounded medications are mixed or altered by pharmacies based on specific patient needs. While reputable compound pharmacies can deliver high-quality products, they do not face the same level of regulatory oversight that FDA-approved drugs undergo. This means the quality, purity, and potency of compounded semaglutide or tirzepatide may vary from one pharmacy to another.
When you obtain compounded medications from an unverified or low-quality source, you run the risk of receiving a product that may not meet necessary safety standards. For example, a compounded semaglutide using a semaglutide salt instead of a semaglutide base can result in ineffective, inconsistent, or unfavorable results. Using the semaglutide salt has a greater potential for drug instability and variability which can increase the risk of adverse effects or therapeutic failure. This can not only undermine your weight loss journey but also put your health at serious risk.
Risks of Inconsistent Dosing
Semaglutide and tirzepatide require precise dosing to achieve optimal results and minimize side effects. Compounded versions of these medications may have inconsistent dosing, either too high or too low, which could result in adverse side effects or reduced effectiveness. Unlike commercially available versions that undergo rigorous testing for consistency, compounded medications may lack that same level of quality control.
Safety Concerns: The FDA Warning
In fact, the FDA has issued warnings regarding the safety of some compounded versions of semaglutide or tirzepatide, especially those made using active pharmaceutical ingredients (APIs) that are not approved for compounding (i.e. semaglutide salts). Patients need to be aware of these potential safety risks and should always confirm whether the compounded medication they are receiving comes from a reputable, compliant pharmacy.
How to Protect Yourself
If you are not able to obtain any of the FDA-approved GLP-1 agonist or GLP-1/GIP agonist medications (such as Zepbound, Mounjaro, Wegovy, Ozempic, or Rybelsus) for any reason (common reasons are: lack of insurance, lack of formulary coverage, high cost, lack of supply/backorder) and you are considering a compounded product, here are suggestions for choosing the best compounding pharmacy for you.
1. Verify the Pharmacy’s Credentials: Ensure that the compounding pharmacy you use is licensed, accredited, and follows stringent quality control measures.
Check the state licensing board website to see if there have been any complaints or disciplinary actions made against the pharmacy facility.
Look for accreditation from organizations like the Pharmacy Compounding Accreditation Board (PCAB). Accreditation is an extra optional step that some compounding pharmacies take to be legitimized by a third party.
Ask if the pharmacy follows Current Good Manufacturing Practice (CGMP).
cGMP (Current Good Manufacturing Practices) are regulations enforced by the FDA to ensure that drugs, medical devices, biologics, and food products are consistently produced and controlled to meet quality standards. cGMP is followed in FDA regulated manufacturers of pharmaceuticals and 503B compounding pharmacies, but not 503A compounding pharmacies.
2. Research the Medication’s Source: Don’t hesitate to ask questions about the source of the active ingredients used in your compounded medication. Ensure that your compounding pharmacy adheres to the highest standards and uses FDA-approved APIs whenever possible.
Confirm that semaglutide (or tirzepatide) base, not semaglutide (or tirzepatide) salt, is used in the compounding process.
Request a certificate of analysis (COA) of the active pharmaceutical ingredient, which should be semaglutide (tirzepatide) base.
Ask if they have third-party confirmation of potency, stability, and sterility testing of the final product.
3. Consult Your Physician: Always consult with your healthcare provider before starting any compounded medication. They can help you assess whether compounded semaglutide or tirzepatide is appropriate for your situation and guide you to trustworthy pharmacies.
Conclusion
While compounded semaglutide and tirzepatide may seem like an attractive alternative to FDA-approved medications, it’s essential to remain vigilant about where you get these treatments. Quality matters, especially when it comes to your health. By taking the time to verify the source and quality of your compounded medications, you can ensure that you are on the safest and most effective path to achieving your weight loss goals.
Footnotes:
Regulatory agencies like the US Food and Drug Administration (FDA) have expressed caution around compounded semaglutide and tirzepatide. Professional societies like the Obesity Medicine Association (OMA) advise against compounded peptides because they lack clinical trials that prove their safety and efficacy.
A Checklist for Compounded Semaglutide or Tirzepatide by Beverly Tchang, MD
Dr. Cardona is board certified in family and obesity medicine and is the founder and physician owner of Cardona Direct Primary Care and RefineMD Aesthetics. The clinic offers medical weight loss programs, and under the direct supervision of Dr. Cardona, compound semaglutide or tirzepatide can be prescribed and managed safely. Cardona Direct Primary Care only sends prescriptions for compound semaglutide and tirzepatide to a verified 503B compounding pharmacy. Visit our website for more information of all our services or call the office (904) 551-4625 to schedule a consultation.
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