With shortages affecting brand-name GLP-1 medications and costs exceeding $1,000/month without insurance, many people are turning to compounded versions. But what exactly is compounded semaglutide or tirzepatide, and is it safe? Here's what you need to know.
What Is Compounded Medication?
Compounding is the practice of creating customized medications by licensed pharmacies. Compounded GLP-1 medications use the same active ingredients as brand-name versions but are prepared individually rather than mass-manufactured. They became legally available when brand-name versions were added to the FDA shortage list.
Key Differences
| Feature | Brand Name | Compounded |
|---|---|---|
| FDA Approval | Fully approved | Regulated but not FDA approved |
| Cost (without insurance) | $900-1,300/month | $200-500/month |
| Active Ingredient | Semaglutide/Tirzepatide | Same active ingredients |
| Delivery | Pre-filled pen | Vial + syringes |
| Insurance Coverage | Sometimes covered | Rarely covered |
Safety Considerations
Quality Compounding Pharmacies
Look for 503A or 503B registered pharmacies. 503B facilities operate under stricter FDA oversight and are generally considered safer. PCAB accreditation is another quality marker.
Potential Risks
- • Less standardized manufacturing process
- • Variable quality between pharmacies
- • Some use "semaglutide salt" forms with less research
- • No long-term safety data specific to compounded versions
- • Risk of contamination if pharmacy standards are poor
Red Flags to Avoid
- • Pharmacies without verifiable licenses
- • Prices that seem too good to be true
- • No requirement for prescription
- • Foreign or unverifiable sources
- • "Research chemical" or peptide suppliers
Questions to Ask Your Provider
- Which compounding pharmacy do you use?
- Is it a 503A or 503B registered pharmacy?
- What form of semaglutide do they use (base vs. salt)?
- How is potency and sterility verified?
- What happens if there's a quality issue?
The Legal Landscape
Compounded GLP-1 medications exist in a legal gray area:
- Legal to compound when brand versions are on FDA shortage list
- Novo Nordisk and Eli Lilly have challenged compounders
- Regulations may change as shortages resolve
- Some states have stricter rules than others
The Bottom Line
Compounded GLP-1 medications offer a more affordable alternative to brand-name versions, but quality varies significantly. If you choose compounded medication, use a reputable telehealth provider or pharmacy with proper credentials. The safest approach is brand-name medication from a licensed pharmacy, but compounded versions from quality sources can be a reasonable option when cost or availability is a barrier.