How do offices procure and administer compounded versions of semaglutide (glucagon-like peptide-1 (GLP-1) receptor agonist) or tirzepatide (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist)?

Procuring and Administering Compounded GLP-1 Receptor Agonists in Medical Offices

Medical offices should NOT procure or administer compounded versions of semaglutide or tirzepatide as these products circumvent FDA oversight, may lack quality control, and pose significant risks to patient safety and outcomes. 1

Understanding Compounded GLP-1 Medications

Compounded versions of GLP-1 receptor agonists like semaglutide and the dual GIP/GLP-1 receptor agonist tirzepatide have become increasingly sought after due to:

1. High demand for these medications for diabetes management and weight loss
2. Supply shortages of FDA-approved versions
3. Cost considerations (FDA-approved versions can be expensive)

However, these compounded versions present significant concerns:

• They lack FDA approval and quality control standards
• May have inconsistent potency and purity
• Can contain harmful contaminants
• May not deliver the expected clinical outcomes

FDA-Approved Options vs. Compounded Versions

FDA-Approved Medications

• Semaglutide (Ozempic®, Wegovy®) - GLP-1 receptor agonist 2
• Tirzepatide (Mounjaro®, Zepbound®) - dual GIP/GLP-1 receptor agonist 2

These medications have demonstrated significant efficacy for:

• Glycemic control in type 2 diabetes 3
• Weight management 2
• Cardiovascular risk reduction 2

Proper Procurement Channels

Medical offices should only procure these medications through:

• Licensed pharmaceutical wholesalers
• Direct from manufacturers
• Licensed specialty pharmacies

Why Compounded Versions Should Be Avoided

1. Safety concerns: Unregulated products may contain incorrect dosing or contaminants
2. Legal liability: Prescribing non-FDA approved compounded versions may expose providers to legal risks
3. Efficacy concerns: Compounded versions may not deliver the same clinical benefits as FDA-approved products
4. Patient harm risk: Adverse events from compounded products may not be tracked or reported properly

Alternative Approaches for Access and Affordability

If access to FDA-approved medications is challenging:

1. Patient assistance programs: Many manufacturers offer programs to help eligible patients access medications at reduced costs
2. Insurance navigation: Work with insurance companies to determine coverage options
3. Step therapy approaches: Follow evidence-based algorithms starting with metformin and adding other agents as needed 2
4. Generic alternatives: Consider other FDA-approved medications with similar mechanisms when appropriate

Pitfalls to Avoid

• Purchasing from online vendors: Some websites sell semaglutide or tirzepatide "for research purposes only" which circumvents prescription requirements 1
• Compounding pharmacies without proper credentials: Even legitimate compounding pharmacies may not have the specialized equipment or expertise to properly compound these complex peptide medications
• Assuming bioequivalence: Compounded versions may not have the same pharmacokinetic properties as FDA-approved products

Conclusion

While the demand for GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists continues to grow due to their impressive efficacy for both glycemic control and weight management 2, medical offices should prioritize patient safety by only procuring and administering FDA-approved versions through legitimate supply chains. The risks associated with compounded versions far outweigh any potential cost savings or accessibility benefits.