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FDA guidanceCompounded GLP-1 drugs: what FDA says consumers should know
Compounded drugs can have a role in patient care, but FDA emphasizes that they are not FDA-approved and do not undergo FDA premarket review for safety, effectiveness or quality.
Three distinctions that matter
Not “generic” by default
FDA warns telehealth marketers not to describe compounded drugs as generic versions of FDA-approved drugs or as the same as approved products.
Pharmacies are not “FDA-approved”
FDA says describing compounding pharmacies or outsourcing facilities as FDA-approved or FDA-licensed is misleading.
Dosing and quality concerns
FDA has reported adverse events and dosing errors associated with compounded semaglutide and tirzepatide products. It advises patients to discuss dosing and administration with their healthcare provider or compounder.
Consumer questions
- Why is a compounded product being considered for me?
- What is the exact formulation and concentration?
- Who compounded it and where is that entity licensed?
- How should the dose be measured and administered?
- Who do I contact with medication questions or adverse effects?
Medical note: This page summarizes public FDA guidance. It does not tell you whether a compounded or approved drug is appropriate for you.
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- FDA: What telehealth companies should know when promoting compounded drugs.
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