FDA & Compounded GLP-1s: Consumer Questions
What recent FDA communications mean for people researching compounded semaglutide or tirzepatide.
Key points
- FDA states that compounded drugs are not FDA-approved.
- FDA has warned telehealth companies about promotion that implies compounded GLP-1 products are the same as approved products.
- FDA policy for compounding changes with supply conditions and applicable legal requirements, so current agency guidance matters.
How to use this guide
Use this article to prepare questions and understand terminology, then rely on your licensed clinician, dispensing pharmacy, FDA-approved labeling where applicable, and current FDA guidance for medication-specific decisions.
What to verify before making a decision
Confirm the exact product, FDA approval status, prescriber, dispensing pharmacy, total amount billed today, renewal terms, cancellation rules and available clinical follow-up. Program terms can change, so merchant-specific claims should be checked at the source.
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Sources & update standard
Merchant-specific claims are based on HealthRX’s currently published materials. Regulatory distinctions are checked against FDA materials. We date-stamp substantive reviews because pricing, supply conditions and compounding policy can change.