What is the difference between a compounded product and an FDA-approved one?
Updated: 2026-09-09 · Safety and evidence
Short answer
An approved medicine has gone through regulatory review of efficacy, safety and manufacturing, and every batch is made under that approval. A compounded product is prepared by a pharmacy for a specific need and does not go through that review: neither the finished product nor its batches are FDA-approved.
In plain English
- Approved = reviewed dossier, official label, manufacturing inspected under that authorisation.
- Compounded = prepared by a pharmacy; lawful in defined circumstances, but the finished product is not approved.
- FDA has specifically warned about issues with compounded versions of GLP-1 drugs, including salt forms that differ from the approved active ingredient.
- 'Compounded' does not mean illegal — it means nobody reviewed that specific product for you.
What we know
- Compounded drugs are not FDA-approved and are not reviewed batch by batch the way approved drugs are.
- FDA has published notices about products containing semaglutide outside the approved medicines.
What we don't know yet
- Quality varies between compounders and cannot be judged from the outside.
- There are no comparable efficacy data between compounded versions and the approved drug.
Sources
External links to official sources or peer-reviewed studies.