Physician-reviewed
Are compounded medications FDA-approved?
Medically reviewed byClay Buchanan, MD·Last reviewed September 2026
No. Compounded medications are not FDA-approved. The FDA does not review them for safety, effectiveness, or quality. They are prepared by a licensed pharmacy for a specific patient based on a prescription, and they can be appropriate when a clinician determines so.
Why they’re still used
Compounding fills gaps — custom doses, alternate forms, or combinations — when a commercial product doesn’t fit a patient’s needs.
What we promise
We label compounded status clearly and never place “FDA-approved” next to a compounded product.
Frequently asked
Should compounded worry me?
Not inherently. The key is knowing what you’re getting — which is why we state the category every time.
References
- FDA: Compounding and the FDA — Questions and Answers.
This page is for general education. It is not medical advice and does not create a clinician–patient relationship.