Compounding is not an approval
FDA, the Food and Drug Administration, reviews evidence about specific medicine products and their uses.
Compounding means making a custom medicine to meet the needs of a patient.
As of September 26, 2026, no compounded medicine has FDA approval, including one from a licensed pharmacy.
Ask what prevents an approved product from meeting the medical need.
Read the basis
What the source establishes
Before a custom medicine is sold, FDA does not check its quality, how well it works or its safety.