Beside the evidence
FDA review and medicines made to order
The US Food and Drug Administration (FDA) has given no approval to compounded medicines, as of September 2026.
Before a compounded product is marketed, FDA does not check its quality, benefits or safety.
A medicine made to order can be legal if it meets compounding rules. FDA says it may help when approved medicines cannot meet a patient’s medical need.
Ask the clinician which rules allow the exact medicine being offered to you.
Read the FDA account of compounding