The idea to question
A custom-made medicine has passed the same review as the ready-made version.
The short answer
Compounding is the name for a pharmacist’s or doctor’s preparation of a patient’s medicine. FDA, the Food and Drug Administration, describes a role for compounds in September 2026 when an approved option is unavailable or cannot meet the need. FDA’s compounding answers
Ask what the change does for you
Someone unable to swallow tablets may need a different form. Another person might need a dye left out because of an allergy. FDA’s compounding answers
A useful question is: “Which need of mine does this change meet?” Ask what ready-made options were considered too.
Custom does not mean reviewed
In September 2026, FDA’s position is that compounds reach the market without its prior checks of quality, benefit and safety. FDA on preparation quality
As of September 2026, US pharmacy-compounding law restricts making copies of available medicines repeatedly or in unusually large amounts. The pharmacy-compounding statute
The rule treats a changed preparation differently if whoever writes the prescription judges that it makes a significant difference for that patient. Then the changed medicine falls outside this copying restriction. A price saving alone is not enough. The pharmacy-compounding statute
Ask whoever writes your prescription: “What needs changing for me, and how would that change help?” There is no single amount of change given here that would qualify everyone.
Ask which rule permits the particular preparation being offered, and what patient need it meets.