Made-to-order medicine · An explainer
What does compounded mean?
This word matters because it tells you something about how the medicine was prepared. It also leaves questions to ask about why it is being offered.
Prepared to order: review and limits.
A medicine can be prepared for an order through a process called compounding, carried out by a pharmacist or doctor. The medicine is prepared this way rather than supplied ready-made by a drug company.
FDA · What compounding involvesAn allergy to a dye is one reason a person may need compounding when approved medicine cannot meet that need, says the Food and Drug Administration (FDA). FDA handles medicine review at the federal level.
FDA · Why a patient might need compoundingThe finished medicine has not had FDA review.
Compounded drugs reach patients without FDA checking their safety, effect, or quality beforehand. As of September 26, 2026, these preparations carry no FDA approval.
FDA · What has not been reviewedRegistering a facility with FDA neither gives its products approval nor gives the facility FDA's endorsement.
FDA · Registration of an outsourcing facilityKeep the product question separate from the pharmacy question. Ask which medicine is planned and who will prepare it. Ask why it is being offered as a tablet, injection, or another type.
Ask why the change matters for you.
Federal rules place limits on making close copies of available medicines repeatedly or in large amounts, as of September 26, 2026. A prescriber can document how changing the medicine makes an important difference to a named patient's care. That change can mean the medicine does not count as a copy under these rules.
Federal law via Cornell · Copies and the patient's needA price cut by itself cannot qualify as an important change in that patient's medicine.
Ask the prescriber to explain the reason in words you understand. Ask how an approved product was considered. Keep the explanation with the written care plan.
For example, ask whether a dye you are allergic to could be left out. Ask the prescriber why that change matters for you.