Start with the words
What does a custom medicine mean?
Compounding is the word for preparing a custom medicine. The reason for making it matters.
What is being made
With compounding, the medicine is prepared by a doctor or pharmacist instead of supplied as a drug maker’s finished product.
A pharmacist is the health professional trained to work with medicines. Ask which pharmacy makes the preparation and why this form is being considered.
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FDA: the purpose of compoundingWhen it can serve a need
FDA, the Food and Drug Administration, says a custom preparation may help when an approved product does not meet a patient’s need or is unavailable.
As of September 26, 2026, making a medicine to order can be legal. The rules depend on what is in it, what product it resembles, and who prepares it.
Permission to make one custom medicine does not cover every peptide. A prescriber is the person giving care who orders a medicine. Ask which rule permits preparation of this particular medicine.
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FDA: rules for raw ingredientsWhat review it has not had
At the September 26, 2026 check, compounded preparations lacked FDA approval; the agency had not reviewed their quality, safety, or ability to work before marketing.
An FDA registration records the business. It does not mean FDA has checked or approved its made-to-order medicines.
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FDA: limits of reviewA lower price does not settle the rule
Federal rules limit pharmacists and doctors making routine copies of an available medicine. A medicine changed for one named patient may be an exception. The prescriber must identify a change that matters medically for that person.
A dye allergy might call for a preparation that leaves that dye out; someone unable to swallow tablets might need a liquid medicine.
For that person, the prescriber still needs to explain why the change matters medically. Under the rule checked on September 26, 2026, a cheaper price does not qualify as a medical difference.