Have you been offered a compounded medicine? Ask what change is needed for your care and who will prepare it. Made to order tells you how it is prepared. Ask why a ready-made medicine will not meet your needs.
What compounding is
Preparing a medicine around an individual patient's needs, in place of supplying a ready-made product, is called compounding.
It is useful to ask why the proposed medicine needs that work.
What has not been reviewed?
For US medicine review, the agency is the Food and Drug Administration, or FDA for short.
Compounded medicines go to market without FDA review of safety, quality, or how well the medicine works, as of September 26, 2026.
For this medicine, there is no FDA review before sale to rely on.
Ask the prescriber why they propose it for you and what is known about its benefits and risks.
Source note
A pharmacy filling a named prescription
Under federal law section 503A, pharmacies or doctors generally make medicine for one named patient with a valid prescription, as of September 26, 2026.
A prescription is a medicine order from someone allowed to write it. Ask: Is this medicine being made for me under that rule? Which pharmacy or doctor will make it?
A maker preparing batches
Sterile means free of living germs.
As of September 26, 2026, federal law section 503B allows an FDA-registered maker to prepare batches of sterile medicines without prescriptions naming each patient.
This kind of maker is called an outsourcing facility and often supplies clinics and hospitals.
It must follow factory quality rules and is inspected by the FDA; registering does not give its medicines FDA approval.
A prescription medicine still needs a valid prescription when it is handed out to you.
Ask: Who makes this medicine? Who supplies it to me? Who writes my prescription?
Source note
A question about copies
Federal limits apply to compounding that amounts to copying a ready-made medicine, as of September 26, 2026.
Under 503A, a medicine change may be allowed when it makes a significant difference to that named patient's care.
Ask: What is being changed from the ready-made medicine? How does that change help meet my medical need? What permits this pharmacy to make it? A low price does not explain that need.