Understand the medicine
What does compounded medicine mean?
Compounded means made to order. The reason for making it matters.
Who makes it?
Compounding is the preparation of medicine to order by a licensed pharmacist or doctor, or a registered medicine-making business.
That business has FDA registration for making medicine in sterile batches. A sterile medicine contains no living germs.
Ask which pharmacy or business will make the medicine. Record the maker’s name apart from the service providing care.
Why would a person need this?
Compounding, in the explanation from the Food and Drug Administration (FDA), can meet a person’s medical need when an approved product cannot.
An allergy to a dye or difficulty swallowing a tablet are examples in FDA’s explanation.
As of September 2026, these preparations still do not have FDA approval, even when a well-run pharmacy makes them.
FDA does not review their safety, effectiveness, and quality before marketing.
Do all compounders work under the same rules?
As of September 2026, federal law has two sets of rules for making medicine to order. A pharmacy can make it for a named patient with a prescription. A separate set covers businesses registered with FDA that make batches of sterile medicine.
Ask whether your medicine comes from a pharmacy making it for you or a business making batches.
Registering the business with FDA does not give the medicines it makes FDA approval.
- What medical need makes this preparation necessary?
- Which pharmacy or facility makes it?
- What is its name on my paperwork?