Lane: compounded medicine
Made to order is a separate lane.
Compounding can meet a real patient need. It also comes with a different kind of oversight.
What the term means
Compounding is when a pharmacist or doctor prepares medicine for an individual order instead of supplying a ready-made drug-company product.
As of September 2026, compounded medicines do not carry FDA approval. Before one is sold, the FDA has not reviewed it for safety, effectiveness or quality.
Two kinds of maker
A regular compounding pharmacy—called 503A after its part of the law—makes medicine for one named patient with a prescription. A larger compounding business—called a 503B outsourcing facility in the law—can make batches of sterile medicine, which is made to be free of germs. It must follow federal factory quality rules. Ask which kind made yours: a 503A pharmacy should have a prescription naming you, while a 503B facility should appear on the FDA’s public list.
“FDA registered” means the business put its name and facility information on an FDA list. Joining that list is the business’s choice; it does not mean the FDA approved the business or anything it makes.
The useful question is not simply “Is it compounded?” Ask why this made-to-order version is needed for this patient.
Read the public sources
These links support the factual parts of this page. They are not care businesses.
- FDA on compounded medicines
- FDA on compounded medicine quality
- FDA list of larger compounding facilities
- Federal rule on FDA lists and approval
This page links to the public record behind each factual claim.