Product two / made to order
Compounded is a process, not a guarantee
It tells you how a medicine was made. It does not, by itself, tell you that the FDA reviewed it or that federal and state law allow how it is offered.
Plain meaning
A pharmacy or doctor makes the medicine to order
When medicine is compounded, a pharmacist or doctor prepares it for a patient instead of using a drug company’s finished product.
In September 2026, a compounded medicine had no FDA approval, and the agency did not review the finished product before it was supplied.
Regular compounding pharmacy
As of September 2026, federal law calls a pharmacy that makes medicine for a named patient with a prescription a 503A pharmacy. Ask the pharmacy whether it works under section 503A, then check its state pharmacy record.
Large compounding facility
As of September 2026, federal law calls a site that can make many units of sterile medicine together for places that provide medical care a 503B outsourcing facility.
FDA registration does not grant approval
In September 2026, an FDA registration still did not show agency approval of the facility or its products.
Questions about who made it
Ask what need the made-to-order product meets
- Which pharmacy or facility makes it?
- Is the prescription for one named patient?
- What makes this option different from an available approved product?
- Who answers product and storage questions?
- Where can the pharmacy license be checked?
Endnotes by chapter
Public records used here
Links open public or standards records. They do not lead to care businesses.