Pharmacy
Pharmacy checklist: find who makes it
The short version
A compounded preparation is made by a pharmacy or clinician rather than supplied as an FDA-approved finished medicine.
The most useful first question is which pharmacy actually makes and ships the preparation.
Start with the name. Check the state record. Keep the label close. Each step is quick, and each one answers a different question.
The two compounding paths
The law names two kinds of place that mix medicines to order. You only need the names to recognise them on a label or a website.
As of September 2026, the first kind is an everyday pharmacy filling a prescription written for a single, named person. The law calls it a 503A pharmacy.
The second kind is a larger plant that makes batches of sterile medicines for clinics and hospitals. It does not need a prescription with your name on it. The law calls it a 503B outsourcing facility.
A 503B plant must follow the quality rules that drug factories follow, and FDA inspects it. An ordinary 503A pharmacy is watched mainly by its state board of pharmacy.
Either way, ask which kind is making your medicine, and check its record.
Run the checks in order
- What is the pharmacy’s full business name?
- Is it licensed in the state where I live?
- Is the licence current, with no fines, suspensions, or other penalties on the state board’s public record?
- Is it an ordinary pharmacy or a larger outsourcing plant?
- Does the label name the same pharmacy?
- Who answers product and storage questions?
FDA provides a state-by-state pharmacy licence lookup and warns against buying from any online pharmacy you cannot find on the list for its state.
Registration is not approval
An outsourcing facility can appear on the FDA registration list without FDA approving the facility or any product it makes.
Use a registration as one check, then read inspection and state-board records where available.