Patient-specific pharmacy
An everyday pharmacy preparing medicine for a single, named, prescribed patient. Officials call it a 503A pharmacy, after the section of federal law; the number is only a label.
COMPOUNDING CHAPTER / MADE TO ORDER
Where made-to-order medicine fits
In compounding, a patient’s medicine is prepared to order by a pharmacist or doctor. It can meet a need a ready-made drug cannot, but it skips the approval review the Food and Drug Administration (FDA) gives ready-made drugs.
SEARCH→CHECK→CARE
Two kinds of place that make medicine to order
Outsourcing facility
A larger facility producing germ-free (sterile) medicines in batches, commonly supplied to clinics and hospitals, without a patient’s name on each order. Officials call it a 503B facility.
What FDA review does not happen
The FDA does not check each made-to-order medicine for safety, effectiveness, or manufacturing quality before it reaches a patient.
The larger 503B facility is held to drug-factory quality rules, and the FDA inspects it. The ordinary 503A pharmacy is exempt from those factory rules; state pharmacy rules still apply to it.
Copies have limits
As of September 2026, a pharmacy generally may not make what is basically a copy of a medicine already on sale. The exception is when the prescribing doctor records a change that matters for that one patient’s health.
There is one more exception. During an official nationwide shortage of a medicine, pharmacies may make versions of it. When the shortage ends, that permission ends too.
MYTH / TAP TO CHECK
Custom-made means the FDA approved it for one person.
THE FACT
No. A patient-specific prescription can fit a compounding rule, but it does not turn the finished medicine into an FDA-approved drug.
The short version
Where these facts come fromGOVERNMENT PAGES
These links open the public records used for this chapter.