Notebook entry
Approved
The FDA approves one particular medicine for particular health problems. Ask the doctor whether your problem is one of them.
No compounded medicine held FDA approval as of September 2026.
The FDA had not checked if each one was safe, worked well or met its quality rules before sale.
Notebook entry
Registered and licensed
As of September 2026, federal registration did not mean FDA approval.
Registration did not show that FDA had approved the site or its products.
A licence shows that the state allows a person or pharmacy to work there. It does not show that every medicine they offer is right for you.
Notebook entry
Compounded and accredited
Federal law allows two kinds of made-to-order medicine maker.
A regular pharmacy can make a drug for one person who has a prescription; in the law this is a 503A pharmacy, named after the section of the law it comes from.
A bigger site can make sterile, germ-free medicine in batches, often for clinics and hospitals; its legal name is a 503B outsourcing facility.
These big 503B sites had to meet drug-factory quality rules as of September 2026, and the FDA inspected them.
An ordinary 503A pharmacy was not bound by those factory standards; the state board of pharmacy was its main day-to-day watchdog.
Accreditation means an outside body has checked that a compounding pharmacy follows national quality standards for making medicines; it checks the process, not each batch.
Accreditation is not a licence, and it does not make a medicine FDA-approved.
Brief source notes
FDA compounding questions and answersA federal starting point for made-to-order medicine.
Federal registration ruleThe rule says registration does not confer approval.