Understand the medicine
What does FDA approval tell me?
The initials FDA refer to the federal agency that reviews medicines: Food and Drug Administration.
Is approval about a whole care service?
FDA approval concerns a specific medicine for particular uses, rather than every product with a similar name.
As of September 2026, FDA guidance explains that health care providers, including doctors’ offices, do not receive its approval.
Ask the medicine’s full name and how it is taken: by tablet, shot, or another method. Then ask which health problem it would treat.
Does a government code prove approval?
A product’s National Drug Code is no proof of approval, the FDA explains in guidance recorded in September 2026.
A drug directory uses a National Drug Code to identify a product. Request the approval record for that product; a code alone does not answer the question.
Under the rules recorded in September 2026, FDA registration gives neither a facility nor its products approval.
Does preparation to order change a medicine’s status?
As of September 2026, FDA guidance says compounded medicines are not FDA-approved.
Before these medicines reach the market, the agency has not checked how safe or effective they are, or their quality.
Compounded means made to order. Ask what particular medical need an approved product would leave unmet.