Does “FDA registered” mean approved?
FDA stands for Food and Drug Administration, a US agency whose work includes reviewing medicines.
“FDA registered” can refer to a company adding the place where it makes medicines to the FDA’s records.
That entry is called registration; a medicine’s entry in the records is called a listing.
As of September 2026, FDA consumer guidance says neither entry means the agency has approved the company or the medicine.
With FDA approval, the agency has reviewed evidence that a specific medicine works and is safe enough for its stated use.
The company’s entry in FDA records does not show that the medicine passed this review.
Is a custom medicine an approved generic?
A compounded medicine is prepared to order. A generic copies a brand medicine and has approval for that copy.
As of September 2026, the FDA’s advertising guidance says calling a made-to-order medicine an approved generic is misleading.
It also calls it misleading to describe a made-to-order medicine as the same as an FDA-approved medicine.
What does a report of harm prove?
The FDA’s medicine-problem report website lets the public look through reports of unwanted effects.
The website is called the Adverse Event Monitoring System (AEMS), formerly FAERS.
Such a report does not confirm that the medicine caused the problem, the FDA cautions.
Those reports also cannot show how often a problem happens among people using a medicine.