The FDA does not directly approve compounded medications, however each of the active ingredients in a compounded formula are individually FDA approved, although the use of an FDA approved medication in the setting of custom compounded doses is considered "off-label" usage. Furthermore, in order to compound multiple active ingredients together, the specialty compounding pharmacy doing so must have specific FDA compounding licensing. Our capsules and topicals are all made in facilities that have such FDA compounding licensing.
It is worth noting that the FDA “approves” medications and it “clears” medical devices. There is no such thing as an FDA cleared medication or an FDA approved device.