FDA Oversight
The U.S. Food and Drug Administration's regulatory authority over compounding pharmacy operations, distinct from FDA approval of individual drug products.
FDA oversight, in the context of wholesale compounded preparations, refers to the U.S. Food and Drug Administration's regulatory authority over compounding pharmacy operations themselves. This is distinct from FDA approval of individual drug products: a 503A pharmacy operates under FDA oversight of compounding standards, but the specific compounded preparations it produces are not FDA-approved drugs.
503B outsourcing facilities are registered directly with the FDA and inspected to a stricter standard than 503A pharmacies, including current Good Manufacturing Practice (cGMP) compliance. Both pathways operate under federal FDA oversight; neither produces FDA-approved drugs at the preparation level.
When a wholesale supplier states that their preparations come from "licensed pharmacies under FDA oversight," they are referring to oversight of the compounding pharmacy operation, not approval of the individual preparation as a drug.