Tap to compare
Approved and compounded medicines can both be real medicines. They do not pass through the same review.
As of September 2026, FDA approval applies to a specific product and a named use.
FDA-approved medicines as of September 2026 included the semaglutide products Ozempic and Wegovy and the tirzepatide products Mounjaro and Zepbound.
Ask which approved product and which use the clinician is discussing.
As of September 2026, compounding means a pharmacy or clinician makes a medicine to order instead of using a ready-made approved product.
As of September 2026, a compounded medicine had no FDA approval, meaning the FDA had not verified its safety, effectiveness, or quality before sale.
As of September 2026, a 503A pharmacy generally makes medicine for one named patient, while a 503B outsourcing facility can make sterile batches.
Ask why the approved option does not meet the patient’s specific need and which pharmacy will make the product.