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(P50 AA024333, RF1 NS133812, R01 DK130227, R01 DK120679, P01 HL147823, and DOD KC2210163 to J.M.B.)

The FDA's guidance is unambiguous: compounded products should be used only when a patient has a "specific medical need" that cannot be met by the approved product, such as an allergy to an inactive ingredient or a required dose that is not commercially available [9]