Branded Rx Product definition
Branded Rx Product means (a) product required under Section 503 of the Federal Food, Drug and Cosmetic Act to bear an “Rx Only” symbol and that are marketed under an FDA-approved New Drug Application, including Schedule II Narcotics, excluding Authorized Generics (Authorized Generics being defined as those Generic Pharmaceutical Products marketed under a New Drug Application) or (b) biologic product licensed under Section 351 of the Public Health Service Act and classified by the FDA as a brand prescription pharmaceutical.