Under section 503A of the FD&C Act, bulk drug substances used in compounding must either be components of FDA-approved drug products, the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph.
Draft guidances for industry on FDA’s interim policy on compounding using bulk drug substances under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Under section 503A of the FD&C Act, bulk drug substances used in compounding must either be components of FDA-approved drug products, the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph.
