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As required under section 503A of the Food, Drug, and Cosmetic Act (FD&C Act), FDA is developing a list of bulk drug substances that are not the subject of an applicable United States Pharmacopeia or National Formulary monograph, or a component of an FDA-approved drug, that can be used to compound drug products eligible for the exemptions identified in section 503A of the FD&C Act. This proposed rule will identify the criteria proposed for evaluating bulk drug substances for inclusion on the list and the first 10 substances considered. It will identify those substances FDA proposes for inclusion on, the list and those substances FDA proposes not be placed on the list.