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This rule will establish the statutorily required list of additional bulk drug substances that may be used to compound drug products that qualify for the exemptions in section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (the section 503A exemptions). Currently, the only bulk drug substances that may be used to compound drug products that qualify for the section 503A exemptions are those that are the subject of an applicable United States Pharmacopeia or National Formulary monograph, or a component of an FDA-approved drug. This final rule will also identify the criteria for evaluating additional bulk drug substances that may be used to compound drug products that qualify for the section 503A exemptions and list substances that were considered and are not included. The rule will provide clarity to stakeholders about what bulk drug substances can be used to compound drug products that qualify for the section 503A exemptions by identifying additional bulk drug substances.