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This proposed rule proposes to add additional bulk drug substances to the list of bulk drug substances that may be used to compound drug products that qualify for the exemptions in section 503A of the FD&C Act (the List). Currently, the only bulk drug substances that may be used to compound drugs that qualify for the section 503A exemptions are those that are the subject of an applicable United States Pharmacopeia or National Formulary monograph, a component of an FDA-approved drug, or those that FDA has already placed on the List. This proposed rule will identify approximately 30 additional bulk drug substances nominated by stakeholders for the List and explain whether FDA proposes the substance be included on the List.