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FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act: One key condition: Facility generally cannot compound drugs using bulk drug substances unless that substance appears on the FDA's '503B Bulks List' (substances for which there is a demonstrated clinical need) or the compounded drug is on the FDA's active drug shortage list

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(Treasure Island, FL: StatPearls Publishing)