List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies three bulk drug substances that FDA has considered and is proposing not to include on the list: Bumetanide, nicardipine hydrochloride, and vasopressin. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.