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The FDA 503A Bulks List is the federal list of certain bulk drug substances that may be used in traditional patient-specific compounding when there is no applicable USP or NF drug-substance monograph and the substance is not a component of an FDA-approved drug

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This narrow focus overlooks emerging regulators [e.g., the recently identified ferroptosis suppressor protein 2 (FSP2) or the lipid kinase PI3K] and fails to account for the kidneys inherent structural and functional heterogeneity