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The FDA 503A Bulks List is the list established in federal regulation for certain bulk drug substances that may be used to compound patient-specific medications under section 503A when the substance does not have an applicable United States Pharmacopeia or National Formulary drug-substance monograph and is not a component of an FDA-approved drug

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Given the diversity in body composition, diet, and health behaviors across populations, the authors emphasize the importance of assessing how these medications perform in different global contexts

[PMID: 9164325] PubMed record related to this compound for laboratory literature review