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FDA Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf
Content:
This guidance sets forth the Food and Drug Administration’s (FDA or Agency) interim regulatory policy concerning compounding using bulk drug substances under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act).
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