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FDA Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities



This guidance sets forth the Food and Drug Administration’s (“FDA” or “the Agency”) policy regarding repackaging by state-licensed pharmacies, Federal facilities, and facilities that register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).

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