FDA Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
Titel:
FDA Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
Internet:
Herkunft/Verlag:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434174.pdf
Inhalt:
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).