FDA Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities

Titel:
FDA Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities
Herkunft/Verlag:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM534812.pdf

Inhalt:
This guidance sets forth the FDA’s policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered 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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