FDA Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities
Title:
FDA Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM534812.pdf
Content:
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)