Recordkeeping - Radiopharmaceutical Compounding and Repackaging GFI, Biological Products GFI

Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

Documents and Forms

Document Name Document Type
Compounding-and-Repackaging-of-Radiopharmaceuticals-by-State-Licensed-Nuclear-Pharmacies (2024).pdf Other-Agency Guidance
Mixing--Diluting--or-Repackaging-Biological-Products-Outside-the-Scope-of-an-Approved-Biologics-License-Application (2024).pdf Other-Agency Guidance

Information Collection (IC) Details