Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Title:
Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434171.pdf
Content:
This guidance is intended for entities considering whether to register with the Food and Drug Administration (FDA or Agency) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).