FDA Guidance for Industry: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Title:
FDA Guidance for Industry: Prescription Requirement Under
Section 503A of the Federal Food, Drug, and Cosmetic Act
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496286.pdf
Content:
This guidance sets forth the Food and Drug Administration’s (FDA or Agency) policy concerning certain prescription requirements for compounding human drug products for
identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act(FD&C Act or Act).