FDA Guidance for Industry: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act
Title:
FDA Guidance for Industry: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496287.pdf
Content:
This guidance describes how FDA intends to apply section 503A of the FD&C Act to drugs compounded by licensed pharmacists or physicians in state-licensed hospital or health system pharmacies for use within the hospital or health system.