The United States Pharmacopeia (USP) is a non-profit organization that develops standards for human and animal drugs as well as food ingredients and dietary supplements.
For pharmaceutical compounding facilities, USP has guidelines in four general chapters:
- USP <795> Pharmaceutical Compounding – Nonsterile Preparations
- USP <797> Pharmaceutical Compounding – Sterile Preparations
- USP <800> Hazardous Drugs – Handling in Healthcare Settings
- USP <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging
These four chapters provide guidelines for safety considerations, personnel qualification and training, facilities and engineering controls, microbiology and surface monitoring, cleaning and disinfection, and much more. Continue reading “USP Guidelines for Compounding Facilities”