Pharmacy USP SOPs (USP 795, 797, 800)
US Pharmacopeia (USP) SOPs
USP Chapter 795 and Chapter 797 are standards for compounding pharmacies that prepare nonsterile and sterile preparations, respectively. USP 797 has more stringent requirements for environmental controls, engineering controls, and personnel training and testing than USP 795. USP 797 also incorporates the provisions of USP 800, which is a standard for protecting employees from exposure to hazardous drugs.
Resources:
Differences between USP 795, 797, and 800 Cleanrooms
USP 795
Cleaning and Sanitizing USP 795
Equipment and Components USP 795
Master Formulations and Compounding Records USP 795
Packaging and Transport USP 795
Personal Hygiene and Garbing USP 795
USP 797
Cleaning, Disinfecting, Deactivation, and Sporicidal Application USP 797 & 800
Equipment / Components USP 797
Master Formulation / Compounding Record USP 797
Packaging and Transport USP 795
Personal Hygiene and Garbing USP 797
USP 800
Cleaning, Disinfecting, Deactivation, and Sporicidal Application USP 797 & 800
Equipment and Components USP 800
Packaging and Transport USP 800