USP 797 Guidelines.pdf

Personnel performing compounding procedures must follow hygiene and garbing requirements, including hand washing, sterile gloves, low-lint garments, face masks, and hair covers. Hand hygiene involves removing debris, washing with soap and water, drying with low-lint towels, and applying an alcohol-based hand rub. Compounding records must include component information, preparation date and time, internal identification number, and quality control results. Personnel must complete training, demonstrate knowledge and skills, and pass competency evaluations, including gloved fingertip and thumb sampling and media fill testing, every 12 months. Sampling procedures involve using microbial growth agar and incubating for 48 hours at 30°-35° and 5 additional days at 20°-25°. Media-fill testing simulates compounding activities, manipulates sterile or nonsterile components, and incubates for 14 days to detect microorganisms.