Examples of USP 797 Tasks

CAPS (Central Admixture Pharmacy Services) list these examples of what it will take to comply with USP 797:

Daily

  • Every bottle, vial, syringe, bag, etc. brought into the clean room must be decontaminated.
  • Storeroom carts can't go into the buffer room and vice versa.
  • No cardboard, paper towels, or cotton items in the buffer zone or clean room.
  • Minimize traffic flow into and out of the buffer zone.
  • No gum, candy, or food in the buffer area.
  • Arrange items in hood to avoid blocking air flow.
  • Daily cleaning and sanitizing of all buffer room carts, equipment, hoods, work surfaces, and floors.
  • Daily calibration and verification of accuracy of all automated compounding equipment.
  • Documentation of all compounding activities.
  • No makeup or jewelry.
  • Scrub hands and arms to elbow.
  • Hair covers, shoe covers, knee-length coats or coveralls, and gloves.
  • Sterile or nonsterile gloves. (Nonsterile gloves must be sanitized with sterile filtered alcohol.)
  • Re-sanitize gloves frequently with sterile filtered alcohol.
  • Coveralls can be reused throughout the day, but all other items should not be reused.
  • Verification of compounding activity conducted by someone other than the compounder to ensure proper measurement, reconstitution, and component usage.
  • Visual inspection: no PM, no leakage, accuracy and thoroughness of labeling.
  • For high-risk compounding, sterility and bacterial endotoxin testing, filter integrity testing.
  • Labeling in compliance with storage and expiration dating requirements.

Ongoing

  • Clean and sanitize anteroom weekly and shelving monthly.
  • Clean and sanitize buffer room shelves at least weekly.
  • Routine disinfecting and air quality testing: weekly air bio-burden for high-risk areas, and monthly for low- and medium-risk areas.
  • Review of environmental monitoring and enforcement of alert and action limit contingency programs.
  • Review of calibration data and enforcement of contingency programs.
  • Review of cleaning logs and compounding documentation to ensure compliance, with enforcement of contingency plans for noncompliance.
  • Patient monitoring and adverse event reporting.

Semiannually/Annually

  • High-risk compounding training and documentation for all personnel involved in compounding sterile preparations initially and semiannually — written and didactic review.
  • Semiannual media fills for high-risk compounding.
  • Low- and medium-risk compounding training and documentation for all personnel involved in compounding sterile preparations initially and annually — written and didactic review.
  • Annual media fills for low- and medium-risk compounding for all personnel involved in compounding sterile preparations.
  • Room, hood, and equipment certification.
  • Analysis of Quality Assurance program and effectiveness.