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licensing and certification

General Acute Care Hospital - Pharmacy Clean Room and Sterile Compounding
New or Remodeled Clean Room Administrative Review

Examples of Documentation the Pharmaceutical Consultant Unit May Request to Review

  • Certificate of Occupancy issued by the Office of Statewide Health Planning and Development
  • California Board of Pharmacy Sterile Compounding License and Inspector’s Report
  • Equipment and environmental certification reports (complete and including viable air/surface), completed under dynamic operating conditions
    • If issues are indicated in the report, documentation on how they were resolved
  • All cleaning logs from the date of certification to present
  • Temperature logs (room and refrigerator/freezer), from date of certification to present
  • Differential pressure monitoring logs from date of certification to present (not applicable for segregated compounding area)
  • All hospital-approved policies and procedures for sterile IV compounding
  • A drawing of the compounding space, including all of the following:
    • The location of the heating, ventilation, and air-conditioning supply and returns
    • Doors
    • Pressure monitoring devices
    • Primary engineering controls (PEC)
    • Pass-through areas
    • Water sources (sinks), refrigerators, cabinets, and countertops 
  • Employee competency reports, including for new equipment and processes
  • High resolution digital images of the completed project, showing all of the following:
    • Ante and buffer areas
    • All doors, ceiling lights, windows, walls, sinks, and refrigerators
    • Pass-through areas
    • Pressure monitoring devices
    • Air supply and returns
    • The PEC room placement
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