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Proposed USP 800 Summary

Proposed USP 800 Summary
HD = Hazardous Drugs
CSP = Compounded Sterile Preparation
ACPH = Air Changes per Hour
BUD = Beyond Use Date

– Changes from USP 797

  • Eliminates low volume hazardous in non-negative pressure room
  • Allowance for immediate use hazardous low/ medium risk CSP similar to non-hazardous CSPs

– Facility Design & Engineering Controls

  • A BSC or CACI used for hazardous CSPs should not be used for non-hazardous UNLESS non-hazardous CSP in placed in bag prior to removal and labeled for proper handling
  • BSC or CACI can occasionally be used for non-sterile hazardous prep, but clean & disinfect thoroughly before sterile CSP
  • HDs shall be stored separately in manner to prevent contamination & personnel exposure

– Room to have negative pressure and at least 12 ACPH
– Storage in proper HD Buffer room can meet this storage need
– Refrigerated HD to be in dedicated refrigerator in storage room
– If refrigerator is in cleanroom. Consider an exhaust behind compressor
– HDs should be stored at or below eye level

– Engineering Controls

  • HDs mixed in BSC or CACI in negative pressure (0.01” wc) with 12 ACPH separate from other prep areas
  • All BSC/ CACIs shall be externally vented
  • Sink for hand washing and eye rinsing available, but NOT in ISO 7 buffer area

– Non-Sterile HD Compounding

  • Performed in BSC or Powder Hood

– Unidirectional airflow not required
– Powder hood/ BSC shall be externally vented

  • Powder Hood/ BSC in separate room with

– 12 ACPH and Negative Pressure (0.01” wc)
– Smooth, seamless and impervious surfaces due to difficult cleaning

– Sterile HD Compounding

  • HEPA Filtered Uni-directional airflow in Class II or III BSC or CACI

– Smoke studies conducted every 6 month
– Class II BCS Type A2, B1 or B2 are acceptable

  • Three Sterile HD Configurations

– BSC/ CACI in ISO 7 Cleanroom with 30 ACPH

  • Rooms attached to negative pressure room should be positive with pressure indicators
  • Anteroom attached to HD room. ISO 7, 30ACPH and Positive 0.02” wc
  • Ante divided into “Clean” side and “Dirty” side. Sink on “Clean” side
  • Not recommended to connect HD Buffer room to non-HD Buffer, but
  • Area for garbing/ degarbing in HD Buffer Room
  • Method to move waste and HD CSPs from room and minimize contamination – Ex. Pass Thrus, Sealed Containers

– CACI that meets 797 requirements in negative pressure 12 ACPH room
– BSC in negative pressure 12 ACPH room with Max BUD of 12 hrs.
– Engineering Control Operation

  • BSC/ CACI should operate continuously
  • If shut down, power on, clean then wait time as per manufacturer before using

– Personal Protective Equipment

  • Shall be worn when:

– Receiving intact supplies
– Receiving suspected/ broken supplies
– Transporting intact supplies or compounded HDs
– Stocking/ inventory control in compounding area
– Non-sterile compounding
– Sterile compounding
– Administering
– Routine cleaning
– Collecting/ disposing patient waste
– Managing spills
– Gloves

  • Labeled as ASTM Tested
  • Two pairs when compounding, administering, managing spills or disposing of HDs
  • When preparing. Outer glove to be Sterile
  • CACI shall have Sterile Glove over CACI Glove
  • Change glove every 30 minutes
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