1.Patient harmed by compounded sterile preparations - ANSWER microbial contamination, excessive
bacterial endotoxins, variability in strength of ingredients, chemical/physical contaminants,
inappropriate quality of ingredients
2. non sterile compounding examples - ANSWER products used orally, topically on skin or to fill gaps
when not commercially available
3. aesptic - ANSWER state of being free from microbial contamination
4. sterile compounded items - ANSWER injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal
inhalations, baths for live organs, tissue implants, irrigation for wounds or cavities
5.Risk Level Classification - ANSWER Low Risk, Medium Risk, High Risk, Immediate Use Risk
6. Low Risk Examples - ANSWER -compounding piggybacks or hydration fluids in a ISO 5 laminar flow
hood (LVP with KCl and or vitamins)
-Dual Chamber parenteral nutrition container with no more than 2 additives
7. Medium-risk examples - ANSWER -TPN using manual or automated devices
-filling device reservoirs with more than 3 sterile drug products and evacuation of air before dispensing
-transfer of volumes from multiple ampules or vials into one or more final sterile containers
8. High risk examples - ANSWER bulk drug containers, sterilization requirements, non-sterile components
- non-sterile to sterile
9. Immediate Risk Examples - ANSWER emergent use preparations -made at bedside or OR
10. Low Risk Beyond Use Dating - ANSWER Room Temp - 48 hours
, Refrigerated - 14 days
Frozen - 45 days
Segregated-less than 12 hours
11.Medium Risk Beyond Use Dating - ANSWER Room Temp- 30 hours
Refrigerated - 9 days
Frozen - 45 days
12. High Risk Beyond Use Dating - ANSWER Room Temp - 24 hours
Refrigerated - 3 days
Frozen - 45 days
13. Immediate Use Beyond Use Dating - ANSWER Room Temp - 1 hour
14. CSP Sterilization - ANSWER 0.22 micron filter
15. Multi Use Vials BUD - ANSWER 28 Days
16. Ampule BUD - ANSWER none
17. Single Use Vial BUD - ANSWER manuf recommenced (4 to 8 hours) or 12 hours after entering
18. High Risk CSP Testing quantity - ANSWER more than 25 identical CSP
19. Non hazardous hoods - ANSWER Laminar airflow workbench (LAFW) compounding containment
isolator (CAI)
20. Hazardous hoods - ANSWER biological safety cabinet (BSC) compounding aseptic containment
isolator (CACI)