USP 797 Flashcards
What is covered in USP 797
Definitions
Responsibility of Compounding Personnel
CSP Microbial Contamination Risk Levels
Personnel Training and Evaluation in Aseptic Manipulation Skills
Immediate-Use CSPs
Hazardous Drugs as CSPs
Suggested Standard Operating Procedures
Storage and Beyond-Use Dating
Patient or Caregiver Training
797 Enforcement
Done by CDC because it can cause infections
Costs of compliance
Inexpensive cost to train personnel on aseptic technique, hand cleansing, and garbing.
Pharmacy responsibility in compounding
Determining the risk level of each compounds sterile preparation
Immediate release BUD
1 hour, room T and refrigerated
Low risk BUD
48 hours room T and 14 days refrigerated
Low risk with 12 hour BUD
12 hours
Medium risk BUD
30 hours room T, 9 days refrigerated
High-risk BUD
24 hours room T, 3 days
Direct compounding area
Surface in hood
Primary engineering control
Hoom
Cleanest to dirtiest areas in pharmacy
Surface in hood
Hood
Buffer and Ante area
General pharmacy
ISO class 5
Where the hood is
ISO 7
Buffer area or cleanroom
ISO 8
Ante area
