Lecture 12 Flashcards
1
Q
USP 795
A
Non-sterile Preparations
2
Q
USP 797
A
Sterile Preparations
3
Q
USP 800
A
Hazardous Substances
4
Q
USP 1191
A
Stability Considerations in Dispensing Practice
5
Q
The expiration date of compounded products is determined by…
A
- the Pharmacist
• Beyond-use date
• Assign conservatively
• Follow recommendations in USP
6
Q
Low vs Medium vs High Risk
A
– Low Risk
• All compounding under Class 100 conditions
• Only sterile
• Prompt/simple procedures
– Medium Risk • No broad spectrum bacteriostatic • Complex aseptic manipulations • Multiple doses in one • Unusually long procedure
– High Risk
• Nonsterile ingredients
• Sterile ingredients exposed to air quality inferior to Class 100
• Terminal sterilization, but no endotoxin testing
7
Q
Maximum Beyond-Use Date
A
Room Temp
- Low: 48 hr
- Medium: 30 hr
- High: 24 hr
Fridge:
- Low: 14 days
- Medium: 9 days
- High: 3 days
Frozen:
- All 45 days or less
