BUD Dates Flashcards
CRT
Controlled Room Temperature
20 to 25 Celsius
____ is the hour and date after which a CSP may not be used, stored, or transported.
Beyond Use Date
Refrigerator Temp
2 to 8 Celsius
Freezer Temp
-25 to -10 celsius
When deciding on a beyond-use date for a product should we use stability testing or USP guided BUDs.
Whichever is shorter.
Unlike non-sterile compounding, stability test may not overrule USP EVER.
Category 1 USP compounded in a segregated compounding area (SCA) storage conditions.
- 12 hours at CRT
- 24 hours (refrigerated)
Category 2 CSP is aseptically processed, with no sterility testing, and only sterile starting component. What is the BUD.
- 4 days (CRT)
- 10 days (refrigerator)
- 45 days (freezer)
Category 3 CSP aseptically processed, sterility tested, and passing all applicable tests for category 3s. What is the BUD?
- 60 days (CRT)
- 90 days (refrigerator)
- 120 days (freezer)
Category 3 CSP terminally sterilized, sterility tested, and passing all applicable tests for CSPs. What is the BUD?
- 90 days (CRT)
- 120 days (refrigerator)
- 180 days (freezer)
_____ is a larger solution compounded to provide doses for many patients.
Stock Solutions
____ is the time from when a product or preparation is opened or punctured until the point it can no longer be used.
In use time.
In-Use time for stock solutions
12 hours.
If an infusion is started before the beyond-use date, can it be continued after the beyond-use date?
Yes.
What is the BUD of a single-dose ampule used in any environment?
Discard immediately after use.
What is the BUD of a single-dose container in room air?
Discard immediately after use.
