BUDs Only Flashcards
Nonpreserved aqueous dosage forms?
14 days refrigerated
Preserved aqueous dosage forms?
35 days refrigerated or room temp
Oral nonaqueous solutions?
90 days refrigerated or room temperature
Non-oral nonaqueous dosage forms?
180 days refrigerated or room temp
Nonsterile/USP 795 competency conducted every ___ months?
12 months
Category 1 or 2 garbing should be tested every ___. Air quality should be tested every ___ and surfaces should be tested every ___.
Category 1 + 2:
Garbing = every 6 months
Air quality = every 6 months
Surface testing = every month
Category 3 garbing should be tested every ___. Air quality should be tested every ___ and surfaces should be tested every ___.
Category 3:
Garbing = every 3 months
Air quality = every month
Surfaces = every week
Designated persons AND compounding overseers should have garbing/media fill tested every ____.
Every 12 months
Category 1 CSP at room temperature?
≤ 12 hrs
Category 1 CSP refrigerated?
≤ 24 hrs
Aseptically processed, no sterility testing with non-sterile ingredients? (Room temp, Fridge, Freezer)
Room temp = 1 day
Fridge = 4 days
Freezer = 45 days
Aseptically processed, no sterility testing with only sterile ingredients? (Room temp, Fridge, Freezer)
Room temp = 4 days
Fridge = 10 days
Freezer = 45 days
Aseptically processed, with sterility testing with only sterile ingredients? (Room temp, Fridge, Freezer)
Room temp = 30 days
Fridge = 45 days
Freezer = 60 days
Terminally sterilized Category 2, no sterility testing? (Room temp, Fridge, Freezer)
Room temp = 14 days
Fridge = 28 days
Freezer = 45 days
Terminally sterilized Category 2, with sterility testing? (Room temp, Fridge, Freezer)
Room temp = 45 days
Fridge = 60 days
Freezer = 90 days
