BUD Flashcards
Non preserved aqueous dosage forms
14 days Refrigerated
Preserved aqueous dosage forms
35 days fridge or room temp
Oral nonaqueous liquids
90 days fridge or room temp
Other nonaqueous non-oral dosage forms in USP795
180 days fridge or room temp
Category 1 CSP
Room temp up to 12 hours.
Fridge up to 24 hours.
Category 2
Aseptically processed
No sterility testing
Prepared with at least one non sterile component
Room temp up to 1 day.
Fridge up to 4 days.
Freezer up to 45 days.
Category 2
Aseptically processed
No sterility testing
Prepared with only sterile components
Room temp up to 4 days.
Fridge up to 10 days.
Freezer up to 45 days.
Category 2
Aseptically processed
Passed sterility testing
Room temp up to 30 days.
Fridge up to 45 days.
Freezer up to 60 days.
Category 2
Terminally sterilized
No sterility testing
Room temp up to 14 days.
Fridge up to 28 days.
Freezer up to 45 days.
Category 2
Terminally sterilized
Passed sterility testing
Room temp up to 45 days.
Fridge up to 60 days.
Freezer up to 90 days.
Category 3
Aseptically prepared
Passed sterility testing
Room temp up to 60 days.
Fridge up to 90 days.
Frozen up to 120 days.
Category 3
Terminally sterilized
Passed sterility testing
Room temp up to 90 days.
Fridge up to 120 days.
Frozen up to 180 days.
