BUDs

Question 1

BUD for a product compounded in a SCA if at room temperature

Answer 1

12 hours

Question 2

BUD for a product compounded in a SCA if refrigerated

Answer 2

24 hours

Question 3

BUD of a non-sterile non-preserved aqueous formulation (Aw >/= 0.6)

Answer 3

14 days - store in refrigerator

Question 4

BUD of a non-sterile preserved aqueous formulation (Aw >/= 0.6)

ex. creams, solutions

Answer 4

35 days

Question 5

BUD of a non-sterile nonaqueous oral liquid (Aw < 0.6)

Answer 5

90 days

Question 6

BUD of a non-sterile nonaqueous formulation (other than an oral liquid) with Aw < 0.6

Answer 6

180 days (6 months)

Question 7

Per USP 797 update: BUD of an immediate-use CSP

Answer 7

4 hours (regardless of temp)

Question 8

Per USP 797 update: BUD of a Category 1 CSP (room temp & refrigerated)

Answer 8

Room temp: 12 hours
Refrigerated: 24 hours

Question 9

Per USP 797 update: BUD of a Category 2 CSP (room temp, refrigerated, & frozen)

Answer 9

Room temp: 1-45 days
Refrigerated: 4-60 days
Frozen: 45-90 days

Question 10

Per USP 797 update: BUD of a Category 3 CSP (room temp, refrigerated, & frozen)

Answer 10

Room temp: 60-90 days
Refrigerated: 90-120 days
Frozen: 120-180 days

Question 11

environment for preparation of an immediate-use CSP

Answer 11

Uncontrolled [no primary engineering control (PEC)]

Question 12

environment for preparation of a Category 1 CSP

Answer 12

ISO 5 PEC in a segregated compounding area (SCA)

Question 13

environment for preparation of a Category 2 CSP

Answer 13

ISO 5 PEC in a cleanroom

Question 14

environment for preparation of a Category 3 CSP

Answer 14

ISO 5 PEC in a cleanroom with additional requirements