USP <797> CSPs: Official and Revised BUDs

Question 1

“Official” 2008: low-risk in segregated compounding area (SCA)

Answer 1

stable for 12 hours in controlled room temperature (CRT)

Question 2

“Official” 2008: low-risk

Answer 2

48 hours at CRT, 14 days in a refrigerator, and 45 days in a freezer

Question 3

“Official” 2008: medium-risk

Answer 3

30 hours at CRT, 9 days in a refrigerator, and 45 days in a freezer

Question 4

“Official” 2008: high-risk

Answer 4

24 hours at CRT, 3 days in a refrigerator, and 45 days frozen

Question 5

“Revised” 2019: category 1 (high-risk)

Answer 5

≤ 12 hours at CRT & ≤ 24 hours in a refrigerator

Question 6

“Revised” 2019: category 2 (low-risk); aseptically processed, no sterility, only sterile starting components

Answer 6

4 days at CRT, 10 days in a refrigerator & 45 days in a freezer

Question 7

“Revised” 2019: category 2 (low-risk); aseptically processed, no sterility, ≥ 1 nonsterile starting components

Answer 7

1 day at CRT, 4 days in a refrigerator & 45 days in a freezer