Beyond Use Dating Proposed <797>

Question 1

All sterile ingredients, aseptic technique, SCA environment

Answer 1

12hours RT, 24 hours cold

Question 2

All sterile ingredients, aseptic technique, no sterility test, clean room environment,

Answer 2

4 days RT, 10 days cold, 45 days frozen

Question 3

Aseptically prepared in a cleanroom, 1 or more non sterile starting component, no sterility testing

Answer 3

1 day RT, 4 days cold, 45 days frozen

Question 4

Aseptically prepared in a cleanroom, sterility test performed, does not meet category 3 standards

Answer 4

30 days RT, 45 days cold, 60 days frozen

Question 5

Terminally sterilized product, compounded in a cleanroom, no sterility testing performed

Answer 5

14 days RT, 28 days cold, 45 days frozen

Question 6

Compounded in a cleanroom, terminally sterilized, sterility testing performed

Answer 6

45 days RT, 60 days cold, 90 days frozen

Question 7

Aseptically processed, sterility tested, passed all applicable tests for Category 3

Answer 7

60 days RT, 90 days cold, 120 days frozen

Question 8

Terminally sterilized, sterility tested, passed all applicable testing for Category 3

Answer 8

90 days RT, 120 days cold, 180 days frozen