USP <797> "Revised" Compounded Sterile Preparations (CSPs)

Question 1

Category 1 and 2 CSPs are distinguished based on:

Answer 1

1) conditions under which they were made 2) the probability for microbial growth 3) the time period within which they must be used

Question 2

Category 1 CSPs are typically prepared in an:

Answer 2

unclassified Segregated Compounding Area (SCA) and have shorter BUDs

Question 3

Category 1 CSPs are typically prepared in a:

Answer 3

“cleanroom suite” and have longer BUDs

Question 4

Several factors are considered when establishing BUDs for category 2 CSPs including:

Answer 4

1) aseptic processing and sterilization methods 2) starting components 3) sterility testing 4) storage conditions