Ch 7 - USP <797>: Pharmaceutical
Compound-Sterile Preparations UPDATED
ACTUAL Exam Questions and CORRECT
Answers
Batch - CORRECT ANSWER - More than one unit of a product compounded in a single
process
Beyond-Use Date (BUD) - CORRECT ANSWER - The date and time at which a
compounded sterile preparation (CSP) must be discarded and cannot be used any longer
Category 1 CSP - CORRECT ANSWER - A CSP assigned a BUD of 12 hours or less at
controlled room temperature or 24 hours or less when refrigerated.
Category 2 CSP - CORRECT ANSWER - A CSP assigned in a BUD of greater than 12
hours room temperature or greater than 24 hours when refrigerated.
Certificate of Analysis (COA) - CORRECT ANSWER - A report provided by the
manufacturer or supplier to indicate specifications and results of testing for the item
Disinfectant - CORRECT ANSWER - Chemical agent used to destroy bacteria, fungi, and
viruses
Pyrogen-Free - CORRECT ANSWER - A substance that lacks fever-inducing toxins
Media Fill Test - CORRECT ANSWER - A process stimulating compounding processes
or products to ensure that microbial growth is not present
Preservative - CORRECT ANSWER - A substance used to prevent microbial growth
Compound-Sterile Preparations UPDATED
ACTUAL Exam Questions and CORRECT
Answers
Batch - CORRECT ANSWER - More than one unit of a product compounded in a single
process
Beyond-Use Date (BUD) - CORRECT ANSWER - The date and time at which a
compounded sterile preparation (CSP) must be discarded and cannot be used any longer
Category 1 CSP - CORRECT ANSWER - A CSP assigned a BUD of 12 hours or less at
controlled room temperature or 24 hours or less when refrigerated.
Category 2 CSP - CORRECT ANSWER - A CSP assigned in a BUD of greater than 12
hours room temperature or greater than 24 hours when refrigerated.
Certificate of Analysis (COA) - CORRECT ANSWER - A report provided by the
manufacturer or supplier to indicate specifications and results of testing for the item
Disinfectant - CORRECT ANSWER - Chemical agent used to destroy bacteria, fungi, and
viruses
Pyrogen-Free - CORRECT ANSWER - A substance that lacks fever-inducing toxins
Media Fill Test - CORRECT ANSWER - A process stimulating compounding processes
or products to ensure that microbial growth is not present
Preservative - CORRECT ANSWER - A substance used to prevent microbial growth
