Ch 7 - USP <797>: Pharmaceutical
Compound-Sterile Preparations Exam
2025 Questions and Answers
Batch - ANSWER✔✔-More than one unit of a product compounded in a single process
Beyond-Use Date (BUD) - ANSWER✔✔-The date and time at which a compounded
sterile preparation (CSP) must be discarded and cannot be used any longer
Category 1 CSP - 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 - 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) - ANSWER✔✔-A report provided by the manufacturer or
supplier to indicate specifications and results of testing for the item
Disinfectant - ANSWER✔✔-Chemical agent used to destroy bacteria, fungi, and viruses
Pyrogen-Free - ANSWER✔✔-A substance that lacks fever-inducing toxins
COPYRIGHT © 2025 ALL RIGHTS RESERVED
Compound-Sterile Preparations Exam
2025 Questions and Answers
Batch - ANSWER✔✔-More than one unit of a product compounded in a single process
Beyond-Use Date (BUD) - ANSWER✔✔-The date and time at which a compounded
sterile preparation (CSP) must be discarded and cannot be used any longer
Category 1 CSP - 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 - 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) - ANSWER✔✔-A report provided by the manufacturer or
supplier to indicate specifications and results of testing for the item
Disinfectant - ANSWER✔✔-Chemical agent used to destroy bacteria, fungi, and viruses
Pyrogen-Free - ANSWER✔✔-A substance that lacks fever-inducing toxins
COPYRIGHT © 2025 ALL RIGHTS RESERVED
