Ch 7 - USP <797>: Pharmaceutical
Compound-Sterile Preparations
2025/2026 Exam Questions and
Corresponding Answers with Surety of
100% Pass Mark
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
Media Fill Test - 🧠ANSWER ✔✔A process stimulating compounding
processes or products to ensure that microbial growth is not present
Preservative - 🧠ANSWER ✔✔A substance used to prevent microbial
growth
Chapters 1 through 999 are considered requirements and are enforceable
by the: - 🧠ANSWER ✔✔FDA
Segregated Unclassified Compounding Area (SCA) - 🧠ANSWER ✔✔A
designed space (area or room) that contains a primary engineering control
(PEC) where Category 1 compounds can be prepared
Compound-Sterile Preparations
2025/2026 Exam Questions and
Corresponding Answers with Surety of
100% Pass Mark
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
Media Fill Test - 🧠ANSWER ✔✔A process stimulating compounding
processes or products to ensure that microbial growth is not present
Preservative - 🧠ANSWER ✔✔A substance used to prevent microbial
growth
Chapters 1 through 999 are considered requirements and are enforceable
by the: - 🧠ANSWER ✔✔FDA
Segregated Unclassified Compounding Area (SCA) - 🧠ANSWER ✔✔A
designed space (area or room) that contains a primary engineering control
(PEC) where Category 1 compounds can be prepared
