KAPS Documentation and Record Keeping 2

Question 1

Under USP <1> guidelines, which statement best describes a compounding log entry?

Accepted Answer

It must include the lot numbers of all components used

Answer

Compounding log entries must capture lot numbers of all components to enable traceability in the event of a recall or patient safety issue.

Question 2

A pharmacist discovers an entry in the dispensing log was made with the wrong patient name. The correct action is to:

Accepted Answer

Draw a single line through the error, write the correction, and initial/date the change

Answer

GMP documentation practice requires errors to be corrected with a single line, keeping the original readable, followed by the correct entry with initials and date.

Question 3

Which federal regulation specifically governs the record-keeping requirements for Schedule II controlled substances in a retail pharmacy?

Accepted Answer

21 CFR Part 1304

Answer

21 CFR Part 1304 (DEA regulations) establishes the record-keeping and inventory requirements for controlled substances including Schedule II drugs.

Question 4

A batch manufacturing record (BMR) differs from a master production record (MPR) in that the BMR:

Accepted Answer

Documents the actual execution of a specific production batch

Answer

The BMR is a batch-specific document capturing actual data (weights, times, operator signatures) from one production run, while the MPR is the approved master template.

Question 5

How long must a pharmacy retain dispensing records for non-controlled prescription medications under most state board of pharmacy regulations?

Accepted Answer

2–5 years depending on the state

Answer

Most state boards of pharmacy require retention of non-controlled prescription records for 2–5 years, though the exact period varies by state law.

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

KAPS Documentation and Record Keeping 2