KAPS Documentation and Record Keeping 2 — Questions and Answers
Question 1: Under USP <1> guidelines, which statement best describes a compounding log entry?
- It must include the lot numbers of all components used (Correct answer)
- It only requires the pharmacist's initials at final verification
- It is optional for non-sterile preparations
- It replaces the need for a master formulation record
Correct answer: It must include the lot numbers of all components used
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:
- Draw a single line through the error, write the correction, and initial/date the change (Correct answer)
- Use correction fluid to cover the error and write over it
- Destroy the page and rewrite the entire log entry
- Leave the error and attach a sticky note with the correct information
Correct answer: Draw a single line through the error, write the correction, and initial/date the change
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?
- 21 CFR Part 1304 (Correct answer)
- 21 CFR Part 211
- USP <797>
- HIPAA Privacy Rule
Correct answer: 21 CFR Part 1304
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:
- Documents the actual execution of a specific production batch (Correct answer)
- Serves as the template for future productions
- Is created before any manufacturing begins
- Is maintained only by quality assurance personnel
Correct answer: Documents the actual execution of a specific production batch
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?
- 2–5 years depending on the state (Correct answer)
- 6 months
- 10 years minimum federally
- Only until the prescription is filled
Correct answer: 2–5 years depending on the state
Most state boards of pharmacy require retention of non-controlled prescription records for 2–5 years, though the exact period varies by state law.
Question 6: In an electronic pharmacy information system, which feature is most critical for ensuring documentation integrity?
- Audit trail that records all user actions with timestamps (Correct answer)
- Ability to delete incorrect entries without a trace
- Shared login credentials for efficiency
- Automatic data overwrite to save storage space
Correct answer: Audit trail that records all user actions with timestamps
An audit trail that timestamps and attributes all changes to specific users is essential for maintaining the integrity and accountability of electronic pharmacy records.
Question 7: A pharmacy receives a partial delivery of a controlled substance. Which documentation action is required at that time?
- Record the quantity received on the DEA Form 222 or CSOS record and note the shortage (Correct answer)
- Wait until the complete order arrives before documenting anything
- Discard the partial order and reorder the full quantity
- Document only when the remaining quantity is delivered
Correct answer: Record the quantity received on the DEA Form 222 or CSOS record and note the shortage
The pharmacist must immediately record the quantity actually received on the DEA Form 222 or its electronic equivalent, noting any discrepancy from the ordered quantity.
KAPS Documentation and Record Keeping 2
Under USP guidelines, which statement best describes a compounding log entry?