KAPS Documentation and Record Keeping 3

Question 1

Which element is required on a compounded sterile preparation (CSP) label under USP <797>?

Accepted Answer

Beyond-use date and time

Answer

USP <797> mandates that CSP labels include the beyond-use date (BUD) and time to ensure preparations are not used after their established stability limit.

Question 2

A technician makes a math error on a compounding worksheet and corrects it before the pharmacist verifies. What is the proper documentation step?

Accepted Answer

Cross out the error with a single line, write the correct value, and initial and date the correction

Answer

Any correction to pharmaceutical documents must preserve the original entry and show who corrected it and when, consistent with GMP data integrity principles.

Question 3

According to DEA regulations, which form must be used to document the return of Schedule II substances to a reverse distributor?

Accepted Answer

DEA Form 222 (or CSOS equivalent)

Answer

Transfers of Schedule II controlled substances, including returns to a reverse distributor, require completion of DEA Form 222 or its CSOS electronic equivalent.

Question 4

The term 'data integrity' in pharmaceutical documentation refers to:

Accepted Answer

Ensuring records are complete, consistent, accurate, and attributable throughout the data lifecycle

Answer

Data integrity encompasses the ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, and Enduring.

Question 5

An investigational drug study requires pharmacy records to document each dose dispensed. Which document best serves this purpose?

Accepted Answer

Investigational Drug Dispensing Log

Answer

An investigational drug dispensing log tracks patient ID, dose, date/time, lot number, and dispensing personnel to meet FDA investigational drug accountability requirements.

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

KAPS Documentation and Record Keeping 3