CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 2

Question 1

Which of the following is a required element on the label of a compounded sterile preparation?

Accepted Answer

The beyond-use date and time

Answer

The beyond-use date and time must appear on every CSP label.

Question 2

What is the purpose of a Master Formulation Record (MFR) in sterile compounding?

Accepted Answer

To provide a standardized formula and procedure for preparing a specific CSP

Answer

The MFR contains the complete approved formula, equipment, procedure, and quality checks for a specific CSP.

Question 3

What is documented in a Compounding Record (CR)?

Accepted Answer

The specific details of each individual batch prepared

Answer

The CR documents every detail of an individual compounding event: who prepared it, what ingredients and lots were used, quality checks performed, and final product details.

Question 4

How long must compounding records be retained according to USP 797?

Accepted Answer

As dictated by state regulations and organizational policy

Answer

USP 797 requires records be maintained but defers to state pharmacy regulations for specific retention periods.

Question 5

What information must be documented when a CSP fails a quality check?

Accepted Answer

The nature of the failure, corrective actions taken, and disposition of the failed product

Answer

When a CSP fails a quality check, the event must be fully documented including what failed, corrective actions, and product disposition.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 2