CSPT Labeling and Documentation 4

Question 1

Which regulatory body requires that CSP labels include a statement indicating the preparation is a compounded preparation and not FDA-approved?

Accepted Answer

State Board of Pharmacy

Answer

State Boards of Pharmacy require labeling that identifies a preparation as compounded and not commercially manufactured or FDA-approved.

Question 2

When a CSP is prepared in multiple containers from one compounding record, what must appear on each individual container label?

Accepted Answer

All required label elements including lot number, BUD, and strength

Answer

Each individual container must bear a complete label with all required elements so it can stand alone as a fully identified preparation.

Question 3

A pharmacist accidentally omits the administration route from a CSP label for an IV preparation. What is the most significant patient safety risk?

Accepted Answer

The medication could be administered via the wrong route, causing serious harm

Answer

Omitting the route of administration from an IV label risks wrong-route administration, which can be fatal (e.g., intrathecal vs. IV).

Question 4

According to USP <797>, what information must be documented in the compounding record that is NOT required on the patient label?

Accepted Answer

Identity and quantity of each component used

Answer

The compounding record must document each individual component's identity and quantity, whereas the patient label shows only the final preparation's name and strength.

Question 5

A CSP label reads 'Vancomycin 1 g/250 mL NS.' A nurse asks what concentration this represents in mg/mL. What is the correct answer?

Accepted Answer

4 mg/mL

Answer

1 g = 1,000 mg divided by 250 mL equals 4 mg/mL.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Labeling and Documentation 4