PTCE Pharmacy Quality Assurance 2

Question 1

Which regulatory body requires pharmacies to have a written quality assurance program for compounding?

Accepted Answer

USP

Answer

USP sets standards for compounding quality assurance, including requirements for written policies and procedures.

Question 2

A beyond-use date (BUD) for a non-sterile aqueous preparation compounded from commercial drug products and stored at room temperature should not exceed:

Accepted Answer

14 days

Answer

Per USP <795>, non-sterile aqueous preparations compounded from manufactured drug products have a BUD of no more than 14 days when refrigerated or at room temperature.

Question 3

When performing a visual inspection of a compounded sterile preparation (CSP), which finding would require immediate rejection?

Accepted Answer

Particulate matter floating in the solution

Answer

Visible particulate matter in a sterile preparation is a critical quality defect and the preparation must be rejected immediately.

Question 4

What is the purpose of an end-product potency test in pharmacy compounding?

Accepted Answer

To confirm the correct amount of active ingredient is present

Answer

Potency testing verifies that the compounded preparation contains the labeled amount of active pharmaceutical ingredient within acceptable limits.

Question 5

Which temperature range is considered 'refrigerated' storage per USP standards?

Accepted Answer

2°C to 8°C

Answer

USP defines refrigerated storage as a controlled temperature between 2°C and 8°C (36°F to 46°F).

(PTCE) Pharmacy Technician Certification Exam Practice Test

(PTCE) Pharmacy Technician Certification Exam Practice Test

PTCE Pharmacy Quality Assurance 2