PTCE Pharmacy Quality Assurance 2 — Questions and Answers
Question 1: Which regulatory body requires pharmacies to have a written quality assurance program for compounding?
- DEA
- USP (Correct answer)
- FDA
- The Joint Commission
Correct answer: USP
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:
- 6 months
- 14 days (Correct answer)
- 30 days
- 90 days
Correct answer: 14 days
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?
- Slightly amber color in a naturally colored solution
- Particulate matter floating in the solution (Correct answer)
- A fill volume 1 mL below the expected 250 mL
- A label printed in a slightly smaller font
Correct answer: Particulate matter floating in the solution
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?
- To verify the product's color and odor
- To confirm the correct amount of active ingredient is present (Correct answer)
- To measure the viscosity of the preparation
- To check sterility of the final container
Correct answer: To confirm the correct amount of active ingredient is present
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?
- 0°C to 4°C
- 2°C to 8°C (Correct answer)
- 8°C to 15°C
- -25°C to -10°C
Correct answer: 2°C to 8°C
USP defines refrigerated storage as a controlled temperature between 2°C and 8°C (36°F to 46°F).
Question 6: A pharmacy quality assurance program should include which of the following components?
- Staff scheduling and payroll records
- Medication error tracking and analysis (Correct answer)
- Customer satisfaction surveys only
- Inventory purchase orders
Correct answer: Medication error tracking and analysis
Medication error tracking and analysis is a core component of a pharmacy QA program to identify patterns and implement corrective actions.
Question 7: What does a Certificate of Analysis (COA) from a raw material supplier confirm?
- The supplier's DEA registration status
- That the material meets specified quality standards (Correct answer)
- The market price of the active ingredient
- The supplier's shipping capabilities
Correct answer: That the material meets specified quality standards
A COA documents that the raw material has been tested and meets identity, purity, potency, and quality specifications.
PTCE Pharmacy Quality Assurance 2
Which regulatory body requires pharmacies to have a written quality assurance program for compounding?