PTCE Compounding 2 — Questions and Answers
Question 1: Which beyond-use date (BUD) applies to a non-aqueous compounded preparation stored at room temperature?
- 6 months or the earliest manufacturer expiration date, whichever is sooner (Correct answer)
- 14 days
- 30 days
- 1 year
Correct answer: 6 months or the earliest manufacturer expiration date, whichever is sooner
USP <795> assigns non-aqueous formulations a BUD of 6 months or the earliest component expiration, whichever comes first.
Question 2: What is the primary purpose of a levigating agent in ointment preparation?
- To reduce particle size and improve uniform distribution of the active ingredient (Correct answer)
- To increase viscosity of the base
- To act as a preservative
- To lower the melting point of the ointment
Correct answer: To reduce particle size and improve uniform distribution of the active ingredient
Levigating agents (e.g., mineral oil, glycerin) wet and reduce powder particle size before incorporation into an ointment base.
Question 3: A pharmacy technician is preparing a 2% hydrocortisone cream using a 10% hydrocortisone cream and a plain cream base. What compounding method is being used?
- Geometric dilution (Correct answer)
- Trituration
- Levigation
- Fusion
Correct answer: Geometric dilution
Geometric dilution involves progressively adding and mixing equal amounts of base to a potent ingredient to ensure uniform distribution.
Question 4: Which USP chapter governs sterile compounding quality standards for pharmacy-prepared products?
- USP <797> (Correct answer)
- USP <795>
- USP <800>
- USP <1151>
Correct answer: USP <797>
USP <797> sets the standards for sterile compounding including environmental monitoring, BUDs, and personnel training.
Question 5: When compounding a suppository using the fusion method, which step is critical to prevent sedimentation of the active drug?
- Continuously stirring the mixture until it congeals (Correct answer)
- Heating the base to at least 100°C
- Adding the drug after the base solidifies
- Refrigerating immediately after pouring
Correct answer: Continuously stirring the mixture until it congeals
Continuous stirring until congealing keeps the active ingredient evenly suspended throughout the suppository base.
Question 6: Which type of water is required for sterile compounding preparations?
- Sterile Water for Injection (SWFI) (Correct answer)
- Distilled water
- Purified water
- Tap water filtered through 0.45 micron
Correct answer: Sterile Water for Injection (SWFI)
SWFI meets USP standards for pyrogen limits and sterility required in sterile compounding.
Question 7: A compounded preparation's label must include all of the following EXCEPT:
- The prescriber's DEA number (Correct answer)
- Beyond-use date
- Directions for use
- Name and strength of the active ingredient
Correct answer: The prescriber's DEA number
The DEA number is not a required label element for compounded preparations unless the preparation is a controlled substance prescription.
PTCE Compounding 2
Which beyond-use date (BUD) applies to a non-aqueous compounded preparation stored at room temperature?