CPhT Compounding 2 — Questions and Answers
Question 1: Which beyond-use date (BUD) applies to an unpreserved aqueous oral solution compounded in a non-sterile environment under USP <795>?
- 14 days refrigerated (Correct answer)
- 30 days refrigerated
- 6 months at room temperature
- 90 days at room temperature
Correct answer: 14 days refrigerated
USP <795> assigns unpreserved aqueous oral solutions a BUD of 14 days when stored under refrigeration.
Question 2: When compounding a suppository base, cocoa butter is classified as what type of base?
- Fatty (oleaginous) base (Correct answer)
- Water-soluble base
- Emulsifying base
- Hydrophilic base
Correct answer: Fatty (oleaginous) base
Cocoa butter is a classic fatty (oleaginous) suppository base that melts at body temperature.
Question 3: A pharmacy technician is preparing a 2% salicylic acid ointment using fusion. Which step is MOST critical to product uniformity?
- Cooling the base before adding salicylic acid
- Adding the drug to the fully melted base with constant stirring during cooling (Correct answer)
- Heating the drug and base separately, then combining
- Filtering the final product through gauze
Correct answer: Adding the drug to the fully melted base with constant stirring during cooling
Constant stirring while the mixture cools prevents drug particle settling and ensures uniform distribution.
Question 4: Which piece of equipment is used to measure small volumes of liquid (0.1–1 mL) most accurately during non-sterile compounding?
- Conical graduate
- Cylindrical graduate
- Syringe (Correct answer)
- Beaker
Correct answer: Syringe
Syringes are more accurate than graduates for volumes under 1 mL due to their narrow bore and precise graduations.
Question 5: In the context of compounding, what does 'levigation' mean?
- Dissolving a drug in a solvent under heat
- Reducing particle size by triturating with a small amount of liquid (Correct answer)
- Measuring a drug by displacement
- Filtering a suspension to remove large particles
Correct answer: Reducing particle size by triturating with a small amount of liquid
Levigation reduces particle size by triturating the powder with a levigating agent (e.g., glycerin) to form a smooth paste.
Question 6: What is the primary reason a pharmacy must perform a risk assessment before compounding a preparation that is commercially available?
- To determine the correct BUD
- To justify that the compounded preparation meets a specific patient need not met by the commercial product (Correct answer)
- To establish the compounding fee
- To choose between USP <795> and USP <797>
Correct answer: To justify that the compounded preparation meets a specific patient need not met by the commercial product
Federal and state regulations require documented justification showing a patient-specific need that the commercial product cannot fulfill.
Question 7: A pharmacist asks a technician to prepare a 1:20 w/v solution of potassium permanganate. How many grams of potassium permanganate are needed to make 500 mL?
- 10 g
- 25 g (Correct answer)
- 50 g
- 100 g
Correct answer: 25 g
1:20 w/v means 1 g per 20 mL; for 500 mL: 500 ÷ 20 = 25 g.
CPhT Compounding 2
Which beyond-use date (BUD) applies to an unpreserved aqueous oral solution compounded in a non-sterile environment under USP ?