Pharmacy Compounding 4 — Questions and Answers
Question 1: A compounder needs to prepare 200 mL of a 2% w/v solution from a 10% w/v stock solution. How many mL of stock solution are needed?
- 10 mL
- 20 mL
- 40 mL (Correct answer)
- 50 mL
Correct answer: 40 mL
Using C1V1 = C2V2: (10%)(V1) = (2%)(200 mL), so V1 = 40 mL.
Question 2: According to USP <797>, Category 1 CSPs (compounded sterile preparations) with no antimicrobial preservative stored at room temperature have a BUD of:
- 12 hours
- 24 hours (Correct answer)
- 48 hours
- 72 hours
Correct answer: 24 hours
USP <797> (2023) assigns a 24-hour BUD at controlled room temperature for Category 1 CSPs without antimicrobial preservatives.
Question 3: Which type of water is required for preparing compounded sterile preparations (CSPs)?
- Tap water
- Distilled water
- Sterile Water for Injection (WFI) (Correct answer)
- Deionized water
Correct answer: Sterile Water for Injection (WFI)
Sterile Water for Injection (WFI) meets USP standards for sterility, pyrogen limits, and ionic purity required for CSPs.
Question 4: When compounding a capsule, what excipient is commonly added as a glidant to improve powder flow?
- Magnesium stearate
- Colloidal silicon dioxide (Cab-O-Sil) (Correct answer)
- Lactose
- Microcrystalline cellulose
Correct answer: Colloidal silicon dioxide (Cab-O-Sil)
Colloidal silicon dioxide functions as a glidant by reducing interparticulate friction and improving powder flow in capsule filling.
Question 5: A pharmacy must conduct media-fill testing when performing sterile compounding. The primary purpose is to:
- Test the potency of the finished product
- Verify the aseptic technique of the compounder (Correct answer)
- Determine the beyond-use date
- Check for endotoxin contamination
Correct answer: Verify the aseptic technique of the compounder
Media-fill testing uses a growth medium in place of the drug to simulate the compounding process and verify that the compounder's aseptic technique does not introduce contamination.
Question 6: Which packaging material is preferred for light-sensitive compounded preparations?
- Clear glass containers
- Amber glass or amber plastic containers (Correct answer)
- White HDPE containers
- Stainless steel containers
Correct answer: Amber glass or amber plastic containers
Amber glass or plastic protects photosensitive preparations by blocking UV and visible light wavelengths that cause degradation.
Question 7: According to USP <800>, which category of hazardous drugs requires full containment controls (C-PEC + C-SEC) even for non-sterile compounding?
- NIOSH Table 2 drugs only
- NIOSH Table 3 antineoplastic drugs
- NIOSH Table 1 antineoplastic drugs (Correct answer)
- All drugs on any NIOSH table
Correct answer: NIOSH Table 1 antineoplastic drugs
NIOSH Table 1 antineoplastic (chemotherapy) agents require the highest level of containment engineering controls under USP <800>.
Pharmacy Compounding 4
A compounder needs to prepare 200 mL of a 2% w/v solution from a 10% w/v stock solution.
How many mL of stock solution are needed?