Compounding Flashcards
7 cards from real CPHT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Compounding flashcards as text
Under USP , which category of compounded sterile preparations (CSPs) has a permitted BUD of up to 45 days?
Answer: Category 2 CSPs stored at controlled cold temperature
Category 2 CSPs stored at controlled cold temperature (2–8 °C) may have a BUD of up to 45 days per USP (2023 revision).
Which ISO classification is required for the direct compounding area (DCA) when preparing sterile CSPs under a laminar airflow workbench (LAFW)?
Answer: ISO Class 5
The direct compounding area inside a LAFW must maintain ISO Class 5 (≤100 particles ≥0.5 µm per cubic foot).
A technician adds 10 mL of a 50% dextrose solution to 90 mL of sterile water for injection. What is the final dextrose concentration?
Answer: 5%
Dextrose mass = 10 mL × 0.50 = 5 g; final volume = 100 mL; concentration = 5 g/100 mL = 5%.
When compounding a sterile preparation, which action BEST prevents touch contamination?
Answer: Keeping gloved hands downstream of critical sites
Keeping hands downstream (between the HEPA filter and the critical site) ensures unidirectional airflow sweeps over the critical site without contamination from hands.
What is the purpose of a media-fill test in a sterile compounding pharmacy?
Answer: To qualify personnel aseptic technique using a microbial growth medium in place of the drug
Media-fill tests simulate the compounding process using trypticase soy broth to assess whether a compounder's technique introduces microbial contamination.
Amphotericin B for injection must NOT be reconstituted with normal saline because:
Answer: Electrolytes cause the colloidal dispersion to precipitate
Amphotericin B forms a colloidal dispersion that precipitates in the presence of electrolytes like sodium chloride.
Which statement about closed-system transfer devices (CSTDs) is correct?
Answer: CSTDs are primarily used to prevent environmental release of hazardous drugs
CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug vapors or aerosols outside the system.