CSPT - Compounded Sterile Preparation Technician Hazardous Drug Compounding Questions and Answers 2 — Questions and Answers
Question 1: According to USP 800, which type of primary engineering control is required for compounding sterile hazardous drugs?
- Horizontal LAFW
- Class II BSC or CACI with external exhaust (Correct answer)
- Any PEC with a HEPA filter
- Standard compounding aseptic isolator
Correct answer: Class II BSC or CACI with external exhaust
USP 800 requires sterile hazardous drugs to be compounded in a Class II BSC or CACI that provides both sterility and containment.
USP 800 mandates specific engineering controls for hazardous drug compounding. A horizontal LAFW is explicitly prohibited because it blows potentially hazardous aerosols toward the operator. The PEC must be placed in a negative-pressure room with at least 12 ACPH.
Question 2: What type of PPE is specifically required when handling hazardous drugs that is NOT required for standard sterile compounding?
- Hair cover
- Chemotherapy-tested gloves (Correct answer)
- Shoe covers
- Face mask
Correct answer: Chemotherapy-tested gloves
Hazardous drug handling requires chemotherapy-tested gloves evaluated for permeation by specific hazardous drugs per ASTM D6978 standards.
USP 800 requires gloves specifically tested for resistance to chemotherapy drug permeation per ASTM D6978. Double gloving is required for HD compounding. The outer glove should be changed every 30 minutes or immediately if compromised.
Question 3: What is the required pressure relationship for the room containing a BSC used for hazardous drug compounding?
- Positive pressure relative to adjacent areas
- Negative pressure relative to adjacent areas (Correct answer)
- Equal pressure to adjacent areas
- Pressure does not matter if BSC has external exhaust
Correct answer: Negative pressure relative to adjacent areas
The HD compounding room must be maintained at negative pressure to prevent hazardous drug vapors from migrating outward.
USP 800 requires the HD compounding room to maintain negative pressure of at least -0.01 inches of water column relative to all adjacent areas. This is the opposite of standard non-hazardous sterile compounding.
Question 4: How should hazardous drug spills be handled in the compounding area?
- Wipe up with paper towels and 70% IPA
- Use a designated spill kit with appropriate PPE and containment materials (Correct answer)
- Evacuate and call the fire department
- Dilute with sterile water before wiping
Correct answer: Use a designated spill kit with appropriate PPE and containment materials
Hazardous drug spills must be managed using a dedicated spill kit that includes appropriate PPE, absorbent materials, and containment supplies.
Every area where hazardous drugs are handled must have an accessible HD spill kit. The procedure involves donning appropriate PPE, containing the spill, absorbing the liquid, cleaning the area, and disposing of contaminated materials in hazardous waste containers.
Question 5: What is the NIOSH List and why is it important for sterile compounding technicians?
- A list of approved HEPA filter manufacturers
- A list of drugs identified as hazardous requiring special handling precautions (Correct answer)
- A list of certified compounding pharmacies
- A list of approved cleaning agents for cleanrooms
Correct answer: A list of drugs identified as hazardous requiring special handling precautions
The NIOSH List identifies drugs that require special handling and engineering controls described in USP 800.
A drug is considered hazardous if it exhibits carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structural similarity to drugs meeting these criteria. The list is organized into three groups.
Question 6: What is the maximum beyond-use date for a Category 1 CSP compounded from sterile hazardous drug components under USP 797?
- 12 hours at controlled room temperature
- 24 hours at controlled room temperature
- 48 hours at controlled room temperature
- The same BUD as non-hazardous Category 1 CSPs (Correct answer)
Correct answer: The same BUD as non-hazardous Category 1 CSPs
Hazardous drug status alone does not change the BUD assignment under USP 797. BUDs are determined by compounding category and storage conditions.
Under revised USP 797, beyond-use dates are determined by the CSP compounding category and storage conditions, not by whether the drug is hazardous. What USP 800 changes for hazardous drugs is the engineering controls, PPE, and handling procedures.
CSPT - Compounded Sterile Preparation Technician Hazardous Drug Compounding Questions and Answers 2
According to USP 800, which type of primary engineering control is required for compounding sterile hazardous drugs?