Mixed Deck — All CSPT Topics Flashcards

How should corrective and preventive actions (CAPA) be implemented?

Answer: Identify root cause, implement corrective action, develop preventive measures, document everything, verify effectiveness

CAPA requires systematic root cause analysis, immediate correction, preventive measures, documentation, and follow-up verification.

A technician notices that a vial of vancomycin powder for injection has turned slightly yellow. What is the appropriate action?

Answer: Quarantine the vial and report to the pharmacist

Any visual change in an API or drug product is grounds for quarantine and pharmacist evaluation, as discoloration may indicate degradation.

What does a 'beyond-use date' (BUD) on a compounded sterile preparation represent?

Answer: The date and time after which the preparation should not be used, based on sterility and stability data

BUD is assigned based on sterility risk category, storage conditions, and available stability data, and represents the limit of safe use specific to the compounded product.

Which personal behavior is MOST likely to compromise aseptic technique during sterile compounding?

Answer: Adjusting PPE inside the cleanroom by touching the face or hair

Touching the face or hair while gloved inside the cleanroom contaminates the gloves and can transfer microorganisms to critical sites.

Which storage condition is required for most reconstituted protein-based injectable medications?

Answer: Refrigerated (2–8°C)

Most reconstituted protein-based injectables require refrigeration at 2–8°C to prevent protein degradation and maintain potency.

A vial of methotrexate is dropped and broken in the sterile compounding area. In addition to cleaning up the spill using a hazardous drug spill kit, what must occur regarding the waste generated from the cleanup?

Answer: All spill cleanup materials (absorbent pads, PPE, broken glass) must be placed in a sealed, labeled hazardous drug waste container and disposed of as chemotherapy waste

All materials used to clean up a hazardous drug spill — including absorbent pads, PPE (gown, gloves, mask), and any broken container pieces — are contaminated with hazardous drug and must be treated as hazardous waste. They must be sealed in a properly labeled chemotherapy waste container. Regular biohazard or trash disposal is a regulatory violation.

Which of the following hazardous drugs is classified as a DEA Schedule II controlled substance AND requires compliance with both DEA disposal regulations AND hazardous drug handling guidelines?

Answer: Morphine for injection (compounded)

Morphine is a DEA Schedule II controlled substance. When compounded as a sterile preparation, it must comply with DEA regulations for controlled substance disposal (e.g., witnessed waste, destruction logs) AND any applicable hazardous drug handling protocols if classified as hazardous. Methotrexate and cyclophosphamide are hazardous drugs but are not controlled substances.

What USP chapter applies to endotoxin (pyrogen) testing of large-volume parenteral preparations like TPN?

Answer:

USP Bacterial Endotoxins Test is used to detect pyrogens in large-volume parenterals including TPN formulations.

How frequently must viable environmental monitoring (both air and surface) be performed in ISO Class 5 and ISO Class 7 areas of a Category 2 CSP compounding operation per USP ?

Answer: Monthly

USP requires that viable environmental monitoring of ISO Class 5 and ISO Class 7 areas in Category 2 operations be conducted at least monthly under dynamic (in-use) conditions.

Which surface material is most appropriate for cleanroom walls and ceilings?

Answer: Smooth, non-porous, and resistant to sanitizing agents

Cleanroom surfaces must be smooth, non-porous, non-shedding, and resistant to damage from cleaning agents.

Which of the following BEST describes 'terminal sterilization' as opposed to 'aseptic processing'?

Answer: Sterilizing the final sealed container after filling to achieve a defined sterility assurance level

Terminal sterilization involves sterilizing the product after it has been filled and sealed in its final container (e.g., autoclaving a sealed vial). This is contrasted with aseptic processing, where sterile components are combined under aseptic conditions but the final container is never subjected to a sterilization step.

A dopamine drip is ordered at 5 mcg/kg/min for a 70 kg patient. The bag contains 400 mg in 250 mL. What is the infusion rate in mL/hr?

Answer: 13.1 mL/hr

5 mcg/kg/min × 70 kg = 350 mcg/min; 400 mg/250 mL = 1.6 mg/mL = 1600 mcg/mL; 350 mcg/min ÷ 1600 mcg/mL × 60 = 13.1 mL/hr.

An IV bag labeled '2 mg/mL' morphine must deliver 0.05 mg/kg/hr to a 60 kg patient. What rate in mL/hr is required?

Answer: 1.5 mL/hr

0.05 mg/kg/hr × 60 kg = 3 mg/hr; 3 mg/hr ÷ 2 mg/mL = 1.5 mL/hr.

A drug has an osmolarity of 1500 mOsm/L. If diluted to 500 mL with D5W, what is the approximate osmolarity?

Answer: 750 mOsm/L

1500 mOsm/L × 1 L ÷ 2 (500 mL dilution) → 750 mOsm/L approximate midpoint.

Which personal protective equipment (PPE) item must be sterile when used for compounding Category 2 CSPs in an ISO 5 direct compounding area?

Answer: Sterile gloves

Sterile gloves are the only PPE component that must be sterile, as they directly contact critical sites; other garbing items are non-shed but not sterile.

Which document serves as the official, detailed 'recipe' that must be created for a compounded sterile preparation that will be made more than once, ensuring consistency across different batches?

Answer: Master Formulation Record

The Master Formulation Record (MFR) is the detailed recipe that provides all necessary information to compound a specific preparation, including ingredients, quantities, procedures, and labeling instructions. A Compounding Record, in contrast, is the log created for each specific time a preparation is made, documenting the lot numbers and personnel involved in that particular instance.

You need to prepare 200 mL of a 10% solution using pure drug powder. How much powder (in grams) is required?

Answer: 20 g

10% w/v = 10 g/100 mL; for 200 mL: 10 × 2 = 20 g.

When compounding a 3-in-1 TPN admixture, what is the CORRECT order of component addition to minimize the risk of calcium-phosphate precipitation?

Answer: Dextrose → Phosphate → Amino acids → Calcium → Lipids

Adding dextrose first, then phosphate followed by amino acids and calcium last (before lipids) ensures the components are well-diluted before potentially reactive ions meet.

A CSP label reads 'Vancomycin 1 g/250 mL NS.' A nurse asks what concentration this represents in mg/mL. What is the correct answer?

Answer: 4 mg/mL

1 g = 1,000 mg divided by 250 mL equals 4 mg/mL.

A TPN order calls for 50 mL of 8.5% amino acids. How many grams does this provide?

Answer: 4.25 g

8.5% means 8.5 g per 100 mL. For 50 mL: 8.5 divided by 100 times 50 equals 4.25 g.