CSPT Medication and Component Handling 4 — Questions and Answers
Question 1: When receiving a shipment of APIs for sterile compounding, which action is most critical before accepting the materials?
- Verify COA matches the purchase order specifications (Correct answer)
- Immediately transfer materials to the cleanroom
- Check that packaging is visually intact only
- Confirm the delivery driver's credentials
Correct answer: Verify COA matches the purchase order specifications
A Certificate of Analysis (COA) must be verified against purchase order specifications to confirm identity, purity, and potency before accepting any API shipment.
Question 2: Which storage condition is required for most reconstituted protein-based injectable medications?
- Room temperature (20–25°C)
- Refrigerated (2–8°C) (Correct answer)
- Frozen (−20°C)
- Controlled room temperature with desiccant
Correct answer: Refrigerated (2–8°C)
Most reconstituted protein-based injectables require refrigeration at 2–8°C to prevent protein degradation and maintain potency.
Question 3: A technician notices that a vial of vancomycin powder for injection has turned slightly yellow. What is the appropriate action?
- Use it immediately before further discoloration occurs
- Quarantine the vial and report to the pharmacist (Correct answer)
- Mix it and check final solution color instead
- Return it to the shelf if within expiration date
Correct 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.
Question 4: Under USP <797>, which beyond-use date (BUD) category applies to a Category 1 compounded sterile preparation?
- 12 hours at room temperature or 24 hours refrigerated (Correct answer)
- 72 hours at room temperature or 14 days refrigerated
- 12 hours at room temperature or 48 hours refrigerated
- 24 hours at room temperature or 7 days refrigerated
Correct answer: 12 hours at room temperature or 24 hours refrigerated
USP <797> Category 1 CSPs have a BUD of 12 hours at controlled room temperature or 24 hours refrigerated.
Question 5: Which technique is used to transfer a hazardous drug from a vial to a syringe while maintaining negative pressure?
- Drawing air into the syringe equal to the drug volume before insertion
- Using a closed-system drug transfer device (CSTD) (Correct answer)
- Inverting the vial and withdrawing without equalizing pressure
- Venting the vial with an 18-gauge needle before withdrawal
Correct answer: Using a closed-system drug transfer device (CSTD)
Closed-system drug transfer devices (CSTDs) mechanically prohibit the transfer of environmental contaminants and prevent aerosol or liquid escape when handling hazardous drugs.
Question 6: What is the correct order of addition when preparing a TPN (total parenteral nutrition) admixture to prevent precipitation?
- Dextrose, amino acids, lipids, electrolytes
- Amino acids first, then dextrose, electrolytes, and lipids last (Correct answer)
- Lipids, dextrose, amino acids, then electrolytes
- Electrolytes, lipids, dextrose, then amino acids
Correct answer: Amino acids first, then dextrose, electrolytes, and lipids last
Amino acids are added first to buffer electrolytes, followed by dextrose, then electrolytes, with lipids added last to avoid destabilizing the emulsion.
Question 7: A compounding technician is preparing an ophthalmic solution and must filter the preparation. Which filter pore size is appropriate?
- 5 micron
- 1 micron
- 0.45 micron
- 0.22 micron (Correct answer)
Correct answer: 0.22 micron
A 0.22-micron filter is used for sterilization of ophthalmic and other sterile preparations, removing bacteria and particulates.
CSPT Medication and Component Handling 4
When receiving a shipment of APIs for sterile compounding, which action is most critical before accepting the materials?