Medication and Component Handling Flashcards

When receiving a shipment of APIs for sterile compounding, which action is most critical before accepting the materials?

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.

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 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.

Under USP , which beyond-use date (BUD) category applies to a Category 1 compounded sterile preparation?

Answer: 12 hours at room temperature or 24 hours refrigerated

USP Category 1 CSPs have a BUD of 12 hours at controlled room temperature or 24 hours refrigerated.

Which technique is used to transfer a hazardous drug from a vial to a syringe while maintaining negative pressure?

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.

What is the correct order of addition when preparing a TPN (total parenteral nutrition) admixture to prevent precipitation?

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.

A compounding technician is preparing an ophthalmic solution and must filter the preparation. Which filter pore size is appropriate?

Answer: 0.22 micron

A 0.22-micron filter is used for sterilization of ophthalmic and other sterile preparations, removing bacteria and particulates.