Compounded Sterile Preparations Pharmacy Sample Questions

A 503A compounding pharmacy at a health-system centralized compounding facility was inspected by the Food and Drug Administration (FDA) following a complaint. A FDA form 483 was issued to the pharmacy. What is the correct response from the pharmacy?

A hospital pharmacy received a shipment of antineoplastic hazardous drugs. Where should the shipment be unpacked?

Which organization regulates disinfectants by evaluating and registering manufacturer data submitted for microbiocidal activity, stability, toxicity, and contact time for labeling indicated uses?

When preparing a horizontal laminar airflow workbench for compounding a sterile product, compounding personnel should:

Compounding involving only transfer, measuring, and mixing manipulations using not more than three commercially manufactured sterile products and not more than two entries into any container describes what type of compounding risk level?

Which ingredient is incompatible and must not be added to a 3-in-1 parenteral nutrition admixture?

What is the most appropriate delivery route for a parenteral nutrition formulation with an osmolarity of 1,230 mOsm/L?

An emergency department nurse administered pancuronium instead of influenza vaccine to a patient. The patient experienced some respiratory depression but not permanent injuries. After a root cause analysis (RCA), the team determined the causes to be similar size and labels on the vials. Additionally, the look alike vials had been stored adjacent to each other in the refrigerator. What was the most appropriate action plan that resulted from the RCA?

How often must non-high risk compounding personnel demonstrate proficiency through hands-on testing/evaluation?

How often should personnel pass written and media-fill testing of aseptic work skills when working with sterile ingredients?