CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 1

Question 1

A technician is preparing a label for a batch of fentanyl 50 mcg/mL PCA syringes for hospital floor stock. Which of the following pieces of information is uniquely required on the label for this batch-prepared CSP?

Accepted Answer

A control or lot number assigned by the pharmacy.

Answer

According to USP <797>, batch-prepared Compounded Sterile Preparations (CSPs) require a unique internal control or lot number. This allows for tracking and potential recall of the entire batch if a problem is discovered. Patient-specific information is not used for floor stock, administration time is determined by nursing, and the prescriber's DEA number is part of the prescription record, not the CSP label.

Question 2

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?

Accepted Answer

Master Formulation Record

Answer

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.

Question 3

A technician is performing a final check on a patient-specific IV bag before it is dispensed. The label includes the patient's name, the drug and concentration, the BUD, and storage instructions. Which one of the following critical pieces of information is missing from this label?

Accepted Answer

The route of administration.

Answer

The route of administration (e.g., 'For Intravenous Use Only') is a mandatory and critical component of a CSP label to prevent potentially fatal administration errors. While information like diluent lot numbers and technician names are documented on the compounding record, the route of administration must be clearly stated on the final label for the person administering the medication.

Question 4

When completing the documentation for a specific batch of sterile preparations, which information would be recorded on the Compounding Record but NOT on the Master Formulation Record?

Accepted Answer

The specific lot numbers and expiration dates of the components used.

Answer

The Master Formulation Record is the static recipe. The Compounding Record documents a specific compounding event. Therefore, the actual lot numbers and expiration dates of the ingredients used for that specific preparation are recorded only on the Compounding Record. This provides traceability for that specific batch.

Question 5

A technician is preparing an IV infusion of paclitaxel, a chemotherapy agent. In addition to the standard CSP label, which of the following auxiliary labels is most critical to place on the final container according to USP standards?

Accepted Answer

"Hazardous Drug - Handle with Care"

Answer

USP General Chapter <800> requires that all dispensed hazardous drugs (HDs) have a label clearly indicating that they are hazardous. An auxiliary label such as "Hazardous Drug - Handle with Care" or a similar warning is essential to alert all healthcare personnel who handle the medication to use appropriate precautions.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 1