Labeling and Documentation Flashcards

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?

Answer: A control or lot number assigned by the pharmacy.

According to USP , 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.

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.

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?

Answer: The route of administration.

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.

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?

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

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.

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?

Answer: "Hazardous Drug - Handle with Care"

USP General Chapter 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.

According to USP labeling requirements, which of the following must be clearly displayed on the label of every compounded sterile preparation?

Answer: The beyond-use date (BUD).

The beyond-use date (BUD) is a core requirement for all CSP labels. The BUD indicates the date and time after which the preparation should not be used, ensuring its sterility and stability for patient safety. Other information like cost, supplier, or ISO class is part of facility records but not required on the final patient label.