CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 2 — Questions and Answers
Question 1: Which of the following is a required element on the label of a compounded sterile preparation?
- The technician personal phone number
- The beyond-use date and time (Correct answer)
- The wholesale acquisition cost
- The name of the drug manufacturer
Correct answer: The beyond-use date and time
The beyond-use date and time must appear on every CSP label.
USP 797 mandates specific labeling elements for all CSPs. The BUD and time communicate the period during which the CSP can be expected to maintain its sterility, stability, and potency. Other required elements include patient name, ingredient names and quantities, total volume, route of administration, and storage conditions.
Question 2: What is the purpose of a Master Formulation Record (MFR) in sterile compounding?
- To track inventory levels
- To provide a standardized formula and procedure for preparing a specific CSP (Correct answer)
- To document employee training records
- To record equipment maintenance schedules
Correct answer: To provide a standardized formula and procedure for preparing a specific CSP
The MFR contains the complete approved formula, equipment, procedure, and quality checks for a specific CSP.
The MFR is a foundational document required by USP 797. It must be reviewed and approved by the designated person before being placed into service. Any changes require formal review and re-approval.
Question 3: What is documented in a Compounding Record (CR)?
- Only the final product weight
- The specific details of each individual batch prepared (Correct answer)
- The annual facility inspection results
- Patient insurance information
Correct answer: The specific details of each individual batch prepared
The CR documents every detail of an individual compounding event: who prepared it, what ingredients and lots were used, quality checks performed, and final product details.
The CR is created each time a CSP is prepared and provides a complete audit trail for that specific batch. It enables full traceability of every component and step involved.
Question 4: How long must compounding records be retained according to USP 797?
- 6 months
- 1 year
- 3 years
- As dictated by state regulations and organizational policy (Correct answer)
Correct answer: As dictated by state regulations and organizational policy
USP 797 requires records be maintained but defers to state pharmacy regulations for specific retention periods.
Most state boards of pharmacy require retention of compounding records for a minimum of 3 years. Many facilities adopt 5-7 years as a conservative approach. Records must be readily retrievable throughout the retention period.
Question 5: What information must be documented when a CSP fails a quality check?
- Nothing, just discard it
- The nature of the failure, corrective actions taken, and disposition of the failed product (Correct answer)
- Only the date of the failure
- Only reported for controlled substances
Correct answer: The nature of the failure, corrective actions taken, and disposition of the failed product
When a CSP fails a quality check, the event must be fully documented including what failed, corrective actions, and product disposition.
Documentation feeds into the facility ongoing quality improvement process. Patterns of failures may indicate equipment problems, training deficiencies, or formulation issues that need systemic correction.
Question 6: What must be included on the label of a CSP intended for a specific patient?
- Patient Social Security number
- Patient name and any other identifiers required by organizational policy (Correct answer)
- Patient full medical history
- Patient insurance policy number
Correct answer: Patient name and any other identifiers required by organizational policy
Patient-specific CSP labels must include the patient name and additional identifiers to ensure correct administration.
Most facilities require a second identifier such as a medical record number or date of birth. Additional required elements include all standard CSP label requirements.
CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 2
Which of the following is a required element on the label of a compounded sterile preparation?