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Labeling and Documentation Flashcards

6 cards from real CSPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 Labeling and Documentation flashcards as text

  1. Which of the following is a required element on the label of a compounded sterile preparation?

    Answer: The beyond-use date and time

    The beyond-use date and time must appear on every CSP label.

  2. What is the purpose of a Master Formulation Record (MFR) in sterile compounding?

    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.

  3. What is documented in a Compounding Record (CR)?

    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.

  4. How long must compounding records be retained according to USP 797?

    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.

  5. What information must be documented when a CSP fails a quality check?

    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.

  6. What must be included on the label of a CSP intended for a specific patient?

    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.

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