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Regulatory Compliance Flashcards

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

Read the first 7 Regulatory Compliance flashcards as text

  1. Under the DSCSA, which data elements make up the product identifier on a prescription drug package?

    Answer: NDC, serial number, lot number, and expiration date

    The DSCSA product identifier includes the NDC, a unique serial number, lot number, and expiration date, encoded in a 2D data matrix barcode.

  2. A specialty pharmacy determines that a product it received is illegitimate under the DSCSA. Within what time frame must it notify FDA and affected trading partners?

    Answer: Within 24 hours

    Once a product is determined illegitimate, FDA and trading partners must be notified within 24 hours, typically using FDA Form 3911.

  3. How long must a dispenser keep DSCSA transaction information, history, and statements?

    Answer: 6 years

    The DSCSA requires trading partners to retain transaction documentation for at least 6 years from the date of the transaction.

  4. Which component of a REMS program may require pharmacies to be specially certified before dispensing a drug?

    Answer: Elements to Assure Safe Use (ETASU)

    ETASU can require prescriber and pharmacy certification, documentation of safe-use conditions, and patient monitoring or enrollment.

  5. Under the 2023 revision of USP , what is the maximum beyond-use date for a Category 1 compounded sterile preparation stored in a refrigerator?

    Answer: 24 hours

    Category 1 CSPs have a BUD of no more than 12 hours at controlled room temperature or 24 hours refrigerated.

  6. Under USP , how often must an entity review its Assessment of Risk for hazardous drugs it chooses not to handle with all containment requirements?

    Answer: At least every 12 months

    USP requires the Assessment of Risk to be reviewed at least every 12 months and documented.

  7. A theft of Schedule II drugs is discovered at a specialty pharmacy. What must happen first under DEA rules?

    Answer: Notify the DEA Field Division Office in writing within one business day of discovery

    Registrants must notify DEA in writing within one business day of discovering a significant theft or loss, then complete DEA Form 106.